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Natalie Khawam, Esq, MBA, MS 400 North Tampa Street, Suite 950

Loretta Poston, Esq. Tampa, Florida 33602


Samantha Postlewaite, Esq. Office: 813.944.7853
Javier Soto, Esq. Fax: 813.434.2173

June 28, 2017

Mr. Michael Adelman


VA Healthcare - VISN 4 Director
Department of Veterans Affairs
323 North Shore Drive, Suite 400
Pittsburgh, PA 15212

Re: Written Reply to Notice of Proposed Removal, Dr. Dale Klein


Request for Verbal Reply Opportunity to be made in person at Poplar Bluff, MO

Dear Mr. Adelman, Deciding Official:

On behalf of my client, Dr. Dale Klein, a double Board Certified Pain Management Specialist,
at the John J. Pershing VA Medical Center, Poplar Bluff, Missouri (PB-VAMC), we submit this
response to the May 31, 2017, Notice of Proposed Removal.

The two primary concerns we address in the Notice of Proposed Removal are:

1) The Proposed Removal is continued reprisal against Dr. Klein for making disclosures
involving fraud, waste, abuse of authority, and misuse of resources, mismanagement, and
public safety. The proposed penalty against Dr. Klein is due to him reporting issues with:
patient and health care safety involving controlled drugs, the mismanagement of the
pain management program at the PB-VAMC,
patient safety in managing healthcare related to reentry of physicians into medical
practice,
VISN 15 not acting to address reported wrongdoings at the PB-VAMC,
VHA not acting to address the wrongs at PB-VAMC, and
VISN and PB-VAMC not responding to address the wrongs at Poplar Bluff until an OIG
report substantiated the noted matters reported by Dr. Klein, (however, the VAMC then
submitted false information of only 10 patients being impacted).
Other disclosures made including the reentry process required for the medical
practitioner status, for Dr. Klein, based on PB-VAMC Officials isolating Dr. Klein and
removing his privileges for over a year.
2) The Proposed Removal is not supported, does not follow required VA Standards of
Practice and violates protections for Bargaining Unit Employees (BUE). Management at the
PB-VAMC ordered Dr. Klein to put VA patients at the risk of harm through managements actions
of degrading his specialty currency status, amid mitigation factors that remove the penalty
proposed from being applied in this matter Article 17, Master Collective Bargaining Agreement
(MCBA), and the Follow the Rules Act at P. Law 115-40, the Whistleblower Protection
Enhancement Act (WPEA). This was done with reckless disregard to the harm caused by keeping
Dr. Klein away from his medical practice of pain management and patient care for over a year.
For the past year, Dr. Klein has repeatedly tried to mitigate the degradation of his medical practical
skills due to his forced removal from medical practice by the PB-VAMC management. Yet, the
PB-VAMC has continued its reprisal on Dr. Klein by either denying and refusing to accommodate
his requests to continue to see patients, for time off to take Continuing Medical Education (CME)
courses, and to work remotely or telework to review patient cases for pain consults (also suggested
to ease the extremely hostile atmosphere the PB-VAMC has created around Dr. Klein).
The PB-VAMC has repeatedly ignored physician reentry concerns, amid their own counsels
warnings about Dr. Kleins reentry issues. Not to mention, Dr. Nair, the Chief of Staff at PB-
VAMC, has stated in a sworn statement that there was no work for Dr. Klein to be ordered to
perform at PB-VAMC and that his skills were of no use to the PB-VAMC, showing that the PB-
VAMCs concerns were contradictory and potentially made in bad faith. A review of Dr. Nairs
sworn statement alone indicates that the proposed removal of Dr. Klein is not just a farce, but also
an indication that the shared concerns of Dr. Nair and Dr. Klein for patient safety, and reporting
of the same, led to the proposed removal. Further, that all evidence is constructed by those listed
in EEO complaints and represent supported Prohibited Personnel Practices against Dr. Klein.
In addition, the proposed removal was provided contrary process/CBA (as delivered, no
representative copied), and did not identify a deciding official until June 13, 2017.

Background

Dr. Klein cares deeply for Americas Veterans. He has built his career by advocating for
patients that endure pain from tragic, complex injuries and medical ailments. His skills and drive
are needed in the VA system. No doubt, his credentials and expertise in pain management was
what attracted the VA to retain Dr. Klein as the first Director of the Poplar Bluff VA Medical
Center Pain Management Clinic (PMC). Prior to employment with the PMC, in the private sector,
Dr. Klein was a highly credentialed pain management consultant, having been offered a pain
management position with earnings at over $750,000 a year.
Since he became employed as a pain management specialist at PB-VAMC, Dr. Klein
immediately noticed the subpar pain management program at the PB-VAMC that did not meet
medical guidelines for patient safety, nor the legal guidelines for controlled substances use in such
a program. He has worked towards, and worried over, achieving the wellbeing of his patients and
the patients assigned for pain consults to provide the best care possible to our Veterans. One of
Dr. Kleins concerns was that he never received promised resources and law adherence on Opioid
uses at the PB-VAMC, which are necessities to run the PMC. In a VA Office of Inspector General

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(OIG) report, a sampling was taken of the 25,000 pain management related patients, and revealed
gross violations of patient safety rules related to Opioids and other controlled substance protocol
violations, at the VAMC which was a direct result of Dr. Kleins complaints to and against
officials at senior levels at VAMC and VISN. (https://www.va.gov/oig/pubs/VAOIG-16-01077-
255.pdf).
Further, Dr. Klein reported other gross violations of policy, rules, regulations, laws, and
mismanagement and abuse of authority, that have been founded. Some of the violations include,
gross mismanagement of the PMC program by supervisory medical staff at Poplar Bluff VA
Medical Center (including his direct supervisor, Dr. Krishnan and the chief of staff, Dr. Nair) as
concluded as supported by the Office of Special Counsel (OSC). Most of the management officials
over Dr. Klein at PB-VAMC and witnesses listed to the deciding official as supporting the PMCs
proposed removal have been named in Equal Employment Opportunity (EEO) and OSC
Complaints by Dr. Klein including the proposing official. The impact and awareness of Dr.
Kleins disclosures, due to media coverage, is wide spread over the entire VA (VHA) to include
every VISN, which is also alleged to have resulted in this proposed removal rather than legitimate
reasons offered by the same.
The proposed action to terminated Dr. Klein simply constitutes continued acts of reprisal by
the PB-VAMC. Dr. Klein, prior to these acts of the PB-VAMC, had a stellar record with no
discipline. It was only after Dr. Kleins disclosures that he was put before a review board (not for
patient care) which ended with the PB-VAMC terminating him while on probation. However,
the PB-VAMCs decision to terminate Dr. Klein was prevented by the OSC with the Merit Systems
Protection Board (MPSB) issuance of a Stay, while the OSC investigated his disclosures. Then,
based on an investigation of Prohibited Personnel Practices taken against Dr. Klein by the PB-
VAMC and management staff -- including Dr. Nair, the proposing official -- the OSC issued a
Prohibited Personnel Practices (PPP) Report in which several of Dr. Kleins disclosures were
determined to be founded.
It was after the OSCs issuance of the PPP Report that the PB-VAMC decided to keep Dr.
Klein after the MSPBs Stay expired. However, now instead of helping Dr. Klein return to duty,
the PB-VAMC engaged in more acts of reprisal, and in the anomalous practice of denying a proper
reentry process to Dr. Klein. Without the proper reentry process, the PB-VAMC is forcing
him to violate law, medical oaths, and VA handbooks and regulations. The reentry process is
designed to prevent doctors that have been away from practice for a period of time from providing
care or treatment to patients that may result in patient harm. By the PB-VAMC assigning clinical
work to Dr. Klein without the proper reentry process, including clarifying he had in fact been
re-credentialed (after removing his credentialing after the initial termination attempt) to perform
medical procedures at the PB-VAMC, and failing to provide an assessment of his currency to
practice in his specialties, Dr. Klein has been subjected to continual reprisal for his disclosures.

3
The reprisal and bad faith of the PB-
VAMC go even further than denying Dr.
Klein the proper reentry process. The
PB-VAMC has claimed it ordered Dr.
Klein to see patients and that there were
patients waiting to be seen by Dr. Klein.
However, there is evidence to show the
PB-VAMC never intended to assign pain
consults to Dr. Klein. In fact, the evidence
shows that the PB-VAMC never intended,
and has made no attempt, to schedule
patients for pain consults at Poplar Bluff
since the beginning of this year (2017),
even before asking Dr. Klein to take start
seeing patients. (See right).
In sum, the PB-VAMC was found to
have reprised against Dr. Klein for
escalating trivial matters up his chain of
command. Now, they are reprising against
him for escalating serious matters up the
chain of command, including patient
safety and physician reentry process.
The previous Stays issued by the MPSB, at the request of the OSC exemplifies the intricacies
of this matter and the mendacity of the charges brought forth in this instant proposal to remove Dr.
Klein, amid a cloud of uncertainty as to his credentialing, and the PB-VAMC refusing to clarify
to Dr. Klein, or his representatives if he is even credentialed to practice medicine at PB-VAMC.
(See, attached). Additionally, the Stays were issued amid Dr. Klein finding falsified documents
in his eOPF showing that somehow during his fired and removed time period, for which his
medical privileges were removed, he was marked as fully successful as though he was allowed to
perform his duties. Such a violation of Title 18 U.S.C 1001 provides a criminal offence amid the
patient safety issues at hand for the falsified documents.
Jurisdiction of Deciding Official Disputed
Dr. Klein has reported actions by VISN 15 individuals that oversee PB-VAMC personnel in
complaints to VA OIG, and other authorities, and complained to VHA and VACO officials about
the same. VISN 4 officials are overseen by VHA and VACO. VISN 15 officials are supervised by
VHA and VACO. VISN 15 officials had to seek approval of VACO to get another VISN to decide
this matter. Therefore, there is a question of bias in the arrangement made here. Further, Dr. Klein
is a VISN 15 employee. Dr. Klein is not hired by or supervised by any other VISN or VA Medical
Center and he is not credentialed to practice medicine in any other VISN or VA Medical Center.
As such, having a VISN 4 official act as deciding official for a VISN 15 employee is challenged
as not having property authority and for improper line of supervision authorization and process,
creating bias and singling out Dr. Klein to VISN 4. Such a decision would normally be handled
at the VAMC level. The extraordinary step taken here outside of normal procedures does not
remove a cloud of controversy from this matter, but rather adds to the controversy, in addition
to other parties being brought in. (e.g., VA Handbook 5005/17, June 15, 2006; VA Handbook

4
5021/19, December 17, 2015, authority for decisions may be delegated downward). Involving
another VISN shows there is something wrong with the process, because it exposes Dr. Klein to
more negative attention outside his line of supervision. Not to mention, Dr. Adelman is not a pain
management specialist, and as such, the evidence relating to this matter regarding re-entry of Dr.
Klein to medical practices and the intricacies of Dr. Kleins specialty in doing so may be more
appropriately heard by a deciding official familiar with this specialty area. Additionally, the
evidence submitted by PB-VAMC was created by the management of PB-VAMC, and the
designated deciding official is not the appropriate individual, especially because Dr. Klein was
denied the opportunity to develop his own evidence, such as obtaining copies of his government
emails, his clinical records, and so forth.
Bias Created by PBVAMC in Process
On June 21, 2017, the PB-VAMC sent emails containing receipts from what it claims are
attempts to serve Dr. Klein a copy of the evidence file, despite Dr. Klein being employed at the
PB-VAMC and reporting to the PBVAMC physically such that the evidence file could have easily
been served in person. The emails were copied to Mr. Adelman, the deciding official. The emails
contain additional information and documents that were not included in the evidence file and
were detrimental to Dr. Kleins sufficient review and represent facts not in the proposed removal
as charges. (Evidence file delivery dispute or not being available, or no ability to serve an evidence
file with HR representative representing Dr. Klein in negative light). The additional information
and documents sent by the PB-VAMC has created bias to the deciding official and is objected to
as a critical due process error. Dr. Klein was not allowed to respond to the delivery issue, rather
the PBVAMC labor specialist took it upon himself to accuse and charge the delivery process
against the employee without it being part of the proposal, tainting this decision process.
Employees have a right to due process and to have an unbiased decision-maker adjudicate their
case. A due process violation may occur if the agency allows an individual's basic rights to be
determined by a biased decision-maker or in a way that the risk of unfairness is intolerably
high. Svejda v. Department of Interior, 81 FMSR 5376 (MSPB 1981). In Boddie v. Department
of the Navy, 87 FMSR 7046 (Fed. Cir. 1987), the Federal Circuit held that an agency committed
harmful error when it failed to follow its internal disciplinary procedure requiring discipline to be
effected at the lowest practical supervisory level. It appears such due process violations have
occurred here as discussed above. In this matter, the VHA is promoting it cant manage this matter
within VISN 15, or at Poplar Bluff VAMC. This is highly irregular, and it indicates further process
violations and bias. Such irregularities and process violations, are detrimental to the fairness of
this process, and adds to the iniquitousness that Dr. Klein has consistently brought to attention
since he was initially removed. More specifically, the PB-VAMC was made to rehire Dr. Klein,
and then the PB-VAMC gave up and relented by giving up on removing him because it was
found to have committed a prohibited personnel practice. Then the PBVAMC turns around, and
now seek to remove him, after creating the circumstances of the present safety issues. Simply,
PBVAMC refuses to address its problems and farming out decisions as a scheme to avoid liability
does not resolve the issue at hand created by the PB-VAMC a deal of proper reentry for Dr. Klein
and avoidance of self-created patient safety issues.
Further, Dr. Klein, is entitled to Weingarten rights. He was denied these rights by the Associate
Director in admitted contact over the matter of the Stay and termination. Therefore, any
conversation occurring between Barlage and Klein is against the Labor Statute, and Unfair Labor
Practice.

5
Agency Reasons for Removal are Unlawful
The proposed removal contains direct evidence that the Agencys pretextual reasons
for removing Dr. Klein are his persistent disclosures and opposition to the Agency's failure to fully
comply with laws pertaining to controlled substances, PB-VAMC staff turning a blind eye to
patient controlled substances diversion schemes, PB-VAMC staff endangerment of patient safety
by violation of controlled substance protocols, CARA Act violations, violations of VA Patient
Safety Policy rules, regulation violations related to patients treated for pain, and employment
related regulatory matters concerning medical safety practices governed by law.
According to VA Policy the Order Must be Proper
(VA Handbook 5025/15, Table of penalties, Item #19, Orders)
In the instant matter, Dr. Klein reports wrong doings, again potential harm to Veterans from
forcing him into unsupervised patient care roles without clarifying his credentialing or assessing
his skills, despite his not meeting the credentialing requirements of his specialties because of what
the Poplar Bluff VAMC Officials did to him in violation of prohibited personnel practices. Dr.
Klein attempted to mitigate the detrimental effect of the PB-VAMC removing his medical
privileges in March 2016 on his physician and pain management skills by attempting to gain
permission to perform CMEs, and other training. However, the PB-VAMC denied these requests.
Removing Dr. Klein from patient care, patient interaction, medical practice, and reviewing patient
charts, left Dr. Klein in a state of diminishing ability to keep currency in his specialties, and no
longer able to serve in the capacity he was prior to the PB-VAMCs reprisal, without proper reentry
process. In short, based on medical industry requirements, federal law, and common sense, any
instructions from PB-VAMC for Dr. Klein to see patients (to date not defined by the PB-VAMC)
is improper and not a valid instruction. The suggestion to see patients creates a harassing and
hostile atmosphere, and is intended as reprisal not as a constructive manner of resolving the
critical patient safety issue created by the PB-VAMCs harmful actions against Dr. Klein.
First, as a medical provider PB-VAMC and VHA should know better and more hold the
standard of care provided to Veterans in a higher regard. The medical literature reflects that
removal of a doctor from medical practice causes negative effects on a doctors ability and
confidence. More so, the impact is increased the longer a doctor is out and the complexity of
the medical skills involved. This is well known in the U.S. Armed Forces, where specialty
doctors deploy for prolonged periods away from the specialties to perform combat medical
support roles:
US Army pediatricians are required to deploy for extended periods of time and have limited
opportunities to practice the full range of their pediatric skills. This break in clinical practice is
associated with a significant decline in perceived comfort with both routine and acute pediatric
care.1
Further, all studies by the National Institutes of Health, and the Department of Defense,
consistently find in the following principle: [t]here was significant perceived degradation in both
the surgical and clinical skills of those deploying for >6 months, and the degradation was
correlated with the length of time deployed. Most surgical specialists felt that it took them 3 to 6

1
Facilitating physician reentry to practice: perceived effects of deployments on US army pediatricians' clinical and
procedural skills. Braun L, Sawyer T, Kavanagh L, Deering S. J Continuing Education Health Prof. 2014 Fall;
34(4):252-9. doi: 10.1002/chp.21256. PMID: 25530295

6
months to return to their clinical and surgical performance baseline upon returning from a
deployment and that 6 months was the most amount of time they could be deployed without a
significant decrement in skills.2 Moreover, degradation is seen in doctors on family medicine that
deploy away from their normal course of practice: [f]amily physicians deploying to support
combat operations feel less comfortable with critical clinical skills across the spectrum of care.
Refresher training could be provided with standardized approach to these needs with a goal of
maintaining full scope primary care providers.3 Lastly, a study on degradation of physician skills
focused on three areas - the impact of time and length of break from practice, how this impact
differs by type of practice, and mitigating factors for any diminution or loss of skills, which found:
(Perez et al, 2013; Arthur et al, 1998, Wisher et al, 1995; Goodwin, 2006; Leonard
and Martin, 2007; Sanders, 2001) The reviews surmise that long periods of non-
use lead to skills fade and that skills fade differs according to the individual, the
context and the type of task cite[ing] Arthur et als 1998 finding that: after 365
days of non use or non-practice, the average participant's performance was
reduced by almost a full standard deviation {d = -0.92).4
Moreover, 6 months appeared as the average time for skill degradation to be noticed (based on
a study of Canadian doctors on maternity leave),5 and another study, Stromski et al (2005)
measuring retention of cricothyroidectomy skills (in emergency residents at 2 months and again at
up to 18 months since training (n 17). The research found significant decline between the two
periods.6 Still more, a large number of studies on adult Advanced Life Support (ALS) show that
knowledge and skills decay at six months to a year from training and that skills decline faster than
knowledge (Yang et al, 2012; Mohammad et al, 2014).7 Yet even more, Smith, Gilcreast and
Pierce (2008) evaluate nurses advanced cardiac life support (ACLS) and basic life support (BLS)
skills after 3, 6, 9 and 12 months in a repeat measures study. They find that whilst nurses retained
the theoretical knowledge from their training, their skills in performing ACLS and BLS degraded
quickly. They also found that ACLS skills degrade faster than BLS skills with 63% passing BLS
at 3 months and 58% at 12 months. Only 30% of participants passed ACLS skills at 3 months and
14% at 12 months.8 They cite earlier studies (outside of the date range of this review) that have
also demonstrated that resuscitation skills fade fast. Yet more, Madden (2006) reports on retention
of CPR skills in 18 Republic of Ireland nursing students. At four months since CPR training
students had significant deterioration in knowledge and psychomotor skills, consistent with earlier
studies.9

2
Perceived effects of deployments on surgeon and physician skills in the US Army Medical Department, 1: Deering
SH, Rush RM Jr, Lesperance RN, Roth BJ., Department of Obstetrics and Gynecology, Andersen Simulation
Center, Madigan Army Medical Center, Uniformed Services University of the Health Sciences, University of
Washington School of Medicine, Tacoma, WA, USA. Am J Surg. 2011 May;201(5):666-72. doi:
10.1016/j.amjsurg.2011.01.006. PubMed PMID: 21545919.
3
Perceived Clinical Skill Degradation of Army Family Physicians After Deployment, Tyler R. Reese, MD; Shad H.
Deering, MD; Laurie B. Kavanagh, MPH; Douglas M. Maurer, DO, MPH; Society of teac hers of Family Medicine;
See: http://www.stfm.org/FamilyMedicine/Vol47Issue5/Reese343, Last checked June 21, 2017).
4
Skills fade: a review of the evidence that clinical and professional skills fade during time out of practice, and of
how skills fade may be measured or remediated, Oates, Jennifer Louise, General Medical Council, 2014 (UK).
5
Id.
6
Id.
7
Id.
8
Id.
9
Id.

7
Interventional pain management or interventional pain medicine is a medical subspecialty
which treats pain with invasive interventions such as facet joint injections, nerve
blocks (interrupting the flow of pain signals along specific nervous system pathways),
neuroaugmentation (including spinal cord stimulation and peripheral nerve, stimulation),
vertebroplasty stimulation), vertebroplasty kyphoplasty, nucleoplasty, endoscopic discectomy and
implantable drug delivery systems.10 The specialty of Pain Medicine, or Algiatry, is a discipline
within the field of medicine that is concerned with the prevention of pain, and the evaluation,
treatment and rehabilitation of persons in pain. Some conditions may have pain and associated
symptoms arising from a discrete cause, such as postoperative pain or pain associated with a
malignancy, or may be conditions in which pain constitutes the primary problem, such as
neuropathic pains or headaches.11 This may encompass: Caudal epidural injections, Lumbar
interlaminar epidural injections, Lumbar/sacral transforaminal epidural injections, Cervical
epidural injections, Thoracic epidural injections, Lumbar/sacral medial branch and L5 dorsal
ramus blocks, Cervical medial branch blocks, Thoracic medial branch blocks, Lumbar/sacral facet
joint nerve radiofrequency neurolysis, Cervical medial branch radiofrequency neurolysis, Thoracic
medial branch radiofrequency neurolysis, Sacroiliac joint injections, Cervical sympathetic blocks,
Lumbar paravertebral sympathetic blocks, Intercostal nerve blocks, Lumbar discography, Celiac
plexus blocks (not Splancnic nerve blocks), Percutaneous epidural adhesiolysis, Spinal cord
stimulation lead placement, and other. Pain Medicine Specialists use a broad-based approach to
treat all pain disorders, ranging from pain as a symptom of disease to pain as the primary
disease. The pain physician serves as a consultant to other physicians but is often the principal
treating physician (as distinguished from the primary care physician) and may provide care at
various levels, such as treating the patient directly, prescribing medication, prescribing
rehabilitative services, performing pain relieving procedures, counseling patients and families,
directing a multidisciplinary team, coordinating care with other health care providers and
providing consultative services to public and private agencies pursuant to optimal health care
delivery to the patient suffering from pain. The objective of the pain physician is to provide quality
care to the patient suffering from pain. The pain physician may work in a variety of settings and is
competent to treat the entire range of pain encountered in delivery of quality health care.12 Pain
Medicine specialists typically formulate comprehensive treatment plans, which consider the
patients' cultural contexts, as well as the special needs of the pediatric and geriatric populations.
Evaluation techniques include interpretation of historical data; review of previous laboratory,
imaging, and electrodiagnostic studies; assessment of behavioral, social, occupational, and
avocational issues; and interview and examination of the patient by the pain specialist.13
In this matter, the PB-VAMC created the health and safety concerns not Dr. Klein. The PB-
VAMC intentionally committed prohibited personnel practices that it knew would lead to a
practitioner losing skills and know-how in a highly regulated and skilled area.
The concerns by Dr. Klein are not made up, and are creditable, and are very well-defined
safety protocols, rules, regulations, and serious concerns of safety being ignored (see instructions
provide on September 20, 2016, Back in the Saddle Again: Credentialing Conundrums

10
American Society of Interventional Pain Physicians (ASIPP.org) Website
11
American Board of Pain Medicine website (ABPM.org).
12
Id.
13
Id.

8
Surrounding the Reentry Physician, at the Education Conference & Exhibition, by Elizabeth J.
Korinek, MPH, of the National Assn of Medical Staff Services):

9
Despite this process being
straightforward, the consistent, persistent,
denial by VHA, of its OWN PATIENT
SAFETY GUIDELINES, and medical
literature, on simplifying reentry,
demonstrates a VHA bias against Dr. Klein
who is not an ordinary physician, rather a
specialist. The VHA is arguing that Dr.
Klein should begin treating patients, issuing
drugs, making complex diagnosis, after not
seeing a patient in over a year. NO
HOSPITAL IN AMERICA would allow,
without proper assessment of currency in
practice, and reentry process, for purposes
of organization liability, and patient safety,
under such circumstances, for a doctor to simply resume seeing patients. See attached.

First, the PB-VAMC ITSELF created and promulgated the argument that Dr. Klein could
not see patients for over a year based on safety concerns, and the VAMC is not addressing its
own concerns noted below, as argued by the Agencys own counsel, in assigning Dr. Klein to
simply report back to work as a specialist in pain management, without benefit of reentry process:

REASONS VAMC REFUSED TO ALLOW DR. KLEIN TO PRACTICE MEDICINE


Since the Poplar Bluff facility no longer maintains a full-time Pain Management Clinic,
it is expected that the number and frequency of Pain Management consultation requests
from other providers will be relatively limited. (Agencys RESPONSE [TO] THIRD
REQUEST FOR EXTENSION OF STAY OF PERSONNEL ACTION on November 2,
2016)
It is not expected that Dr. Klein will be engaged in these matters for a full eight-hour day
every workday. (Agencys RESPONSE [TO] THIRD REQUEST FOR EXTENSION OF
STAY OF PERSONNEL ACTION on November 2, 2016)
Reestablishing and staffing a pain management clinic, where none presently exists, and
then getting patients scheduled, is also not a realistic option. (Agencys August 15, 2016,
letter to the MSPB and OSC in response to the Boards Order on July 18, 2016)
While Dr. Klein does meet the minimum requirements to be considered for appointment
or detail to a primary care or urgent care position, asking a clinician who has, since he
completed his internship in 1998, focused exclusively on the practice of the specialties of
anesthesiology and/or pain management is not fair to Dr. Klein or his potential patients.
(Agencys August 15, 2016, letter to the MSPB and OSC in response to the Boards Order
on July 18, 2016)
To the extent, Dr. Klein is concerned that his clinical skills as an Anesthesiologist or Pain
Management Specialist will deteriorate through non-use or inactivity, working in a
Primary Care or Urgent Care setting will do nothing to alleviate the problem. (Agencys

10
August 15, 2016, letter to the MSPB and OSC in response to the Boards Order on July 18,
2016)
Telling him to now practice medicine in either Primary Care or Urgent Care would be
unfair to both Dr. Klein and his patients. The potential for a clinical error or omission
would adversely affect our veterans. (Declaration of Chief of Staff, Dr. Nair, on August
12, 2016 attachment to Agencys August 15, 2016, letter to the MSPB and OSC in
response to the Boards Order on July 18, 2016)
I have considered the possibility of modifying the nature and scope of the duties of any
of our existing physician positions to accommodate the specific clinical skills of Dr. Klein.
I have concluded this is simply not practicable. (Declaration of Chief of Staff, Dr. Nair,
on August 12, 2016 attachment to Agencys August 15, 2016, letter to the MSPB and
OSC in response to the Boards Order on July 18, 2016)
Our Medical Center does not perform any surgical procedures that require the
administration of anesthesia and we no longer have a pain management clinic.
(Declaration of Chief of Staff, Dr. Nair, on August 12, 2016 attachment to Agencys
August 15, 2016, letter to the MSPB and OSC in response to the Boards Order on July 18,
2016)
There is simply nothing for Dr. Klein to do unless we take on the enormous task of
expanding the nature and scope of the clinical services provided at this facility.
(Declaration of Chief of Staff, Dr. Nair, on August 12, 2016 attachment to Agencys
August 15, 2016, letter to the MSPB and OSC in response to the Boards Order on July 18,
2016)
OSCs request to restore Dr. Klein to his official positon of record, with all the attendant
duties, is simply not practicable in view of the closure of the clinic where Dr. Klein
worked. (Agencys RESPONSE TO U.S. OFFICE OF SPECIAL COUNSELS INITIAL
REQUEST FOR STAY OF PERSONNEL ACTION on May 31, 2016)
Even if the Board should determine that it has the authority to overturn the Agencys May
28, 2016, action to separate Dr. Klein, it is not practicable, or even possible, to restore
him to the duties he was performing prior to the actions which led to his separation.
(Agencys RESPONSE TO U.S. OFFICE OF SPECIAL COUNSELS INITIAL
REQUEST FOR STAY OF PERSONNEL ACTION on May 31, 2016)
The Director and Chief of Staff at the John J. Pershing VA Medical Center had already
determined, prior to the OSCs request for a stay, that the VA Medical Center lacked
sufficient resources to properly support a pain management clinic and, therefore, closed
the clinic. (Agencys RESPONSE TO U.S. OFFICE OF SPECIAL COUNSELS
INITIAL REQUEST FOR STAY OF PERSONNEL ACTION on May 31, 2016)
Even if the OSC had never become involved in this matter, there would be no action
contemplated by the Agency to find someone to replace Dr. Klein or to attempt to keep the
clinic where he worked open for the treatment of patients. (Agencys RESPONSE TO
U.S. OFFICE OF SPECIAL COUNSELS INITIAL REQUEST FOR STAY OF
PERSONNEL ACTION on May 31, 2016)
Thus, if it is the ultimate decision of the Board that Dr. Klein should be returned to

11
employment with the Agency, it will not be possible to reassign him to the Pain
Management Clinic where he was formerly employed. (Agencys RESPONSE TO U.S.
OFFICE OF SPECIAL COUNSELS INITIAL REQUEST FOR STAY OF PERSONNEL
ACTION on May 31, 2016)

At the heart of the OSC request to extend the stay is a hope that Dr. Klein can somehow
be restored to his former position as a pain management physician at a facility that does
not have any present need or use for a physician with his skills and privileges. (Agencys
Response to Petitioner's Stay Extension dated 6/30/2016 on July 7, 2016

. . . the only way for the Agency to utilize Dr. Klein as a clinician at the Poplar Bluff
facility is for the Agency to re-establish a Pain Management Clinic so that he could,
essentially, return to his previous role at the Agency. Agencys RESPONSE TO U.S.
OFFICE OF SPECIAL COUNSEL'S SECOND REQUEST FOR EXTENSION OF STAY
OF PERSONNEL ACTIONS on September 2, 2016)
The above was made in sworn statements and assertions purported to true assertions by the
Agency, including, but not limited to, Dr. Nair, the PB-VAMC leadership, and even the VISN 15,
to the Office of Special Counsel (OSC), and the Merit Systems Protection Board (MSPB).
Therefore, based on the above, Dr. Klein is forced to question messages that, [h]e is needed
immediately, patients want to see him, and that the hospital wants to know when he can start
seeing patients amidst Dr. Klein requesting for clarification as to whether he is credentialed at
the VAMC and the Agency providing no response to this request. All the while, Dr. Klein is being
ordered to perform as a physician with no response to his reasonable and repeated inquiries about
updating his currency in practicum in response to agency notations to MPSB about his out of
practice status and his absence from the practice of his subspecialty. Yet, all senior management
at the VAMC Director, Associate Director, Chief of Staff, and his immediate supervisor go silent
as to credentialing and training. The present confusion is created by the VAMC management. Dr.
Klein has asked for clarification and received no orders or guidance.
With respect for the complexity of the practice that Dr. Klein engages in,14 it seems the PB-
VAMC all of a sudden wishes to serve our nations Veterans, start a pain management clinic, has
pain patients waiting to be seen, and has a need through our clients expertise, which it diminished
for over a year, without paying attention to the risks created by sidelining our client for over a year.
In consult with various VA doctors, VA Handbooks, and advice by medical credentialing
associations, it is critical that Dr. Klein seek proper reentry process due to the PPPs impacting
his practitioner abilities. The health and patient care issues disclosed, found and not corrected,
presents a danger to Veterans (patients) and legal jeopardy to the VA Hospital. Specifically, in
this case, we have a doctor that has not performed interventional pain medicine for over a year,
being asked by a chief of staff to perform complex analysis and procedures involving pain and

14
Benefits and Risks of Opioids in Arthritis Management, Michael Clark, MD, MPH, see:
https://www.hopkinsarthritis.org/patient-corner/disease-management/benefits-and-risks-of-opioids-for-chronic-pain-
management/, last checked June 12, 2017; Bioethics in Practice The Ethics of Opiate Use and Misuse from a
Hospitalists Perspective, Marianna Maumus, MD, see: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4482551/,
last checked June 13, 2017.

12
complex analysis and procedures involving pain and intervention procedures for managing pain
for complex medical musculoskeletal, psychological, and nerve conditions without assessing the
level of practicum Dr. Klein can provide after being kept away from the practice and care of
patients for over a year.
In proposing to remove Dr. Klein, the Agency will be doing both itself and its patients
(Veterans), a great disservice. The only pain management specialist at the VAMC, Dr. Klein, amid
grave consequences and possible irreparable harm if a patient is harmed, spelled out by his
certifications and the required oaths, Federal and state law, and VA Handbooks for which he was
hired, who simply wants to work within the law and the rules for pain management, is being fired
for reporting serious and gross violations of law, to which the Collective Bargaining Agreement,
federal law, and MSPB case precedent, allow room for the employee to not participate in. He
simply wants a reentry process that safeguards patient safety so he does not harm a patient. Dr.
Klein wants to practice with patient safety and care as a priority.
Obedience is the cornerstone of the efficiency of any service. The exception to this rule in
Federal employment pertains to situations where obedience would place the employee in a clearly
dangerous situation, or when complying with the order would cause him irreparable harm, see:
Cooke v. U.S. Postal Service, 95 FMSR 5142, 67 MSPR 401 (MSPB 1995); Parbs v. U.S. Postal
Service, 107 LRP 71367, 107 MSPR 559 (MSPB 2007); Pedeleose v. Department of Defense and
Office of Personnel Management, 109 LRP 7818, 110 MSPR 508 (MSPB 2009).
Also, under 5 U.S.C. 2302(b)(9)(D), agencies cannot take or fail to take, or threaten to
take or fail to take, any personnel action against any employee or applicant for employmentfor
refusing to obey an order that would require the individual to violate a law, rule, or regulation
(as noted by the recently enacted Follow the Rules Act). For example, in terms of statutes (laws),
the following have been held as improper orders by the MSPB: Orders to store classified
information on insufficiently secure systems, Special Counsel ex. rel Hickey v. Department of
Homeland Security (2013) (nonprecedental); Orders that would result in the violation of laws
pertaining to the certification of travel vouchers, Davis v. Department of Defense (2006); Orders
to make Social Security disability claim awards higher than what is appropriate, Krafsur v.
Davenport (2013); Orders to backdate a signature on credit card transaction documents, Dick v.
Department of Health and Human Services (2014) (the MSPB judge in this case assumed that
the refusal to carry out such an order could be construed as therefusal to obey an orderto
backdate his signature in violation of law).
Dr. Klein did not have an order to perform physician duties. He was asked if he would
perform duties. In fact, Dr. Klein several times asked if the requests were an Order for
clarification and to not be insubordinate. However, if such an Order was given, it was improper.
First, 18. U.S.C. 1001, provides: whoever, in any matter within the jurisdiction of the
executive, legislative, or judicial branch of the Government of the United States, knowingly and
willfullyfalsifies, conceals, or covers up by any trick, scheme, or device a material fact; makes
any materially false, fictitious, or fraudulent statement or representation; or makes or uses any
false writing or document knowing the same to contain any materially false, fictitious, or
fraudulent statement or entry; shall be fined under this title, imprisoned not more than 5 years
Dr. Klein was being asked to falsely represent his credentials as updated and proper for pain
management services and anesthesiology, in seeing patients when the PBVAMC would not even
give him a copy of his credentialing through a Freedom of Information Act request (highly

13
unusual). Second, 21, U.S.C. 841-843, relates to criminal violations for controlled substance
offenses and, 21, U.S.C. 822, 823 which governs registration for doctors that dispense controlled
substances and requires strict adherence to controlled substance laws. Noted is that 21, U.S.C.
823 provides that action may be taken against practices and individuals noted as performing
actions that may be found not relevant to and consistent with the public health and safety.
In addition, under 21 U.S.C. 824, suspension or removal of a Drug Enforcement
Administration (DEA) certificate may be made when there is imminent danger to the public
health or safety due to the failure of the registrant to maintain effective controls against
diversion or otherwise comply with the obligations of a registrant under this subchapter or
subchapter II, there is a substantial likelihood of an immediate threat that death, serious bodily
harm, or abuse of a controlled substance will occur in the absence of an immediate suspension of
the registration. Dr. Klein, as a licensed physician, is required to follow the law.
VA OIG report, dated June 1, 2017, outlines founded violations against the PB-VAMC
concerning Opioids (controlled substances). Dr. Klein does not wish to participate in violations
of Federal controlled substance laws which is why he reported this matter. This confirms the
issues noted above. Dr. Klein is entitled to not participate in violations of controlled substance
laws and subject himself to criminal penalties. The VA simply said this matter involved 10 patients
founded by the OIG. However, OIG sampled 10 patients, out of 25,000 at the VAMC. Therefore,
the concerns for violations of law are real, and have been founded, as reported by Dr. Klein, at VA
OIG.
Additionally, rules and regulations are matters an employee must adhere to when they may
result in violations of said rules or regulations, or cause harm. The MCBA, Article 17, 11-13,
makes it clear that a refusal to obey an unlawful order will not subject the employee to disciplinary
action, adverse action, or major adverse action, and that employees are authorized to request and
obtain clarified orders. Further, it is a prohibited personnel practice at 5 U.S.C. 2302(b)(9)(d) to
discipline an employee under these circumstances e.g., refusing to follow orders that will cause
a violation of law or safety violations that can lead to harm. See Also: Public Law 115-40 (Follow
the Rules Act) (employees have right to refuse Orders that require the employee to disobey rules,
regulations, and laws).
Dr. Klein requested clarification of whether he was being ordered to violate federal law and
regulations related to his specialty, pain management, which involves use of controlled substances.
As such, his concern is that he will made liable for criminal and administrative charges, from DEA,
under 21 C.F.R. 1306.04, 1306.07, 1306.11, 1306.12. These regulations pertain to
prescription practices for controlled drugs, amid them: using prescriptions for legitimate purposes,
ensuring the prescription is issued in the proper course of professional practice, and determinations
related to pain management prescriptions are properly rendered (the latter would fall on Dr. Kleins
qualifications for the VAMC). Moreover, Dr. Kleins duties are governed by VA Handbook
1108.01, November 16, 2010, which outlines VHA policy and regulations, and corresponding
DEA regulations and rules on use of controlled substances, including operating an Opioid
treatment program. It is noted that [p]ain experts at VA say that in hindsight they have been
overmedicating veterans, and doctors at the Pentagon and VA now say that the use of the
painkillers contributes to family strife, homelessness and even suicide among veterans. A study by
the American Public Health Association in 2011 also showed that the overdose rate among VA

14
patients is nearly double the national average.15 Therefore, Dr. Klein has legitimate concerns
about his role at the VA amid his knowledge and medical specialty currency being decimated by
the VA arbitrary actions noted by OSC as a prohibited personnel practice.
According to the VAs National Center for Patient Safety: Reducing or eliminating harm
to patients is the real key to patient safety. Efforts that focus exclusively on eliminating errors will
fail. We'll never eliminate all individual errors. The goal is to design systems that are fault
tolerant, so that when an individual error occurs, it does not result in harm to a patient.16 Also,
the VA states: Only those events that are intentionally unsafe acts can result in the assignment of
blame and punitive action. Intentional unsafe acts, as they pertain to patients, are any events that
result from a criminal act, a purposefully unsafe act, or an act related to alcohol or substance abuse
on the part of a provider or patient abuse. Id. Here, practicing medicine, after being absent from
the medical field for over a year, especially within the subspecialties Dr. Klein performs, would
be a decisive unsafe act, as noted in this submission, as noted by the referenced authorities in this
submission.
The Department of Veterans Affairs National Center for Patient Safety (NCPS) was
founded on the belief that this faulty approach must be abandoned17 (practicing medicine with no
concern for patient safety). The real goal of a patient safety program should be to prevent harm
to patients by significantly improving the probability that a desired patient outcome can be
achieved. This goal can only be accomplished by taking a systems approach to problem solving,
focusing on prevention, not punishment. Id. For staff to believe that patient safety is a priority,
that message must come from the chief executive officer and staff leaders, and not occasionally. It
must be part of the way business is conducted daily. Id. Denying reentry assessment and process
is out of place with VA practice. At VAMCs, doctors out of practice for months are sent for reentry
process at that VAMC.
According to the medical community: simulation is a unique tool for the potential reentry
of out-of-practice physicians due to its ability to assess situational awareness [and] critical
reasoning skills.18 Further:
Time away from practice can lead to a decay of knowledge, degradation in the
ability to apply knowledge, and/or deterioration in clinical skills. On the most
fundamental level, an assessment of readiness for independent practice requires an
evaluation of whether the physician knows what is required to carry out professional
duties. Higher level skills include a demonstration that the physician knows how to
apply knowledge (competence), and that they can show how they provide care
(performance). The highest-level assessment evaluates whether the
physician does what they show that they can do. Written examinations test
15
New rules on narcotic painkillers cause grief for veterans and VA Emily Wax-Thibodeaux, February 18, 2015,
Washington Post, see: https://www.washingtonpost.com/politics/veterans-struggle-to-renew-their-prescriptions-
amid-new-opioid-rules/2015/02/18/4d42d63a-acb3-11e4-9c91-e9d2f9fde644_story.html?utm_term=.c0f3e286297c,
last checked June 19, 2017.
16
Https://www.patientsafety.va.gov/about/approach.asp, Last checked June 12, 2017.
17
Developing a Culture of Safety, Joe Murphy, APR, the author discusses the founding beliefs, principles, and
goals of the VA National Center for Patient Safety that result in a positive safety culture.
https://www.patientsafety.va.gov/docs/joe/fed_practitioner_2013_tagged.pdf, last checked June 13, 2017.
18
Assessing Competence for Reentry: What Matters Most? Randolph H. Steadman, M.D., M.S.; Daniel J. Cole, M.D.,
July 2013, Editorial Views, See: http://anesthesiology.pubs.asahq.org/article.aspx?articleid=1918300, last checked
June 15, 2017.

15
cognitive knowledge; therefore, their relevance is restricted primarily to test
knowledge. An assessment of what matters most, performance in the clinical
setting, is more difficult, with inherent limitations and risks. One limitation is the
inability to assess performance during infrequent life-threatening events, which can
undermine the validity of an assessment performed during routine patient care.
Moreover, using the clinical setting to test anesthesiologists responses
undermines patient safety, as performance failures can have deleterious
consequences for patients.19
The above is consistent with VA Patient safety rules and regulations. Further, for the two
specialties Dr. Klein holds board certifications in, anesthesiology (pain management), and pain
management (ABPM), the requirements are even more stringent for reentry requirements into
practice, if currency in practice is not maintained, to ensure patient safety. For the subspecialty of
Anesthesiologist, Anesthesiology, with its focus on technology, undergoes continual changes in
practice patterns as new drugs are developed and new technical advances are made.20 Moreover,
the definition of a clinically active diplomate [anesthesiology] is: at least one day per week
during 12 consecutive months over the previous three years.21 For the specialty of pain medicine
under the ABPM, the requirement for continued certification for the upcoming March 2018 term
is: must have been engaged in the Clinical Practice of Pain Medicine (algiatry), on a substantial
basis, for at least 18 months, of which at least 6 months must be contiguous, within the 24-month
period ending March 31, 2018.22 Dr. Klein has been denied this by the VAMC. Therefore, the
VAMC must bring Dr. Klein into compliance with his specialties and certifications in order to
perform as required for his specialty. Further, the requirements at time of application for
certification or recertification in pain management is: At the time of application applicants must
be engaged in the clinical practice of pain medicine (algiatry) on a substantial basis.23 Dr. Klein
has been obstructed toward this by the VAMC. Additionally, there are CME requirements,24 and
other requirements Dr. Klein cannot meet presently because of the VAMC prohibited personnel
practices against him.

19
Id.
20
An Advanced Specialty Training Program in Anesthesiology: A Special Educational Fellowship Designed to Return
Community Anesthesiologists to Clinical Practice, Larson, C Philip Jr MD; Steadman, Randolph H. MD, Anesthesia
& Analgesia: July 2006 - Volume 103 - Issue 1 - pp 126-130. Also, See: http://journals.lww.com/ anesthesia-
analgesia/pages/articleviewer.aspx?year=2006&issue=07000&article=00026&type=Fulltext, Last checked June 16,
2017.
21
The American Board of Anesthesiolgy, http://www.theaba.org/PDFs/Status-Designation/Clinically-Active, last
checked June 18, 2017.
22
See: American Board of Pain Medicine, http://www.abpm.org/uploads/files/2018_cert _bulletin.pdf, Last checked
June 18, 2017, p 8.
23
Id.
24
Id.

16
In addition to personal
requirements, Dr. Klein has
constantly and persistently reported
and warned against a lack of
equipment at the PB-VAMC
purported pain clinic which
apparently is on unequipped room.
He is literally assigned an empty
unequipped room, that is not sterile,
for practice. It is well established that
failure to comply with an order
because of the failure of equipment
necessary to complete the task does
not constitute insubordination. Allen
v. Department of Agriculture, 88
FMSR 5208, 37 MSPR 234 (MSPB
1988). Here, the VA is totally in
control. Dr. Klein, through his attorneys and himself has notified the agency of missing equipment
for safe practices and has received no help.
Therefore, regarding the proposal to remove, the Agencys allegations are dishonest Dr. Klein
attempted to clarify requests NOT orders --that could result in patient harm, and thus were
improper. All his supervisors, including the Director, and the proposing official, refused to clarify
if they had issued an Order after the illegal nature of the initial request was pointed out by Dr.
Klein which would require him to violate law or rule and regulations. The PB VAMC simply
could have stated you are Ordered, but it did not. Dr. Klein, again and again, requested to be
advised if an Order had been issued, and advised he would comply with any order issued. Again,
the supervisors, including the medical center director, amid an OIG report noting violations in
the pain management program, as reported by Dr. Klein, refused to clarify if an Order was being
issued. Again, Dr. Klein made it clear he would obey an Order and again, all supervisors
cowardly refused to clarify if the request made or notice transmitted was an Order.
Now comes the Agency through deliberate untruths, and claims Dr. Klein refused to obey
Orders that did not exist as evidenced by the Agencys supervisory silence. This matter is simple,
Dr. Klein did not disobey an order amidst the presence of concerns over subjecting Veterans to
risk of harm from Dr. Kleins nonpractice for over a year amid a host of precedent requirements
to catch up and integrate into his specialties in medicine, and the supervisory chain of command
cowardly refusing to acknowledge if an Order was issued. The agencys absence of denying or
admitting an order was issued shows that the charges as made are not supported, and makes the
proposal to remove based on failing to follow an order moot, and an insult, as well as a prohibited
personnel practice, since any order under the explained circumstances would be illegal.
Therefore, this matter involves the Agency citing to activity that reflects Dr. Kleins devotion
to patients and their safety, as a basis for removing him: frequent and demanding communications
about safety and procedure in training him after forcing him to sit out medical practice for over
a year, matters involving Opioid issues audited by the OIG such as consults by non-doctors (e.g.,
the PharmD at PB-VAMC), constant inquiries about routine case management deficiencies
involving pain management patients, disagreement with staff plans of actions that endanger

17
patients and violate controlled substances laws and patient safety protocols, requests of
clarifications of a failure to order him to perform any of the accused of actions he did not perform
- after he requested an Order for each of the issues based on his reporting illegal results from such
requests for his performing those acts voluntarily that would be against medical best practices to
ensure patient safety, addressing failure to follow compliance with VA Policy and patient safety
laws/rules, failure to identify duties he was assigned to including refusing to provide copy of
his credential files to ascertain, in the midst of safety and legal concerns, how the hospital was
falsifying his credentialing files to show his medical status was up to date, amid being sat out of
medical practice for over a year and missing required CME and other medical and protocol
updated training, and addressing the Agencys failure to provide evidence that he is actually
credentialed at the medical center after terminating him in March 2016 and then only stating he
wont be removed, after removing his credentials for over 1 year, disallowing him time to
complete CMEs, stating in court (MPSB) there is no need for a pain management clinic at Poplar
Bluff VA Medical Center, and no need for his services. See, Removal, p.1-3 (except charge 2). An
employee's refusal to obey an order that he believes would violate safety regulations may be
protected under the "irreparable harm exception" to the "obey now, grieve later" rule. Larson v.
Department of the Army, 102 FMSR 5236, 91 MSPR 511 (MSPB 2002).
It is an illuminating contradiction to note that Agencys legal counsel noted that the Agency felt
that Dr. Klein was wrong to ask questions about medical practices he was hired to oversee or
advise on (pain management) to ensure patients needs were being met legally and safely. It is
further illuminating that the Agency perceived these efforts as "failure to follow orders" when Dr.
Klein requested an Order and the agency simply failed to respond after Dr. Klein pointed to
serious patient safety concerns. Removal, p 1-3 (except Charge 2).
In addition, the Agency misstates and falsify
claims Dr. Klein somehow was improper in
communicating to Dr. Bhatt, in a parking lot,
not at the hospital, a claim not reported
contemporaneously with the occurrence, and
not complained of to Dr. Klein, who has never
been noted for such communications, despite
complaints about his communications on
alleged wrongdoings at the VAMC by Dr. Klein
since March 2016 the basis for his termination
then that was stayed by the MSPB based on
prohibited personnel practices. For instance, the
Agency claims Dr. Klein accused Dr. Krishnan
of using some indian mentality but provides
no quotes or actual statements made. Removal,
p 3 (charge 2). Further, this is the direct
supervisor reported for patient safety violations
by Dr. Klein, and reported frequently to the VA
Police (noted later) for parking in Veterans
parking spaces as noted in the picture above,
a violation of 38 U.S.C. 1.218. What the impression by Dr. Krishnan of what Dr. Klein stated
no one can be certain about, but Dr. Klein, unlike Dr. Krishnan, has been found truthful by OIG,
in allegations made. Further, the management individual involved, based on the enormity of

18
medical malpractice and wrongdoing alleged, and his parking habits reported to VA Police, has a
credibility obstacle in making his statement believable more so after the OIG vindicated all of
Dr. Kleins reported Opioid concerns as founded which would have been supervised by Dr.
Krishnan, if it occurred as the OIG noted. This remains not investigated or prosecuted by the VA,
despite standing Orders for doctors to obey medical safety protocols and drug diversion control
practices to protect patient safety the goal of Dr. Klein. See Attached.
Further, the Agency seems to present generalized information without any specifics other
than referral to individuals Dr. Klein has filed EEO or OSC complaints about, not presenting
clearly and convincingly, the action taken is for other than blowing the whistle. Simply,
the Agency gives no credit to Dr. Kleins statements, despite his foundation for truth exemplified
by OIG and OSC reports that show VAMC medical supervisory staff is not truthful.
Whistleblowers are no strangers to accusations of not being team players, as noted in the
public declarations that lead to the passage of the WPEA. Dr. Kleins position was particularly
prone to attack from other offices within the agency because he was specifically tasked to perform
medical duties that impacted other medical practitioners, in that pain management encompasses
review of pain issues in a wide variety of medical cases and the use of controlled substances, a
highly-regulated medication. Pain management is specialized medical field. No one at Poplar Bluff
VA Medical Center matches Dr. Kleins knowledge of the field including patient safety know-
how prior to his being removed, isolated, and treated like a pariah despite Veterans to serve.
Dr. Kleins protected disclosures are legion; He kept Agency management apprised of the
numerous Opioid and hiring and other violations and attempted to work with the agency to enforce
compliance, and patient safety, to no personal advantage.
The Agency's statements in its proposal are all strong indicators of the Agency's animus
against Dr. Klein for his disclosures of the founded issues by the OIG, and again, of patient safety
issues, and the wrongful conduct of a pain management program at Poplar Bluff VA Medical
Center. Under the federal Whistleblower Protection Act, 5 U.S.C, 1221(e)(2) (see also, 5 C.F.R.
1209.7(b)), when a federal employee shows that protected activity, such as disclosing violations,
refusing to participate in violations, and participating in proceedings, was a contributing factor
in an adverse action, the agency cannot thereafter prevail unless it proves that it would have taken
the same adverse action by clear and convincing evidence. See also 5 U.S.C. 2302(b)(1), (8) and
(9). The Supreme Court has imposed the clear and convincing standard only to protect interests
that are far more precious than any property right. Santosky v. Kramer, 455 U.S. 745, 758-59
(1982) (termination of parental rights); see also, e.g., Addington v. Texas, 441 U.S. 418, 424
(1979) (requiring interests more substantial than mere loss of money). It is a heightened standard
of proof that concede[s] the possibility of error but ensure[s] that the error is generally in one
direction. Ralph K. Winter, Jr., The Jury and the Risk of Non-persuasion, 5 Law & Soc'y Rev. 335,
339-40 (1971); cf. 4 William Blackstone, Commentaries *352 ([B]etter that ten guilty
persons escape, than that one innocent suffer.). For employers, this is a tough standard, and not by
accident. Congress appears to have intended that employers face a difficult time defending
themselves. Stone Webster Eng. Corp. v. Herman, 115 F.3d 1568, 1572 (11th Cir. 1997). The
Federal Circuit spoke to the reasons for this elevated burden on agencies in Whitmore v.
Department of Labor, 680 F.3d 1353 (Fed. Cir. 2012). There, the Federal Circuit stated at p. 1377
that the law seeks to balance the public interest of protecting whistleblowers with an eye toward
the inherent advantages agency management would otherwise have: As Senator Grassley has often
said, whistleblowers typically are treated like skunks at a Sunday afternoon picnic." See:

19
https://www.grassley.senate.gov/news/commentary/whistleblowers-pump-transparency (Last
checked June 12, 2017). In this proposal, there is no requirement for a whistleblower to specifically
label he/her disclosures as such. The proposal seems aimed at preventing Dr. Klein from reporting
he requires proper reentry process as a practitioner in a field reported in the media as resulting in
deaths from Opioid addictions and overdoses. The lack of up to date information and rules can
mean the difference between catching a problem and saving lives, or not (e.g., Dr. Klein notes that
in the past he recommended intubation of a patient/veteran, Dr. Nair refused and superseded Dr.
Kleins decision, and the Patient/Veteran expired later). This further reflects Dr. Klein is in a
predicament created by the VAMC report wrongs, be reprised against, do you job, be superseded
but complain and be reprised against. Who is serving Veterans in this matter? Could the Veterans
life in the matter noted by Dr. Klein be saved if not for the decision reported as made by Dr. Nair?
The laws protecting whistleblowers from retaliatory personnel actions provide important
benefits to the public, yet whistleblowers are at a severe evidentiary disadvantage to succeed in
their defenses. Thus, the tribunals hearing those defenses must remain vigilant to ensure that an
agency taking adverse employment action against a whistleblower carries its statutory burden to
proveby clear and convincing evidencethat the same adverse action would have been taken
absent the whistleblowing.
In Whitmore, the Court considered the employee's admission about the following
conduct: Whitmore put his foot in the way and told Dubois that if he ever spit on
him again, he would knock him into the basement. *** In the hallway Whitmore encountered Dave
Schmidt, director of OSA, standing in a narrow passageway between a wall and some filing
cabinets. *** Whitmore claimed Schmidt would not allow him to pass to Goddard's
office. Whitmore then physically pushed past Schmidt while yelling get out of my way, and
possibly also spit on Schmidt. Whitmore expressed that he was so angry he could have just cold
cocked [Mr. Schmidt] right then and there for blocking his way out of the area. Even with this
evidence, the Court could not conclude that the agency would have fired Whitmore without
considering his protected activity. The Peace Corps has not alleged any misconduct by Ms. Greene
anywhere near this level of seriousness. More pointedly here, the Federal Circuit explained at p.
1376 that: Perhaps most glaringly absent from the AJ's decision is any serious discussion of the
facts and circumstances surrounding how Whitmore's whistleblowing in 2005 marked
the beginning of his increasingly strained relationships with OSHA officials, and how his
disclosures paralleled his increasingly poor performance reviews and adverse personnel actions
after decades of exceptional service.
In December 2012, Congress passed the Whistleblower Protection Enhancement
Act (WPEA) to clarify precisely this protection. 5 U.S.C. 2302(b)(8); Senate Report No. 112-
155, p. 4 (the 1994 amendments were intended to reaffirm the Committee's long-held view that
the WPA's plain language covers any disclosure[.]). The 1994 House Committee report on the
WPA stated, "Perhaps the most troubling precedents involve the ... inability to understand that
'any' means 'any.' The WPA protects "any" disclosure evidencing a reasonable belief of
specified misconduct[.]" As to the manner of raising her concerns, the Secretary of Labor held
that, [t]he right to engage in statutorily-protected activity permits some leeway for impulsive
behavior, which is balanced against the employer's right to maintain order and respect in its
business by correcting insubordinate acts." Kenneway v. Matlack, 1988-STA-20 (Sec'y June 15,
1996), slip op. at 3. A key inquiry is whether the employee has upset the balance that must
be maintained between protected activity and shop discipline. The issue of whether an employee's

20
actions are indefensible under the circumstances turns on the distinctive facts of the
case. Id. (citations omitted).
Dissenters and whistleblowers rarely win popularity contests or Dale Carnegie awards.
They are frequently irritating and unsettling. These qualities, however, do not necessarily make
their views wrong or unhelpful, and the Supreme Court has concluded that it is in the
public interest and consonant with the First Amendment for them to express opinions on subjects
of public concern without fear of retaliation. Cudahy, J., dissenting in Greenberg v. Kmetko, 840
F.2d 467, 477 (7th Cir. 1988) (en banc) See also Lajoie v. Environmental Management Systems,
Inc., 1990-STA-3 (Sec'y Oct. 27, 1992) (where a complainant who has engaged in a protected
activity also engages in spontaneous intemperate conduct privately communicated over the
telephone, the intemperate conduct does not remove the statutory protection nor provide the
respondent with a legitimate, nondiscriminatory reason for adverse action.); NLRB v. Mueller
Brass Co., 501 F.2d 680, 685-6 (5th Cir. 1974) (termination unjustified where employee
called supervisor a damn liar and invited him to step outside to settle matters because the outburst
was provoked).
In Trustees of Boston Univ. v. NLRB, 548 F.2d 391, 393 (1st Cir. 1977) (citing NLRB v.
M B Headwear Co., 349 F.2d 170, 174 (4th Cir. 1965)), the Court wisely understood the interplay
of an employer's animus and the employee's reaction. The Court explained: The circumstances of
Plaintiff's alleged misbehavior must be considered in evaluating her conduct. . . . [Boss] provoked
an angry response from Plaintiff, and now seeks to use it to justify a termination. An
employer cannot provoke an employee to the point where she commits such an indiscretion as is
shown here and then rely on this to terminate her employment. [internal citation
omitted.] 3 n Moravec v. H C M Transp., Inc., 90-STA-44 (Sec'y Jan. 6, 1992), the Secretary
of Labor found that the employee's impulsive behavior of hollering and shouting at supervisor
during a discussion about his complaint was not sufficient to justify discipline. Moravec, slip op.
at 8 10. Martin v. Dep of the Army, 93-SDW-1 (Sec'y July 13, 1995) arose under the Safe Drinking
Water Act (SDWA), 42 U.S.C. 300j-9(i). The protected activity consisted of complaints to
supervisors and to the Army Inspector General about claimed violations of SDWA. The
Secretary found that the employee's conduct was disruptive, but not indefensible under
the circumstances. The employee conduct in Whitmore, supra, was even more egregious, yet the
Federal Circuit said it did not permit the employer to engage in retaliation. Dr. Kleins conduct, in
contrast, consists of emails which threatened no violence, and contained no hollering at all
simply, documented and difficult to dismiss complaints of harm to patients from having him see
patients without assessing his current medical status as a practitioner (based on being forced to sit
in isolation for over a year) and forcing him into patient care matters without any updated training
on VA procedures (amid his credentialing file possibly falsified to show he is up to date on
credentialing and training). Imagine the doctor operating on your loved one, or intubating a loved
one, states they have not practiced for over a year, and have not studied or kept their credentials
current? Would you approve?
It would be ironic, if not absurd, to hold that one loses the protection of a whistleblower
statute if one gets visibly (or audibly) upset about discriminatory conduct. Hertz v.
Luzenac America, Inc., 370 F.3d 1014, 1022 (10th Cir. 2004). It is equally unfair to subject Dr.
Klein to a hostile work environment, and then punish Dr. Klein for becoming upset about it (by
degrading his ability to see patients through prohibited personnel practices).
II. THE CASE LAW DOES NOT SUPPORT REMOVAL

21
In Holligan v. USPS, 75 MSPR 372, 374 (1997), the appellant was accused of behavior that
"increased the potential for violence at the postal facility under [his] supervision". The Board
upheld the administrative judge's determination that the "maximum reasonable" penalty was a 4-
level demotion and reassignment rather than the Agency's 11-grade demotion
and reassignment. Id. at 373. In Gore v. VA, 68 MSPR 100 (1995), rev'd on other
grounds, the appellant was found, inter alia, to have publically humiliated her subordinate. The
Board mitigated the Agency's 30-day suspension to a 15-day suspension. In Hughey v. Dep't
of Treasury, 59 MSPR 480, the Board mitigated the Agency's demotion to a 30-day suspension.
In Johnson v. Dept of Justice, 65 M.S.P.R. 46, 49 (1994) the agency demoted the appellant
after discovering that he had made statements about a co-worker such as "dumb nigger",
"porch monkey", and "this looks like it was written by a nigger". In Moultrie v. Dept of
Navy, 65 M.S.P.R. 153, 161 (1994), the Board determined that removal was too harsh a penalty,
even though the appellant was found to have said that she would throw [her co-worker's] ass onto
the street, and even though the appellant had a prior disciplinary record that included a 14-day
suspension. The charges, therefor, involving Dr. Bhatt are false and unsupported as to agency
discipline sought and allegations made.
Charges are Multiples of One Improper Instruction
Disregard of an order that is repeated within a short period of time by the same or other managers
generally will not support multiple charges of insubordination. Stephens v. Department of the Air
Force, 87 FMSR 5564, 34 MSPR 649 (MSPB 1987). In the Charges filed the Agency simply uses
one instruction by Director Hall, noted for committing a prohibited Personnel Practice against Dr.
Klein, as multiple offenses. There are no multiple refusals to carry out what Dr. Halls initial email
shows is a suggestion and hope and at worst an improper order. She is not happy her initial
improper and illegal order cant gain evidence to fire Dr. Klein, so she concocts multiple Order
specifications from her initial Order. The issue here is did Dr. Hall properly re-integrate Dr. Klein
to the work he is supposed to perform, which the PBVAMC argued at MPSB does not exist at
PBVAMC.
III. THE FACTS DO NOT SUPPORT REMOVAL
The bulk of Dr. Kleins factual disputes with the Agency's allegations are outlined in letters
provided to the OSC and OIG, and the letters provided by the Whistle Blower Law Firm to Agency
counsel, dated. See Attached.
VHA DIRECTIVE 2009-053 October 28, 2009, directs that all clinical staff ... should have ...
ongoing education and training.
...each staffing group must clearly delineate its specific pain management responsibilities
and abilities and ensure that all its members receive training adequate to meet these
responsibilities and to maintain these abilities.
Education and training must be relevant to the specific needs of the patient population
and clinical setting that provider groups serve, and should include, as appropriate,
pharmacologic (especially opiates and including education regarding physical
dependency, pseudo addiction, tolerance, and potential for addiction, overdose and/or
suicide; appropriate titration; side effects and benefits) and non-pharmacologic
(including psychological, physical, complementary, and spiritual) treatment modalities.
Annual pain management education for clinical staff is highly recommended ...

22
It is highly recommended that Pain Medicine Physician specialists obtain and
maintain one or more ... certifications
It is recommended that they should also obtain yearly pain-relevant continuing client,
refers to a specific type of pain specialist, practicing a subspecialty of pain medicine. The
subspecialty of interventional techniques includes those techniques that are more
substantial and even sometimes invasive for treating and managing various pain
conditions making the an interventional pain doctor, such as our requirements of
ongoing training and patient contact experience even more vital. Again, organization
and delivery of integrated pain care throughout the VHA (see: educate/train all team
members to their discipline specific competencies as part of VA overall pain
management approaches (see: https://www.va.gov/painmanagement/).
Based on VHA rules and promulgated policy, Dr. Klein refused no proper orders. He pointed to
the Agency, and even Dr. Nair himself, telling the MPSB and OSC he could not practice medicine
at Poplar Bluff VA Medical Center because of the danger he brought patients or because the pain
management program did not exist and he was not needed. Dr. Klein did not state to VA he would
not see patients. To the contrary, he demanded the proper update of his credentials to safely see
patients and sought out opportunity to update his CMEs which was denied. Simply, the agency
presents a proposal full of holes, amid due process violations in service of the proposal (slipped
under a door, evidence file not provided despite this being mandatory on request by Dr. Klein
see, Article 14, Section 8, MCBA). The HR personnel then lie to Dr. Klein and insist a copy
was sent to his law firm when such a copy was not sent. The agencys action, exemplifying
mendacity, demonstrate the proposal is a result of directed reprisal for disclosures made, and is not
supported as proffered.
Charges / Specifications
Charge 1, Failure to Follow Order
SPECIFICATION 1:
On May 12, 2017, Dr. Patricia Hall sent you a memo directing you to examine and treat veterans
beginning on Monday, May 15, 2017. The Associate Medical Center Director, Seth Barlage, met
with you to address and resolve the eight concerns you stated needed to be resolve before you
examined and treat patients. Those concerns were either resolved prior to and by the elate of May
12, 2017.
On May 16, 2017 at approximately 2:27pm, Dr. Patricia Hall sent you an email stating that the
Specialty Clinic contacted her that a patient was quite insistent that he see you (Dr. Klein). The
patient was provided an alternative appointment to the CBOC in Cape Girardi but he was quite
insistent on seeing you. You responded on May 16, 2017 at 4:47pm that you were not going to see
this patient until concerns expressed by your attorneys were resolved.
You failed to follow the orders of Dr. Hall I because you have not, to date, seen any patients or
otherwise engaged in patient care.
EMPLOYEE REPONSE:
A. Any meeting with Associate Director Barlage was not about settling of any issues Since
at the time of the meetings, Dr. Klein was fired from the VAMC, his credentials removed, and he
was at VAMC only by a stay granted by the MSPB preventing removal based on prohibited

23
personnel practices, that remained unaddressed. There is no written documentation of
conversations with Barlage, and no written agreements, and Dr. Klein disputes that any agreement
was reached. Further, in her whitepaper letter to Dr. Klein, Dr. Hall admits there was no agreement.
B. The employee, Dr. Klein, was entitled to Weingarten rights. He was denied these rights by
the Associate Director in admitted contact over the matter of the stay and termination. Therefore,
any conversation occurring between Barlage and Klein is against the Labor Statute, and Unfair
Labor Practice. For the agency to attempt to reflect such involuntary meetings as an agreement is
absurd.
C. There are absolutely no written documents showing an agreement between Associate
Director Barlage and Dr. Klein on any matter as claimed.
D. The email from Associate Director Barlage appears to be dated May 12, 2017, the same
day the Office of Special Counsel is again seeking a stay with the MPSB, amid Congress acting to
pass a law on behalf of Dr. Klein, because of Dr. Kleins situation, to ensure a stay can be
performed at MSPB without a quorum, after OSC issued a Prohibited Personnel Practice (PPP)
Report finding PPPs against the management at PB-VAMC for similar action as now occurring
removal based on complaints about patient safety.
E. There are no records from ANY patient trying to see Dr. Klein. There are no records
showing a prepared medical treatment room or a prepared access of resources for Dr. Klein to
perform any review.
F. Dr. Klein did not refuse any order. He stated he needed conditions precedent in order ot
be able to comply with the request by the patient - See Attached (letter from Whistleblower Law
Firm).
G. On May 15, Dr. Klein, through representation, which he is entitled for this non-title 38
matter, under Article 14, Section 8, master collective bargaining agreement (MSCBA), sent a letter
to Dr. Hall asking for clarification of his continued employment letter received on plain white
paper, with no instructions, and no renewal of his medical credentials at Poplar Bluff VA Medical
Center. See Attached. Dr. Hall failed to reply.
H. On May 16, no email from a patient was forwarded to Dr. Klein. On May 16, there was no
orders to Dr. Klein issued. See Attached.
I. There was a communication from Patricia Hall, undated, unsworn, stating there is no plan
to remove you. However, Dr. Klein was already removed as of March 2016, and had been
Ordered rehired by the MSPB, based on OSC investigation of prohibited personnel practices. The
communication from Hall was not on official stationary, was not confirmed by the HR, and
contained no SF50 or other forms, showing the personnel action. The communication further
shows no agreement with the associate director by stating I hope you will agree with my
assessment that these steps address your concerns. Dr. Klein timely replied his concerns were
not addressed. No further communications ensued. There were no Orders to assume duties as a
doctor, no instructions on retraining or training updates, and so on.
J. On May 15, 2017, Dr. Klein, through Counsel, submitted to the VA a 7-page clarification
letter outlining Dr. Kleins concerns, and a counteroffer for settlement. The letter clearly pointed
to issues needing to be addressed so that Dr. Klein could assume his position as physician
addressing. The agency did not respond and there were no Orders issued. The provided settlement
agreement differed from the claimed agreement by the associate director.

24
K. On May 15, an email from Dr. Kleins Counsel, Mrs. Poston, to Agency Counsel, Mr.
Anfang, and Mrs. Hall, again complained about violations of representation and that all matters
were to be addressed to Dr. Kleins Counsel. Mrs. Hall replied on May 15 in an email to the
employee, not the representative, stating she acknowledged no meeting would be held at her office
and providing no Orders.
L. On May 15, 2017, Mr. Anfang, Agency Counsel asked for Dr. Klein to identify obstacles
to performing duties in a manner that was safe for patients admitting obstacles to any suggested
work Dr. Hall had sent to Dr. Klein, showing no orders had been issued. Mr. Anfang did not
address any of the patient safety concerns Dr. Klein brought forward through his counsel.
M. On May 16, by letter, Dr. Kleins Counsel responded to Mr. Anfang, outlining the obstacles
to returning to physician duties in the specialty role Dr. Klein fulfills and is being asked of him.
N. On May 17, 2017, Mr. Anfang responds to the above letter acknowledging no Orders,
confusion and dispute as to an agreement that does not exist in writing and is a combination of
multiple emails, and contradicts Agency counsel which argued at MPSB that the doctor could
not practice medicine at PB-VAMC, there was no position for him, but now he can practice
medicine and can see patients. Mr. Anfang refuses to provide a waiver for malpractice to Dr. Klein,
and communicates no orders to perform medical work.
O. Dr. Klein has asked to see patients, his requests have not been fulfilled or responded to.
Further, See Attached, shows the agency is disingenuous in stating Dr. Klein wont see patients.
Despite stating the noted patient was trying to see Dr. Klein, no such patients were listed as
requiring a consult in mandatory scheduling for such consults (See Attached, May 2017 dates).
SPECIFICATION 2:
On May 22, 2017 at approximately 12:53 pm, you were sent an email by your new supervisor,
Vijayachandran Nair, MD, Chief of Staff, of his expectations for you to see patients in the pain
management clinic. Dr. Nair stated that refusing to see patients is not an option and you were
expected to see patients, make appropriate diagnoses, prescribe medication as necessary, and
schedule necessary follow-ups. You were instructed by Dr. Nair to start seeing patients no later
than Wednesday, May 24, 2017. Dr. Nair also requested specifics on the training that you claimed
you needed.
On May 23, 2017 at approximately 5:50 pm Mary Baker sent out an email to all that Dr. Bhatt
has been designated as Acting Chief of Staff from May 24, 2017 until May 29, 2017.
On May 23, 2017 at approximately 3:43 pm, Dr. Nair sent another email to you stating he was
still waiting on specifics from you regarding the types of duties for which you will need training
and the type of training you will need. Dr. Nair also repeated that remaining in your office and
refusing to see patients is not an option and that the expectation is for you to start performing your
duties now: reviewing consults, seeing patients, making appropriate diagnoses, prescribing
medications, and scheduling necessary follow-ups, no later than Wednesday, May 24, 2017.
You failed to follow the orders of Dr. Nair because you have not, to date, seen any patients or
otherwise engaged in patient care.
EMPLOYEE REPONSE:
1. On May 22, Dr. Klein received no such notice as stated. First, Dr. Nair reported in a Sworn
statement to MSPB that there is no MSPB clinic at Poplar Bluff, no need for Dr. Klein, Dr.

25
Kleins skills are no updated or needed, there are no pain patients at Poplar Bluff, etc. See
Attached.
2. Email dated May 22, 2017, at 12:53 PM, states Dr. Klein is expected to see patients in the
pain management center BUT there is no pain management center as noted in agency
arguments to MPSB, and in Dr. Nairs sworn testimony to the MSPB.
3. Dr. Nair, in his email of May 22, 2017, at 12:53PM states: I do not understand why you
would not be able to see patients, make appropriate diagnoses, prescribe medications, as
necessary, and schedule necessary follow-ups. Not only does this show an inaccurate
understanding of what a pain management specialist does, but reflects no orders made. Dr.
Klein, through representation, explained the obstacles, See Attached, and Dr. Nair
describes these obstacles in his sworn testimony to MSPB (See Attached). Dr. Klein
advised he was prepared to see patients when the obstacles could be addressed and agreed
to see patients. The wording of the proposal shows there was no orders and nonblack of
compliance i.e., you have not u, up to date, seen any patients However, Dr. Klein has
been waiting for patients to be assigned, and according to VA Records, See Attached, none
have been.
4. On May 23, 2017, at 11:58 AM, in an email from Dr. Klein, to Dr. Nair, Dr. Klein
describes:
a. Imagine my surprise after sidelining me for over a year, in which you denied me
training, you are now requesting I see patients, after you have denied the need for
my skills or the need for pain management care for our Veterans at PBVAMC - you
even suggested I was a risk to patients. I am concerned about your lack of integrity
and that you appear to harbor no good will toward our Veterans, never mind me,
my career, or my safety. You are failing to properly return me to the medical
practice baseline I held before you isolated me in an office and refused to let me
see patients, or even train as a doctor. There is no response by Dr. Nair.
b. My attorney brought to Agency's attention my concerns related to the status of
currency in my medical knowledge required for the position which you forcibly
removed me from and refused to allow me to perform training for, but now want
me to perform without any training or return to medical baseline. I still have no
response from you on this concern. There is no response from Dr. Nair.
c. I am concerned that during the past year your own attorney (Agency counsel) has
argued to the MSPB that I was a liability risk, and now - when convenient or
pressured - you want me to perform patient care without any steps taken by you in
providing me with any type of training, system updates, access to patient
information, and the like. The very continued education, review of patient charts,
and consults that I have requested and have been denied or not given
permissions/access to over the past year. I still have no response from you on this
concern. Again, there is no reply from Dr. Nair. There is not even an attempt at
assessment of Dr. Kleins level of currency to practice medicine, under his
specialty.
d. I have just learned that under Sections 502, 902, 912, 913, 922, 924, 941, at
minimum, of the Comprehensive Addiction and Recovery Act (CARA), you may

26
be imputing on me responsibilities and liabilities I am not ready to assume after you
took away my privileges illegally (per the Office of Special Counsel). I have had
no exposure to this new law and program. Again, there is no reply from Dr. Nair.
e. I have learned that this Hospital has been assigning what amounts to my prior
duties to a pharmacist. That pharmacist has brought forward certain concerns in an
email, and I too have similar concerns of being asked to commit an offense against
Title 21 of the U.S. Code, involving controlled substances, or against CARA.
There is no response from Dr. Nair.
f. I want a complete audit by an outside entity of all pain consults performed while
I was in solitary confinement. Your actions here amount to violations of law since
pharmacists have limited authority to perform pain consults, and you stripped my
ability to perform within my specialties. You seem to NOT offer guidance, training,
or care, in how you force me now to simply perform - without taking precautions
and training me. Why? There is no response by Dr. Nair.
g. ALSO, for me to return to any patient duties, against my will now, please clarify
you are ORDERING ME TO SEE PATIENTS after I have advised that you
degraded my medical knowledge and skills and are placing the VA and Veterans at
risk of harm and damages. Please be clear what you are ORDERING me to do. I
will do as ORDERED there is no reply by Dr. Nair.
h. If you cannot resolve this, please advise who can. Dr. Nair does not respond
and fails to address this matter after asking for this information.
5. Dr. Klein NEVER refused to see patients he requested making his know-how and skills
current in written correspondence that went unanswered by the administration. He asked
for assurances his violations of law based on instructions to violate the law, would not be
held against him he received no such assurances. See Attached.
6. Amid See Attached, the claim Dr. Nair did not know what training Dr. Klein needed is
false, reflecting the mendacity of the specification to Charge 1 made. Dr. Nair is fully aware
of the issues regarding training and currency in status more so since he was willing to
provide a statement to MSPB on this matter.
SPECIFICATION 3:
On May 24, 2017 at approximately 10:12 am, Dr. Patricia Hall, Medical Center Director sent
you an email stating her expectation that you see patients on that day.
On May 25, 2017, at approximately 10:19 am you were sent an email from Dr. Yogesh Bhatt,
Acting Chief of Staff, that he attempted to talk with you in person regarding the seven patient
referrals you had been assigned and failed to see.
As of this date, you have not seen any patients or otherwise provided any patient care.
You failed to follow the orders of Dr. Hall because you have not, to date, seen any patients or
otherwise engaged in patient care.
EMPLOYEE RESPONSE:
1. There was no order by Dr. Hall to see patients. There was no order shown above from Dr.
Bhatt. None is listed in the evidence file.

27
2. Dr. Klein requested clarification, noting illegal and safety issues, (See Attached), and there
was no reply.
3. Records for May show no such 7 referrals in the mandatory VAMC records systems for
pain management consults. Therefore, the agency is either being untruthful, or falsifying
federal records related to patient scheduling and accounting (secret wait lists). See
Attached.
4. Dr. Bhatt is noted in emails as not responding to Dr. Klein.
SPECIFICATION FOUR:
On May 24, 2017 at approximately 10:12am you sent the Medical Center Director an email asking
if Dr. Bhatt is your supervisor. You stated you still had issues that must be addressed regarding
the PMC (Pain Management Clinic). You alleged that the pain management nurse had not reached
out to you and would not talk to you and requested for advice on how you could start seeing
patients. Or. Hall responded to your email on May 24, 2017 at 10:12am that Dr. Bhatt is the acting
COS, that he is seeing patients at the CI3OC in Paragould, and he asked for Dr. Krishnan to make
sure you have what you needed to start seeing Veterans on this date. Dr. Hall stated that the PMC
Nurse was with Dr. Krishnan this morning but would convey to her that you were ready to
coordinate with your nurse.
At 2:57pm on May 24, 2017 Kimberly Gum, RN Specialty Clinic Nurse Manager- Pain
Management went to your office accompanied by Lonnie Phillips, RN.
You were informed by Ms. Gum that she had a brown folder that contained three (3) Choice and
four (4) Non-VA consults for you. She placed the folder on your desk.
You did not take the folder. You stated you needed your legal counsel to be a present at this
meeting. Ms. Gunn terminated the meeting.
You failed to follow the orders of Dr. Shall because you have not, to date, seen any patients or
otherwise engaged in patient care.
EMPLOYEE RESPONSE:
1. Regarding Gum and the brown folder. Gum did not at any time, that day or any day, give
Dr. Klein any patients to see. There is no such evidence in the evidence file.
2. There is no Dr. Shall listed in the above specification or orders from a Dr. Shall therefore,
there is no Orders from Dr. Shall disobeyed. The clarity reflects on due process in response
to this specification.
3. The provision of representation is statutory 5 U.S.C. 7114(a)(2) & (5).
4. There is no doubt that amid prohibited personnel practices founded against Dr. Klein, and
his position of being tasked with illegal acts, or activities that can harm patients, amid
threats to his safety, and job safety, this matter is governed by Weingarten. NLRB v. J.
Weingarten, Inc., 420 U.S. 251 (1975).

28
5. Ms. Gunn chose to terminate the interview or interaction with Dr. Klein, which is her right
under Weingarten, as Supervisor, if the employee asks for representation.25
6. As described by the agency, Ms. Gunn provided no orders and was not a supervisory
official over Dr. Klein and thus could not provide orders.
7. There are no pain management patients at PB-VAMC according to Dr. Nair - See
Attached. Therefore, the statement is false, or inconsistent with the chief of staff affidavit
to MSPB.
FOR ALL SPECIFICATIONS
The American Pain Society26 believes that the principles of medical ethics published by the
American Medical Association should apply to all clinical disciplines engaged in pain therapy with
patients. The following principles have each been altered so that the word physician has been
replaced by the phrase healthcare provider A healthcare provider shall deal honestly with
patients and colleagues, and strive to expose those healthcare providers deficient in character and
competence or who engage in fraud or deception healthcare provider shall respect the law and
also recognize a responsibility to seek changes in those requirements which are contrary to the
best interests of the patient a healthcare provider shall continue to study; apply and advance
scientific knowledge A healthcare provider, in the provision of appropriate patient care, except
in emergencies, shall be free to choose whom to serve, with whom to associate, and the
environment in which to provide healthcare services. The Code of Ethics for Anesthesiologists27
provides: A physician shall be dedicated to providing competent medical care with compassion
and respect for human dignity and rights ... A physician shall uphold the standards of
professionalism, be honest in all professional interactions, and strive to report physicians deficient
in character or competence, or engaging in fraud or deception to appropriate entities ... A physician
shall respect the law and also recognize a responsibility to seek changes in those requirements
which are contrary to the best interests of the patient. Moreover, the American Medical
Association in its Code of Medical Ethics unequivocally states, A physician should expose,
without fear or loss of favor, incompetent or corrupt, dishonest, or unethical conduct on the part
of members of the profession.28

25
NLRB v. J. Weingarten, Inc., 420 U.S. 251 (1975), Rule 1: The employee must make a clear request for union
representation before or during the interview. The employee cannot be punished for making this request. Rule 2: After
the employee makes the request, the employer must choose from among three options: grant the request and delay
questioning until the union representative arrives and (prior to the interview continuing) the representative has a
chance to consult privately with the employee; deny the request and end the interview immediately; or give the
employee a clear choice between having the interview without representation, or ending the interview. Rule 3: If the
employer denies the request for union representation, and continues to ask questions, it commits an unfair labor
practice and the employee has a right to refuse to answer. The employer may not discipline the employee for such a
refusal.
26
Ethical Principles for Pain-Related Clinical Practice, American Pain Society, http://americanpainsociety.org/ about-
us/code-of-ethics/overview, last checked June 18, 2017.
27
Guidelines for the Ethical Practice of Anesthesiology, https://www.google.com/url?sa=t
&rct=j&q=&esrc=s&source=web&cd=3&ved=0ahUKEwjltYDU6c3UAhXJOSYKHb9UAcwQFgguMAI&url=http
%3A%2F%2Fwww.asahq.org%2F~%2Fmedia%2Flegacy%2Ffor%2520members%2Fdocuments%2Fstandards%25
20guidelines%2520stmts%2Fethical%2520practice%2520of%2520anesthesiology.pdf&usg=AFQjCNF3hBt6tLOw
DhftVDyq0w_RxlMJIA&sig2=U6bHfD-RTSqjGQC4hYUjPg, last checked June 18, 2017.
28
AMA Code of Medical Ethics, Opinions on Professional Rights and Responsibilities, sec 9.04:264.

29
From the above, it is clear Dr. Klein did not disobey proper orders. Further, Dr. Kleins
actions are protected by 5 U.S.C. 2302(b)(9)(D). Lastly, MPSB has upheld the ability of an
employee to uphold law, and safeguard from irreparable harm. The agency offers disputed conflict
that amount to he said she said.
CHARGE TWO: Offensive Language
On May 23, 2017 at approximately 5:50 pm Mary Baker sent out an email to all facility staff that
Dr. Bhatt has been designated as Acting Chief of Staff from May 24, 2017 until May 29, 2017.
Dr. Bhatt delegated to Dr. Balamurugan Krishnan the task of discussing the pain clinic restart
with you. Dr. Krishnan called you. You insisted on discussing employees parking in the Veterans
parking lot. You then accused Or. Krishnan on imposing the Indian mentality and Indian Hindu
caste system on him. You then hung up on Dr. Krishnan.
EMPLOYEE RESPONSE:
1. First the above is unclear. Was there or not a meeting in a parking lot? Second, Dr. Klein
admits that in an email, he was notified for the day Dr. Bhatt was the acting COS for
Nair. He denies the rest as untrue. Dr. Bhatt provides to documentation to support the
allegation made (i.e., contemporaneous report of contact, sworn statement).
2. Immediately, he tried to contact Dr. Bhatt after being notified Dr. Bhatt was the COS.
3. He was told Dr. Bhatt was in Arkansas working that day at a CBOC seeing patients.
4. Dr. Klein called that CBOC but Dr. Bhatt refused to take a telephone call from Dr. Klein.
5. Dr. Klein recalls (See Attached) that in an email from Dr. Hall, she specifically stated Dr.
Bhatt is ready to take my call that day or has time to speak with me that day, or something
to that effect. However, Dr. Bhatt did not speak with Dr. Klein and would not even take a
telephone call from him.
6. While Dr. Klein did receive a telephone call from Dr. Krishnan that morning of the day
noted, when he received the telephone call from Krishnan, no one had told Dr. Klein that
Dr. Krishnan was the acting COS for Dr. Bhatt, who was the acting COS for Dr. Nair.
7. Dr. Klein was confused why Dr. Krishnan called him because he was no longer assigned
as his supervisor, based on Orders from Dr. Hall, based on communications to him (See
Attached), according to the Associate Director (See Attached).
8. Dr. Krishnan would not tell Dr. Klein why he called. This perpetuated conflict and hostility
based on prior complaints of illegal activity against Krishnan, which OSC investigated., as
did OIG.
9. When the telephone conversation was over, Krishnan, had not at any time told Dr. Klein
why he called. Dr. Klein took (understood) the telephone call to be yet another example of
Krishnan harassing him as he has done many times in the past by calling or stopping by
Dr. Kleins room (where the VAMC has Dr. Klein in isolation).
10. Dr. Klein was alarmed that Dr. Krishnan seemed much more interested in trying to argue
with him than trying to communicate a work-related matter.
11. Dr. Klein DENIES ever stating the word "Hindu". Dr. Klein advises (See Attached) he
does not think he has used that word the entire time he has lived in Poplar Bluff, MO.

30
12. Dr. Klein advises that Dr. Krishnan and Dr. Nair continually tell him that he should
immediately shut up because that is the way it's expected and done in their Indian culture.
This was a reason for the EEO complaint against Dr. Krishnan. Dr. Klein does admit telling
Dr. Krishnan that we are not in India (meaning: workplace rules such as CBA, and
Federal laws, apply at VAMC).
13. In the past, Dr. Klein reported to a VA police officer that Krishnan routinely and frequently
over an extended period parked in Veterans' parking spaces at the VAMC. Dr. Klein took
pictures of such violations of Federal law (38 USC 1.218) see earlier picture in this
submitted response. Dr. Klein alleged Dr. Krishnan parks illegally so he does not have to
walk as far to the entrance of the medical center. When reported, Dr. Klein was told by
the VA police officer that the administration oversees the VA police department and they
could not do anything because essentially administrators are the police officers'
bosses. Nevertheless, such dishonesty by Dr. Krishnan reflects on the credibility of the
claim by Dr. Krishnan as to the encounter.
14. Dr. Krishnans credibility is therefore suspect in his claims based on his motive to reprise
against Dr. Klein for reported illegal Opioid matters (founded by OIG), parking violations
noted, and EEO complaints and OSC complaint filed against him. Dr. Kleins complaints
were founded by OSC and OIG.
Dr. Klein disputes whether many of the allegations in the proposed removal occurred. Being
cautious and safety oriented is not misconduct. Frequent communication from a
supervisor, innately tasked with supervision of a subordinate, often in extremely sensitive
situations is not Contradicting prior actions of a subordinate is not misconduct, even if it causes
the subordinate to waste time, if the prior action was inadequate or misguided. In fact, failing to
correct a subordinate's error is far more likely to result in greater harm, yet the proposed removal
shows no concern over this issue. Further, exercising discretion regarding which meetings a
subordinate is to attend is not misconduct.
Providing inconsistent guidance, while understandably possibly frustrating for a subordinate,
is not misconduct. This is especially so, as inconsistent guidance frequently results from new
information or analysis that requires changing the appropriate course of action.
In essence, Charge 1, specifications 1-4, accuse Dr. Klein of being too devoted to the care
of patients he specializes in caring for by wanting to see proper protocols in place to prevent
harm. It is revealing that the Agency seems more upset that Dr. Klein was double-checking that
legal options were being properly explained, and his quoting safety issues back to management,
than whether the Veterans that seek treatment were in fact being adequately cared for, in line with
the proper pain management protocols which OIG found were being violated (as Dr. Klein
claimed). These are critical moments for patients, and perhaps a better way of viewing Dr.
Kleins actions might be through the old adage, "it is better to be safe than sorry." Woven
throughout is the recognition of Dr. Kleins determination to protect patients in the face of
entrenched internal opposition to his safety concerns, created by the VA Medical Center. The
Agency characterizes Dr. Klein as being confrontational and argumentative , and fails to see that
the very nature of his position required Dr. Klein to correct the Agency's prior practices, which
had endangered the safety of countless patients through the same acts it was now trying to induce
Dr. Klein to perform (improper protocols and lacking updated know-how, related to pain
management matters). Fighting to create a safety-conscious medical staff, in the deadly practice

31
of pain management, amid concerns for overdoes and addiction, is not misconduct. Stating that he
was somehow disrespectful to Dr. Krishnan is absurd, amid the seriousness of issues involved.
OTHER Review of Scope of Work for Physician
According to the scope to the scope of work provided to Dr. Klein:
Clinical privileges must be recommended by the Chief of Staff and granted by the Director
of the Poplar Bluff VA Medical Center. We have no reply on this from the VAMC as
to granted credentialing
Employment is contingent on the ability of the physician to be credentialed by the VA
Network Credentialing Office. We have no reply on this from the VAMC as to
granted credentialing
According to reviewed SF50 and performance records (in an email to management, on June 6,
2017, at 7:15 AM, Dr. Klein reported to management):
I want to bring to your attention, as a disclosure under the law, I was finally given access
to review my SF50 in my eOPF today and it shows I received a successful performance
review during the period of time that I was kept away from patients, practice and medical
work.
I am concerned that someone at the PBVAMC has possibly falsified federal records that
impact patient safety and personnel records. Please provide the corresponding proficiency
review, and information on updated CMEs I should have.
Also, please provide a letter from you stating you have passed me in the requirements of
my Board certifications and please provide me with a copy of my current credentialing
records.
I have met with the nurse assigned to me by the VAMC with the nurse's supervisor (Gum).
However, the nurse has not interacted with me as to any particular process, training or plan
for patient care nor have I been made aware of the nurse's certifications or abilities as they
relate to pain management care.
Dr. Nair, as a fellow medical practitioner, you should realize you are not just endangering
patient safety, but performing actions contrary to the joint commission requirements, and
requirements of my sub-specialty. I will see patients, as I have been ordered to do, and I
will send you my requests to review and sign the patient charts going forward.
Mitigation Attempt by Dr. Klein
Medical Skills decline over time.29 There is substantial evidence that time out of practice does
impact on skills retention. Skills have been shown to decline over periods ranging from 6 to 18
months, according to a curve, with a steeper decline at the outset and a more gradual decline as
time passes. The amount of time between learning and losing a skill varies between skills and
between individuals, with many mitigating factors30

29
http://www.gmc-uk.org/Skills_fade_literature_review_final_Report.pdf_60956354.pdf, Last checked June 25,
2017.
30
Id.

32
SUMMARY
The following facts are not in dispute: Dr. Klein is a whistleblower and is under protection
of the WPEA. Dr. Krishnan parks in Veterans spaces. Dr. Kleins allegations of Opioid and other
wrongdoings at VAMC have been founded. Dr. Klein reports patient safety concerns stemming
from him being assigned to immediate physician duties without proper reentry process and NO
ONE at the VAMC, VISN, and VHA, took notice, offered help, or worked with Dr. Klein on this
matter. Instead, a proposal to remove Dr. Klein is issued and the concern expressed for patient
safety by Dr. Klein is not addressed. Further, no reentry training/process has been allowed for Dr.
Klein. Moreover, there is no written agreement between Mr. Barlage and Dr. Klein for Dr. Klein
to see patients, and the medical profession agrees that being away from medical practice, more so
medical subspecialties, creates patient safety concerns and practitioner skill and knowledge
deficits. In summary, Dr. Kleins arguments that he is ready to see patients, but request to update
his skills and know-how first, is supported by law and medical literature.
Another matter that is clear is that there are no orders regarding, and the Agencys chances
to clarify that the communications to Dr. Klein are orders, by Dr. Hall and Dr. Nair, were never
taken. Further, the communications reflect confusion over Dr. Kleins preparedness, more so when
Dr. Nair requests Dr. Klein participate in an intubation (See attached) which is NOT Dr. Kleins
medical practice, and has not been for over 10 years.
The emails between Dr. Hall and Dr. Klein are not about Orders and are unclear. Dr. Klein
sought clarification and NONE was provided. The emails between Dr. Nair and Dr. Klein are
equally unclear the same Dr. Nair that swore in a court document Dr. Klein could not work at
the VAMC, should not work, and cant serve Veterans now asks him to see patients in violations
of medical oaths to protect patients, DEA laws, and VA regulations and policies, without replying
to Dr. Kleins requests for proper reentry process.
Federal employees that engage in appeals and grievances over workplace matters have
protection against reprisal under 5 U.S.C. 2302(b)(9), and this coverage "does not turn on the
substance of an employee's testimony," and retaliatory actions are prohibited regardless of how
unreasonable an employer finds the testimony. Kubicko v. Ogden Logistics Services, 181 F.3d 544,
554 (4th Cir. 1999); U.S. v. Glover, 170 F.3d 411 (4th Cir. 1999). When an employee, such as Dr.
Klein, makes disclosures to management of patient safety concerns relating to his reentry into
critical fields, amid Opioid problems founded by the VA OIG within the pain management
practices at PBVAMC, those are protected as opposition to retaliation, even though the employee
made some of those disclosures in response to a management inquiry for his return to medical
practice. The Agency's allegations that Dr. Kleins actions amounted to not obeying Orders, is hog
wash, poppycock, and Codswallop completely unsupported. Therefore, if Dr. Klein is welcomed
at VA after reporting Opioid violations, the VA should transfer him, not fire him. The law,
previously mentioned is clear everyone must follow the rules and VA cant force Dr. Klein to
perform medical procedures and practices against laws and regulations/rules meant to provide for
patient safety and ensure a proper quality healthcare practice is maintained. Dr. Klein is a licensed
professional and knows the risks of treating patients within his specialty can be severe. This is
evidenced in that after Dr. Klein, through attorneys, identified needed reentry options, the Agency
simply refused to engaged in discussion or realistic option offers seeming to accept that Veterans
(patients) will be harmed by Dr. Klein if his skills are not updated.

33
Given the foregoing, we believe that the Agency's removal of Dr. Klein cannot
be sustained, even absent his affirmative defense of whistleblowing reprisal, for which the
Agency must justify its penalty by clear and convincing evidence. We are requesting by this letter
an oral reply as well; please contact me directly to schedule a mutually agreeable time and place.
The location for the oral reply must be convenient for the employee, and the CBA mandates
grievances be face-to-face and as a deciding official any grievance on this matter will be a VACO
grievance. We request the verbal reply be performed at PB-VAMC.

Best,

____________________________
Natalie K. Khawam, Esq., MBA, MS
Whistleblower Law Firm, P.A.
400 N. Tampa St., Suite 950
Tampa, FL 33602-4700
Office: (813) 944-7853
Nataliek@813whistle.com
Attorney for Complainant

34
Natalie Khawam, Esq, MBA, MS 400 North Tampa Street, Suite 950
Loretta Poston, Esq. Tampa, Florida 33602
Samantha Postlewaite, Esq. Office: 813.944.7853
Javier Soto, Esq. Fax: 813.434.2173

May 17, 2017


Michael E. Anfang
Deputy Chief Counsel
Department of Veterans Affairs
1201 Walnut Street, Suite 800
Kansas City, MO 64106

Mr. Anfang,

We appreciate your opinion on the matter of Dr. Kleins employment. We want to correct
some misinformation in your communication that we find incongruous to the record on this matter,
as developed by your office. We want to ensure our nations Veterans have the highest standard
of care and that Dr. Klein is given the ability to have training and the proper tools and equipment
to provide the high standard of care he prides himself on giving the Veterans. The standard of care
in which he was denied the ability to keep current when he was kept in solitary confinement in an
office without access to patient records, software, training, or even the ability to consult with other
doctors. We would hope that these are similar goals of the VA, however, we are not seeing any
steps towards addressing these very critical concerns for doctor or patient care.
We are sure you can appreciate that a doctor needs certain tools and updated training in
order to provide a patient with the appropriate care. With our concerns further heightened due to
the current actions taken by the Agency in direct contradiction of the Agencys proclamations to
the MSPB about the PBVAMC not having a need for a pain management clinic, the extreme
burden to get a pain clinic and pain patients to the PBVAMC, and no need for a doctor with Dr.
Kleins abilities, we are underscoring the below events and contradictions to clarify our heightened
concerns .
Agencys August 15, 2016 letter to the MSPB and OSC in response to the
Boards Order on July 18, 2016, Agency counsel stated, . . . reestablishing and
staffing a pain management clinic, where none presently exists, and then getting
patients scheduled, is also not a realistic option.
Agencys August 15, 2016 letter to the MSPB and OSC in response to the
Boards Order on July 18, 2016, Enclosure of the Affidavit of Chief of Staff, Dr.
Nair, on August 12, 2016, states [t]here is simply nothing for Dr. Klein to do unless
we take on the enormous task of expanding the nature and scope of the clinical
services provided at this facility.
Then in the Agencys Response to U.S. Office of Special Counsels Initial
Request for Stay of Personnel Action on May 31, 2016, Agency counsel stated,
[f]urther, the OSCs request to restore Dr. Klein to his official positon of record,
with all of the attendant duties, is simply not practicable in view of the closure of
the clinic where Dr. Klein worked. And goes on to state, . . . it is not practicable,
or even possible, to restore him to the duties he was performing prior to the actions
which led to his separation. And, . . . it will not be possible to reassign him to the
Pain Management Clinic where he was formerly employed.
Then in the Agencys Response to the U.S. Office of Special Counsels
Motion to Modify the Order Granting Initial Stay Request on June 11, 2016,
Agency counsel stated that the pain management clinic, is not like an emergency
room or primary care clinic. One cannot expect a parade of patients to be corning
through the door just as soon as the clinic announces it is "open for business," so to
speak. Patients must be referred to the clinic by primary care providers.
Then in the Agencys Response to Petitioner's Stay Extension dated
6/30/2016 on July 7, 2016, Agency counsel stated, [a]t the heart of the OSC
request to extend the stay is a hope that Dr. Klein can somehow be restored to his
former position as a pain management physician at a facility that does not have any
present need or use for a physician with his skills and privileges. The Agency goes
on to state, [h]owever, there is no reason in law or fact to require the Department
of Veterans Affairs to establish a pain management clinic in Poplar Bluff and begin
scheduling patients at that clinic.
In some of Dr. Kleins direct concerns to the PBVAMC about the pain clinic that was
closed down, he was not provided the facilities or equipment to perform the procedures necessary
for patient pain management care. Please advise if the pain management clinic is fully operational
with staff, equipment, and that the facilities are equipped with all up-to-date necessary, safety
tools. Also, Dr. Klein has had great concern for his own safety, as in the past when he has requested
VA police assistance, his panic alarm requests were ignored and no response by VAPD was given.
Please assure us that if Dr. Klein were to need any assistance for his own safety, with patients or
in general, his panic alarm or calls will be answered in accordance the protocols required by the
VA.
As to your email sent May 16, 2017:
1. You advise you were not notified as to the email matter by your client. Please ensure your
client is advising you of its actions against our client, as this is the matter we are trying to address.
2. The concerns filed at OSC impact his job at the VA. Therefore, your statement that OSC
report not withstanding is discerning. It is the legal issue looming over the actions we bring to
you, as Agency counsel, to address. You have not addressed this.
3. We agree Dr. Klein is an employee. However, Dr. Klein has an obligation to the Veterans,
as his patients, and VA, as his employer, but the VA has an obligation to him to provide him with
all of the necessary tools and training to perform his obligations.
4. You state, he is a VA employee receiving compensation. As a result, the VA has a
reasonable expectation for him to perform his duties. We are confused your offices
communications and the Poplar Bluff Directors Office Communications, for over a year,
has argued against this very premise.
Further, it was the Hospital Director that removed him from performing his duties, keeping
him confined to a room without access to patients, charts, or software. In fact his requests to do
Continued Medical Education courses fell on deaf ears and were not approved. The Director at
Poplar Bluff caused a deficit in status of his ability, as practitioner, to be current on the medical
changes in his field. Yet, you simply ignore these concerns despite bringing this up within
motions filed at OSC and MSPB. Please clarify if the Agency is waiving all training, any policy
and practical/practice requirements for Dr. Kleins profession and specialty under joint
commission, in this matter.
Dr. Klein is meeting his responsibilities as an employee by reporting the deficit created
against him by the Poplar Bluff Director, and seeking to remedy that deficit, to again begin serving
patients with the highest standard of care our Veterans deserve. We believe that is remedied by
action, such as approving training as specified in our proposal rather than arguing about
compensation and not performing duties duties in which the VA seemed just fine with for over
a year, and you argued was proper on behalf of the VA.
5. You offer, again, obtuse descriptions of secret meetings between Mr. Barlage to Dr. Klein.
We see no agreement, signed or otherwise, that resolves the issues noted to OSC or resolves any
impediments to Dr. Klein returning to practice. We cannot confirm any conversations are
accurately portrayed in Mr. Barlages email because our client disagrees with some of the items
listed.
For your understanding, since the matter was under dispute and litigation, your office and
ours should have been made privy to such communications, if they occurred as stated, to avoid the
confusion everyone is having at this time. Would you like to set a time to sit down and discuss
this with the involved parties and try to reach a written agreement?
6. You state, remind you that during the course of the MSPBs continued stays of the
removal, the VA agreed to allow Dr. Klein to see patients. This does not address training issues
also noted at OSC. You ignore this vital fact. This is not a janitor in a VA Hospital. This is a
highly-credentialed doctor with licenses and requirements for continuing education and patient
contact experiences.
7. You state, [n]ow that the VA has made it clear it will not be implementing the removal,
the VA has moved from agreeing Dr. Klein can see patients to expecting him to see patients. Our
client is concerned about continued reprisal, the needed training and patient contact experiences
as required by a host of VA policies and rules/laws. Our client expects to practice medicine, when
returned to his baseline, so he can practice within the high standard of care our Veterans deserve
and the guidelines of the joint commission, his certifications, VA policy, and so on. Please advise
what steps are being taken to provide the doctor the ability to see patients within these requirements
and standard of care.
8. You state, [a]s I stated previously, Poplar Bluff VA Medical Center management has no
desire to put patients at risk. However, then you state, [i]f you or Dr. Klein can specifically
articulate how Dr. Klein who has communicated to management previously that he wants to see
patients would be lowering the standard of care by seeing patients now, then the VA can conduct
an evaluation. Our proposal addresses this by stating that an evaluation by Poplar Bluff would be
akin to allowing the fox to check the hens at the hen house, amid the report by OSC. If you want
to discuss this further, we are available. We have articulated our concerns in our proposal a
proposal to which both, you and the hospital have failed to respond.
The training issues must be addressed. Dr. Kleins concerns are valid as you are asking
him to see patients with the full liability of the Agencys past actions resting on his shoulders alone
in a facility of individuals that commit prohibited personnel practices against him. The same
individuals that have argued for a year that his skills are not needed, have attempted to terminate
him, and have sent him to the confinement of a cubicle for a year - allowing his patient contacts
and the practice of his pain management procedures to degrade. Then, those same individuals
decide, amid congressional action, to continue his stayed employment with no explanation, during
arguments by your office of malpractice concerns, and no impartial or non-Poplar Bluff affiliated
party has yet to meet with Dr. Klein to assess his readiness for patient care, software access,
program training, pain clinic requirements, etc. Any such assessment can only be performed by a
similarly credentialed practitioner, such as the doctor at New Orleans. As an attorney, that defends
the VA in malpractice claims, surely you can identify with this concern.
We are available to discuss this at any time with you. I would suggest a global approach,
with OSC present. Please advise if you are interested in settling matters. However, make no
misjudgment, it is our view the doctor may report any and all activity assigned to all proper
authorities, including his patients, about what has occurred, and that the VA is forcing him, through
threat of job loss, to perform, without proper acclamation from the Agencys year-long
confinement period without patient interaction.
Unless this is resolved, we anticipate continuing litigation and more WPEA claims. Is your
office interested in resolving this matter for Americas Veterans? We are. Please advise.

Best,

Natalie K. Khawam, Esq., MBA, MS


Whistleblower Law Firm, P.A.
400 N. Tampa St., Suite 950
Tampa, FL 33602-4700
Office: (813) 944-7853
Nataliek@813whistle.com
Attorney for Complainant
Natalie Khawam, Esq, MBA, MS 400 North Tampa Street, Suite 950
Loretta Poston, Esq. Tampa, Florida 33602
Samantha Postlewaite, Esq. Office: 813.944.7853
Javier Soto, Esq. Fax: 813.434.2173

May 30, 2017

Dear Mr. Angfang,

On May 24, 2017, you and Director Hall implied that Dr. Klein has the tools discussed on a
call with counsel and OSC. However, Dr. Klein has not received access or information as
requested for his position and/or his ability to see patients.

1. Electronic patient medical record software CPRS Dr. Klein does have access to this
program, however he needs additional training in the upgrades that have been made to the
software for proper CPRS use.
2. Radiology software the software was added Dr. Kleins computer last week, however
he does not have a username or password to access the software and he needs training in
the softwares upgrades and functions, to include how to adjust/set program preferences,
to optimize patient care.
3. Dictation software to use with CPRS Dr. Klein still does not have this software
available to him and has not received any information as to when it will be available. Dr.
Klein also understands that this program has been upgraded since he last had access to it
and will need the appropriate training to optimize patient care.
4. Dr. Klein has met with the nurse assigned to him by the VAMC with the nurses
supervisor (Gum). However, the nurse has not interacted with Dr. Klein as to any particular
process, training, or plan for patient care. The nurses certifications or abilities have not
been discussed with Dr. Klein as related to pain management care. Will Dr. Klein be
supervising his nurse? Will he provide performance reviews?
5. Dr. Nair will be Dr. Kleins supervisor. Does Dr. Nair have pain management
background to supervise and consult on patients with Dr. Klein during his re-acclamation
period? Will Dr. Nair second sign all charts and consults?
6. The position information sent What are the measurements to which Dr. Klein will be
assessed to determine patient and doctor quality of care? Performance?
7. SF-50 Dr. Klein has not been provided with or explained how to access his SF-50s
8. Clinic location 3 clinic spaces Dr. Klein currently occupies Dr. Klein is currently in
the Clinic where he is to see patients? He occupies 3 spaces?
a. What pain management tools and supplies are being provided to Dr. Klein to be
able to provide pain management care to patients?
b. What specific location within the hospital is designated as the Pain Management
Clinic?
Dr. Klein is looking forward to treating Veterans with the highest standard of care, that our
Veterans deserve and that he was proudly providing over a year ago. However since Dr. Klein has
been in confinement without access to practice or patients, he is reasonably requesting for a period
of re-acclamation to properly provide pain procedures and review any changes in Pain
Management guidelines.
At this time, please provide:

1. All of Dr. Kleins SF-50 forms since he began with the PBVAMC and the SF50 showing
his present assignment/position
2. Dr. Kleins credentialing records at PBVAMC, as to current status, and who updated his
status in the credentialing records
3. How the PBVAMC will provide Dr. Klein training in the software programs discussed
above
4. When will the PBVAMC provide the dictation software needed by Dr. Klein for patient
care.
5. Is the Agency waiving any malpractice and professional standards issues that may come
up until Dr. Klein is back to currency in his profession and specialty?
a. We need to see a progressive plan of exposure and training. We are concerned, and
remain so, that he is likely to be attacked by management on his professional
currency and we are not seeing attention to this matter.
b. Unless a progressive exposure and patient contact plan is put in writing, we have
no option but to recommend to Dr. Klein that all patient contact be reported to the
OIG as possible violation of patient safety issues and that he is being forced to see
patients without being returned to baseline and these actions may be considered
a hostile work environment for which an EEO complaint may be filed against
present supervisors, and amended at every assignment. Also, we must recommend
that the same be reported to the Joint Commission.
6. Can the PBVAMC temporarily approve Dr. Klein to shadow and have consults with Dr.
Sanjay Sharma, at New Orleans, VAMC? He is a similarly credentialed pain management
physician as Dr. Klein.
a. The training and shadowing regimen would involve a reasonable amount of time
and is dependent on many factors. Since Dr. Klein has not performed procedures
for more than a year, he would need to do simple procedures before he could
perform the more complex procedures. Re-integration on those procedures can
take a varied amount of time because it depends on how often those procedures are
performed at the New Orleans VA. Any procedures performed at Poplar Bluff
VAMC would be limited to those he can gain experiences back in at New Orleans,
until he is back up to where he was before being kept from patient care over a year
ago.
b. An alternative would be for Dr. Klein to consult with Dr. Sharma at the New
Orleans VAMC on all of his consults and patients to ensure the highest level of care
for our Veterans. Dr. Nair would therefore not be a technical supervisor on any
consults and any issue of pain management would be reviewed at New Orleans
VAMC.
At this time, without additional safeguards for Dr. Klein and Veteran patients, for every
medical chart that comes before Dr. Klein, he will ask for a second medical signature and he will
make the appropriate disclosures in support of our Veterans for each assignment.
In addition, please provide a written Memoradom from Director Hall of the PBVAMC
specifying that Dr. Klein is instructed to see patients without the concerns herein being addressed.
Unless there is an Memorandum signed by Director Hall, we consider Director Hall to agree with
us that these matters need to be addressed as stated.
Please provide the requested information by close of business on Thursday, June 1, 2017. If
you have any questions or concerns, please contact my office.

Best,

____________________________
Natalie K. Khawam, Esq., MBA, MS
Whistleblower Law Firm, P.A.
400 N. Tampa St., Suite 950
Tampa, FL 33602-4700
Office: (813) 944-7853
Nataliek@813whistle.com
Attorney for Complainant
From: Barlage, Seth W.
Sent: Friday, May 12, 2017 11:44 AM
To: Klein, Dale J.
Subject: PMC Follow Up

Dr. Klein,
You and I have met on three separate occasions recently to discuss the issues surrounding the PMC
that the you believe need resolution. I have diligently been looking into all of those issues, and
based on my responses below, I believe there are no items preventing the full restart of the PMC.
Please review my responses, and let me know if you have any questions or concerns.

1. Confirmatory Testing The current practice remains in effect, which is the lab will process
all provider orders for confirmatory testing. If a provider believes confirmatory testing is
clinically indicated, the provider may place the order for confirmatory testing. All positive
UDS specimens are held in the lab for 7 days, giving the provider the opportunity to order
confirmatory testing if thats what the provider wants.
a. You are free to order confirmatory testing as you deem clinically necessary.
i. For your information, an in-house UDS cost $0.98. Confirmatory testing
for benzos cost $16.33 and opiates costs $24.49.
2. Neuro-Radiologist Reads As you and I discussed, I have confirmed that the St. Louis VA
has a fellow-trained neuro-radiologist on staff. I have had discussions with the St. Louis
Chief of Radiology and she sees no problem with their neuro-radiologist doing the occasional
initial read for when you request a neck/spine MRI. Based on what you told me, the possible
workload sent to the St. Louis provider is 1-2 per week, which is what I told St. Louis. Our
local radiology department has confirmed they can ensure that the initial read request is
sent to the appropriate St. Louis provider.
a. If a need arises early next week to order a neck/spine MRI, you will need to let me
know immediately so I can help ensure that we work through this new process. In
the meantime, I will work with both St. Louis and Poplar Bluff staff to sure up the
process.
b. St. Louis neuro-radiologist may wish to speak directly to you to work out the
process. Ill let you know if that request comes through. Ultimately, it appears it will
be a memorandum of understanding (MOU) between us and St. Louis. Entirely
doable and something that can happen quickly.
3. Change of Supervisor Your new supervisor effective Monday, May 10, 2017 for both
administrative and clinical needs will be Dr. Nair.
4. Writing Scripts You are free to write scripts as you deem necessary in order to provide the
appropriate level of care to the Veterans you will be treating.
5. Accessing Patient Records Related to Pain Consults When you receive pain consults, you
are free to access each respective patients record to evaluate the next appropriate steps
related to addressing the consult.
6. Pain Nurse Your pain nurse will be Lonnie P. He does not require any additional training
specific to assisting you in the pain clinic. As you and I discussed, he will however need to
work with you to discuss your expectations within your clinic.
7. Medical Supplies for Procedures As you and I discussed, please work with your Pain
Nurse and Carolyn Hill in Logistics to acquire the necessary supplies needed for your
procedures.
a. I will have Ms. Hill come visit you and Lonnie to begin work on providing your clinic
with the necessary supplies.
8. Isite Radiology Software Adjustments I have confirmed that in order for the optimization
of the software to occur, you must be logged into your computer. The settings are specific
to the user, which requires the user to be logged in. Our local staff can make the
adjustments. I will have the appropriate staff come to your office either today or Monday
morning to make the simple adjustments, but you must be logged in as the user for the
settings to be changed for you.

Recommended PMC Restart Process:

All medical center providers will be notified that the PMC is activated and that you are
available and awaiting their consultation requests.
Your primary focus will be to review 100% of pain consults and to make the appropriate
determination if you will provide the treatment or if the consult should be converted to
Choice/Care in the Community consult.
o This will apply specifically to providers at VA Medical Center here in Poplar Bluff only
because CBOC providers are authorized to enter a Choice consult for any specialty
service not offered at their respective CBOC. However, if the CBOC patient
specifically requests to be treated by the VA in your clinic, the CBOC provider will
place the appropriate consult to your clinic.
There are currently some pending consults (local and Choice/Care in the Community) that
should be sent your way for review and determination ASAP.
Your clinic scheduling profile/grid will be populated with slots to allow for full scheduling.
Use Monday morning to work with Carolyn Hill (Logistics) and Lonnie C. on the supplies, and
work with Lonnie C. and the 3rd floor scheduling staff on the process for reviewing and
scheduling consults.

If you have any questions or concerns, please let me know. Also, I will be happy to meet with you in
person if needed. Just let me know if you would like me to schedule a face-to-face meeting.

Seth W. Barlage
Associate Medical Center Director
John J. Pershing VA Medical Center
Poplar Bluff, MO
Subject: Dr. Dale Klein
Date: Monday, May 15, 2017 at 7:08:44 AM Eastern Daylight Time
From: LoreAa Poston
To: Ten Haaf, Patricia, michael.anfang@va.gov, Hall, Patricia L. (POP)
CC: Natalie Khawam, Javier Soto

A8achments: Ltr for Dr. Klein -Poplar Blu VAMC 5-15-2017.pdf, SetAgr Dr. Klein v DVA 5-15-2017.pdf

Please see attached documents. These documents are also being sent in hardcopy via certified mail for your
convenience.

If you have any questions or concerns, please contact our office.

--
Kindest regards,

Loretta C. Poston, Esq.


Managing Attorney
Whistleblower Law Firm, P.A.
400 N. Tampa Street, Suite 950
(813) 944-7853 Office
(813) 434-2173 Facsimile

--
NOTE: The Florida Bar Disciplinary Counsel requires that all recipients of e-mail correspondence relative to legal matters be notified that (1) e-mail
communication is not a secure method of communication, (2) any e-mail that is sent to you or by you may be copied and held by various computers it
passes through as it goes from me to you and vice versa, (3) persons not participating in our communications may intercept our communications by
improperly accessing your computer or my computer or even some computer unconnected to either of us which the e-mail passed through. If you want
future communications to be sent in a different fashion, please let me know.

Privileged and Confidential: Unless otherwise indicated or obvious from the nature of the transmittal, the information contained in this message is
privileged and/or confidential information intended solely for the use of the addressee. If the reader of this message is not the intended recipient, or
the employee or agent responsible to deliver it to the intended recipient, you are hereby notified that any dissemination, distribution or copying of this
communication or any of the information in it is strictly prohibited. If you have received this communication in error, please advise the sender by reply
e-mail and then delete the message. Thank you.

Page 1 of 1
Natalie Khawam, Esq, MBA, MS 400 North Tampa Street, Suite 950
Loretta Poston, Esq. Tampa, Florida 33602
Samantha Postlewaite, Esq. Office: 813.944.7853
Javier Soto, Esq. Fax: 813.434.2173

May 15, 2017

VIA CERTIFIED MAIL AND EMAIL CORRESPONDENCE


Director Patricia L. Hall, RN, MSN, PhD
John J. Pershing VA Medical Center
1500 North Westwood Blvd
Poplar Bluff, MO 63901

Dear Director Hall:


We have reviewed the offer you made to Dr. Klein on May 12, 2017, in an unofficial
letter stating you will not remove Dr. Klein from employment, despite your refusal of the Office
of Special Counsels (OSC) request to informally extend the Merit Systems Protection Board
(MPSB) Stay Order. It appears you have chosen to rescind the April 28, 2016 removal action
initiated by you, however, your decision to rescind your unwarranted termination does not
constitute corrective action required by the OSC, or law.
There are several concerns we have over this offer and your request that Dr. Klein abruptly
begin seeing patients on Monday, May 15, 2017. We require further action from you to bring this
matter to an official and legally supported resolution. As you know, this is the same removal
action that you were forced to stay by the MPSB, through intervention by the OSC, amid
allegations of Prohibited Personnel Practices (PPP) against you and the VA Medical Center in
Poplar Bluff, MO, over the last year.
First, your Agency Counsel, Mr. G.M. Jeff Keys, has asserted various concerns over Dr.
Kleins diminished skills, or inaccessible role as a physician, to the MSPB, and the OSC, resulting
from Dr. Klein being involuntarily and entirely removed from the practice of medicine for over
one year, at Poplar Bluff VA Medical Center. Mr. Keys communicated these concerns to MSPB
and OSC, on May 31, 2016, June 11, 2016, June 30, 2016, August 12, 2016, August 15, 2016,
September 2, 2016, and on November 2, 2016.
Moreover, Mr. Keys communications were quite clear: The Director and Chief of Staff at the
John J. Pershing VA Medical Center had already determined that the VA Medical Center lacked
sufficient resources to properly support a pain management clinic. Further, on June 30, 2016,
Agency Counsel stated: there is just nothing for Dr. Klein to do at the Poplar Bluff VA Medical
Center that would allow him to utilize his clinical skills and credentials. Agency counsel went
on to add: Not only is the Agency liable, under the Federal Tort Claims Act, for any acts or
commissions of our clinical staff which fail to meet the applicable standard of care and cause
harm or injury to our patients, the Agency is also potentially liable for failing to properly screen,
assign and/or train our staff so as to ensure those staff members have the appropriate skills,
training and experience to perform the clinical tasks to which they are assigned.
As such, we are extremely concerned your letter to Dr. Klein does not contain a legal
sufficiency review acknowledgement from your counsel, as the requests for Dr. Klein to begin
seeing patients made in your letter directly contradict the assertions made to both MSPB and OSC
by the agency through your counsel. Also, your letter is not on Agency letterhead and does not
appear to be officially sanctioned. As a result, you are placing our client in a position of incurring
liability from unresolved issues related to your forceful actions against him that have prevented
him from seeing patients for over one year. Moreover, your request that Dr. Klein report to work
ready to see patients on May 15, 2017, appears to be adding to the patient safety risks our client
reported to the OSC, that resulted in the ongoing legal action involving MSPB and OSC for more
than a year.
Additionally, your letter fails to address the concerns expressed by your Agency Counsel,
which are also concerns shared by our client. We understand that the Agency is to waive all
discipline, performance, competency, and liability issues and actions against our client for any
practice of medicine he engages in at Poplar Bluff VA Medical Center (VAMC) when he begins
seeing patients on May 15, 2017. If the above is not the case, Dr. Klein requires appropriate time
for proper acclimation back into the practice of his profession, specialty, and Board certifications,
as demanded by the Joint Commission, and VA Handbook 2009-053. Your offer opens our client
to face possible liability and discipline for engaging in duties he cannot safely perform without
adequate re-training, progressive patient contact experience, integration to his specialty, and the
practice of medicine in general because of your actions against him.
We find it appropriate to note the lack of interest in serving Americas Veterans
displayed by your action against our client on April 2016, and a letter that contradicts
Agencys legal Counsels opinions. Our client cannot perform duties contrary to Agency
policy, Joint Commission requirements, and his specialty requirements. Most importantly
Dr. Klein will not place Veterans at risk of injury because you refuse to properly address the
matter of the Prohibited Personnel Practices (PPP) that impacted his medical practitioner
skills and currency in those skills, that are still left unrectified by your letter, including
resolving the matter of related injury/damages under law.
The removal action you initiated against our client, that you were forced to stay by the MSPB,
through intervention of the OSC, is not remedied by your letter. The letter you provided to Dr.
Klein on Friday, May 12, 2017, without a legal sufficiency statement by Agency counsel, was after
the U.S. Senate passed a bill providing an easier path to the stay, which we expect will become
law shortly, giving you little choice in the matter, amid the PPP report recently delivered by OSC
to the VA this past week, provides little comfort or assurances that our client can revive his career
or that the barrage of reprisal he has endured will stop at the facility you supervise.
We are also deeply concerned in the broad and vague verbiage used in your letter. The letter
lacks any content addressing the issues vital to our client and his concerns about patient/veteran
safety he has brought before you and the Office of Inspector General (OIG) and OSC. Your letter
creates no practical and safe path for our client to return to his former duties, and reflects a gross
and negligent approach to medicine, amid missing legal sufficiency review by agency counsel,
placing your integrity in question as to whether this is a good faith offer.

Page 2 | Dr. Klein


Contents may be protected by 5 USC 552a
Dr. Kleins medical knowledge and skills have been deeply harmed by your reprehensible
actions of keeping him in isolation without the ability to continue evolving his knowledge and
apply his skills to the veterans that need it the most. Practitioners need current knowledge of
established and evolving biomedical, clinical, and cognate sciences, and how to apply this
knowledge to patient care. This requires completion of educational and training requirements as
well as on-the-job experiences, in-service training, and continuing education. Practitioners require
technical and clinical skills to perform specific privileges/procedures. Such skills are based on
both knowledge and the ability to apply the knowledge. Clinical judgment, imperative for
practitioners, refers to the observations, perceptions, impressions, recollections, intuitions, beliefs,
feelings, inferences of providers. These clinical judgments are used to reach decisions, individually
and/or collectively with other providers, about a patients diagnosis and treatment. Clinical
judgment comes from daily interactions with other medical professionals and cases/patients, as
well as ongoing educational efforts. On all the above, daily and periodic contacts and work
experiences are critical.
For Dr. Klein, the above has been obstructed, denied, and otherwise encumbered, for over one
year, after you, as the deciding official, ordered he sit in a room, not practice medicine at Poplar
Bluff VA Medical Center (VAMC), and made written threats against his medical license, all
without just cause. Following this history of actions taken by you against our client, we hope you
can understand why your offer made in a letter, not on agency letterhead, without review of your
counsel, who has made multiple written motions that contradict your letter, appears to overlook
the harm resulting by you in both acknowledgement and remedy.
Dr. Klein came from the private sector to work with Veterans and provide the highest care
possible to our Nations Veterans. The medical profession is considered a noble profession
because it helps in preserving life. A patient generally approaches a doctor/hospital based on
reputation. Expectations of a patient are two-fold: doctors and hospitals are expected to provide
medical treatment with all the knowledge and skill at their command and secondly, they will not
do anything to harm the patient in any manner either because of their negligence, carelessness, or
reckless attitude by staff or leaders. Medical malpractice is professional negligence by act or
omission by a health care provider in which the treatment provided falls below the accepted
standard of practice in the medical community and causes injury or death to the patient, with most
cases involving medical error. Yet, when Dr. Klein saw the substandard practices being taken at
your hospital, his concerns fell on deaf ears. Instead of raising the hospitals standard of care for
our Veterans, you tried to silence our client through the numerous acts of reprisal and attempted
to terminate his employment. Again, your letter appears to have overlooked this harm in
acknowledgement and remedy.
As the field of medicine learns more about the complexities of pain, it has become more
important to have physicians with specialized knowledge and skills to treat these conditions such
as pain management specialists. We believe concerns such as these were behind the VHA Director
2009-053, issued in 2009. With an increasing number of new and complex drugs, techniques, and
technologies becoming available every year, frequency of training and experiences is vital for the
pain management specialist. This is even more crucial because the pain management specialist
plays an important role in coordinating additional care such as physical therapy, psychological
therapy, and rehabilitation programs to offer patients a comprehensive treatment plan with a
multidisciplinary approach to the treatment of their pain. Since many types of chronic pain require
a complex treatment plan, as well as specialized interventional techniques, pain specialists today

Page 3 | Dr. Klein


Contents may be protected by 5 USC 552a
must have more training than in the past, and this usually means frequency in training, patient
contact experience, and board certifications and maintenance of those certifications, which
require frequency in patient contact experiences. Lastly, an interventional pain doctor, such as our
client, refers to a specific type of pain specialist, practicing a subspecialty of pain medicine. The
subspecialty of interventional techniques includes those techniques that are more substantial and
even sometimes invasive for treating and managing various pain conditions making the
requirements of ongoing training and patient contact experience even more vital. Again, in this
matter, our client has been obstructed, denied, and otherwise encumbered, for over one year, in his
practice of medicine and his specialty. Your letter seems to have overlooked this harm and liability
in acknowledgement or remedy.
In 2000, as part of a national effort to address the widespread problem of underassessment and
under treatment of pain, the Joint Commission (formerly the Joint Commission on Accreditation
of Healthcare Organizations [JCAHO]) introduced standards for organizations to improve care for
patients with pain. Consistently, the focus is on training of the medical specialists and compliance
with ever changing host of requirements and complexities in the field. In 2009, the U.S. Veterans
Health Administration (VHA) adopted "Standards of Pain Management" to improve the
organization and delivery of integrated pain care throughout the VHA (see: VHA DIRECTIVE
2009-053 October 28, 2009). The information in this handbook is supported by the VA website
publicizing, educate/train all team members to their discipline specific competencies as part of
VA overall pain management approaches (see: https://www.va.gov/painmanagement/). The VA
directive, among other requirements, specifies: develop, implement, and disseminate education
and training tools to assist VHA clinicians in acquiring the skills necessary to provide high-quality
pain assessment and treatment. It also notes that the Facility Director, in consultation with the
Chief of Staff is responsible for ensuring that objectives of the VHA National Pain
Management Strategy are met, including A stepped care model of pain care is fully
implemented Accepted standards of pain care are met [described in the Attachment A of the
Directive as follows]:
All clinical staff should have ongoing education and training.
each staffing group must clearly delineate its specific pain management
responsibilities and abilities and ensure that all its members receive training
adequate to meet these responsibilities and to maintain these abilities.
Education and training must be relevant to the specific needs of the patient
population and clinical setting that provider groups serve, and should include,
as appropriate, pharmacologic (especially opiates and including education
regarding physical dependency, pseudo addiction, tolerance, and potential for
addiction, overdose and/or suicide; appropriate titration; side effects and
benefits) and non-pharmacologic (including psychological, physical,
complementary, and spiritual) treatment modalities.
Annual pain management education for clinical staff is highly recommended
When feasible, facilities are encouraged to provide interactive "workshop"
formats for learning specific cognitive and behavioral skills.
It is highly recommended that Pain Medicine Physician specialists obtain and
maintain one or more certifications
It is recommended that they should also obtain yearly pain-relevant continuing
medical education.

Page 4 | Dr. Klein


Contents may be protected by 5 USC 552a
Once again, your letter not only overlooks the harm you have caused to Dr. Klein in remedy and
acknowledgment, but also ignores your own Agencys directives on standard of care.

Your Letter to Dr. Klein


The letter you provided to Dr. Klein is not on agency letterhead. It states your goal is for our
client to, examine and treat our veteran patients on May 15 but offers no remedy to achieve
the stated goal. Your letter then states there were three meetings with the associate director
regarding your offer and request for him to abruptly see patients beginning May 15, 2017.
However, none of these meetings are documented, in writing, or signed by our client as agreeing
to what was stated. Further, none of these meetings cover the concerns over the employment
practices in dispute, and these meetings excluded his legal representatives and your own.
Moreover, none of these three meetings, included agency counsel approval or endorsement. Most
concerning, Mr. Barbage did not detail the steps needed for our client to treat patients. Further,
while you state, I hope you will agree with my assessment that these steps address your concerns,
they fail to even come close, as noted herein. Our client does not agree with your recollection and
assertion of facts and discussion.
Also, you state in your letter, I look forward to hearing on Monday that you reported to work
ready, willing, and able to treat our nations Veterans. Due to the precarious situation, your
request puts our client in, for Dr. Klein to report to work, ready and willing to start regaining his
credentials and experience, we require the enclosed settlement agreement to be executed for
protection of all parties interests. Therefore, we have taken the liberty to enclose a
settlement/agreement for you to sign, since you purport to want to settle this matter, and if your
letter is candid, you should have no problem negotiating a settlement to this matter quickly. We
urge you to contact Agency Counsel on this matter. Our client is reporting to work with the
enclosed proposed settlement - ready, willing and able to regain his credentialing, skills, training
experiences, and resolve this matter. As directed by your legal counsel he cannot, as a continuing
VA employee -- treat or consult on patients, without up-to-date and frequent training, to ensure
our nations Veterans are served properly and agency policy is followed. In that regard, again,
please see our proposed settlement.
Also, your letter is of great concern because it seems contrary to what the Agency presented to
MSPB and OSC:
Since the Poplar Bluff facility no longer maintains a full-time Pain Management Clinic,
it is expected that the number and frequency of Pain Management consultation requests
from other providers will be relatively limited.
It is not expected that Dr. Klein will be engaged in these matters for a full eight-hour
day every workday.
Reestablishing and staffing a pain management clinic, where none presently exists, and
then getting patients scheduled, is also not a realistic option.
While Dr. Klein does meet the minimum requirements to be considered for
appointment or detail to a primary care or urgent care position, asking a clinician who
has, since he completed his internship in 1998, focused exclusively on the practice of
the specialties of anesthesiology and/or pain management is not fair to Dr. Klein or his
potential patients.

Page 5 | Dr. Klein


Contents may be protected by 5 USC 552a
To the extent, Dr. Klein is concerned that his clinical skills as an Anesthesiologist or
Pain Management Specialist will deteriorate through non-use or inactivity, working in
a Primary Care or Urgent Care setting will do nothing to alleviate the problem.
Telling him to now practice medicine in either Primary Care or Urgent Care would be
unfair to both Dr. Klein and his patients. The potential for a clinical error or omission
would adversely affect our veterans.
I have considered the possibility of modifying the nature and scope of the duties of any
of our existing physician positions to accommodate the specific clinical skills of Dr.
Klein. I have concluded this is simply not practicable.
Our Medical Center does not perform any surgical procedures that require the
administration of anesthesia and we no longer have a pain management clinic.
There is simply nothing for Dr. Klein to do unless we take on the enormous task of
expanding the nature and scope of the clinical services provided at this facility.
OSCs request to restore Dr. Klein to his official positon of record, with all the attendant
duties, is simply not practicable in view of the closure of the clinic where Dr. Klein
worked.
Even if the Board should determine that it has the authority to overturn the Agencys
May 28, 2016, action to separate Dr. Klein, it is not practicable, or even possible, to
restore him to the duties he was performing prior to the actions which led to his
separation.
The Director and Chief of Staff at the John J. Pershing VA Medical Center had already
determined, prior to the OSCs request for a stay, that the VA Medical Center lacked
sufficient resources to properly support a pain management clinic and, therefore, closed
the clinic.
Even if the OSC had never become involved in this matter, there would be no action
contemplated by the Agency to find someone to replace Dr. Klein or to attempt to keep
the clinic where he worked open for the treatment of patients.
Thus, if it is the ultimate decision of the Board that Dr. Klein should be returned to
employment with the Agency, it will not be possible to reassign him to the Pain
Management Clinic where he was formerly employed.
At the heart of the OSC request to extend the stay is a hope that Dr. Klein can somehow
be restored to his former position as a pain management physician at a facility that does
not have any present need or use for a physician with his skills and privileges.
. . . the only way for the Agency to utilize Dr. Klein as a clinician at the Poplar Bluff
facility is for the Agency to re-establish a Pain Management Clinic so that he could,
essentially, return to his previous role at the Agency.
If the Board should grant the OSC request to extend the stay for any additional period(s)
of time, the Agency does not object to a temporary detail of Dr. Klein
Therefore, based on the above, it seems you suddenly wish to serve out nations Veterans,
through our clients expertise, which you diminished for over a year, without paying attention to
the risks created by your actions in sidelining our client. It is our legal advice to our client, in
consult with various VA doctors, that he cannot practice, until the PPPs impacting his practitioner
abilities, and the employment safety, be remedied, as well as damages incurred. 38 C.F.R. 0.601
states:
VA's Core Values the foundation for the way VA employees should interact
with each other regardless of their grade, specialty area, or location. The Core

Page 6 | Dr. Klein


Contents may be protected by 5 USC 552a
Values are noted as Integrity, Commitment, Advocacy, Respect, and Excellence.
Together, the first letters of the Core Values spell I CARE.

Expecting our client to practice medicine without resolving the concerns that have been reported
regarding the standards of care for our veteran seems to ignore ICARE. Further, amid you stating
to us in the meeting that took place on Friday, May 12, 2017, in the late afternoon, that you have
no guidance on this, in an agency with multiple legal resources available to it it is simply
frightening for Americas Veterans to hear any VA medical center director say such a critical
decision comes with no guidance. Either you lied in your letter to our client, or you are purposely
intending to engage in further PPPs and violation of rules that exist to protect patients and our
client. Moreover, the email, from the associate director, in which you claim eight issues are
discussed, is more alarming. It suggests negligence in medical care at the facility, which our client
reported, and you are trying to address without addressing the actual PPPs resulting from your
actions. Therefore, your letter appears contrary to the best interests of Veterans at the Poplar Bluff
VAMC, are contrary your legal counsels writings, and does not resolve our clients concerns.
Please provide a response to the submitted settlement proposal. I urge you to discuss this
settlement offer with your Counsel. Our client remains unable to practice outside his current
proficiency status created by your actions. Further, a host of damages remain unaddressed, as well
as safety concerns, for the Prohibited Personnel Practices that took place. It is my sincere intention
to settle this matter amicably which is why I am enclosing a settlement offer. A copy is being
provided to your regional counsel and the Office of Special Counsel. This settlement offer will
expire at 5:00 P.M. on the Tuesday, May 18, 2017, unless I receive a response from you before
that date and time, and agreement is reached to extend.
Should further adverse actions be taken against our client will be considered further reprisal.
We believe enclosed is in the best interests of all parties, and especially our Veterans. If you
have any questions, please do not hesitate to me.

Best,

____________________________
Natalie K. Khawam, Esq., MBA, MS
Whistleblower Law Firm, P.A.
400 N. Tampa St., Suite 950
Tampa, FL 33602-4700
Office: (813) 944-7853
Nataliek@813whistle.com

Page 7 | Dr. Klein


Contents may be protected by 5 USC 552a
Subject: RE: Mee'ng
Date: Monday, May 15, 2017 at 12:57:00 PM Eastern Daylight Time
From: Hall, Patricia L. (POP)
To: LoreEa Poston, Klein, Dale J.
A7achments: image002.png, image003.png

Thank you.

Patricia L. Hall PhD, FACHE


Medical Center Director
John J. Pershing VA Medical Center
Poplar Blu, MO
573-778-4649

From: Loretta Poston [mailto:lposton@813whistle.com]


Sent: Monday, May 15, 2017 11:54 AM
To: Hall, Patricia L. (POP); Anfang, Michael
Cc: Natalie Khawam; Javier Soto; Klein, Dale J.; McMurray, Elizabeth; Shilling, Sheri S.
Subject: [EXTERNAL] Re: Meeting

Director Hall,

This communication is in response to the email sent to our client, Dr. Dale Klein, at 1044a this morning. As
you are aware, Dr. Klein is represented by counsel and communications regarding his employment or
settlement should be directed through counsel.

We appreciate your acknowledgment of our communications sent earlier. We are awaiting a response from
Agency counsel on this matter, to include the Office of General Counsel and OSC.

Thank you for your time and consideration.

--
Kindest regards,

Loretta C. Poston, Esq.


Managing Attorney
Whistleblower Law Firm, P.A.
400 N. Tampa Street, Suite 950
(813) 944-7853 Office
(813) 434-2173 Facsimile

--
NOTE: The Florida Bar Disciplinary Counsel requires that all recipients of e-mail correspondence relative to legal matters be notified that (1) e-mail
communication is not a secure method of communication, (2) any e-mail that is sent to you or by you may be copied and held by various computers it
passes through as it goes from me to you and vice versa, (3) persons not participating in our communications may intercept our communications by
improperly accessing your computer or my computer or even some computer unconnected to either of us which the e-mail passed through. If you want
future communications to be sent in a different fashion, please let me know.

Page 1 of 2
Privileged and Confidential: Unless otherwise indicated or obvious from the nature of the transmittal, the information contained in this message is
privileged and/or confidential information intended solely for the use of the addressee. If the reader of this message is not the intended recipient, or
the employee or agent responsible to deliver it to the intended recipient, you are hereby notified that any dissemination, distribution or copying of this
communication or any of the information in it is strictly prohibited. If you have received this communication in error, please advise the sender by reply
e-mail and then delete the message. Thank you.



From: Hall, Patricia L. (POP)
Sent: Monday, May 15, 2017 10:44 AM
To: Klein, Dale J.
Subject: Mee'ng

Dr. Klein,
I am assuming that because of the email from your aEorney, you are declining the 1000 mee'ng in my
oce. I just didnt want to leave my oce to con'nue my day un'l I was certain. Please let me know.
Thank you

Patricia L. Hall PhD, FACHE
Medical Center Director
John J. Pershing VA Medical Center
Poplar Blu, MO
573-778-4649

Page 2 of 2
Subject: RE: Mee'ng
Date: Monday, May 15, 2017 at 6:39:58 PM Eastern Daylight Time
From: Anfang, Michael
To: LoreFa Poston, Hall, Patricia L. (POP)
CC: Natalie Khawam, Javier Soto, Klein, Dale J., McMurray, Elizabeth, Shilling, Sheri S.
A8achments: image001.png, RE_ PMC Follow Up.pdf

Ms. Poston:

I assume the response you are waiting for from VA counsel is to todays letter from Ms. Khawam to Dr.
Patricia Hall. My email is based on that assumption. The letter expressed concerns that Dr. Patricia
Halls letter to Dr. Klein created potential liability, including a negligent approach to medicine. Dr.
Halls letter stating the expectation for Dr. Klein to work today, and thereafter, was in no way meant to
put patients or Dr. Kleins license or ability to treat patients at risk. Prior to the letters issuance
which was official, despite not being on VA letterhead Dr. Klein delineated obstacles to seeing
patients at the Poplar Bluff VA Medical Center, his place of employment. Mr. Seth Barlage, the Poplar
Bluff VA Medical Center Associate Director, sent an email (attached as a .pdf document) to Dr. Klein
that addressed ways management has worked, and will continue to work, to overcome those obstacles.
Dr. Halls letter referred to that email. As you can see, none of the obstacles Dr. Klein identified
included any lack of necessary competency or ability for him to be engaged in patient care. If there are
other obstacles Dr. Klein identifies, Poplar Bluff VA Medical Center management will review them and
act accordingly.

The VA will not be implementing the removal previously issued Dr. Klein. In the event Dr. Halls letter
was not clear enough on that point, I am restating it here. Dr. Halls letter was an expression of the way
forward.

I will discuss with the Office of Special Counsel possible formal resolution of its case. In the interim,
Dr. Klein remains a VA employee with the expectation of Poplar Bluff VA Medical Center management
that he will perform the duties his supervisors assign to him. As I said, if there are obstacles Dr. Klein
identifies that keep him from performing those duties in a manner that is safe for our veteran patients
and him, he should raise them.

Michael E. Anfang
Deputy Chief Counsel
Department of Veterans Affairs
Office of Chief Counsel, Midwest District - West
IA, IL, KS, MI/UP, MN, MO, ND, NE, SD, WI
1201 Walnut Street, Suite 800
Kansas City, MO 64106
816.701.3082 (phone)
816.922.4810 (fax)
michael.anfang@va.gov (email)

From: Loretta Poston [mailto:lposton@813whistle.com]


Sent: Monday, May 15, 2017 11:54 AM
To: Hall, Patricia L. (POP); Anfang, Michael
Cc: Natalie Khawam; Javier Soto; Klein, Dale J.; McMurray, Elizabeth; Shilling, Sheri S.
Subject: [EXTERNAL] Re: Meeting

Page 1 of 3

Director Hall,

This communication is in response to the email sent to our client, Dr. Dale Klein, at 1044a this morning. As
you are aware, Dr. Klein is represented by counsel and communications regarding his employment or
settlement should be directed through counsel.

We appreciate your acknowledgment of our communications sent earlier. We are awaiting a response from
Agency counsel on this matter, to include the Office of General Counsel and OSC.

Thank you for your time and consideration.

--
Kindest regards,

Loretta C. Poston, Esq.


Managing Attorney
Whistleblower Law Firm, P.A.
400 N. Tampa Street, Suite 950
(813) 944-7853 Office
(813) 434-2173 Facsimile

--
NOTE: The Florida Bar Disciplinary Counsel requires that all recipients of e-mail correspondence relative to legal matters be notified that (1) e-mail
communication is not a secure method of communication, (2) any e-mail that is sent to you or by you may be copied and held by various computers it
passes through as it goes from me to you and vice versa, (3) persons not participating in our communications may intercept our communications by
improperly accessing your computer or my computer or even some computer unconnected to either of us which the e-mail passed through. If you want
future communications to be sent in a different fashion, please let me know.

Privileged and Confidential: Unless otherwise indicated or obvious from the nature of the transmittal, the information contained in this message is
privileged and/or confidential information intended solely for the use of the addressee. If the reader of this message is not the intended recipient, or
the employee or agent responsible to deliver it to the intended recipient, you are hereby notified that any dissemination, distribution or copying of this
communication or any of the information in it is strictly prohibited. If you have received this communication in error, please advise the sender by reply
e-mail and then delete the message. Thank you.



From: Hall, Patricia L. (POP)
Sent: Monday, May 15, 2017 10:44 AM
To: Klein, Dale J.
Subject: Mee'ng

Dr. Klein,
I am assuming that because of the email from your aForney, you are declining the 1000 mee'ng in my
oce. I just didnt want to leave my oce to con'nue my day un'l I was certain. Please let me know.
Thank you

Patricia L. Hall PhD, FACHE
Medical Center Director
John J. Pershing VA Medical Center
Poplar Blu, MO
573-778-4649

Page 2 of 3
From: Anfang, Michael
To: Anfang, Michael
Subject: RE: PMC Follow Up
Date: Monday, May 15, 2017 5:10:44 PM

From: Barlage, Seth W.


Sent: Friday, May 12, 2017 11:44 AM
To: Klein, Dale J.
Subject: PMC Follow Up

Dr. Klein,
You and I have met on three separate occasions recently to discuss the issues surrounding the PMC
that the you believe need resolution. I have diligently been looking into all of those issues, and
based on my responses below, I believe there are no items preventing the full restart of the PMC.
Please review my responses, and let me know if you have any questions or concerns.

1. Confirmatory Testing The current practice remains in effect, which is the lab will process
all provider orders for confirmatory testing. If a provider believes confirmatory testing is
clinically indicated, the provider may place the order for confirmatory testing. All positive
UDS specimens are held in the lab for 7 days, giving the provider the opportunity to order
confirmatory testing if thats what the provider wants.
a. You are free to order confirmatory testing as you deem clinically necessary.
i. For your information, an in-house UDS cost $0.98. Confirmatory testing
for benzos cost $16.33 and opiates costs $24.49.
2. Neuro-Radiologist Reads As you and I discussed, I have confirmed that the St. Louis VA
has a fellow-trained neuro-radiologist on staff. I have had discussions with the St. Louis
Chief of Radiology and she sees no problem with their neuro-radiologist doing the occasional
initial read for when you request a neck/spine MRI. Based on what you told me, the possible
workload sent to the St. Louis provider is 1-2 per week, which is what I told St. Louis. Our
local radiology department has confirmed they can ensure that the initial read request is
sent to the appropriate St. Louis provider.
a. If a need arises early next week to order a neck/spine MRI, you will need to let me
know immediately so I can help ensure that we work through this new process. In
the meantime, I will work with both St. Louis and Poplar Bluff staff to sure up the
process.
b. St. Louis neuro-radiologist may wish to speak directly to you to work out the
process. Ill let you know if that request comes through. Ultimately, it appears it will
be a memorandum of understanding (MOU) between us and St. Louis. Entirely
doable and something that can happen quickly.
3. Change of Supervisor Your new supervisor effective Monday, May 10, 2017 for both
administrative and clinical needs will be Dr. Nair.
4. Writing Scripts You are free to write scripts as you deem necessary in order to provide the
appropriate level of care to the Veterans you will be treating.
5. Accessing Patient Records Related to Pain Consults When you receive pain consults, you
are free to access each respective patients record to evaluate the next appropriate steps
related to addressing the consult.
6. Pain Nurse Your pain nurse will be Lonnie P. He does not require any additional training
specific to assisting you in the pain clinic. As you and I discussed, he will however need to
work with you to discuss your expectations within your clinic.
7. Medical Supplies for Procedures As you and I discussed, please work with your Pain
Nurse and Carolyn Hill in Logistics to acquire the necessary supplies needed for your
procedures.
a. I will have Ms. Hill come visit you and Lonnie to begin work on providing your clinic
with the necessary supplies.
8. Isite Radiology Software Adjustments I have confirmed that in order for the optimization
of the software to occur, you must be logged into your computer. The settings are specific
to the user, which requires the user to be logged in. Our local staff can make the
adjustments. I will have the appropriate staff come to your office either today or Monday
morning to make the simple adjustments, but you must be logged in as the user for the
settings to be changed for you.

Recommended PMC Restart Process:

All medical center providers will be notified that the PMC is activated and that you are
available and awaiting their consultation requests.
Your primary focus will be to review 100% of pain consults and to make the appropriate
determination if you will provide the treatment or if the consult should be converted to
Choice/Care in the Community consult.
o This will apply specifically to providers at VA Medical Center here in Poplar Bluff only
because CBOC providers are authorized to enter a Choice consult for any specialty
service not offered at their respective CBOC. However, if the CBOC patient
specifically requests to be treated by the VA in your clinic, the CBOC provider will
place the appropriate consult to your clinic.
There are currently some pending consults (local and Choice/Care in the Community) that
should be sent your way for review and determination ASAP.
Your clinic scheduling profile/grid will be populated with slots to allow for full scheduling.
Use Monday morning to work with Carolyn Hill (Logistics) and Lonnie C. on the supplies, and
work with Lonnie C. and the 3rd floor scheduling staff on the process for reviewing and
scheduling consults.

If you have any questions or concerns, please let me know. Also, I will be happy to meet with you in
person if needed. Just let me know if you would like me to schedule a face-to-face meeting.

Seth W. Barlage
Associate Medical Center Director
John J. Pershing VA Medical Center
Poplar Bluff, MO
Subject: re: Dr. Dale Klein
Date: Tuesday, May 16, 2017 at 4:04:19 PM Eastern Daylight Time
From: LoreBa Poston
To: Michael Anfang
CC: Natalie Khawam, Klein, Dale J., Javier Soto, McMurray, Elizabeth, Shilling, Sheri S.

A8achments: 2017.5.16 LeBer Dr. Klein-nal.pdf

Dear Mr. Anfang,

Please see the attached letter in reference to our client, Dr. Dale Klein.

--
Kindest regards,

Loretta C. Poston, Esq.


Managing Attorney
Whistleblower Law Firm, P.A.
400 N. Tampa Street, Suite 950
(813) 944-7853 Office
(813) 434-2173 Facsimile

--
NOTE: The Florida Bar Disciplinary Counsel requires that all recipients of e-mail correspondence relative to legal matters be notified that (1) e-mail
communication is not a secure method of communication, (2) any e-mail that is sent to you or by you may be copied and held by various computers it
passes through as it goes from me to you and vice versa, (3) persons not participating in our communications may intercept our communications by
improperly accessing your computer or my computer or even some computer unconnected to either of us which the e-mail passed through. If you want
future communications to be sent in a different fashion, please let me know.

Privileged and Confidential: Unless otherwise indicated or obvious from the nature of the transmittal, the information contained in this message is
privileged and/or confidential information intended solely for the use of the addressee. If the reader of this message is not the intended recipient, or
the employee or agent responsible to deliver it to the intended recipient, you are hereby notified that any dissemination, distribution or copying of this
communication or any of the information in it is strictly prohibited. If you have received this communication in error, please advise the sender by reply
e-mail and then delete the message. Thank you.

Page 1 of 1
Natalie Khawam, Esq, MBA, MS 400 North Tampa Street, Suite 950
Loretta Poston, Esq. Tampa, Florida 33602
Samantha Postlewaite, Esq. Office: 813.944.7853
Javier Soto, Esq. Fax: 813.434.2173

May 16, 2017


Michael E. Anfang
Deputy Chief Counsel
Department of Veterans Affairs
1201 Walnut Street, Suite 800
Kansas City, MO 64106

Dear Mr. Anfang,

We appreciate your email, however it not does not respond to the issues we raised on behalf of our
client, Dr. Klein in our correspondence to Director Hall on May 15, 2017. You state that if Dr. Klein has
identified obstacles that hinder him from performing the duties management assigns to him that he raises
them. However, our letter identifies those obstacles, and as his counsel, we are bringing these obstacles to
the attention of management on his behalf. We remain solution-oriented and aim to amicably resolve the
obstacles, but simply stating that Dr. Klein remains a VA employee with the expectation of Poplar Bluff
VA Medical Center management that he will perform the duties his supervisor assigns him appears to
disregard these issues and delays the identification of a solution to the Poplar Bluff matters concerning our
client. We have identified several continuing issues and concerns below, that require attention and
resolution:

1. This morning our client reported that his Outlook email account and program was removed from
his computer which is denying access to his work email account. The adverse action of removing of Dr.
Kleins email access constitutes a continuing pattern of workplace hostility and harassment, which as you
aware, are the topics of his complaints that are currently pending with the OSC and EEOC. Unfortunately,
this adverse action taken against our client occurred after we put you and the Director on notice that any
further adverse actions would be considered further retaliation.

2. Our correspondence expressly addressed that our clients OSC complaint for PPPs is still pending,
and that the Agencys actions in this complaint have detrimentally impacted Dr. Kleins ability to perform
his duties at the Pain Management Clinic, and more generally as a practitioner of medicine. This is
completely disregarded by your correspondence, and is not addressed by Director Halls correspondence,
that also fails to address the remedies requested by Dr. Klein for this matter. Our inquiry regarding the
formal resolution of our clients complaint remains unresolved by your correspondence.

3. The PDF email you enclosed from Mr. Barlage does not show or constitute a signed agreement
settling any dispute between Dr. Klein and Mr. Barlage, and while we appreciate you forwarding the
correspondence, it does not address our concerns also raised to Director Hall. The one-way communication
from Mr. Barlage is not an agreement between Mr. Barlage and Dr. Klein, and in no way, resolves the
issues raised to Director Hall or within our clients pending complaint with OSC. We are confused as to
what you contend the email shows or how it responds to our concerns to the Director.
4. You appear to have mischaracterized the issues raised by us regarding Dr. Kleins current ability
to abruptly commence with his regular visitations of patients after over one year of isolation. Again, you
address these as issues Dr. Klein may have identified, however, these were issues expressly raised by your
office to OSC and MSPB in your offices motions to the Board. While we share those concerns, especially
in the context of the Directors recent, rushed decision to require Dr. Klein to see patients, we are only
reiterating what your office previously stated to OSC and MSPB. This directly relates to our inquiry about
the Agencys intentions and concerns for Dr. Kleins license and ability to treat patients and the safety of
patients. You fail to address our concerns or to explain the contradiction between your offices previous
assertions to the Board and OSC and the Director Halls letter, which you identify in your email as an
official correspondence authorized by your office. If you are unable to clarify this matter, please indicate
so and direct us to someone who can. It is problematic to understand how your offices representations to
the Board, and the current opinion of your office and the Poplar Bluff VAMC, could both be good faith
assertions when they are contradictory in substance.

5. Please note, we represent Dr. Klein and we represent his concerns. Therefore, as stated above, we
are responding to you to raise these issues on his behalf. Our correspondence to Director Hall also raised
our clients issues. Dr. Kleins concerns have been communicated to you, the Director, and OSC, in
writing. Although, you state Dr. Klein is expected to perform the duties assigned by his supervisor, and
Dr. Klein does not wish to disobey VA Policy, he cannot be expected to lower the standard of care he
provides to patients of the VAMC, which is why addressing our concerns over his acclimation back into
practice is critical to both of our goals. Also, central to these concerns is Dr. Kleins distress about the
Director at Poplar Bluff forcibly impacting his ability to practice. The Director has the obligation and
liability to respond to these concerns and provide solutions and clarification for Dr. Kleins acclimation
back into practice to provide the best standard of care for our Veterans. Neither Mr. Barlages email
correspondence, nor your email response, addresses the necessary acclimation period or process for
implementing such acclimation. It is imperative that this be addressed, and we are specifically inquiring as
to whether this issue will be addressed. However, if you are waiving all potential liability for failing to
provide Dr. Klein an acclimation period to bring him back to the status quo following the degradation
of his medical skills caused by Director Halls actions in preventing him from practicing medicine
for over one year including ensuring his standard of care is made compliant with all current
practices and procedures -- then please advise. If not, the concerns we communicated require a response
and a solution from both the Director and Agency counsel.

6. We understand that at this time, the Agencys prior termination of our client is not being
implemented, however , due to the Agencys recent actions and lack of formal resolution of the issues raised
in our correspondence, we believe this for other than good faith reasons. This is appears to be demonstrated
by (a) the correspondence made by the Director without the use of agency representation, (b) the inclusion
of the email correspondence from Mr. Barlage as if it constitutes some sort of agreement or resolution of
our clients pending complaint with OSC without explanation, (c) consistent communications from your
office over the past year arguing against our clients return to Poplar Bluff noting that there is not work for
him to perform at the Poplar Bluff VAMC, and, most importantly, (d) the Directors recent actions
attempting to require our client to immediately begin seeing patients after one year of preventing him from
performing the duties of his position.

7. In order to officially resolve the reprisal issues our client has faced at the VAMC, including
damages incurred to date, we are providing a proposed settlement agreement to you, as Counsel to the
Agency. Such agreement will need to be reached in order to resolve the issues discussed, and also includes
appropriate terms addressing Dr. Kleins acclimation back into his specialty, and field, in conjunction with
examining and consulting patients at the VAMC.

Page 2
Again, your email correspondence is not responsive to our clients concerns, and appears to further
convolute and confuse the issues we are raising. However, our clients concerns over the Agencys actions
and contradictions made by your office have been clearly communicated, and we are hopeful you will work
with us towards an amicable solution rather than confusing the issues further.

Please note that any further actions against our client, will be considered additional acts of reprisal
and will be reported accordingly.

To be clear, we agree that Dr. Klein remains a VA employee. However, as stated in our letter, he
is expected to perform his medical services as guided by VA Policy, and appropriate medical and specialty
standards for which he was hired for by the VA to perform. His ability to remain acclimated to this level
has been detrimentally impacted by Director Halls action. Again, for this reason, your assertion that Dr.
Klein meets the expectation of Poplar Bluff VA Medical Center management that he will perform the
duties his supervisors assign to him is incongruous to your offices previous writings, VA medical
guidelines, and the medical standards. It was your office that noted patient safety and malpractice concerns,
which is why Director Halls recent actions are also of serious concern to us and our client.

You stated that, if there are obstacles Dr. Klein identifies that keep him from performing those
duties in a manner that is safe for our veteran patients and him, he should raise them. This is our second
address of these issues, and hope that we can now begin to work with you to resolve these continuing issues.

We would like to resolve these issues, yet the concerns for harm against Veterans caused by the
actions of Director, Patricia Hall, continue to go unaddressed. Dr. Klein has a duty to protect his patients
and ensure the standard of care is met pursuant to the Hippocratic Oath he swore when began his medical
career. As such, Dr. Klein has an obligation to report any misconduct or violation against his patients
interests, and to report any orders that place him and others at risk. We believe the removal of his access
to Outlook email is an attempt to frustrate his ability to do so. In the interests of upholding his ethical duties
as a physician, any assignment to medical duties contrary to the interests of his patients will be met with
the strongest legal response against all responsible personnel and authorities to protect our Veterans and
our client.

We appreciate your time and efforts, and we remain prepared to help resolve this matter.

Best,

Natalie K. Khawam, Esq., MBA, MS


Whistleblower Law Firm, P.A.
400 N. Tampa St., Suite 950
Tampa, FL 33602-4700
Office: (813) 944-7853
Nataliek@813whistle.com
Attorney for Complainant

Page 3
Subject: pa#ent request
Date: Tuesday, May 16, 2017 at 5:46:59 PM Eastern Daylight Time
From: Klein, Dale J.
To: Hall, Patricia L. (POP)
CC: LoreLa Poston, sshilling@osc.gov

Director Hall,

I will be more than happy to meet with the Veteran so long as my attorney's concerns brought before the Agency are
resolved. Please contact Agency counsel, and have Agency counsel discuss the resolution of these matters with my attorney.

Please let me know when all concerns are resolved, so I may serve our nation's Veterans with the attention and standard of
care they deserve.

Thank you.

Kindest regards,

Dale J. Klein, M.D.

-----Original Message-----
From: Hall, Patricia L. (POP)
Sent: Tuesday, May 16, 2017 2:27 PM
To: Klein, Dale J. <Dale.Klein@va.gov>
Subject: patient request

Specialty Clinic contacted me with the following today:


A patient was quite insistent that he see you for his pain consult. Since, as of Monday, you still felt you were unable to see
patients, he was provided an alternative appointment option in Cape, but he was quite insistent that he see you. Please let Kim
Gum, Kathy Haas or myself how you would prefer we answer the Veteran.

Patricia L. Hall PhD, FACHE


Medical Center Director
John J. Pershing VA Medical Center
Poplar Bluff, MO
573-778-4649

Page 1 of 1
Subject: Re: Dr. Dale Klein
Date: Wednesday, May 17, 2017 at 4:29:38 PM Eastern Daylight Time
From: LoreDa Poston
To: Anfang, Michael
CC: Natalie Khawam, Klein, Dale J., Javier Soto, McMurray, Elizabeth, Shilling, Sheri S.

A9achments: 2017.5.17 LeDer Dr. Klein.pdf

Hello Mr. Anfang,

Please see the attached letter. Thank you.

--
Kindest regards,

Loretta C. Poston, Esq.


Managing Attorney
Whistleblower Law Firm, P.A.
400 N. Tampa Street, Suite 950
(813) 944-7853 Office
(813) 434-2173 Facsimile

--
NOTE: The Florida Bar Disciplinary Counsel requires that all recipients of e-mail correspondence relative to legal matters be notified that (1) e-mail
communication is not a secure method of communication, (2) any e-mail that is sent to you or by you may be copied and held by various computers it
passes through as it goes from me to you and vice versa, (3) persons not participating in our communications may intercept our communications by
improperly accessing your computer or my computer or even some computer unconnected to either of us which the e-mail passed through. If you want
future communications to be sent in a different fashion, please let me know.

Privileged and Confidential: Unless otherwise indicated or obvious from the nature of the transmittal, the information contained in this message is
privileged and/or confidential information intended solely for the use of the addressee. If the reader of this message is not the intended recipient, or
the employee or agent responsible to deliver it to the intended recipient, you are hereby notified that any dissemination, distribution or copying of this
communication or any of the information in it is strictly prohibited. If you have received this communication in error, please advise the sender by reply
e-mail and then delete the message. Thank you.

From: Michael Anfang <Michael.Anfang@va.gov>


Date: Wednesday, May 17, 2017 at 8:32 AM
To: LoreDa Poston <lposton@813whistle.com>
Cc: Natalie Khawam <nataliek@813whistle.com>, "Klein, Dale J." <Dale.Klein@va.gov>, Javier Soto
<javiers@813whistle.com>, "McMurray, Elizabeth" <emcmurray@osc.gov>, "Shilling, Sheri S."
<sshilling@osc.gov>
Subject: RE: Dr. Dale Klein

Ms. Poston:

My responses to the points of Ms. Khawams letter are:

1. I will look into the concerns about Dr. Kleins Outlook account. I do not currently have
information on that subject.
2. Dr. Kleins concerns about OSCs report notwithstanding, he is a VA employee receiving
compensation. As a result, the VA has a reasonable expectation for him to perform his duties.
3. I do not understand your confusion about the email from Mr. Barlage to Dr. Klein. It was based
on several meetings that occurred between Dr. Klein and Mr. Barlage. Read together with letter
from Dr. Patricia Hall to Dr. Klein, Mr. Barlages email clearly lays out all the measures the
Poplar Bluff VA Medical Center management has taken, and will take, so that Dr. Klein can
Page 1 of 3
Poplar Bluff VA Medical Center management has taken, and will take, so that Dr. Klein can
successfully perform his duties as a pain management specialist. Dr. Klein is a VA employee.
There is no need for a signed agreement between an employee and management before the
employee performs the duties expected of him.
4. I do not know how to address this point other than to remind you that during the course of the
MSPBs continued stays of the removal, the VA agreed to allow Dr. Klein to see patients. Now
that the VA has made it clear it will not be implementing the removal, the VA has moved from
agreeing Dr. Klein can see patients to expecting him to see patients.
5. This point says Dr. Klein cannot be expected to lower the standard of care. As I stated
previously, Poplar Bluff VA Medical Center management has no desire to put patients at risk. If
you or Dr. Klein can specifically articulate how Dr. Klein who has communicated to
management previously that he wants to see patients would be lowering the standard of care
by seeing patients now, then the VA can conduct an evaluation.

Michael E. Anfang
Deputy Chief Counsel
Department of Veterans Affairs
Office of Chief Counsel, Midwest District - West
IA, IL, KS, MI/UP, MN, MO, ND, NE, SD, WI
1201 Walnut Street, Suite 800
Kansas City, MO 64106
816.701.3082 (phone)
816.922.4810 (fax)
michael.anfang@va.gov (email)

From: Loretta Poston [mailto:lposton@813whistle.com]


Sent: Tuesday, May 16, 2017 3:04 PM
To: Anfang, Michael
Cc: Natalie Khawam; Klein, Dale J.; Javier Soto; McMurray, Elizabeth; Shilling, Sheri S.
Subject: [EXTERNAL] re: Dr. Dale Klein

Dear Mr. Anfang,

Please see the attached letter in reference to our client, Dr. Dale Klein.

--
Kindest regards,

Loretta C. Poston, Esq.


Managing Attorney
Whistleblower Law Firm, P.A.
400 N. Tampa Street, Suite 950
(813) 944-7853 Office
(813) 434-2173 Facsimile

--
NOTE: The Florida Bar Disciplinary Counsel requires that all recipients of e-mail correspondence relative to legal matters be notified that (1) e-mail
communication is not a secure method of communication, (2) any e-mail that is sent to you or by you may be copied and held by various computers it
passes through as it goes from me to you and vice versa, (3) persons not participating in our communications may intercept our communications by
improperly accessing your computer or my computer or even some computer unconnected to either of us which the e-mail passed through. If you want
future communications to be sent in a different fashion, please let me know.

Privileged and Confidential: Unless otherwise indicated or obvious from the nature of the transmittal, the information contained in this message is
privileged and/or confidential information intended solely for the use of the addressee. If the reader of this message is not the intended recipient, or
the employee or agent responsible to deliver it to the intended recipient, you are hereby notified that any dissemination, distribution or copying of this

Page 2 of 3
communication or any of the information in it is strictly prohibited. If you have received this communication in error, please advise the sender by reply
e-mail and then delete the message. Thank you.

Page 3 of 3
Natalie Khawam, Esq, MBA, MS 400 North Tampa Street, Suite 950
Loretta Poston, Esq. Tampa, Florida 33602
Samantha Postlewaite, Esq. Office: 813.944.7853
Javier Soto, Esq. Fax: 813.434.2173

May 17, 2017


Michael E. Anfang
Deputy Chief Counsel
Department of Veterans Affairs
1201 Walnut Street, Suite 800
Kansas City, MO 64106

Mr. Anfang,

We appreciate your opinion on the matter of Dr. Kleins employment. We want to correct
some misinformation in your communication that we find incongruous to the record on this matter,
as developed by your office. We want to ensure our nations Veterans have the highest standard
of care and that Dr. Klein is given the ability to have training and the proper tools and equipment
to provide the high standard of care he prides himself on giving the Veterans. The standard of care
in which he was denied the ability to keep current when he was kept in solitary confinement in an
office without access to patient records, software, training, or even the ability to consult with other
doctors. We would hope that these are similar goals of the VA, however, we are not seeing any
steps towards addressing these very critical concerns for doctor or patient care.
We are sure you can appreciate that a doctor needs certain tools and updated training in
order to provide a patient with the appropriate care. With our concerns further heightened due to
the current actions taken by the Agency in direct contradiction of the Agencys proclamations to
the MSPB about the PBVAMC not having a need for a pain management clinic, the extreme
burden to get a pain clinic and pain patients to the PBVAMC, and no need for a doctor with Dr.
Kleins abilities, we are underscoring the below events and contradictions to clarify our heightened
concerns .
Agencys August 15, 2016 letter to the MSPB and OSC in response to the
Boards Order on July 18, 2016, Agency counsel stated, . . . reestablishing and
staffing a pain management clinic, where none presently exists, and then getting
patients scheduled, is also not a realistic option.
Agencys August 15, 2016 letter to the MSPB and OSC in response to the
Boards Order on July 18, 2016, Enclosure of the Affidavit of Chief of Staff, Dr.
Nair, on August 12, 2016, states [t]here is simply nothing for Dr. Klein to do unless
we take on the enormous task of expanding the nature and scope of the clinical
services provided at this facility.
Then in the Agencys Response to U.S. Office of Special Counsels Initial
Request for Stay of Personnel Action on May 31, 2016, Agency counsel stated,
[f]urther, the OSCs request to restore Dr. Klein to his official positon of record,
with all of the attendant duties, is simply not practicable in view of the closure of
the clinic where Dr. Klein worked. And goes on to state, . . . it is not practicable,
or even possible, to restore him to the duties he was performing prior to the actions
which led to his separation. And, . . . it will not be possible to reassign him to the
Pain Management Clinic where he was formerly employed.
Then in the Agencys Response to the U.S. Office of Special Counsels
Motion to Modify the Order Granting Initial Stay Request on June 11, 2016,
Agency counsel stated that the pain management clinic, is not like an emergency
room or primary care clinic. One cannot expect a parade of patients to be corning
through the door just as soon as the clinic announces it is "open for business," so to
speak. Patients must be referred to the clinic by primary care providers.
Then in the Agencys Response to Petitioner's Stay Extension dated
6/30/2016 on July 7, 2016, Agency counsel stated, [a]t the heart of the OSC
request to extend the stay is a hope that Dr. Klein can somehow be restored to his
former position as a pain management physician at a facility that does not have any
present need or use for a physician with his skills and privileges. The Agency goes
on to state, [h]owever, there is no reason in law or fact to require the Department
of Veterans Affairs to establish a pain management clinic in Poplar Bluff and begin
scheduling patients at that clinic.
In some of Dr. Kleins direct concerns to the PBVAMC about the pain clinic that was
closed down, he was not provided the facilities or equipment to perform the procedures necessary
for patient pain management care. Please advise if the pain management clinic is fully operational
with staff, equipment, and that the facilities are equipped with all up-to-date necessary, safety
tools. Also, Dr. Klein has had great concern for his own safety, as in the past when he has requested
VA police assistance, his panic alarm requests were ignored and no response by VAPD was given.
Please assure us that if Dr. Klein were to need any assistance for his own safety, with patients or
in general, his panic alarm or calls will be answered in accordance the protocols required by the
VA.
As to your email sent May 16, 2017:
1. You advise you were not notified as to the email matter by your client. Please ensure your
client is advising you of its actions against our client, as this is the matter we are trying to address.
2. The concerns filed at OSC impact his job at the VA. Therefore, your statement that OSC
report not withstanding is discerning. It is the legal issue looming over the actions we bring to
you, as Agency counsel, to address. You have not addressed this.
3. We agree Dr. Klein is an employee. However, Dr. Klein has an obligation to the Veterans,
as his patients, and VA, as his employer, but the VA has an obligation to him to provide him with
all of the necessary tools and training to perform his obligations.
4. You state, he is a VA employee receiving compensation. As a result, the VA has a
reasonable expectation for him to perform his duties. We are confused your offices
communications and the Poplar Bluff Directors Office Communications, for over a year,
has argued against this very premise.
Further, it was the Hospital Director that removed him from performing his duties, keeping
him confined to a room without access to patients, charts, or software. In fact his requests to do
Continued Medical Education courses fell on deaf ears and were not approved. The Director at
Poplar Bluff caused a deficit in status of his ability, as practitioner, to be current on the medical
changes in his field. Yet, you simply ignore these concerns despite bringing this up within
motions filed at OSC and MSPB. Please clarify if the Agency is waiving all training, any policy
and practical/practice requirements for Dr. Kleins profession and specialty under joint
commission, in this matter.
Dr. Klein is meeting his responsibilities as an employee by reporting the deficit created
against him by the Poplar Bluff Director, and seeking to remedy that deficit, to again begin serving
patients with the highest standard of care our Veterans deserve. We believe that is remedied by
action, such as approving training as specified in our proposal rather than arguing about
compensation and not performing duties duties in which the VA seemed just fine with for over
a year, and you argued was proper on behalf of the VA.
5. You offer, again, obtuse descriptions of secret meetings between Mr. Barlage to Dr. Klein.
We see no agreement, signed or otherwise, that resolves the issues noted to OSC or resolves any
impediments to Dr. Klein returning to practice. We cannot confirm any conversations are
accurately portrayed in Mr. Barlages email because our client disagrees with some of the items
listed.
For your understanding, since the matter was under dispute and litigation, your office and
ours should have been made privy to such communications, if they occurred as stated, to avoid the
confusion everyone is having at this time. Would you like to set a time to sit down and discuss
this with the involved parties and try to reach a written agreement?
6. You state, remind you that during the course of the MSPBs continued stays of the
removal, the VA agreed to allow Dr. Klein to see patients. This does not address training issues
also noted at OSC. You ignore this vital fact. This is not a janitor in a VA Hospital. This is a
highly-credentialed doctor with licenses and requirements for continuing education and patient
contact experiences.
7. You state, [n]ow that the VA has made it clear it will not be implementing the removal,
the VA has moved from agreeing Dr. Klein can see patients to expecting him to see patients. Our
client is concerned about continued reprisal, the needed training and patient contact experiences
as required by a host of VA policies and rules/laws. Our client expects to practice medicine, when
returned to his baseline, so he can practice within the high standard of care our Veterans deserve
and the guidelines of the joint commission, his certifications, VA policy, and so on. Please advise
what steps are being taken to provide the doctor the ability to see patients within these requirements
and standard of care.
8. You state, [a]s I stated previously, Poplar Bluff VA Medical Center management has no
desire to put patients at risk. However, then you state, [i]f you or Dr. Klein can specifically
articulate how Dr. Klein who has communicated to management previously that he wants to see
patients would be lowering the standard of care by seeing patients now, then the VA can conduct
an evaluation. Our proposal addresses this by stating that an evaluation by Poplar Bluff would be
akin to allowing the fox to check the hens at the hen house, amid the report by OSC. If you want
to discuss this further, we are available. We have articulated our concerns in our proposal a
proposal to which both, you and the hospital have failed to respond.
The training issues must be addressed. Dr. Kleins concerns are valid as you are asking
him to see patients with the full liability of the Agencys past actions resting on his shoulders alone
in a facility of individuals that commit prohibited personnel practices against him. The same
individuals that have argued for a year that his skills are not needed, have attempted to terminate
him, and have sent him to the confinement of a cubicle for a year - allowing his patient contacts
and the practice of his pain management procedures to degrade. Then, those same individuals
decide, amid congressional action, to continue his stayed employment with no explanation, during
arguments by your office of malpractice concerns, and no impartial or non-Poplar Bluff affiliated
party has yet to meet with Dr. Klein to assess his readiness for patient care, software access,
program training, pain clinic requirements, etc. Any such assessment can only be performed by a
similarly credentialed practitioner, such as the doctor at New Orleans. As an attorney, that defends
the VA in malpractice claims, surely you can identify with this concern.
We are available to discuss this at any time with you. I would suggest a global approach,
with OSC present. Please advise if you are interested in settling matters. However, make no
misjudgment, it is our view the doctor may report any and all activity assigned to all proper
authorities, including his patients, about what has occurred, and that the VA is forcing him, through
threat of job loss, to perform, without proper acclamation from the Agencys year-long
confinement period without patient interaction.
Unless this is resolved, we anticipate continuing litigation and more WPEA claims. Is your
office interested in resolving this matter for Americas Veterans? We are. Please advise.

Best,

Natalie K. Khawam, Esq., MBA, MS


Whistleblower Law Firm, P.A.
400 N. Tampa St., Suite 950
Tampa, FL 33602-4700
Office: (813) 944-7853
Nataliek@813whistle.com
Attorney for Complainant
From: Nair, Vijayachandran VHAPOP
Sent: Monday, May 22, 2017 12:53 PM
To: Klein, Dale J. <Dale.Klein@va.gov>
Cc: Gum, Kim <Kim.Gum@va.gov>; Nair, Vijayachandran VHAPOP <Vijayachandran.Nair@va.gov>;
Hall, Patricia L. (POP) <Patricia.TenHaaf2@va.gov>
Subject: Pain Clinic

Dr. Klein,
As you aware, I have been named as your new supervisor. You have already received communications -
directly and through your attorney - that you are expected to see patients in the pain management clinic. I
understand your attorney has raised questions about training that you may require. We are still waiting to
hear specifics. But in the interim, remaining in your office, refusing to see patients, is not an option. I do
not understand why you would not be able to see patients, make appropriate diagnoses, prescribe
medications, as necessary, and schedule necessary follow-ups. I wish for us to have an effective, cordial
relationship. But for that to happen I need you to be engaged. I expect you to start seeing patients now,
but certainly no later than this Wednesday , May 24, 2017.

Respectfully yours,

Vijayachandran Nair, MD
CHIEF OF STAFF

John J. Pershing VAMC


1500 N. Westwood Blvd
Poplar Bluff, MO 63901
TEL: 573-778-4691
Subject: Pain Management Clinic
Date: Tuesday, May 23, 2017 at 11:58:36 AM Eastern Daylight Time
From: Klein, Dale J.
To: Nair, Vijayachandran VHAPOP
CC: Hall, Patricia L. (POP), Barlage, Seth W., Gum, Kim, LoreRa Poston, sshilling@osc.gov

Dr. Nair,
As a professional, I warn you that negligent practices in hospitals can lead to a host of potentially serious mistakes, including
medication errors (wrong dosage or wrong medication), anesthesia errors, and even wrong-site surgery. Of course, hospital
malpractice involving poor implementation of proper protocols is not the only source of patient risk. Injury or prolonged
illness has been caused by misdiagnosis, delayed diagnosis, or other critical errors by medical professionals out of practice for
any amount of time. Imagine my surprise after sidelining me for over a year, in which you denied me training, you are now
requesting I see patients, after you have denied the need for my skills or the need for pain management care for our Veterans
at PBVAMC - you even suggested I was a risk to patients. I am concerned about your lack of integrity and that you appear to
harbor no good will toward our Veterans, never mind me, my career, or my safety. You are failing to properly return me to the
medical practice baseline I held before you isolated me in an office and refused to let me see patients, or even train as a
doctor.
My attorney brought to Agency's attention my concerns related to the status of currency in my medical knowledge required
for the position which you forcibly removed me from and refused to allow me to perform training for, but now want me to
perform without any training or return to medical baseline. I still have no response from you on this concern.
I am concerned that during the past year your own attorney (Agency counsel) has argued to the MSPB that I was a liability
risk, and now - when convenient or pressured - you want me to perform patient care without any steps taken by you in
providing me with any type of training, system updates, access to patient information, and the like. The very continued
education, review of patient charts, and consults that I have requested and have been denied or not given permissions/access
to over the past year. I still have no response from you on this concern.
I have just learned that under Sections 502, 902, 912, 913, 922, 924, 941, at minimum, of the Comprehensive Addiction and
Recovery Act (CARA), you may be imputing on me responsibilities and liabilities I am not ready to assume after you took
away my privileges illegally (per the Office of Special Counsel). I have had no exposure to this new law and program. Further,
I have learned that this Hospital has been assigning what amounts to my prior duties to a pharmacist. That pharmacist has
brought forward certain concerns in an email, and I too have similar concerns of being asked to commit an offense against
Title 21 of the U.S. Code, involving controlled substances, or against CARA. Further, I want a complete audit by an outside
entity of all pain consults performed while I was in solitary confinement. Your actions here amount to violations of law since
pharmacists have limited authority to perform pain consults, and you stripped my ability to perform within my specialties.
You seem to NOT offer guidance, training, or care, in how you force me now to simply perform - without taking precautions
and training me. Why?
Please clarify you are waiving training requirements under the Joint Commission, medical licensing, and my Board
certifications, and waiving any and all liability to me, for any negligent act that may occur, or violation of protocol that may
occur, or harm that may occur, as a result of the lag or lack of knowledge I may have, after you ordered me removed as a
doctor and placed me in a position in which I could not train or maintain my currency in medical practice - because you did
not like the high standards in which I practiced medicine. Please be advised I must warn all patients of what has occurred and
why I practice by providing warnings, including my belief that you are placing Patients at risk by your management of the
medical practices at this VAMC. In addition, for every patient assigned, and every chart provided, I do intend to file a separate
disclosure of safety issue, and provide such to the OIG, as required by law, and my experiences here, until my training is
completed by an independent assessment (not at PBVAMC).
If you cannot resolve this, please advise. Please refer me to someone that can.
ALSO, for me to return to any patient duties, against my will now, please clarify you are ORDERING ME TO SEE PATIENTS
after I have advised that you degraded my medical knowledge and skills and are placing the VA and Veterans at risk of harm
and damages. Please be clear what you are ORDERING me to do. I will do as ORDERED, but for now I cannot perform
duties that endanger Veterans, and my career. Voluntarily, I intend to ask for someone to second sign any medical chart I
touch. If ORDERED, I will make the appropriate disclosures in support of our Veterans for each assignment. I understand I
may provide this information to Congress freely to ensure safety of our Veterans, also.
If you cannot resolve this, please advise who can.

Kind regards,

Dale J. Klein, M.D.

-----Original Message-----
From: Nair, Vijayachandran VHAPOP
Sent: Monday, May 22, 2017 12:53 PM

Page 1 of 2
To: Klein, Dale J. <Dale.Klein@va.gov>
Cc: Gum, Kim <Kim.Gum@va.gov>; Nair, Vijayachandran VHAPOP <Vijayachandran.Nair@va.gov>; Hall, Patricia L. (POP)
<Patricia.TenHaaf2@va.gov>
Subject: Pain Clinic

Dr. Klein,
As you aware, I have been named as your new supervisor. You have already received communications - directly and through
your attorney - that you are expected to see patients in the pain management clinic. I understand your attorney has raised
questions about training that you may require. We are still waiting to hear specifics. But in the interim, remaining in your
office, refusing to see patients, is not an option. I do not understand why you would not be able to see patients, make
appropriate diagnoses, prescribe medications, as necessary, and schedule necessary follow-ups. I wish for us to have an
effective, cordial relationship. But for that to happen I need you to be engaged. I expect you to start seeing patients now, but
certainly no later than this Wednesday , May 24, 2017.

Respectfully yours,

Vijayachandran Nair, MD
CHIEF OF STAFF

John J. Pershing VAMC


1500 N. Westwood Blvd
Poplar Bluff, MO 63901
TEL: 573-778-4691

Page 2 of 2
From: Nair, Vijayachandran VHAPOP
Sent: Tuesday, May 23, 2017 3:43 PM
To: Klein, Dale J. <Dale.Klein@va.gov>
Cc: Hall, Patricia L. (POP) <Patricia.TenHaaf2@va.gov>; Gum, Kim <Kim.Gum@va.gov>; Nair, Vijayachandran
VHAPOP <Vijayachandran.Nair@va.gov>
Subject: Pain Management Clinic

Dr. Klein:

Thank you for your response. Please be assured that I would never intentionally put patients at risk. I previously
concluded, and still conclude, that despite a period of time of you not seeing patients, you have the requisite
education, skills and ability to perform the following duties now: review consults, see patients, make appropriate
diagnoses, prescribe medications, as necessary, and schedule necessary follow-ups. I appreciate there might be other
duties that will require training. I am still waiting for specifics from you regarding the types of duties for which you
will need training and the type of training you believe you will need. But I repeat what I said previously: remaining
in your office, refusing to see patients, is not an option.

I expect you to start performing these duties now: reviewing consults, seeing patients, making appropriate
diagnoses, prescribing medications, as necessary, and scheduling necessary follow-ups. I look forward to you being
involved in patient care. Again, you must be involved no later than tomorrow morning, May 24, at the start of your
tour of duty.

Respectfully yours,

Vijayachandran Nair, MD
CHIEF OF STAFF

John J. Pershing VAMC


1500 N. Westwood Blvd
Poplar Bluff, MO 63901
TEL: 573-778-4691
Subject: RE: Dr. Bha+ has been designated Ac6ng Chief of Sta from 5/24/17 through 5/29/17
Date: Wednesday, May 24, 2017 at 11:39:55 AM Eastern Daylight Time
From: Klein, Dale J.
To: Hall, Patricia L. (POP)
CC: Barlage, Seth W., Nair, Vijayachandran VHAPOP, Krishnan, Balamurugan, Po+s, Ginger, Gum, Kim,
Lore+a Poston, sshilling@osc.gov

Patricia,

In your email below, you say Bhatt is my supervisor and he "is available". This morning, multiple times I've called to speak
with him but he will not take a telephone call from me. Please advise.

Regards,

Dale J. Klein, M.D.

-----Original Message-----
From: Hall, Patricia L. (POP)
Sent: Wednesday, May 24, 2017 10:12 AM
To: Klein, Dale J. <Dale.Klein@va.gov>
Cc: Baker, Mary (VHAPOP) <Mary.Baker10@va.gov>; Barlage, Seth W. <Seth.Barlage@va.gov>
Subject: RE: Dr. Bhatt has been designated Acting Chief of Staff from 5/24/17 through 5/29/17

Dr. Bhatt is the acting COS. He is seeing patients in Paragould but is available. He asked Dr. Krishnan to simply make sure
you had what you needed to start seeing Veterans today while he was in clinic seeing patients. Kim was with Dr. Krishnan this
morning to make sure she helped facilitate the nursing. I will convey to her that you are ready to coordinate with your nurse.
IT can be arranged today, but your CPRS is already available and that would be a good start for seeing patients.
As an agency, we have done everything I am aware of to provide all staff a safe environment. If you have specific other
requests, please let me know. I will be pulling all the information on the panic alarm you pushed for an unknown reason this
morning. I do know the police did not disregard your alarm and sent more than one officer immediately to your room.
Please specify any other questions you may have. I am sure your supervisor will address them as appropriate.
Per your supervisor, it is an expectation you start to see patients today.

Patricia L. Hall PhD, FACHE


Medical Center Director
John J. Pershing VA Medical Center
Poplar Bluff, MO
573-778-4649

-----Original Message-----
From: Klein, Dale J.
Sent: Wednesday, May 24, 2017 9:50 AM
To: Hall, Patricia L. (POP) <Patricia.TenHaaf2@va.gov>
Cc: Barlage, Seth W. <Seth.Barlage@va.gov>; Nair, Vijayachandran VHAPOP <Vijayachandran.Nair@va.gov>; Baker, Mary
(VHAPOP) <Mary.Baker10@va.gov>; lposton@813whistle.com; sshilling@osc.gov
Subject: FW: Dr. Bhatt has been designated Acting Chief of Staff from 5/24/17 through 5/29/17

Patricia,

I wanted to speak with Dr. Nair, who I was informed is my supervisor; re: questions about re-opening the PMC.

This morning, I was informed Nair is on vacation and unavailable.

The email below states Dr. Bhatt is the acting COS through next week Monday. Does that mean Bhatt is my supervisor? This
morning, someone informed me Bhatt is seeing patients today in Paragould, Arkansas. At this time, I'm unsure who my
supervisor is. Please advise who I'm supposed to report too?

There are still issues that must be addressed regarding the PMC. The following is not a complete list. I was informed the

Page 1 of 2
name of the nurse who the VA assigned to the PMC. I have reached out to that nurse multiple times but that nurse will not
talk with me. Please advise how I could start seeing patients today when the last time I spoke with the nurse who has been
assigned to the PMC was several months ago, and at that time, the nurse expressed his concern to me that he has not ever
worked in a PMC and he did not know what he was supposed to do. Please advise.

The last time I checked, I still do not have all of the software on my computer that is needed to provide the best care
possible. My chain of command has informed me verbally and in writing many times over the course of a long period of time
that IT issues would be taken care in a timely manner. How do you expect me to provide patient care today without this IT
support? When do you anticipate all IT issues will be addressed and rectified to include training for any software programs
that have been upgraded since you closed the PMC in March 2016?

Recently, I stopped by your office to speak with you about my personal safety. As you recall, you refused to discuss the matter
with me and abruptly walked away from the conversation. This morning, I spoke with Seth Barlage regarding my personal
safety. Barlage stated the VA police will not be providing security protection for me while I'm on property. Who am I
supposed to contact with security concerns? Barlage further stated to me that the VA will not provide security protection for
me. Please advise why the VA has refused to provide this safety? This morning, I pressed the panic alarm and then
immediately called the VA police. The officer who answered the phone would not speak with me and I heard someone in the
background say that the panic alarm is from room 3040A (my location) and to disregard it. That is the second time VA police
have disregarded the panic alarm. Why are the VA police disregarding the panic alarms that come from my location?

I await your email response.

Regards,

Dale J. Klein, M.D.

PS: Administration, to include you, still has not responded to numerous other questions I have asked. When do you
anticipate those questions will be answered?

-----Original Message-----
From: Baker, Mary (VHAPOP)
Sent: Tuesday, May 23, 2017 5:50 PM
To: POPBLUFF-Dist D <POPBLUFF-DistD@va.gov>; POPBLUFF-APN <POPBLUFF-APN@va.gov>; POPBLUFF-Quad
Support <POPBLUFF-QuadSupport@va.gov>; POPBLUFF-MAAs <VHAPOPMaas@med.va.gov>; POPBLUFF-Dist A
<VHAPOPDISTA@va.gov>; POPBLUFF-AO <POPBLUFF-AO@va.gov>
Subject: Dr. Bhatt has been designated Acting Chief of Staff from 5/24/17 through 5/29/17

https://vaww.visn15.portal.va.gov/pop/Lists/Acting_Designations/Current.aspx

Mary Baker
Chief of Staff Secretary
573-778-4691

Page 2 of 2
Subject: What date do you an,cipate all issues will be addressed AND rec,ed?
Date: Wednesday, May 24, 2017 at 12:37:11 PM Eastern Daylight Time
From: Klein, Dale J.
To: Hall, Patricia L. (POP)
CC: Barlage, Seth W., Nair, Vijayachandran VHAPOP, BhaT, Yogesh, Krishnan, Balamurugan, PoTs,
Ginger, Gum, Kim, LoreTa Poston, sshilling@osc.gov

Patricia,

I continue to patiently wait for all of the issues I have brought to my chain of commands' attention to be addressed AND
rectified so I could provide the best care possible for the Veterans in the PMC. What date do you anticipate that all of those
issues will be addressed AND rectified?

Regards,

Dale J. Klein, M.D.

-----Original Message-----
From: Klein, Dale J.
Sent: Wednesday, May 24, 2017 11:33 AM
To: Hall, Patricia L. (POP) <Patricia.TenHaaf2@va.gov>
Cc: Barlage, Seth W. <Seth.Barlage@va.gov>; Nair, Vijayachandran VHAPOP <Vijayachandran.Nair@va.gov>; Bhatt, Yogesh
<Yogesh.Bhatt@va.gov>; Krishnan, Balamurugan <Balamurugan.Krishnan@va.gov>; Potts, Ginger <Ginger.Potts@va.gov>;
Gum, Kim <Kim.Gum@va.gov>; lposton@813whistle.com; sshilling@osc.gov
Subject: Inapposite response

Patricia,

But according to multiple of your employees to include the VA police staff, the VA will not provide security protection to
me. Why is your answer inapposite to your staffs' statements?

Regards,

Dale J. Klein, M.D.

-----Original Message-----
From: Hall, Patricia L. (POP)
Sent: Wednesday, May 24, 2017 10:59 AM
To: Klein, Dale J. <Dale.Klein@va.gov>
Subject: RE: I continue to wait for answers to the numerous questions I have asked

The VA police are here to protect and serve all. As I said, your needs will be addressed . Your CPRS is active.
If you have other questions please specify to your supervisor and I am sure they will be addressed as appropriate.

Patricia L. Hall PhD, FACHE


Medical Center Director
John J. Pershing VA Medical Center
Poplar Bluff, MO
573-778-4649

-----Original Message-----
From: Klein, Dale J.
Sent: Wednesday, May 24, 2017 10:25 AM
To: Hall, Patricia L. (POP) <Patricia.TenHaaf2@va.gov>
Cc: Barlage, Seth W. <Seth.Barlage@va.gov>; Nair, Vijayachandran VHAPOP <Vijayachandran.Nair@va.gov>; Bhatt, Yogesh
<Yogesh.Bhatt@va.gov>; Krishnan, Balamurugan <Balamurugan.Krishnan@va.gov>; Potts, Ginger <Ginger.Potts@va.gov>;
Gum, Kim <Kim.Gum@va.gov>; lposton@813whistle.com; sshilling@osc.gov
Subject: I continue to wait for answers to the numerous questions I have asked

Page 1 of 3
Patricia,

Why did Barlage inform me the VA police will not provide me security protection?

Why did Barlage inform me the VA will not provide me security protection?

In the past, why did the VA police order multiple employees to "disregard" the panic alarm from my location?

Administration has informed me verbally and in writing that IT issues would be taken care of in a timely manner. Why have
those issues to date, still not been taken care? However, you expect me to see patients today? How can I provide the best care
possible to Veterans without all the issues that I've brought to my chain of command's attention being address AND rectified?

I await your email response.

I continue to await answers to numerous other questions I have asked administration, to include you.

Regards,

Dale J. Klein, M.D.

-----Original Message-----
From: Klein, Dale J.
Sent: Wednesday, May 24, 2017 10:14 AM
To: lposton@813whistle.com
Cc: sshilling@osc.gov
Subject: FW: Dr. Bhatt has been designated Acting Chief of Staff from 5/24/17 through 5/29/17

-----Original Message-----
From: Hall, Patricia L. (POP)
Sent: Wednesday, May 24, 2017 10:12 AM
To: Klein, Dale J. <Dale.Klein@va.gov>
Cc: Baker, Mary (VHAPOP) <Mary.Baker10@va.gov>; Barlage, Seth W. <Seth.Barlage@va.gov>
Subject: RE: Dr. Bhatt has been designated Acting Chief of Staff from 5/24/17 through 5/29/17

Dr. Bhatt is the acting COS. He is seeing patients in Paragould but is available. He asked Dr. Krishnan to simply make sure
you had what you needed to start seeing Veterans today while he was in clinic seeing patients. Kim was with Dr. Krishnan this
morning to make sure she helped facilitate the nursing. I will convey to her that you are ready to coordinate with your nurse.
IT can be arranged today, but your CPRS is already available and that would be a good start for seeing patients.
As an agency, we have done everything I am aware of to provide all staff a safe environment. If you have specific other
requests, please let me know. I will be pulling all the information on the panic alarm you pushed for an unknown reason this
morning. I do know the police did not disregard your alarm and sent more than one officer immediately to your room.
Please specify any other questions you may have. I am sure your supervisor will address them as appropriate.
Per your supervisor, it is an expectation you start to see patients today.

Patricia L. Hall PhD, FACHE


Medical Center Director
John J. Pershing VA Medical Center
Poplar Bluff, MO
573-778-4649

-----Original Message-----
From: Klein, Dale J.
Sent: Wednesday, May 24, 2017 9:50 AM
To: Hall, Patricia L. (POP) <Patricia.TenHaaf2@va.gov>
Cc: Barlage, Seth W. <Seth.Barlage@va.gov>; Nair, Vijayachandran VHAPOP <Vijayachandran.Nair@va.gov>; Baker, Mary
(VHAPOP) <Mary.Baker10@va.gov>; lposton@813whistle.com; sshilling@osc.gov
Subject: FW: Dr. Bhatt has been designated Acting Chief of Staff from 5/24/17 through 5/29/17

Patricia,

Page 2 of 3
I wanted to speak with Dr. Nair, who I was informed is my supervisor; re: questions about re-opening the PMC.

This morning, I was informed Nair is on vacation and unavailable.

The email below states Dr. Bhatt is the acting COS through next week Monday. Does that mean Bhatt is my supervisor? This
morning, someone informed me Bhatt is seeing patients today in Paragould, Arkansas. At this time, I'm unsure who my
supervisor is. Please advise who I'm supposed to report too?

There are still issues that must be addressed regarding the PMC. The following is not a complete list. I was informed the
name of the nurse who the VA assigned to the PMC. I have reached out to that nurse multiple times but that nurse will not
talk with me. Please advise how I could start seeing patients today when the last time I spoke with the nurse who has been
assigned to the PMC was several months ago, and at that time, the nurse expressed his concern to me that he has not ever
worked in a PMC and he did not know what he was supposed to do. Please advise.

The last time I checked, I still do not have all of the software on my computer that is needed to provide the best care
possible. My chain of command has informed me verbally and in writing many times over the course of a long period of time
that IT issues would be taken care in a timely manner. How do you expect me to provide patient care today without this IT
support? When do you anticipate all IT issues will be addressed and rectified to include training for any software programs
that have been upgraded since you closed the PMC in March 2016?

Recently, I stopped by your office to speak with you about my personal safety. As you recall, you refused to discuss the matter
with me and abruptly walked away from the conversation. This morning, I spoke with Seth Barlage regarding my personal
safety. Barlage stated the VA police will not be providing security protection for me while I'm on property. Who am I
supposed to contact with security concerns? Barlage further stated to me that the VA will not provide security protection for
me. Please advise why the VA has refused to provide this safety? This morning, I pressed the panic alarm and then
immediately called the VA police. The officer who answered the phone would not speak with me and I heard someone in the
background say that the panic alarm is from room 3040A (my location) and to disregard it. That is the second time VA police
have disregarded the panic alarm. Why are the VA police disregarding the panic alarms that come from my location?

I await your email response.

Regards,

Dale J. Klein, M.D.

PS: Administration, to include you, still has not responded to numerous other questions I have asked. When do you
anticipate those questions will be answered?

-----Original Message-----
From: Baker, Mary (VHAPOP)
Sent: Tuesday, May 23, 2017 5:50 PM
To: POPBLUFF-Dist D <POPBLUFF-DistD@va.gov>; POPBLUFF-APN <POPBLUFF-APN@va.gov>; POPBLUFF-Quad
Support <POPBLUFF-QuadSupport@va.gov>; POPBLUFF-MAAs <VHAPOPMaas@med.va.gov>; POPBLUFF-Dist A
<VHAPOPDISTA@va.gov>; POPBLUFF-AO <POPBLUFF-AO@va.gov>
Subject: Dr. Bhatt has been designated Acting Chief of Staff from 5/24/17 through 5/29/17

https://vaww.visn15.portal.va.gov/pop/Lists/Acting_Designations/Current.aspx

Mary Baker
Chief of Staff Secretary
573-778-4691

Page 3 of 3
Subject: Refused legal counsel AGAIN
Date: Wednesday, May 24, 2017 at 3:22:06 PM Eastern Daylight Time
From: Klein, Dale J.
To: Hall, Patricia L. (POP)
CC: Barlage, Seth W., Nair, Vijayachandran VHAPOP, BhaS, Yogesh, Krishnan, Balamurugan, PoSs,
Ginger, Gum, Kim, Shepard, Debby, LoreSa Poston, sshilling@osc.gov

Patricia,

At 1353 today, there was a knock on the door of my room and someone said they would like to speak with me. I inquired who
and if anyone was with them. The person responded Debby Shepard and I heard someone talking with her but Shepard
refused to tell me the name of the person(s) who was with her. I wanted my legal counsel to be involved with the meeting but
Shepard said that was not necessary.

Patricia, to date, you have not answered many of my legitimate questions to include why I am denied legal counsel for
meetings. I am receptive to moving things along to include having meetings but you and your staff continue to refuse to allow
me representation and refer to the meetings as off the record. Why?

Regards,

Dale J. Klein, M.D.

-----Original Message-----
From: Klein, Dale J.
Sent: Wednesday, May 24, 2017 12:58 PM
To: Hall, Patricia L. (POP) <Patricia.TenHaaf2@va.gov>
Cc: Barlage, Seth W. <Seth.Barlage@va.gov>; Nair, Vijayachandran VHAPOP <Vijayachandran.Nair@va.gov>; Bhatt, Yogesh
<Yogesh.Bhatt@va.gov>; Krishnan, Balamurugan <Balamurugan.Krishnan@va.gov>; Potts, Ginger <Ginger.Potts@va.gov>;
Gum, Kim <Kim.Gum@va.gov>; Phillips, Lonnie (VHAPOP) <Lonnie.Phillips1@va.gov>; Shepard, Debby
<Debby.Shepard@va.gov>; lposton@813whistle.com; sshilling@osc.gov
Subject: Outstanding issues

Patricia,

This morning at 1100, Kim Gum, R.N. and Lonnie Phillips, R.N. stopped by my room. Gum stated, she was told to stop by my
room and talk with me to determine if anything else needed to be taken care of so I could see patients "today". I responded
that there are still outstanding issues that I have brought to my chain of commands' attention numerous times over a long
period of time; verbally and in writing. I asked Gum if she had been provided a list of outstanding issues and she responded,
"No." I offered to let Gum and Phillips look at documentation that I have that lists extensively and in detail what needs to be
completed prior to a PMC opening. Gum responded that perhaps another day she would look at that documentation. Gum
stated she would check with administration to try and get the list of outstanding issues and both Gum and Phillips left my
room at 1113.

At 1138 Debby Shepard and Charles Morse stopped by my room. Shepard stated they were here because, "We want to fix your
computer." Shepard stated the reason the radiology software issue had not been taken care of in the past is because I refused
to allow it. I politely responded that was a false statement. Then Shepard redacted her statement and stated it was not my
fault.

While in my room, Shepard called (I think) IT to have someone load the software program onto my computer. After the
program was loaded, I was unsuccessful with logging into the program because Shepard said she made a mistake with
creating my user name. Shepard and Morse left my room. At 1210, Shepard and Morse returned to my room. Morse stated,
"We have STAT exams we are holding up." I expressed that it would be appropriate to take care of the STAT exams. Morse
stated it was my fault this software issue has not been taken care of. I'm unaware of how it could be my fault since I do not
have the authorization to remove software from my work computer or to load software onto my work computer. Morse was
aggressive and trying hard to blame me for the radiology software program not being rectified. I politely explained to Shepard
and Morse that I refused to argue with them and they walked away. I continue to not have access to that specific radiology
program because I have to be given a user name and password to gain initial access. Please advise.

Patricia, there are still outstanding issues that must be rectified so I could provide the best care possible for the Veterans. I
have been ordered to see patients today. Even though you and others have failed to provide the infrastructure for me to

Page 1 of 2
provide standard of care to Veterans, I am willing to move forward. However, how do you expect me to provide the best care
possible if you and others continue to fail to address and rectify issues that I have brought to my chain of commands' attention
many times beginning a couple years ago?

I have requested verbally and in writing multiple times to be given the opportunity to have legal counsel for meetings. You
continue to refuse to allow me to have access to my legal counsel when meetings occur. Why?

I await your email response with specific answers to not only the above questions, but other questions I have asked my chain
of command in the past.

Regards,

Dale J. Klein, M.D.

Page 2 of 2
From: Hall, Patricia L. (POP)
Sent: Wednesday, May 24, 2017 4:19 PM
To: Klein, Dale J. <Dale.Klein@va.gov>
Cc: Anfang, Michael <Michael.Anfang@va.gov>
Subject: FW: Follow-up call with OSC and Dr. Klein's attorneys

Following up an attorney requests. Please see below.

Patricia L. Hall PhD, FACHE
Medical Center Director
John J. Pershing VA Medical Center
Poplar Bluff, MO
573-778-4649




From: Anfang, Michael
Sent: Wednesday, May 24, 2017 3:04 PM
To: Hall, Patricia L. (POP) <Patricia.TenHaaf2@va.gov>
Subject: Follow-up call with OSC and Dr. Klein's attorneys

Following up on our call earlier, Dr. Kleins attorneys today said Dr. Klein needs:

1. Access to the electronic patient medical record. I have confirmed that Dr. Klein has had
CPRS access since 2015.
2. Other unspecified software. Dr. Klein, when you allow the staff back in to finish setting up
your Intellispace software, it will be complete.
3. Identification of his supervisor. Specified May 12th Dr. Nair.
4. Identification of the nurse assigned to work with him. Lonnie has been with Dr. Klein twice
today.
5. Delivery of his position description, performance plan and performance standards. Scope is
attached
6. The identity of the specific location where Dr. Klein will see patients The 3 clinic spaces
Dr. Klein currently occupies.


Michael E. Anfang
Deputy Chief Counsel
Department of Veterans Affairs
Office of Chief Counsel, Midwest District - West
IA, IL, KS, MI/UP, MN, MO, ND, NE, SD, WI
1201 Walnut Street, Suite 800
Kansas City, MO 64106
816.701.3082 (phone)
816.922.4810 (fax)
michael.anfang@va.gov (email)

Pain Physician (Table 1 or 2, Tier 1)

1. SCOPE OF WORK (SERVICES):

a. The physician shall be Board Certified in Family Medicine, Internal Medicine or


PM&R and provide care to the veteran patients in the Multidisciplinary Pain
Management Program at John J. Pershing VA Medical Center in Poplar Bluff, MO.
Fellowship training in pain medicine is desired but not required. Certification or
experience in Pain Management is preferred.

b. The physician shall provide services to include, but not be limited to


diagnosing, treating and managing patients with chronic pain conditions according to
standard, usual and acceptable or customary methods and techniques including
medication management with opioids and minor interventional pain procedures. The
physician will report to the Associate Chief of Staff, Specialty Care Services or his
designated surrogate. The physician will work independently, caring for outpatients in
an established clinic will do consultation on patients at inpatient and CLC settings. The
physician shall be expected to cooperate with and participate in medical duties or
functions related to quality of care review and improvement, including orientation to
Poplar Bluff VAMC safety and infection control procedures. The physician may have
additional duties as collaborative support for a nurse practitioner or physicians
assistant. This position will be part of the multidisciplinary Pain Management Program
(mPMP).

c. The services to be performed by the physician shall be under the general


direction of the Associate Chief of Staff, Specialty Care Services.

d. Associate Chief of Staff, Specialty Care Services and/or designee shall


monitor performance through direct or indirect observation as well as observation of
work results on an on-going daily basis.

e. The physician may be exposed to surroundings which involve moderate risks


or discomfort which require special precautions, i.e., infectious diseases, verbal and
physical abuse from the emotionally disturbed patient.

f. The physician may have personal contact with patients, family, visitors and
other employees, including contract employees of various VA services.

g. Contact with patients is for the purpose of medical care and information
sharing as it relates to the medical care and special requirements. Contact with
physicians and other ancillary services personnel are required for information sharing
and consultation. Contacts with visitors and family members are required for information
sharing as it relates to a particular patient.

h. Ages of patients served may vary greatly and include young (20s and 30s
years of age); middle-aged (40s and 50s years of age); and older patients (60 and

6/24/2014
upwards. Patients may have varying degrees of service connected and non-service
connected disabilities.

i. Dress apparel: Employee shall be required to dress in a professional manner.

j. Medical Record documentation shall be completed timely and in accordance


with hospital policy. Notes and encounters are filed electronically using the
Computerized Patient Record System (CPRS).

2. HOURS OF WORK: The physician may be required to furnish services on all


calendar days. Work hours shall be defined as follows: Regular Tour of Duty: Monday
through Friday from 8:00 a.m. through 4:30 p.m. Due to the nature of the work, the
physician may occasionally be required to stay later than 4:30 p.m., as required. Call
duty on weekends will be required.

3. QUALIFICATIONS: Clinical privileges must be recommended by the Chief of Staff


and granted by the Director of the Poplar Bluff VA Medical Center. The physician must
provide complete credentialing and privileging information in a timely, expeditious way
to the VA Network Credentialing Office. Employment is contingent on the ability of the
physician to be credentialed by the VA Network Credentialing Office.

4. SPECIAL REQUIREMENTS:

a. The physician shall understand and agree to the following:

(1) Confidentiality of Records Federal Statutes protects computer access to


information.

(2) Patient information is to be used ONLY in accordance with the duties and
responsibilities of the position.

(3) The physician is responsible for adhering to the policies and procedures
regarding security and reporting any suspected violations and security.

b. The physician shall participate in activities of the VAMC that are designed to meet
the requirements of The Joint Commission as they apply to the position.

c. VA shall provide personal protective equipment (PPE), as required, as well as


training on use. Failure to returns items issued to the employee following termination of
employment shall result in a charge against payment.

d. The physician shall be subject to VAs Drug-Free Workplace Policy and may
receive a drug test and is subject to random drug testing thereafter. This includes
situations of reasonable suspicion and accident or unsafe practice testing.

6/24/2014
Subject: FW: What date do you an.cipate you will begin coopera.ng?
Date: Wednesday, May 24, 2017 at 4:47:26 PM Eastern Daylight Time
From: Klein, Dale J.
To: Hall, Patricia L. (POP)
CC: Barlage, Seth W., Nair, Vijayachandran VHAPOP, BhaT, Yogesh, Krishnan, Balamurugan, PoTs,
Ginger, Gum, Kim, Phillips, Lonnie (VHAPOP), LoreTa Poston, sshilling@osc.gov

Patricia,

I did not ask to use email as a forum to debate. Once again, I'm trying to organize and move forward with trying to build a
first class PMC. It has become increasingly difficult because of the obstacles you have purposely made and the uncooperation
I'm forced to deal with from you and your staff.

If they came to simply help me as you stated in your email below, then why did I get uncooperation?

I'm confused. In your most recent email you stated, "I am fully aware of when we have met." In a previous email you stated, "
I have not had any meetings with you so I cannot answer your question about your attorney."

You have stated multiple times today in writing that my supervisor could assist me. I have tried but to date, my supervisor
will not take a telephone call from me. What date do you anticipate my supervisor will be available/willing to speak with me?

I continue to wait for your email response with your specific answers to the questions I have asked you which to date you have
refused to answer.

Regards,

Dale J. Klein, M.D.

-----Original Message-----
From: Hall, Patricia L. (POP)
Sent: Wednesday, May 24, 2017 3:35 PM
To: Klein, Dale J. <Dale.Klein@va.gov>
Subject: RE: What date do you anticipate you will begin cooperating?

Dr. Klein,
I will not use the email as a forum to debate. Those staff were coming to assist you. They were not there to conduct a formal
meeting or have a supervisory discussion with you. They came simply to help you with the operations of the pain clinic.

I am fully aware of when we have met.

If you have any specific questions regarding clinic operations, I am sure that your supervisor can answer them as appropriate.

Patricia L. Hall PhD, FACHE


Medical Center Director
John J. Pershing VA Medical Center
Poplar Bluff, MO
573-778-4649

-----Original Message-----
From: Klein, Dale J.
Sent: Wednesday, May 24, 2017 3:31 PM
To: Hall, Patricia L. (POP) <Patricia.TenHaaf2@va.gov>
Cc: Barlage, Seth W. <Seth.Barlage@va.gov>; Nair, Vijayachandran VHAPOP <Vijayachandran.Nair@va.gov>; Bhatt, Yogesh
<Yogesh.Bhatt@va.gov>; Krishnan, Balamurugan <Balamurugan.Krishnan@va.gov>; Potts, Ginger <Ginger.Potts@va.gov>;
Gum, Kim <Kim.Gum@va.gov>; Phillips, Lonnie (VHAPOP) <Lonnie.Phillips1@va.gov>; lposton@813whistle.com;
sshilling@osc.gov
Subject: What date do you anticipate you will begin cooperating?

Patricia,

Page 1 of 3
Kim and Lonnie stopped by my room unannounced. Gum stated since I requested my legal counsel to be present for the
meeting, since she and Lonnie did not have legal counsel, they would be unable to have the meeting with me.

Debby stopped by my room unannounced. She would not answer questions and refused to allow me legal counsel. What date
do you anticipate that you and your staff will start to cooperate as I try to build the infrastructure so the best care possible
could be provided to the Veterans in the PMC?

You stated, "I have not had any meetings with you so I cannot answer your question about your attorney." I could go back to
my meeting notes and give you dates of meetings you had with me if you would like?

Beginning more than two years ago, I have provided the PB VA administration verbally and in writing many issues that should
be addressed and rectified so the Veterans would receive the highest quality care possible in the PMC. To date, why have you
not addressed AND rectified all of those issues? I do believe that some of the issues have been ADDRESSED. However, just
addressing an issue does not mean it got rectified. What date do you anticipate you will address AND rectify all of the issues I
have outlined?

I await your email response with specific answers to all of the questions I have asked you and others in the past.

Regards,

Dale J. Klein, M.D.

-----Original Message-----
From: Hall, Patricia L. (POP)
Sent: Wednesday, May 24, 2017 2:26 PM
To: Klein, Dale J. <Dale.Klein@va.gov>
Subject: RE: Outstanding issues

I am glad to hear Kim and Lonnie are meeting with you to discuss the specifics of your clinic operations.
It is my understanding that Debby is rectifying your software need. Please allow them to finish.
I have not had any meetings with you so I cannot answer your question about your attorney.
Please let me know what other specific questions you have.

Patricia L. Hall PhD, FACHE


Medical Center Director
John J. Pershing VA Medical Center
Poplar Bluff, MO
573-778-4649

-----Original Message-----
From: Klein, Dale J.
Sent: Wednesday, May 24, 2017 12:58 PM
To: Hall, Patricia L. (POP) <Patricia.TenHaaf2@va.gov>
Cc: Barlage, Seth W. <Seth.Barlage@va.gov>; Nair, Vijayachandran VHAPOP <Vijayachandran.Nair@va.gov>; Bhatt, Yogesh
<Yogesh.Bhatt@va.gov>; Krishnan, Balamurugan <Balamurugan.Krishnan@va.gov>; Potts, Ginger <Ginger.Potts@va.gov>;
Gum, Kim <Kim.Gum@va.gov>; Phillips, Lonnie (VHAPOP) <Lonnie.Phillips1@va.gov>; Shepard, Debby
<Debby.Shepard@va.gov>; lposton@813whistle.com; sshilling@osc.gov
Subject: Outstanding issues

Patricia,

This morning at 1100, Kim Gum, R.N. and Lonnie Phillips, R.N. stopped by my room. Gum stated, she was told to stop by my
room and talk with me to determine if anything else needed to be taken care of so I could see patients "today". I responded
that there are still outstanding issues that I have brought to my chain of commands' attention numerous times over a long
period of time; verbally and in writing. I asked Gum if she had been provided a list of outstanding issues and she responded,
"No." I offered to let Gum and Phillips look at documentation that I have that lists extensively and in detail what needs to be
completed prior to a PMC opening. Gum responded that perhaps another day she would look at that documentation. Gum
stated she would check with administration to try and get the list of outstanding issues and both Gum and Phillips left my
room at 1113.

At 1138 Debby Shepard and Charles Morse stopped by my room. Shepard stated they were here because, "We want to fix your
computer." Shepard stated the reason the radiology software issue had not been taken care of in the past is because I refused

Page 2 of 3
to allow it. I politely responded that was a false statement. Then Shepard redacted her statement and stated it was not my
fault.

While in my room, Shepard called (I think) IT to have someone load the software program onto my computer. After the
program was loaded, I was unsuccessful with logging into the program because Shepard said she made a mistake with
creating my user name. Shepard and Morse left my room. At 1210, Shepard and Morse returned to my room. Morse stated,
"We have STAT exams we are holding up." I expressed that it would be appropriate to take care of the STAT exams. Morse
stated it was my fault this software issue has not been taken care of. I'm unaware of how it could be my fault since I do not
have the authorization to remove software from my work computer or to load software onto my work computer. Morse was
aggressive and trying hard to blame me for the radiology software program not being rectified. I politely explained to Shepard
and Morse that I refused to argue with them and they walked away. I continue to not have access to that specific radiology
program because I have to be given a user name and password to gain initial access. Please advise.

Patricia, there are still outstanding issues that must be rectified so I could provide the best care possible for the Veterans. I
have been ordered to see patients today. Even though you and others have failed to provide the infrastructure for me to
provide standard of care to Veterans, I am willing to move forward. However, how do you expect me to provide the best care
possible if you and others continue to fail to address and rectify issues that I have brought to my chain of commands' attention
many times beginning a couple years ago?

I have requested verbally and in writing multiple times to be given the opportunity to have legal counsel for meetings. You
continue to refuse to allow me to have access to my legal counsel when meetings occur. Why?

I await your email response with specific answers to not only the above questions, but other questions I have asked my chain
of command in the past.

Regards,

Dale J. Klein, M.D.

Page 3 of 3
Subject: My supervisor refused to have a mee2ng with me
Date: Thursday, May 25, 2017 at 10:53:14 AM Eastern Daylight Time
From: Klein, Dale J.
To: Hall, Patricia L. (POP)
CC: Barlage, Seth W., Nair, Vijayachandran VHAPOP, BhaT, Yogesh, Krishnan, Balamurugan, Gum, Kim,
Phillips, Lonnie (VHAPOP), LoreTa Poston, sshilling@osc.gov

Patricia,

After I received the email below, I called Dr. Bhatt's office and spoke with him. I informed Bhatt that I would like to move
things forward with the PMC and I'm receptive to having a meeting with my supervisor; which it's my understanding is
Bhatt. I informed Bhatt that I would have my legal counsel participate in the meeting. Bhatt responded that he refused to
have a meeting with me if my legal counsel is involved.

Patricia, could you please explain to me how we can move forward if you and your staff continue to refuse to cooperate?

Regards,

Dale J. Klein, M.D.

-----Original Message-----
From: Bhatt, Yogesh
Sent: Thursday, May 25, 2017 9:30 AM
To: Klein, Dale J. <Dale.Klein@va.gov>
Subject: consults

Dr.Klein, I want to come by to see you about the review of consults.let me know.

Bhatt Yogesh

Page 1 of 1
Subject: (none)
Date: Thursday, May 25, 2017 at 2:15:58 PM Eastern Daylight Time
From: Klein, Dale J.
To: Hall, Patricia L. (POP)
CC: Nair, Vijayachandran VHAPOP, BhaL, Yogesh, LoreLa Poston, sshilling@osc.gov

Dr. Hall,

My counsel, Agency counsel and OSC counsel are currently in discussion on a plan of action for patient care, employee access
and a few other items to facilitate seeing patients, to provide the best care to our Veterans.

Please advise if you are ordering me to see patients despite steps that are being discussed by all counsel and after voicing my
concerns as they relate to Veteran care. Please be clear and specific to what you are ordering me to do. Also, for every
medical chart that comes before me, I intend to ask for a second signature and I will make the appropriate disclosures in
support of our Veterans for each assignment.

Kind regards,

Dale J. Klein, M.D.

-----Original Message-----
From: Hall, Patricia L. (POP)
Sent: Thursday, May 25, 2017 10:41 AM
To: Klein, Dale J. <Dale.Klein@va.gov>
Subject: RE: Correction of misinformation that has been disseminated

I can see that you and others have very different perceptions of events and discussions.
Are you willing to see patients today?
If you have specific questions for me or your supervisor regarding seeing patients as your supervisor asked you to do, please
let us know what we can address.
Otherwise, I will not use email as a forum to debate incongruent perceptions.

Patricia L. Hall PhD, FACHE


Medical Center Director
John J. Pershing VA Medical Center
Poplar Bluff, MO
573-778-4649

-----Original Message-----
From: Klein, Dale J.
Sent: Thursday, May 25, 2017 10:33 AM
To: Hall, Patricia L. (POP) <Patricia.TenHaaf2@va.gov>
Cc: Barlage, Seth W. <Seth.Barlage@va.gov>; Nair, Vijayachandran VHAPOP <Vijayachandran.Nair@va.gov>; Bhatt, Yogesh
<Yogesh.Bhatt@va.gov>; Krishnan, Balamurugan <Balamurugan.Krishnan@va.gov>; Gum, Kim <Kim.Gum@va.gov>;
Phillips, Lonnie (VHAPOP) <Lonnie.Phillips1@va.gov>; lposton@813whistle.com; sshilling@osc.gov
Subject: Correction of misinformation that has been disseminated

Patricia,

I would like to correct the misinformation that Bhatt stated below.

Gum did NOT presented me with any consults yesterday or today.

I did NOT refuse to meet with Bhatt. In fact, I clearly stated to Bhatt that I would like to move forward with the PMC and I'm
receptive to meeting with him. After I informed Bhatt that I would like my legal counsel to participate, Bhatt is the one who
refused to meet with me. He stated he would not have a meeting with me if my legal counsel is involved.

Additionally, at 1017 this morning the following occurred. I saw Seth Barlage walking towards me. Barlage looked at me and
I responded with "Good morning". Barlage did not verbally say anything and gave me a rude look. Do you consider Barlage's
behavior to be consistent with the VA's iCARE values?

Page 1 of 2
Your employees refuse to talk with me. They tell me off the record that they do not want to be seen or to have you know that
they are communicating with me because they are fearful they will be retaliated against. Because you have instilled this fear
in your employees, it makes it more challenging for me to build a strong foundation for a top notch PMC.

I continue to wait for an email response from you with your specific answers to the many questions I have asked that to date,
you have not answered.

Regards,

Dale J. Klein, M.D.

-----Original Message-----
From: Bhatt, Yogesh
Sent: Thursday, May 25, 2017 10:19 AM
To: Klein, Dale J. <Dale.Klein@va.gov>
Cc: Hall, Patricia L. (POP) <Patricia.TenHaaf2@va.gov>; Nair, Vijayachandran VHAPOP <Vijayachandran.Nair@va.gov>;
Bhatt, Yogesh <Yogesh.Bhatt@va.gov>
Subject: consults

Dr.Klein, I attempted to talk to you in person,which you refused without your legal counsel.
Are you going to review the consults which were presented to you by Ms.Gum yesterday?

Bhatt Yogesh

Page 2 of 2
From: Hall, Patricia L. (POP)
Sent: Friday, May 26, 2017 10:46 AM
To: Klein, Dale J. <Dale.Klein@va.gov>
Subject: RE:

Thank you for your response. I was simply inquiring based on your supervisor's email from Monday:

Dr. Klein,
As you aware, I have been named as your new supervisor. You have already received communications - directly and
through your attorney - that you are expected to see patients in the pain management clinic. I understand your
attorney has raised questions about training that you may require. We are still waiting to hear specifics. But in the
interim, remaining in your office, refusing to see patients, is not an option. I do not understand why you would not
be able to see patients, make appropriate diagnoses, prescribe medications, as necessary, and schedule necessary
follow-ups. I wish for us to have an effective, cordial relationship. But for that to happen I need you to be engaged. I
expect you to start seeing patients now, but certainly no later than this Wednesday , May 24, 2017.

Respectfully yours,

Vijayachandran Nair, MD
CHIEF OF STAFF

Patricia L. Hall PhD, FACHE


Medical Center Director
John J. Pershing VA Medical Center
Poplar Bluff, MO
573-778-4649

-----Original Message-----
From: Klein, Dale J.
Sent: Thursday, May 25, 2017 1:16 PM
To: Hall, Patricia L. (POP) <Patricia.TenHaaf2@va.gov>
Cc: Nair, Vijayachandran VHAPOP <Vijayachandran.Nair@va.gov>; Bhatt, Yogesh
<Yogesh.Bhatt@va.gov>; lposton@813whistle.com; sshilling@osc.gov
Subject:

Dr. Hall,

My counsel, Agency counsel and OSC counsel are currently in discussion on a plan of action for patient care,
employee access and a few other items to facilitate seeing patients, to provide the best care to our Veterans.

Please advise if you are ordering me to see patients despite steps that are being discussed by all counsel and after
voicing my concerns as they relate to Veteran care. Please be clear and specific to what you are ordering me to
do. Also, for every medical chart that comes before me, I intend to ask for a second signature and I will make the
appropriate disclosures in support of our Veterans for each assignment.

Kind regards,

Dale J. Klein, M.D.

-----Original Message-----
From: Hall, Patricia L. (POP)
Sent: Thursday, May 25, 2017 10:41 AM
To: Klein, Dale J. <Dale.Klein@va.gov>
Subject: RE: Correction of misinformation that has been disseminated
I can see that you and others have very different perceptions of events and discussions.
Are you willing to see patients today?
If you have specific questions for me or your supervisor regarding seeing patients as your supervisor asked you to
do, please let us know what we can address.
Otherwise, I will not use email as a forum to debate incongruent perceptions.

Patricia L. Hall PhD, FACHE


Medical Center Director
John J. Pershing VA Medical Center
Poplar Bluff, MO
573-778-4649

-----Original Message-----
From: Klein, Dale J.
Sent: Thursday, May 25, 2017 10:33 AM
To: Hall, Patricia L. (POP) <Patricia.TenHaaf2@va.gov>
Cc: Barlage, Seth W. <Seth.Barlage@va.gov>; Nair, Vijayachandran VHAPOP <Vijayachandran.Nair@va.gov>;
Bhatt, Yogesh <Yogesh.Bhatt@va.gov>; Krishnan, Balamurugan <Balamurugan.Krishnan@va.gov>; Gum, Kim
<Kim.Gum@va.gov>; Phillips, Lonnie (VHAPOP)
<Lonnie.Phillips1@va.gov>; lposton@813whistle.com; sshilling@osc.gov
Subject: Correction of misinformation that has been disseminated

Patricia,

I would like to correct the misinformation that Bhatt stated below.

Gum did NOT presented me with any consults yesterday or today.

I did NOT refuse to meet with Bhatt. In fact, I clearly stated to Bhatt that I would like to move forward with the
PMC and I'm receptive to meeting with him. After I informed Bhatt that I would like my legal counsel to
participate, Bhatt is the one who refused to meet with me. He stated he would not have a meeting with me if my
legal counsel is involved.

Additionally, at 1017 this morning the following occurred. I saw Seth Barlage walking towards me. Barlage looked
at me and I responded with "Good morning". Barlage did not verbally say anything and gave me a rude look. Do
you consider Barlage's behavior to be consistent with the VA's iCARE values?

Your employees refuse to talk with me. They tell me off the record that they do not want to be seen or to have you
know that they are communicating with me because they are fearful they will be retaliated against. Because you
have instilled this fear in your employees, it makes it more challenging for me to build a strong foundation for a top
notch PMC.

I continue to wait for an email response from you with your specific answers to the many questions I have asked that
to date, you have not answered.

Regards,

Dale J. Klein, M.D.

-----Original Message-----
From: Bhatt, Yogesh
Sent: Thursday, May 25, 2017 10:19 AM
To: Klein, Dale J. <Dale.Klein@va.gov>
Cc: Hall, Patricia L. (POP) <Patricia.TenHaaf2@va.gov>; Nair, Vijayachandran VHAPOP
<Vijayachandran.Nair@va.gov>; Bhatt, Yogesh <Yogesh.Bhatt@va.gov>
Subject: consults

Dr.Klein, I attempted to talk to you in person,which you refused without your legal counsel.
Are you going to review the consults which were presented to you by Ms.Gum yesterday?

Bhatt Yogesh
Subject: Dr. Klein
Date: Tuesday, May 30, 2017 at 8:03:37 PM Eastern Daylight Time
From: LoreAa Poston
To: Michael Anfang, Hall Patricia
CC: Shilling, Sheri S., Natalie Khawam, Javier Soto, Klein, Dale J.

A8achments: 2017.5.30 LeAer PBVAMC Dr. Klein .pdf

Hello Mr. Anfang,

Please see the attached letter on behalf of Dr. Klein.

--
Kindest regards,

Loretta C. Poston, Esq.


Managing Attorney
Whistleblower Law Firm, P.A.
400 N. Tampa Street, Suite 950
(813) 944-7853 Office
(813) 434-2173 Facsimile

--
NOTE: The Florida Bar Disciplinary Counsel requires that all recipients of e-mail correspondence relative to legal matters be notified that (1) e-mail
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passes through as it goes from me to you and vice versa, (3) persons not participating in our communications may intercept our communications by
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future communications to be sent in a different fashion, please let me know.

Privileged and Confidential: Unless otherwise indicated or obvious from the nature of the transmittal, the information contained in this message is
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Page 1 of 1
Natalie Khawam, Esq, MBA, MS 400 North Tampa Street, Suite 950
Loretta Poston, Esq. Tampa, Florida 33602
Samantha Postlewaite, Esq. Office: 813.944.7853
Javier Soto, Esq. Fax: 813.434.2173

May 30, 2017

Dear Mr. Angfang,

On May 24, 2017, you and Director Hall implied that Dr. Klein has the tools discussed on a
call with counsel and OSC. However, Dr. Klein has not received access or information as
requested for his position and/or his ability to see patients.

1. Electronic patient medical record software CPRS Dr. Klein does have access to this
program, however he needs additional training in the upgrades that have been made to the
software for proper CPRS use.
2. Radiology software the software was added Dr. Kleins computer last week, however
he does not have a username or password to access the software and he needs training in
the softwares upgrades and functions, to include how to adjust/set program preferences,
to optimize patient care.
3. Dictation software to use with CPRS Dr. Klein still does not have this software
available to him and has not received any information as to when it will be available. Dr.
Klein also understands that this program has been upgraded since he last had access to it
and will need the appropriate training to optimize patient care.
4. Dr. Klein has met with the nurse assigned to him by the VAMC with the nurses
supervisor (Gum). However, the nurse has not interacted with Dr. Klein as to any particular
process, training, or plan for patient care. The nurses certifications or abilities have not
been discussed with Dr. Klein as related to pain management care. Will Dr. Klein be
supervising his nurse? Will he provide performance reviews?
5. Dr. Nair will be Dr. Kleins supervisor. Does Dr. Nair have pain management
background to supervise and consult on patients with Dr. Klein during his re-acclamation
period? Will Dr. Nair second sign all charts and consults?
6. The position information sent What are the measurements to which Dr. Klein will be
assessed to determine patient and doctor quality of care? Performance?
7. SF-50 Dr. Klein has not been provided with or explained how to access his SF-50s
8. Clinic location 3 clinic spaces Dr. Klein currently occupies Dr. Klein is currently in
the Clinic where he is to see patients? He occupies 3 spaces?
a. What pain management tools and supplies are being provided to Dr. Klein to be
able to provide pain management care to patients?
b. What specific location within the hospital is designated as the Pain Management
Clinic?
Dr. Klein is looking forward to treating Veterans with the highest standard of care, that our
Veterans deserve and that he was proudly providing over a year ago. However since Dr. Klein has
been in confinement without access to practice or patients, he is reasonably requesting for a period
of re-acclamation to properly provide pain procedures and review any changes in Pain
Management guidelines.
At this time, please provide:

1. All of Dr. Kleins SF-50 forms since he began with the PBVAMC and the SF50 showing
his present assignment/position
2. Dr. Kleins credentialing records at PBVAMC, as to current status, and who updated his
status in the credentialing records
3. How the PBVAMC will provide Dr. Klein training in the software programs discussed
above
4. When will the PBVAMC provide the dictation software needed by Dr. Klein for patient
care.
5. Is the Agency waiving any malpractice and professional standards issues that may come
up until Dr. Klein is back to currency in his profession and specialty?
a. We need to see a progressive plan of exposure and training. We are concerned, and
remain so, that he is likely to be attacked by management on his professional
currency and we are not seeing attention to this matter.
b. Unless a progressive exposure and patient contact plan is put in writing, we have
no option but to recommend to Dr. Klein that all patient contact be reported to the
OIG as possible violation of patient safety issues and that he is being forced to see
patients without being returned to baseline and these actions may be considered
a hostile work environment for which an EEO complaint may be filed against
present supervisors, and amended at every assignment. Also, we must recommend
that the same be reported to the Joint Commission.
6. Can the PBVAMC temporarily approve Dr. Klein to shadow and have consults with Dr.
Sanjay Sharma, at New Orleans, VAMC? He is a similarly credentialed pain management
physician as Dr. Klein.
a. The training and shadowing regimen would involve a reasonable amount of time
and is dependent on many factors. Since Dr. Klein has not performed procedures
for more than a year, he would need to do simple procedures before he could
perform the more complex procedures. Re-integration on those procedures can
take a varied amount of time because it depends on how often those procedures are
performed at the New Orleans VA. Any procedures performed at Poplar Bluff
VAMC would be limited to those he can gain experiences back in at New Orleans,
until he is back up to where he was before being kept from patient care over a year
ago.
b. An alternative would be for Dr. Klein to consult with Dr. Sharma at the New
Orleans VAMC on all of his consults and patients to ensure the highest level of care
for our Veterans. Dr. Nair would therefore not be a technical supervisor on any
consults and any issue of pain management would be reviewed at New Orleans
VAMC.
At this time, without additional safeguards for Dr. Klein and Veteran patients, for every
medical chart that comes before Dr. Klein, he will ask for a second medical signature and he will
make the appropriate disclosures in support of our Veterans for each assignment.
In addition, please provide a written Memoradom from Director Hall of the PBVAMC
specifying that Dr. Klein is instructed to see patients without the concerns herein being addressed.
Unless there is an Memorandum signed by Director Hall, we consider Director Hall to agree with
us that these matters need to be addressed as stated.
Please provide the requested information by close of business on Thursday, June 1, 2017. If
you have any questions or concerns, please contact my office.

Best,

____________________________
Natalie K. Khawam, Esq., MBA, MS
Whistleblower Law Firm, P.A.
400 N. Tampa St., Suite 950
Tampa, FL 33602-4700
Office: (813) 944-7853
Nataliek@813whistle.com
Attorney for Complainant
From: Gum, Kim
Sent: Monday, June 05, 2017 2:51 PM
To: Klein, Dale J. <Dale.Klein@va.gov>
Cc: Nair, Vijayachandran VHAPOP <Vijayachandran.Nair@va.gov>; Hall, Patricia L. (POP)
<Patricia.TenHaaf2@va.gov>; Anfang, Michael <Michael.Anfang@va.gov>; lposton@813whistle.com;
Missal, Michael J. (OIG) <Michael.Missal@va.gov>; sshilling@osc.gov; Miller, Chandra D. (Candy)
<Chandra.Miller1@va.gov>
Subject: RE: Consults

Dr Klein in order to address the following: "Please advise who the patients are, where I will see the
patients, what time is the appointments for the patients, and who will be available for consult and
signatures to their charts."

1) I have the consults and can bring them for review.


2) Your exam rooms will be utilized for all appointments
3) Appointionment times are mutually decided between the veteran and clerk based upon your
availability.
4) Please refer to your supervisor regarding consigning of notes.

Respectfully,

Kim Gum, RN
Nurse Manager Cardiology GI, GU, Ortho services
(573) 686-4151 ext. 54409
Cell 718-3712

" The strength of the team is each individual member. The strength of each member is the team."
Phil Jackson.

-----Original Message-----
From: Klein, Dale J.
Sent: Monday, June 05, 2017 12:53 PM
To: Gum, Kim <Kim.Gum@va.gov>
Cc: Nair, Vijayachandran VHAPOP <Vijayachandran.Nair@va.gov>; Hall, Patricia L. (POP)
<Patricia.TenHaaf2@va.gov>; Anfang, Michael <Michael.Anfang@va.gov>; lposton@813whistle.com;
Missal, Michael J. (OIG) <Michael.Missal@va.gov>; sshilling@osc.gov
Subject: Consults

Ms. Gum,
I understand that through your email the VA is ordering me to see patients, since Dr. Nair (my assigned
supervisor) is cc'd on this correspondence.
As ordered, I will see patients, as the VA is aware of my concerns of not having all the appropriate tools
for patient care and that I have not been brought up to date on the changes in pain management law,
treatment, and patient pain management care. Nor has the PBVAMC made me aware if my
credentialing/privileging is current and approved for patient care.
However, please be aware that I cannot perform duties or procedures that could endanger Veterans. For
patient and doctor safety, I intend to ask for someone to second sign any medical chart I touch and I will
make the appropriate disclosures in support of our Veterans for each assignment. I understand I may also
provide this information to Office of the Medical Inspector and the Office of Inspector General freely to
ensure safety of our Veterans.
Please advise who the patients are, where I will see the patients, what time is the appointments for the
patients, and who will be available for consult and signatures to their charts.

Regards,

Dale J. Klein, M.D.

-----Original Message-----
From: Gum, Kim
Sent: Monday, June 05, 2017 9:03 AM
To: Klein, Dale J. <Dale.Klein@va.gov>
Cc: Nair, Vijayachandran VHAPOP <Vijayachandran.Nair@va.gov>
Subject: Consults

Dr. Klein I have two(2) NON VA Pain consults pending, are you willing to see these patients? Please let
me know NLT 1300 today so that we can send to Choice if you are not able.
No response equates to a negative response.

Thank you,

Kim Gum, RN
Nurse Manager Cardiology GI, GU, Ortho services
(573) 686-4151 ext. 54409
Cell 718-3712

" The strength of the team is each individual member. The strength of each member is the team."
Phil Jackson.
Subject: RE:
Date: Tuesday, June 6, 2017 at 9:00:30 AM Eastern Daylight Time
From: Nair, Vijayachandran VHAPOP
To: Klein, Dale J.
CC: Hall, Patricia L. (POP), Ford, Crystal, Gum, Kim, Phillips, Lonnie (VHAPOP), Anfang, Michael, LoreRa
Poston, Missal, Michael J. (OIG), sshilling@osc.gov

Dr. kline,
I am not a physician who is a pain specialist and I will not cosign your not(- for your records)

Vijayachandran Nair, MD
CHIEF OF STAF

John J. Pershing VAMC


1500 N. Westwood Blvd
Poplar Bluff, MO 63901
TEL: 573-778-4691

-----Original Message-----
From: Klein, Dale J.
Sent: Tuesday, June 06, 2017 7:15 AM
To: Nair, Vijayachandran VHAPOP <Vijayachandran.Nair@va.gov>
Cc: Hall, Patricia L. (POP) <Patricia.TenHaaf2@va.gov>; Ford, Crystal <Crystal.Ford@va.gov>; Gum, Kim
<Kim.Gum@va.gov>; Phillips, Lonnie (VHAPOP) <Lonnie.Phillips1@va.gov>; Anfang, Michael <Michael.Anfang@va.gov>;
lposton@813whistle.com; Missal, Michael J. (OIG) <Michael.Missal@va.gov>; sshilling@osc.gov
Subject:

Dr. Nair,
I am looking forward to treating Veterans with the highest standard of care that our Veterans deserve, and that I was proudly
providing over a year ago. However, since I have been in confinement without access to practice or patients, I have been
reasonably requesting for a period of re-acclamation to properly provide pain procedures and review any changes in Pain
Management guidelines.
I want to bring to your attention, as a disclosure under the law, I was finally given access to review my SF50 in my eOPF today
and it shows I received a successful performance review during the period of time that I was kept away from patients, practice
and medical work. I am concerned that someone at the PBVAMC has possibly falsified federal records that impact patient
safety and personnel records. Please provide the corresponding proficiency review, and information on updated CMEs I
should have. Also, please provide a letter from you stating you have passed me in the requirements of my Board certifications
and please provide me with a copy of my current credentialing records.
Maybe you can answer a question for me, is the Agency waiving any malpractice and professional standards issues that may
come up until I am back to currency in my profession and specialty? Until a progressive exposure and patient contact plan is
put in writing, I will have to report patient contact to the OIG as possible violation of patient safety issues and that I am being
forced to see patients without being returned to "baseline" - and these actions may also be considered a hostile work
environment for which an EEO complaint may be filed against present supervisors, and amended at every assignment.
I have met with the nurse assigned to me by the VAMC with the nurse's supervisor (Gum). However, the nurse has not
interacted with me as to any particular process, training or plan for patient care nor have I been made aware of the nurse's
certifications or abilities as they relate to pain management care. In full disclosure, I must also make the nurse aware of my
current situation and that he will need to document that he has been made aware of my requests and concerns, per patient
seen.
Please be aware that I cannot perform duties or procedures that could endanger Veterans. For patient and doctor safety, I
intend to ask you as my supervisor, Dr. Nair, to second sign any medical chart I touch and I will make the appropriate
disclosures in support of our Veterans for each assignment. I understand I may also provide this information to Office of the
Medical Inspector and the Office of Inspector General freely to ensure safety of our Veterans.
Dr. Nair, as a fellow medical practitioner, you should realize you are not just endangering patient safety, but performing
actions contrary to the joint commission requirements, and requirements of my sub-specialty.
I will see patients, as I have been ordered to do, and I will send you my requests to review and sign the patient charts going
forward.

Regards,

Dale J. Klein, M.D.

Page 1 of 1
the AMERICAN ACADEMY of PAIN MEDICINE

ETHICS
CHARTER
the AMERICAN ACADEMY of PAIN MEDICINE

ETHICS
CHARTER

AAPM Council on Ethics


Michel Y. Dubois, MD, chair New York, NY
John Banja, PhD Atlanta, GA
David Brushwood, JD RPh Gainesville, FL
Perry G. Fine, MD Salt Lake City, UT
Rollin M. Gallagher, MD MPH Philadelphia, PA
Hugh Gilbert, MD Winnetka, IL
Daniel Hamaty, MD Naples, FL
Lynn Jansen, PhD RN Edison, NJ
David Joranson, MSSW Madison, WI
Allen H. Lebovits, PhD New York, NY
Philipp M. Lippe, MD San Jose, CA
Timothy F. Murphy, PhD Chicago, IL
Robert Orr, MD Burlington, VT
Ben A. Rich, JD PhD Sacramento, CA

This document is the result of a meeting of the AAPM Council on Ethics, which
took place in Chicago, IL, on December 13 and 14, 2003. That meeting was made
possible by an unrestricted grant from Janssen Medical Affairs LLC.
Contents
Part I. Foundations for the Ethical Practice of Pain Medicine
Preamble . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Professional Relationships and the Physicians Duty to the Patient . . . . . . . 6
Societal Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Part II. Ethical Opinions
Clinical Concerns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Pain Medicine at the End of Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Third Parties and the Patient-Physician Relationship . . . . . . . . . . . . . . . . . . 14
Research Concerns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Empathy in the Practice of Pain Medicine* . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Disparities in Pain Medicine* . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Legal Testimony* . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Appendix A. American Medical Association
Principles of Medical Ethics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Appendix B. American Medical Association
Declaration of Professional Responsibility . . . . . . . . . . . . . . . . . . . . . . . . . 31
Addendum. Statement on Conflicts of Interest: Interaction Between
Physicians and Industry in Pain Medicine. . . . . . . . . . . . . . . . . . . . . . . . . . 32

*Adopted December 2007.

Ethics Charter n 3
Part I. Foundations for the Ethical Practice of Pain
Medicine

PREAMBLE
The American Academy of Pain Medicine (AAPM) is a medical specialty
society representing physicians practicing in the field of Pain Medicine.
The management of pain is fundamental to the practice of medicine.
All physicians have an obligation to address acute and persistent pain.
Adequate assessment and management of many types of pain states
require a multidisciplinary or interdisciplinary approach with one phy-
sician having primary responsibility for coordination and continuity of
care.
AAPM endorses both the American Medical Associations (AMA) Principles
of Medical Ethics, which focus on our primary obligation to our patients, and
the AMAs Declaration of Professional Responsibility, which specifies the
duties of physicians to humanity (see Appendixes A and B). The AAPM
Ethics Charter is a complementary document developed to address the unique
scope and breadth of the practice of Pain Medicine.
The ethical imperative to provide relief from pain requires all physicians to
apply themselves toward improvement in the following areas:
rBTTFTTNFOUPGUIFQBJOTVGGFSFSBTBXIPMFQFSTPO JODMVEJOHBMMSFMFWBOU
biological, social, psychological, and spiritual dimensions pertaining to
etiology and impact of pain
rUSFBUNFOUPGUIFQFSTPOJOQBJOXJUIDPNQFUFODFBOEDPNQBTTJPO
rFEVDBUJPO PG QSPGFTTJPOBM DPMMFBHVFT  QBUJFOUT  UIF QVCMJD  BOE QPMJDZ
makers on the principles and methods of Pain Medicine
rTVQQPSUPGBOEPSQBSUJDJQBUJPOJOCBTJDBOEDMJOJDBMQBJOSFTFBSDI
rBEWPDBDZUPFOTVSFBDDFTTUPQBJODBSFBOEJUTDPOUJOVPVTJNQSPWFNFOU
AAPM supports the normalization of Pain Medicine within all patient care
settings so that exceptional interest, commitment, and moral courage are
not required to meet the needs of patients in pain, and especially those with
persistent or complex pain disorders. AAPM further recognizes and accepts a
commitment to overcome professional and social obstacles to the alleviation
of human pain. Specifically, this includes the commitment to
rGBDJMJUBUFQBUJFOUBDDFTTUP1BJO.FEJDJOFTFSWJDFT
rFODPVSBHFNFEJDBMJOTUJUVUJPOTUPBTTJHOQSJPSJUZUPSPVUJOFQBJOBTTFTT-
ment and management
rFODPVSBHF B GPDVT PO UIF EJBHOPTJT BOE USFBUNFOU PG VOEFSMZJOH DPOEJ-
tions that contribute to pain
rBWPJEBDUJOHPOVOXBSSBOUFEQBUJFOUDMBJNTPGEJTBCJMJUZ
rFODPVSBHFQSPGFTTJPOBMFEVDBUJPOPOBEFRVBUFBOEUIPSPVHIBTTFTTNFOU
of pain in all patients
rQSPWJEFFEVDBUJPOBCPVUBEFRVBUFBTTFTTNFOUPGEJTBCJMJUZBSJTJOHGSPN
persistent pain problems

Ethics Charter n 5
rGBNJMJBSJ[FNFNCFSTBOEDPMMFBHVFTXJUIOFXFWJEFODFCBTFEGJOEJOHT
and concepts about pain, its assessment, and its treatment
rQSPWJEF FEVDBUJPO JO QBJO USFBUNFOUmSFMBUFE TVCTUBODF NJTVTF  BCVTF 
addiction, and diversion, including risk assessment and management
rBTTJTUJOSFTPMWJOHDPODFSOTBCPVUJBUSPHFOJDBEEJDUJPOBOEJUTEFUFDUJPO 
prevention, and management
rQBSUJDJQBUFJO1BJO.FEJDJOFmSFMBUFEBEWPDBDZBOEQPMJDZEFWFMPQNFOU

PROFESSIONAL RELATIONSHIPS AND THE PHYSICIANS DUTY TO


THE PATIENT
The assessment and management of complex or persistent pain condi-
tions often require interdisciplinary evaluation and treatment of patients,
requiring collaboration among healthcare professionals.1,2,3 Pain special-
ists need to recognize, understand, and respect the ethical bounds of their
collaborative relationships in the context of their primary ethical obliga-
tions to the patient. Commonly encountered interprofessional domains
that pose potential ethical challenges for pain specialists are elaborated
below.

EXPERTISE
Patients in pain commonly seek complementary or alternative medicine
methods.4,5 Because many patients do not tell their healthcare profession-
als about their use of these treatments, the potential for significant harm
exists, especially from adverse interactions with other pharmacologic
agents the patient is using. Pain specialists need to be educated about and
aware of these methods, particularly about herbal medicine, and they
need to ask their patients about their use of complementary methods at
the initial evaluation. Pain specialists have a duty to inform patients of
potentially harmful effects of these modalities. The Current Opinions in
the AMAs Code of Medical Ethics caution that it is unethical to engage in
or to aid and abet in treatment which has no scientific basis and is dan-
gerous, is calculated to deceive the patient by giving false hope, or which
may cause the patient to delay in seeking proper care.6
Many chronic pain patients will see multiple healthcare professionals in
an effort to get pain relief. In the course of taking the patients history and
reviewing the records, pain specialists may come across treatment and care
that seem to be significantly below the standard of care or that may appear
to be incompetently administered or even to be harmful to the patient. The
AMAs Code of Medical Ethics unequivocally states, A physician should
expose, without fear or loss of favor, incompetent or corrupt, dishonest, or
unethical conduct on the part of members of the profession.7 It is strongly
recommended that incompetent or unethical professionals undergo corrective
BDUJPOTVDIBTNBOEBUPSZFEVDBUJPOBOEPSQFFSDPVOTFMJOH5IJTBJNJTCFTU
accomplished if concerns are reported through appropriate channels, such as
state medical societies, peer review organizations, or licensing boards.

6 n the AMERICAN ACADEMY of PAIN MEDICINE


Pain Medicine is a relatively new field of specialization that is evolving
in tandem with pharmacologic and procedural advances that mandate
continuing medical education (CME). While there may be mandatory,
state-regulated CME requirements for continued licensure, fulfillment
of mandatory state CME requirements does not necessarily fulfill the
physicians ethical obligation to maintain his or her medical expertise.8
Maintaining professional expertise is particularly important for pain special-
ists because research indicates that an alarming amount of misinformation
and potentially harmful attitudes concerning pain exist among other
healthcare professionals, adversely affecting patient care.9

TYPE OF PRACTICE
The ethical conduct of Pain Medicine practice should be uniform, regard-
less of the practice setting or the physicians employment arrangement.
Private Practice. A primary challenge for private practice specialists is
practicing in a setting where access to other specialists may be restricted, not
easily available, or fraught with lengthy delays or long and difficult com-
mutes for the patient. In an effort to circumvent these difficulties and help the
patient expeditiously, practitioners may be tempted to perform an evaluation
or treatment procedure that is outside their area of specialty or expertise. This
problem is often exacerbated in private practice, where financial pressures
and incentives may be very strong. It is unethical for health professionals to
provide treatment that exceeds their training or scope of practice or to recom-
mend interventions that are not purely in the best interest of the patient.
Academic Practice. Ethical dilemmas arise in settings where accommodating
the training needs of medical students, residents, and fellows may conflict
with maintaining adequate care for patients. The bioethical principles of
nonmaleficence and beneficence demand adequate support and supervision
for all trainees. Decisions about medical interventions should be made inde-
pendent of trainees needs for experience and potential financial benefits to
attending staff and the institution. Patients need to be fully informed of the
training status of those involved with their care, and their autonomous right
to choose whomever they want treating them must be preserved. Explaining
the benefits of trainees participation often helps patients in their decision:
Patients should be informed of the identity and training status of individu-
als involved in their care. . . . Patients are free to choose from whom they
receive treatment. . . . Health care professionals should relate the benefits of
medical student participation.10

REFERRALS AND CONFLICTS OF INTEREST


Pain specialists often act as consultants to other parties. Regardless of
the referral source, physicians should retain their primary professional
duty to the patient. This duty is compromised when the pain specialist
is asked by the referral source to perform a procedure, such as a nerve
block, that the pain specialist does not believe accords with the standard

Ethics Charter n 7
of care, or when the pain specialist is asked to depart from his or her
normal practice (e.g., when the referral source forbids a consultation
or referral with a psychologist). Ethical practice requires independent
judgment to determine indications for any diagnostic test or potentially
therapeutic procedure. This determination can be derived only from suf-
ficient evaluation and examination of the patient, prior to the provision
of a treatment.
Furthermore, because the onset of pain may result from accidental injury
or other causes of trauma,11 referrals to pain specialists may come from
third-party sources such as attorneys or workers compensation boards. In
such instances, the pain specialist must exercise his or her best judgment
and not accede to any unreasonable demands or pressures from third par-
ties that might abridge standard practices or work against the patients best
interests.
Economic pressures and incentives, and the desire to maintain good rela-
tionships with referral sources, should not compromise the pain specialists
primary responsibilities to the patient.
Pain specialists need to disclose any financial interest they have in their
referrals to other facilities (e.g., a rehabilitation facility, gym, pharmacy,
imaging facility, or surgicenter). The AMAs Current Opinions in its Code of
Medical Ethics notes that in general, physicians should not refer patients to a
health care facility which is outside their office practice and at which they do
not directly provide care or services when they have an investment interest
in that facility. . . . The physician needs to have personal involvement with
the provision of care on site.12 An exception to the requirement of personal
involvement is made if there is a demonstrated need in the community
for the facility and alternative financing is not available.13 But even in these
exceptional cases, full disclosure of an investment interest to the patient as well
as provision of alternative facilities and assurances that the patient will not be
treated differently if he or she chooses a different facility is recommended.13
Referral within an interdisciplinary practice, which is the standard of care
in Pain Medicine, also poses potential conflicts: When services are provided
by more than one physician, each physician should submit his or her own
bill to the patient and be compensated separately, if possible.14 Financial
arrangements, including those that pose potential conflicts of interest, should
be clearly described and transparent to all parties.

RELATIONSHIPS WITH PHARMACISTS


Pharmacotherapy is the mainstay of long-term Pain Medicine for many
patients with disabling pain. A Pain Medicine physician may obtain
information from a pharmacist regarding prescriptions and refill pat-
terns when it is in the best interest of the patient. A Pain Medicine physi-
cian may communicate to a pharmacist concerns regarding a patients
drug therapy, particularly any unusual occurrences. In order to protect

8 n the AMERICAN ACADEMY of PAIN MEDICINE


confidentiality, only relevant information should be disclosed.
By virtue of their unique role, pharmacists can find themselves at the
center of conflicts that may emerge around the prescribing and dispensing
of Pain Medicine, involving both physicians and patients. Although the
pharmacists questioning of prescription validity may seem to challenge the
physicians judgment or the patients legitimacy, the pharmacists respon-
sibility to verify prescriptions for their medical legitimacy should be respect-
ed. Inquiries from a pharmacist to validate the accuracy, legality, or medical
necessity of a prescription should be responded to quickly and respectfully.
Reports to law enforcement of attempts to acquire pain medications illegally
need to be based on confirmed firsthand information.
In keeping with the bioethical principle of justice, all essential and com-
monly used drugs for Pain Medicine should be available to all patients at
all pharmacies regardless of geographic location. Pain Medicine physicians
should work to reduce disparities in prescription practices or stocking that
are based on unfounded racial, ethnic, or socioeconomic demographics. We
recognize that patients have the right to have a prescription filled wherever
they wish.15 When necessary to promote safe and effective patient care, a
Pain Medicine physician may insist that a patient use only one pharmacy, as
long as the patient is free to choose the pharmacy, in order to ensure compli-
ance and safety in treatment.

SOCIETAL RESPONSIBILITIES
Physicians have long recognized their responsibilities to individual
patients. The importance of this ethical commitment was first expressed
in the Hippocratic Oath, written more than 2,500 years ago: Whatever
houses I may visit, I will come for the benefit of the sick.16 It is also
expressed in the World Medical Associations Declaration of Geneva,
adopted in 1948 after offensive lapses in medical ethics during World
War II: I will practice my profession with conscience and dignity; the
health of my patient will be my first consideration.17 Although medical
ethics does not require limitless sacrifice from physicians, some physi-
cians have shown exemplary virtue in caring for their patients, even
when doing so has exposed them to personal risk and required personal
sacrifice. Exemplary physicians are often the physicians who exceed their
duties to patients, treating patients humanely and serving as advocates of
their needs and interests.
Human health does not depend only on treatment by physicians. Social
and political circumstances profoundly influence the health and well-being
of all people. It is not enough to care for individual patients if the causes
of their ill health are rooted in harmful social practices and unjust political
arrangements.18 Access and equity in social and political matters directly
affect human health. For example, health is directly affected by access to
adequate food, clean water, and safe housing. It is also directly affected by

Ethics Charter n 9
protection from chemical toxins and political disturbances. The adequacy
of social responses to natural disasters also affects human health. Medical
ethics has come to acknowledge the direct link between human health and
the social environment. For that reason, medical ethics now acknowledges
a responsibility on the part of physicians to protect health through social
interventions.
In the United States, the AMA recognizes social responsibility for human
health in this way: A physician shall recognize a responsibility to par-
ticipate in activities contributing to the improvement of the community and
the betterment of public health.19 Because physicians have different skills
and expertise, they can meet this responsibility in a variety of ways, rang-
ing from provision of direct care to the indigent to political advocacy. This
social responsibility of physicians has been recognized as a core element of
the AMAs Declaration of Professional Responsibility: Medicines Social
Contract with Humanity, adopted in 2001 (see Appendix B). Among other
things, the declaration commits physicians to work toward the development
of advances in medicine and public health. Specifically, the declaration com-
mits physicians to educate people about threats to the health of humanity
and to advocate for the social, economic, educational, and political changes
necessary to relieve suffering and to advance human well-being.
A number of social and political obstacles to improving the theory and
practice of Pain Medicine currently exist. These include inadequate training
and education in the management of pain, real and perceived barriers to
the use of pain medications, and inadequate research in pain control. These
obstacles directly affect the ability to treat patient suffering. Consequently,
Pain Medicine physicians have a responsibility to educate the public about
advances in Pain Medicine and to work toward better medical education and
training in Pain Medicine. Pain management physicians also have a respon-
sibility to promote research in Pain Medicine and to help eliminate social
prejudices and legal obstacles that interfere with the medical management
of pain.
These responsibilities may be carried out in a variety of ways. Acting on
their own, individual Pain Medicine physicians can educate the public about
advances in Pain Medicine through teaching, writing, and lecturing on the
subject. Success in overcoming regulatory and legal obstacles to effective
Pain Medicine, however, will require concerted and organized efforts on
the part of the profession as a whole. Real, meaningful reform will require
members of the profession to participate in reform of regulatory policy and
practice and to ensure that safe practice guidelines for pain treatment are
taken into account when legislators draft regulations and laws that apply to
pain. To encourage collective action, professional organizations representing
Pain Medicine physicians have a responsibility to regularly review the status
of Pain Medicine and to advocate publicly for the changes in regulations and
laws that compromise the ethical practice of Pain Medicine.

10 n the AMERICAN ACADEMY of PAIN MEDICINE


Part II. Ethical Opinions

CLINICAL CONCERNS
PROBLEMS OF DECISION-MAKING CAPACITY IN PATIENTS WITH PAIN
Physicians who treat patients in pain must be aware of their patients
decision-making capacity. In a medical setting, pain itself can alter deci-
sion-making capacity, and iatrogenic causes, including pharmacologic
and psychological influences, may exacerbate a patients vulnerability
to undue influences. In recognition of the patients right to self-deter-
mination, physicians who treat such patients are ethically and legally
obligated to assess and evaluate their patients decision-making capacity.
Autonomous informed consent requires
1. understanding of information and consequences
2. demonstration of insight
3. reason and judgment
4. the ability to evince a decision or articulate a preference
5. voluntariness.20
The patients decision to proceed with any course of therapy should be
voluntary and should express the patients authentic desires and wishes.
Patients decision making should meet all five criteria. The physician whose
patient does not adequately meet these criteria needs to determine whether
the patient has identified a surrogate decision maker or, in instances in which
withholding or discontinuing life-prolonging treatment is being considered,
whether an advance directive exists. In some instances, a patient with dimin-
ished or impaired decision-making capacity can participate in various aspects
of health care decision making. The attending physician should promote the
autonomy of such individuals by involving them to a degree commensurate
with their capabilities.21
In all instances, the physician must secure informed consent to treatment
from a legally valid source, whether it be the competent patient or the incom-
petent patients surrogate. Nevertheless, certain patients with diminished
capacity may be able to participate in some or even all decisions pertaining
to their care. Ethical dilemmas may arise when the physician believes that the
surrogates decision may be contrary to the patients best interest. The physi-
cians ethical and legal obligations are to advance the patients welfare. The
attending physician may wish to consult with an ethics committee or ethics
consultant in such cases. When a physician believes that a decision is clearly
not what the patient would have decided or could not be reasonably judged
to be within the patients best interests, the dispute should be referred to an
ethics committee before resorting to the courts.21

Ethics Charter n 11
PSYCHOSOCIAL AND SYSTEMS BARRIERS TO SHARED DECISION MAKING IN THE
TREATMENT OF PAIN
In addition to assessing the patients decision-making capacity, the phy-
sician should strive to enable the patient to participate in the decision-
making process. Physicians should encourage their patients to document
their treatment preferences.21 The physician should be cognizant of the
psychosocial barriers to shared decision making in the treatment of pain.22
Adversarial processes, such as workers compensation claims or litigation,
are common external influences in Pain Medicine settings. Other sources
or causes of influence on patient decision making include ethnocultural
beliefs or traditions, family, work, and financial pressures, literacy and
language comprehension, and the stigma of opioid use.
Systems barriers that compromise shared decision making in pain treat-
ment often include the influence of third-party payers, historical racial or
ethnic biases with resultant absence of trust, poor communication and dis-
continuity of care, delayed or denied care, and insufficient resources (e.g.,
time pressures, poor access to consultants).
Physicians have an obligation to consider the implications of cost or the avail-
ability of therapeutics in the development of a plan of care. Physicians should
educate themselves about resources that may be available to ensure or facilitate
their patients ability to comply financially and socially with a plan of care.

CONFIDENTIALITY AND ITS LIMITS IN THE CONTEXT OF PAIN MEDICINE


Physicians are legally and ethically required to protect patient confiden-
tiality and the privacy of patients medical information. The information
disclosed to a physician during the course of the relationship between
physician and patient is confidential to the greatest possible degree.23
Physicians should share information with third parties only with the
consent of the patient on the basis of the third parties right and need to
know, and even in those instances physicians should share only relevant
information. Exceptions to ensuring patient confidentiality can be made
in certain circumstances, such as when the threat of bodily harm to oth-
ers or to the patient is present. In such circumstances, notification of law
enforcement authorities is required.
It should be recognized that because of the multidisciplinary practice of
Pain Medicine today, relationships with other pain specialists, as well as with
third-party payers, attorneys, and other agencies, place demands related to
the sharing of patient information. The free exchange of information between
professionals is thought to improve patient care. Psychologists reports, which
often contain sensitive information, may present particular ethical conflicts of
confidentiality. Patients need to be fully informed about the limits of confiden-
tiality between team members and other interested parties.24

12 n the AMERICAN ACADEMY of PAIN MEDICINE


MISMANAGEMENT OF PAIN
Mismanagement of pain includes actions on the part of a physician that
constitute the insufficient or inadequate assessment of pain or the poor,
inadequate, or otherwise ineffective treatment of pain.25 Mismanagement
of pain during all phases of life is a breach of the physicians duty of
beneficence.
State laws and regulatory practices may lead physicians into patterns of
mismanagement. Nonetheless, physicians have an obligation to be knowl-
edgeable about prescribing laws in their state, and when these laws contra-
dict patients best interests, physicians have a duty to advocate for change in
these laws.

PAIN AND ADDICTION


1BUJFOUTXJUIQBJOEJTPSEFSTXIPBSFBEEJDUFEUPESVHTBOEPSBMDPIPM
deserve the same competent pain assessment and management that all
other patients deserve. However, managing the pain of these patients
may pose special challenges to physicians.
Physicians have an obligation to educate themselves about standards of
care in addictive disease and substance abuse disorders and should make use
of resources to comanage these patients, when indicated.26,27
Physicians have an obligation to be knowledgeable about prescribing and
practice laws in their state, especially in regard to controlled substances.26,28
When laws contradict patients best interests, physicians have a duty to
advocate for change in these laws. Physicians have an obligation to evaluate
and distinguish among the psychophysiologic-pharmacologic phenomena of
tolerance, physical dependence, chemical coping, substance abuse or misuse,
addiction, and pseudoaddiction.
The principle of balance recognizes that opioids are indispensable for the
relief of pain and suffering, that they also may be abused, and that efforts
to address abuse should not interfere with legitimate medical practice and
patient care. The principle creates an ethical framework for the use of con-
trolled substances in all patients with pain, where opioids are efficacious,
while preventing abuse or diversion.26,29

PAIN MEDICINE AT THE END OF LIFE


RELIEF FROM PAIN
The management of pain at the end of life is often recognized as pos-
ing special difficulties for physicians.29,30,31 Physicians caring for patients
with terminal illness are ethically required to manage pain, according
to currently available clinical science. Satisfactory compliance with this
requirement may necessitate consultation with colleagues who have spe-
cial skill and expertise in managing pain at the end of life.
Physicians should discuss with the patient his or her wishes regarding
the treatment of pain at the end of life. Physicians who are treating patients

Ethics Charter n 13
with disease processes that may be life-limiting should diligently assist their
patients in developing goal-directed advance directives, and they should be
faithful in implementing these choices.

COMFORTABLE DYING AND PATIENT SELF-DETERMINATION


The end outcome measures of safe and comfortable dying and self-
determined life closure, elaborated by the National Hospice and
Palliative Care Organization, pertain to the management of refractory
pain experienced by patients with certain end-stage pain-producing ill-
nesses. When pain motivates a patients intention to end his or her life,
all reasonable means to relieve pain should be sought.
A physicians inability to relieve pain does not justify intentional hastening
or causing the death of his or her patient.32,33 Euthanasia, defined as the inten-
tional administration of a lethal substance in order to cause death as a means
of relieving suffering, is illegal throughout the United States.34
Physicians caring for patients suffering with a terminal illness or an
advanced disease frequently worry about hastening death through the use
of opioids. This worry has been determined to be scientifically and medi-
cally unfounded. There is no evidence to demonstrate that titrating opioids
to achieve relief of pain causes a foreseeable risk of causing death. In any
case, medical ethics has long accepted pain control as an ethically defensible
practice, even if it has unintended consequences in affecting the duration of
a patients life.35,36

PALLIATIVE SEDATION FOR INTRACTABLE SYMPTOMS


The duty of beneficence and the principle of proportionality require phy-
sicians to consult with those who have ample expertise in palliative care if
they are unable to meet the patients needs prior to resorting to palliative
sedation.37,38,39 Palliative sedation is a medically humane, ethical, and legal
alternative to the intentional hastening of death. This practice involves
the physicians inducing and maintaining deep sleep to relieve pain that
is refractory to standard palliative care.40,41 Palliative sedation should be
reserved as an intervention of last resort for the management of pain.
Patients experiencing profound existential or psychological suffering
TIPVMESFDFJWFQTZDIPMPHJDBMBOEPSTQJSJUVBMJOUFSWFOUJPOTGSPNBTQF-
cialist trained to relieve end-of-life suffering.37 Palliative sedation should
be implemented and maintained by those with sufficient experience and
expertise in end-of-life care, and in this procedure in particular.42,43

THIRD PARTIES AND THE PATIENT-PHYSICIAN RELATIONSHIP


Physicians caring for persons in pain should understand that the prac-
tice of pain and palliative medicine is a rapidly evolving field. As in all
advanced fields of medicine, other parties have a necessary vested inter-
est in that fields developments as they affect the cost and effectiveness

14 n the AMERICAN ACADEMY of PAIN MEDICINE


of care. These third parties have social, economic, and political agendas
that can positively influence both the profession and the public. The
process of informing third parties about Pain Medicines positions on
therapeutic modalities, as well as on those treatments that should not be
applied to those suffering with pain, and persuading them to adhere to
these positions, requires a combination of communication, collaboration,
sensitivity, and advocacy.
In their relationships with managed care and other third-party agencies
and regulators, physicians caring for persons in pain should specifically
rFOHBHFNBOBHFEDBSFBHFODJFTJOBOBDUJWFNBOOFSUIBUFOTVSFTUIBUDPNQF-
tent pain care is provided
rUVSO UP PUIFST JO UIF DPNNVOJUZ  CPUI PO B DBTFCZDBTF CBTJT BOE JO
more general policy initiatives, for support in influencing the approaches
taken by managed-care and third-party regulators. It may be of par-
ticular benefit to enlist other pain care physicians in the community or
region, as well as voluntary agencies committed to the support of those
in pain
rFOHBHFJOBEWPDBDZGPSUIPTFJOQBJOUISPVHIUIFFEVDBUJPOPGNBOBHFE
care and third-party regulators
rQSPNPUFQPMJDJFTBOEQSPDFEVSFTUIBUSFDPHOJ[FUIFJNQPSUBODFPGQBJO
and symptom management in patient care.44,45,46
Physicians caring for persons in pain should recognize the unique role
that pharmaceutical companies play in pain-related clinical research and
education, and in some circumstances, patient assistance programs to pro-
vide needed drugs. Pain specialists and their organizations are cautioned to
avoid conflicts of interest that may arise from consultation agreements and
educational programs. Compensation that bears no relationship to the time
and effort expended by the physician in educational or research activities
should be eschewed. All physicians should recognize the need for lifelong
learning, and all physicians should recognize that the receipt of substantial
gifts, consulting fees, or honoraria should be commensurate with the nature
and extent of educational or research contributions. Gifts of substantial value
or remuneration out of proportion to educational or research activities are
inappropriate and unethical.47,48
Physicians with particular knowledge and expertise in pain and symptom
management have a singular responsibility to assume educational and advo-
cacy roles for competent and compassionate pain relief as an essential fea-
ture of sound patient care. Fulfillment of these important roles may include
offering testimony within the judicial system or providing expert opinions to
oversight and policy-making agencies. In the context of these interactions, it
is necessary for physicians to
rLFFQDPNQMFUF BDDVSBUF BOEDMFBSSFDPSETPGQBJODBSF JODMVEJOHUIF
use of valid instruments to measure pain, suffering, and physical and
mental impairment, as well as improvements in level of function and
quality of life

Ethics Charter n 15
rCFQSFQBSFEUPFYQMBJOUIFDPOUFOUPGUIFJSNFEJDBMBOETVSHJDBMSFDPSET
related to pain care fully and objectively
rTVQQPSUUIFKVEJDJBMTZTUFNCZQSPWJEJOHDPNQFUFOU DSFEJCMFFWJEFODF
concerning patients physical and psychological pain and pain-related
disorders. In this process, the educational role of the medical profes-
sional is paramount, and physicians caring for people in pain should
provide only testimony and opinions that can be asserted with a reason-
able degree of medical certainty and that are based upon the physicians
knowledge of the particular patients diagnosis, prognosis, and both
current and anticipated levels of impairment
rQSPWJEF UFTUJNPOZ UIBU JT CBMBODFE  PCKFDUJWF  BOE DPOTJTUFOU XJUI UIF
best current standards of the medical profession regardless of whether
the physician is testifying as a factual or expert witness for the plaintiff
or defendant.49,50,51,52

RESEARCH CONCERNS
ETHICAL USE OF DRUGS AND TECHNOLOGIES FOR NONAPPROVED INDICATIONS
The field of Pain Medicine is relatively new and has a nascent evidence
base. Innovations in therapy that serve the best interest of patients are to
be encouraged, within the accepted constructs of ethically and method-
ologically sound research practices.
In the face of severe pain, patients may become desperate and be willing to
try anything that the physician suggests. Care must be taken to avoid active
or passive, intentional or unintentional (inadvertent) coercion. The physi-
cian must inform the patient of any recommended therapies that have not
been validated by peer-reviewed evidence and fully inform patients of the
potential risks.
Although Food and Drug Administration guidelines and labeling approv-
als for drug use are important, these do not override physicians primary
responsibility to adequately treat the pain and suffering of their patients.
Use of medication outside of FDA approval should be for individual patient
benefit and justified by sufficient need and the exercise of sound clinical judg-
ment. These thought processes (the rationale for off-label use of a drug)
should be documented in the medical record, and any adverse drug reaction
should be reported immediately to the proper regulatory agency.
Pain Medicine physicians should also subject novel clinical innovations
to formal scientific trials as soon as practical, a practice recommended by
the 1978 Belmont Report of the National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research.

INFORMED CONSENT
Because of the unique nature of pain and suffering and because patients
with pain have particular vulnerabilities concerning dependency and
psychological needs, extra care must be taken to ensure voluntary

16 n the AMERICAN ACADEMY of PAIN MEDICINE


informed consent and adequate participation in decision making. Pain
Medicine physicians should actively participate in institutional review
boards in order to share their expertise in providing informed review of
evaluation of risks and benefits of proposed studies as well as their pro-
cedures for ensuring voluntary participation and informed consent.

USE OF PLACEBOS
A placebo is an inert substance that is used with some subjects in clinical
trials to provide a basis for comparison with other subjects who actually
receive the drug under study. The use of placebos is well established in
randomized clinical trials and is ethical as long as certain conditions are
met. A placebo-controlled study design is generally accepted when harm
to patients from not using other known effective treatment is minimal,
when the tested treatment is unproven, and when reasonable evidence
exists of more benefits for future patients. It is unethical to deny patients
enrolled in controlled trials the benefit of treatment already proven effec-
tive. The use of a placebo control must be explicitly explained to patients
who are being asked to serve as research subjects. In placebo-controlled
trials on patients with pain, rescue medications must be available.53
Placebo use for the treatment of pain in other than research settings is usu-
ally considered unjustifiable, both for ethical and clinical reasons.

EMPATHY IN THE PRACTICE OF PAIN MEDICINE


Adopted December 2007.
John Banja, PhD; Gil Fanciullo, MD MS; Daniel Hamaty, MD; Lynn Jansen, PhD RN; Bob Orr, MD

Empathy is the engagement of one person in the emotional or intellectual


experiences of another. Unlike sympathy, which involves identifying with
the experiences of another, empathy requires reflective and imaginative
effort on the part of the empathizer.54,55 Importantly, however, this effort is
not one-sided. The empathic encounter is dynamic and interpersonal. This
means that while the empathizer must cultivate the capacity for imagin-
ing the perspectives to which she lacks immediate access54, the person for
whom empathy is shown must also cultivate the capacity for honesty in
self-expression.
Empathic engagement plays an important role in the healing
relationship.55,56,57 Clinicians who empathize with their patients are able
to discern aspects of their patients experiences that might otherwise
go unrecognized.58 The insight gained from empathic engagement
better enables clinicians to diagnose and achieve therapeutic ends. This
apparent link between empathy and optimal therapeutic outcome has
encouraged the view that empathy is not just a form of emotional or
intellectual engagement, but a form of moral engagement as well.56
Despite its importance, the empathetic encounter between clinician and
patient is often difficult to realize. In the context of pain management, pain

Ethics Charter n 17
specialists face special challenges in cultivating empathetic engagement
with their patients. The kind of effort required to sustain an empathic
encounter with a patient is often at odds with background psychosocial
and physiological responses to pain.59 Patients experiencing chronic
pain, for example, often develop coping mechanisms (physiologic and
emotional) that hinder honest self-expression or accurate interpretation of
their pain. Similarly, difficulties in managing chronic pain can lead pain
specialists to experience feelings of anger or professional inadequacy.
Displacement of these feelings onto the patient hinders the development
of empathy.59,60 Finally, even when pain specialists successfully initiate
empathic engagement with their patients, these background psychosocial
and physiological responses to pain can distort the empathetic encounter.
They can cause the pain specialist to inaccurately perceive the patients pain
or distress. This empathetic inaccuracy can result in the undertreatment
or overtreatment of pain.59
The American Academy of Pain Medicine (AAPM) recognizes the
therapeutic role that empathy plays in the effective treatment of pain.
However, AAPM also recognizes that empathic engagement in the
context of pain management can be uniquely challenging. To facilitate the
development of empathic accuracy in the context of pain management,
AAPM encourages pain specialists to do the following:
1. Acquire an understanding of the specific ways in which the patients per-
sonal experience of pain can undermine the development of a therapeutic
empathic relationship.
2. Acquire an understanding of the specific ways in which their own self-
protective responses to the patient may undermine the development of
an empathic relationship.
3. Define specific steps to identify and correct empathic inaccuracies that
may hinder the appropriate treatment of pain.
4. Realize that, although the experience of pain is personal, the develop-
ment of a therapeutic empathic response to pain depends on interper-
sonal involvement between the clinical team and the patient.59 Reliance
on the interdisciplinary model can provide a good structure to cultivate
empathic engagement as well as to identify and respond to the kinds of
problems raised above.60

DISPARITIES IN PAIN MEDICINE


Adopted December 2007.
Michael Francis, MD; Carmen Green, MD; Allen H. Lebovits, PhD; Knox H. Todd, MD

The American Academy of Pain Medicine (AAPM) endorses the World


Health Organization (WHO) declaration that pain relief is a human right. The
Academy advocates strongly for access to high-quality pain care for all per-
sons, seeking to overcome any and all inequities that exist. AAPM embraces
the American Medical Associations statement on disparities, affirming that

18 n the AMERICAN ACADEMY of PAIN MEDICINE


disparities in medical care based on immutable characteristics such as race must
be avoided. Whether such disparities in health care are caused by treatment deci-
sions, differences in income and education, sociocultural factors, or failures by
the medical profession, they are unjustifiable and must be eliminated. Physicians
should examine their own practices to ensure that racial prejudice does not affect
clinical judgment in medical care.61 While federal agencies have paid increas-
ing attention to healthcare disparities in recent years,62 the impact of pain on
individual patients lives, their families, and society are notably absent in
most federal research agencys strategic plans and position statements. The
reality today is that there has been little impetus or effort among agencies
of influence to promote, no less uphold, an acceptable standard of pain care
among all groups of patients.
There continues to be major disparities based upon patient sociodemo-
graphic factors (e.g., race, ethnicity, socioeconomic status, age, gender)
for all types of pain (e.g., nociceptive, neuropathic) and across all settings
(e.g., inpatient, outpatient).63 Overall, minorities report significantly more
psychological and physical morbidity, including Posttraumatic Stress
Disorder and disability, than non-Hispanic whites across the age con-
tinuum.64,65 Respondents of an American Pain Society (APS) and AAPM
survey on ethical concerns in pain care identified pain management at
the end of life and the general undertreatment of pain (particularly in
the elderly and children) as the major ethical dilemmas confronting the
practice of pain.66 Neither racial nor ethnic disparities in pain care were
identified as a concern. Although lack of patient access to pain services
was identified as the sixth most significant ethical dilemma in pain, the
qualitative comments referred to the lack of 24-hour coverage and lack
of certified practitioners rather than insufficient access due to race and
ethnicity or socioeconomic status (SES).
Several ethical and healthcare policy considerations must be addressed
to optimize pain assessment and treatment for those at particular risk for
substandard pain care.67 There are many predictors of pain care dispari-
ties: SES, race and ethnicity, language, geography, extremes of age, gen-
der differences, health literacy, specific types of pain-related conditions
FH  )*7"*%4
 TQFDJGJD DPNPSCJEJUJFT FH., substance use disorders),
and others. AAPMs Ethics Charter identifies many of these but will focus
on those that affect people most commonly: SES, race and ethnicity, and
geographic location.

SOCIOECONOMIC DISPARITIES
Access to healthcare is strongly influenced by financial status.67 Research
suggests that Pain Medicine physicians give preferential treatment to more
profitable patients.67 The principle of distributive justice would dictate
that all patients under similar clinical circumstances would receive equal
access to all necessary and indicated treatment modalities. Prevailing
economic forces coupled with insensible and even discriminatory policies

Ethics Charter n 19
within our healthcare system proscribe against fair treatment for many
patients in pain. Low SES is broadly associated with poor access to care,
fewer community healthcare resources, and higher overall morbidity
and mortality rates.68,69,70 Overall, minority persons are much more likely
to be poor than non-Hispanic whites. Health insurance has allowed
improved access and health, but 15% of non-Hispanic whites in the U.S.
are uninsured as compared to 18% of Asians and Pacific Islanders, 20%
of African Americans, and 32% of Hispanics.71 Minority persons without
insurance are half as likely to have a regular physician when compared
to insured African Americans, limiting their access to specialty care such
as Pain Medicine.72

RECOMMENDATIONS
Because pain is a universal experience with a substantial health impact,
all physicians should support efforts to ensure access to high-quality pain
care for all, without regard to the patients financial means. Advocating
for reforms in public policy to remove barriers to access to care through
the provision of some form of healthcare coverage (insurance or its
equivalent) for all persons is an ethical imperative. Successful implemen-
tation of such policy reform will lessen health disparities in general and
disparities in pain care in particular.

GEOGRAPHIC DISPARITIES
It has been well-demonstrated that a persons place of residence strongly
influences his or her access to health-related services.73 Overall, locations
with relatively poor healthcare resources, especially for specialist-level
pain care, tend to correlate with the percentage of minority inhabitants,
although there is substantial variation in racial and ethnic disparities
across geographic lines. Perhaps the only consistent pattern is that pain
specialists tend to practice in urban areas. There is an insufficient number
of pain specialists overall, requiring that primary care physicians provide
care even for patients with complex pain management needs, particularly
in rural settings.
Although pain complaints are one of the most common reasons that
people seek medical care, studies consistently report that physicians
receive very little education specifically directed at managing pain.
Patients requiring specialized pain care may need to travel long distances
for evaluation and treatment. In addition, the availability of essential
medications required for the treatment of pain varies geographically,
even within metropolitan areas and across a state.74,75 Pharmacies located
in minority and low-income neighborhoods are less likely to carry opioid
analgesics than those in nonminority neighborhoods. The reluctance
to prescribe and the decreased ability to obtain pain medications both
complicate appropriate pain management for racial and ethnic minority
persons and impair their overall health and well-being.

20 n the AMERICAN ACADEMY of PAIN MEDICINE


RECOMMENDATIONS
1. Pain Medicine physicians, in concert with pain management advocacy
groups, should identify regional variations in the quality and availabil-
ity of pain care and promote the development of training programs and
public policy initiatives to fill the need of underserved areas.
2. Pain Medicine physicians must work in concert with pain management
advocacy groups and regulatory agencies to eliminate barriers both to
prescribing and obtaining indicated analgesics.
3. Pain Medicine physicians must advocate for and help organize improved
pain management education to primary care physicians and other health-
care professionals practicing in areas with limited access to specialized
pain care.

RACIAL AND ETHNIC DISPARITIES


The bioethical principle of justice is severely strained when there are
racial and ethnic disparities in treating individuals with pain. A recent
Institute of Medicine (IOM) report identified consistent and overwhelm-
ing racial and ethnic disparities in health and health care for a wide
variety of illness and healthcare services but only briefly addressed pain
care.76 IOM clearly documented the disparities in providing pain care for
acute pain problems in the emergency room and for cancer pain. More
recent reviews further document racial and ethnic differences in a variety
of settings (e.g., emergency departments, inpatient, nursing homes) and
conditions (e.g., nociceptive, neuropathic, and experimental pain).64,65
These reports conclude that racial and ethnic minorities are at risk
for poor pain assessment when compared to non-Hispanic whites. The
pain complaints of racial and ethnic minorities, the elderly, and women
are often handled less aggressively by physicians than those of non-
Hispanic white men. Minority persons often report increased pain and
pain-related sequelae while being at increased risk for undertreatment.
These differences in pain assessment and treatment by physicians are
based upon patients demographic characteristics regardless of type or
cause of pain.
Studies in the emergency department found a two-fold increase in the
amount of analgesics administered to white patients with acute pain from
long-bone fractures compared with comparably injured racial minorities.
Differences were not accounted for by other patient sociodemographic
factors, substance use, or medical characteristics.63 In another study using
black and white actors presenting with acute chest pain, women and
minorities received inferior pain care. A survey of 13,625 elderly nursing-
home residents with cancer pain showed that blacks were less likely to
have their pain assessed and were 63% more likely than whites to not
receive any pain medications.77 Additionally, minorities carry a higher
disease burden than non-Hispanic whites, adding to the diminished

Ethics Charter n 21
physical, social, and emotional health imposed by persistent pain.
Recent work reveals that there are generational differences in pain
reports and pain-related sequelae among blacks, with younger patients
reporting more distress than their older counterparts. The cultural
reasons for this are not completely clear; but, over time, this has
significant implications for an increasingly aging society.
In addition, minority patients are prescribed less potent analgesics
and are significantly undertreated using the WHOs pain management
guidelines. African Americans were significantly less likely to receive
a prescription for a COX-2 inhibitor than Caucasians.78 Emanuel has
noted that even in end-of-life care, services such as hospice care are more
available for the well-heeled white sectors of society than others.79
The workers compensation literature provides additional evidence
for disparate pain care with racial and ethnic minorities receiving less
treatment and lower disability ratings while being twice as likely to be
disabled 6 months following occupational back injuries.

RECOMMENDATIONS
Ongoing research and monitoring of disparities related to ethnic or
racial background are required in order to inform public policies that
can remediate inequities in pain care. Pain Medicine physicians have an
ethical obligation to advocate for research funding and policy changes to
eliminate disparities and optimize pain care among all patients.

ACCESS TO PAIN CARE


Racial and ethnic minorities have less access to primary care, resulting in
fewer referrals to pain management specialists, and they are at an increased
risk of having their pain complaints discounted and undertreated. Many
minority patients with pain complaints believed that they should have
been referred to specialty pain care sooner, felt that ethnicity influenced
pain care, and reported that persistent pain is a major financial burden
more so than whites.
Racial and ethnic disparities in pain care may result from patient and
clinician-level factors. Minority patients are more likely to refuse rec-
ommended therapies, adhere poorly to treatment regimens, and delay
seeking medical care.80,81 These behaviors are the consequence of patients
mistrust in physicians (lack of identification with and empathy from
mostly white practitioners), past negative experiences with the health-
care system, and limited health literacy.82 Physician sources of racial
and ethnic disparities may result from bias or prejudice, stereotyping,
poor cross-cultural communication skills (i.e., cultural competency), and
greater clinical uncertainty when treating minority patients.83,84 Physician-
patient congruence has been shown to improve compliance. However,
physicians from racially and ethnically diverse backgrounds are under-
represented in medicine.

22 n the AMERICAN ACADEMY of PAIN MEDICINE


RECOMMENDATIONS
1. Pain Medicine physicians should provide culturally competent care to
reduce the potential for miscommunication, stigma, and stereotyping.
This can be accomplished through a commitment to ongoing continuing
education programs that focus on cross-cultural competence.
2. Pain Medicine physicians should advocate for cultural competence edu-
cation and training programs at their professional conferences.
3. Pain Medicine physicians should become involved in undergraduate
and postgraduate education opportunities to engage and inspire minor-
ity students to pursue careers in Pain Medicine.

LEGAL TESTIMONY
Adopted December 2007.
David Brushwood, JD RPh; Michel Y. Dubois, MD; Gil Fanciullo, MD MS; Hugh Gilbert, MD;
Daniel Hamaty, MD; Philipp M. Lippe, MD; Ben A. Rich, JD PhD; Knox H. Todd, MD
As professionals with specialized knowledge and experience, Pain
Medicine physicians have an obligation to assist in the administration of
justice.85 The courts frequently call on Pain Medicine physicians to par-
ticipate in a variety of legal proceedings to establish and interpret medi-
cal diagnoses, prognoses, and treatments. Pain Medicine physicians who
participate in legal proceedings should do so only within the boundaries
of their training, expertise, and professional experience. They should also
avoid any real and perceived conflicts of interest that could undermine
their ability to testify in a prepared and truthful manner. Pain Medicine
physicians should decline compensation in an amount or of a type (e.g.,
contingency) that may influence the objectivity of their testimony.

SPECIFIC OPINIONS
r $PNQFUFODF
Pain Medicine physicians vary widely in regard to their background,
training, and practice. Pain Medicine physicians who commit themselves
to participate in legal proceedings should have a good faith basis to
believe that they possess the knowledge, skills, and experience required
to assess the case under review and render an informed and credible
opinion on the matter or matters at issue.
r 1SFQBSBUJPO
Expert witnesses should thoroughly review all pertinent aspects of, and
documents pertaining to, the case and the relevant science that informs
the opinions offered.
r 0CKFDUJWJUZ
An expert witness may not become an advocate or partisan for either
side in the legal proceedings. Testimony must be impartial and unbi-
ased.

Ethics Charter n 23
r *OUFHSJUZ
An expert witness will testify honestly and truthfully and ensure that his
or her testimony is consistent with the facts of the case.
r 'BJSDPNQFOTBUJPO
It is unethical for a physician to accept compensation that is contingent
upon the outcome of litigation.
r "WBJMBCJMJUZGPSQFFSSFWJFX
An expert witness will make his or her testimony available for peer
review when requested.
r 4UBOEBSEPGDBSF
An expert witnesss testimony should reflect current scientific thought
and standards of care that have gained acceptance among peers in the
relevant field.85 If a medical witness knowingly provides testimony
based on a theory not widely accepted in the profession, the witness
should characterize the theory as such. Also, testimony pertinent to a
standard of care must consider standards that prevailed at the time the
event under review occurred. Finally, the expert witness must articulate
the national standard of care and clearly identify any personal differ-
ences of opinion concerning it.
rAs witness for ones own patients
When Pain Medicine physicians are called on to testify in matters that
could adversely affect their patients medical interest, they should
decline to testify, unless the patient provides a fully informed and vol-
untary consent or the provision of the opinion is required by law. If, as
a result of legal proceedings, the patient and the physician are placed in
adversarial positions, it may be appropriate for the treating physician
to transfer the care of the patient to another physician.85 In any case, the
Pain Medicine physician must hold the patients medical interest para-
mount, including the confidentiality of the patients health information,
unless the Pain Medicine physician is authorized or legally compelled to
disclose the information.85
r $POGMJDUPGJOUFSFTU
An expert witness should recuse himself or herself if there is an actual or
apparent conflict of interest (e.g., financial, promotional, emotional), or
should take appropriate measures to resolve such a conflict.

24 n the AMERICAN ACADEMY of PAIN MEDICINE


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Ethics Charter n 29
Appendix A. American Medical Association Principles
of Medical Ethics
PREAMBLE
The medical profession has long subscribed to a body of ethical state-
ments developed primarily for the benefit of the patient. As a member
of this profession, a physician must recognize responsibility to patients
first and foremost, as well as to society, to other health professionals,
and to self. The following Principles adopted by the American Medical
Association are not laws, but standards of conduct which define the
essentials of honorable behavior for the physician.
I. A physician shall be dedicated to providing competent medical care,
with compassion and respect for human dignity and rights.
II. A physician shall uphold the standards of professionalism, be honest in
all professional interactions, and strive to report physicians deficient in
character or competence, or engaging in fraud or deception, to appro-
priate entities.
III. A physician shall respect the law and also recognize a responsibility
to seek changes in those requirements which are contrary to the best
interests of the patient.
IV. A physician shall respect the rights of patients, colleagues, and other
health professionals, and shall safeguard patient confidences and pri-
vacy within the constraints of the law.
V. A physician shall continue to study, apply, and advance scientific
knowledge, maintain a commitment to medical education, make rel-
evant information available to patients, colleagues, and the public,
obtain consultation, and use the talents of other health professionals
when indicated.
VI. A physician shall, in the provision of appropriate patient care, except in
emergencies, be free to choose whom to serve, with whom to associate,
and the environment in which to provide medical care.
VII. A physician shall recognize a responsibility to participate in activities
contributing to the improvement of the community and the betterment
of public health.
VIII. A physician shall, while caring for a patient, regard responsibility to
the patient as paramount.
IX. A physician shall support access to medical care for all people.

Adopted June 1957; revised June 1980; revised June 2001.

30 n the AMERICAN ACADEMY of PAIN MEDICINE


Appendix B. American Medical Association Declaration
of Professional Responsibility
PREAMBLE
Never in the history of human civilization has the well-being of each
individual been so inextricably linked to that of every other. Plagues and
pandemics respect no national borders in a world of global commerce
and travel. Wars and acts of terrorism enlist innocents as combatants
and mark civilians as targets. Advances in medical science and genetics,
while promising great good, may also be harnessed as agents of evil.
The unprecedented scope and immediacy of these universal challenges
demand concerted action and response by all.
As physicians, we are bound in our response by a common heritage of
caring for the sick and the suffering. Through the centuries, individual phy-
sicians have fulfilled this obligation by applying their skills and knowledge
competently, selflessly, and at times heroically. Today, our profession must
reaffirm its historical commitment to combat natural and man-made assaults
on the health and well-being of humankind. Only by acting together across
geographic and ideological divides can we overcome such powerful threats.
Humanity is our patient.

DECLARATION
We, the members of the world community of physicians, solemnly com-
mit ourselves to:
1. Respect human life and the dignity of every individual.
2. Refrain from supporting or committing crimes against humanity and
condemn all such acts.
3. Treat the sick and injured with competence and compassion and without
prejudice.
4. Apply our knowledge and skills when needed, though doing so may put
us at risk.
5. Protect the privacy and confidentiality of those for whom we care and
breach that confidence only when keeping it would seriously threaten
their health and safety or that of others.
6. Work freely with colleagues to discover, develop, and promote advances
in medicine and public health that ameliorate suffering and contribute to
human well-being.
7. Educate the public and polity about present and future threats to the
health of humanity.
8. Advocate for social, economic, educational, and political changes that
ameliorate suffering and contribute to human well-being.
9. Teach and mentor those who follow us, for they are the future of our
caring profession.
We make these promises solemnly, freely, and upon our personal and
professional honor.

Ethics Charter n 31
Addendum. Statement on Conflicts of Interest:
Interaction Between Physicians and Industry in
Pain Medicine
American Academy of Pain Medicine Ethics Council

The relationship between physicians and industry-supported continu-


ing medical education (CME), research, and innovation are critical to the
advancement of medical knowledge in Pain Medicine. However, physi-
cians and industry have fundamentally different goals. To ensure that
these relationships are principled and ethical, all parties must be aware of
the conflicts of interest they present and strive to manage them ethically
and with transparency.

DEFINITION OF CONFLICT OF INTEREST IN MEDICINE


A conflict of interest is a situation in which someone in a position of trust,
such as a physician or medical research scientist, has competing professional
or personal interests that have the potential to influence patient care or
other professional primary obligations such as research and education.
A conflict of interest exists if a reasonable observer finds it plausible
that the average person could be, but not necessarily would be, swayed
by secondary interests. Secondary interests can be broadly divided into
personal, professional, or financial. Conflicts of interest are common
throughout medicine. Perhaps the most important is the convergence of
professional responsibilities and economic self-interests.

BIAS: A POTENTIAL CONSEQUENCE OF CONFLICT OF INTEREST


A conflict of interest can create bias. It cannot be overemphasized that
this type of bias is a neuro-psycho-social process that is subconscious and
not purposeful. Bias has the potential to influence and change behavior
and clinical decisions about patient care, education, and research. It
may influence the way researchers interpret their results and the results
of others, and it may influence the emphasis and recommendations of
medical educators. Bias also affects the way an audience evaluates and
interprets publications and lectures, and what conclusions are accepted
and retained.
Most physicians believe they can resist bias and its consequences
by virtue of their integrity, education, intellect, and scientific training,
but evidence from sound social science research contradicts this belief.
Paradoxically, although physicians often believe they can resist the bias
and behavioral changes inherent in conflicts of interest, they are likely to
believe their peers cannot.
Physicians generally practice ethically, but their judgments may be
influenced by economic self-interests. Research shows that when faced
with equal choices, people tend to default to their self-serving interests.

32 n the AMERICAN ACADEMY of PAIN MEDICINE


Gifting and payment for educational and research services are forms
of influence that stimulate the process and engender the need for
reciprocity. A German proverb states, Whose bread I eat, his song I sing.
Research also suggests that physicians who may benefit personally from
recommending or prescribing a certain treatment will subconsciously
find a way to justify that decision as being the best for the patient.

DISCLOSURE
Disclosure has become the mainstay for mitigating conflicts of interest.
Most medical organizations, CME providers, and journal editors require
speakers, authors, consultants, and others to disclose all potential con-
flicts. Traditionally, disclosing potential conflicts has been seen as an
appropriate way to manage them, but recent evidence suggests disclo-
sure might do little to mitigate the potential conflict. Rather, disclosure
unfairly places the burden of managing the conflict on those to whom
the disclosure is made, charging them with determining how skeptical
to be about the objectivity of the individual with the potential conflict
(American Medical Association Council on Ethical and Judicial Affairs,
unpublished data, 2008).
Recent research suggests that in some circumstances disclosure can
actually be counter-productive. In order for disclosure to be at least
somewhat effective, the discloser and audience must understand and
accept the subconscious nature of bias and its effects. In addition, the
audience must be aware of the magnitude of the effects of the influence,
which is difficult to estimate. It has been established that advisors give
more biased advice after disclosing that they have a conflict of interest.
There are many reasons that disclosure may be ineffective or counter-
productive. Physicians differ in what they consider a conflict of interest, and
therefore disclosure may be incomplete. Furthermore, it is rarely verified.
In addition, when advisors instinctively feel their recommendations
might be discounted because of their disclosure, they may subconsciously
counter this by further skewing the way they present the information so as
to justify their actions. In some instances, dollar amounts of remuneration
are not specified but instead are lumped into broad categories that are
difficult to pin down. For disclosure to be most meaningful, exact dollar
amounts and value of materials should be disclosed.
There may also be an unexpected and paradoxical effect on a patient
who is told about a physicians, educators, researchers, or authors
conflict of interest. The disclosure might engender unwarranted trust
that would reduce the patients scrutiny. In addition, transference is a
powerful emotional force between patient and physician. In order to
act as a good patient and avoid the appearance of distrust, the patient
may be less, rather than more, inclined to choose another option or seek
a second opinion.

Ethics Charter n 33
In theory, divestiture is the preferred way to manage conflicts.
Nevertheless, at this time, despite its limitations, disclosure is attractive
as a practical way to manage conflict. However, disclosure needs to be
more specific, more rigid, and strictly enforced.

RECUSAL
Conflicted individuals are expected to recuse themselves (i.e., abstain
from decisions) when a conflict exists. The imperative for recusal var-
ies depending on how the circumstances of the case might implicate
common-sense ethics, codified ethics, or state statute.

SPECIFIC CONFLICTS OF INTEREST


CONSULTANTS AND ADVISORY BOARDS
Background: Consultants to industry are essential, and it is ethical for
physicians to participate. Consultants can make significant contributions
to medical care and innovation. However, consultants can be either true
experts or token consultants who are selected because they are high
users or potential users of a drug, product, or medical device. Consulting
for multiple competing companies does not mitigate the bias.
Recommendations: Consultants should be thought leaders with expertise
that is recognized by their peers. They should bring something of value to a
pharmaceutical or device manufacturer by virtue of an invention, innovation,
published research or reviews, or extensive clinical expertise at minimum.
There should be a written contract between the consultant and the company
with details of the deliverable work product and time lines clearly defined.
Payment should be fair and reasonable, commensurate with the value of
the work product, and represent fair market value for time and intellectual
property.

CONTINUING MEDICAL EDUCATION


Background: The goal of CME is to provide objective medical information
to physicians to improve patient care. Industry can and does play a large,
legitimate, and significant role in CME. It is ethical, reasonable, and nec-
essary for physicians, institutions, and organizations to rely on funding
from industry for purposes of education. However, CME programs must
follow strict guidelines to minimize industry influence on CME content
to ensure public confidence.
Recommendations: CME programs must be conducted independently of
any content input from industry. It is preferred that CME be at formal orga-
nizational meetings, not just at those that are marketing events for industry,
especially if there is only one company involved or if a commercial interest
pays for tuition, travel, and lodging of attendees. Speakers should be thought
leaders in their field with established expertise on the specific subject based
on their research, publications, and experience. Speakers must stringently
adhere to the latest Accreditation Council for Continuing Medical Education

34 n the AMERICAN ACADEMY of PAIN MEDICINE


(ACCME) guidelines. Lectures should be free of specific product endorse-
ments and brand names. They should be evidence-based and well referenced.
With rare exception for specialized, technical images, audiovisuals should be
created by the speaker and neither created nor edited by the corporate spon-
sor. Industry representatives should have no say in the lecture content.
Speakers should be funded by the CME provider organization, not directly
by any company. Industry can contribute to a central fund, which acts as a
firewall, to subsidize the costs of the overall meeting. Attendees at confer-
ences should not be funded by industry. It is ethical for speakers to receive
funding for travel, basic expenses, hotel, and a reasonable honorarium, but
conflicts of interests are better managed when the immediate source of the
funds is the conference sponsor rather than an identifiable, private source.

SPEAKERS BUREAUS
Background: Speakers are an essential part of the CME process. However,
there is the danger of bias when speakers have direct industry support.
Speakers should not be local physician opinion leaders or simply high
prescribers or users of a drug or product.
Recommendations: The recommendations for speakers are those outlined
above for CME.

MEETINGS WITH SALES AND MARKETING REPRESENTATIVES OF PHARMACEUTICAL


COMPANIES AND DEVICE MANUFACTURERS
Background: Sales and marketing representatives of pharmaceutical
companies and device manufacturers engage in marketing; the primary
goal of which is to influence a physicians prescribing practices or the
use of a product. Some physicians receive a significant amount of their
medical information about drugs and devices from these representatives,
although it is well recognized that this information is very biased.
It is very well established that gifts, even of small items, including free
lunches, have significant influence on physician prescribing. With the con-
siderable opportunity for physicians to receive unbiased knowledge updates
on-line and at formal medical meetings, the educational value of the phar-
maceutical representative is doubtful.
The role of samples is more complex, but merits careful thought. So-called
free samples are not really free. Samples create a bias to prescribe the medica-
tion to patients. Some good can come from providing indigent patients with
medications they are not able to obtain through usual pharmacy sources,
but it is rare that the newer medications are significantly better than the less
expensive alternatives.
Recommendations: The only absolute means to prevent influence from con-
tact with sales and marketing pharmaceutical representatives is for physi-
cians to eliminate visits from industry representatives and not accept gifts of
any sort, including meals. The role of samples is more complex and must be
individualized.

Ethics Charter n 35
FUNDING FOR RESEARCH
Background: It is ethical, reasonable, and necessary to accept funding
from industry for research. Researchers must understand the complex
and inherent biases involved. Industry-funded research maintains an
implicit expectation of positive findings. Research design may favor the
companys product. Ghost authors may be hired to write an industry-
sponsored paper, but private practice physicians or academic physician
researchers might be solicited to appear as the author, (i.e., simply
have their name put on the paper). In multicenter studies, data submit-
ted to a central depository are controlled by a company and may not be
available for all the researchers to review. That company, in turn, can be
hired by the funding source and, thus, has conflicts of its own. There are
a disproportionate percentage of positive findings in research funded by
industry. Studies with negative findings are often not submitted.
Recommendations: All prospective randomized-controlled studies should be
registered. They must be reviewed by an institutional review board (IRB) at
which those with conflicts of interest recuse themselves.
A physician should not claim authorship unless he or she has made a
TJHOJGJDBOU JOUFMMFDUVBM DPOUSJCVUJPO UP UIF SFTFBSDI BOEPS XSJUJOH PG UIF
manuscript. The primary author must accept responsibility for the conduct
of the study, have access to the data, and control the decision as to whether,
when, and where to submit the manuscript. In a manuscript, full disclosure
for each author must be stated. Researchers should not accept ghost writ-
ers. Physicians should not allow industry to have the right to prevent an
author from submitting a manuscript for publication. Academic researchers
who are primary equity holders may need to have their involvement in the
research project considerably limited or they might need to divest their hold-
ings entirely.

INSTITUTIONAL REVIEW BOARDS (IRB)


Background: Some IRB members think relationships with industry can be
beneficial when reviewing research protocols because of the knowledge
obtained by the relationship with industry. More than one-third of IRB
members have relationships with industry and 15% have had protocols
presented to their IRBs that were sponsored by a company with which
they had a relationship. Most, but not all were disclosed. More than half
of IRBs have no formal disclosure system.
Recommendations: IRBs should have formal disclosure and recusal policies.
If a conflict of interest exists with respect to an industry-sponsored research
protocol, those with conflicts should not participate in the discussion or
voting. Some IRBs might choose to exclude the member with a conflict of
interest from the meeting during the discussion and voting, which would
constitute the clearest and least ambiguous resolution.

36 n the AMERICAN ACADEMY of PAIN MEDICINE


PHYSICIAN-INVESTORS
Background: Physicians have the right to invest in publicly traded medical
companies, especially through publicly traded equities or mutual funds,
provided the investor has no private or insider knowledge beyond that
which is known to the general public.
Recommendations: Physicians should not invest privately and directly in
a company for which they are conducting research, unless the physician is
uniquely skilled in the procedure and it is unreasonable that someone else can
be trained instead. Physicians should not invest privately in companies if it is
possible that they will speak or write for any of that companys products.

FURTHER RECOMMENDATIONS
The only definitive remedy for conflicts of interest is to eliminate them,
but in many instances this is neither possible nor practical. Therefore, a
more reasonable approach is to identify conflicts of interest and to accept
the fact that conflicts exert influence, may create bias, and might influ-
ence physician behavior. It is necessary to develop responsible means
to mitigate their effects. It must be accepted that although we cannot
exercise unlimited control of our instinctive behaviors, we are capable of
modifying them, in part by restructuring our relationships and interac-
tions. In addition, we can commit to the principle of practicing evidence-
based medicine founded on medical evidence, which is examined and
promulgated by a peer-review editorial process that systematically
attempts to counteract bias.

September, 2008

Ethics Charter n 37
Bibliography
Bekelman J, Li Y, Gross C. Scope and impact of financial conflicts of interest
in biomedical research: a systematic review. JAMA. 2003;289:454-465.
Brennan T, Rothman D, Blank L, et al. Health industry practices that cre-
ate conflicts of interest: a policy proposal for academic medical centers.
JAMA. 2006;295:429-433.
Brody H. The company we keep: why physicians should refuse to see phar-
maceutical representatives. Ann Fam Med. 2005;3:82-85.
Campbell EG, Weissman JS, Vogeli C, et al. Financial relationships between insti-
tutional review board members and industry. N Engl J Med. 2006;355:2321-
2329.
Coyle SL. Physician-industry relations. Part 2: organizational issues. Ann
Intern Med. 2002;136:403-406.
Jibson M. Interactions between physicians and industry: a guide for clini-
cians. Focus. 2007;5:398-406.
Loewenstein G. The behavioral economics perspective. In: Korn D and
Ehringhaus S (eds). The scientific basis of influence and reciprocity: a sympo-
sium. June 12, 2007. Available at www.aamc.com.
Montague R. The perspective from neuroscience. In: Korn D and Ehringhaus
S (eds). The scientific basis of influence and reciprocity: a symposium. June 12,
2007. Available at www.aamc.com.
Morgan MA, Dana J, Loewenstein G, et al. Interactions of doctors with the
pharmaceutical industry. J Med Ethics. 2006;32(10):559-563.
Scott IA. On the need for probity when physicians interact with industry.
Intern Med J. 2006;36(4):265-269.
Thompson DF. Understanding financial conflicts of interest. N Engl J Med.
1993;329(8):573-576.
Wall LL, Brown D. The high cost of free lunch. Obstet Gynecol. 2007;110:169-
173.

38 n the AMERICAN ACADEMY of PAIN MEDICINE


Back Cover

American Academy of Pain Medicine


8735 W Higgins Rd, Suite 300 Chicago, IL 60631
847/375-4731 847/375-6477 fax
Fact Sheet on Physician Re-entry
Definition of physician re-entry

A return to clinical practice in the discipline in which one has been trained or certified
following an extended period of clinical inactivity not resulting from discipline or
impairment.

Scope of the issue

How many reentering physicians are there?


The numbers of physicians who either reenter practice or desire to reenter practice are not clear;
however, one study has estimated that 10,000 physicians could reenter practice each year.

Why do physicians take a leave of absence from clinical practice?


A physician might take a leave of absence from clinical practice for many reasons, including
family leave (maternity and paternity leave, and child rearing); other caretaking and relationship
issues; personal health reasons; career dissatisfaction; or alternate careers such as administration,
military service, and humanitarian leave.

Why do physicians return to clinical practice?


Physicians seek re-entry to practice when their need to care for family is not as immediate or
when their own health improves. Other reasons include community needs, missing the practice
of medicine, too much free time, financial considerations, and desire for a new challenge.

What are key barriers to re-entry?


Lack of information on re-entry programs
Liability and credentialing issues
Lack of consistency in regulatory guidelines/licensure and maintenance of certification
Lack of certification related to program completion
Financial cost of reentering practice
Lack of access to existing programs
Limited number of re-entry programs
Lack of information on the re-entry process

1
The AMAs ten guiding principles for a physician re-entry program system
1. Accessible by geography, time and cost
2. Collaborative to improve communication and resource sharing
3. Comprehensive to cover relevant areas
4. Ethical based on principles of medical ethics
5. Flexible to maximize program usefulness
6. Modular to meet the specific needs of individual physicians
7. Innovative in employing state-of-the-art educational formats and content
8. Accountable by establishing mechanisms for assessment and evaluation
9. Stable to ensure adequate funding for programs
10. Responsive to changing circumstances

Survey of medical boards

The AMA annually publishes the State Medical Licensure Requirements and Statistics. The
process of compiling information (including physician re-entry) for this annual publication
involves sending the Physician Licensure Survey to boards of medical examiners (54 allopathic
and 14 osteopathic in the United States and its territories). The 2010 Physician Licensure Survey
was sent to 68 Boards of Medicine, and 78% (N=53) responded. Below are highlights from the
findings on physician re-entry.

51% of medical boards have a policy on physician re-entry


2.8 years is the average length of time out of practice (range is from 1 10 years) after
which state medical boards require reentering physicians to complete a re-entry program
55% of medical boards without a physician re-entry policy are either currently developing
or planning to develop a re-entry policy
92% of medical boards do not require a physician to engage in a certain amount of patient
care for relicensure

Additional Resources

American Academy of Pediatrics Physician Reentry into the Workforce Project


www.physicianreentry.org

American Medical Association Physician Re-entry Website


http://www.ama-assn.org/go/reentry

For more information, including references, please contact the AMA Medical Education
Group, Division of Undergraduate Medical Education

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An Advanced Specialty Training Program in


Anesthesiology: A Special Educational Fellowship
Designed to Return Community
Anesthesiologists to Clinical Practice
Larson, C Philip Jr MD; Steadman, Randolph H. MD

Section Editor(s): Dexter, Franklin

Anesthesia & Analgesia: July 2006 - Volume 103 - Issue 1 - pp 126-130 (/anesthesia-
analgesia/toc/2006/07000)
doi: 10.1213/01.ane.0000220903.33100.15
Economics, Education, and Policy: Special Article

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Anesthesiology, with its focus on technology, undergoes continual changes in practice patterns as new drugs are developed and
new technical advances are made. What is being taught anesthesia residents today is not the same as what was taught in the
1970s and 1980s. We addressed the issue of upgrading previously trained physicians' knowledge and technical skills to those of
current graduates by developing the program described below.

ADVANCED SPECIALTY TRAINING PROGRAM (ASTP)


The ASTP was created within the Department of Anesthesiology at the University of California, Los Angeles (UCLA) Medical
Center in 1994 (http://www.anes.ucla.edu/dept/fellowship.html (http://www.anes.ucla.edu/dept/fellowship.html)). The
objective was to address the perceived need for a program that could provide a detailed evaluation of a community
anesthesiologist's academic and clinical skills and augment those skills where appropriate through didactic and clinical
teaching. The program is geared toward retraining anesthesiologists who have been out of practice or whose skills are in
question. The UCLA Human Subjects Protection Committee has approved the disclosure of the data included in this report.

APPLICATION PROCESS
To be eligible for the program, an applicant must document graduation from an allopathic or osteopathic medical school, have
completed training in anesthesiology from an Accreditation Council for Graduate Medical Education-accredited institution,
have a valid California medical license, and current medical liability insurance. If the candidate has a history of substance
abuse, enrollment in or completion of a state-approved diversion program is required. The application process requires
completion of an application form, submission of a curriculum vitae, and payment of an application fee of $525. This fee is not
refundable but is applied to the program tuition, which is $1000 per month of training. These funds are used to cover the
administrative costs of the program. Fellows are responsible for arranging local housing.

Once the ASTP Fellow begins the program, individualized goals are established to meet identified needs. The program length
varies for each Fellow based on the time required to satisfactorily meet their specific objectives. At enrollment the Fellow is
given a blank copy of the evaluation form used by the faculty (Table 1).

Table 1

Enrollees are encouraged to bring a portable computer or personal digital assistant with them for recording data daily regarding
their clinical activities. The Fellows are expected to keep case logs of each anesthetic that they provide and submit the data to
the Director at the conclusion of the fellowship. These data are used to prepare letters of reference on conclusion of the
program.

EDUCATIONAL PROGRAM
Initially, the Fellow is assigned primarily to work with the ASTP Director, usually on a 1:1 basis. Once the Fellow is oriented to
the environment and the ASTP Director is confident that the Fellow can train effectively with other faculty, educational
experiences are broadened. During this time, the faculty-to-Fellow teaching ratio is never more than 1:2. The assignments begin
with anesthetics for orthopedics, urology, general surgery, head and neck surgery, and gynecology. With increased experience,

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participants may be assigned to provide more complex anesthetics for neurosurgery, thoracic, pediatric and/or transplantation
surgery, and/or be assigned to ambulatory surgery. Most Fellows also spend one or more weeks providing obstetrical
anesthesia. They are given opportunities to demonstrate proficiency in managing difficult airways including use of laryngeal
mask airways, intubating catheters, and fiberoptic intubation. They are expected to demonstrate proficiency in all aspects of
invasive monitoring, including pulmonary artery catheterization. Emphasis is placed on use of syringe pumps, use of newer
drugs, and prevention and management of hemodynamic disturbances. Fellows are also given 2.5 h/wk of didactic education
and one half-day of crisis management using a full-scale, high-fidelity simulator, all of which are part of the continuing
educational programs for anesthesia residents. The multiple demands on a Fellow's time do not allow us to provide more than
one or two simulation sessions while in the program.

FELLOW EVALUATION
The criteria used to evaluate the Fellow are identical to those used to evaluate residents for graduation. The evaluation begins
with an assessment by the ASTP Director, who works with the Fellow on a one-to-one basis until he deems the Fellow's
performance satisfactory. At this point the Fellow is assigned to other services to broaden the Fellow's clinical experiences.
These experiences are selected based on the Fellow's expectations of their work assignments when they resume independent
practice. Rotations on other services increase the number of faculty providing independent evaluations. At the conclusion of the
fellowship, the participating faculty members complete a summary evaluation of the Fellow's performance (Table 1) by
assigning assessments of satisfactory or unsatisfactory in the areas noted in addition to comments. A Fellow is expected to
remain in the program until he/she meets the same level of clinical competence as a graduating resident in the clinical services
for which training has been received. The ultimate goal for all Fellows is to be able to provide safe, competent, effective
anesthesia services within the scope of their practice.

At the conclusion of the fellowship, a letter is prepared detailing the duration of the fellowship, types of procedures for which
anesthetic care was provided, number of patients anesthetized, patient's ages and ASA physical status, anesthetic drugs and
techniques used, and any complications that occurred. This letter is given to the Fellow and any designate of his/her choice. No
diploma or other type of certificate is provided.

RESULTS
Twenty-five Fellows have participated in the program as of 2005 (Table 2). Eleven others completed the application process but
did not enroll. One Fellow completed the program twice because of a 4-yr hiatus from anesthesia practice. Eighteen of the 25
Fellows were diplomates of the American Board of Anesthesiology before program entry while one passed the oral examination
during the program. The majority of Fellows were from California, although Fellows from Arizona, Nevada, New Jersey, Texas,
Utah, and Washington have enrolled.

Table 2

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Eleven of the Fellows were actively practicing anesthesia at the time of enrollment. For 7 of the 11, the reason for enrollment
was concern by a practice group, hospital or both regarding their clinical competency. For all 7 Fellows, the mandating body
identified the area(s) of concern, but did not define the curriculum to be provided. Issues generally centered on adequacy of
technical skills, ability to exercise sound judgment in a stressful environment, or ability to deal with complex anesthetic issues.
The remaining 4 Fellows in active practice enrolled because they felt a need to upgrade their clinical skills. Fourteen Fellows
had been away from active clinical anesthesia practice for 1.5 to 9 yr. Fellows had terminated anesthesia practice for a variety of
reasons including serious illness and time spent in non-medical fields or working in other medical disciplines.

The time spent in the ASTP averaged 9 wk (range, 3 to 24 wk). Time in the program depended primarily on performance and
the number of clinical experiences (i.e., obstetric, thoracic, etc.) they desired. Given the small number of participants, we were
not able to distinguish any differences in program duration based upon the Fellow's age, time away from practice, or history of
substance abuse.

The number of cases in which the Fellows participated ranged from 15 for a Fellow enrolled for 3 wk to 174 cases for a Fellow
enrolled for 24 weeks. Fellows averaged 7 to 8 cases per week. All of the Fellows administered anesthesia to patients whose ASA
physical status was III, IV, or V, and all anesthetized one or more patients designated as an emergency. The minimum number
of faculty supervisors per Fellow was 5 and the maximum was 23. The simulator became operational 1 yr after the ASTP was
started; 21 of 25 Fellows received that experience.

Twenty-four Fellows achieved satisfactory clinical competence evaluations by the faculty and successfully completed the
program. One Fellow was terminated after 4 wk in the program because of continuing unsatisfactory performance with minimal
likelihood of improvement.

To evaluate the impact of the ASTP on their subsequent clinical practice, each Fellow completed a one-page survey (Table 3).
Responses were received from 22 of the 25 Fellows. Most of the Fellows had no suggestions for improvement of the program. A
few suggested that an orientation manual would be helpful, and this has been implemented. Another recent addition to the
educational program is the requirement that Fellows view the videotaped orientation lectures prepared for the incoming
resident staff.

Table 3

DISCUSSION
Continuing medical education throughout a lifetime of medical practice is essential for maintaining clinical competency.
Updating the skills of anesthesiologists takes less time than training medical school graduates new to the field. However, there
are few programs for this purpose (1). There is an abundance of programs for meeting state continuing medical education
requirements (2). Most are in the form of weekend meetings, or weeklong updates, typically held in hotels or resorts. Courses
are also available that focus specifically on teaching a new technology such as transesophageal echocardiography. Our program
differs from those described in the literature in several ways. First, it features a flexible curriculum that focuses on individual
needs rather than a fixed curriculum. Second, the program features direct contact using patients rather than computers,
animals, or models. Existing skills are observed and, where deficient, corrections are made. In addition, important new skills

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are developed. The most common new skill is fiberoptic intubation for the management of the difficult airway. Fiberoptic
intubation was not part of the anesthetic curriculum for most enrollees when they were in residency training. Developing this
skill has been one of the most popular and rewarding features of the program. Another has been the use and interpretation of
transesophageal echocardiography as a tool for caring for patients with cardiovascular disease undergoing noncardiac surgery.
Third, as a result of intense and continuous supervision, areas needing improvement are quickly identified and corrected.
Fourth, the location of the program in a tertiary care hospital results in many complex cases; many patients have a difficult
medical or surgical history (i.e., prior organ transplant), or the proposed surgical procedure is new or complicated. By the
completion of the program it is doubtful that a Fellow would encounter anesthetic problems that he/she had not faced or
discussed while in training. Fifth, the Fellows undergo daily practical oral examinations while providing patient care and attend
weekly didactic instruction. In many cases these interactions rekindle an interest in knowledge acquisition. Sixth, the use of the
simulator exposed the Fellows to crisis management and allowed them to reflect on and discuss their leadership and critical
thinking skills. These sessions lacked a formal assessment, as the number of scenarios encountered was not sufficient to permit
a global evaluation. Finally, the training emphasizes aspects of anesthesia practice that enrich both the specialist and the
specialty. Many of the Fellows wrote in their evaluation of the ASTP that they had never experienced the appreciation of
patients for the preoperative telephone call and had forgotten the joys of making postoperative rounds beyond the recovery
room.

Review of the literature did not identify any comparable program in anesthesia elsewhere in the United States. There is a
program at the University of California, San Diego called the Physician Assessment and Clinical Education program
(www.paceprogram.ucsd.edu (http://www.paceprogram.ucsd.edu)), which is designed primarily for physicians in any
discipline who are perceived to be having problem(s) with clinical care or who are referred to the program by the Medical Board
of California. The Physician Assessment and Clinical Education program involves a 2-day assessment of the individual, followed
by the development of a didactic education program and a week spent observing clinical practice. There is no direct contact with
patients while in the program.

Methods for assessing the clinical performance of physicians once they have completed their training and have successfully
completed one of the 24 specialty examinations offered by the American Board of Medical Specialties are very limited.
Standards of performance are illusive, and outcome-based or process-based measures of performance are fraught with
problems (3). Direct observation is the most important method of evaluating trainees' clinical skills (4). Others have suggested
we can move assessment back to the real world of the workplace as a result of the development of less standardized, but
nevertheless reliable, methods of practice-based assessment (5).

Although the ASTP is an effective method for assessing clinical performance, it may not be applicable to large numbers of
physicians for reasons of cost and lack of facilities and personnel to implement the program (1). Furthermore, it is reasonable to
question whether completion of the ASTP results in a sustained improvement in clinical competence. As with any educational
program, it is difficult to document that the experience enhanced clinical skills or produced a sustained improvement in clinical
care. An indirect measure of the value of the program is the fact that no hospital or medical group has expressed continued
reservations or concerns about a Fellow's clinical competence after he/she has completed the program.

The public health aspect of ASTP is threefold. First, it allows the clinician whose knowledge or clinical skills are in question to
have them evaluated and, where deficient, upgraded to the current standards established by experienced educators. Evidence
indicates that the public wants the medical profession to do more to assess the clinical competence of practicing physicians than
is currently the case (6). Second, it allows physicians who have left medicine for whatever reason to re-enter clinical practice
safely. This is particularly important in anesthesiology, a specialty that lacks sufficient numbers of trained physicians to meet
the current or projected clinical needs. Third, it provides a mechanism for health care facilities to credential applicants for
medical staff privileges in critically needed specialties using an independent evaluation of their competency.

http://journals.lww.com/anesthesia-analgesia/pages/articleviewer.aspx?year=2006&issue=07000&article=00026&type=Fulltext Page 5 of 6
An Advanced Specialty Training Program in Anesthesiology: A... : Anesthesia & Analgesia 6/19/17, 6:42 PM

In summary, we believe that the ASTP at UCLA provides a valuable service to individual anesthesiologists, to the specialty, and
to patients by providing previously trained anesthesiologists access to updated training and education that allow them to return
to the mainstream of clinical practice. This program may also serve as a model for much needed, similar programs in other
disciplines and in other parts of the United States.

ACKNOWLEDGMENTS
The authors would like to acknowledge the late Joseph Gabel, MD (Professor and former Chair, Department of Anesthesiology,
UCLA School of Medicine, Los Angeles, California, USA) for his creation of the concept of the ASTP and his substantial efforts
toward its realization.

REFERENCES
1. Mark S, Gupta J. Reentry into clinical practice: challenges and strategies. JAMA 2002;288:109096.
2. Tetzlaff JE, Schoenwald P, Jackman D, Smith J. Continuing medical education and the anesthesiologist. J Clin Anesth
1999;11:16472.
3. Landon BE, Normand LT, Blumenthal D, Daley J. Physician clinical performance assessment; prospects and barriers. JAMA
2003;290:11839.
4. Holmboe ES. Faculty and the observation of trainees' clinical skills: problems and opportunities. Acad Med 2004;79:1622.
5. Van der Vleuten CP, Schuwirth LW. Assessing professional competence from methods to programmes. Med Educ
2005;39:30917.
6. Brennan TA, Horwitz RI, Duffy FD, et al. The role of physician specialty board certification status in the quality movement.
JAMA 2004;292:103843.

2006 International Anethesia Research Society

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July 22, 2015

Questions to Ask Regarding Physician Re-Entry

There are many reasons why a physician may need to take an extended absence from practice. The complexity of the re-
entry process and the unique challenges you face may be mitigated by answering several questions and conducting
research on the process.

Does ASA have a list of anesthesiology departments that offer re-entry programs?
The ASA does not have a list of anesthesia re-entry programs. However, we recommend that you contact the nearest
anesthesia residency program or the program where you completed your residency for an individualized discussion of
your options. For reference, the Federation of State Medical Boards (FSMB) and the Physician Re-Entry Into the
Workforce Project maintain a list of re-entry programs.

How can my medical board help me?


We strongly encourage you to research whether your State Board of Medicine has a re-entry policy (30 boards do as of
2012). Your state medical board may be able to advise you on requirements related to education (reorientation),
licensure, credentialing, privileging and other necessary documents.

What are some questions that I should be prepared to answer?


Although not an exhaustive list, physicians seeking re-entry should be able to answer the questions listed below.
Questions should be informed upon how long you have been out of clinical practice.
1. When did I complete residency?
2. Am I Board certified?
3. Am I in Maintenance of Certification (MOCA)?
4. Is my state license current?
5. Why have I been out of practice?

What types of reorientation activities should I expect as part of the re-entry process?
Depending on your course of re-entry and the program that you enroll in, you may expect to complete a number of
activities. Such activities may include: 1.) Classroom didactic work; 2.) Simulations; 3.) Clinical observations; 4.)
Supervised one-on-one practice; 5.) Full clinical practice with an oversight plan; 6.) Functional independence. How
quickly you move through these and other required stages may depend on the program, your competency and how long
you may have been out of practice.

Are there financial resources available for me to access?


Financial resources for training and re-entry purposes will be dependent upon the re-entry program or facility assisting
with your re-orientation. Approved place of residency or fellowship may be available in some instances. In other
instances, the program may ask that, once you complete your course of study, you commit a certain amount of time to
clinical care for that particular program or facility. Of course, the physician seeking re-entry should find out the expected
cost of the program.

Where can I go to find more information about physician re-entry in general?


The American Medical Association (AMA) has a significant number of resources for your consideration. We also
recommend recent publications from the Federation of State Medical Boards (FSMB) regarding questions that boards
expect to receive from physicians seeking to re-enter practice. Last, we recommend reviewing a recent article in Medical
Staff Briefing that describes how one medical school (Drexel University) approaches physician re-entry.

Quality and Regulatory Affairs may be contacted at (202) 289-2222 or by email at qra@asahq.org.

CMSS Position on Physician Reentry


ApprovedbyCouncil11/19/11
Minoredits1/18/12

Introduction

TheCouncilofMedicalSpecialtySocieties(CMSS)recognizestheneedforpolicyonphysicianreentry
intoclinicalpractice.Thisneedhasbecomemoreapparentasmedicalspecialtysocieties,certifying
boardsandothershaverecognizedthatmorephysiciansareseekingtoreenterclinicalpracticeaftera
hiatus.TheAmericanCongressofObstetriciansandGynecologists,forexample,hasestimatedthat
therecouldbeseveralhundredinactiveobstetriciansthatcouldcontributethatthatspecialtys
workforce.Physicianreentryinarapidlychangingpracticeenvironmenthasanimpactonpatient
safety,workforceshortages,andmedicaleducation.Furthermore,physiciandeparturefromandlater
reentryintoclinicalpracticecouldbeviewedasanormalpartofthecareertrajectoryofagrowing
numberofphysicians.

ThisdocumentservesasacalltoactionfortheCMSSanditsmembersocietiestoaddressthecomplex
topicofphysicianreentry.Asdecisionsarebeingmadethatwillinfluencethephysicianworkforce,the
individualphysicianandthepublic,medicalsocietiesmusthaveastrongrole.Inphysicianreentry
planning,theuniqueneedsofphysiciansindifferentspecialtieshavegonelargelyunaddressed.Medical
specialtysocietiesareuniquelypositionedtoprovidetheseperspectivesandtocreateandimplement
suchpolicies,sincetheycanbothsupporttheirreenteringcolleaguesaswellaspromotepatientsafety
andqualityofcareintheirdisciplines.CMSSisuniquelypositionedtoserveasaconveningagencyfor
themanystakeholderswhoareinvolvedinphysicianreentry,andtoensuretheperspectivesof
specialtysocietiesfigureprominentlyinthesedeliberations.Toservethebestinterestsofreentering
physicians,toprovideprotectiontosociety,andtoinformregulatorybodies,CMSSshouldcarefully
considerbothpolicyonphysicianreentryandimplicationsforstrategicimplementation.

Definition

Forthepurposesofthisstatementwedefinephysicianreentryasreturningtotheprofessional
activity/clinicalpracticeforwhichonehasbeentrained,certified,orlicensedafteranextendedperiod
ofabsence.1Physicianreentryisnotremediation,resultingfromdisciplinaryinterventionduetoa
breachofmedicalethics,substanceabuse,lossofonesmedicallicenseorsimilarevents.2

ReentryStudies

Althoughthenumberofstudiesonphysicianreentryremainslimited,thesestudiesalongwith
anecdotalevidencesuggestamyriadofreasonswhyaphysicianmayleaveclinicalpracticeandthen
seektoreenter.Theseinclude,butarenotlimitedto:theneedtocareforchildrenand/orelders,
1

personalillness,financialconsiderations(suchasthehighcostofmedicalliabilityinsurancepremiums),
pursuingacareeroutsideofclinicalmedicine,militaryservice,andtheinabilitytoidentifyparttimeor
moreflexiblepracticeoptions.Anothercategoryofreenteringphysiciansincludesphysicianswhohave
retiredbut,forreasonsrangingfromfinancialtopersonalpreference,seektoreturntotheworkforce.2

Thereislittledataavailableonthenumberofphysicianswhoarecurrentlyinactive,theexperienceof
thephysicianpriortothehiatus,thosewhowereinactivebuthavesincereturnedtoclinicalpractice,or
thoseanticipatingtakingaleaveofabsencefromclinicalpracticeintheforeseeablefuture.Anumberof
recent,butlimitedstudiesprovidesomemuchneededinformationondemographiccharacteristicsof
reenteringphysicians.36Forexample,onestudypublishedin2011lookedatinactivephysiciansunder
theageof65intheAmericanMedicalAssociation(AMA)Masterfile,findingthatphysicianswhohad
beeninactivebuthadreenteredtheworkforcewereevenlydividedbetweengendersandweremost
likelytopracticeInternalMedicineorFamilyMedicine.6Whiletherangeisfrom15years,inmost
states,physicianswhotakealeaveofabsencefrompracticeforaperiodof2ormoreyearsare
recommendedtoparticipateinaphysicianreentryprogrambeforereturningtoclinicalpractice.7

EducationalNeeds

Aswithmanycomplexissues,thechallengesposedbytheprocessofphysicianreentryintothe
workforceandthespecialneedsofthispopulationofphysiciansareformidable.Barrierstophysician
reentryaremultipleanddiverse.Fortheindividualphysician,theyrangefromrequirementsthatmay
bevague,arbitrary,andmayhavechangedovertime(ormayinthefuture)tofailuretomaintain
knowledgeintheirclinicalspecialtybecausetheydonotanticipateareturntomedicine.Therearealso
challengesfacedbytheprospectiveemployer,hospitalcredentialinggroupsandothers.Whileall
physiciansareinvolvedinlifelonglearning,theneedsofreenteringphysicianareoftendifferent.There
maybe,forexample,inproceduralspecialties,alackofunderstandingandcomfortwithtechnological
advancesthataphysicianinactivepracticewouldnotexperience.7Theeducationalneedsofphysicians
whowishtoreturntoclinicalpracticearediverse.Forexample,howcanphysiciansneedsfora
structured,coordinatededucationalsystembebalancedwiththerequirementfortailored,
individualizedandspecialtyspecificeducationalopportunities?Canthisbedonewithoutcreating
financialimpedimentsforthephysiciansaswellastheinstitutionsthatwillneedtohostandsupport
suchprograms?Howmightsuchprograms(andthephysicianswhoparticipateinthem)befundedin
thefuture?

Fortunately,aframeworkforconsideringmanyoftheseissuesandquestionshasbeendeveloped.
Workingthroughaconsensusprocess,theAmericanMedicalAssociation,theFederationofState
MedicalBoardsandtheAmericanAcademyofPediatricshasdevelopedaseriesofrecommendations.
Theseaddressbroadcategoriesthatinclude:regulatorypolicies;physicianreentryprogrampolicies;
researchandevaluation;programfunding;andcollaborationandcommunicationamongstakeholders.8
ThetimingispropitiousfortheCMSStoconsidertheserecommendationsorothersthatwilladvance

specialtysocietiesinvolvementinaddressingthechallengesinvolvedinphysicianreentryintothe
workforce.

RoleofMedicalSocieties

CMSSbelievesthereareopportunitiestomeetthesechallenges.Medicalsocietieswillplayakeyroleby
offeringcontinuingmedicaleducationcoursestargetedtotheneedsofinactiveandreentering
physicians.Societiesshouldanticipatechangeandmakeplansdespitethepaucityofdata.Theyshould
alsodevelopresourcesandmechanismstoassistphysicianswhentheywishtoreturntopractice.
Societiescanfurthersupporttheirmemberswhoarereenteringtheworkforcebypromotingflexibility
inpracticeoptionsandeducationalsystems.

Individualphysiciansneedtoolsthatwillsupporttheirreentryintotheworkforce,whilethepublicand
thepatientsthesephysicianswillserveareentitledtoqualitypatientcare.Medicalsocietiesstandat
thecriticaljunctureoftheneedsandinterestsofallwhoareinvolvedinphysicianreentryintothe
workforce.CMSSiswellsuitedtoeducateitsmembersaboutthesecomplextopicsandtoprovidea
forumfortheirconsideration.Equallyimportantwillbetoworkwithmembersocietiestodevelopa
strategytocommunicatethereentrycomponentsandregulatoryissuestophysicians.Doingsowillhelp
ensurethatallinvolvedwillbekeptuptodateoncurrentpoliciesandprocedures.

Recommendation

CMSScallsuponitsmembermedicalsocieties,certifyingboardsinthespecialties,andotherkey
stakeholderssuchasstatelicensingauthorities,insurersandemployers,tocollaborativelydevelopa
comprehensiveapproachtophysicianreentryintothemedicalworkforce.

References

1. ThePhysicianReentryintotheWorkforceProject.APhysicianReentryintotheWorkforce
Inventory.ElkGroveVillage,IL:AmericanAcademyofPediatrics;2010.Availableat:
http://www.physicianreentry.org/yahoo_site_admin/assets/docs/Inventory_Checklist_Web_V
ersion.10125922.pdf.AccessedJuly8,2011.

2. MulveyHJ,JewettEA,MerlineA,ToweyKJ.Pediatriciansover50reenteringclinicalpractice:
implicationsforphysiciansandtheregulatorycommunity.JournalofMedicalRegulation.
2010;96:712.

3. BowerEA,EnglishC,ChoiD,etal.Aneducationalinterventiontoreturnnonpracticing
physicianstoclinicalactivity:acasestudyinphysicianreentry.JournalofContinuingEducation
intheHealthProfessions.2010;30:8994.

4. VarjavandN.Physicianreentry:onewaytoaddressthephysicianshortage.PhysiciansNews
Digest[onlineedition].Availableat:http://www.physiciansnews.com/2010/08/12/physician
reentryonewaytoaddressthephysicianshortage/.AccessedMarch1,2011.


5. FreedGL,AbrahamLM,BrzoznowskiKF.Inactivephysicians:thestateofourunderstanding.J
Pediatr.2007;151:431434.

6. Jewett,EA,BrothertonSE,RuchRossH.AnationalsurveyofinactivephysicianintheUnited
StatesofAmerica:enticementstoreentry.HumanResourcesforHealth.2011;9:7.

7. ThePhysicianReentryintotheWorkforceProject.IssueBrief:ReentryBarriers.ElkGrove
Village,IL:AmericanAcademyofPediatrics;2010.Availableat:
http://www.physicianreentry.org/yahoo_site_admin/assets/docs/IssueBriefRe
EntryBarriers.23782515.pdf.AccessedJuly6,2011.

8. AmericanMedicalAssociation.Physicianreentrytotheworkforce:recommendationsfora
coordinatedapproach.Chicago,IL:AmericanMedicalAssociation;2010.Availableat
http://www.amaassn.org/ama1/pub/upload/mm/40/physicianreentry
recommendations.pdf.AccessedJuly8,2010.

Code of Ethics | APS 6/20/17, 9:24 PM

LOGIN

Funding
Membership Annual Meeting Education Opportunities Get Involved About Us

Code of Ethics Who's Who in APS

Organizational Structure
Preamble Strategic Plan
The American Pain Society strongly endorses the History of APS
view that the professional activities of its
Position Statements
members must be conducted in accordance with
Code of Ethics
the highest ethical standards. Given the diversity
of the membership, the standards advanced by Con=ict of Interest Policy
the Society must speci@cally address animal IASP
research, clinical research, and clinical practice. To
Newsroom
accomplish this, the Society recognizes the
valuable contributions of other professional Career Center
organizations whose published guidelines for Call for Volunteers
ethical practice may apply to a large segment of
the membership.

Reference is made to several documents below,


and they may be reviewed for a fuller exposition of
the ethical principles accepted by the American
Pain Society.

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Code of Ethics | APS 6/20/17, 9:24 PM

Ethical Principles Endorsed by


APS
Ethical Principles for Pain-Related
Animal Research
The American Pain Society endorses the ethical
guidelines for investigations of experimental pain
in conscious animals published by the
International Association for the Study of Pain and
the guidelines for the use of animals published by
the Society for Neuroscience. The fundamental
principle guiding both these documents is that
ethical animal research requires that the
investigator attempt to minimize pain and avoid
unnecessary distress or discomfort at all times.
The acquisition and care of experimental animals
should be performed in accordance with the
guidelines published by the National Institutes of
Health.

The American Pain Society is a national chapter of


the International Association for the Study of Pain.
The following guidelines, adopted by the
International Association for the Study of Pain, are
most relevant to the Society:

1. It is essential that the intended experiments on


pain in conscious animals be reviewed
beforehand by scientists and lay persons. The
potential bene@t of such experiments to our

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Code of Ethics | APS 6/20/17, 9:24 PM

understanding of pain mechanisms and pain


therapy needs to be shown. The investigator
should be aware of the ethical need for a
continuing justi@cation of his investigations.
2. If possible, the investigator should try the pain
stimulus on himself; this principle applies for
most noninvasive stimuli causing acute pain.
3. To make possible the evaluation of the levels of
pain, the investigator should give a careful
assessment of the animal's deviation from
normal behavior. To this end, physiological and
behavioral parameters should be measured.
The outcome of this assessment should be
included in the manuscript.
4. In studies of acute or chronic pain in animals,
measures should be taken to provide a
reasonable assurance that the animal is
exposed to the minimal pain necessary for the
purposes of the experiment.
5. An animal presumably experiencing chronic
pain should be treated for relief of pain, or
should be allowed to self-administer analgesic
agents or procedures, as long as this will not
interfere with the aim of the investigation.
6. Studies of pain in animals paralyzed with a
neuromuscular blocking agent should not be
performed without a general anesthetic or an
appropriate surgical procedure that eliminates
sensory awareness.
7. The duration of the experiment must be as
short as possible and the number of animals

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Code of Ethics | APS 6/20/17, 9:24 PM

involved kept to a minimum.

Ethical Principles for Pain-Related


Clinical Research
The ethics of research involving normal human
volunteers or patients have been clari@ed by
several international and national organizations.
The American Pain Society endorses the
principles enunciated by the World Medical
Association, the World Health Organization and
the Council for International Organizations of
Medical Sciences, the American College of
Physicians, and the American Psychological
Association.

Several of the principles included in these


documents are germane to pain-related research.
Each pain practitioner involved in pain-related
clinical research should observe the following
principles:

1. All planned clinical studies should be reviewed


by an independent committee on human
research prior to implementation. The
committee, which should include scientists,
healthcare practitioners, and lay persons,
should evaluate the risks inherent in the
research and the extent to which the
signi@cance of the potential results justi@es the
risks involved, even if minimal. The committee
also should ensure that potential subjects have
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Code of Ethics | APS 6/20/17, 9:24 PM

the opportunity to provide informed consent


prior to participation.
2. Informed consent implies that potential
subjects are fully apprised of the goals,
procedures, and risks of the study. Potential
subjects must be able to decline, and those who
consent must be able to withdraw prior to
completion, without any risk of penalty.
3. Those who may be incapable of giving fully
informed consent, including children and adults
who are not fully competent, should not be used
in pain research unless it is essential to the
goals of the experiment. In the latter
circumstance, consent must also be obtained
from an individual with legal responsibility for
the welfare of the subject.
4. In pain studies, the minimal intensity of noxious
stimulation necessary to the goals of the
experiment should be established beforehand
and not exceeded during the study. Subjects
should be able to stop the painful stimulus at
will. In research on clinical pain, the use of
placebos or sham treatments require that
alternative methods of pain relief be available to
those patients who require it.

Ethical Principles for Pain-Related


Clinical Practice
The American Pain Society believes that the
principles of medical ethics published by the
American Medical Association should apply to all

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Code of Ethics | APS 6/20/17, 9:24 PM

clinical disciplines engaged in pain therapy with


patients. The following principles have each been
altered so that the word physician has been
replaced by the phrase healthcare provider:

1. A healthcare provider shall be dedicated to


providing competent medical service with
compassion and respect for human dignity.
2. A healthcare provider shall deal honestly with
patients and colleagues, and strive to expose
those healthcare providers de@cient in
character and competence or who engage in
fraud or deception.
3. A healthcare provider shall respect the law and
also recognize a responsibility to seek changes
in those requirements which are contrary to the
best interests of the patient.
4. A healthcare provider shall respect the rights of
patients, of colleagues, and of other health
professionals, and shall safeguard patient
con@dences within the constraints of the law.
5. A healthcare provider shall continue to study;
apply and advance scienti@c knowledge; make
relevant information available to patients,
colleagues and the public; obtain consultations;
and use the talents of other health
professionals when indicated.
6. A healthcare provider, in the provision of
appropriate patient care, except in emergencies,
shall be free to choose whom to serve, with
whom to associate, and the environment in

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Code of Ethics | APS 6/20/17, 9:24 PM

which to provide healthcare services.


7. A healthcare provider shall recognize a
responsibility to participate in activities
contributing to an improved community.

8735 W. Higgins Road, Suite 300,


Chicago, IL 60631

847.375.4715
CAREER CENTER
info@americanpainsociety.org
NEWSROOM

2017 American Pain Society Privacy Policy

http://americanpainsociety.org/about-us/code-of-ethics/overview Page 7 of 7
Physician Reentry into Clinical Practice:
Regulatory Challenges
...........................................

Gretchen P. Kenagy, Ph.D.


Senior Research Associate, Undergraduate Medical Education, American Medical Association

Barbara S. Schneidman, M.D., M.P.H.


Clinical Professor, Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine

Barbara Barzansky, Ph.D., M.P.H.E.


Director, Undergraduate Medical Education, American Medical Association

Claudette E. Dalton, M.D.


Emeritus Faculty, Anesthesiology and Medical Education, University of Virginia School of Medicine

Carl A. Sirio, M.D.


Professor, Drexel University School of Medicine

Susan E. Skochelak, M.D., M.P.H.


Vice President, Medical Education, American Medical Association

A B S T R A C T : Physician reentry to clinical practice is fast becoming recognized as an issue of central


importance in discussions about the physician workforce. While there are few empirical studies, existing
data show that increasing numbers of physicians take a leave of absence from practice at some point during
their careers; this trend is expected to continue. The process of returning to clinical practice is coming
under scrutiny due to the publics increasing demand for transparency regarding physician competence.
Criteria for medical licensure often do not include an expectation of ongoing clinical activity. Physicians
who maintain a license but do not practice for a period of time, therefore, may be reentering the workforce
with unknown competency to practice. This paper: (1) presents survey data on current physician reentry
policies of state medical boards; (2) discusses the findings from the survey within the context of regulatory
challenges that impact physician-reentry; and (3) offers recommendations to facilitate the development
of comprehensive, coordinated regulatory policies on physician reentry.
Keywords: physician reentry, state medical and osteopathic boards, regulation, physician reentry policy,
competence, licensure, workforce

Introduction Consumer groups such as the American Association


Physician reentry is defined by the American Medical of Retired Persons (AARP) and the Citizens Advocacy
Association as: A return to clinical practice in the Center (CAC) as well as the medical profession
discipline in which one has been trained or certified itself have called for tying re-licensure to evidence
following an extended period of clinical inactivity not that physicians possess the requisite knowledge
resulting from discipline or impairment.1 Reentering and skills to practice. Both undergraduate and
physicians leave clinical practice voluntarily and as graduate medical education is increasingly struc-
such are distinct from remediating physicians, who tured around the demonstration of a series of
have demonstrated deficiencies in physician per- competencies. Maintenance of Certification (MOC)
formance. Further, reentering physicians return to and the newly proposed Maintenance of Licensure
the field of practice which they left and, thus, are (MOL) are reflections of this emphasis on continu-
different from physicians who are retraining in ous competency assessment.
order to move into a new area of clinical practice.1
Currently, all of these activities are directed at physi-
Physician reentry is a concept that may be poorly
cians who are actively practicing medicine. However,
understood by many practitioners.
regulators recognize that physicians who have been
A number of factors are driving a new emphasis away from clinical practice and seek to return must be
on lifelong evidence of physician competence and included as well. In this new environment of increased
assessment of performance in medical practice. focus on physician competence and assessment of

10 | J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 7 , N O 1 2011 Federation of State Medical Boards


performance, physicians returning to clinical practice challenge, wish to help fulfill community needs
after a hiatus pose unique challenges for state or simply have too much free time.7
medical licensing boards, whose primary objective
There is little data on whether physicians who
is public protection.2
return to clinical practice undergo assessment
As the new focus on competence assessment con- of their knowledge, skills and training and/or
tinues to develop, state boards will need to shape education before returning to patient care
systems that effectively address the performance activities. One study found, however, that among
of both practicing physicians and those who wish to 107 reentering pediatricians, 79 percent did
reenter medicine after an extended absence. As a not undergo training before returning to care for
starting point in this process, a better understanding patients.5,8 While more studies are needed on, for
is needed of how state boards currently address example, the relationship between time away from
physician reentry. practice and the need for training prior to reentry,
the ability of physicians to move in and out
This paper addresses that need by (1) presenting
of practice without oversight by state medical
survey data on current physician reentry polices
licensing boards is a limitation of the current
of state medical licensing boards; (2) discussing
medical regulatory process.
the findings from the survey within the context
of physician reentry regulatory challenges; and The status of a physicians medical licensure is
(3) offering recommendations to facilitate the develop- a key factor in the reentry process. Physicians
ment of comprehensive, coordinated regulatory with an active license have more options, as most
policies on physician reentry. are not required by medical boards to disclose
their clinical activity during the licensure renewal
Background process. One study found only about one-third of
The careers of todays physicians look markedly dif- medical licensing boards (N = 64) asked physi-
ferent from those of previous generations. The belief cians about their clinical activity status both at
that successful physicians must sacrifice personal initial licensure and at renewal.9 According to the
lives for their profession is giving way to an unprec- authors of the study, the majority of boards in the
edented desire by both male and female physicians United States allow physicians to hold and renew
for a work-life balance.3 Physicians may expect to an unrestricted active license to practice medicine,
take time away from practice at some point during although they may not have cared for a patient in
years.9 However, the options of physicians without
an active license are much more limited. To return
I N T H I S N E W E N V I RO N M E N T O F I N C R EA S E D to practice, they must contact their state medical
F O C US ON P HYS I C I A N CO M P E T E N C E A N D licensing board, which will direct their steps toward
reentry. The lack of regulatory precedent for
AS S ES S M E N T O F P E R FO R M ANC E , P H YS I CI A N S
reentering physicians, including licensure and
RETURNING TO CLINIC AL PRACTICE AFTER credentialing requirements, is a major challenge for
A H I AT U S P O S E U N I Q U E C H A L L E N G E S F O R state medical licensing boards and, ultimately, for
S TAT E M E D I C A L L I C E N S I N G BOA R D S . physicians without an active medical license.10
Despite the flexibility afforded physicians with
active medical licenses, successful return to
their careers for reasons that include family leave
clinical practice can be a difficult journey. Lack
(maternity/paternity leave, child rearing); caretaking
of consistency across jurisdictions in regulatory
and personal-relationships issues; health issues;
requirements, including licensure, is a significant
career dissatisfaction; pursuit of alternate careers,
barrier. The growing importance of physician
such as administration or military service; and
reentry as a workforce issue means that state
humanitarian leave.47
medical licensing boards will increasingly need to
Physicians may seek reentry to clinical practice address competency and patient safety for
for a variety of reasons. Often they return when physicians in active practice, and for physicians
their need to care for family is no longer pressing who do not actively provide patient care throughout
or when they have overcome a health issue. Some their careers, as well. Boards will need to do
physicians return because they miss the practice this in the midst of increasing calls for transparency
of medicine, have financial needs, want a new in the regulatory process.

2011 Federation of State Medical Boards J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 7 , N O 1 | 11


In response, regulatory bodies are moving away physician reentry policy. The most recent survey
from requiring physicians to demonstrate sufficient was sent to 64 State Boards of Allopathic and
knowledge and skills at just one point in time, and Osteopathic Medical Examiners in the U.S.; medical
are beginning to embrace the concept of requiring boards in U.S. territories were excluded. Fifty-nine
assessment as part of relicensure a process of the 64 medical boards responded to the survey,
known as Maintenance of Licensure (MOL).11 The for a response rate of 92 percent.
Federation of State Medical Boards (FSMB) has
A summary of the aggregate findings in the 2010
been working on a process for MOL since 2003,
survey for the questions related to physician reentry
including conducting a study on the role of state
is presented here. The findings represent a snap-
medical boards in ensuring continued competence
shot of specific physician reentry-related regulations
among physicians and the development of recom-
and procedures among these medical boards.
mendations for use by state medical boards.
The FSMB defines MOL as the process by which
Physician reentry policy
a licensee demonstrates that he/she has main-
The survey asked Does your board have a policy
tained his or her competence and qualifications for
on physician reentry (as defined by the AMA) for
purposes of continued licensure.12
physicians who have left the active practice of
The three components of MOL are: (1) reflective self medicine and want to reenter practice? Thirty
assessment; (2) assessment of knowledge and skills; (51 percent) of the responding medical boards
and (3) performance in practice.1112 Of particular agreed that they have a policy on physician reentry.
relevance to physician reentry is component 3, Of the 29 medical boards without a physician
performance in practice, which states that physicians reentry policy, 16 (55 percent) are either currently
developing or planning to develop a policy. Put
another way, out of the 59 medical boards in this
AS TH E N E W FO C U S O N C O M P E T E N C E sample, 78 percent have, are developing, or are
AS S ES S M E N T CO N T I N U E S TO D E V E L OP, planning to develop a policy on physician reentry.
S TAT E BOA R DS WI L L N E E D TO S H AP E
Length of time out of practice
SYS TE M S T HAT E FFE C T I V E LY A D D RE S S T H E
The 30 medical boards with a physician reentry
PE RF O R M AN C E O F B OT H P R AC T I C I N G policy were asked What is the length of time out of
PH YS I C I A N S A N D T HO S E W HO W I S H TO practice after which your board requires reentering
RE E N TE R M E D I C I N E . physicians to complete a reentry program? Among
the 25 medical boards that responded to the
question, the average length of time was 2.8 years
must demonstrate accountability for performance and ranged from 1 to 10 years. The modal (most
in their practice using a variety of methods that common) response was 2 years.
incorporate reference data to assess their performance
in practice and guide improvement.12 This component Patient care requirements for relicensure
of the proposed framework for MOL indicates that All of the medical boards were asked Does your
physicians must have ongoing involvement in patient board require a physician to engage in a certain
care a difficult, if not impossible, requirement for amount of patient care for relicensure? The vast
reentering physicians. majority of medical boards (92 percent) do not.
State medical licensing boards have a responsibility
Data collection on reentry
to assure the public that physicians possess the
Medical boards were asked Are you keeping
requisite knowledge and skills to practice medicine
records on the number of physicians the board
and, thus, will likely have the authority to establish
considered for reentry? Most (90 percent) medical
MOL requirements.12
boards are not collecting this information.
State medical licensure requirements and statistics: Among the six that do keep records on the num-
data on physician reentry into practice ber of physicians considered for reentry, five were
The AMA annually publishes the State Medical allopathic boards and five had reentry policies. One
Licensure Requirements and Statistics, which board that did not have a reentry policy is keeping
is based on a survey that includes questions on records and plans to develop a policy.

12 | J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 7 , N O 1 2011 Federation of State Medical Boards


Discussion may add further confusion. Findings from a study of
Approximately three quarters of state medical licens- the relationship between the volume of procedures
ing boards who responded to the survey either have practiced by physicians and medical outcomes show
a reentry policy or are in the process of developing that the less a procedure is practiced, the greater
or planning to develop one. This is an indication of the likelihood of complication.15 In a systematic
the growing importance of physician reentry within review of the medical literature to study the relation-
medicine and the recognition by boards of medicine ship between experience in caring for patients and
of the need to address the issue. Boards of performance quality, it was concluded that physicians
medicine seem to be developing physician reentry who have been in practice longer have less factual
policies and processes independent of one another; knowledge then their less-experienced counterparts
the scope and direction of these policies remain even after adjusting for patient volume.16
unclear. An unintended consequence of a lack of
The explanation for the results of the latter study,
consistency among state medical licensing boards
however, may, in fact, have implications for reentering
may be increased difficulty for physicians to reen-
physicians who are also in need of updating their
ter clinical practice, particularly if physicians have
knowledge and skills. With changes in technology
moved from one state to another during their time
and an increase in the volume of medical infor-
away from practice or are participating in reentry
mation, there is a growing need for regulation to
programs in a state other than their own.
assess competency so that patient safety and
There is little comprehensive information about quality of care are ensured.11,1617 Access to current
the decay rate of specific areas of knowledge and medical knowledge, including changing technologies,
skill. Thus, a physicians need to update his or her must be factored into physician reentry policies
knowledge, skills and practice prior to reentry that address education and training.
is not clearly defined. This is important information
While not all physicians may need to update their
for medical licensing boards as they address
skills before reentering practice, the current structure
policies concerning reentry. The assumption that a
of the licensure system may be preventing medical
physician who has been away from clinical practice
regulatory bodies from making that assessment.
needs to update his or her knowledge and skills
Studies are needed on how time spent away from
may be particularly true for medical specialties that
clinical practice affects the clinical skills of physicians
rely heavily on technology. It is important to note,
and, ultimately, the quality of care. In addition to
however, that while this makes sense intuitively, no
studies have been conducted to test this assump-
tion across specialties and practice areas. T H E BE L I E F T HAT S UCCE S S F UL P H YS I CI A N S

Further, studies are needed that would help determine M US T S ACR I F I CE P E R S ON A L L I V E S F OR


the cut-off point after which a physicians knowl- T H E I R P ROF E S S I ON I S G I V I N G WAY TO A N
edge and/or skills in a particular area deteriorate. UN P R EC E D E N TE D D E S I R E BY B OT H
Our findings show that on average, medical boards M A L E A N D F E M AL E P H YS I CI A N S F OR A
require reentering physicians to participate in
WO R K - L I F E B AL A N CE .
education and training (in the form of a physician
reentry program) after they have been away from
practice for close to three years. However, leading guiding state medical boards, these data could
medical organizations such as the FSMB and the potentially be used to develop and refine reentry
American Board of Medical Specialties (ABMS), program curricula and assessment methods.
have recommended a two-year time limit.1314 The
States vary in their definition and criteria for
fact that the time after which a physician should
maintaining an active medical license. According
be mandated to participate in a formal reentry
to our findings, most (92 percent) state medical
process 1 to 10 years varies so widely perhaps
boards do not require a specified amount of patient
best illustrates the difficulty state medical boards
care for relicensure. To date, this has allowed
are experiencing when making this determination
physicians who take a hiatus from clinical practice
without adequate evidence.
to maintain an active license.
Literature intended to inform the decisions by medical
MOL, if implemented, will present challenges,
licensing boards of when reentering physicians
but also opportunities, for the physician reentry
should receive additional education and training

2011 Federation of State Medical Boards J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 7 , N O 1 | 13


process. The new requirement could lead to better including performance in practice, for inactive
data collection on physician engagement in practice, physicians. We offer the following recommenda-
including data on physicians who do not actively tions as a step toward meeting these challenges.
participate in patient care. Our findings show that
the majority (90 percent) of medical boards are not Recommendations for developing regulatory
collecting information on physician reentry. It is policies on reentry
anticipated that there will be an influx of reentering The recommendations are a product of a 2010
physicians who will come to the attention of boards conference titled Physician Reentry to Clinical
Practice: Overcoming Regulatory Challenges Confer-
ence, sponsored by the AMA and in collaboration
B OAR D S O F M E D I C I N E S E E M TO BE
with the FSMB and American Academy of Pediatrics
D E V E L O P IN G P HYS I C I A N RE E N T RY P OL I CI E S (AAP). The overall goal of these recommendations
AN D PRO CE S S E S I N D E P E N D E N T O F O N E is to ensure that there is a comprehensive, trans-
AN OT H E R ; T HE S C O P E A N D D I R EC T I O N O F parent, and feasible regulatory process that also
ensures public safety for use with physicians who
TH E SE PO L I C I ES R E M A I NS U N CL E A R .
desire to return to clinical practice. The recommen-
dations are designed for medical licensing boards to
of medicine if, for example, performance in consider as they develop and implement physician
practice is implemented. The new requirement reentry policies. For the purposes of this discussion,
will change the trajectory to reentry for physicians only the recommendations from the conference
who have maintained active licenses as they pertinent to regulatory issues are included. (The
will now have to be accountable to medical boards. complete set of conference recommendations
is available online at http://www.ama-assn.org/
The licensure renewal process could include
resources/doc/med-ed-products/physician-reentry-
data collection of the number of patient hours
recommendations.pdf.)
physicians spend providing clinical care to patients.
Physicians who have been out of clinical practice, The recommendations suggest that development
but who have maintained licenses, may not be of a physician reentry regulatory process should be
able to resume practice without first demonstrating comprehensive and inclusive, involving relevant stake-
outcomes from clinical practice as part of MOL holder-groups, and it should have the following goals:
component 3, performance in practice. This may
1) Develop an understanding of the expectations
place reentering physicians at a disadvantage,
and needs relevant stakeholder groups
particularly if they have been out of practice for a
including physicians, patients, regulators, and the
significant period of time. An unintended conse-
public have for a physician reentry system.
quence of performance in practice requirements
may be that reentry physicians are at risk of losing 2) Develop physician reentry policy guidelines
their active license. across state medical licensing jurisdictions
that are consistent and evidence-based.
Increased visibility of physicians desiring and
These guidelines should clarify:
achieving reentry is an opportunity for medical
licensing boards to collect much-needed information U/ii}vi>>vVV>
to gain a better understanding of the physician practice which necessitates participating
reentry population as a whole. A clearer under- in a reentry process;
standing of these physicians will benefit medical
U/i`iwvVii
boards in developing reentry policies that result
in clinical care constitutes active clinical
in the return of physicians who provide competent
practice and the clinical practice requirements
care to patients.
for maintaining licensure; and
In sum, medical boards face many challenges to
U/i>VvviV>L>`
developing physician reentry regulatory policies
certification on maintenance of licensure.
including (1) lack of consistency in state medical
licensing laws and regulations; (2) lack of a 3) Establish mechanisms to permit reentering
coordinated database on reentering physicians physicians to engage in clinical practice
and physicians needing a reentry process; and under supervision as they participate in a
(3) issues related to maintenance of licensure, reentry program.

14 | J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 7 , N O 1 2011 Federation of State Medical Boards


These include: References
1. American Medical Association. Physician reentry. Available
Uii`V>V]}>`>ii`V>
at: http://www.ama-assn.org/ama1/pub/upload/mm/377/
education program, teaching hospital and cmerpt_6a-08.pdf. Accessed October 18, 2010.
medical home, as well as non-traditional sites 2. Law MT, Hansen ZK. Medical licensing board characteristics
such as mental health hospitals and nursing and physician discipline: An empirical analysis. J Health Polit
homes) that provides reentering physicians Policy Law. 2010;35(1):63-93.
with opportunities for supervised clinical 3. Keeton K, Fenner DE, Johnson RB, Hayward RA. Predictors of
practice in their previous clinical fields; physician career satisfaction, work-life balance, and burnout.
Obstet Gynecol. 2007;109(4):949-955.
U>Vi`i>}Vii>} 4. Mark S, Gupta J. Reentry into clinical practice. JAMA.
reentry program participants to work under 2002;288(9):1091-1096.
supervision; and 5. Mulvey H, Jewett E. Physician reentry into the workforce.
Available at: http://www.physicianreentry.org/yahoo_site_
U->ii`V>Vi}L>`i>L} admin/assets/docs/Reentry_Web_5-08.307134631.ppt.
a non-disciplinary licensure status option Accessed September 23, 2010.
for reentering physicians during their reentry 6. Grace ES, Korniek EJ, Weitzel LB, Wentz DK. Physicians
education and training. reentering clinical practice: Characteristics and clinical
abilities. J Cont Ed in Health Prof. 2010;30(3):180-186.
4) State medical licensing boards and medical 7. Adams KE, Allen R, Cain JM. Physician reentr y:
societies should develop a process for a A concept whose time has come. Obstetric Gynecol.
certificate of program completion that meets 008;111(5):1195-1198.
the need to document physician competency 8. Mulvey H, Jewett EA, Merline A, Towey KJ. Pediatricians over
to return to practice. 50 reentering clinical practice: Implications for physicians and
the regulatory community. J Med Licensure and Regulation.
5) Study the feasibility of introducing alternate 2010;96(2):7-12.
licensure tracks for reentering physicians that 9. Freed GL, Dunham KM, Abraham L. Protecting the public:
allow a limited scope of practice. State medical board licensure policies for active and inactive
physicians. Pediatrics. 2009;123:643-652.
6) Establish a national physician reentry database to: 10. Bower EA, English C, Choi D, Cedfeldt AS, Girard DE.
Education to return nonpracticing physicians to clinical
U*`i}>>Vv>iii} activity: A case study in physician reentry. J Cont Ed in
physicians; and Health Prof. 2010;30(2):89-94.
11. Chaudhry HJ, Rhyne J, Cain FE, Young A, Crane M, Bush F.
U/>Vi`ii]V>Li Maintenance of licensure: Protecting the public, promoting
of reentering physicians, program costs quality health care. J Med Licensure and Regulation.
and outcomes. 2010;96(2):13-20.
12. Federation of State Medical Boards. Board Report 10-3:
Addressing the regulatory challenges of physician Maintenance of Licensure. Available at: http://www.fsmb.org/
reentry through a comprehensive process is pdf/mol-board-report-1003.pdf. Accessed October 13, 2010.
necessary to demonstrate to the public and to 13. Federation of State Medical Boards. Special committee
employers that reentering physicians are competent to address regulation of reentry to practice. Newsline
to provide quality care to patients upon their return (May/June 2010). http://www.fsmb.org/pdf/pub-nl-may-
june-2010.pdf. Accessed December 29, 2010.
to clinical practice and to fulfill the high practice
standards of the medical profession. To achieve 14. American Board of Medical Specialties (ABMS). Clinically
active terms redefined in a push for clarity in reporting.
this standard, it will be necessary for physician Available at: http://www.abms.org/News_and_Events/
reentry stakeholders including medical regulators, news_archive/release_ClinicalActivityStatus_12_07.aspx.
medical associations, physician reentry programs, Accessed November 8, 2010.
researchers and reentry physicians to work 15. Freemen JV, Wang Y, Curtis JP, Heidenreich PA, Hlatky
collaboratively. The above recommendations, MA. The relation between hospital procedure volume and
complications of cardioverter-defibrillator implantation from
informed by data from state medical boards and the implantable cardioverter-defibrillator registry. J Am Coll
input from reentry stakeholders, address physician Cardiol. 2010;56(14):1133-1139.
reentry challenges including the need for increased 16. Choudhry NK, Fletcher RH, Soumerai SB. Systematic review:
consistency across state medical boards. These The relationship between clinical experience and quality of
recommendations serve as a mechanism to develop health care. Ann Intern Med. 2005;142:260-273.

relevant, effective policies to return reentry 17. Institute of Medicine. To Err is Human: Building a Safer
Health System. Kohn LT, Corrigan JM, Donaldson MS. Eds.
physicians to providing high-quality care for patients.
Washington, D.C.: National Academy Press, 2000.

2011 Federation of State Medical Boards J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 7 , N O 1 | 15


GUIDELINES FOR THE ETHICAL PRACTICE OF ANESTHESIOLOGY
Committee of Origin: Ethics
(Approved by the ASA House of Delegates on October 15, 2003, and last amended on
October 22, 2008)

PREAMBLE
Membership in the American Society of Anesthesiologists is a privilege of physicians who are
dedicated to the ethical provision of health care. The Society recognizes the Principles of Medical
Ethics of the American Medical Association (AMA) as the basic guide to the ethical conduct of its
members.
AMA Principles of Medical Ethics (2001)
The medical profession has long subscribed to a body of ethical statements developed primarily
for the benefit of the patient. As a member of this profession, a physician must recognize
responsibility to patients first and foremost, as well as to society, to other health professionals and
to self. The following Principles adopted by the American Medical Association are not laws but
standards of conduct which define the essentials of honorable behavior for the physician.
I. A physician shall be dedicated to providing competent medical care with compassion and
respect for human dignity and rights.
II. A physician shall uphold the standards of professionalism, be honest in all professional
interactions, and strive to report physicians deficient in character or competence, or
engaging in fraud or deception to appropriate entities.
III. A physician shall respect the law and also recognize a responsibility to seek changes in those
requirements which are contrary to the best interests of the patient.
IV. A physician shall respect the rights of patients, colleagues and other health professionals
and shall safeguard patient confidences and privacy within the constraints of the law.
V. A physician shall continue to study, apply and advance scientific knowledge, maintain a
commitment to medical education, make relevant information available to patients,
colleagues and the public, obtain consultation, and use the talents of other health
professionals when indicated.
VI. A physician shall, in the provision of appropriate patient care except in emergencies, be free
to choose whom to serve, with whom to associate and the environment in which to provide
medical care.
VII. A physician shall recognize a responsibility to participate in activities contributing to
improvement of the community and betterment of public health.
VIII. A physician shall, while caring for a patient, regard responsibility to the patient as
paramount.
IX. A physician shall support access to medical care for all people.

The practice of anesthesiology involves special problems relating to the quality and standards of
patient care. Therefore, the Society requires its members to adhere to the AMA Principles of
Medical Ethics and any other specific ethical guidelines adopted by this Society.
GUIDELINES FOR THE ETHICAL PRACTICE OF ANESTHESIOLOGY
ASA ETHICAL GUIDELINE
There may be specific circumstances when elements of the following guidelines may not apply and
wherein individualized decisions may be appropriate.
I. Anesthesiologists have ethical responsibilities to their patients.
1. The patient-physician relationship involves special obligations for the physician that
include placing the patients interests foremost, faithfully caring for the patient and being
truthful.
2. Anesthesiologists respect the right of every patient to self-determination.
Anesthesiologists should include patients, including minors, in medical decision-making
that is appropriate to their developmental capacity and the medical issues involved.
Anesthesiologists should not use their medical skills to restrain or coerce patients who
have adequate decision-making capacity.
3. Anesthetized patients are particularly vulnerable, and anesthesiologists should strive to
care for each patients physical and psychological safety, comfort and dignity.
Anesthesiologists should monitor themselves and their colleagues to protect the
anesthetized patient from any disrespectful or abusive behavior.
4. Anesthesiologists should keep confidential patients medical and personal information.
5. Anesthesiologists should provide preoperative evaluation and care and should facilitate the
process of informed decision-making, especially regarding the choice of anesthetic
technique.
6. If responsibility for a patients care is to be shared with other physicians or nonphysician
anesthesia providers, this arrangement should be explained to the patient. When directing
non-physician anesthesia providers, anesthesiologists should provide or ensure the same
level of preoperative evaluation, care and counseling as when personally providing these
same aspects of anesthesia care. Anesthesiologists should be guided by the most recently
adopted ASA Statement on the Anesthesia Care Team.
7. When directing nonphysician anesthesia providers or physicians in training in the actual
delivery of anesthetics, anesthesiologists should remain personally and continuously
available for direction and supervision during the anesthetic; they should directly
participate in the most demanding aspects of the anesthetic care.
8. Anesthesiologists should provide for appropriate postanesthetic care for their patients.
9. Anesthesiologists should not participate in exploitive financial relationships.
10. Anesthesiologists share with all physicians the responsibility to provide care for patients
irrespective of their ability to pay for their care. Anesthesiologists should provide such
care with the same diligence and skill as for patients who do pay for their care.
II. Anesthesiologists have ethical responsibilities to medical colleagues.
1. Anesthesiologists should promote a cooperative and respectful relationship with their
professional colleagues that facilitates quality medical care for patients. This
responsibility respects the efforts and duties of other care providers including physicians,
medical students, nurses, technicians and assistants.
2. Anesthesiologists should provide timely medical consultation when requested and should
seek consultation when appropriate.
GUIDELINES FOR THE ETHICAL PRACTICE OF ANESTHESIOLOGY
3. Anesthesiologists should cooperate with colleagues to improve the quality, effectiveness
and efficiency of medical care.
4. Anesthesiologists should advise colleagues whose ability to practice medicine becomes
temporarily or permanently impaired to appropriately modify or discontinue their practice.
They should assist, to the extent of their own abilities, with the re-education or
rehabilitation of a colleague who is returning to practice.
5. Anesthesiologists should not take financial advantage of other physicians, nonphysician
anesthesia providers or staff members. Verbal and written contracts should be honest and
understandable, and should be respected.
III. Anesthesiologists have ethical responsibilities to the health care facilities in which they
practice.
1. Anesthesiologists should serve on health care facility or specialty committees. This
responsibility includes making good faith efforts to review the practice of colleagues and
to help develop departmental or health care facility procedural guidelines for the benefit of
the health care facility and all of its patients.
2. Anesthesiologists share with all medical staff members the responsibility to observe and
report to appropriate authorities any potentially negligent practices or conditions which
may present a hazard to patients or health care facility personnel.
3. Anesthesiologists personally handle many controlled and potentially dangerous
substances and, therefore, have a special responsibility to keep these substances secure
from illicit use. Anesthesiologists should work within their health care facility to develop
and maintain an adequate monitoring system for controlled substances.
IV. Anesthesiologists have ethical responsibilities to themselves.
1. The achievement and maintenance of competence and skill in the specialty is the primary
professional duty of all anesthesiologists. This responsibility does not end with
completion of residency training or certification by the American Board of
Anesthesiology.
2. The practice of quality anesthesia care requires that anesthesiologists maintain their
physical and mental health and special sensory capabilities. If in doubt about their health,
then anesthesiologists should seek medical evaluation and care. During this period of
evaluation or treatment, anesthesiologists should modify or cease their practice.
V. Anesthesiologists have ethical responsibilities to their community and to society.
1. An anesthesiologist shall recognize a responsibility to participate in activities contributing
to an improved community.
2. An anesthesiologist who serves as an expert witness in a judicial proceeding shall possess
the qualifications and offer testimony in conformance with the ASA Guidelines for
Expert Witness Qualifications and Testimony.
GUIDELINES FOR THE ETHICAL PRACTICE OF ANESTHESIOLOGY
Committee of Origin: Ethics
(Approved by the ASA House of Delegates on October 15, 2003, last amended on
October 19, 2011, and reaffirmed on October 16, 2013)

PREAMBLE
Membership in the American Society of Anesthesiologists is a privilege of physicians who are
dedicated to the ethical provision of health care. The Society recognizes the Principles of Medical
Ethics of the American Medical Association (AMA) as the basic guide to the ethical conduct of its
members.
AMA Principles of Medical Ethics (2001)
The medical profession has long subscribed to a body of ethical statements developed primarily
for the benefit of the patient. As a member of this profession, a physician must recognize
responsibility to patients first and foremost, as well as to society, to other health professionals and
to self. The following Principles adopted by the American Medical Association are not laws but
standards of conduct which define the essentials of honorable behavior for the physician.
I. A physician shall be dedicated to providing competent medical care with compassion and
respect for human dignity and rights.
II. A physician shall uphold the standards of professionalism, be honest in all professional
interactions, and strive to report physicians deficient in character or competence, or
engaging in fraud or deception to appropriate entities.
III. A physician shall respect the law and also recognize a responsibility to seek changes in those
requirements which are contrary to the best interests of the patient.
IV. A physician shall respect the rights of patients, colleagues and other health professionals
and shall safeguard patient confidences and privacy within the constraints of the law.
V. A physician shall continue to study, apply and advance scientific knowledge, maintain a
commitment to medical education, make relevant information available to patients,
colleagues and the public, obtain consultation, and use the talents of other health
professionals when indicated.
VI. A physician shall, in the provision of appropriate patient care except in emergencies, be free
to choose whom to serve, with whom to associate and the environment in which to provide
medical care.
VII. A physician shall recognize a responsibility to participate in activities contributing to
improvement of the community and betterment of public health.
VIII. A physician shall, while caring for a patient, regard responsibility to the patient as
paramount.
IX. A physician shall support access to medical care for all people.

1
The practice of anesthesiology involves special problems relating to the quality and standards of
patient care. Therefore, the Society requires its members to adhere to the AMA Principles of
Medical Ethics and any other specific ethical guidelines adopted by this Society.

ASA ETHICAL GUIDELINE


There may be specific circumstances when elements of the following guidelines may not apply and
wherein individualized decisions may be appropriate.
I. Anesthesiologists have ethical responsibilities to their patients.
1. The patient-physician relationship involves special obligations for the physician that
include placing the patients interests foremost, faithfully caring for the patient and being
truthful.
2. Anesthesiologists respect the right of every patient to self-determination.
Anesthesiologists should include patients, including minors, in medical decision-making
that is appropriate to their developmental capacity and the medical issues involved.
Anesthesiologists should not use their medical skills to restrain or coerce patients who
have adequate decision-making capacity.
3. Anesthetized patients are particularly vulnerable, and anesthesiologists should strive to
care for each patients physical and psychological safety, comfort and dignity.
Anesthesiologists should monitor themselves and their colleagues to protect the
anesthetized patient from any disrespectful or abusive behavior.
4. Anesthesiologists should keep confidential patients medical and personal information.
5. Anesthesiologists should provide preoperative evaluation and care and should facilitate the
process of informed decision-making, especially regarding the choice of anesthetic
technique.
6. If responsibility for a patients care is to be shared with other physicians or nonphysician
anesthesia providers, this arrangement should be explained to the patient. When directing
non-physician anesthesia providers, anesthesiologists should provide or ensure the same
level of preoperative evaluation, care and counseling as when personally providing these
same aspects of anesthesia care. Anesthesiologists should be guided by the most recently
adopted ASA Statement on the Anesthesia Care Team.
7. When directing nonphysician anesthesia providers or physicians in training in the actual
delivery of anesthetics, anesthesiologists should remain personally and continuously
available for direction and supervision during the anesthetic; they should directly
participate in the most demanding aspects of the anesthetic care.
8. Anesthesiologists should provide for appropriate postanesthetic care for their patients.
9. Anesthesiologists should not participate in exploitive financial relationships.
10. Anesthesiologists share with all physicians the responsibility to provide care for patients
irrespective of their ability to pay for their care. Anesthesiologists should provide such
care with the same diligence and skill as for patients who do pay for their care.

2
II. Anesthesiologists have ethical responsibilities to medical colleagues.
1. Anesthesiologists should promote a cooperative and respectful relationship with their
professional colleagues that facilitates quality medical care for patients. This
responsibility respects the efforts and duties of other care providers including physicians,
medical students, nurses, technicians and assistants.
2. Anesthesiologists should provide timely medical consultation when requested and should
seek consultation when appropriate.
3. Anesthesiologists should cooperate with colleagues to improve the quality, effectiveness
and efficiency of medical care.
4. Anesthesiologists should advise colleagues whose ability to practice medicine becomes
temporarily or permanently impaired to appropriately modify or discontinue their practice.
They should assist, to the extent of their own abilities, with the re-education or
rehabilitation of a colleague who is returning to practice.
5. Anesthesiologists should not take financial advantage of other physicians, nonphysician
anesthesia providers or staff members. Verbal and written contracts should be honest and
understandable, and should be respected.
III. Anesthesiologists have ethical responsibilities to the health care facilities in which they
practice.
1. Anesthesiologists should serve on health care facility or specialty committees. This
responsibility includes making good faith efforts to review the practice of colleagues and
to help develop departmental or health care facility procedural guidelines for the benefit of
the health care facility and all of its patients.
2. Anesthesiologists share with all medical staff members the responsibility to observe and
report to appropriate authorities any potentially negligent practices or conditions which
may present a hazard to patients or health care facility personnel.
3. Anesthesiologists personally handle many controlled and potentially dangerous
substances and, therefore, have a special responsibility to keep these substances secure
from illicit use. Anesthesiologists should work within their health care facility to develop
and maintain an adequate monitoring system for controlled substances.
IV. Anesthesiologists have ethical responsibilities to themselves.
1. The achievement and maintenance of competence and skill in the specialty is the primary
professional duty of all anesthesiologists. This responsibility does not end with
completion of residency training or certification by the American Board of
Anesthesiology.
2. The practice of quality anesthesia care requires that anesthesiologists maintain their
physical and mental health and special sensory capabilities. If in doubt about their health,
then anesthesiologists should seek medical evaluation and care. During this period of
evaluation or treatment, anesthesiologists should modify or cease their practice.

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V. Anesthesiologists have ethical responsibilities to their community and to society.
1. An anesthesiologist shall recognize a responsibility to participate in activities contributing
to an improved community.
2. An anesthesiologist who serves as an expert witness in a judicial proceeding shall possess
the qualifications and offer testimony in conformance with the ASA Guidelines for
Expert Witness Qualifications and Testimony.
3. An anesthesiologist shall not engage in misconduct in research and/or publication.

4
BYLAWS AND RULES
OF THE MEDICAL STAFF

VETERANS HEALTH ADMINISTRATION (VHA)

THE WILLIAM S. MIDDLETON MEMORIAL


VETERANS HOSPITAL & CLINICS

MADISON, WISCONSIN

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Table of Contents
PREAMBLE 1
DEFINITIONS 1
ARTICLE I. NAME 4
ARTICLE II. PURPOSE 4
ARTICLE III. MEDICAL STAFF MEMBERSHIP 5
Section 3.01 Eligibility for Membership on the Medical Staff 5
Section 3.02 Qualifications for Medical Staff Membership and Clinical Privileges 6
Section 3.03 Code of Conduct 7
ARTICLE IV. ORGANIZATION OF THE MEDICAL STAFF 9
Section 4.01 Leaders 9
Section 4.02 Leadership 10
Section 4.03 Clinical Services 10
ARTICLE V. MEDICAL STAFF COMMITTEES 13
Section 5.01 General 13
Section 5.02 Executive Committee of the Medical Staff 13
Section 5.03 Committees of the Medical Staff 15
Section 5.04 Committee Records and Minutes 20
Section 5.05 Establishment of Committees 20
ARTICLE VI. MEDICAL & SERVICE-LEVEL STAFF MEETINGS 20
ARTICLE VII. APPOINTMENT AND ONGOING CREDENTIALING 21
Section 7.01 General Provisions 21
Section 7.02 Application Procedures 23
Section 7.03 Process and Terms of Appointment 25
Section 7.04 Credentials Evaluation and Maintenance 26
Section 7.05 Local/VISN-Level Compensation Panels 27
ARTICLE VIII. CLINICAL PRIVILEGES 27
Section 8.01 General Provisions 27
Section 8.02 Process and Requirements for Requesting Clinical Privileges 28
Section 8.03 Process and Requirement for Requesting Renewal of Clinical Privileges 29
Section 8.04 Processing an Increase or Modification of Privileges 30
Section 8.05 Recommendations and Approval for Initial/Renewal, Modification/
Revision of Clinical Privileges 30

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Section 8.06 Exceptions 31
ARTICLE IX INVESTIGATION AND ACTION 34
ARTICLE X. FAIR HEARING AND APPELLATE REVIEW 37
ARTICLE XI. RULES AND REGULATIONS 40
ARTICLE XII. AMENDMENTS 41
ARTICLE XIII. ADOPTION 41
MEDICAL STAFF RULES 42
1. GENERAL 42
2. PATIENT RIGHTS 42
3. RESPONSIBILITY FOR CARE 44
4. PHYSICIANS' ORDERS 48
5. ROLE OF ATTENDING STAFF 49
6. MEDICAL RECORDS 50
7. INFECTION CONTROL 53
8. CONTINUING EDUCATION 53
9. HEALTH STATUS AND IMPAIRED PROFESSIONAL PROGRAM 54
10. PEER REVIEW 54
11. DISCLOSURE POLICY - VHA DIRECTIVE 2008-002 54
12. QUALITY MANAGEMENT DIRECTIVE - VHA DIRECTIVE 2008-061 55
13. PART-TIME PHYSICIAN REQUIREMENTS FOR TIME & ATTENDANCE 55
14. PATIENT SAFETY INITIATIVES 55
15. CONFLICT OF INTEREST 55

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PREAMBLE
Recognizing the Medical Staff is responsible for the quality of care delivered by its members
and accountable to the Governing Body for all aspects of that care, the Medical Staff practicing
at the William S. Middleton Memorial Veterans Hospital in Madison, Wisconsin (hereinafter
sometimes referred to as the Hospital, Facility, or Organization) hereby organizes itself for self-
governance in conformity with the laws, regulations, and policies governing the Department of
Veterans Affairs (VA), Veterans Health Administration (VHA), and the Bylaws and rules
hereinafter stated. These Bylaws and rules are consistent with all laws and regulations
governing the VHA, and they do not create any rights or liabilities not otherwise provided for in
laws or VHA regulations.

The William S. Middleton Memorial Veterans Hospital comprises an 87-bed acute care facility
with patient care programming that includes (but is not limited to) home based primary care,
tele-health, intensive mental health community support, and residential substance abuse
treatment. The Hospital also is responsible for five community based outpatient clinics
(CBOCs), supports a Veterans Outreach Center in Madison, an Annex Clinic in Madison, and a
26-bed Community Living Center (CLC).

Portions of these Bylaws are required by the VA, VHA, or The Joint Commission (TJC). These
sections should be maintained in accordance with all current regulations, standards, or other
applicable requirements. Prior versions of Bylaws and rules and regulations must be
maintained in accordance with the Sarbanes-Oxley Act which states that Bylaws and rules are
permanent records and should never be destroyed. They must be maintained in accordance
with Record Control System (RCS) 10-1, 10Q.

DEFINITIONS
For the purpose of these Bylaws, the following definitions shall be used:
1. Appointment: As used in this document, the term appointment refers to appointment to the
Medical Staff. It does not refer to appointment as a VA employee but is based on having an
appropriate personnel appointment action, scarce medical specialty contract, or other
authority to provide independent medical, mid-level, and/or patient care services at the
facility. Both VA employees and contractors providing patient care services must receive
appointments to the Medical Staff.
2. Associate Director (AD): The AD fulfills the responsibilities of the Director as defined in
these Bylaws when serving in the capacity of Acting Director.
3. Associate Director for Patient Care Services (AD-PCS): The AD-PCS (or Nurse Executive)
is a registered nurse who is responsible for the full-time, direct supervision of nursing
services and who meets licensing requirements as defined by Title 38. S/he is the
Chairperson of the Nurse Executive Council (NEC) and a member of the Medical Executive
Council (MEC). The AD-PCS is a member of the Quadrad Leadership team and as such,
acts as full assistant to the Director in the efficient management of clinical and patient care
services to eligible patients. S/he actively manages the credentialing and scope of practice
system for relevant mid-level and certain allied health staff and in ensuring the ongoing
education of the nursing staff.

1
4. Associated Health Professional: As used in this document, the term Associated Health
Professional is defined as those clinical professionals other than doctors of allopathic,
dental, and osteopathic medicine. These professionals include, but are not limited to:
Pharmacists (PharmDs), psychologists, podiatrists, and optometrists. Associated Health
Professionals function under either defined clinical privileges or a defined scope of practice.
5. Automatic Suspension of Privileges: Suspensions that are automatically enacted whenever
the defined indication occurs, and do not require discussion or investigation. Examples are
exceeding the allowed medical record delinquency rate when such delinquency does not
impact patient care or failure to maintain qualifications for appointment. Privileges are
automatically suspended until the records are completed or the delinquency rate falls to an
acceptable level. Reactivation must be endorsed by the MEC.
6. Chief of Staff (COS): The COS is the President of the Medical Staff and Chairperson of the
MEC and acts as full assistant to the Director in the efficient management of clinical and
medical services to eligible patients, the active maintenance of a medical C&P and/or scope
of practice system for licensed independent practitioners (LIPS), mid-level practitioners, and
associated health practitioners. The COS ensures the ongoing medical education of
Medical Staff.
7. Community Based Outpatient Clinic (CBOC): A health care site (in a fixed location) that is
geographically distinct or separate from the parent medical facility. A CBOC can be a site
that is VA-operated and/or contracted. A CBOC must have the necessary professional
Medical Staff, access to diagnostic testing and treatment capability, and the referral
arrangements needed to ensure continuity of health care for currently and potentially eligible
veteran patients. A CBOC must be operated in a manner that provides veterans with
consistent, safe, high-quality health care, in accordance with VA policies and procedures
8. Director: The Director (also referred to as the Chief Executive Officer) is appointed by the
Governing Body to act as its agent in the overall management of the facility. The Director is
assisted by the COS, the AD, the AD-PCS, and the MEC.
9. Governing Body: The term Governing Body refers to the Director. The Director is
responsible for the oversight and delivery of health care by all employees and specifically
including the Medical Staff credentialed and privileged by the relevant administrative offices
and facility approved processes.
10. Licensed Independent Practitioner (LIP): The term LIP refers to any individual permitted by
law and by the William S. Middleton Memorial Veterans Hospital to provide care and
services, without direction or supervision, within the scope of the individuals license and
consistent with individually granted privileges. In this organization, this includes physicians,
dentists, and nurse practitioners. It may also include individuals who can practice
independently, who meet this criterion for independent practice.
11. Medical Staff: The body of all LIPs and other practitioners credentialed through the Medical
Staff process that are subject to the Medical Staff Bylaws. This body may include others,
such as retired practitioners who no longer practice in the organization but wish to continue
their membership in the body. The Medical Staff includes both members of the organized
Medical Staff and non-members of the organized Medical Staff who provide health care
services.
12. Mid-Level Practitioner: Mid-level practitioners are those health care professionals who are
not LIPs and who may practice independently on defined clinical privileges as defined in
these Bylaws and by the laws defined by the State of Wisconsin, mid-level practitioners
include: Physician assistants (PA), and Certified Registered Nurse Anesthesist (CRNAs).
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Mid-level practitioners may have prescriptive authority as allowed by federal regulation,
and/or state of licensure statute and regulations, under the supervision of a credentialed and
privileged LIP when required. Mid-level practitioners do not have independent admitting
privileges to the acute care hospital but may admit to residential programs. They may
initiate prescriptions for non-formulary drugs or prescribe controlled substances in
accordance with state of licensure statutes and regulations.
13. Organized Medical Staff: The body of LIPs who are collectively responsible for adopting
and amending Medical Staff Bylaws (i.e., those with voting privileges) and for overseeing the
quality of care, treatment, and services provided by all individuals with clinical privileges.
14. Outpatient Clinic: An outpatient clinic is a health care site where evaluations and treatments
of ambulatory patients occur and whose oversight is assigned to a medical facility.
15. Peer Recommendation: Information submitted by an individual(s) in the same professional
discipline as the applicant reflecting their perception of the practitioners clinical practice,
ability to work as part of a team, and ethical behavior or the documented peer evaluation of
practitioner-specific data collected from various sources for the purpose of evaluating
current competence.
16. Primary Source Verification: Documentation from the original source of a specific credential
that verifies the accuracy of a qualification reported by an individual health care practitioner.
This can be a letter, documented telephone contact, or secure electronic communication
with the original source.
17. Proctoring: Proctoring is the activity by which a practitioner is assigned to observe the practice
of another practitioner performing specified activities and to provide required reports on those
observations. If the observing practitioner is required to do more than just observe, i.e.,
exercise control or impart knowledge, skill, or attitude to another practitioner to ensure
appropriate, timely, and effective patient care, the action constitutes supervision. Such
supervision may be a reduction of privileges.
18. Professional Standards Board (PSB): The PSB, a subcommittee of the MEC, acts as a
Credentials Committee on credentialing and clinical privileging matters of the Medical Staff,
making recommendation on such matter to the Executive Committee of the Medical Staff as
defined in these Bylaws. This board also may act on matters involving allied health and mid-
level practitioners such as granting prescriptive authority, scope of practice, and appointment.
Some professional standards boards (e.g., nursing, etc.) are responsible for advancement and
other issues related to their respective professions.
19. Rules: Refers to the specific rules set forth that govern the Medical Staff of the facility. The
Medical Staff shall adopt such rules as may be necessary to implement more specifically the
general principles found within these Bylaws. Rules are a separate document from the
Bylaws. They can be reviewed and revised by the MEC and without adoption by the
Medical Staff as a whole. Such changes shall become effective when approved by the
Director.
20. Teleconsultation: The provision of advice on a diagnosis, prognosis, and/or therapy from a
provider to another provider using electronic communications and information technology to
support the care provided when distance separates the participants, and where hand-offs on
care is delivered at the site of the patient by a health care provider.
21. Telemedicine: The provision of care by a health care provider that directs, diagnoses, or
otherwise provides clinical treatment delivered using electronic communications and
information technology when distance separates the provider and the patient.

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22. VA Regulations: The regulations set by Department of Veterans Affairs and made
applicable to its entities in compliance with federal laws. (Example: Code of Federal
Regulation (CFR) 38 7402)

ARTICLE I. NAME
The name of this organization shall be the Medical Staff of the Department of Veterans Affairs,
William S. Middleton Memorial Veterans Hospital.

ARTICLE II. PURPOSE


The purposes of the Medical Staff shall be to:
1. Assure that all patients receive safe, efficient, timely, and appropriate care that is subject to
continuous quality improvement practices.
2. Assure that all patients being treated for the same health problem or with the same
methods/procedures receive the same level or quality of care. Primary care programs will
assure continuity of care and minimize institutional care.
3. Establish and assure adherence to ethical standards of professional practice and conduct.
4. Develop and adhere to facility-specific mechanisms for appointment to the Medical Staff and
delineation of clinical privileges.
5. Provide educational activities that relate to: Care provided, findings of quality of care review
activities, and expressed needs of caregivers and recipients of care.
6. Maintain a high level of professional performance of practitioners authorized to practice in
the facility through continuous quality improvement practices and appropriate delineation of
clinical privileges.
7. Assist the Governing Body in developing and maintaining rules for Medical Staff governance
and oversight.
8. Provide a medical perspective, as appropriate, to issues being considered by the Director
and Governing Body.
9. Develop and implement performance and safety improvement activities in collaboration with
the staff and assume a leadership role in improving organizational performance and patient
safety.
10. Provide channels of communication so that medical and administrative matters may be
discussed and problems resolved.
11. Establish organizational policy for patient care and treatment and implement professional
guidelines from the Under Secretary for Health, Veterans Health Administration.
12. Provide education and training, in affiliation with established programs, and assure that
educational standards are maintained. Care will be taken to appropriately document
supervision of resident physicians and other trainees.
13. Initiate and maintain an active continuous quality improvement program addressing all
aspects of medical practice. Daily operations will be the subject of continuous quality
improvement, as defined through organizational publications.
14. Coordinate and supervise the scope of practice of all mid-level and appropriate allied health
practitioner staff so that their rights and practice goals are achieved and integrated

4
expeditiously to benefit the care of patients. Each mid-level and appropriate allied health
practitioner should have a scope of practice statement as well as the means employed to
coordinate and supervise their function with the Medical Staff.
15. To provide the best possible inpatient and outpatient care to all persons who are medically
and legally entitled to treatment.
16. To provide channels of communication so that matters of a medico-administrative nature
may be discussed and problems resolved.
17. To establish hospital policies for patient care and treatment, and to implement professional
guidelines.
18. To provide education and training, in affiliation with the University of Wisconsin School of
Medicine and Public Health and assure that educational standards are maintained.
19. To initiate and review medical research programs.

ARTICLE III. MEDICAL STAFF MEMBERSHIP

Section 3.01 Eligibility for Membership on the Medical Staff


1. Membership: Membership on the Medical Staff is a privilege extended only to, and
continued for, professionally competent physicians, dentists, optometrists, podiatrists, and
psychologists who continuously meet the qualifications, standards, and requirements of
VHA, this facility, and these Bylaws.
2. Categories of the Medical Staff: The Medical Staff shall be divided into four categories as
follows:
a. The Active Staff: The Active Staff consists of those employed as full-time and part-time
physicians, dentists, optometrists, podiatrists, and psychologists. Physician staff has
primary responsibility for patient care and treatment and are appointed to a specific
service, shall serve on Medical Staff committees, and shall be required to attend Medical
Staff meetings as defined in the rules and regulations of the Medical Staff.
b. The Consultant Staff: The Consultant Staff consists of physicians and dentists of
recognized competence including, but not restricted to, full-time or part-time members of
the faculty of the University of Wisconsin School of Medicine and Public Health. These
physicians and dentists visit the hospital on a regular or "on-call schedule to attend or
consult with the Active Staff in the care and treatment of patients. They may also be
active in the teaching, training, and research programs. Such individuals will be
assigned to a specific service, may serve on designated Medical Staff committees, and
may or may not be required to attend Medical Staff meetings. The Bylaws also apply to
those consultants who are providing services to patients on a without compensation
(WOC) basis.
c. The Contractual Staff: The Contractual Staff consist of staff that is hired on a contractual
basis to provide practitioner services. While such individuals are prohibited by regulation
from exercising leadership duties, they may be expected to perform in the following
capacities: Serve as professional director for the activities being performed; serve on
appropriate medical facility committees and/or boards; monitor and evaluate the quality
and appropriateness of patient care services provided and assure that identified
problems are resolved. They may or may not be required to attend Medical Staff
meetings.
d. Other Licensed Independent Practitioners (LIPs): This category contains all other full-
and part-time individuals (nurse practitioners, podiatrists, optometrists, and
5
psychologists) who are permitted by Wisconsin State Law and the hospital to practice
independently. Like other practitioners, the privileges delineated for them by the hospital
may be less than the array allowed by law.
e. There shall be two categories of practitioners overseen by the Medical Staff:
i) Advanced Practitioners: These are practitioners for whom the Medical Staff may
establish broad scopes. This category includes advanced practice nurses who have
not yet requested and been granted privileges, specialty nurses, clinical pharmacists,
nurse anesthetists, and physician assistants.
ii) Other Health Care Professionals: These professionals are required to meet
approved standards and to maintain approved levels of proficiency as requirements
for the performance of certain services involved in the direct care of patients. The
Medical Staff may choose to grant them appropriately narrow scopes of practice.
3. Decisions regarding Medical Staff membership are made without discrimination for reasons
such as race, color, religion, national origin, gender, sexual orientation, lawful partisan
political affiliation, marital status, physical or mental handicap when the individual is qualified
to do the work, age, membership or non-membership in a labor organization, or on the basis
of any other criteria unrelated to professional qualifications.

Section 3.02 Qualifications for Medical Staff Membership and Clinical Privileges
1. Criteria for Clinical Privileges: To qualify for Medical Staff membership and clinical
privileges, individuals who meet the eligibility requirements identified in Section 3.01 must
submit evidence as listed below. Applicants not meeting these requirements will not be
considered. This determination of ineligibility is not considered a denial:
a. Active, current, full, and unrestricted license to practice individual's profession in a state,
territory, or commonwealth of the United States or the District of Columbia as required
by VA employment and utilization policies and procedures.
b. Education applicable to individual Medical Staff members as defined, for example
holding a doctoral level degree in medicine, osteopathy, or dentistry from an approved
college or university.
c. Relevant training and/or experience consistent with the individual's professional
assignment and the privileges for which he/she is applying. This may include any
internship, residencies, fellowships, board certification, and other specialty training.
d. Current competence, consistent with the individual's assignment and the privileges for
which he/she is applying.
e. Health status consistent with physical and mental capability of satisfactorily performing
the duties of the Medical Staff assignment within clinical privileges granted.
f. Complete information consistent with requirements for application and clinical privileges
as defined in Articles VII and VIII or of these Bylaws for a position for which the facility
has a patient care need, and adequate facilities, support services and staff
g. Satisfactory findings relative to previous professional competence and professional
conduct.
h. English language proficiency.
i. Current professional liability insurance as required by federal and VA acquisition
regulations for those individuals providing service under contract.
j. A current picture hospital ID card or a valid picture ID issued by a state or federal agency
(e.g., drivers license or passport).

6
Citizens of the United States or hold an appropriate visa; exceptions may be made when
hiring an individual will not conflict with pertinent VHA regulations as interpreted by VISN 12
Human Resources.
2. Clinical Privileges and Scope of Practice: While only LIPs may function with defined clinical
privileges, not all LIPs are permitted by this facility and these Bylaws to practice
independently. All practitioners listed below are subject to the Bylaws whether they are
granted defined clinical privileges or not.
a. The following practitioners will be credentialed and privileged to practice independently:
i) Physicians
ii) Dentists
iii) Certified Nurse Practitioners
b. The following practitioners will be credentialed and may be privileged to practice
independently if in possession of state license/registration that permits independent
practice and authorized by this facility:
i) Advanced Practice Nurses
ii) Clinical Social Workers
iii) Doctors of Pharmacy
iv) Clinical Pharmacists
v) Psychologists
vi) Audiologists
vii) Speech Pathologists
viii) Podiatrists
ix) Optometrists
c. The following practitioners will be credentialed and will practice under a scope of
practice with appropriate supervision:
i) Physician Assistants
d. The following practitioners will be credentialed and will practice under a scope of
practice with appropriate supervision when not granted clinical privileges as in "b" above.
i) Advanced Practice Nurse

3. Change in Status: Members of the Medical Staff as well as all practitioners practicing
through privileges or a scope of practice must agree to provide care to patients within the
scope of their delineated clinical privileges or scope of practice and advise the Director,
through the COS, of any change in ability to fully meet the criteria for Medical Staff
membership, the ability to carry out clinical privileges which are held, and any changes in
the status of professional credentials, such as, but not limited to, loss of licensure, clinical
privileges, or certification, as well as any pending or proposed action against a credential,
such as, but not limited to, licensure, clinical privileges, certification, professional
organization or society as soon as able, but no longer than 15 days after notification of the
practitioner.

Section 3.03 Code of Conduct


1. Acceptable Behavior: The VA expects that members of the Medical Staff will serve
diligently, loyally, and cooperatively. They must avoid misconduct and other activities that
conflict with their duties; exercise courtesy and dignity; and otherwise conduct themselves,
both on and off duty, in a manner that reflects positively upon themselves and the VA.
Acceptable behavior includes the following: (1) being on duty as scheduled; (2) being
impartial in carrying out official duties and avoiding any action that might result in, or look as

7
though, a Medical Staff member is giving preferential treatment to any person, group or
organization; (3) not discriminating on the basis of race, age, color, sex, religion, national
origin, politics, marital status, or disability in any employment matter or in providing benefits
under any law administered by VA; (4) not making a governmental decision outside of
official channels; (5) not taking any action that impedes government efficiency and
economy, affects ones impartiality, or otherwise lowers public confidence in the federal
government; and (6) with certain exceptions in accordance with 5 C.F.R. 2635, not asking
for or accepting any gift, tip, entertainment, loan, or favor, or anything of monetary value for
oneself or any member of ones family from any person or organization that is seeking or
has a business or financial relationship with the VA to avoid the appearance that ones
official actions might be influenced by such gifts.
2. Disruptive Behavior and Inappropriate Behavior: VA recognizes that the manner in which
its practitioners interact with others can significantly impact patient care. VA strongly urges
its providers to fulfill their obligations to maximize the safety of patient care by behaving in a
manner that promotes both professional practice and a work environment that ensures high
standards of care. The Accreditation Council for Graduate Medical Education highlights the
importance of interpersonal/communication skills and professionalism as two of the six core
competencies required for graduation from residency. Providers should consider it their
ethical duty to foster respect among all health care professionals as a means of ensuring
good patient care. Conduct that could intimidate others to the extent that it could affect or
potentially may affect quality and safety will not be tolerated. These behaviors, as
determined by the organization, may be verbal or non-verbal, may involve the use of rude
and/or disrespectful language, may be threatening, or may involve physical contact.

Disruptive behavior is a style of interaction with physicians, hospital personnel, patients,


family members, or others that interferes with patient care. Behaviors such as foul
language; rude, loud, or offensive comments; and intimidation of staff, patients, and family
members are commonly recognized as detrimental to patient care. Furthermore, it has
become apparent that disruptive behavior is often a marker for concerns that can range
from a lack of interpersonal skills to deeper problems, such as depression or substance
abuse. As a result, disruptive behavior may reach a threshold such that it constitutes
grounds for further inquiry by the MEC into the potential underlying causes of such
behavior. Behavior by a provider that is disruptive could be grounds for disciplinary action.

VA distinguishes disruptive behavior from constructive criticism that is offered in a


professional manner with the aim of improving patient care. VA also reminds its providers
of their responsibility not only to patients, but also to themselves. Symptoms of stress, such
as exhaustion and depression, can negatively affect a providers health and performance.
Providers suffering such symptoms are encouraged to seek the support needed to help
them regain their equilibrium.

Providers, in their role as patient and peer advocates, are obligated to take appropriate
action when observing disruptive behavior on the part of other providers. VA urges its
providers to support their hospital, practice, or other health care organization in their efforts
to identify and manage disruptive behavior, by taking a role in this process when
appropriate.

3. Professional Misconduct: Behavior by a professional that creates the appearance of a


violation of ethical standards or has compromised ethical standards will not be tolerated.

8
4. Ethics: Full-time Medical Staff members may provide professional care for remuneration
outside the VA if it is provided to non-VA patients and outside the staff members tour of
duty. Furthermore, Medical Staff is subject to callback and are responsible for ensuring that
any outside employment they accept will not conflict with their VA responsibilities. The
Principles of Ethics of the American Medical Association (AMA), the American Dental
Association (ADA), the American Nurses Association (ANA), the American Podiatric
Medical Association, the American Optometry Association, and VA national and Madison
VAH ethics policies shall serve as guidelines for the professional conduct of members of
the Medical Staff. Evidence of unethical behavior or behavior-causing discredit to the
hospital is cause for separation of any member of the Medical Staff.

ARTICLE IV. ORGANIZATION OF THE MEDICAL STAFF

Section 4.01 Leaders


1. Composition:
Chief of Staff
2. Qualifications:
Chief of Staff. The COS must be a physician who has had appropriate experience in
medical practice, academic affairs, and administration. It is understood that any individual
selected as COS shall be a member of the Medical Staff and have privileges ex officio to
act as a consultant in evaluating all aspects of patient care and other professional services
provided by the hospital. However, the COS may also apply for and be granted specific
privileges to provide direct patient care as outlined in Article VII.
3. Selection:
Chief of Staff. The selection of a COS begins with a Search Committee selected by the
Director with the consent of the Network Director. The Director should seek advice from the
Dean of the University of Wisconsin School of Medicine and Public Health in selecting the
Search Committee. The Search Committee shall determine a list of applicants for the
position who warrant further evaluation. Each of these candidates should be interviewed by
members of the MEC and by the Search Committee. The Committee shall make
recommendations to the Director regarding acceptable candidates for the COS along with
an explanation or their perceived strengths and weaknesses. From this list, the Hospital
Director recommends candidates to the Network Director. The Network Director is
responsible for nominating an individual from the recommended candidates and provides
information about that individual to the Management Support Office and the VA PSB (VA
Central Office). After VA Central Office has completed a technical review of the candidate,
the Under Secretary for Health selects the candidate and the Network Director then
appoints the COS on behalf of the Governing Body.
Tenure of the COS is determined by the Governing Body, represented by the Network
Director. Although the COS is not an elected officer, he/she may be removed through
the processes described in MP-5, Part II, Chapters 6 (Proficiency Rating System), 8
(Disciplinary Actions), 9 (Separations), 10 (Physical Requirements), and VHA
Supplements hereto consistent with these Bylaws. Procedures to reduce or revoke the
clinical privileges of the COS are identified within VHA Handbook 1100.19, March 19,
2001, Credentialing and Privileging. Other questions or concerns about removal
procedures should be directed to the Network Director, and/or the Director of Network
Support, VA Central Office, Washington, D.C., and/or the Office of Regional Counsel
9
4. Duties:
Chief of Staff. The COS acts as the executive officer of the Medical Staff. The COS
presides over meetings of the MEC. The COSs office shall facilitate effective
communication between the Medical Staff and the Governing Body using written
documents and appropriate meetings. The COS will represent the Medical Staff at
regularly scheduled hospital administrative meetings and meetings of the Executive
Leadership Planning Board (ELPB) and shall assure that the Medical Staff is appropriately
represented in any hospital deliberation affecting the discharge of Medical Staff
responsibilities. ELPB is one forum for discussing patient satisfaction, patient safety, and
sentinel events. The COS will also act as the main representative of the Medical Staff with
respect to physician trainee issues. The COS, or designee, is a member of the University
of Wisconsin Graduate Medical Education (UW GME) Oversight Committee that monitors
the quality of such education. This Committee conducts internal reviews of all specialty
training programs. As part of that review, resident supervision, and working conditions are
included. In addition, the COS submits an annual report on residency training programs to
the VA Office of Academic Affiliations.

Section 4.02 Leadership


The Organized Medical Staff, through its committees and service chiefs, provides counsel
and assistance to the COS and Director regarding all facets of patient care, treatment, and
services including evaluating and improving the quality and safety of patient care services.

Section 4.03 Clinical Services


1. Characteristics:
a. Clinical services are organized to provide clinical care and treatment under leadership of
a service chief.
b. Clinical services encompass all medical and dental programs directly related to patient
care and treatment, professional education, and research, and are organized into the
following services:
i) Anesthesiology, dental, medicine, ambulatory care, social work, rehabilitation,
pharmacy, mental health, neurology, nursing, pathology and laboratory medicine,
radiology, research, and surgery.
c. All services, except for pharmacy, social work, rehabilitation, and nursing, are overseen
directly by a Medical Staff member. Service leaders who are Medical Staff members
must have appropriate board certification or equivalency for the service being overseen.
If the service chief is not board certified, the C&P file must contain documentation that
the individual has been determined to be equally qualified based on experience,
background, and training; this is in accordance with VHA Handbook 1100.19,
Credentialing and Privileging. Pharmacy Service and Nursing Service contain
practitioners overseen by the Medical Staff.
d. Ambulatory Care Service is overseen by the Associate Chief of Staff (ACOS) for
Ambulatory Care. This ACOS may delegate duties to the Chief of Primary Care. The
ACOS for Ambulatory Care oversees the operation of clinics outside the hospital building
which are affiliated with the hospital. Research is overseen by the ACOS for Research.
Each of the other services is directed by a service chief who is responsible to the COS
for the administrative and clinical activities of the service. The chief of each service in
turn is responsible to each respective University of Wisconsin School of Medicine and
Public Health department head for quality of professional activities as they relate to the
teaching program. Because pathology, laboratory medicine, and radiology are operated
10
as a VISN 12 service line, the service line chief reports both to the Network Director and
to the COS. The service line chief has responsibilities similar to other service chiefs with
respect to the provision of care and quality of professional activities of the professional
staff assigned to this area.
e. The overall operation of professional services is under the supervision of the COS.
f. Clinical services hold service-level meetings at least quarterly.

2. Functions:
a. Provide for quality and safety of the care, treatment, and services provided by the
service. This requires ongoing monitoring and evaluation of quality and safety,
(including access, efficiency, and effectiveness); appropriateness of care and treatment
provided to patients (including that provided under temporary privileges or emergency
care absent privileges); patient satisfaction activities; patient safety and risk
management activities; and utilization management.
b. Assist in identification of important aspects of care for the service, identification of
indicators used to measure and assess important aspects of care, and evaluation of the
quality and appropriateness of care. Utilize VHA performance measures and monitors
as a basis for assessing the quality, timeliness, efficiency, and safety of service
activities.
c. Maintain records of meetings that include reports of conclusions, data,
recommendations, responsible person, actions taken, and an evaluation of effectiveness
of actions taken. These reports are to be forwarded in a timely manner through
channels established by the Medical Staff, at a minimum on a basis.
d. Develop criteria for recommending clinical privileges for members of the service and
ensure that ongoing professional practice evaluation is continuously performed and
results are utilized at the time of re-privileging.
e. Define and/or develop clinical privilege statements including levels (or categories) of
care that include all requirements of VHA Handbook 1100.19.
f. Develop policies and procedures to assure effective management, ethics, safety,
communication, and quality within the service.
g. Annually review privilege templates for each service and make recommendations to
MEC.

3. Selection and Appointment of Service Chiefs: Medical service chiefs are appointed by the
Director based upon the recommendation of the COS. A service chief may be removed by
the COS after consultation with the Director for unprofessional, inappropriate, or unethical
behavior as delineated in the hospital Code of Conduct.
4. Duties and Responsibilities of Service Chiefs: The service chief is administratively
responsible for the operation of the service and its clinical and research efforts, as
appropriate. In addition to duties listed below, the service chief is responsible for assuring
the service performs according to applicable VHA performance standards. These are the
performance requirements applicable to the service from the national performance contract,
and cascade from the overarching requirements delegated to the Chief of the Medical Staff.
These requirements are described in individual performance plans for each service chief.
Service chiefs are responsible and accountable for:
a. Completing Medical Staff Leadership and Provider Profiling on-line training within three
months of appointment as service chief.
b. Clinically related activities of the service.

11
c. Administratively related activities of the department, unless otherwise provided by the
organization.
d. Continued surveillance of the professional performance of all individuals in the service
who have delineated clinical privileges through FPPE/OPPE.
e. Recommending to the Medical Staff the criteria for clinical privileges that are relevant to
the care provided in the service.
f. Recommending clinical privileges for each member of the service.
g. Assessing recommendations for off-site sources of needed patient care, treatment, and
services not provided by the service and communicating the recommendations to the
relevant organizational authority.
h. The integration of the service into the primary functions of the organization.
i. The coordination and integration of interdepartmental and intradepartmental services.
j. The development and implementation of policies, manuals, and procedures that guide
and support the provision of care, treatment, and services.
k. The assurance of a sufficient number of qualified and competent persons to provide
care, treatment, and service.
l. The determination of the qualifications and competence of service personnel who are
not LIPs and who provide patient care, treatment, and services.
m. The continuous assessment and improvement of the quality of care, treatment, and
services.
n. The maintenance of and contribution to quality control programs, as appropriate.
o. The orientation and continuing education of all persons in the service.
p. The assurance of space and other resources necessary for the service defined to be
provided for the patients served.
q. Annual review of all clinical privilege forms to ensure that they correctly and adequately
reflect the services being provided at the facility. This review is noted by date of review
being included on the bottom of each privilege delineation form.
r. Conducting at least quarterly clinical service meetings each year to review service
issues.

5. The ACOS for Ambulatory Care and service chiefs who are members of the Medical Staff
are:

a. Responsible for recommending to the Medical Staff the criteria for clinical privileges or
scopes of practice in their services.
b. Responsible for recommending clinical privileges and scopes of practice for practitioners
overseen by their services.
c. Responsible for continuing surveillance of the professional performance of Medical Staff
members who exercise privileges within their services.
d. Responsible (in concert with the AD-PCS and Chief of Pharmacy as needed) for
continuing surveillance of the professional performance of practitioners with scopes of
practice who are collaborating with Medical Staff members in their services.
6. The ACOS for Research is responsible for assuring that research is conducted by members
of the Medical Staff in an ethical manner and in accordance with all applicable VHA policies
and regulations.

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ARTICLE V. MEDICAL STAFF COMMITTEES

Section 5.01 General


1. Committees are either standing or special.
a. There are a number of standing committees that report to the MEC. Those standing
committees are outlined in hospital memorandum, Executive Leadership and Planning
Board, No. 00-29.
i) The functions and memberships of the Medical Staff standing committees are
outlined in numbered hospital memoranda specific to each committee. It is the
expectation that the standing committees will review and analyze data and trends,
take necessary action, and follow up on those actions. They will present a summary
report of trended data and actions completed to MEC, at a minimum, on an annual
basis and at times they deem necessary for MEC assistance. Each of these
standing committees meets at least two-thirds of scheduled dates.
b. Special Committees or Reports: Appropriate special committees shall exist to review
and analyze special services or functions provided in the hospital.
c. The review by the MEC of such committees and reports constitutes the mechanism by
which the MEC establishes and maintains patient care standards.

2. All committee members, regardless of whether they are members of the Medical Staff, are
eligible to vote on committee matters unless otherwise set forth in these Bylaws.
3. The presence of 25% of committee members will constitute a quorum.
4. The members of all standing committees, other than the MEC, are appointed by the COS,
unless otherwise stated in these Bylaws.
5. Unless otherwise set forth in these Bylaws, the chair of each committee is appointed by the
COS.
6. Robert's Rules of Order will govern all committee meetings.

Section 5.02 Executive Committee of the Medical Staff


1. Characteristics: The MEC serves as the Executive Committee of the Medical Staff. The
members of the MEC are:
a. COS, Chairperson, voting
b. Clinical service chiefs, voting
c. Practitioners appointed through the Medical Staff process, voting
d. Director, or designee, ex-officio, non-voting
e. AD-PCS, ex-officio, non-voting
f. Other facility staff as may be called upon to serve as resources or attend committee
meetings at the request of the chairperson, with or without vote. For example, a PA may
be called to be present when an action affecting another PA is being considered. Any
member of the Medical Staff (with or without vote) is eligible for consideration.
g. The majority of the voting members must be fully licensed physicians of medicine or
osteopathy.
h. The Medical Staff has delegated authority to the MEC. Authority maybe removed by a
two thirds majority vote of the active Medical Staff.

2. Functions of the Medical Executive Council (MEC):

13
a. Acts on behalf of the Medical Staff within the scope of its responsibilities as defined by
the Organized Medical Staff.
b. Maintains process for reviewing credentials and delineation of clinical privileges and/or
scopes of practice to ensure authenticity and appropriateness of the process in support
of clinical privileges and/or scope of practice requested; to address the scope and quality
of services provided within the facility.
c. Acts to ensure effective communications between the Medical Staff and the Director.
d. Makes recommendations directly to the Director regarding the:
i) Organization, membership, structure, and function of the Medical Staff
ii) Process used to review credentials and delineate privileges for the Medical Staff
iii) Delineation of privileges for each practitioner credentialed
e. Coordinates the ongoing review, evaluation, and quality improvement activities and
ensures full compliance with Veterans Health Administration Clinical Performance
Measures, TJC, and relevant external standards.
f. Oversees process in place for instances of for-cause concerning a Medical Staff
members competency to perform requested privileges.
g. Oversees process by which membership on the Medical Staff may be terminated
consistent with applicable laws and VA regulations.
h. Oversees process for fair-hearing procedures consistent with approved VA mechanisms.
i. Monitors Medical Staff ethics and self-governance actions.
j. Advises facility leadership and coordinates activities regarding clinical policies, clinical
staff recommendations, and accountability for patient care.
k. Receives and acts on reports and recommendations from Medical Staff committees
including those with quality of care responsibilities, clinical services, and assigned
activity groups and makes needed recommendations to the Governing Body.
l. Assists in development of methods for care and protection of patients and others at the
time of internal and external emergency or disaster, according to VA policies.
m. Acts upon recommendations from the PSB, which is a subcommittee of the MEC.
n. Acts upon recommendations from the Physical Standards Board, which includes the
evaluation of physical and mental fitness of all Medical Staff upon referral by the
occupational health physician. The Physical Standards Board may have the same
membership as the local physician PSB or members may be designated for this purpose
by the health care facility Director. Boards may be conducted at other VA health care
facilities.
o. Provides oversight and guidance for fee basis/contractual services.
p. Annually reviews and makes recommendations for approval of the service-specific
privilege lists.
q. Initiating, developing, and approving Medical Staff Bylaws and rules and regulations.
Changes will be communicated to the Medical Staff.
r. Approving or disapproving amendments to the Medical Staff Bylaws and rules and
regulations. Changes will be communicated to the Medical Staff.

3. Meetings:
a. Regular Meetings: Regular meetings of the MEC shall be held at least ten times
throughout the year. The date and time of the meetings shall be established by the
Chair for the convenience of the greatest number of members of the Committee. The
Chairmen of the various committees of the Medical Staff shall attend regular meetings of
the MEC when necessary to report the activities and recommendations of their
committees; and may attend at other times with the consent of the COS. Such
attendance shall not entitle the attendee to vote on any matter before the MEC.

14
b. Emergency Meetings: Emergency meetings of the MEC may be called by the COS to
address any issue which requires action of the Committee prior to a regular meeting.
The agenda for any emergency meeting shall be limited to the specific issue for which
the meeting was called, and no other business may be taken up at an emergency
meeting. In the event that the COS is not available to call an emergency meeting of the
MEC, the Director as the Governing Body or Acting COS, acting for the COS, may call
an emergency meeting of the Committee.
c. Meeting Notice: All MEC members shall be provided at least seven days advance
written notice of the time, date, and place of each regular meeting and reasonable
notice, oral or written, of each emergency meeting.
d. Agenda: The COS, or in his absence, such other person as provided by these Bylaws,
shall chair meetings of the MEC. The Chair shall establish the agenda for all meetings,
and a written agenda shall be prepared and distributed prior to committee meetings.
e. Quorum: A quorum for the conduct of business at any regular or emergency meeting of
the MEC shall be a majority of the voting members of the Committee, unless otherwise
provided in these Bylaws. Action may be taken by majority vote at any meeting at which
a quorum is present. The majority of the voting members must be fully licensed
physicians of medicine or osteopathy.
f. Minutes: Written minutes shall be made and kept on all meetings of the MEC, and shall
be open to inspection by practitioners who hold membership or privileges on the Medical
Staff.
g. Communication of Action: The Chair at a meeting of the MEC at which action is taken
shall be responsible for communicating such action to any person who is directly
affected by it.

Section 5.03 Committees of the Medical Staff


1. The following standing committees hereby are established for the purpose of (a) evaluating
and improving the quality of health care rendered, (b) reducing morbidity or mortality from
any cause or condition, (c) establishing and enforcing guidelines designed to keep the cost
of health care within reasonable bounds, (d) reviewing the professional qualifications of
applicants for Medical Staff membership, (e) reviewing the activities of the Medical Staff
and mid-level and allied health practitioners, (f) reporting variances to accepted standards
of clinical performance by, and in some cases to, individual practitioners, and (g) for such
additional purposes as may be set forth in the charges to each committee. The following
committees submit reports to the ELPB on a systematic basis or as requested by the
Hospital Director.
a. Infection Control Committee:
i) Charge: Determine the types of surveillance and infection control activities to ensure
an effective hospital-wide program; enforce prevention and control measures when
deemed necessary by the Chief of Infectious Disease, Infection Control Practitioner.
and/or committee; work with the responsible service chiefs and other hospital staff to
correct deficiencies and monitor compliance with established processes [per
Committees rev 3, HM 111-12]. Submit committee minutes to the PIQC quarterly
and report a summary of its activities to the MEC annually.
ii) Composition:
Chief, Infectious Disease, Chairman
Nurse Manager, Operating Room
Nurse Administrative Representative
Patient Safety Manager
Nursing Representative
15
Supervisory Medical Technologist
Chief, Supply, Processing, and Distribution
Organizational Improvement Representative
Infection Control Practitioner
Facility Engineer
Chief, Biomedical Engineering
Employee Health Nurse
Dental Representative
Chief, Environmental & Support Service
Respiratory Therapy Representative
Industrial Hygienist
Safety Manager
MRSA Prevention Coordinator
Pharmacy Representative
iii) Meetings: Meets bimonthly
b. Invasive Procedure and Blood Usage Review Committee:
i) Charge: Establish mechanisms to ensure that only those operations and invasive
procedures which are clinically indicated are performed, and that the pathology of
any tissue removed is appropriate. Ensure that blood products are available and
transfused appropriately.
ii) Composition:
Chief Pathologist, VISN 12 Pathology and Laboratory Medicine Service
Chief, Hematology Section, Medical Service
Chief, Anesthesiology Service or designee
Chief, Medicine or designee
Chief, Surgery Service or designee
Associate Director for Patient Care Services or designee
Blood Bank Supervisor
Organizational Improvement Analyst
iii) Meetings: The Committee will hold not less than ten regularly scheduled meetings a
year. Blood Usage Review meetings will be held at least quarterly.
c. Medical Records Committee:
i) Charge: Oversee all aspects of the Consolidated Health Record (CHR), both
electronic and paper format. Approve all forms and overprints that become a
permanent part of the CHR. Systematically review a sample of medical records to
ensure compliance with all medical, legal, administrative, and accreditation
requirements.
ii) Composition:
ACOS/Ambulatory Care or designee
Chief, Surgical Service or designee
Manager, Organizational Improvement
Compliance Officer
Chief, Health Information Management Section (HIMS)
Chief Inpatient Nursing or designee
Coding and Discharge Processing Supervisor, HIMS
Clinical Application Coordinator, Office of COS
iii) Meetings: Quarterly
d. Mental Health Executive Committee:
i) Charge: The William S. Middleton Memorial Veterans Hospital will establish and
maintain a Mental Health Executive Council that includes representation from core

16
mental health professional disciplines and specialty mental health programs. The
Mental Health Executive Council is responsible for:
1. Proposing strategies to improve care and consulting with management on
methods for improvement and innovation in treatment programs
2. Working to coordinate communication among and between various departments
and specialty mental health programs
3. Reviewing the mental health impact of facility-wide policies that include, but are
not limited to policies on:
a. Patient rights, privileges, and responsibilities
b. Restraints and seclusion
c. Management of suicidal behavior
d. Management of mental health emergencies
ii.) Composition :
Chief, Mental Health Service Line
Manager, Primary Mental Health Division
Manager, Psychosocial Rehab Division
Manager, Addiction Disorder Treatment Program
Manager, Compensated Work Therapy
Manager, MHICM and MHICM-RANGE
Manager, CBOC Mental Health Services
Manager, Homeless Services
Coordinator, Outpatient Clinic
Coordinator, Rockford CBOC Mental Health
Coordinator, Wellness Program
Charge Nurse, Mental Health Outpatient Services
Executive Psychologist
Local Recovery Coordinator
Suicide Prevention Coordinator
Chief, Social Work Service
Representative, Madison Vet Center
Administrative Officer, Mental Health Service Line
Secretary, Mental Health Service Line
Veterans (Madison and various CBOCs)
iii.) Meetings: Meetings are held monthly
e. Patient Safety Committee:
i) Charge: (a) Participate in developing and implementing an integrated
interdisciplinary facility-wide program to monitor the quality and safety of patient care
and to promote an effective and efficient utilization of person-power, facilities, and
services; (b) facilitate mechanisms for correction of problems identified; (c) review
the performance monitoring activities of each service and the hospital; (d) assist all
facility services and departments in identifying and evaluating problems in ancillary
service utilization and encourage solutions which enhance quality of care; (e) fulfill
the review requirements of TJC, and other external reviewing organizations; (f) report
to the COS, MEC, and Director pertinent issues concerning the quality control and
performance improvement efforts.
Analyze safety data to identify trends and needed actions.
Identify patient safety priorities.
Initiate action teams to address issues and priorities.
Ensure and track the implementation of TJC standards for patient safety.
Identify and facilitate staff patient safety training needs.

17
Review and assess reports from Root Cause Analysis teams, action teams, risk
assessments, patient tracer reports, and other safety reports.
Review VA Patient Safety and Hazard Alerts, TJC Sentinel Event Alerts, and assure
local compliance.
Assure that local policies are in compliance with national directives/handbooks.
Review implementation and progress for ongoing national safety initiatives as
determined by Institute for Healthcare Improvement (IHI), TJC, or VHA in
collaboration with those responsible for implementing these special initiatives.
Alert leadership to patient safety issues that may need resources or other assistance
that is beyond the control of the Committee.
Submit committee minutes to the PIQC quarterly and report a summary of its
activities to the MEC annually.
ii) Composition:
Patient Safety Manager (provides technical and administrative support)
Associate Director for Patient Care Services/Nurse Executive
Manager, Organizational Improvement
Safety Manager
Chief, Pharmacy Service
Chief Medical Resident
Suicide Risk Coordinator
Chief, Mental Health Service Line
Chief, Perioperative and Emergency Nursing Service
Chief, Inpatient Nursing
iii) Meetings: The Committee meets at least ten times per year.
f. Peer Review Committee:
i) Charge: Establish policy, procedures, and responsibilities for the peer review
process used to evaluate the practice of practitioners when circumstances suggest
the need for such review.
Oversee the peer review process. Reconsider all peer review cases, whether done
through a hospital committee or individual, when the level of care has been
determined to be Level 2 or 3. Review a sufficient and representative sample of
Level 1 peer review cases to ensure the validity and reliability of the findings and to
evaluate the peer review process.
ii) Composition:
Chief of Staff, Chair
Chief, Surgery Service or designee
Chief, Mental Health Service Line or designee
Associate Director for Patient Care Services or designee
Chief, Pharmacy Service or designee
Manager, Organizational Improvement or designee, Advisor
Ad hoc members invited at the discretion of the Chair to assist in the peer review
process
iii) Meetings: The Committee will meet at least quarterly.
g. Professional Standards Board (PSB)(also serves as Credentials Committee) :
i) Charge: Review applications for appointment to the Medical Staff referred to it by
the COS or his designee(s); review the recommendations of the COS and service
chiefs; conduct personal interviews of candidates at its discretion; conduct a
personal interview with the COS and/or service chief in all instances of disapproval of
an application by the COS and/or service chief or both. In the event of the intent of
the Committee to recommend disapproval, personal interviews shall be held with the
COS and service chief, if appropriate and with the candidate after written notification
18
to the candidate of the intended disapproval. Between recredentialing cycles, review
the status and appropriateness of clinical privileges when cases are referred by the
COS or service chief. At the request of the COS, review new/proposed changes to
delineation of clinical privileges form(s); recommend appropriate action to the PSB or
MEC.
ii) Composition:
COS
Chief Medicine Service
Chief Surgery Service
Chief Mental Health
ACOS Ambulatory Care
iii) Meetings: Monthly
h. Research and Development (R&D):
i) Charge: Evaluate the quality, design, desirability, and feasibility of each new R&D
proposal, continuing R&D project, and application for funding, to assure high
scientific standards, adherence to the Human Research Protection Program Plan,
adequate safety measures, and proper use of animal subjects.
Recommend the distribution of R&D funds, space, personnel, equipment, supplies,
use of animal facilities, and other common resources, based on the VA Research
and Development Information System (RDIS) Budget Allocation.
Recommend approval of the receipt and use of non-VA financial support for research
and development to be conducted in the facility or by members of the VA staff even if
conducted outside the facility and review of grant budgets and other budgetary
issues.
Advise the Director on the recommendation to the ACOS/R&D of candidates for the
position of ACOS/R&D.
Fulfill such other functions as may be specified by the Director.
ii) Composition:
Facility ISO (ex-officio/non-voting)
Chief of Staff (ex-officio/non-voting)
Distinguished Scientist
Professor of Medicine, UW
Staff Neurologist
Associate Chief of Staff for Research
Research Compliance Officer (ex-officio/non-voting)
Research Scientist, UW
Clinical Neuropsychology Specialist, GRECC
Research Scientist, GRECC (alternate for Clinical Neuropsychology Specialist)
Chief, Mental Health Service Line
Staff Psychiatrist (alternate for Chief, Mental Health Service Line)
Privacy Officer (ex-officio/non-voting)
Chief, Electron Microscopy
Clinical Practice Program Manager, Nursing Service or Magnet Program Manager
Administrative Officer, Research Service (ex-officio/non-voting)
Chief, Cardiology Section
Clinical Pharmacy Coordinator, Chair
Staff Physician, Pulmonary Section
Director (ex-officio/non-voting)
iii) Meetings: The Committee meets 11-12 times per year.
i. Therapeutic Agents and Pharmacy Review Committee:

19
i) Charge: Recommend professional policies regarding evaluation, selection,
procurement, distribution, use, safe practices, and other matters pertinent to
pharmaceuticals; recommend programs designed to meet the needs of the
professional staff of the facility for complete current information on matters related to
pharmaceuticals and current pharmaceutical practices.
Develops and maintains a drug formulary; develops or approves policies and
procedures relating to the selection, preparation, distribution, handling, use, safe
administration, and monitoring of drugs and diagnostic testing material.
ii) Composition: Members of medical, nursing, pharmacy, and administrative staffs
iii) Meetings: Monthly

2. Other committees not mentioned here are outlined in Executive Leadership Board
memorandum.
3. Information Flow to MEC: All Medical Staff committees, including but not limited to those
listed above, will submit minutes of all meetings to the MEC in a timely fashion after the
minutes are approved and will submit such other reports and documents as required and/or
requested by the MEC.

Section 5.04 Committee Records and Minutes


1. Committees prepare and maintain reports to include data, conclusions, recommendations,
responsible person, actions taken, and evaluation of results of actions taken. These reports
are to be forwarded in a timely manner through channels established by the Medical Staff,
at a minimum on a quarterly basis.
2. Each committee provides appropriate and timely feedback to the services relating to all
information regarding the service and its providers.
3. Each committee shall review and forward to the MEC, a synopsis of any subcommittee
and/or workgroup findings.

Section 5.05 Establishment of Committees


1. The MEC may, by resolution and upon approval of the Director, without amendment of
these Bylaws, establish additional standing or special committees to perform one or more
Medical Staff functions.
2. The MEC may, by resolution and upon approval of the Director, dissolve or rearrange
committee structure, duties, or composition as needed to better accomplish Medical Staff
functions.

ARTICLE VI. MEDICAL & SERVICE-LEVEL STAFF MEETINGS


1. Regular Meetings: Regular meetings of the Medical Staff shall be held at least quarterly. A
record of attendance shall be kept.
2. Special Meetings: Special meetings of the entire Medical Staff may be called at any time
by the COS or at the request of the Director or the MEC. A meeting shall also be held upon
the request of any three Medical Staff members. At any such meeting, only that business
set forth in the notice thereof will be transacted. Notice of any such meeting shall be
deemed sufficient if it is given in writing to the Medical Staff at least forty-eight (48) hours
prior thereto. Members of the Medical Staff may request a special meeting either through
the COS or Director in writing and stating the reason(s) for the request.

20
3. Quorum: For purposes of Medical Staff business, 25% of the total membership of the
Medical Staff membership entitled to vote constitutes a quorum.
4. Meeting Attendance: Members of the Medical Staff are encouraged to attend all service-
level meetings.

ARTICLE VII. APPOINTMENT AND ONGOING CREDENTIALING

Section 7.01 General Provisions


1. Independent Entity: The William S. Middleton Memorial Veterans Hospital is an
independent entity, granting privileges to the Medical Staff through the MEC and Governing
Body as defined in these Bylaws. Credentialing and privileging are performed prior to initial
appointment. Medical Staff, mid-level practitioner, and allied health practitioner
reappointments may not exceed two years, minus one day from the date of last
appointment or reappointment date. Medical Staff and mid-level and allied health
practitioners must practice under their privileges or scope of practice.
2. Credentials Review: All LIPs, and all mid-level and allied health practitioners who hold
clinical privileges or scope of practice will be subjected to full credentials review at the time
of initial appointment and reappraisal for granting of clinical privileges and after a break in
service. All mid-level and allied health practitioners will be subjected to full credentials
review at the time of initial appointment, appraisal, or reappraisal for granting a scope of
practice with prescriptive authority. Credentials that are subject to change during leaves of
absence shall be reviewed at the time the individual returns to duty. Practitioners are
appointed for a maximum period of two years.
3. Deployment/Activation Status:
a. When a member of the Medical Staff has been deployed to active duty, upon notification,
the privileges will be placed in a deployment/activation status and the credentialing file
will remain active. Upon return of the practitioner from active duty, in accordance with
the Uniformed Services Employment and Reemployment Rights Act of l994 (USERRA),
the practitioner will update the credentialing file to current status.
b. After verification of the updated information is documented, the information will be
referred to the practitioners service chief then forwarded to the MEC for
recommendation to restore privileges to active, current status, based on evidence of
current competence. Special circumstances may warrant the service chief and
Executive Committee to put a focused professional practice evaluation (FPPE) in place
to support current competence. The Director has final approval for restoring privileges to
active and current status.
c. In those instances where the privileges lapsed during the call to active duty, the
practitioner must provide additional references or information needed for verification and
all verifications must be completed prior to reappointment.
d. In those instances where the practitioner was not providing clinical care while on active
duty, the practitioner in cooperation with the service chief must consider the privileges
held prior to the call to active duty and whether a request for modification of these
privileges should be initiated, on a short-term basis. These providers may be returned to
a pay status, but may not be in direct patient care.

4. Employment or Contract: Appointments to the Medical Staff occur in conjunction with VHA
employment or under a VHA contract or sharing agreement. The authority for these actions
is based upon:
21
a. Provisions of 38 U.S.C. 7401 in accordance with VA Handbook 5005, Part II, Chapter 3,
VHA Handbooks and applicable Agreement(s) of Affiliation in force at the time of
appointment.
b. Federal law authorizing VA to contract for health care services.

5. Initial Focused Professional Practice Evaluation (FPPE):

a. The initial FPPE is a process whereby the Medical Staff evaluates the privilege-specific
competence of a practitioner who does not have documented evidence of competently
performing the requested privilege at the organization. This occurs with a new
practitioner or an existing practitioner who requests a new privilege. The performance
monitoring process is defined by each service and must include;
i) Criteria for conducting performance monitoring
ii) Method for establishing a monitoring plan specific to the requested privilege
iii) Method for determining the duration of the performance monitoring
iv) Circumstances under which monitoring by an external source is required.
b. An initial Medical Staff appointment does not equate to Human Resources employment.
FPPE does not equate to a probationary period. The FPPE is separate and distinct from
the HR probationary review listed below;
i) Initial and certain other appointments made under 38 U.S.C. 7401(l), 7401(3), 5
U.S.C. 3301 are probationary. During the probationary period, professional
competence, performance, and conduct will be closely evaluated under applicable
VA policies, procedures, and regulations.
ii) If, during this period, the employee demonstrates an acceptable level of performance
and conduct, the employee will successfully complete the probationary period.
Supervisors and managers apply the same processes to the evaluation of individuals
employed under provision of 38 U.S.C. 7405 and those utilized under contracts and
sharing agreements.

6. Ongoing Professional Practice Evaluation (OPPE):

a. The on-going monitoring of privileged practitioners is essential to confirm the quality of


care delivered. This is called the OPPE. This allows the facility to identify professional
practice trends that impact the quality of care and patient safety. Such identification
may require intervention by the Medical Staff leadership. Criteria-based privileges
make the on-going monitoring of privileges easier for Medical Staff leadership. Each
service chief should consider what hospital, regional, state, national, and specialty
standards, activities, and data are available to meet these needs. The maintenance of
certification is not sufficient in and of itself. There are a number of activities such as
direct observation, clinical discussions, and clinical pertinence reviews that, if
documented, can also be incorporated into the on-going monitoring process. Data must
be practitioner specific, reliable, easily retrievable, timely, defensible, comparable, and
risk adjusted where appropriate.
i) The timeframe for ongoing monitoring is bi-annually.
ii) With very few exceptions, VHA data standing alone is not protected by 38 U.S.C.
5705. Its use would dictate the appropriate protections under law. Data that
generates documents used to improve the quality of health care delivered or the
utilization of health care resources is protected by 38 U.S.C. 5705. Data that is not
previously identified as protected by 38 U.S.C. 5705 and is collected as provider-
specific data could become part of a practitioners provider profile, analyzed in the

22
facilitys defined on-going monitoring program, and compared to pre-defined facility
triggers or de-identified quality management data.
iii) In those instances where a practitioner does not meet established criteria, the
service chief has the responsibility to document these facts. These situations can
occur for a number of reasons and do not preclude a service chief recommending
the renewal of privileges, but the service chief must clearly document the basis for
the recommendation of renewal of privileges.
iv) The PSB and the Executive Committee of the Medical Staff must consider all
information available, including the service chiefs recommendation and reasons for
renewal when criteria have not been met, prior to making their recommendation for
the granting of privileges to the Director. This deliberation must be clearly
documented in the minutes.
v) The Director shall weigh all information available, as well as the recommendations, in
the determination of whether or not to approve the renewal of privileges and
document this consideration.

Section 7.02 Application Procedures


1. Completed Application: Applicants for appointment to the Medical Staff must submit a
complete application. The applicant must submit credentialing information through VetPro
as required by VHA guidelines. The applicant is bound to be forthcoming, honest, and
truthful (1100.19 page 9). To be complete, applications for appointment must be submitted
by the applicant on forms approved by the VHA, entered into the internet-based VHA
VetPro credentialing database, and include authorization for release of information pertinent
to the applicant and information listed below. The applicant has the right to correct any
information that is factually incorrect by documenting the new information with a comment
that the previously provided information was not correct. Follow-up with the verifying entity
is necessary to determine the reason for the discrepancy if the practitioner says the
information provided is factually incorrect.
a. Items specified in Article III, Section 2, Qualifications for Medical Staff Membership,
including:
i) Active, current, full, and unrestricted license
ii) Education
iii) Relevant training and/or experience
iv) Current professional competence and conduct
v) Physical and mental health status
vi) English language proficiency
vii) Professional liability insurance (contractors only)
viii) Basic life support education
ix) To qualify for moderate sedation and airway management privileges, the practitioner
will have specific, approved clinical privileges and will acknowledge that they have
received a copy of The Sedation and Analgesia by Non-Anesthesia Providers
policy and agree to the guidelines outlined in the policy.
b. U.S. Citizenship: Applicants must be citizens of the United States. When it is not
possible to recruit qualified citizens, practitioners otherwise eligible for Medical Staff
appointment who are not citizens will be eligible for consideration for appointment with
proof of current visa status and Immigration and Naturalization Service documentation
regarding employment authorization, pursuant to qualifications as outlined in 38 U.S.C.
7405 and VA Handbook 5005, Part II, Chapter 3. (Exceptions to the citizenship
requirement may be made when hiring an individual will not conflict with pertinent VHA
regulations as interpreted by VISN 12 Human Resources.)
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c. References: The names and addresses of a minimum of four individuals who are
qualified to provide authoritative information regarding training/experience, competence,
health status and/or fulfillment of obligations as a Medical Staff member within the
privileges requested are required. At least one of the references must come from the
current or most recent employer or for individuals completing a residency; one reference
must come from the residency training program director. The Director may require
additional information.
d. Previous Employment: A list of all health care institutions or other organizations where
the practitioner is/has been appointed, utilized, or employed (held a professional
appointment), including:
i) Name of health care institution or practice
ii) Term of appointment or employment and reason for departure
iii) Privileges held and any disciplinary actions taken or pending against privileges,
including suspension, revocation, limitations, or voluntary surrender
e. DEA/CDS Registration: A description of:
i) Status, either current or inactive
ii) Any previously successful or currently pending challenges to, or the voluntary
relinquishment of, the practitioners DEA/CDS registration
f. Sanctions or Limitations: Any sanction or penalty by any licensing authority, including
current pending challenges, whether a license or registration ever held to practice a
health occupation by the practitioner has been suspended, revoked, voluntarily
surrendered, or not renewed.
g. Liability Claims History: Status (open, pending, closed, dismissed, etc.) of any claims
made against the practitioner in the practice of any health occupation including final
judgments or settlements, if available.
h. Loss of Privileges: Voluntary or involuntary termination of Medical Staff membership or
voluntary or involuntary limitation, reduction, or loss of clinical privileges at another
health care facility.
i. Release of Information: Authorization for release of information, including written
consent to the inspection of records and documents pertinent to applicant's licensure,
training, experience, current competence, and health status.
j. Pending Challenges: Pending challenges against the practitioner by any hospital,
licensing agency, professional group, or society.
k. Whether any complaint or report has been filed with the National Practitioner Date Bank
(NPDB), Federation of State Medical Boards (FSMB), state licensing board, or
disciplinary body or professional specialty association.

2. Primary Source Verification: In accordance with VHA Handbook 1100.19, Credentialing


and Privileging, and VA Handbook 5005, Part II, Chapter 3 the facility will obtain primary
source verification of:
a. A minimum of four references for initial credentialing, and two for re-credentialing, from
individuals able to provide authoritative information regarding information as described in
Article III, Section 2a above.
b. Verification of current or most recent clinical privileges held, if available.
c. Verification of status of all licenses current and previously held by the applicant.
d. Evidence and verification of the ECFMG (Educational Commission for Foreign Medical
Graduates) certificate for foreign medical graduates, if claimed.
e. Evidence and verification of board certification or eligibility, if applicable.
f. Verification of education credentials used to qualify for appointment including all
postgraduate training.

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g. Evidence of registration with the NPDB Proactive Disclosure Service and the Healthcare
Integrity and Protection Data Bank, for all members of the Medical Staff and those
practitioners with clinical privileges.
h. For all physicians screening will be accomplished through the FSMB Physician Data
Center. This screening will report all licenses known to FSMB ever held by the
physician. If the screen results in a disciplinary alert, primary source information from
the state licensing board for all actions related to the disciplinary alert as well as a
statement from the practitioner will be obtained.
i. Confirmation of health status on file as documented by a physician approved by the
Organized Medical Staff.
j. Evidence and verification of the status of any alleged or confirmed malpractice.
k. The applicants agreement to provide continuous care and to accept the professional
obligations defined in the Medical Staff Bylaws, rules, and regulations for the facility to
which the application is being made.
l. A signed consent for an inspection of all records and documents pertinent to his/her
application for Medical Staff membership or clinical privileges and to appear for an
interview, if required or requested.

3. The applicants attestation to the accuracy and completeness of the information submitted.
4. Burden of Proof: The applicant has the burden of obtaining and producing all needed
information for a proper evaluation of the applicants professional competence, character,
ethics, and other qualifications. The information must be complete and verifiable. The
applicant has the responsibility for furnishing information that will help resolve any doubts
concerning such qualifications. Failure to provide necessary information within 30 days of
the request to the applicant may serve as a basis for denial of employment consideration.
5. VetPro Required: All health care providers must submit credentialing information into
VetPro as required by VHA policy.

Section 7.03 Process and Terms of Appointment


1. Chief of Service Recommendation: The chief of the service or equivalent responsible
person to which the applicant is to be assigned is responsible for recommending
appointment to the Medical Staff based on evaluation of the applicant's completed
application, credentials, demonstrated competency, and a determination that service criteria
for clinical privileges are met. The service chief or ACOS or their designee will verify the
identity of new Medical Staff and confirm that the individual applying for appointment and
privileges is the same person whose credentials were verified. Accepted verification
includes any form of photo identification from a state or federal agency (drivers license,
passport, etc.) or current picture hospital ID card.
2. CMO Review: In order to ensure an appropriate review is completed in the credentialing
process the applicants file must be submitted to the VISN Chief Medical Officer (CMO) for
review and recommendation as to whether to continue the appointment and privileging
process prior to presentation to the MEC if the response from the NPDB-HIPDB query
indicates that any of the following criteria is met: There have been, for or on behalf of the
applicant, (a) three or more medical malpractice payments, (b) a single medical malpractice
payment of $550,000 or more, or (c) two medical malpractice payments totaling $1,000,000
or more. The higher level review by the VISN CMO is to assure that all circumstances,
including the individuals explanation of the specific circumstances in each case, are
weighed against the primary source verification and that the appointment is still appropriate.
The VISN CMO may consult with Regional Counsel as needed to determine the appropriate
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documents for primary source verification of the basis for medical malpractice payments.
The VISN CMO review will be documented on the service chiefs approval screen in VetPro
as an additional entry. Review by the CMO is also required for applicants for initial
appointment who have had any licensure actions or may have any pending licensure
actions. (This must be accomplished within 90 days of receipt of application and related
documents by the COS, or as soon thereafter as possible.)
3. MEC Recommendation: The PSB and MEC recommend Medical Staff appointment based
on evaluation of credentials of each applicant and a determination that Medical Staff criteria
for clinical privileges are met. There must be at least a simple majority of Medical Staff
members of the MEC present to conduct business regarding appointments and
reappointments.
4. Director Action: Recommended appointments to the Medical Staff should be acted upon by
the Director within 30 work days of receipt of a fully complete application, including all
required verifications, references, and recommendations from the appropriate service chief
and MEC.
5. Applicant Informed of Status: Candidates for appointment who have submitted complete
applications as defined by these Bylaws will receive written notice of appointment or non-
appointment, or return of the application because of inadequate information. In the case of
privilege denial, the applicant is also informed of the reason for denial. The credentialing
coordinator notifies the service secretaries of MEC decisions regarding privileging requests.
After Governing Body approval, the approved privilege list is sent to the service secretary
who in turn sends it to the practitioner.

Section 7.04 Credentials Evaluation and Maintenance


1. Evaluation of Competence: Determination will be made (through evaluation of all
credentials, peer recommendations, available quality of care information including Medical
Staff monitors) that the practitioner applying for clinical privileges has demonstrated current
competence in professional performance, judgment, clinical, and/or technical skill to
practice within clinical privileges requested.
2. Good Faith Effort to Verify Credentials: A good faith effort will be made to verify, with
primary sources, all credentials claimed. A good faith effort to verify is defined as
successful verification, or satisfactory evidence, that verification is not possible (records
destroyed, health care institution closed, private practice partner deceased, etc.). When it
is not possible to obtain documentation, an entry will be placed in the file stating the reason
and a secondary source will be sought. The entry will describe the effort made to obtain the
information with dates and signature of the individual(s) responsible for the effort. It will
also indicate when a secondary source, e.g., copy of diploma, confirmation from someone
in practice or training at the same time, is being used in lieu of primary-source verification.
The applicant should assist in providing required information for this documentation.
3. Maintenance of Files: A complete and current C&P file including the electronic VetPro file
will be established and maintained for each provider requesting privileges. Maintenance of
the C&P file is the responsibility of the COS. Any time a file is found to lack required
documentation, without an entry as noted above in paragraph two describing the efforts
made to obtain the information, effort will be made to obtain the documentation.
4. Focused Professional Practice Evaluation (FPPE): A FPPE will be initiated at time of initial
appointment with privileges, at the time of request for additional privileges, or in case of a
for-cause event requiring a focused review.

26
a. A FPPE, implemented at time of initial appointment, will be based on the practitioners
previous experience and competence. The evaluation can be defined as comprising a
specific time frame, number of procedures or cases, chart reviews, etc. and should be
discussed with the practitioner by the service chief.
b. A FPPE at the time of request for additional privileges will be for a period of time, a
number of procedures, and/or chart review to be set by the service chief.
c. A FPPE initiated by a for-cause event will be set by the service chief. FPPE for cause,
where there is concern regarding competence and the care being rendered to patients,
may require direct supervision and appropriate action on privileges i.e., summary
suspension
d. The FPPE monitoring process will clearly define and include the following:
i) Criteria for conducting the FPPE
ii) Method for monitoring for specifics of requested privilege
iii) Statement of the triggers for which a for-cause FPPE is required
iv) Measures necessary to resolve performance issues which will be consistently
implemented
e. Information resulting from the FPPE process will be integrated into the service specific
performance improvement program (non-Title 38 U.S.C. 5705 protected process),
consistent with the services policies and procedures.
f. If at any time the service chief or designee cannot determine the competence of the
practitioner being evaluated during the FPPE process, one or more of the following may
occur at the discretion of the service chief:
i) Extension of FPPE review period
ii) Modification of FPPE criteria
iii) Privileges (initial or additional) may not be maintained (appropriate due process will
be afforded to the practitioner)
iv) Termination of existing privileges (appropriate due process will be afforded to the
practitioner and will be appropriately terminated and reported)

Section 7.05 Local/VISN-Level Compensation Panels


Local and VISN-level compensation panels recommend the appropriate pay table, tier level and
market pay amount for individual Medical Staff members, as outlined in VA Handbook 5007,
Part IX/21. Appointment actions recommended by the PSB require a separate review for a pay
recommendation by the appropriate compensation panel.

ARTICLE VIII. CLINICAL PRIVILEGES

Section 8.01 General Provisions


1. Clinical privileges are granted for a period of no more than two years.
2. Reappraisal of privileges is required of each Medical Staff member and any other
practitioner who has clinical privileges. Reappraisal is initiated by the practitioner's service
chief at the time of a request by the practitioner for new privileges or renewal of current
clinical privileges.
a. Although the reappraisal process occurs biennially, ongoing professional practice
evaluation is designed to continuously evaluate a practitioners performance.
b. Reappraisal requires verification of satisfactory completion of sufficient continuing
education to satisfy state licensure and Medical Staff requirements.
c. For initial and reappointment, all time-limited credentials, including peer appraisals must
be current within 180 days of submission of the application. The term current applies to
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the timeliness of the verification and use for the C&P process. If the delay between the
candidates application and appointment, reappointment, or reporting for duty is greater
than 180 calendar days, the candidate must update all time-limited credentials and
information, including but not limited to licensure, current competence, and supplemental
questions. The updated information must be verified prior to consideration by the MEC.
The verification date of a time-limited credential cannot be more than 120 days prior to
the effective date of the privileges (1100.19 pages 7).

3. A practitioner may request modification or accretion of existing clinical privileges by


submitting a formal request for the desired change(s) with full documentation to support the
change to the service chief.
4. Associated health and mid-level practitioners who are permitted by law and the facility to
provide patient care services may be granted scope of practice, clinical privileges and/or
prescriptive authority based on their assignments, responsibilities, qualifications, and
demonstrated competence.
5. Requirements and processes for requesting and granting privileges are the same for all
practitioners who seek privileges regardless of the type of appointment or utilization
authority under which they function, their professional discipline, or position.
6. Practitioners with clinical privileges are approved for and have clinical privileges in one
clinical service but may be granted clinical privileges in other clinical services. Clinical
privileges granted extend to all physical locations of the designated service(s) within the
jurisdiction of the organization and its patient service area. In those instances where
clinical privileges cross to a different designated service, all service chiefs must recommend
the practice.
7. Exercise of clinical privileges within any service is subject to the rules of that service and to
the authority of that service chief.
8. When certain clinical privileges are contingent upon appointment to the faculty of an
affiliate, loss of faculty status results in termination of those privileges specifically tied to the
faculty appointment.
9. Telemedicine: All practitioners involved in the provision of telemedicine are subject to all
existing requirements for C&P, as identified in VHA Handbook 1100.19, Credentialing and
Privileging, and related VISN policies.
10. Teleconsultation: All practitioners providing teleconsultation services are subject to existing
requirements for C&P, as identified in VHA Handbook 1100.19, Credentialing and
Privileging and related VISN policies.

Section 8.02 Process and Requirements for Requesting Clinical Privileges


1. Burden of Proof: When additional information is needed, the practitioner requesting clinical
privileges must furnish all information and other supporting documents needed for a proper
evaluation of qualifications, professional competence, conduct, and ethics. The information
must be complete, accurate, and verifiable. If questions arise, the requesting practitioner is
responsible for furnishing information to clarify concerns or issues on qualifications. Failure
to provide necessary information within 30 days of request may result in denial of clinical
privileges.
2. Requests in Writing: All requests for clinical privileges must be made in writing by the
practitioner and include a statement of the specific privileges being requested in a format
approved by the Medical Staff.
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3. Credentialing Application: The practitioner applying for initial clinical privileges must submit
a complete application for privileges that includes:
a. Complete appointment information as outlined in Section 2 of Article VI.
b. Application for clinical privileges as outlined in this article.
c. Evidence of professional training and experience in support of privileges requested.
d. A statement of the practitioners physical and mental health status as it relates to
practitioners ability to function within privileges. This must be confirmed by a physician
acceptable to the Organized Medical Staff. Reasonable evidence of health status may
be required by the MEC.
e. A statement of the current status of all licenses and certifications held.
f. A description of any and all (1) sanctions, including those by a hospital, state licensing
agency, or any other professional health care organization/professional organization/
society; (2) voluntary or involuntary relinquishment of licensure or registration; (3)
malpractice claims, suits, or settlements (e.g., final judgment or settlements); and (4)
reduction or loss of privileges at any other hospital within 15 days of the adverse action.
g. Names of other hospitals at which privileges are held and requests for copies of current
privileges held.
h. Names and addresses of references qualified to provide authoritative information
regarding training, experience, competence, health status, and fulfillment of obligations
as a Medical Staff member within the privileges requested.
i. Evidence of successful completion of an approved BLS education.

4. Bylaws Receipt and Pledge: Prior to the granting of clinical privileges, Medical Staff
members or applicants must pledge to provide for continuous care of their patients and
agree to abide by the professional obligations in accordance with the Bylaws and rules.
5. Moderate Sedation and Airway Management: To qualify for moderate sedation and airway
management privileges, the practitioner must have specific, approved clinical privileges and
acknowledge that he/she has received a copy of sedation and analgesia by non-anesthesia
providers policy and agree to the guidelines outlined in the policy.

Section 8.03 Process and Requirement for Requesting Renewal of Clinical Privileges
1. Application: The practitioner applying for renewal of clinical privileges must submit the
following information:
a. An application for clinical privileges as outlined in Section 2 of this Article. This includes
submission of the electronic recredentialing application through VetPro. Since practice,
techniques, and facility missions change over time, it is expected that modifications,
additions, or deletions to existing clinical privileges will occur over time. Practitioners are
encouraged to consider carefully and discuss the appropriateness of specific privileges
with the appropriate service chief prior to formal submission of privilege requests.
b. Supporting documentation of professional training and/or experience not previously
submitted.
c. A statement of the practitioners physical and mental health status as it relates to
practitioners ability to function within privileges. This must be confirmed by a physician
acceptable to the Organized Medical Staff. Reasonable evidence of health status may
be required by the MEC.
d. Documentation of continuing medical education related to area and scope of clinical
privileges, (consistent with minimum state licensure requirements) not previously
submitted.

29
e. A statement of the current status of all licenses, licenses previously held which have
lapsed since last appointment, and certifications held. The status of all licenses and
certifications must be validated. This applies to licenses held in multiple states for the
same professional discipline or practice.
f. A description of any and all (1) sanctions, including those by a hospital, state licensing
agency, or any other professional health care organization/professional organization/
society; (2) voluntary or involuntary relinquishment of licensure or registration; (3)
malpractice claims, suits, or settlements (e.g., final judgment or settlements); and (4)
reduction or loss of privileges at any other hospital within 15 days of the adverse action.
g. Names and addresses of two peers who are qualified to provide authoritative information
regarding training, experience, competence, health status, and fulfillment of obligations
as a Medical Staff member within the privileges requested.
h. Names of other hospitals or facility at which privileges are held and requests for copies
of current privileges held.

2. Verification: Before granting subsequent clinical privileges, the C&P office will ensure that
the following information is on file and verified with primary sources, as applicable:
a. Current and previously held licenses in all states.
b. Current and previously held DEA/State CDS registration
c. NPDB-HIPDB PDS registration
d. FSMB query
e. Physical and mental health status information from applicant
f. Physical and mental health status confirmation
g. Professional competence information from peers and service chief, based on results of
ongoing professional practice monitoring and FPPE
h. Continuous education to meet any local requirements for privileges requested
i. Board certifications, if applicable
j. Quality of care information

Section 8.04 Processing an Increase or Modification of Privileges


1. A practitioners request for modification or accretion of, or addition to, existing clinical
privileges is initiated by the practitioners submission of a formal request for the desired
change(s) with full documentation to support the change to the clinical service chief. This
request will initiate the recredentialing process as noted in the VHA Handbook 1100.19.
2. Primary source verification is conducted if applicable, e.g., provider attests to additional
training.
3. Current NPDB-HIPDB PDS registration prior to rendering a decision.
4. A modification or enhancement of, or addition to, existing clinical privileges requires the
approval of the MEC followed by the Director's/Governing Bodys approval.
Section 8.05 Recommendations and Approval for Initial/Renewal,
Modification/Revision of Clinical Privileges

1. Peer recommendations from individuals who can provide authoritative information regarding
training, experience, professional competence, conduct, and health status are required.
2. The respective service chief where the applicant is requesting clinical privileges is
responsible for assessing all information and making a recommendation regarding whether
to grant clinical privileges.
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a. Recommendations for initial, renewal, or modification of privileges are based on a
determination that applicant meets criteria for appointment and clinical privileges for the
service including requirements regarding education, training, experience, references,
and health status.
b. Recommendation for clinical privileges subsequent to those granted initially are based
on reappraisal of physical and mental health status, peer recommendations, continuing
education, professional performance, judgment, clinical and/or technical skills, and
quality of care including results of monitoring and evaluation.

3. The MEC, or the committee responsible for the Medical Executive Function, recommends
granting clinical privileges to the Director (Governing Body) based on each applicant
successfully meeting the requirements for clinical privileges as specified in these Bylaws. A
subcommittee of the MEC can make the initial review and recommendation but this
information must be reviewed and approved by the MEC.
4. Clinical privileges are acted upon by the Director within 30 calendar days of receipt of the
MEC recommendation to appoint. The Directors action must be verified with an original
signature.
5. Originals of approved clinical privileges are placed in the individual practitioners C&P file.
A copy of approved privileges is given to the practitioner and is readily available to
appropriate staff for comparison with practitioner procedural and prescribing practices.
6. Scope of practice and prescriptive authority for mid-level and associate health practitioners
is obtained through the respective service chief where the applicant is requesting clinical
privileges.

Section 8.06 Exceptions


1. Temporary Privileges for Urgent Patient Care Needs: Temporary clinical privileges for
emergent or urgent patient care needs may be granted at the time of an initial appointment
for a limited period of time (not to exceed 60 calendar days) by the Director or Acting
Director on the recommendation of the COS.
a. Temporary privileges are based on verification of the following:
i) One, active, current, unrestricted license with no previous or pending actions
ii) One reference from a peer who is knowledgeable of and confirms the practitioners
competence and who has reason to know the individual's professional qualifications
iii) Current comparable clinical privileges at another institution
iv) Response from NPDB-HIPDB PDS registration with no match
v) Response from FSMB with no reports
vi) No current or previously successful challenges to licensure
vii) No history of involuntary termination of Medical Staff membership at another
organization
viii) No voluntary limitation, reduction, denial, or loss of clinical privileges
ix) No final judgment adverse to the applicant in a professional liability action
b. A completed application must be submitted within three calendar days of temporary
privileges being granted and credentialing completed.

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2. Expedited Process:
a. The practitioner must submit a completed application through VetPro.
b. The Facility:
i) Verifies education and training
ii) Verifies one active, current, unrestricted license from a state, territory, or
commonwealth of the United States or the District of Columbia;
iii) Receives confirmation on the declaration of health, by a physician designated by or
acceptable to the facility, of the applicants physical and mental capability to fulfill the
requirement of the clinical privileges being sought
iv) Queries licensure history through the FSMB Physician Data Center and receives a
response with no report documented;
v) Receives confirmation from two peer references who are knowledgeable of and
confirm the physicians competence, including at least one from the current or most
recent employer(s) or institution(s) where the applicant holds or held privileges, or
who would have reason to know the individual's professional qualifications.
vi) Verifies current comparable privileges held in another institution
vii) Receives a response from NPDB-HIPDB PDS registration with no match
viii) Verifies that there are no current or previously successful challenges to licensure.
ix) Verifies that there is no history of involuntary termination of Medical Staff
membership at another organization
x) Verifies that there is no history of voluntary limitation, reduction, denial, or loss of
clinical privileges
xi) Verifies that there is no history of final judgments adverse to the applicant in a
professional liability action
c. A delegated subcommittee of the MEC, consisting of at least two voting members of the
full committee, recommends appointment to the Medical Staff.
d. The recommendation by the delegated subcommittee of the MEC must be acted upon
by the Director.
e. Full credentialing must be completed within 60 calendar days of the date of the
Directors/Governing Bodys signature and presented to the MEC for ratification.

3. Emergency Care: Emergency care may be provided by any individual who is a member of
the Medical Staff or who has been granted clinical privileges, within the scope of the
individual's license, to save a patient's life or save the patient from serious harm. Once
imminent danger has passed, the care of the patient should be transferred as appropriate.
Emergency care may also be provided by properly supervised residents of the facilitys
affiliated residency training programs.
4. Disaster Privileges: Also described in the facilitys Emergency Management Plan:
a. In the event of the implementation of the organization-wide disaster management plan,
disaster privileges may be approved by the COS or in his/her absence the Acting COS if
it is determined that it is not possible to handle the influx of patients with the existing
practitioners. Any of the following will be accepted as credentials verification process for
emergency volunteers to provide patient care in the facility:
i) Evidence of a current license (pocket card sufficient) to practice.
ii) And one of the following:
(1) A current medical facility photo ID card.
(2) Identification indicating that the individual is a member of a Disaster Medical
Assistance Team (DMAT).

32
(3) Identification that the individual has been granted authority to render patient care
in emergency circumstances by a federal, state, or municipal entity.

b. The documentation will serve as credentials verification for a period not to exceed ten
calendar days or length of the disaster, whichever is shorter. Primary source verification
of licensure will be obtained within 72 hours after the disaster is under control or as soon
as possible in extraordinary circumstances.
c. In circumstances where communication methods utilized to verify credentials fail or are
unavailable beyond the ten calendar days or the length of the declared disaster,
whichever is shorter, noted in paragraph b above, the practitioner must be converted to
temporary privileges in accordance with VHA Handbook 1100.19, Credentialing and
Privileging, for a period not to exceed 60 working days.
d. An assigned, appropriately credentialed and privileged physician oversees the
professional practice of each volunteer, LIP, mid-level practitioner, and allied health
practitioner.
e. The quality of the care and service rendered by each volunteer practitioner with disaster
privileges must be evaluated at the end of 72 hours and a determination made as to
whether or not the practitioner will be permitted to continue providing services.

5. Inactivation of Privileges: The inactivation of privileges occurs when a practitioner is not an


actively practicing member of the Medical Staff for an extended period of time such as
extended sick leave or sabbatical with or without clinical practice while on sabbatical.
a. When the practitioner returns to the facility, C&P activities are similar to the initial
credentialing process with the exception that non-time limited information, e.g.,
education and training, does not need to be verified again. Inactivation of privileges may
not be used as a substitute for termination of Medical Staff appointment and/or
revocation of privileges where such action(s) is warranted.
b. At the time of inactivation of privileges, including separation from the Medical Staff, the
Director ensures that within seven calendar days of the date of separation, information is
received suggesting that practitioner met generally accepted standards of clinical
practice and there is no reasonable concern for the safety of patients in accordance with
VHA Handbook 1100.18.

6. Deployment and Activation Privilege Status: In those instances where a practitioner is


called to active duty, the practitioners privileges are placed in a deployment and/or
Activation Status. The credential file remains active with the privileges in this new status. If
at all possible, the process described below for returning privileges to an active status is
communicated to the practitioner before deployment.
a. Facility staff request that a practitioner returning from active duty communicate with the
facility staff as soon as possible upon returning to the area.
b. After the electronic credentials file has been reopened for credentialing, the practitioner
must update the licensure information, health status, and professional activities while on
active duty.
c. The credentials file must be brought to a verified status. If the practitioner performed
clinical work while on active duty, an attempt is made to confirm the type of duties, the
practitioners physical and mental ability to perform these duties, and the quality of the
work. This information must be documented.
d. The verified credentials, the practitioners request for returning the privileges to an active
status, and the service chiefs recommendation are presented to the MEC for review and
recommendation. The documents reviewed, the determination, and the rationale for the
33
determination of the MEC is documented and forwarded to the Director for
recommendation and approval of restoring the practitioners privileges to current and
active status from deployment and/or activation status.
e. In those instances when the practitioners privileges did not expire during deployment,
the expiration date of the original clinical privileges at the time of deployment continues
to be the date of expiration of the restored clinical privileges.
f. In those instances where the privileges lapsed during the call to active duty, the
practitioner needs to provide additional references for verification and facility staff need
to perform all verifications required for reappointment.
g. In those instances where the practitioner was not providing clinical care while on active
duty, the practitioner in cooperation with the service chief, must consider whether a
request for modification of the privileges held prior to the call to active duty should be
initiated on a short-term basis.
h. If the file cannot be brought to a verified status and the practitioners privileges restored
by the Director, the practitioner can be granted a temporary appointment to the Medical
Staff not to exceed 60 calendar days during which time the C&P process must be
completed. In order to qualify for this temporary appointment, when returning from
active duty the following must be documented in VetPro:
i) Verification that all licenses that were current at the time of deployment and/or
activation are current and unrestricted with no previous or pending adverse actions
on the Temporary Enrollment Screen
ii) Registration with the NPDB-HIPDB PDS with no match
iii) A response from the FSMB with no match
iv) Marking of the Temporary Enrollment Screen as reinstatement from Deployment
and/or Activation
v) Documentation of the Temporary Appointment on the Appointment Screen not to
exceed 60 calendar days

ARTICLE IX. INVESTIGATION AND ACTION


1. Request for Investigation: Whenever the behaviors, activities, and/or professional
conduct of any practitioner with delineated clinical privileges are considered to be
detrimental to patient care, to pose a threat to patient safety, to be lower than the
standards of the Medical Staff, or to represent professional misconduct, disruptive
behavior, or inappropriate behavior, as defined in these Bylaws, investigation of such
practitioner may be requested by the chief of any clinical service, the chair of any
standing committee of the Medical Staff, the COS or the Director. All requests for
investigation must be made in writing to the COS supported by reference to specific
activities or conduct, which constitute the grounds for the request. The COS promptly
notifies the Director in writing of the receipt of all requests. A management review will
be recommended for investigation of HR standards. Concerns regarding professional
competency will be referred to a PSB. Material that is obtained as part of a protected
performance improvement program (i.e., under 38 U.S.C. 5705), may not be disclosed
in the course of any action to reduce or revoke privileges, nor may any reduction or
revocation of privileges be based directly on such performance improvement data. If
such information is necessary to support a change in privileges, it must be developed
through mechanisms independent of the performance improvement program, such as
administrative reviews and boards of investigation. In these instances, the performance
improvement data may have triggered the review; however, the quality improvement
information is confidential and privileged in accordance with 38 U.S.C. 5705 and,

34
therefore, must be rediscovered through the administrative review or investigation
process.
2. Fact-Finding Process: Whenever the COS receives a request for investigation as
described in paragraph 1 of this Article IX, a fact-finding process will be implemented.
This fact-finding process should be completed within 14 days or there needs to be
documentation as to why that was not possible. If the results of the fact-finding process
indicate that there is reasonable cause to believe that the behaviors, activities, and/or
professional conduct the practitioner are likely to be detrimental to patient care, to pose
a threat to patient safety, to be lower than the standards of the Medical Staff, or to
represent professional misconduct, disruptive behavior, or inappropriate behavior, as
defined in these Bylaws, the COS may impose a summary suspension of privileges in
accordance with the Medical Staff Bylaws and will initiate a review by the PSB.
3. Review by the Professional Standards Board (PSB): The PSB investigates the charges
and makes a report of the investigation to the MEC within 14 days after the PSB has
been convened to consider the request for corrective action. Pursuant to the
investigation, the practitioner being investigated has an opportunity to meet with the
PSB to discuss, explain, or refute the charges against him/her. This proceeding does
not constitute a hearing and none of the procedural rules set forth in Article X of these
Bylaws apply thereto. An investigation by the PSB is an administrative matter and not
an adversarial hearing. A record of such proceeding is made and included with the
committees findings, conclusions and recommendations reported to the MEC.
4. Medical Executive Council (MEC) Action: Within 14 days after receipt of a report from
the PSB, the MEC acts upon the request. If the action being considered by the MEC
involves a reduction, suspension, or revocation of clinical privileges, or a suspension or
revocation of Medical Staff membership, the practitioner is permitted to meet with the
MEC prior to the Committees action on such request. This proceeding does not
constitute a hearing and none of the procedural rules set forth in Article X of these
Bylaws apply thereto. A record of such proceeding is made by the MEC.
a. The MEC may reject or modify the recommendations; issue a warning, a letter of
admonition, or a letter of reprimand; impose terms of probation or a requirement for
consultation; recommend reduction, suspension, or revocation of clinical privileges;
recommend that an already imposed suspension of clinical privileges be terminated,
modified, or sustained; or recommend that the practitioners staff membership be
suspended or revoked.
b. Any recommendation by the MEC for the reduction, suspension, or revocation of
clinical privileges, or for the suspension or revocation of Medical Staff membership,
entitles the practitioner to the rights set forth in Article X of these Bylaws.
c. Reduction of privileges may include, but not be limited to, functioning under
supervision1, restricting performance of specific procedures, or prescribing and/or
dispensing controlled substances. Reduction of privileges may be time limited and/or
have restoration contingent upon some condition, such as demonstration of recovery
from a medically disabling condition or further training in a particular area.
d. Revocation of privileges refers to the permanent loss of clinical privileges.

5. Summary Suspension of Privileges: The Director has the authority, whenever


immediate action must be taken in the best interest of patient care, to summarily

1
See the definition of Proctoring for an explanation of the difference between proctoring and supervision.
35
suspend, for cause, or portion of a practitioners delineated clinical privileges. Such
suspension shall become effective immediately upon imposition by the Director.
a. The COS convenes the PSB to investigate the matter, meet with the practitioner if
requested, and make a report thereof to the MEC within 14 days after the effective
date of the summary suspension.
b. Immediately upon the imposition of a summary suspension, the service chief or the
COS provides alternate medical coverage for the patients of the suspended
practitioner.

6. Automatic Suspension of Privileges: An automatic suspension occurs immediately upon


the occurrence of specific events.
a. The Medical Staff membership and clinical privileges of any practitioner with
delineated clinical privileges shall be automatically suspended if any of the following
occurs:
i) The practitioner is being investigated, indicted, or convicted of a misdemeanor or
felony that could impact the quality and safety of patients.
ii) Failure on the part of any staff member to complete medical records in
accordance with system policy will result in progressive disciplinary action to
possible indefinite suspension.
iii) The practitioner is being investigated for fraudulent use of the government credit
card.
iv) Failure to maintain the mandatory requirements for membership to the Medical
Staff.
b. The COS convenes the PSB to investigate the matter and make a report thereof to
the MEC within 14 days after the effective date of the automatic suspension.
c. Immediately upon the occurrence of an automatic suspension, the service chief or the
COS provides alternate medical coverage for the patients of the suspended
practitioner.
d. If there are more than three automatic suspensions of privileges in one calendar year,
or more than 20 days of automatic suspension in one calendar year, a thorough
assessment of the need for the practitioner's services must be performed and
documented and appropriate action taken.

7. Union Representation: When the practitioner is a union member, he/she has the right to
representation in the interview processes described in paragraphs one through six of
this Article IX.
8. Actions Not Constituting Corrective Action: The PSB will not be deemed to have made
a proposal for an adverse recommendation or action, or to have made such a
recommendation, or to have taken such an action, and the right to a hearing will not
have arisen, in any of the following circumstances:
a. The appointment of an ad hoc investigation committee
b. The conduct of an investigation into any matter
c. The making of a request or issuance of a directive to an applicant or a practitioner to
appear at an interview or conference before the Credentials Committee, any ad hoc
investigating committee, the COS, or any other committee or sub-committee with
appropriate jurisdiction in connection with any investigation prior to a proposed
adverse recommendation or action
d. The failure to obtain or maintain any other mandatory requirement for Medical Staff
membership
36
e. The imposition of proctoring or observation on a Medical Staff member which does
not restrict clinical privileges or the delivery of professional services to patients;
f. The issuance of a letter of warning, admonition, or reprimand
g. Corrective counseling
h. A recommendation that the practitioner be directed to obtain retraining, additional
training, or continuing education
i. Any recommendation or action not "adversely affecting" (as such term is defined in
Section 431(1) of the Health Care Quality Improvement Act) any applicant or
practitioner, or which is not based on a subjective determination of the professional
competency or conduct of the applicant or practitioner

ARTICLE X. FAIR HEARING AND APPELLATE REVIEW


1. Reduction of Privileges:
a. Prior to any action or decision by the Director regarding reduction of privileges, the
practitioner will receive written notice of the proposed changes in privileges from the
COS. The notice will include:
i) A description of the reason(s) for the change.
ii) A statement of the practitioners right to be represented by counsel or a
representative of the individuals choice, throughout the proceedings.
b. The practitioner will be allowed to review all evidence not restricted by regulation or
statute upon which proposed changes are based. Following that review, the
practitioner may respond in writing to the COS written notice of intent. The
practitioner must submit a response within ten workdays of the COS written notice.
If requested by the practitioner, the COS may grant an extension for a brief period,
normally not to exceed ten additional workdays except in extraordinary
circumstances.
c. Information will be forwarded to the Director for decision. The Director will make a
decision on the basis of the record. If the practitioner disagrees with the Directors
decision, a hearing may be requested. The practitioner must submit the request for
a hearing within five workdays after receipt of decision of the Director.
2. Convening a Panel: The Director must appoint a review panel of three unbiased
professionals, within five workdays after receipt of the practitioner's request for hearing.
These three professions will conduct a review and hearing. At least two members of the
panel must be members of the same profession. If specialized knowledge is required, at
least one member of the panel must be a member of the same specialty. This review
panel hearing is the only hearing process conducted in connection with the reduction of
privileges. Any other review processes must be conducted on the basis of the record.
The hearing will proceed as follows:

a. The practitioner must be notified in writing of the date, time, and place of the
hearing. The date of the hearing must not be less than 20 workdays and not more
than 30 workdays from the date of notification letter.
b. During such hearing, the practitioner has the right to:
i) Be present throughout the evidentiary proceedings.
ii) Be represented by an attorney or other representative of the practitioner's choice
iii) Cross-examine witnesses.
3. In cases involving reduction of privileges, a determination must be made as to whether
disciplinary action should be initiated.

37
4. The panel must complete the review and submit the report within 15 workdays from the
date of the close of the hearing. Additional time may be allowed by the Director for
extraordinary circumstances or cause.

a. The panel's report, including findings and recommendations, must be forwarded to the
Director, who has authority to accept, reject, accept in part, or modify the review panel's
recommendations.
b. The Director must issue a written decision within ten workdays of the date of receipt of
the panel's report. If the practitioner's privileges are reduced, the written decision must
indicate the reason(s). The signature of the Director constitutes a final action and the
reduction is reportable to the NPDB.
c. If the practitioner wishes to appeal the Directors decision, the practitioner may appeal
to the appropriate VISN Director within five workdays of receipt of the facility Director's
decision. This appeal option will not delay the submission of the NPDB report. If the
Directors decision is overturned on appeal, the report to the NPDB must be withdrawn.
d. The VISN Director must provide a written decision, based on the record, within 20
workdays after receipt of the practitioner's appeal.
e. The hearing panel chair shall do the following:
a Act to ensure that all participants in the hearing have reasonable opportunity to be
heard and to present oral and documentary evidence subject to reasonable limits on
the number of witnesses and duration of direct and cross examination, applicable to
both sides, as may be necessary to avoid cumulative or irrelevant testimony or to
prevent abuse of the hearing process.
b Prohibit conduct or presentation of evidence that is cumulative, excessive, irrelevant,
or abusive, or that causes undue delay. In general, it is expected that a hearing will
last no longer than a total of 15 hours.
c Maintain decorum throughout the hearing.
d Have the authority and discretion to make rulings on all questions that pertain to
matters of procedure and to the admissibility of evidence.
e Act in such a way that all information reasonably relevant to the continued
appointment or clinical privileges of the individual requesting the hearing is
considered by the hearing panel when formulating its recommendations.
f Conduct argument by counsel on procedural points and do so outside the presence
of the hearing panel.
g Seek legal counsel when he or she feels it is appropriate. Regional Counsel to the
facility should advise the panel chair.
f. Practitioner Rights: The practitioner has the right to be present throughout the
evidentiary proceedings, represented by counsel or a representative of practitioners
choice, cross-examine witnesses, and to purchase a copy of the transcript or tape of the
hearing.
i) The panel will complete its review and submit its report within 15 workdays of the
date of the hearing. Additional time may be allowed by the Director for extraordinary
circumstances or cause. The panels report, including findings and
recommendations, will be forwarded to the Director, who has authority to accept,
accept in part, modify, or reject the review panels recommendations.
ii) The Director will issue a written decision within ten workdays of the day of receipt of
the panels report. If the practitioners privileges are reduced, the written decision will
indicate the reason(s) for the change.
iii) The practitioner may submit a written appeal to the VISN Director within five
workdays of receipt of the Directors decision.

38
iv) The VISN Director will provide a written decision based on the record within 20
workdays after receipt of the practitioners appeal. The decision of the VISN
Director is not subject to further appeal.
v) A practitioner who does not request a review panel hearing but who disagrees
with the Directors decision may submit a written appeal to the appropriate VISN
Director within five workdays after receipt of the Directors decision.
vi) The review panel hearing defined in paragraph d will be the only hearing process
conducted in connection with the reduction of privileges; any other review
processes will be conducted on the basis of the record.
vii) If a practitioner surrenders or voluntarily accepts a restriction of his/her clinical
privileges, or resigns or retires from his/her Medical Staff position with the
Department of Veterans Affairs while the practitioners professional competence
or professional conduct is under investigation to avoid investigation, if greater
than 30 days such action is reported without further review or due process to the
NPDB and the appropriate state licensing boards.

g. Revocation of Privileges:
i) Proposed action taken to revoke a practitioners privileges will be made using
VHA procedures.
(a) In instances where revocation of privileges is proposed for permanent
employees, the proposed revocation will be combined with action to discharge
the employee under Section 7461-7464 of Title 38, United States Code, and VA
Handbook 5021 Employee/Management Relations.
(b) For probationary employees appointed under 38 U.S.C. 7401(1) and 38
U.S.C. 7405, the proposed revocation will be combined with probationary
separation procedures, which constitutes an automatic revocation as contained
in VA Handbook 5021, Employee/Management Relations.
ii) Revocation procedures will be conducted in a timely fashion. If discharge,
separation during probation, or termination of appointment is not proposed,
revocation of clinical privileges may not occur. Even though a revocation of
privileges requires removal from both employment and appointment to the Medical
Staff, in extremely rare cases, there may be a credible reason to reassign the
practitioner to a position not requiring clinical privileges. Such an action may still
result in reporting to the NPDB if the revocation and reassignment is for
substandard care, professional incompetence, or professional misconduct. For
example a surgeons privileges for surgery may be revoked and the surgeon
reassigned to a non-surgical area when doing so is beneficial to meeting other
needs of the facility. Any recommendation by the MEC for the reduction,
suspension, or revocation of clinical privileges, or for the suspension or revocation
of Medical Staff membership, entitles the practitioner to the rights set forth in
Article X of these Bylaws.

h. Reporting to the National Practitioner Data Bank2:


i) Tort (malpractice) claims are filed against the United States government, not
individual practitioners. There is no direct financial liability for named or involved
practitioners. Government attorneys (Regional Counsel, General Counsel, U.S.

2
Reference VHA Handbook 1100.17.
39
Attorney) investigate the allegations, and deny, settle, or defend the case. Claims
that are denied may subsequently go to litigation.
ii) When a claim is settled or a judgment is made against the government (and a
payment made), a VA review is conducted to determine if the involved
practitioners should be reported to the NPDB. The review must determine that
there was substandard care, professional incompetence, or professional
misconduct and if so, is attributable to a licensed practitioner in order to meet
reporting requirements.
iii) Practitioners are also identified and notified at the time a tort claim is filed so that
they may assist regional and general counsel in defending the case and in
decisions concerning denial or settlement.
iv) Post payment reviews are performed nationally by the office of Medical-Legal
Affairs. Accordingly, a letter is now sent to physicians involved in the plaintiffs
case when a tort claim settlement is submitted for review.
v) VA only reports adverse privileging actions that adversely affect the clinical
privileges of Physician and Dentists after a professional review action or if the
practitioner surrenders clinical privileges while under investigation. The
professional review action is the due process (e.g., fair hearing and appeal
process) afforded the practitioner for a reduction or revocation of clinical
privileges. The reference for this is 38 CFR part 46.4 The notice of summary
suspension to the practitioner must include a notice that if a final action is taken,
based on professional competence or professional conduct, both the summary
suspension, if greater than 30 days, and the final action will be reported to the
NPDB. After the final action, the reduction or revocation as well as the summary
suspension if greater than 30 days will be reported.

i. Reporting to State Licensing Boards: VA has a responsibility to report to state licensing


boards appointed or suspended members of the Medical Staff whose behavior or clinical
practice so substantially fails or failed to meet generally accepted standards of clinical
practice as to raise reasonable concern for the safety of patients.
j. Management Authority: Nothing in these procedures restricts the authority of
management to detail or reassign, on a temporary basis, an employee to non-patient
care areas or activities, thus suspending privileges, during the pendency of any
proposed reduction of privileges or discharge, separation, or termination proceedings.
Further, the Director, on the recommendation of the COS, may summarily suspend
privileges, on a temporary basis, when there is sufficient concern regarding patient
safety or specific practice patterns. Individuals appointed under authority of 38
U.S.C.7401(1) and 7405 may be terminated when this is determined to be in the best
interest of VA in accordance with provisions of VHA Handbook 5021,
Employee/Management Relations.

ARTICLE XI. RULES AND REGULATIONS


As may be necessary to implement more specifically the general principles of conduct
found in these Bylaws and to identify the level of clinical practice that is required of each
member of the Medical Staff and of all others with delineated clinical privileges or practicing
under a scope of practice, Medical Staff rules and regulations may be adopted. Rules and
regulations may be adopted, amended, repealed, or added by a majority vote of the
members of the MEC present and voting at any meeting of that Committee where a quorum
exists, provided that written recommendations concerning the proposed amendments were

40
received and reviewed by the members of the Committee prior to the meeting. Medical
Staff rules and regulations must be approved by the Director.

ARTICLE XII. AMENDMENTS


1. The Bylaws are reviewed at least every two years, revised as necessary to reflect current
practices with respect to Medical Staff organization and functions, and dated to indicate the
date of last review. Proposed amendments to the Bylaws may be submitted in writing to
the COS by any member of the Medical Staff. Recommendations for change come directly
from MEC. Changes to the Bylaws are amended, adopted, and voted on by the Organized
Medical Staff as a whole and then approved by the Director. The Bylaws are amended and
adopted by a two-thirds majority endorsement of the active Medical Staff.
2. The Executive Committee may adopt urgent amendments to the rules and regulations that
are deemed necessary for legal or regulatory compliance. After adoption, these urgent
amendments to the rules and regulations will be communicated back to the Organized
Medical Staff for review by email. It there is no conflict, the adoption of the urgent
amendment will stand approved. If a conflict arises, the alternative dispute resolution or
conflict management process should be followed.
3. Written text of proposed significant changes is to be provided to Medical Staff members and
others with clinical privileges. Medical Staff members will be given time to review proposed
changes and are notified of the date proposed changes are to be considered.
4. All changes to the Bylaws require action by both the Organized Medical Staff and Director.
Neither may unilaterally amend the Bylaws.
5. Changes are effective when approved by the Director.

ARTICLE XIII. ADOPTION


These Bylaws shall be adopted upon recommendation of the Organized Medical Staff via vote
that constitutes a quorum. They shall replace any previous Bylaws and shall become effective
when approved by the Director.
RECOMMENDED

Chief of Staff Date

APPROVED

Director Date

41
MEDICAL STAFF RULES

1. GENERAL
A. The rules relate to role and/or responsibility of members of the Medical Staff and
individuals with clinical privileges in the care of any and all patients.
B. Rules of departments or services will not conflict with each other, rules and policies of
the Medical Staff, or with requirements of the Governing Body.
C. The Medical Executive Council (MEC) serves as the executive committee of the Medical
Staff and acts in their behalf. The Committee is responsible for continually reviewing the
quality of the clinical care carried out in the facility.
D. Each of the clinical services shall conduct Medical Staff meetings at least quarterly to
consider findings from ongoing monitoring and evaluation of the quality and
appropriateness of patient care and treatment. Minutes must reflect discussion by
Medical Staff and responsible party of patient care issues, with resultant significant
conclusions, recommendations, action taken, and evaluation of follow-up actions.
E. Information used in quality improvement as referenced in Article IX, cannot be used
when making adverse privileging decisions.

2. PATIENT RIGHTS
A. Patients Rights and Responsibilities: This organization supports the rights of each
patient and publishes policy and procedures to address rights including each of the
following:
i) Reasonable response to requests and need for service within capacity, mission,
laws, and regulations.
ii) Considerate and respectful care that fosters a sense of dignity, autonomy, and civil
rights.
iii) Collaboration with the physician in matters regarding personal health care.
iv) Pain management including assessment, treatment, and education.
v) Information with regard to names and professional status of physicians and all
other health care providers responsible for care, procedures, or treatments.
vi) Formulation of advance directives and appointment of surrogate to make health
care decisions (38 CFR17.32).
vii) Access to information necessary to make care decisions that reflect patient's
wishes, including potential outcomes, risks and benefits, and consequences of
refusal of treatment.
viii) Access to information about patient rights, handling of patient complaints.
ix) Participation of patient or patient's representative in consideration of ethical
decisions regarding care.
x) Access to information regarding any human experimentation or research/education
projects affecting patient care.
xi) Personal privacy and confidentiality of information.
xii) Action by a legally authorized person to exercise a patient's rights if a patient is
judged incompetent in accordance with law or is found by a physician to be
medically incapable of understanding treatment or unable to communicate his/her
wishes.

42
xiii) Authority of the Chief of Staff (COS) or in his/her absence the Acting COS to
approve/authorize necessary surgery, invasive procedure, or other therapy for a
patient who is incompetent to provide informed consent (when no next of kin is
available).
xiv) Foregoing or withdrawing life-sustaining treatment including resuscitation.
xv) Nondiscrimination against individuals who use or abuse alcohol or other drugs and
persons infected with the human immunodeficiency virus.

B. Living Will, Advance Directives, and Informed Consent (38 CFR 17.32):
i) Competent patients have the right to consent to and, equally, to decline any
treatment including the provision of life-sustaining treatment. Accordingly, life-
sustaining treatment will not be provided to competent patients who decline it.
Similarly, life-sustaining treatment will be provided, consistent with prevailing
medical practice, when the competent patient consents or in emergent situations
where informed consent may be implied. When the competent patient withdraws
consent to any treatment to which the patient has previously consented, including
the provision of life-sustaining treatment, such treatment will be withdrawn. He/she
will be informed of the medical consequences of such decisions.
ii) Medical decisions regarding the patient's diagnosis and prognosis, and treatment
options to be presented to the patient, shall be made by the attending physician in
consultation with, as appropriate, other members of the treatment team (38 USC
sections 7331).
iii) With respect to the documentation of decision making concerning life-sustaining
treatment, the following information, at a minimum, will be documented in the
progress notes by the attending physician: The patient's diagnosis and prognosis;
an assessment of the patient's decision making capacity; treatment options
presented to the patient for consideration; the patient's decisions concerning life-
sustaining treatment.
iv) Competent patients will be encouraged, but not compelled, to involve family
members in the decision making process. Patient requests that family members
not be involved in or informed of decisions concerning life-sustaining treatment will
be honored, and will be documented in the medical record.
v) Advance Directives: The patient's right to direct the course of medical care is not
extinguished by the loss of decision making capacity. In order that this right may
be respected in cases involving such patients, VHA recognizes the right of an adult
person to make an advance directive, in writing, concerning all treatment, including
life-sustaining treatment. Any competent patient may execute a declaration
requesting that some or all life-sustaining treatments be withheld or withdrawn.
The desires of any VA patient, as expressed at the time the advance directive is to
be implemented, shall supersede those previously expressed in an advance
directive. In addition, an advance directive may be revoked by a declarant at any
time.
vi) Substituted Judgments: The rights of patients to direct the course of medical
treatment are not extinguished by the lack of decision making capacity or by the
fact that an advance directive has not been previously executed. VHA is directed
by statute to ensure, to the maximum extent practicable, that medical care is
provided only with the full and informed consent of the patient or, in appropriate
cases, the patient's surrogate decision maker. Accordingly, "substituted consent"
shall be secured from an incompetent patient's surrogate decision maker prior to
the initiation of treatment, except in emergent situations. The person making

43
decisions for a terminally ill patient who lacks decision making capacity should act
as that patient's "surrogate" for purposes of consenting to, or declining, life-
sustaining treatment. Life-sustaining treatment will not be withheld or withdrawn
under this paragraph unless the attending physician is satisfied that the decision of
the surrogate decision maker is based on reliable indicators of the direction the
patient would personally give were the patient able to do so. Such indicators might
include, but are not limited to, the following:
(a.) Oral or written statements or directives rendered by the patient during periods
when the patient had decision making capacity.
(b.) Reactions voiced by the patient, when the patient had decision making
capacity, concerning medical treatment administered to others.
(c.) Deductions drawn from the patient's religious, moral, ethical, or philosophical
beliefs, from the patient's value system, or from the patient's consistent
pattern of decision making with respect to prior medical care. In cases where
such indicators are lacking, conflicting, or are insufficient (due, for example,
to remoteness or non-specificity) to form a reliable basis for decision making
based on the patient's own subjective wishes, life-sustaining treatment will be
withheld or withdrawn only when the surrogate decision maker and the
attending physician agree that the withholding or withdrawal of life-sustaining
treatment would be in the patient's best interests. In cases where the
attending physician believes in good faith that the decision of the surrogate
decision maker is equivocal, does not reflect the patient's own desires or best
interests, or is based, even in part, on factors (such as self-interest) other
than the advancement of the patient's own desires or best interests, the
attending physician may decline to implement the decision to withhold or
withdraw life-sustaining treatment. Such cases will be referred to an Ethics
Advisory Committee or similar body or COS.

3. RESPONSIBILITY FOR CARE


A. Conduct of Care :
i) Management of the patient's general medical condition is the responsibility of a
qualified member of the Medical Staff.
(a.) The attending staff physician is responsible for the preparation and
completion of a complete medical record for each patient. This record shall
include a medical examination, an updated problem list, identification data,
chief complaints, personal history, family history, history of present illness,
physical examination, special reports such as consultations, clinical
laboratory, x-ray and others, provisional diagnosis, medical and/or surgical
treatment, operative report, pathological findings, progress notes, doctor's
discharge instructions sheet, including condition on discharge (discharge
note) and final diagnosis, and final summary.
(b.) Pre-operative: A medical history and physical examination is completed
within 30 days before admission or registration, the practitioner must
complete and document an updated examination of the patient by the end of
the next calendar day, prior to surgery or a procedure requiring anesthesia
services. The updated examination of the patient including any changes in
the patients condition, must be completed and documented by a physician,
an oral maxillofacial surgeon, or other qualified licensed individual in
accordance with state law, VHA regulations, and hospital policy.
Medical Assessment of the patient shall include:
44
a. Medical history including:
i. Chief complaint
ii. Details of present illness
iii. Relevant past, social, and family history
iv. Inventory by body system, including pain assessment
v. Summary of the patients psychological needs
vi. Report of relevant physical examinations
vii. Statement on the conclusions or impressions drawn from the
admission history and physical (H&P) examination
viii. Statement on the course of action planned for this episode of
care an its periodic review
ix. Clinical observations, including the result of therapy
(c.) Medical Admission: The staff physician responsible for the patient must sign
the admission note if it is prepared by a resident, intern, or mid-level
practitioner, or make a note on the admission workup or progress notes to the
effect that he/she agrees with the admission workup and findings or make
whatever comments he/she thinks the case warrants, or prepare a complete
admission by the end of the next calendar day. In the event a resident,
intern, or mid-level practitioner prepares an admission workup, all will be
retained. The official workup will contain the responsible Medical Staff
physicians approval signature. All resident documentation will follow
procedures outlined in the VHA Handbook 1400.1 Resident Supervision.
(d.) Community Living Center (CLC): The attending physician or licensed
independent practitioner (LIP) is required to perform the patients medical
history and physical examination within 24 hours prior to or 72 hours after the
patients admission or readmission to the CLC. When the medical H&P
examination is performed by someone other than the attending physician or
LIP within 30 days of admission, the attending physician or LIP performs the
following within 24 hours prior to or 72 hours after the residents admission or
readmission:
a. Reviews the patients medical history
b. Re-examines the patient
c. Updates any findings or other information as needed and provides
a summary of the residents physical condition and psychosocial
status subsequent to the initial medical history and physical
examination
d. Signs and dates the updated information and findings
Each CLC patient is reassessed by the practitioner based on the plan of care
or changes in condition.
(e.) Food and nutrition products are administered only on the prescription or order
of a Medical Staff member, an authorized house staff member, or other
individual who has been granted authority to write such prescriptions or
orders, within their scope of practice.
(f.) Progress note entries should be identified as to the type of entry being made
(resident or attending note), by the providers signature block, or by the
mandated/forced co-signature (H&P, progress note, or discharge summary).
(g.) Progress notes will be written by the practitioner at least once daily on all
acutely ill patients. Progress notes are written for all patients seen for
ambulatory care by the Medical Staff.
(h.) Evidence of required supervision of all care by the attending physician shall
be documented in the medical record, the frequency of notes dependent
45
upon the severity of the illness of the patient. It is a cardinal principle that
responsibility for the care of each patient lies with the staff physician to whom
the patient is assigned and who supervises all care rendered by residents.
(i.) Upon determination that a Do Not Resuscitate (DNR) order is appropriate,
the order must be written by the attending physician in the patient's medical
record. There must be documentation of the order and how the decision was
reached (e.g., discussed with patient or family). At any time a DNR order is
written, the patients rights will be observed. Once the order has been
entered, it is the responsibility of the attending physician to ensure that the
order and its meaning are discussed with appropriate members of the facility
staff, particularly the nursing staff, so that all involved professionals
understand the order and its implications.
(j.) Patients will not be transferred out when the facility has the means to provide
adequate care. Patients who are medically stable for transport may be
authorized for transfer only after authorization is given by the appropriate
provider as defined in facility policy.
ii) Under similar clinical circumstances, the same quality of patient care is provided,
by all individuals with delineated clinical privileges, within and across Departments
and services and between all staff members who have clinical privileges.
iii) There is to be a comparable level of quality of surgical and anesthesia care
throughout the facility.

B. Consultations:
i) Consultation: Except in an emergency, consultation with a qualified physician is
desirable when in the judgment of the patient's physician:
(a.) The patient is not a good risk for operation or treatment,
(b.) The diagnosis is obscure, and/or
(c.) There is doubt as to the best therapeutic measures to be utilized.
ii) Consultant: A consultant must be well qualified to give an opinion in the field in
which his opinion is sought. The status of the consultant is determined by the
Medical Staff and the Professional Standards Boards (PSBs) on the basis of an
individual's training, experience, and competence.
iii) Consultation Essentials:
(a.) Face-to-Face Consultations: A satisfactory consultation includes examination
of the patient and review of the medical record. A written opinion signed by
the consultant must be included in the medical record. When operative
procedures are involved, the consultation note, except in an emergency, shall
be recorded prior to the operation.
(b.) Telehealth, Video Consultations: A satisfactory consultation includes remote
assessment of the patient and review of the medical record. A written opinion
signed by the consultant must be included in the medical record
(c.) E-consultations: A satisfactory consultation includes a chart assessment of
the patients case and a written opinion signed by the consultant must be
included in the medical record.
iv) Responsibility for Requesting Consultations: The patient's physician, through the
chiefs of services, shall make certain that members of the staff do not fail in the
matter of providing consultation as needed.
v) Psychiatric Consultations: Psychiatric consultation must be requested for all
patients who attempt suicide or take a chemical overdose. If the patient refuses to

46
see the consultant, this fact must be documented by the consultant in the medical
record.

C. Discharge Planning: Discharge planning is initiated as early as a determination of need


is made, most often at the time of admission.
i) Discharge planning provides for continuity of care to meet identified needs
ii) Discharge planning is documented in the medical record
iii) Criteria for discharge are determined by the Multidisciplinary Treatment Team
iv) Discharge plans, including patient/caregiver education, medications, treatment,
follow-up, and patient agreement are documented in the medical record

D. Discharge:
i) Patients shall be discharged from the facility only upon the written order of the
physician or mid-level practitioner and the discharge summary will be dictated no
later than the day of discharge. At time of dictating the final summary, the
responsible member of the Medical Staff shall review the medical record to ensure
that documents therein pertain to the patient and contain accurate data. The
record shall be completed within 30 days of the discharge of the patient including
all signatures.
ii) To improve post discharge continuity of care, the discharge summary may be
reviewed in CPRS after being signed by the resident or midlevel provider.
iii) Patients from ambulatory surgery/procedure unit can be discharged based upon
order of LIP familiar with the patient or when the practitioner is not available, based
on relevant Medical Staff approved criteria. The practitioner's name is recorded in
the patient's medical record.

E. Autopsy:
i) Autopsy services are provided by Pathology Service. The availability of these
services will be made known to the family of each decedent and the Medical Staff
will attempt to secure authorization for autopsy examination in all deaths. The
autopsy is a significant instrument for continuous monitoring activity as part of the
performance improvement program within the facility.
ii) There will be legal authorization by the next of kin for autopsy in all instances prior
to the initiation of an autopsy, except as provided in 38 CFR 17-155. Whenever
possible, the physician responsible for the care of the patient at the time of death
will be designated to request permission from the next of kin to perform an autopsy.
iii) Autopsy examination may be performed for medico-legal reasons in cases of
unexpected death upon compliance with 38 CFR 17.155 and JAHVH HPM 11-31
Autopsy Services (which includes criteria for assignment to medico-legal status).
iv) Autopsy Criteria. VHA policy encourages autopsies be requested from next-of-kin
for all deaths, with the request and response documented in the clinical record.
Autopsy performance is tracked for quality management purposes as described in
JAHVH HPM 11-31, Autopsy Policy. Those cases meeting criteria as medical
examiners cases per policy will be referred to the appropriate county medical
examiners office in accordance with state statutes.
v) Cases in which death was due to suspected negligence, incompetence, or criminal
activity require referral to the Medical Examiner, as do all cases in which death may
be due to occupational causes.

47
F. Standard precautions will be vigorously enforced for preventing transmission of
infectious diseases.

4. PHYSICIANS' ORDERS
A. General Requirements:
i) Orders are entered into the electronic medical record (EMR).
ii) Verbal orders are strongly discouraged except in emergency situations.
iii) Telephone orders will be accepted when the provider is not in the facility and
cannot return in a timely manner and does not have ready access remotely to
CPRS. They will be accepted by registered nurses, pharmacists, physician
assistants, advanced practice registered nurses, certified registered nurse
anesthetists, etc. as designated by facility policy and when it clearly is in the best
interest of patient care and efficiency. Appropriate staff receiving the order
telephonically will first write down the verbal order and read back the order to the
physician to ensure correctness. Verbal/telephone orders will be entered by the
nurse or pharmacist and signed electronically by the physician within 24-hours or
the next working day, whichever is earlier.

B. Medication Orders:
i) All drugs used in the facility must be on the national formulary and additions as
approved by the VISN Pharmacy and Therapeutics (P&T) Committee or be
investigational drugs that have been approved by the Research and Development
(R&D) Committee and the facility P&T committee. Exceptions to the foregoing
requirements may be made in use of "provisional drugs" or "non-formulary drugs"
which can be issued under specific conditions. National criteria for non-formulary
medications are developed by the National VA Medical Advisory Panel and/or at
the VISN level. Exceptions are based on an individual patient case-by-case basis.
ii) All drugs used in the facility will be stored and dispensed by the pharmacy.
iii) Duration of Orders:
(a.) Schedule II controlled inpatient drugs will be written for periods not to exceed
seven days for acute or subacute care or 30 days for chronic pain
management. Orders must be reentered by electronic entry into EMR for
each succeeding period of time.
(b.) Schedule III V controlled drugs may be written for a period not to exceed 30
days.
(c.) Antibiotics orders must include the duration of the therapy.
(d.) Orders for all other drugs will be written for a period not to exceed thirty (30)
days from the date the first medication was ordered before they expire and
must be rewritten.
iv) Ambulatory Care Medication Orders:
(a.) All prescriptions must be entered electronically except for Schedule II
Controlled Substances.
(b.) All prescription controlled substances will follow VHA Handbook 1108-1.
(c.) Ninety days is the maximum duration for applicable outpatient prescriptions.
(d.) The number of refills authorized on a single prescription may not to exceed
one year.
v) Domiciliary Care Medication Orders:
(a.) All prescriptions must be entered electronically.
(b.) Controlled substances are limited to a seven day supply.

48
(c.) Thirty days is the maximum duration for domiciliary care prescriptions
vi) Transfer of Patients: When a patient is transferred from one level of care to
another level of care, or there is a change in physician of record, orders must be
written for the new level of care. Where a patient is transferred from one nursing
unit to another but remains under the care of the same physician, the existing
orders remain valid.

C. Standardized Order Sets (protocols): Standardized order sets are reviewed periodically
by section or service chief and modified as needed. All standardized order sets in the
EMR/medical record shall be authenticated by a Medical Staff member and are to be
signed for each usage by Medical Staff. All concerned personnel shall be notified of
revisions to standardized order sets by the section or service chief.
D. Investigational Drugs: Investigational drugs will be used only when approved by the
appropriate R&D Committee and P&T Committee and administered under approved
protocol with patient informed consent, under the direct supervision and legitimate order
of the authorized principal investigator or designated investigator.

E. Informed Consent:
i) Informed consent will be consistent with legal requirements and ethical standards,
as described in facility policy informed consent.
ii) Evidence of receipt of Informed consent, documented in the medical record, is
necessary in the medical record before procedures or treatment for which it is
required.

F. Submission of Surgical Specimens: All tissues and objects except teeth removed at
operation shall be sent to the facility pathologist who shall make such examination as he
may consider necessary to arrive at a pathological diagnosis.
G. Special Treatment Procedures:
i) DNR and Withholding/Withdrawal of Life Sustaining Treatment:
(a.) Documentation requirements in the medical record
(b.) Requirements are described in facility policy memoranda, Medical Staff
Bylaws, and these rules
ii) Sedation/analgesia involves the administration of medications that have a risk for
undesirable side effects, either immediately or delayed, and may be utilized only
within the guidelines of an established protocol in the center policy related to
sedation/analgesia and according to approved privileges. Moderate sedation is
used by those practitioners with approved and current privileges to do so.

5. ROLE OF ATTENDING STAFF


A. Supervision of Residents and Non-Physicians:
i) Residents are supervised by members of the Medical Staff in carrying out their
patient care responsibilities.
ii) Medical staff members who choose not to participate in the teaching program are
not subject to denial or limitation of privileges for this reason alone, except that this
may result in loss of faculty appointment.
iii) Mid-level and certain associate health practitioners are supervised by the Medical
Staff and are monitored under a scope of practice statement.

49
B. Documentation of Supervision of Resident Physicians:
i) Sufficient evidence is documented in the medical record to substantiate active
participation in, and supervision of, the patient's care by the attending physician as
described in facility policy memoranda, Medical Staff Bylaws, these rules, and VHA
Handbook 1400.1, Resident Supervision.
ii) Entries in the medical record made by residents or those non-physicians (e.g.,
PAS, ARNPs, etc.) that require countersigning by supervisory or attending Medical
Staff members are covered by appropriate facility policy and include:
(a.) Medical H&P examination
(b.) Discharge summary
(c.) Operative reports
(d.) Medical orders that require co-signature:
(1) DNR
(2) Withdrawing or withholding life sustaining procedures
(3) Certification of brain death
(4) Research protocols
(5) Investigational drug usage, ONLY permitted by named principal
investigators or co-investigators previously designated in the study.
NOTE: Because medical orders in EMR do not allow a second signature (co-
signature), the attending must either write the order for (1) through (5) above;
or in an urgent/emergency situation, the house staff or non-physician must
obtain verbal concurrence from the attending, document in the progress
notes the discussion and concurrence, and can write and sign the order. The
attending Medical Staff member must then co-sign the progress note noting
the discussion and concurrence within 24 hours.)
iii) Residents are allowed to order laboratory studies, radiology studies,
pharmaceuticals, and therapeutic procedures as part of their assigned levels of
responsibility. In addition, residents are allowed to certify and re-certify treatment
plans as part of their assigned levels of responsibility. These activities are
considered part of the normal course of patient care and require no additional
documentation on the part of the supervising practitioner over and above standard
setting-specific documentation requirements (VHA Handbook 1400 page 6).

C. Designated administrative staff will be authorized to make administrative entries as


approved by the COS. These administrative entries can be for the purposes of: (1)
creating electronic forms for the inclusion into the computerized patient record system,
(2) administratively closing open requests or orders, (3) entering administrative progress
notes, (4) entering notes to disposition consultation requests ,and (5) completing other
requirements as requested by the COS or his/her designee.

6. MEDICAL RECORDS
A. Basic Administrative Requirements:
i) Entries must be electronically entered where possible, which automatically dates,
times, authenticates with method to identify author, may include written signatures.
ii) It is the responsibility of the medical practitioner to authenticate and, as
appropriate, co-sign or authenticate notes by mid-level practitioners.
iii) Final diagnosis and complications are recorded without use of abbreviations and
symbols. A list of abbreviations not to use can be found in related facility policy,

50
and is available in CPRS and VistA. Those abbreviations are not acceptable for
use either handwritten or in the EMR.
iv) Completion and filing of reports of diagnostic and therapeutic procedures must be
accomplished within 24 hours.
v) Release of information is required per policy and standard operating procedures for
the facility.
vi) All medical records are confidential and the property of the facility and shall not be
removed from the premises without permission (Release of Information from the
patient/consultation with the privacy officer as appropriate). Medical records may
be removed from the facilitys jurisdiction and safekeeping only in accordance with
a court order, subpoena, or statute. In case of readmission of a patient, all
previous records on file shall be available for the use of Medical Staff.
vii) Access to medical records of all patients shall be afforded to Medical Staff
members for bona fide study and research, consistent with preserving patient
confidentiality and privacy. Specific confidentiality requirements are found in Title
38 U.S.C. 7332.

B. All Medical Records must contain:


i) Patient identification (name, address, DOB, next of kin)
ii) Medical history including history and details of present illness/injury
iii) Observations, including results of therapy
iv) Diagnostic and therapeutic orders
v) Reports of procedures, tests and their results
vi) Progress notes
vii) Consultation reports
viii) Diagnostic impressions
ix) Conclusions at termination of evaluation/treatment.
x) Informed consent before procedures or treatments undertaken and if not
obtainable, the reason, as stated in Hospital Memorandum, "Informed Consent."

C. Inpatient Medical Records: In addition, the items listed in section B above, all inpatient
records must contain, at a minimum:
i) A history that includes chief complaint, history of present illnesses, medical
illnesses, operations, injuries, medications, allergies, social history (including
occupation, military history, and habits such as alcohol, tobacco, and drugs), family
history, and review of systems.
ii) A complete physical examination includes (but not limited to) general appearance
and a review of body systems, mutation.
iii) Review of the results of pertinent studies which includes but not limited to,
laboratory, radiology tests, and other applicable findings based on the patient
assessed personal history.
iv) Key examination medical impressions will be documented in the note. The note
must be authenticated by provider at the earliest possible time, but always within 24
hours of being written in CPRS.
(a.) If the H&P was completed prior to the admission or procedure, it must be
updated the day of admission. If it is more than 30 days old, a new one must
be completed.
(b.) Inpatient H&P must be completed within 24 hours, 72 hours for CLC, and 7
days for the Domiciliary.

51
v) A discharge plan (from any inpatient admission CLC or domiciliary), including
condition on discharge.
vi) Have a discharge summary (from inpatient or domiciliary) dictated no later than the
day of discharge.
vii) Completed within 30 days of discharge.

D. Outpatient Medical Records: In addition the items listed in section B above, all
outpatient records must contain, at a minimum:
i) A progress note for each visit
ii) Relevant history of illness or injury and physical
iii) Patient disposition and instruction for follow-up care
iv) Referrals and communications to other providers
v) List of significant past and current diagnoses, conditions, procedures, drug allergies
vi) Medication reconciliation, problem, and any applicable procedure and operations
on the Problem List

E. Surgeries and Other Procedures:


i) All aspects of a surgical patients care, including ambulatory surgery, pre-operative,
operative and post-operative care, must be documented. Surgical interventions,
diagnostic procedures, or other invasive procedures must be documented to the
degree of specificity needed to support any associated coding data and to provide
continuity of care.
ii) Preoperative Documentation:
(a.) In all cases of elective and/or scheduled major surgery and/or diagnostic and
therapeutic procedures, and if circumstances permit, in cases of emergency
surgery, the supervising or staff practitioner must evaluate the patient and
write a pre-operative (pre-procedural) note describing: the findings of the
evaluation, diagnosis(es), treatment plan, and/or choice of specific procedure
to be performed; discussion with the patient and family of risks, benefits,
potential complications; and alternatives to planned surgery and signed
consent.
(b.) Invasive procedures and surgeries involving local and/or moderate sedation
require a focused history and physical or Subjective/Objective/Assessment/
Plan (SOAP) note addressing pertinent positive/negative information,
indications for the procedure, known risks related to the procedure, and a
physical exam pertinent to the procedure. A formal consultation to the
service for performing the procedure that includes all required content will
serve as an H&P if done within 30 days, but must be updated the day of the
procedure.
(c.) Except in an emergency, no patient may go to the operating room without a
complete history and physical examination recorded in his/her chart.
(d.) A surgical operation shall be performed only with documented informed
consent of the patient or his/her legal representative except in emergencies
at which time the COS holds jurisdiction.
iii) Immediate Post-Operative Documentation: A post-operative progress note must be
written, or directly entered into the patients health record, by the surgeon
immediately following surgery and before the patient is transferred to the next level
of care.
(a.) The immediate post-operative note must include:
(1) Pre-operative diagnosis
52
(2) Post-operative diagnosis
(3) Technical procedures used
(4) Surgeons
(5) Findings
(6) Specimens removed
(7) Complications
(b.) The immediate post-operative note may include other data items, such as:
(1) Anesthesia
(2) Blood loss
(3) Drains
(4) Tourniquet Time
(5) Plan
iv) Post-Operative Documentation: An operative report must be dictated and
completed by the operating surgeon immediately following surgery. Immediately
means upon completion of the operation or procedure, before the patient is
transferred to the next level of care. The body of the report needs to contain the:
indication for the procedure; operative findings; technical procedure used;
specimens removed; post-operative diagnosis; names of the supervising
practitioner, primary surgeon, and assistants; and the presence and/or involvement
of the supervising practitioner.
v) Post Anesthesia Care Unit (PACU) Documentation:
(a.) PACU documentation must include the patient evaluation on admission to,
and discharge from, the PACU, a time-based record of vital signs and level of
consciousness (either paper or electronic), all drugs administered and their
doses, type, and amounts of intravenous fluids administered, including blood
and blood products, any unusual events including post-anesthesia or post-
procedural complications, and post-anesthesia visits.
(b.) The health record must document the name of the LIP responsible for the
patients release from the recovery room or clearly document the discharge
criteria used to determine release.
(c.) For ICU patients, there needs to be at least one documented post-anesthesia
visit after leaving the PACU. The note needs to describe the presence or
absence of anesthesia-related complications.
(d.) For outpatients, ambulatory surgery personnel (i.e., a nurse) must call the
patient after surgery, to assess any complications, including anesthetic
complications, as appropriate.

7. INFECTION CONTROL
Isolation, standard precautions, and reportable cases as described in Infection Control
Policy.

8. CONTINUING EDUCATION
All Medical Staff members shall participate in their own individual programs of continuing
medical education (CME) in order to keep themselves informed of pertinent new
developments in the diagnostic and therapeutic aspects of patient care, to refresh them in
various aspects of their basic education, and to meet requirements for re-licensure. Medical
Staff members are responsible to see that their own participation in continuing education
programs and conferences both in and outside the facility are documented and verifiable at
the time of reappraisal and re-privileging.

53
9. HEALTH STATUS AND IMPAIRED PROFESSIONAL PROGRAM
The VHA recognizes its responsibility to assist impaired professionals and collaborate with
available programs designed to intervene, monitor, refer to treatment, and advocate for
physicians and dentists.
A. Where there is evidence that a physician or dentist's practice is impaired as a
consequence of chemical dependence or mental or physical illness, the COS' office will
be notified. Practitioners are allowed to self-refer to a program for assistance for
psychiatric, emotional, or physical problems. Assistance in the self-referral may be
obtained from their service chief or COS.
B. In cases of known or suspected impairment due to mental illness or substance use, the
COS may request an assessment by the Impaired Professional Committee (AdHoc).
C. In cases of known or suspected impairment due to physical and/or mental illness, the
COS may request the Director to authorize a special physical examination as authorized
VA Handbook 5019, Part II, and applicable hospital policy. The special physical
examination will be tailored to the clinical circumstances and may involve a physical
examination, imaging studies, neuropsychological testing, or other indicated measures.
The fitness for duty examination will be conducted by or under the direction of the
occupational health program or outside medical examiner, which will assess the findings
and make a recommendation on the practitioner's fitness for duty based on such
findings. If the determination is unfavorable to the practitioner, or in cases of
uncertainty, the findings will be presented to an ad hoc Physical Standards Board.
D. VA and facility policies, responsibilities and procedures of the Employee Assistance
Program and the VA Drug-Free Workplace Program are applicable for physicians,
dentists, and other health care professionals.
E. Confidentiality of the practitioner seeking referral or referred for assistance will be kept,
except as limited by law, ethical obligation, or when the safety of a patient is threatened.
In all instances, every effort will be made to protect the confidentiality of the individual
referred for assistance.
F. The hospital will sponsor periodic educational program regarding illness and impairment
issues. LIPs will be issued written information regarding illness issues at the time of
initial appointment and re-appointment to the Medical Staff.

10. PEER REVIEW


A. All Medical Staff members shall participate in the facility protected peer review program
established by the appropriate VHA policy.
B. All Medical Staff members will complete ongoing required training associated with the
associated VHA policy.
11. DISCLOSURE POLICY VHA DIRECTIVE 2008-002

This policy outlines the hospitals ethical and legal obligation to disclose to patients adverse
events that have been sustained in the course of their care, including cases where the
adverse event may not be obvious or severe, or where the harm may only be evident in the
future. The directive further specifies the required process steps including communications,
documentation, and reporting requirements within VHA.
http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1637;

54
12. Quality Management Directive VHA Directive 2008-061
A. The national and local organizational improvement plans supports the VHAs mission,
vision, values, and goals as well as the VISN 12 Strategic Goals, the VHA strategic
guidance, resource allocation, and associated VHA policies. This quality management plan
is designed to improve the quality of health care structures, processes, and outcomes by
systematically:
i) Defining measures of quality and collecting and analyzing data
ii) Identifying improvement actions
iii) Identifying and managing sentinel events through a defined and implemented process
iv) Utilizing information from data analysis to improve quality and safety
v) Identifying and reducing unanticipated adverse events through a defined and
implemented process
vi) Improving health care in all areas and creating a culture of anticipating and preventing
adverse events
http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1778;

13. PART-TIME PHYSICIAN REQUIREMENTS FOR TIME AND ATTENDANCE

This hospital policy outlines requirements and processes governing part-time physicians
work hours including but not limited to work agreements, the establishment of tours;
adjustable and fixed, record keeping, and the annual reconciliation of hours worked.

14. PATIENT SAFETY INITIATIVES

Patient safety initiatives are designed to identify and manage actual and potential risks
to patient safety, eliminate or control contributing factors to medical and health care
errors, and promote organizational and system-wide learning and sharing of knowledge
to improve patient safety. Strategies are aimed at preventing injuries to patients,
visitors, and staff.

15. CONFLICT OF INTEREST

VHAs commitments to ensure managers and staff engages in ethical business and
health care practices and to ensure compliance with the laws, regulations, and
standards which govern these activities and the highest standards of program integrity.
RECOMMEND:

Date 6/23/2011

Chief of Staff

APPROVE:
Date 6/23/2011

Director
Adopted by the Medical Staff, William S. Middleton Memorial Veterans Hospital, Madison,
Wisconsin, this 23rd Day of June 2011.
55
Physician Reentry into Clinical Practice:
Regulatory Challenges
...........................................

Gretchen P. Kenagy, Ph.D.


Senior Research Associate, Undergraduate Medical Education, American Medical Association

Barbara S. Schneidman, M.D., M.P.H.


Clinical Professor, Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine

Barbara Barzansky, Ph.D., M.P.H.E.


Director, Undergraduate Medical Education, American Medical Association

Claudette E. Dalton, M.D.


Emeritus Faculty, Anesthesiology and Medical Education, University of Virginia School of Medicine

Carl A. Sirio, M.D.


Professor, Drexel University School of Medicine

Susan E. Skochelak, M.D., M.P.H.


Vice President, Medical Education, American Medical Association

A B S T R A C T : Physician reentry to clinical practice is fast becoming recognized as an issue of central


importance in discussions about the physician workforce. While there are few empirical studies, existing
data show that increasing numbers of physicians take a leave of absence from practice at some point during
their careers; this trend is expected to continue. The process of returning to clinical practice is coming
under scrutiny due to the publics increasing demand for transparency regarding physician competence.
Criteria for medical licensure often do not include an expectation of ongoing clinical activity. Physicians
who maintain a license but do not practice for a period of time, therefore, may be reentering the workforce
with unknown competency to practice. This paper: (1) presents survey data on current physician reentry
policies of state medical boards; (2) discusses the findings from the survey within the context of regulatory
challenges that impact physician-reentry; and (3) offers recommendations to facilitate the development
of comprehensive, coordinated regulatory policies on physician reentry.
Keywords: physician reentry, state medical and osteopathic boards, regulation, physician reentry policy,
competence, licensure, workforce

Introduction Consumer groups such as the American Association


Physician reentry is defined by the American Medical of Retired Persons (AARP) and the Citizens Advocacy
Association as: A return to clinical practice in the Center (CAC) as well as the medical profession
discipline in which one has been trained or certified itself have called for tying re-licensure to evidence
following an extended period of clinical inactivity not that physicians possess the requisite knowledge
resulting from discipline or impairment.1 Reentering and skills to practice. Both undergraduate and
physicians leave clinical practice voluntarily and as graduate medical education is increasingly struc-
such are distinct from remediating physicians, who tured around the demonstration of a series of
have demonstrated deficiencies in physician per- competencies. Maintenance of Certification (MOC)
formance. Further, reentering physicians return to and the newly proposed Maintenance of Licensure
the field of practice which they left and, thus, are (MOL) are reflections of this emphasis on continu-
different from physicians who are retraining in ous competency assessment.
order to move into a new area of clinical practice.1
Currently, all of these activities are directed at physi-
Physician reentry is a concept that may be poorly
cians who are actively practicing medicine. However,
understood by many practitioners.
regulators recognize that physicians who have been
A number of factors are driving a new emphasis away from clinical practice and seek to return must be
on lifelong evidence of physician competence and included as well. In this new environment of increased
assessment of performance in medical practice. focus on physician competence and assessment of

10 | J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 7 , N O 1 2011 Federation of State Medical Boards


performance, physicians returning to clinical practice challenge, wish to help fulfill community needs
after a hiatus pose unique challenges for state or simply have too much free time.7
medical licensing boards, whose primary objective
There is little data on whether physicians who
is public protection.2
return to clinical practice undergo assessment
As the new focus on competence assessment con- of their knowledge, skills and training and/or
tinues to develop, state boards will need to shape education before returning to patient care
systems that effectively address the performance activities. One study found, however, that among
of both practicing physicians and those who wish to 107 reentering pediatricians, 79 percent did
reenter medicine after an extended absence. As a not undergo training before returning to care for
starting point in this process, a better understanding patients.5,8 While more studies are needed on, for
is needed of how state boards currently address example, the relationship between time away from
physician reentry. practice and the need for training prior to reentry,
the ability of physicians to move in and out
This paper addresses that need by (1) presenting
of practice without oversight by state medical
survey data on current physician reentry polices
licensing boards is a limitation of the current
of state medical licensing boards; (2) discussing
medical regulatory process.
the findings from the survey within the context
of physician reentry regulatory challenges; and The status of a physicians medical licensure is
(3) offering recommendations to facilitate the develop- a key factor in the reentry process. Physicians
ment of comprehensive, coordinated regulatory with an active license have more options, as most
policies on physician reentry. are not required by medical boards to disclose
their clinical activity during the licensure renewal
Background process. One study found only about one-third of
The careers of todays physicians look markedly dif- medical licensing boards (N = 64) asked physi-
ferent from those of previous generations. The belief cians about their clinical activity status both at
that successful physicians must sacrifice personal initial licensure and at renewal.9 According to the
lives for their profession is giving way to an unprec- authors of the study, the majority of boards in the
edented desire by both male and female physicians United States allow physicians to hold and renew
for a work-life balance.3 Physicians may expect to an unrestricted active license to practice medicine,
take time away from practice at some point during although they may not have cared for a patient in
years.9 However, the options of physicians without
an active license are much more limited. To return
IN T H IS NEW E N V I RON M E N T OF I N CRE A SED to practice, they must contact their state medical
FO CU S O N P HYSI CI AN C OM P E T E N CE A ND licensing board, which will direct their steps toward
reentry. The lack of regulatory precedent for
A S S ES S MEN T OF P E RF OR M AN C E , P H YSI C I A NS
reentering physicians, including licensure and
RETURNING TO CLINIC AL PRACTICE AFTER credentialing requirements, is a major challenge for
A H I AT U S P O S E U N I Q U E C H A L L E N G E S F O R state medical licensing boards and, ultimately, for
S TAT E MED I C AL L I CE N SI N G BOAR D S. physicians without an active medical license.10
Despite the flexibility afforded physicians with
active medical licenses, successful return to
their careers for reasons that include family leave
clinical practice can be a difficult journey. Lack
(maternity/paternity leave, child rearing); caretaking
of consistency across jurisdictions in regulatory
and personal-relationships issues; health issues;
requirements, including licensure, is a significant
career dissatisfaction; pursuit of alternate careers,
barrier. The growing importance of physician
such as administration or military service; and
reentry as a workforce issue means that state
humanitarian leave.47
medical licensing boards will increasingly need to
Physicians may seek reentry to clinical practice address competency and patient safety for
for a variety of reasons. Often they return when physicians in active practice, and for physicians
their need to care for family is no longer pressing who do not actively provide patient care throughout
or when they have overcome a health issue. Some their careers, as well. Boards will need to do
physicians return because they miss the practice this in the midst of increasing calls for transparency
of medicine, have financial needs, want a new in the regulatory process.

2011 Federation of State Medical Boards J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 7 , N O 1 | 11


In response, regulatory bodies are moving away physician reentry policy. The most recent survey
from requiring physicians to demonstrate sufficient was sent to 64 State Boards of Allopathic and
knowledge and skills at just one point in time, and Osteopathic Medical Examiners in the U.S.; medical
are beginning to embrace the concept of requiring boards in U.S. territories were excluded. Fifty-nine
assessment as part of relicensure a process of the 64 medical boards responded to the survey,
known as Maintenance of Licensure (MOL).11 The for a response rate of 92 percent.
Federation of State Medical Boards (FSMB) has
A summary of the aggregate findings in the 2010
been working on a process for MOL since 2003,
survey for the questions related to physician reentry
including conducting a study on the role of state
is presented here. The findings represent a snap-
medical boards in ensuring continued competence
shot of specific physician reentry-related regulations
among physicians and the development of recom-
and procedures among these medical boards.
mendations for use by state medical boards.
The FSMB defines MOL as the process by which
Physician reentry policy
a licensee demonstrates that he/she has main-
The survey asked Does your board have a policy
tained his or her competence and qualifications for
on physician reentry (as defined by the AMA) for
purposes of continued licensure.12
physicians who have left the active practice of
The three components of MOL are: (1) reflective self medicine and want to reenter practice? Thirty
assessment; (2) assessment of knowledge and skills; (51 percent) of the responding medical boards
and (3) performance in practice.1112 Of particular agreed that they have a policy on physician reentry.
relevance to physician reentry is component 3, Of the 29 medical boards without a physician
performance in practice, which states that physicians reentry policy, 16 (55 percent) are either currently
developing or planning to develop a policy. Put
another way, out of the 59 medical boards in this
A S T H E NEW F OC US ON COM P E T E N CE sample, 78 percent have, are developing, or are
A S S ES S MEN T CON T I N UE S TO D E V E L OP, planning to develop a policy on physician reentry.
S TATE B OA R DS W IL L N E E D TO SHA P E
Length of time out of practice
S YS T EMS T HAT E F F E CT I V E LY AD D R ESS THE
The 30 medical boards with a physician reentry
PER FO RM A N CE OF B OT H P R ACT I CI N G policy were asked What is the length of time out of
PH YS IC IA N S AN D T HOSE W HO W I SH TO practice after which your board requires reentering
R EENT ER M E D I CI N E . physicians to complete a reentry program? Among
the 25 medical boards that responded to the
question, the average length of time was 2.8 years
must demonstrate accountability for performance and ranged from 1 to 10 years. The modal (most
in their practice using a variety of methods that common) response was 2 years.
incorporate reference data to assess their performance
in practice and guide improvement.12 This component Patient care requirements for relicensure
of the proposed framework for MOL indicates that All of the medical boards were asked Does your
physicians must have ongoing involvement in patient board require a physician to engage in a certain
care a difficult, if not impossible, requirement for amount of patient care for relicensure? The vast
reentering physicians. majority of medical boards (92 percent) do not.
State medical licensing boards have a responsibility
Data collection on reentry
to assure the public that physicians possess the
Medical boards were asked Are you keeping
requisite knowledge and skills to practice medicine
records on the number of physicians the board
and, thus, will likely have the authority to establish
considered for reentry? Most (90 percent) medical
MOL requirements.12
boards are not collecting this information.
State medical licensure requirements and statistics: Among the six that do keep records on the num-
data on physician reentry into practice ber of physicians considered for reentry, five were
The AMA annually publishes the State Medical allopathic boards and five had reentry policies. One
Licensure Requirements and Statistics, which board that did not have a reentry policy is keeping
is based on a survey that includes questions on records and plans to develop a policy.

12 | J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 7 , N O 1 2011 Federation of State Medical Boards


Discussion may add further confusion. Findings from a study of
Approximately three quarters of state medical licens- the relationship between the volume of procedures
ing boards who responded to the survey either have practiced by physicians and medical outcomes show
a reentry policy or are in the process of developing that the less a procedure is practiced, the greater
or planning to develop one. This is an indication of the likelihood of complication.15 In a systematic
the growing importance of physician reentry within review of the medical literature to study the relation-
medicine and the recognition by boards of medicine ship between experience in caring for patients and
of the need to address the issue. Boards of performance quality, it was concluded that physicians
medicine seem to be developing physician reentry who have been in practice longer have less factual
policies and processes independent of one another; knowledge then their less-experienced counterparts
the scope and direction of these policies remain even after adjusting for patient volume.16
unclear. An unintended consequence of a lack of
The explanation for the results of the latter study,
consistency among state medical licensing boards
however, may, in fact, have implications for reentering
may be increased difficulty for physicians to reen-
physicians who are also in need of updating their
ter clinical practice, particularly if physicians have
knowledge and skills. With changes in technology
moved from one state to another during their time
and an increase in the volume of medical infor-
away from practice or are participating in reentry
mation, there is a growing need for regulation to
programs in a state other than their own.
assess competency so that patient safety and
There is little comprehensive information about quality of care are ensured.11,1617 Access to current
the decay rate of specific areas of knowledge and medical knowledge, including changing technologies,
skill. Thus, a physicians need to update his or her must be factored into physician reentry policies
knowledge, skills and practice prior to reentry that address education and training.
is not clearly defined. This is important information
While not all physicians may need to update their
for medical licensing boards as they address
skills before reentering practice, the current structure
policies concerning reentry. The assumption that a
of the licensure system may be preventing medical
physician who has been away from clinical practice
regulatory bodies from making that assessment.
needs to update his or her knowledge and skills
Studies are needed on how time spent away from
may be particularly true for medical specialties that
clinical practice affects the clinical skills of physicians
rely heavily on technology. It is important to note,
and, ultimately, the quality of care. In addition to
however, that while this makes sense intuitively, no
studies have been conducted to test this assump-
tion across specialties and practice areas. THE BEL I EF TH AT SUC C ESSFU L PHYSI C I A NS

Further, studies are needed that would help determine MU ST SAC RI FI C E PERSONA L L I VES FOR
the cut-off point after which a physicians knowl- THEI R PROFESSI ON I S GI VI NG WAY TO AN
edge and/or skills in a particular area deteriorate. U NPREC ED ENTED D ESI RE B Y BOTH
Our findings show that on average, medical boards MA L E A ND FEMA L E PHYSI C I A NS FOR A
require reentering physicians to participate in
WO RK -L I FE B A L ANC E.
education and training (in the form of a physician
reentry program) after they have been away from
practice for close to three years. However, leading guiding state medical boards, these data could
medical organizations such as the FSMB and the potentially be used to develop and refine reentry
American Board of Medical Specialties (ABMS), program curricula and assessment methods.
have recommended a two-year time limit.1314 The
States vary in their definition and criteria for
fact that the time after which a physician should
maintaining an active medical license. According
be mandated to participate in a formal reentry
to our findings, most (92 percent) state medical
process 1 to 10 years varies so widely perhaps
boards do not require a specified amount of patient
best illustrates the difficulty state medical boards
care for relicensure. To date, this has allowed
are experiencing when making this determination
physicians who take a hiatus from clinical practice
without adequate evidence.
to maintain an active license.
Literature intended to inform the decisions by medical
MOL, if implemented, will present challenges,
licensing boards of when reentering physicians
but also opportunities, for the physician reentry
should receive additional education and training

2011 Federation of State Medical Boards J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 7 , N O 1 | 13


process. The new requirement could lead to better including performance in practice, for inactive
data collection on physician engagement in practice, physicians. We offer the following recommenda-
including data on physicians who do not actively tions as a step toward meeting these challenges.
participate in patient care. Our findings show that
the majority (90 percent) of medical boards are not Recommendations for developing regulatory
collecting information on physician reentry. It is policies on reentry
anticipated that there will be an influx of reentering The recommendations are a product of a 2010
physicians who will come to the attention of boards conference titled Physician Reentry to Clinical
Practice: Overcoming Regulatory Challenges Confer-
ence, sponsored by the AMA and in collaboration
B OA R DS O F M E D I CI N E SE E M TO B E
with the FSMB and American Academy of Pediatrics
DEV ELO PI N G P HYSI CI AN R E E N T RY P OL I C I ES (AAP). The overall goal of these recommendations
AND PRO CE SSE S IN D E P E N D E N T O F O NE is to ensure that there is a comprehensive, trans-
ANOT H ER ; T HE SCOP E AN D D I R ECT I O N OF parent, and feasible regulatory process that also
ensures public safety for use with physicians who
TH ES E PO LI CI ES R E M AI N S UN CL E AR .
desire to return to clinical practice. The recommen-
dations are designed for medical licensing boards to
of medicine if, for example, performance in consider as they develop and implement physician
practice is implemented. The new requirement reentry policies. For the purposes of this discussion,
will change the trajectory to reentry for physicians only the recommendations from the conference
who have maintained active licenses as they pertinent to regulatory issues are included. (The
will now have to be accountable to medical boards. complete set of conference recommendations
is available online at http://www.ama-assn.org/
The licensure renewal process could include
resources/doc/med-ed-products/physician-reentry-
data collection of the number of patient hours
recommendations.pdf.)
physicians spend providing clinical care to patients.
Physicians who have been out of clinical practice, The recommendations suggest that development
but who have maintained licenses, may not be of a physician reentry regulatory process should be
able to resume practice without first demonstrating comprehensive and inclusive, involving relevant stake-
outcomes from clinical practice as part of MOL holder-groups, and it should have the following goals:
component 3, performance in practice. This may
1) Develop an understanding of the expectations
place reentering physicians at a disadvantage,
and needs relevant stakeholder groups
particularly if they have been out of practice for a
including physicians, patients, regulators, and the
significant period of time. An unintended conse-
public have for a physician reentry system.
quence of performance in practice requirements
may be that reentry physicians are at risk of losing 2) Develop physician reentry policy guidelines
their active license. across state medical licensing jurisdictions
that are consistent and evidence-based.
Increased visibility of physicians desiring and
These guidelines should clarify:
achieving reentry is an opportunity for medical
licensing boards to collect much-needed information U/ii}vi>>vVV>
to gain a better understanding of the physician practice which necessitates participating
reentry population as a whole. A clearer under- in a reentry process;
standing of these physicians will benefit medical
U/i`iwvVii
boards in developing reentry policies that result
in clinical care constitutes active clinical
in the return of physicians who provide competent
practice and the clinical practice requirements
care to patients.
for maintaining licensure; and
In sum, medical boards face many challenges to
U/i>VvviV>L>`
developing physician reentry regulatory policies
certification on maintenance of licensure.
including (1) lack of consistency in state medical
licensing laws and regulations; (2) lack of a 3) Establish mechanisms to permit reentering
coordinated database on reentering physicians physicians to engage in clinical practice
and physicians needing a reentry process; and under supervision as they participate in a
(3) issues related to maintenance of licensure, reentry program.

14 | J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 7 , N O 1 2011 Federation of State Medical Boards


These include: References
1. American Medical Association. Physician reentry. Available
Uii`V>V]}>`>ii`V>
at: http://www.ama-assn.org/ama1/pub/upload/mm/377/
education program, teaching hospital and cmerpt_6a-08.pdf. Accessed October 18, 2010.
medical home, as well as non-traditional sites 2. Law MT, Hansen ZK. Medical licensing board characteristics
such as mental health hospitals and nursing and physician discipline: An empirical analysis. J Health Polit
homes) that provides reentering physicians Policy Law. 2010;35(1):63-93.
with opportunities for supervised clinical 3. Keeton K, Fenner DE, Johnson RB, Hayward RA. Predictors of
practice in their previous clinical fields; physician career satisfaction, work-life balance, and burnout.
Obstet Gynecol. 2007;109(4):949-955.
U>Vi`i>}Vii>} 4. Mark S, Gupta J. Reentry into clinical practice. JAMA.
reentry program participants to work under 2002;288(9):1091-1096.
supervision; and 5. Mulvey H, Jewett E. Physician reentry into the workforce.
Available at: http://www.physicianreentry.org/yahoo_site_
U->ii`V>Vi}L>`i>L} admin/assets/docs/Reentry_Web_5-08.307134631.ppt.
a non-disciplinary licensure status option Accessed September 23, 2010.
for reentering physicians during their reentry 6. Grace ES, Korniek EJ, Weitzel LB, Wentz DK. Physicians
education and training. reentering clinical practice: Characteristics and clinical
abilities. J Cont Ed in Health Prof. 2010;30(3):180-186.
4) State medical licensing boards and medical 7. Adams KE, Allen R, Cain JM. Physician reentr y:
societies should develop a process for a A concept whose time has come. Obstetric Gynecol.
certificate of program completion that meets 008;111(5):1195-1198.
the need to document physician competency 8. Mulvey H, Jewett EA, Merline A, Towey KJ. Pediatricians over
to return to practice. 50 reentering clinical practice: Implications for physicians and
the regulatory community. J Med Licensure and Regulation.
5) Study the feasibility of introducing alternate 2010;96(2):7-12.
licensure tracks for reentering physicians that 9. Freed GL, Dunham KM, Abraham L. Protecting the public:
allow a limited scope of practice. State medical board licensure policies for active and inactive
physicians. Pediatrics. 2009;123:643-652.
6) Establish a national physician reentry database to: 10. Bower EA, English C, Choi D, Cedfeldt AS, Girard DE.
Education to return nonpracticing physicians to clinical
U*`i}>>Vv>iii} activity: A case study in physician reentry. J Cont Ed in
physicians; and Health Prof. 2010;30(2):89-94.
11. Chaudhry HJ, Rhyne J, Cain FE, Young A, Crane M, Bush F.
U/>Vi`ii]V>Li
Maintenance of licensure: Protecting the public, promoting
of reentering physicians, program costs quality health care. J Med Licensure and Regulation.
and outcomes. 2010;96(2):13-20.
12. Federation of State Medical Boards. Board Report 10-3:
Addressing the regulatory challenges of physician Maintenance of Licensure. Available at: http://www.fsmb.org/
reentry through a comprehensive process is pdf/mol-board-report-1003.pdf. Accessed October 13, 2010.
necessary to demonstrate to the public and to 13. Federation of State Medical Boards. Special committee
employers that reentering physicians are competent to address regulation of reentry to practice. Newsline
to provide quality care to patients upon their return (May/June 2010). http://www.fsmb.org/pdf/pub-nl-may-
june-2010.pdf. Accessed December 29, 2010.
to clinical practice and to fulfill the high practice
standards of the medical profession. To achieve 14. American Board of Medical Specialties (ABMS). Clinically
active terms redefined in a push for clarity in reporting.
this standard, it will be necessary for physician Available at: http://www.abms.org/News_and_Events/
reentry stakeholders including medical regulators, news_archive/release_ClinicalActivityStatus_12_07.aspx.
medical associations, physician reentry programs, Accessed November 8, 2010.
researchers and reentry physicians to work 15. Freemen JV, Wang Y, Curtis JP, Heidenreich PA, Hlatky
collaboratively. The above recommendations, MA. The relation between hospital procedure volume and
complications of cardioverter-defibrillator implantation from
informed by data from state medical boards and the implantable cardioverter-defibrillator registry. J Am Coll
input from reentry stakeholders, address physician Cardiol. 2010;56(14):1133-1139.
reentry challenges including the need for increased 16. Choudhry NK, Fletcher RH, Soumerai SB. Systematic review:
consistency across state medical boards. These The relationship between clinical experience and quality of
recommendations serve as a mechanism to develop health care. Ann Intern Med. 2005;142:260-273.

relevant, effective policies to return reentry 17. Institute of Medicine. To Err is Human: Building a Safer
Health System. Kohn LT, Corrigan JM, Donaldson MS. Eds.
physicians to providing high-quality care for patients.
Washington, D.C.: National Academy Press, 2000.

2011 Federation of State Medical Boards J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 7 , N O 1 | 15


Physician Reentry into Clinical Practice:
Regulatory Challenges
...........................................

Gretchen P. Kenagy, Ph.D.


Senior Research Associate, Undergraduate Medical Education, American Medical Association

Barbara S. Schneidman, M.D., M.P.H.


Clinical Professor, Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine

Barbara Barzansky, Ph.D., M.P.H.E.


Director, Undergraduate Medical Education, American Medical Association

Claudette E. Dalton, M.D.


Emeritus Faculty, Anesthesiology and Medical Education, University of Virginia School of Medicine

Carl A. Sirio, M.D.


Professor, Drexel University School of Medicine

Susan E. Skochelak, M.D., M.P.H.


Vice President, Medical Education, American Medical Association

A B S T R A C T : Physician reentry to clinical practice is fast becoming recognized as an issue of central


importance in discussions about the physician workforce. While there are few empirical studies, existing
data show that increasing numbers of physicians take a leave of absence from practice at some point during
their careers; this trend is expected to continue. The process of returning to clinical practice is coming
under scrutiny due to the publics increasing demand for transparency regarding physician competence.
Criteria for medical licensure often do not include an expectation of ongoing clinical activity. Physicians
who maintain a license but do not practice for a period of time, therefore, may be reentering the workforce
with unknown competency to practice. This paper: (1) presents survey data on current physician reentry
policies of state medical boards; (2) discusses the findings from the survey within the context of regulatory
challenges that impact physician-reentry; and (3) offers recommendations to facilitate the development
of comprehensive, coordinated regulatory policies on physician reentry.
Keywords: physician reentry, state medical and osteopathic boards, regulation, physician reentry policy,
competence, licensure, workforce

Introduction Consumer groups such as the American Association


Physician reentry is defined by the American Medical of Retired Persons (AARP) and the Citizens Advocacy
Association as: A return to clinical practice in the Center (CAC) as well as the medical profession
discipline in which one has been trained or certified itself have called for tying re-licensure to evidence
following an extended period of clinical inactivity not that physicians possess the requisite knowledge
resulting from discipline or impairment.1 Reentering and skills to practice. Both undergraduate and
physicians leave clinical practice voluntarily and as graduate medical education is increasingly struc-
such are distinct from remediating physicians, who tured around the demonstration of a series of
have demonstrated deficiencies in physician per- competencies. Maintenance of Certification (MOC)
formance. Further, reentering physicians return to and the newly proposed Maintenance of Licensure
the field of practice which they left and, thus, are (MOL) are reflections of this emphasis on continu-
different from physicians who are retraining in ous competency assessment.
order to move into a new area of clinical practice.1
Currently, all of these activities are directed at physi-
Physician reentry is a concept that may be poorly
cians who are actively practicing medicine. However,
understood by many practitioners.
regulators recognize that physicians who have been
A number of factors are driving a new emphasis away from clinical practice and seek to return must be
on lifelong evidence of physician competence and included as well. In this new environment of increased
assessment of performance in medical practice. focus on physician competence and assessment of

10 | J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 7 , N O 1 2011 Federation of State Medical Boards


performance, physicians returning to clinical practice challenge, wish to help fulfill community needs
after a hiatus pose unique challenges for state or simply have too much free time.7
medical licensing boards, whose primary objective
There is little data on whether physicians who
is public protection.2
return to clinical practice undergo assessment
As the new focus on competence assessment con- of their knowledge, skills and training and/or
tinues to develop, state boards will need to shape education before returning to patient care
systems that effectively address the performance activities. One study found, however, that among
of both practicing physicians and those who wish to 107 reentering pediatricians, 79 percent did
reenter medicine after an extended absence. As a not undergo training before returning to care for
starting point in this process, a better understanding patients.5,8 While more studies are needed on, for
is needed of how state boards currently address example, the relationship between time away from
physician reentry. practice and the need for training prior to reentry,
the ability of physicians to move in and out
This paper addresses that need by (1) presenting
of practice without oversight by state medical
survey data on current physician reentry polices
licensing boards is a limitation of the current
of state medical licensing boards; (2) discussing
medical regulatory process.
the findings from the survey within the context
of physician reentry regulatory challenges; and The status of a physicians medical licensure is
(3) offering recommendations to facilitate the develop- a key factor in the reentry process. Physicians
ment of comprehensive, coordinated regulatory with an active license have more options, as most
policies on physician reentry. are not required by medical boards to disclose
their clinical activity during the licensure renewal
Background process. One study found only about one-third of
The careers of todays physicians look markedly dif- medical licensing boards (N = 64) asked physi-
ferent from those of previous generations. The belief cians about their clinical activity status both at
that successful physicians must sacrifice personal initial licensure and at renewal.9 According to the
lives for their profession is giving way to an unprec- authors of the study, the majority of boards in the
edented desire by both male and female physicians United States allow physicians to hold and renew
for a work-life balance.3 Physicians may expect to an unrestricted active license to practice medicine,
take time away from practice at some point during although they may not have cared for a patient in
years.9 However, the options of physicians without
an active license are much more limited. To return
I N T H I S N E W E N V I RO N M E N T O F I N C R EA S E D to practice, they must contact their state medical
F O C US ON P HYS I C I A N CO M P E T E N C E A N D licensing board, which will direct their steps toward
reentry. The lack of regulatory precedent for
AS S ES S M E N T O F P E R FO R M ANC E , P H YS I CI A N S
reentering physicians, including licensure and
RETURNING TO CLINIC AL PRACTICE AFTER credentialing requirements, is a major challenge for
A H I AT U S P O S E U N I Q U E C H A L L E N G E S F O R state medical licensing boards and, ultimately, for
S TAT E M E D I C A L L I C E N S I N G BOA R D S . physicians without an active medical license.10
Despite the flexibility afforded physicians with
active medical licenses, successful return to
their careers for reasons that include family leave
clinical practice can be a difficult journey. Lack
(maternity/paternity leave, child rearing); caretaking
of consistency across jurisdictions in regulatory
and personal-relationships issues; health issues;
requirements, including licensure, is a significant
career dissatisfaction; pursuit of alternate careers,
barrier. The growing importance of physician
such as administration or military service; and
reentry as a workforce issue means that state
humanitarian leave.47
medical licensing boards will increasingly need to
Physicians may seek reentry to clinical practice address competency and patient safety for
for a variety of reasons. Often they return when physicians in active practice, and for physicians
their need to care for family is no longer pressing who do not actively provide patient care throughout
or when they have overcome a health issue. Some their careers, as well. Boards will need to do
physicians return because they miss the practice this in the midst of increasing calls for transparency
of medicine, have financial needs, want a new in the regulatory process.

2011 Federation of State Medical Boards J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 7 , N O 1 | 11


In response, regulatory bodies are moving away physician reentry policy. The most recent survey
from requiring physicians to demonstrate sufficient was sent to 64 State Boards of Allopathic and
knowledge and skills at just one point in time, and Osteopathic Medical Examiners in the U.S.; medical
are beginning to embrace the concept of requiring boards in U.S. territories were excluded. Fifty-nine
assessment as part of relicensure a process of the 64 medical boards responded to the survey,
known as Maintenance of Licensure (MOL).11 The for a response rate of 92 percent.
Federation of State Medical Boards (FSMB) has
A summary of the aggregate findings in the 2010
been working on a process for MOL since 2003,
survey for the questions related to physician reentry
including conducting a study on the role of state
is presented here. The findings represent a snap-
medical boards in ensuring continued competence
shot of specific physician reentry-related regulations
among physicians and the development of recom-
and procedures among these medical boards.
mendations for use by state medical boards.
The FSMB defines MOL as the process by which
Physician reentry policy
a licensee demonstrates that he/she has main-
The survey asked Does your board have a policy
tained his or her competence and qualifications for
on physician reentry (as defined by the AMA) for
purposes of continued licensure.12
physicians who have left the active practice of
The three components of MOL are: (1) reflective self medicine and want to reenter practice? Thirty
assessment; (2) assessment of knowledge and skills; (51 percent) of the responding medical boards
and (3) performance in practice.1112 Of particular agreed that they have a policy on physician reentry.
relevance to physician reentry is component 3, Of the 29 medical boards without a physician
performance in practice, which states that physicians reentry policy, 16 (55 percent) are either currently
developing or planning to develop a policy. Put
another way, out of the 59 medical boards in this
AS TH E N E W FO C U S O N C O M P E T E N C E sample, 78 percent have, are developing, or are
AS S ES S M E N T CO N T I N U E S TO D E V E L OP, planning to develop a policy on physician reentry.
S TAT E BOA R DS WI L L N E E D TO S H AP E
Length of time out of practice
SYS TE M S T HAT E FFE C T I V E LY A D D RE S S T H E
The 30 medical boards with a physician reentry
PE RF O R M AN C E O F B OT H P R AC T I C I N G policy were asked What is the length of time out of
PH YS I C I A N S A N D T HO S E W HO W I S H TO practice after which your board requires reentering
RE E N TE R M E D I C I N E . physicians to complete a reentry program? Among
the 25 medical boards that responded to the
question, the average length of time was 2.8 years
must demonstrate accountability for performance and ranged from 1 to 10 years. The modal (most
in their practice using a variety of methods that common) response was 2 years.
incorporate reference data to assess their performance
in practice and guide improvement.12 This component Patient care requirements for relicensure
of the proposed framework for MOL indicates that All of the medical boards were asked Does your
physicians must have ongoing involvement in patient board require a physician to engage in a certain
care a difficult, if not impossible, requirement for amount of patient care for relicensure? The vast
reentering physicians. majority of medical boards (92 percent) do not.
State medical licensing boards have a responsibility
Data collection on reentry
to assure the public that physicians possess the
Medical boards were asked Are you keeping
requisite knowledge and skills to practice medicine
records on the number of physicians the board
and, thus, will likely have the authority to establish
considered for reentry? Most (90 percent) medical
MOL requirements.12
boards are not collecting this information.
State medical licensure requirements and statistics: Among the six that do keep records on the num-
data on physician reentry into practice ber of physicians considered for reentry, five were
The AMA annually publishes the State Medical allopathic boards and five had reentry policies. One
Licensure Requirements and Statistics, which board that did not have a reentry policy is keeping
is based on a survey that includes questions on records and plans to develop a policy.

12 | J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 7 , N O 1 2011 Federation of State Medical Boards


Discussion may add further confusion. Findings from a study of
Approximately three quarters of state medical licens- the relationship between the volume of procedures
ing boards who responded to the survey either have practiced by physicians and medical outcomes show
a reentry policy or are in the process of developing that the less a procedure is practiced, the greater
or planning to develop one. This is an indication of the likelihood of complication.15 In a systematic
the growing importance of physician reentry within review of the medical literature to study the relation-
medicine and the recognition by boards of medicine ship between experience in caring for patients and
of the need to address the issue. Boards of performance quality, it was concluded that physicians
medicine seem to be developing physician reentry who have been in practice longer have less factual
policies and processes independent of one another; knowledge then their less-experienced counterparts
the scope and direction of these policies remain even after adjusting for patient volume.16
unclear. An unintended consequence of a lack of
The explanation for the results of the latter study,
consistency among state medical licensing boards
however, may, in fact, have implications for reentering
may be increased difficulty for physicians to reen-
physicians who are also in need of updating their
ter clinical practice, particularly if physicians have
knowledge and skills. With changes in technology
moved from one state to another during their time
and an increase in the volume of medical infor-
away from practice or are participating in reentry
mation, there is a growing need for regulation to
programs in a state other than their own.
assess competency so that patient safety and
There is little comprehensive information about quality of care are ensured.11,1617 Access to current
the decay rate of specific areas of knowledge and medical knowledge, including changing technologies,
skill. Thus, a physicians need to update his or her must be factored into physician reentry policies
knowledge, skills and practice prior to reentry that address education and training.
is not clearly defined. This is important information
While not all physicians may need to update their
for medical licensing boards as they address
skills before reentering practice, the current structure
policies concerning reentry. The assumption that a
of the licensure system may be preventing medical
physician who has been away from clinical practice
regulatory bodies from making that assessment.
needs to update his or her knowledge and skills
Studies are needed on how time spent away from
may be particularly true for medical specialties that
clinical practice affects the clinical skills of physicians
rely heavily on technology. It is important to note,
and, ultimately, the quality of care. In addition to
however, that while this makes sense intuitively, no
studies have been conducted to test this assump-
tion across specialties and practice areas. T H E BE L I E F T HAT S UCCE S S F UL P H YS I CI A N S

Further, studies are needed that would help determine M US T S ACR I F I CE P E R S ON A L L I V E S F OR


the cut-off point after which a physicians knowl- T H E I R P ROF E S S I ON I S G I V I N G WAY TO A N
edge and/or skills in a particular area deteriorate. UN P R EC E D E N TE D D E S I R E BY B OT H
Our findings show that on average, medical boards M A L E A N D F E M AL E P H YS I CI A N S F OR A
require reentering physicians to participate in
WO R K - L I F E B AL A N CE .
education and training (in the form of a physician
reentry program) after they have been away from
practice for close to three years. However, leading guiding state medical boards, these data could
medical organizations such as the FSMB and the potentially be used to develop and refine reentry
American Board of Medical Specialties (ABMS), program curricula and assessment methods.
have recommended a two-year time limit.1314 The
States vary in their definition and criteria for
fact that the time after which a physician should
maintaining an active medical license. According
be mandated to participate in a formal reentry
to our findings, most (92 percent) state medical
process 1 to 10 years varies so widely perhaps
boards do not require a specified amount of patient
best illustrates the difficulty state medical boards
care for relicensure. To date, this has allowed
are experiencing when making this determination
physicians who take a hiatus from clinical practice
without adequate evidence.
to maintain an active license.
Literature intended to inform the decisions by medical
MOL, if implemented, will present challenges,
licensing boards of when reentering physicians
but also opportunities, for the physician reentry
should receive additional education and training

2011 Federation of State Medical Boards J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 7 , N O 1 | 13


process. The new requirement could lead to better including performance in practice, for inactive
data collection on physician engagement in practice, physicians. We offer the following recommenda-
including data on physicians who do not actively tions as a step toward meeting these challenges.
participate in patient care. Our findings show that
the majority (90 percent) of medical boards are not Recommendations for developing regulatory
collecting information on physician reentry. It is policies on reentry
anticipated that there will be an influx of reentering The recommendations are a product of a 2010
physicians who will come to the attention of boards conference titled Physician Reentry to Clinical
Practice: Overcoming Regulatory Challenges Confer-
ence, sponsored by the AMA and in collaboration
B OAR D S O F M E D I C I N E S E E M TO BE
with the FSMB and American Academy of Pediatrics
D E V E L O P IN G P HYS I C I A N RE E N T RY P OL I CI E S (AAP). The overall goal of these recommendations
AN D PRO CE S S E S I N D E P E N D E N T O F O N E is to ensure that there is a comprehensive, trans-
AN OT H E R ; T HE S C O P E A N D D I R EC T I O N O F parent, and feasible regulatory process that also
ensures public safety for use with physicians who
TH E SE PO L I C I ES R E M A I NS U N CL E A R .
desire to return to clinical practice. The recommen-
dations are designed for medical licensing boards to
of medicine if, for example, performance in consider as they develop and implement physician
practice is implemented. The new requirement reentry policies. For the purposes of this discussion,
will change the trajectory to reentry for physicians only the recommendations from the conference
who have maintained active licenses as they pertinent to regulatory issues are included. (The
will now have to be accountable to medical boards. complete set of conference recommendations
is available online at http://www.ama-assn.org/
The licensure renewal process could include
resources/doc/med-ed-products/physician-reentry-
data collection of the number of patient hours
recommendations.pdf.)
physicians spend providing clinical care to patients.
Physicians who have been out of clinical practice, The recommendations suggest that development
but who have maintained licenses, may not be of a physician reentry regulatory process should be
able to resume practice without first demonstrating comprehensive and inclusive, involving relevant stake-
outcomes from clinical practice as part of MOL holder-groups, and it should have the following goals:
component 3, performance in practice. This may
1) Develop an understanding of the expectations
place reentering physicians at a disadvantage,
and needs relevant stakeholder groups
particularly if they have been out of practice for a
including physicians, patients, regulators, and the
significant period of time. An unintended conse-
public have for a physician reentry system.
quence of performance in practice requirements
may be that reentry physicians are at risk of losing 2) Develop physician reentry policy guidelines
their active license. across state medical licensing jurisdictions
that are consistent and evidence-based.
Increased visibility of physicians desiring and
These guidelines should clarify:
achieving reentry is an opportunity for medical
licensing boards to collect much-needed information U/ii}vi>>vVV>
to gain a better understanding of the physician practice which necessitates participating
reentry population as a whole. A clearer under- in a reentry process;
standing of these physicians will benefit medical
U/i`iwvVii
boards in developing reentry policies that result
in clinical care constitutes active clinical
in the return of physicians who provide competent
practice and the clinical practice requirements
care to patients.
for maintaining licensure; and
In sum, medical boards face many challenges to
U/i>VvviV>L>`
developing physician reentry regulatory policies
certification on maintenance of licensure.
including (1) lack of consistency in state medical
licensing laws and regulations; (2) lack of a 3) Establish mechanisms to permit reentering
coordinated database on reentering physicians physicians to engage in clinical practice
and physicians needing a reentry process; and under supervision as they participate in a
(3) issues related to maintenance of licensure, reentry program.

14 | J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 7 , N O 1 2011 Federation of State Medical Boards


These include: References
1. American Medical Association. Physician reentry. Available
Uii`V>V]}>`>ii`V>
at: http://www.ama-assn.org/ama1/pub/upload/mm/377/
education program, teaching hospital and cmerpt_6a-08.pdf. Accessed October 18, 2010.
medical home, as well as non-traditional sites 2. Law MT, Hansen ZK. Medical licensing board characteristics
such as mental health hospitals and nursing and physician discipline: An empirical analysis. J Health Polit
homes) that provides reentering physicians Policy Law. 2010;35(1):63-93.
with opportunities for supervised clinical 3. Keeton K, Fenner DE, Johnson RB, Hayward RA. Predictors of
practice in their previous clinical fields; physician career satisfaction, work-life balance, and burnout.
Obstet Gynecol. 2007;109(4):949-955.
U>Vi`i>}Vii>} 4. Mark S, Gupta J. Reentry into clinical practice. JAMA.
reentry program participants to work under 2002;288(9):1091-1096.
supervision; and 5. Mulvey H, Jewett E. Physician reentry into the workforce.
Available at: http://www.physicianreentry.org/yahoo_site_
U->ii`V>Vi}L>`i>L} admin/assets/docs/Reentry_Web_5-08.307134631.ppt.
a non-disciplinary licensure status option Accessed September 23, 2010.
for reentering physicians during their reentry 6. Grace ES, Korniek EJ, Weitzel LB, Wentz DK. Physicians
education and training. reentering clinical practice: Characteristics and clinical
abilities. J Cont Ed in Health Prof. 2010;30(3):180-186.
4) State medical licensing boards and medical 7. Adams KE, Allen R, Cain JM. Physician reentr y:
societies should develop a process for a A concept whose time has come. Obstetric Gynecol.
certificate of program completion that meets 008;111(5):1195-1198.
the need to document physician competency 8. Mulvey H, Jewett EA, Merline A, Towey KJ. Pediatricians over
to return to practice. 50 reentering clinical practice: Implications for physicians and
the regulatory community. J Med Licensure and Regulation.
5) Study the feasibility of introducing alternate 2010;96(2):7-12.
licensure tracks for reentering physicians that 9. Freed GL, Dunham KM, Abraham L. Protecting the public:
allow a limited scope of practice. State medical board licensure policies for active and inactive
physicians. Pediatrics. 2009;123:643-652.
6) Establish a national physician reentry database to: 10. Bower EA, English C, Choi D, Cedfeldt AS, Girard DE.
Education to return nonpracticing physicians to clinical
U*`i}>>Vv>iii} activity: A case study in physician reentry. J Cont Ed in
physicians; and Health Prof. 2010;30(2):89-94.
11. Chaudhry HJ, Rhyne J, Cain FE, Young A, Crane M, Bush F.
U/>Vi`ii]V>Li Maintenance of licensure: Protecting the public, promoting
of reentering physicians, program costs quality health care. J Med Licensure and Regulation.
and outcomes. 2010;96(2):13-20.
12. Federation of State Medical Boards. Board Report 10-3:
Addressing the regulatory challenges of physician Maintenance of Licensure. Available at: http://www.fsmb.org/
reentry through a comprehensive process is pdf/mol-board-report-1003.pdf. Accessed October 13, 2010.
necessary to demonstrate to the public and to 13. Federation of State Medical Boards. Special committee
employers that reentering physicians are competent to address regulation of reentry to practice. Newsline
to provide quality care to patients upon their return (May/June 2010). http://www.fsmb.org/pdf/pub-nl-may-
june-2010.pdf. Accessed December 29, 2010.
to clinical practice and to fulfill the high practice
standards of the medical profession. To achieve 14. American Board of Medical Specialties (ABMS). Clinically
active terms redefined in a push for clarity in reporting.
this standard, it will be necessary for physician Available at: http://www.abms.org/News_and_Events/
reentry stakeholders including medical regulators, news_archive/release_ClinicalActivityStatus_12_07.aspx.
medical associations, physician reentry programs, Accessed November 8, 2010.
researchers and reentry physicians to work 15. Freemen JV, Wang Y, Curtis JP, Heidenreich PA, Hlatky
collaboratively. The above recommendations, MA. The relation between hospital procedure volume and
complications of cardioverter-defibrillator implantation from
informed by data from state medical boards and the implantable cardioverter-defibrillator registry. J Am Coll
input from reentry stakeholders, address physician Cardiol. 2010;56(14):1133-1139.
reentry challenges including the need for increased 16. Choudhry NK, Fletcher RH, Soumerai SB. Systematic review:
consistency across state medical boards. These The relationship between clinical experience and quality of
recommendations serve as a mechanism to develop health care. Ann Intern Med. 2005;142:260-273.

relevant, effective policies to return reentry 17. Institute of Medicine. To Err is Human: Building a Safer
Health System. Kohn LT, Corrigan JM, Donaldson MS. Eds.
physicians to providing high-quality care for patients.
Washington, D.C.: National Academy Press, 2000.

2011 Federation of State Medical Boards J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 7 , N O 1 | 15


SETTLEMENT AGREEMENT AND RELEASE

This Settlement Agreement and Release (Agreement or Settlement) is entered into as of the
date noted at the signature page, by and between DALE KLEIN, MD (referred to hereon as
"Complainant), and the DEPARTMENT OF VETERANS AFFAIRS, POPLAR BLUFF VA
MEDICAL CENTER, POPLAR BLUFF, MO (referred to hereon as "VAMC). Both Complainant
and VAMC are collectively called the Parties.

BACKGROUND

WHEREAS the Parties have agreed to this Agreement, for good and valuable consideration, the
receipt and sufficiency of which is hereby acknowledged, and therefore intending to be legally bound
hereby, agree as follows:

TERMS

1. Litigation. Litigation, or the Litigation, refers to all existing or potential disputes between
the Parties, including, but not limited to, the allegations contained in the Office of Special Counsel
Complaints filed by Complainant, and Equal Employment Opportunity Complaints filed by
Complainant, prior to the date of this agreement, and the Professional Standards Board (PSB) matter
of April 2016.

2. Complainant Obligation.

(A) In consideration of the settlement terms identified in this Agreement, Complainant


hereby voluntarily withdraws any and all pending informal and formal EEO complaints, any appeals
to the Merit Systems Protection Board, any complaints before the Office of Special Counsel, any
grievances, whether formal or informal, any court actions, and all other claims arising under any
federal, state, or local law, regulation, or ordinance, against the Agency, its past and present
administrators or employees, in their personal or official capacities, in any stage of processing in their
entirety.

(B) In exchange for the terms provided in this agreement, Complainant settles, waives,
withdraws, and forever discharges the VAMC, their past and present administrators or employees, in
their personal or official capacities, from any and all complaints, claims, grievances, appeals,
expenses, and damages of any kind, which are or may be asserted by the Complainant, including any
wrongs, or personnel issues, or performance issues, or misconduct issues, based on any event
occurring before the execution of this Agreement, except as stated herein.

(C) Complainant will return to work as a VA Pain Management Specialist Physician,


within the terms provided herein.
3. Agency Obligation.

(A) Pay Complainant $650,000 as compensatory damages. Pay this amount within 30
days. Pay this amount to the direct deposit account of the Complainant. Complainant to provide the
Agency the direct deposit data or form within 5 days of signing this agreement to Agency Director
(facility Director at Poplar Bluff VAMC).

(B) Rescinds with prejudice, waives, dismisses with prejudice, declares null and void
forever, and otherwise voluntarily withdraws/rescinds with prejudice, all complaints, statements,
performance ratings, negative references, statements against, and otherwise not positive or favorable
mentions or references of Complainant, including any all documents related to the PSB of April 2016,
from any forum or venue, any Agency or organization (private or public), and any filing system, or
will offer a retraction with apology, if such has been made and cannot be rescinded. Also, Agency
settles, waives, withdraws, and forever discharges any and all complaints, claims, grievances, appeals,
which are or may be asserted, or have been asserted, as to performance or conduct, against
Complainant, based on any event occurring before the execution of this Agreement, except as stated
herein.

(C) Willingly assist Complainant obtain a hardship transfer to the New Orleans, VA
Medical Center, as soon as possible, and assignment to their pain management center/clinic (PMC).
This assistance/request will begin on the date this agreement is executed. Agency will assist with
telephone calls, forms needed, credentialing, positive references, and so on, to effectuate the transfer
(to include calls to VACO or VHA or VISN(s)). Agency will assist to ensure positive
references during the credentialing process at the transferred to VA Medical Center/facility. The
transfer will be deemed complete when Complainant is credentialed to practice at the New Orleans
Medical Center, and has physically reported to work there.

(D) While the transfer is completed, VA further agrees:

MEDICAL PROFICIENCY

a. Complainant will be cleared to view, see, and treat patients after completing all
requirements for CME, for past 2 years, and completing all requirements for the
certifications he holds, and performing a progressive reintegration plan to the practice of
medicine, as approved by Complainant and supervised entirely by the New Orleans VAMC
Pain Management Clinic Doctor, AND the Chief of Staff of the New Orleans VAMC.

b. Complainant, while at the Poplar Bluff VAMC, will be supervised by the New Orleans
VAMC Pain Management Clinic Doctor, AND the Chief of Staff of the New Orleans
VAMC, for all performance evaluations, assessments, and medical procedures and
processes, and administrative functions/duties.

Signers' Initials ______ ______ ______ ______


Page 2 of 8 | Settlement | Klein v. DVA (MPSB)
c. Complainant will be assisted, at VA expense, to regain proficiency/currency in the practice
of interventional pain management, and medical practice in general, by providing all
necessary training, practicum, practical exercises, educational requirements, and
credentialing requirements, needed, as dictated by the certifications Complainant holds,
and VA Pain management policies and instructions. If no VA facility(ies) is/are able to
return Complainant to baseline proficiency/currency (medical practice and expertise and
confidence held before being taken away from patients for one-year), VA agrees to pay for
all expenses and tuition/costs associated with commercial cadaver courses to gain said
proficiency/currency. Complainant is provided two (2) years after execution of this
agreement to get back to baseline. During this proficiency return effort, Complainant will
only consult by review of medical charts, or perform medical quality assurance reviews,
but not perform actual hands-on patient treatment/care or consults on live cases.
Complainant will be allowed to perform quality assurance reviews from his residence on
telework, and provided all needed computer equipment to make this possible.

d. Complainant will be provided thirty (30) days for CME from the TMS VA system. Agency
agrees to allow Complainant to perform the CMEs on telework, from his residence. Agency
agrees the CMEs will be performed starting on the day after the execution date of this
agreement, in any order or manner determined needed by the Complainant.

e. Return to baseline will be determined by the Complainant in consultation with the New
Orleans Pain Management Center doctor, and the New Orleans VAMC Chief of Staff, and
take into account all requirements of the certifications held by Complainant. This may be
assessed every six months, until the 2 year period for return to proficiency expires.

PERSONNEL MATTERS

f. To expunge from Complainants personnel file all documents which directly or indirectly
have negative comments, remarks or statements of any kind, as determined by
Complainants Attorneys, related to his performance or conduct. For example, expunge and
rescind all personnel records from the removal and PSB, and replaced with continuous
service documentation.

g. To note in reopening of the Pain Management Clinic that it was closed is because the Poplar
Bluff VAMC did not have the infrastructure/resources to sustain this comprehensive
specialty clinic.

h. To not make negative disclosures about Dr. Klein to State Medical Boards, American
Board of Anesthesiology, National Practitioner Data Base or any other agency,
organization or person, based on any events before the execution date of this agreement,
and before Complainant is returned to his baseline.

Signers' Initials ______ ______ ______ ______


Page 3 of 8 | Settlement | Klein v. DVA (MPSB)
i. In providing references, about Dr. Klein, to potential employers, or anyone else, limit
responses to: dates of employment, reason for my discontinuation of employment as noted
in paragraph 3(D)f, that he provided competent care to the Veterans without any
substandard care issues and without any substance abuse issues, and state he is eligible for
rehire.

OTHER

j. Pay all accumulated and documented attorney fees and costs, related to Complainants
EEOC and OSC matters. Complainant will submit invoices for all prior to current counsel
legal fees/costs. For its fees/costs, the Whistleblower Law Firm (WBLF) will submit a final
billing and all invoices to Agency director, within 10 days of the execution date of this
agreement. Legal fees to be paid to WBLF within 30 days, by check sent certified mail,
return receipt, to Whistleblower Law Firm, 400 N Tampa St, Suite 950, Tampa, FL 33602.

k. Hold harmless Complainant for two years from any quality assurance or competency
matter, to allow Complainant to bring his medical expertise, practice, training, and patient
contact experience up to baseline, and for Complainant to recover from the one-year
inactivity period. Further, to make work assignments that commensurate with this
requirement and are progressive in performance requirements and number of assignments,
until full proficiency is achieved within 2 years, or as agreed herein elsewhere.

4. Taxes. Complainant shall be solely responsible for, and legally bound to make payment of,
any taxes determined to be due and owing (including penalties and interest related thereto) to any
federal, state, local, or regional taxing authority because of the payment of funds received because of
this agreement. Complainant understands that Agency has not made, and Complainant does not rely
upon, any representations regarding the tax treatment of the sums paid pursuant to this Agreement.

5. No Outstanding or Known Future Claims/Causes of Action. Each Party affirms that it has not
filed with any governmental agency or court any type of action or report against the other Party, and
currently knows of no existing act or omission by the other Party that may constitute a claim or
liability excluded from this agreement. Also, that this agreement addresses any, and all, claims, related
to the Litigation, and matters described herein.

6. No Admission of Liability. The Parties acknowledge that this Settlement was agreed upon as
a compromise and final settlement of disputed claims noted as Litigation, and that any consideration
herein is not, and may not be construed as, an admission of liability by either Party, and is not to be
construed as an admission that either Party engaged in any wrongful, tortious or unlawful activity.
Parties specifically disclaim and deny (a) any liability in the Litigation, and (b) deny engaging in any
wrongful, tortious or unlawful activity.

Signers' Initials ______ ______ ______ ______


Page 4 of 8 | Settlement | Klein v. DVA (MPSB)
7. Dismissal of Litigation. Parties and respective Counsels shall take whatever actions are
necessary to ensure that the Litigation is dismissed in its entirety as to the Parties. The Parties will
cooperate with each other in securing the dismissal of the Litigation, as appropriate, through their
respective counsels.

8. Confidentiality of Agreement. The Parties expressly understand and agree that this Agreement
and its contents (including, but not limited to, the fact of payment and the amounts to be paid
hereunder) shall remain CONFIDENTIAL and shall not be disclosed to any third party whatsoever,
except the Parties counsel, accountants, financial advisors, tax professionals retained by them, any
federal, state, or local governmental taxing or regulatory authority, and the Parties management, or
others with a need to know, except as required by law or order of court. Any person identified in the
preceding sentence to whom information concerning this Agreement is disclosed is bound by this
confidentiality provision and the disclosing party shall be liable for any breaches of confidentiality
by persons to whom he/she/it has disclosed information about this Agreement in accordance with this
paragraph.

The Parties agree that this Agreement shall not be admissible as evidence in any proceeding except
where one of the Parties to this Agreement seeks to enforce the Agreement or alleges the Agreement
has been breached, or where one of the Parties is ordered to produce the Agreement by a court or
administrative agency of competent jurisdiction.

If any subpoena, order or discovery request (the Document Request) is received by any of the
Parties hereto calling for the production of the Agreement, such Party shall promptly notify the other
Party hereto prior to any disclosure of same. In such case, the subpoenaed Party shall: (a) make
available as soon as practicable (and in any event prior to disclosure), for inspection and copying, a
copy of the Agreement it intends to produce pursuant to the Document Request unless such disclosure
is otherwise prohibited by law; and (b) and, to the extent possible, shall not produce anything in
response to the Document Request for at least ten (10) business days following such notice, unless to
do so violates law or a Court Order. If necessary, the subpoenaed Party shall take appropriate actions
to resist production, as permitted by law, to allow the Parties to try to reach agreement on what shall
be produced. This paragraph is a material part of this Agreement.

Nothing contained in this paragraph shall prevent any Party from stating that the Parties have
amicably resolved all differences, provided, however, that in so doing, the Parties shall not disclose
the fact or amount of any payments made or to be made hereunder and shall not disclose any other
terms of this Agreement or the settlement described herein.

9. Agreement is Legally Binding. The Parties intend this Agreement to be legally binding upon
and shall inure to the benefit of each of them.

Signers' Initials ______ ______ ______ ______


Page 5 of 8 | Settlement | Klein v. DVA (MPSB)
10. Entire Agreement. This Agreement constitutes the entire agreement and understanding of the
Parties and supersedes all prior negotiations and/or agreements, proposed or otherwise, written or
oral, concerning the subject matter hereof. Furthermore, no modification of this Agreement shall be
binding unless in writing and signed by each of the parties hereto.

11. New or Different Facts: No Effect. Except as provided herein, this Agreement shall be, and
remain, in effect despite any alleged breach of this Agreement or the discovery or existence of any
new or additional fact, or any fact different from that which either Party now knows or believes to be
true. Notwithstanding the foregoing, nothing in this Agreement shall be construed as, or constitute, a
release of any Partys rights to enforce the terms of this Agreement.

12. Interpretation. Should any provision of this Agreement be declared or be determined by any
court to be illegal or invalid, the validity of the remaining parts, terms or provisions shall not be
affected thereby and said illegal or invalid part, term or provision shall be deemed not to be a part of
this Agreement. The headings within this Agreement are purely for convenience and are not to be
used as an aid in interpretation. Moreover, this Agreement shall not be construed against either Party
as the author or drafter of the Agreement.

13. Governing Law and Choice of Forum. This Agreement is made and entered into within and
shall be governed by, construed, interpreted and enforced in accordance with the laws of the Merit
Systems Protection Board (MSPB), and Civil Service Act of 1978. Enforcement actions will be filed
at the MSPB within 30 days those actions became identified by the Complainant. Agency and
Complainant Counsel will take steps to enter the agreement at MSPB.

14. Reliance on Own Counsel. In entering into this Agreement, the Parties acknowledge that they
have relied upon the legal advice of their respective attorneys, who are the attorneys of their own
choosing, that such terms are fully understood and voluntarily accepted by them, and that, other than
the consideration set forth herein, no promises or representations of any kind have been made to them
by the other Party. The Parties represent and acknowledge that in executing this Agreement they did
not rely, and have not relied, upon any representation or statement, whether oral or written, made by
the other Party or by that other Partys agents, representatives or attorneys about the subject matter,
basis or effect of this Agreement or otherwise.

15. Counterparts. This Agreement may be executed by the Parties in counterparts, each of which
shall be deemed an original, but all of which together shall constitute one and the same instrument.
Facsimile signatures shall be accepted the same as an original signature. A photocopy of this
Agreement may be used in any action brought to enforce or construe this Agreement.

16. Authority to Execute Agreement. By signing below, each Party warrants and represents that
the person signing this Agreement on its behalf has authority to bind that Party and that the Partys
execution of this Agreement is not in violation of any By-law, Covenants and/or other restrictions
placed upon them by their respective entities, if any.

Signers' Initials ______ ______ ______ ______


Page 6 of 8 | Settlement | Klein v. DVA (MPSB)
17. Further Understandings:

a. This Agreement addresses unique circumstances and shall not serve as precedent or
past practice for resolving any other matter involving the Agency.

b. This Agreement shall NOT be made a part of the record of the Complainant's above-
referenced discrimination (EEOC) complaint(s).

c. If a binding determination is made that any term(s) of this Agreement is/are


unenforceable, such unenforceability shall not affect any other provisions of this Agreement, and the
remaining terms of this Agreement shall, unless prohibited by law, remain effective as if such
unenforceable provision(s) was/were never contained herein.

d. The Aggrieved Person/Complainant enters into this Agreement voluntarily without


duress or coercion. Complainant fully understands all the terms of this Agreement and is aware of the
right to consult an attorney. Further, the Aggrieved Person/Complainant has not waived any rights
or claims that may arise after this Agreement is executed or that the Aggrieved Person/Complainant
is otherwise entitled.

e. Solely as to any claim of discrimination based on age, 40 years or older, the


Parties agree that this Agreement complies with the requirements of the Age Discrimination in
Employment Act and the Older Workers Benefit Protection Act. In particular, The Aggrieved
Person/Complainant is hereby advised of the following: The Aggrieved Person/Complainant is
advised to consult with an attorney before signing and delivering this Agreement. However, the
decision whether to consult with an attorney rests with the Aggrieved Person/Complainant; The
Aggrieved Person/Complainant is advised to read the entire Agreement and to seek clarification of
any provision(s) (s)he does not fully understand before signing this Agreement; The Aggrieved
Person/Complainant is advised that (s)he has not waived any rights or claims that may arise after the
date of the Agreement; The Aggrieved Person/Complainant is advised that (s)he has not waived any
rights or claims to benefits to which (s)he is entitled; The Aggrieved Person/Complainant is advised
that (s)he has twenty-one (21) days from the date of receipt of this Agreement to consider its terms.
Should the Aggrieved Person/Complainant sign this Agreement before the twenty-first (21st) day, the
Aggrieved Persons/Complainants decision to accept a shortening of this period must be knowing
and voluntary and must not be induced by the Agency or by anyone else through fraud,
misrepresentation and/or a threat to withdraw or alter the terms of this Agreement. By signing this
settlement before the expiration of 21-day consideration period, the Aggrieved Person/Complainant
acknowledges that he/she has knowingly and voluntarily waived the consideration period; The
Aggrieved Person/Complainant is advised that (s)he has seven (7) days from the date that all Parties
have signed this Agreement to revoke this Agreement. The Aggrieved Person/Complainant may
revoke this Agreement by delivering written notice of revocation to the VA Regional Counsel, at:
Office of Chief Counsel, Department of Veterans Affairs, 5000 South 5th Avenue, Bldg. 1, Rm.
G131, Hines, IL 60141-3030.

Signers' Initials ______ ______ ______ ______


Page 7 of 8 | Settlement | Klein v. DVA (MPSB)
18. This Agreement shall be effective upon the last required signature identified below or, in the
case of a claim of age discrimination, upon expiration of the 7-day revocation period.

19. Waiver. No failure to exercise and no delay in exercising any right, power or remedy under
this Agreement shall impair any right, power or remedy which any Party may have, nor shall any such
delay be construed to be a waiver of any such rights, powers or remedies or an acquiescence in any
breach or default under this Agreement, nor shall any waiver of any breach or default of any Party be
deemed a waiver of any default or breach subsequently arising.

IN WITNESS WHEREOF, and intending to be legally bound hereby, Parties, purport and promise
to have authority to settle and agree to this release, AND execute this Agreement, consisting of eight
(8) pages (including the signature pages) and having nineteen (19) enumerated paragraphs, by signing
below voluntarily, and with full knowledge of the significance of all its provisions.

PARTIES

FOR THE COMPLAINANT:

___________________________________ __________________________
Complainants Name Date

___________________________________ __________________________
Representative's Name (if any) Date

FOR THE DEPARTMENT:

___________________________________ __________________________
Authorized Agency Officials Name Date

REQUIRED LEGAL SUFFICIENCY REVIEW BY AGENCY COUNSEL

Please note that OGC review of this settlement agreement is only as to its form and legality. The
OGC attorney whose signature appears below makes no representations as to the advisability or
appropriateness of the settlement terms contained herein.

___________________________________ __________________________
Counsel for the Agency Date

Signers' Initials ______ ______ ______ ______


Page 8 of 8 | Settlement | Klein v. DVA (MPSB)
November 1999

I N S T I T U TE OF M E D I C I N E
Shaping the Future for Health

TO ERR IS HUMAN:
BUILDING A SAFER HEALTH SYSTEM

H ealth care in the United States is not as safe as it should be--and can
be. At least 44,000 people, and perhaps as many as 98,000 people, die
in hospitals each year as a result of medical errors that could have
been prevented, according to estimates from two major studies. Even using
the lower estimate, preventable medical errors in hospitals exceed attributable
deaths to such feared threats as motor-vehicle wrecks, breast cancer, and
AIDS.
Medical errors can be defined as the failure of a planned action to be
completed as intended or the use of a wrong plan to achieve an aim. Among
the problems that commonly occur during the course of providing health care
are adverse drug events and improper transfusions, surgical injuries and
wrong-site surgery, suicides, restraint-related injuries or death, falls, burns,
pressure ulcers, and mistaken patient identities. High error rates with serious
consequences are most likely to occur in intensive care units, operating rooms,
and emergency departments.
Beyond their cost in human lives, preventable medical errors exact
other significant tolls. They have been estimated to result in total costs (in-
cluding the expense of additional care necessitated by the errors, lost income
and household productivity, and disability) of between $17 billion and $29
billion per year in hospitals nationwide. Errors also are costly in terms of loss
of trust in the health care system by patients and diminished satisfaction by
both patients and health professionals. Patients who experience a long hospi- Errorsare costly
tal stay or disability as a result of errors pay with physical and psychological in terms of loss of
discomfort. Health professionals pay with loss of morale and frustration at trust in the health
not being able to provide the best care possible. Society bears the cost of er- care system by pa-
rors as well, in terms of lost worker productivity, reduced school attendance tients and dimin-
by children, and lower levels of population health status. ished satisfaction
A variety of factors have contributed to the nations epidemic of medi- by both patients
cal errors. One oft-cited problem arises from the decentralized and frag- and health profes-
mented nature of the health care delivery system--or nonsystem, to some sionals.
observers. When patients see multiple providers in different settings, none of
whom has access to complete information, it becomes easier for things to go
wrong. In addition, the processes by
Types of Errors which health professionals are licensed
Diagnostic
and accredited have focused only limited
Error or delay in diagnosis attention on the prevention of medical er-
Failure to employ indicated tests rors, and even these minimal efforts have
Use of outmoded tests or therapy
Failure to act on results of monitoring or testing
confronted resistance from some health
care organizations and providers. Many
Treatment providers also perceive the medical liabil-
Error in the performance of an operation, procedure, or test
Error in administering the treatment
ity system as a serious impediment to sys-
Error in the dose or method of using a drug tematic efforts to uncover and learn from
Avoidable delay in treatment or in responding to an abnormal test errors. Exacerbating these problems, most
Inappropriate (not indicated) care
third-party purchasers of health care pro-
Preventive vide little financial incentive for health
Failure to provide prophylactic treatment care organizations and providers to im-
Inadequate monitoring or follow-up of treatment
prove safety and qua lity.
Other
Failure of communication Health Care System at Odds with Itself
Equipment failure
Other system failure
The Quality of Health Care in America
SOURCE: Leape, Lucian; Lawthers, Ann G.; Brennan, Troyen A., et al. Pr e-
Committee of the Institute of Medicine
venting Medical Injury. Qual Rev Bull. 19(5):144149, 1993.
(IOM) concluded that it is not acceptable
for patients to be harmed by the health
care system that is supposed to offer healing and comfort--a system that promises,
First, do no harm. Helping to remedy this problem is the goal of To Err is Hu-
man: Building a Safer Health System, the IOM Committees first report.
In this report, issued in November 1999, the committee lays out a compre-
hensive strategy by which government, health care providers, industry, and con-
sumers can reduce preventable medical errors. Concluding that the know-how
already exists to prevent many of these mistakes, the report sets as a minimum
goal a 50 percent reduction in errors over the next five years. In its recommenda-
tions for reaching this goal, the committee strikes a balance between regulatory
and market-based initiatives, and between the roles of professionals and organi-
zations.
One of the reports main conclusions is that the majority of medical er-
rors do not result from individual recklessness or the actions of a particular
group--this is not a bad apple problem. More commonly, errors are caused by
More commonly,
faulty systems, processes, and conditions that lead people to make mistakes or
errors are caused
fail to prevent them. For example, stocking patient-care units in hospitals with
by faulty systems,
certain full-strength drugs, even though they are toxic unless diluted, has re-
processes, and
sulted in deadly mistakes.
conditions that
Thus, mistakes can best be prevented by designing the health system at all
lead people to
levels to make it safer--to make it harder for people to do something wrong and
make mistakes or
easier for them to do it right. Of course, this does not mean that individuals can
fail to prevent
be careless. People still must be vigilant and held responsible for their actions.
them. But when an error occurs, blaming an individual does little to make the system
safer and prevent someone else from committing the same error.

2
Strategy for Improvement

To achieve a better safety record, the report recommends a four-tiered approach:

Establishing a national focus to create leadership, research, tools,


and protocols to enhance the knowledge base about safety. Health care is a
Health care is a decade or more behind many other high-risk industries in decade or more be-
its attention to ensuring basic safety. This is due, in part, to the lack of a single hind many other
designated government agency devoted to improving and monitoring safety high-risk industries
throughout the health care delivery system. Therefore, Congress should create a in its attention to
Center for Patient Safety that would set national safety goals and track progress in ensuring basic
meeting them; develop a research agenda; define prototype safety systems; de- safety.
velop, disseminate, and evaluate tools for identifying and analyzing errors; de-
velop methods for educating consumers about patient safety; and recommend ad-
ditional improvements as needed.
Funding for the center should be adequate and secure, starting with $30
million to $35 million per year and growing over time to at least $100 million an-
nually--modest investments relative to the consequences of errors and to the re-
sources devoted to other public safety issues. The center should be housed within
the Agency for Healthcare Research and Quality (AHRQ), which already is in-
volved in a broad range of quality and safety issues, and has established the infra-
structure and experience to fund research, education, and coordinating activities.

Identifying and learning from errors by developing a nationwide


public mandatory reporting system and by encouraging health care organi-
zations and practitioners to develop and participate in voluntary reporting
systems.
Under the mandatory reporting system, state governments will be required
to collect standardized information about adverse medical events that result in
death and serious harm. Hospitals should be required to begin reporting first, and
eventually reporting should be required by all health care organizations. This
system will ensure a response to specific reports of serious injury, hold health care
organizations and providers accountable for maintaining safety, provide incen-
tives to organizations to implement internal safety systems that reduce the likeli-
hood of errors occurring, and respond to the publics right to know about patient
safety. Currently, about a third of the states have mandatory reporting require-
ments.
Voluntary reporting systems will provide an important complement to the Voluntary reporting
mandatory system. Such systems can focus on a much broader set of errors, systems will pro-
mainly those that do no or minimal harm, and help detect system weaknesses that vide an important
can be fixed before the occurrence of serious harm, thereby providing rich info r- complement to the
mation to health care organizations in support of their quality improvement ef- mandatory system.
forts. To foster participation in voluntary systems, Congress should enact laws to
protect the confidentiality of certain information collected. Without such legisla-
tion, health care organizations and providers may be discouraged from partic i-
pating in voluntary reporting systems out of worry that the information they pro-
vide might ultimately be subpoenaed and used in lawsuits.
3
Raising performance standards and expectations for improve-
ments in safety through the actions of oversight organizations, professional
groups, and group purchasers of health care.
The process of de- Setting and enforcing explicit performance standards for patient safety
veloping and through regulatory and related mechanisms, such as licensing, certification, and
adopting standards accreditation, can define minimum performance levels for health professionals,
also helps to form the organizations in which they work, and the tools (drugs and devices) they use
expectations for to care for patients. The process of developing and adopting standards also helps
safety among pro- to form expectations for safety among providers and consumers.
viders and con- Standards and expectations are not only set through regulations, however.
sumers. The values and norms set by the health professions influence the practice, train-
ing, and education for providers. Thus, professional societies should become
leaders in encouraging and demanding improvements in patient safety, by such
actions as setting their own performance standards, convening and communicat-
ing with members about safety, incorporating attention to patient safety in training
programs, and collaborating across disciplines.
The actions of large purchasers of health care and health care insurance, as
well as actions by individual consumers, also can affect the behaviors of health
care organizations. Public and private purchasers, such as businesses buying in-
surance for their employees, must make safety a prime concern in their contract-
ing decisions. Doing so will create financial incentives for health care organiza-
tions and providers to make needed changes to ensure patient safety.

Implementing safety systems in health care organizations to en-


sure safe practices at the delivery level.
Health care organizations must develop a culture of safety such that
their workforce and processes are focused on improving the reliability and safety
of care for patients. Safety should be an explicit organizational goal that is dem-
onstrated by strong leadership on the part of clinicians, executives, and governing
bodies. This will mean incorporating a variety of well-understood safety princ i-
ples, such as designing jobs and working conditions for safety; standardizing and
simplifying equipment, supplies, and processes; and enabling care providers to
avoid reliance on memory. Systems for continuously monitoring patient safety
also must be created and adequately funded.
Medication errors The medication process provides an example where implementing better
systems will yield better human performance. Medication errors now occur fre-
now occur fre-
quently in hospi- quently in hospitals, yet many hospitals are not making use of known systems for
improving safety, such as automated medication order entry systems, nor are they
tals, yet many hos-
pitals are not mak- actively exploring new safety systems. Patients themselves also could provide a
ing use of known major safety check in most hospitals, clinics, and practice. They should know
which medications they are taking, their appearance, and their side effects, and
systems for im-
they should notify their doctors of medication discrepancies and the occurrence of
proving safety
side effects.

4
Progress Under Way

The response to the IOM report was swift and positive, within both government
and the private sector.
Almost immediately, the Clinton administration issued an executive order
instructing government agencies that conduct or oversee health-care programs to
implement proven techniques for reducing medical errors, and creating a task
force to find new strategies for reducing errors. Congress soon launched a series
of hearings on patient safety, and in December 2000 it appropriated $50 million to
the Agency for Healthcare Research and Quality to support a variety of efforts
targeted at reducing medical errors.
The AHRQ already has made major progress in developing and imple-
menting an action plan. Efforts under way include:
Developing and testing new technologies to reduce medical errors.
Conducting large-scale demonstration projects to test safety interve n-
tions and error-reporting strategies.
Supporting new and established multidisciplinary teams of researchers
and health-care facilities and organizations, located in geographically diverse lo-
cations, that will further determine the causes of medical errors and develop new
knowledge that will aid the work of the demonstration projects.
Supporting projects aimed at achieving a better understanding of how
the environment in which care is provided affects the ability of providers to im-
prove safety.
Funding researchers and organizations to develop, demonstrate, and
evaluate new approaches to improving provider education in order to reduce er-
rors.
Casting its net even more broadly, the AHRQ has produced a booklet of
practical tips on what individual consumers can do to improve the quality of
health-care services they receive. The booklet focuses on key choices that indi-
viduals and their families face, such as choosing doctors, hospitals, and treat-
ments, and it stresses the importance of individuals taking an active role in se-
lecting and evaluating their care. (The booklet is available on the organizations
Web site at www.ahrq.gov.)
In efforts focused at the state level, during the past year the National
Academy for State Health Policy (NASHP) convened leaders from both the ex-
ecutive and legislative branches of the states to discuss approaches to improving
patient safety. The NASHP also helped lead an initiative to better understand
how states with mandatory hospital error-reporting requirements administer and
enforce their programs. (A report on this initiative is available on the organiza-
tions Web site at www.nashp.org). In addition, the Agency for Healthcare Re-
search and Quality has contracted with the National Quality Forum to produce a
list of so-called never events that states might use as the basis of a mandatory
reporting system.
Among activities in the private sector, the Leapfrog Group, an association
of private and public sector group purchasers, unveiled a market-based strategy to
improve safety and quality, including encouraging the use of computerized phys i-

5
cian-order entry, evidence-based hospital referrals, and the use of ICUs staffed by
physicians credentialed in critical care medicine.
Professional groups within the health-care community also have been ac-
tive. As but one example, the Council on Graduate Medical Education (COGME)
and the National Advisory Council on Nurse Education and Practice (NACNEP)
held a joint meeting on Collaborative Education Models to Ensure Patient
Safety. Participants addressed such issues as the effect of the relationships be-
tween physicians and nurses on patient safety, the impact of physician-nurse col-
laboration on systems designed to protect patient safety, and educational pro-
grams to ensure interdisciplinary collaboration to further patient safety. (A report
on the meeting is available on the COGMEs Web site at www.cogme.org.)

Pulling Together

With adequate Although no single activity can offer a total solution for dealing with medical er-
leadership, atten- rors, the combination of activities proposed in To Err is Human offers a roadmap
tion, and resources, toward a safer health system. With adequate leadership, attention, and resources,
improvements can improvements can be made. It may be part of human nature to err, but it is also
be made. part of human nature to create solutions, find better alternatives, and meet the
challenges ahead.

For More Information

Copies of To Err is Human: Building a Safer Health System are available for
sale from the National Academy Press; call (800) 624-6242 or (202) 334-3313 (in
the Washington metropolitan area), or visit the NAP home page at www.nap.edu.
The full text of this report is available at
http://www.nap.edu/books/0309068371/html/

Support for this project was provided by The National Research Council and The
Commonwealth Fund. The views presented in this report are those of the Institute
of Medicine Committee on the Quality of Health Care in America and are not
necessarily those of the funding agencies.

The Institute of Medicine is a private, nonprofit organization that provides health


policy advice under a congressional charter granted to the National Academy of
Sciences. For more information about the Institute of Medicine, visit the IOM
home page at www.iom.edu.

Copyright 2000 by the National Academy of Sciences. All rights reserved.

Permission is granted to reproduce this document in its entirety, with no additions


or alterations

6
COMMITTEE ON QUALITY OF HEALTH CARE IN AMERICA

WILLIAM C. RICHARDSON (Chair), President and CEO, W.K. Kellogg


Foundation, Battle Creek, MI
DONALD M. BERWICK, President and CEO, Institute for Healthcare
Improvement, Boston
J. CRIS BISGARD, Director, Health Services, Delta Air Lines, Inc., Atlanta
LONNIE R. BRISTOW, Past President, American Medical Association, Walnut
Creek, CA
CHARLES R. BUCK, Program Leader, Health Care Quality and Strategy
Initiatives, General Electric Company, Fairfield, CT
CHRISTINE K. CASSEL, Professor and Chairman, Department of Geriatrics
and Adult Development, Mount Sinai Medical Center, New York City
MARK R. CHASSIN, Professor and Chairman, Department of Health Policy,
The Mount Sinai Medical Center, New York City
MOLLY JOEL COYE, Vice President and Director, West Coast Office, The
Lewin Group, San Francisco
DON E. DETMER, Dennis Gillings Professor of Health Management,
University of Cambridge, UK
JEROME H. GROSSMAN, Chairman and CEO, Lion Gate Management, LLC,
Boston
BRENT JAMES, Executive Director, Intermountain Health Care, Institute for
Health Care Delivery Research, Salt Lake City, UT
DAVID McK. LAWRENCE, Chairman and CEO, Kaiser Foundation Health
Plan, Inc., Oakland, CA
LUCIAN LEAPE, Adjunct Professor, Harvard School of Public Health
ARTHUR LEVIN, Director, Center for Medical Consumers, New York City
RHONDA ROBINSON-BEALE, Executive Medical Director, Managed Care
Management and Clinical Programs, Blue Cross Blue Shield of Michigan,
Southfield
JOSEPH E. SCHERGER, Associate Dean for Clinical Affairs, University of
California at Irvine College of Medicine
ARTHUR SOUTHAM, Partner, 2C Solutions, Northridge, CA
MARY WAKEFIELD, Director, Center for Health Policy and Ethics, George
Mason University
GAIL L. WARDEN, President and CEO, Henry Ford Health System, Detroit

7
Study Staff

JANET M. CORRIGAN, Director, Division of Health Care Services, Director,


Quality of Health Care in America Project
MOLLA S. DONALDSON, Project Codirector
LINDA T. KOHN, Project Codirector
TRACY McKAY, Research Assistant
KELLY C. PIKE, Senior Project Assistant

Auxiliary Staff

MIKE EDINGTON, Managing Editor


KAY HARRIS, Financial Advisor
SUZANNE MILLER, Senior Project Assistant

Copy Editor

FLORENCE POILLON

8
Department of Veterans Affairs VHA HANDBOOK 1050.01
Veterans Health Administration Transmittal Sheet
Washington, DC 20420 March 4, 2011

VHA NATIONAL PATIENT SAFETY IMPROVEMENT HANDBOOK

1. REASON FOR ISSUE. This Veterans Health Administration (VHA) Handbook provides
precedence for minimizing the chance of inadvertent harm to patients consequent to their
medical care.

2. SUMMARY OF MAJOR CHANGES. This VHA Handbook is revised to incorporate new


minimum requirements for root cause analysis and Aggregated Reviews of selected categories of
adverse events.

3. RELATED DIRECTIVES. VHA Handbook 1058.1, Requirements for Reporting Research


Events to Facility Oversight Committees and the Office of Research Oversight; VA Directive
0700, Administrative Investigations; VA Handbook 0700, Administrative Investigations.

4. RESPONSIBLE OFFICE. The National Center for Patient Safety (10X) is responsible for
the contents of this VHA Handbook. Questions may be referred to 734-930-5890.

5. RESCISSION. VHA Handbook 1050.1 dated May 23, 2008, is rescinded.

6. RECERTIFICATION. This VHA Handbook is scheduled for recertification on or before


the last working date of March 2016.

Robert A. Petzel, M.D.


Under Secretary for Health

DISTRIBUTION: E-mailed to the VHA Publications Distribution List 3/4/2011

T-1
March 4, 2011 VHA HANDBOOK 1050.01

CONTENTS

VHA NATIONAL PATIENT SAFETY IMPROVEMENT HANDBOOK

PARAGRAPH PAGE

1. Purpose ...................................................................................................................................... 1

2. Background ............................................................................................................................... 1

3. Scope ......................................................................................................................................... 2

4. Definitions ................................................................................................................................. 2
a. Adverse Events .................................................................................................................... 2
b. Aggregated Review ............................................................................................................. 3
c. Close Calls .......................................................................................................................... 3
d. Intentionally Unsafe Acts ................................................................................................... 3
e. Patient Safety ...................................................................................................................... 4
f. Proactive Risk Assessment .................................................................................................. 4
g. Root Cause Analysis (RCA) ............................................................................................... 4
i. Wild Card ............................................................................................................................. 4

5. Goals ......................................................................................................................................... 5

6. Responsibility of the Facility Director ...................................................................................... 5

7. Root Cause Analysis (RCA) ..................................................................................................... 6

8. Sentinel Events .......................................................................................................................... 8

9. Identification and Reporting of Adverse Events, Sentinel Events,


and Close Calls and How to Address Intentionally Unsafe Acts ........................................... 8

10. Review and Analysis of Reported Events ............................................................................. 11

11. RCA Process Requirements for Aggregated Reviews and Individual RCAs ....................... 13

12. Requirements of Individual RCAs ........................................................................................ 13

13. Requirements for Aggregated Reviews ................................................................................ 14

14. Aggregated Review Logs ...................................................................................................... 14

15. Cornerstone Recognition ...................................................................................................... 14

i
VHA HANDBOOK 1050.01 March 4, 2011

CONTENTS Continued

PARAGRAPH PAGE

16. Patient Safety Alerts and Patient Safety Advisories ............................................................. 15

17. Responsibilities of the Patient Safety Manager (PSM) ......................................................... 15

18. Responsibilities of the National Center of Patient Safety (NCPS) ....................................... 16

19. Informing Patients about Adverse Events ............................................................................. 17

20. Compensation for Injured Patients ........................................................................................ 18

APPENDICES

A The Joint Commissions Definition of Reviewable Sentinel Events That May


be Reported to the Joint Commission .............................................................................. A-1

B The Safety Assessment Code (SAC) Matrix ......................................................................... B-1

C Detailed View of the Event Evaluation and Reporting Process ............................................ C-1

D Simplified View of the Root Cause Analysis (RCA) Process ............................................. D-1

ii
March 4, 2011 VHA HANDBOOK 1050.01

VHA NATIONAL PATIENT SAFETY IMPROVEMENT HANDBOOK

1. PURPOSE

This Veterans Health Administration (VHA) Patient Safety Improvement Handbook provides
a procedures used in the accomplishment of VHAs goal of preventing inadvertent harm to
patients consequent to their medical care.

2. BACKGROUND

a. VHA began to put special focus on patient safety improvement in 1997, and began
operation in February 1999 of the National Center for Patient Safety (NCPS) to develop and
implement VHAs patient safety programs. In late 1999, the Institute of Medicine (IOM)
published the To Err is Human report, which brought national attention to the problem of
adverse events in health care, and included the estimate that adverse events were causing from
44,000 to 98,000 deaths per year. The first version of the VHA Patient Safety Improvement
Handbook was developed in 1998. An updated version was distributed in 1999 to provide
guidance on preventing adverse events through implementing new methods at Department of
Veterans Affairs (VA) medical facilities to better understand and address local problems. Then
and now, it is necessary for VA administrative and clinical staff members to have a clear picture
as to what is actually happening in their health care settings, so that appropriate steps can be
taken to prevent harm to patients.

b. VHA's patient safety program has implemented a three-step approach to improving


patient safety which includes:

(1) Understanding the health care continuum as a system, and exploring system
vulnerabilities that can result in patient harm; this being an emphasis in VHAs patient safety
improvement initiatives.

(2) Reporting of adverse events and close calls. This is the primary mechanism through
which VHA NCPS learns about system vulnerabilities and how to address them. Since 2000,
more than 700,000 adverse events and close calls have been reported to the VHA NCPS from
VA medical facilities. These reports have provided valuable opportunities to evaluate the
identified root causes and contributing factors, as well associated actions and outcome measures
to mitigate future events from reoccurring within that facility.

(3) Emphasizing prevention rather than punishment this is the preferred method to mitigate
system vulnerabilities and reduce adverse events; is an important aspect of VHAs patient safety
initiatives.

c. The three-step approach promotes the implementation of knowledge-based actions that


can be formulated, tested, and implemented at the local and national levels to effectively mitigate
system vulnerabilities that can lead to patient harm. NOTE: Ultimately, this effort can be
successful only if emphasis on safety and the responsibility for improving it resides at all levels
of the organization; it requires a team effort.

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d. Incorporation of root cause analysis (RCA), a widely-understood methodology for


dealing with these safety-related issues, has allowed for more accurate and rapid communication
throughout the organization of potential and actual causes of harm to patients, thus building local
and national knowledge about systems vulnerabilities and speeding the process of patient safety
improvement. NOTE: Training is highly recommended for all Patient Safety Managers (PSM)
and other identified key staff involved in RCAs to complement the contents of this Handbook;
reading it alone is not sufficient to achieve maximum desired outcomes. Experience has shown
that individuals who have not undergone appropriate training have been unable to perform in a
consistent and adequate manner. For upcoming training opportunities contact the National
Center for Patient Safety at (734) 930-5890.

e. RCAs do not involve sworn testimony. RCAs can generate written confidential quality
assurance documents if this is appropriately indicated in writing by the appropriate official prior
to initiation of the review. Additionally, the appropriate issuance of the charge memo invokes
this protection.

3. SCOPE

This Handbook:

a. Delineates what types of events are to be considered within the patient safety program and
how they need to be addressed, as well as defining the disposition of other adverse events
resulting from: a criminal act; a purposefully unsafe act; an act related to alcohol or substance
abuse by an impaired provider or staff; or events involving alleged or suspected patient abuse of
any kind.

b. Specifies the method by which the need for conducting an RCA is determined, and the
procedure for communicating related findings throughout the organization. These procedures
address the management component and the frontline patient care needs. NOTE: Directions in
this Handbook for reporting adverse events and close calls do not eliminate the need for the
provider to document or report events related to a patient, or to disclose an adverse event to a
patient, as defined by other requirements.

c. Applies to all VA medical facilities, Community-based Outpatient Clinics (CBOCs),


Consolidated Mail Outpatient Pharmacies (CMOPs) and any other VA facility providing medical
care to Veterans.

4. DEFINITIONS

a. Adverse Events. Adverse events that may be candidates for an RCA are untoward
incidents, therapeutic misadventures, iatrogenic injuries, or other adverse occurrences directly
associated with care or services provided within the jurisdiction of a medical facility, outpatient
clinic, or other VHA facility.

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(1) Adverse events may result from acts of commission or omission (e.g., administration of
the wrong medication, failure to make a timely diagnosis or institute the appropriate therapeutic
intervention, adverse reactions or negative outcomes of treatment).

(2) Some examples of more common adverse events include: patient falls, adverse drug
events, procedural errors or complications, and missing patient events. All adverse events
require reporting and documentation in the VHA Patient Safety Information System (PSIS),
using the WebSPOT software application; the type of review required is determined through
the Safety Assessment Code (SAC) Matrix scoring process (see App. B).

b. Aggregated Review. The Aggregated Review process is a method of analyzing a group


of similar incidents or event types to determine common causes, thereby facilitating coordinated
actions to prevent recurrences. Issues and incidents reviewed via Aggregated Reviews are those
that do not require individual RCAs. The determination of common causes through the use of
Aggregated Reviews provides the opportunity to correct minor issues before they lead to serious
adverse events. Aggregated Reviews are required in three categories of incidents: falls, adverse
drug events and missing patients as described in paragraph 13.

c. Close Calls. A close call is an event or situation that could have resulted in an adverse
event, but did not, either by chance or through timely intervention. Such events have also been
referred to as near miss incidents.

(1) An example of a close call would be a surgical or other procedure almost performed on
the wrong patient due to lapses in verification of patient identification, but caught prior to the
procedure.

(2) Close calls are opportunities for learning and afford the chance to develop preventive
strategies and actions; they receive the same level of scrutiny as adverse events that result in
actual injury. They require reporting and documentation in WebSPOT. NOTE: Just as for
adverse events, the SAC Matrix scoring process and score determines the type of review (see
App. B).

d. Intentionally Unsafe Acts

(1) Intentionally unsafe acts, as they pertain to patients, are any events that result from:

(a) A criminal act,

(b) A purposefully unsafe act,

(c) An act related to alcohol or substance abuse by an impaired provider and/or staff, or

(d) Events involving alleged or suspected patient abuse of any kind.

(2) Intentionally unsafe acts must be dealt with through avenues other than those defined in
this Handbook (i.e., Administrative Investigative Boards (AIBs)), or other administrative
methods as determined by the facility Director and by applicable directives and regulations such

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as VA Directive 0700, VA Handbook 0700. The goal of these investigations, as it is with RCAs,
focuses on answering the questions of what happened, why did it happen, and what can be done
to prevent it from happening again. Unlike RCAs, AIBs can result in individually directed
action in addition to systems improvement.

(3) If an event involves what appears to be an intentionally unsafe act, an AIB or similar
review may be appropriate and an RCA may be inappropriate. However, in some cases it may
be appropriate to do both types of reviews, e.g., an AIB might review a procedure or aspect of
care performed by a provider who might not have had the appropriate credentials or privileges,
and an RCA on the same topic might review the local processes for credentialing and privileging.
An RCA can use information gleaned from an AIB, but due to confidentiality constraints of
RCAs, an AIB cannot use information from an RCA. If there is an intention to perform both
types of reviews on the same incident, the RCA should normally be performed after the
completion of AIB. In the event that an AIB is performed after an RCA is started, members of
the RCA team are not to serve on the AIB team or review group to ensure that the confidentiality
of the RCA process is appropriately maintained and that the perception of the integrity of the
RCA process is preserved. NOTE: The process of conducting AIBs is not addressed in this
Handbook. These methods are not part of the VHA patient safety program and are described in
VA Handbook 0700 and VA Directive 0700, Administrative Investigations.

(4) Unlike RCAs, peer reviews, and other selected reviews, AIBs are not confidential quality
improvement documents and are not protected from release by Title 38 United States Code
(U.S.C.) 5705. Management may also elect to perform an AIB even in cases that are not
perceived to be intentionally unsafe acts as part of their normal supervisory responsibilities. In
such cases it is recommended that the AIB be performed prior to the RCA to prevent confidential
information derived from an RCA from being improperly used in the AIB in question as well as
to avoid the perception that information from an RCA was used improperly (see subpars. 4d(2)
and 4d(3)).

e. Patient Safety. Patient Safety is ensuring freedom from accidental or inadvertent injury
during health care processes.

f. Proactive Risk Assessment. Proactive Risk Assessment is a method of evaluating a


product or process to identify systems vulnerabilities, and their associated corrective actions,
before an adverse event occurs. Proactive Risk Assessment models include Healthcare Failure
Mode and Effect Analysis (HFMEASM) and Failure Mode Effect Analysis (FMEA).

g. Root Cause Analysis (RCA). RCA is a process for identifying the basic or contributing
causal factors that underlie variations in performance associated with adverse events or close
calls (see par. 7).

h. Wild Card. Wild card Aggregated Reviews are those completed on a category of adverse
event other than one of the three required Aggregated Review categories. These may be done on
a category of adverse event of the facilitys choosing. Only actual or potential events with a
SAC score of one or two can be used as a wild card aggregate review. When the actual or
potential SAC score is three for an event that is not in one of the three Aggregated Review

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categories, an individual RCA must be chartered and the adverse event may not be assigned to a
wild card Aggregated Review.

5. GOALS

The Patient Safety Program's goal is to prevent harm to patients. This is accomplished by
taking steps in the way things are done so that the level of faith and trust in the VHA patient
safety system is established and behaviors designed to prevent adverse events become a part of
all-employee behavior. NOTE: This is a never-ending process. In this way a culture of
safety can be formed. The requirements for accomplishing this goal are:

a. Identifying and reporting adverse events (including Sentinel Events), and close calls (see
par. 6).

b. Reviewing adverse events and close calls to identify underlying causes and implementing
changes needed to reduce the likelihood of recurrence (see par. 10). The determination of cause
is aimed at the system issues and is not to be used as a punitive tool. NOTE: The requirements
for initiating a review is determined by the prioritization method defined by the SAC (see App.
B).

c. Disseminating patient safety alerts and lessons learned regarding effective system
modifications throughout VHA (see par. 10) in an effective manner.

d. Completing at least one Proactive Risk Assessment, also known as HFMEA per year for
each of the TJC-accredited programs. NOTE: The VHA requirement remains one per year
(every 12 months) despite the fact that TJC requirement changed to one every 18 months
beginning in 2009 and modified or may modify which programs are expected to complete this
requirement. (Standard LD.04.04.05 EP10).

e. Implementing practices appropriate to Department of Veterans Affairs (VA) settings that


have shown to be effective in preventing adverse events elsewhere. These include practices from
other VA medical facility, or in non-VA hospitals, as described in the published literature, in
communications from NCPS (such as through toolkits and the NCPS web page), or through
publications, notices, and web sites from other organizations.

f. At minimum, submitting an end of fiscal year Patient Safety Annual Report to facility
leaders that provides an overview of Patient Safety program status. Information may include:
program successes, areas for improvement, reports of RCAs, Aggregated Reviews, Sentinel
Events, alerts and advisories, etc.

6. RESPONSIBILITY OF THE FACILITY DIRECTOR

The Facility Director is responsible for:

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a. Designating the PSM, and back up, as the point of contact for the distribution and tracking
of Patient Safety Alerts and Patient Safety Advisories within the facility, including any impacted
CBOCs, domiciliaries and contract care facilities providing care to Veterans.

b. Ensuring Patient Safety Alert actions and Patient Safety Advisory recommendations are
assigned and completed within the timeframes provided with the document.

c. Ensuring that the NCPS is notified when an issue is detected that could affect other VHA
facilities and may require the development of a Patient Safety Alert or Patient Safety Advisory.

d. Ensuring a minimum of eight patient safety analysis processes, i.e., RCAs and Aggregated
Reviews, are completed each fiscal year.

7. ROOT CAUSE ANALYSIS (RCA)

An RCA is a specific type of focused review that is used for all adverse events or close calls
requiring analysis. Consistent use of RCAs further refines the implementation and increases the
quality and consistency of focused reviews. To avoid confusion, the term RCA is used to denote
this type of focused review and must adhere to the procedures provided in this Handbook. RCAs
must be initiated with a specific charter memorandum, and the term Root Cause Analysis must
be used in documents so that they are protected and deemed confidential under 38 U.S.C. 5705,
and its implementing regulations.

(1) RCAs have the following characteristics:

(a) The review is interdisciplinary in nature with involvement of those knowledgeable about
the processes involved in the event and may include staff with varying levels of experience and
educational background.

(b) The analysis focuses primarily on systems and processes rather than individual
performance.

(c) The analysis digs deeper by asking what and why until all aspects of the process are
reviewed and the contributing factors are considered.

(d) The analysis identifies changes that could be made in systems and processes through
either redesign or development of new processes, and systems that would improve performance
and reduce the risk of the adverse event or close call recurrence.

(2) To help adhere to these characteristics, the following five guidelines must be considered
when developing root cause statements:

(a) Root cause statements must include the cause and effect,

(b) Negative descriptions will not be used in root cause statements,

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(c) Each human error has a preceding cause,

(d) Violations of procedure are not root causes, but must have a preceding cause, and

(e) Failure to act is only a root cause when there is a pre-existing duty to act.

(3) To be thorough, an RCA must include:

(a) A determination of the human and other factors most directly associated with the event or
close call and the processes and systems related to its occurrence. There is rarely only one
underlying cause.

(b) Analysis of the underlying systems through a series of why questions to determine
where redesigns might reduce risk.

(c) Identification of system vulnerabilities or risks and their potential contributions to the
adverse event or close call.

(d) Determination of potential improvement in processes or systems that would tend to


decrease the likelihood of such events in the future, or a determination, after analysis, that no
such improvement opportunities exist.

(4) To be credible, an RCA must:

(a) Include participation by the leadership of the organization (this can range from chartering
the RCA team, to direct participation on the RCA team, to participation in the determination of
the corrective action plan) and by individuals knowledgeable about the processes and systems
under review. NOTE: This is not to suggest that the team must consist solely of leaders and
individuals with special knowledge of clinical or other processes thought to be associated with
the adverse event or close call. Valuable contributions have been made by employees with little
background in the clinical or other areas that were thought to be relevant at the outset of the
RCA process. In cases where the facility Director serves on the RCA team, final concurrence
must come from the Veterans Integrated Service Network (VISN) Director, or designee.

(b) Exclude individuals directly involved in the adverse event or close call under review. In
the interest of objectivity, these individuals must not be part of the RCA Team. However, their
experience and knowledge of the situation is vital to the RCA process, so they need to be
interviewed as part of the RCA process and asked for suggestions about how to prevent the same
or similar situations from happening again.

(c) Be internally consistent (i.e., not contradict itself or leave obvious questions
unanswered).

(d) Include consideration of relevant literature.

(e) Identify at least one root cause with a corresponding action and outcome measure.

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(f) Include signed concurrence by the facility Director.

(g) Meet NCPS and TJC requirements. WebSPOT must be used to guide teams through the
RCA process, document the RCA, and provide information to NCPS and the VISN Patient
Safety Officer (PSO).

(5) To be timely, an RCA must be completed, signed by the facility Director and submitted
to the NCPS within 45 days of the facility becoming aware that an RCA is required.

8. SENTINEL EVENTS

Sentinel Events are a type of adverse event defined by TJC as unexpected occurrences
involving death, serious physical or psychological injury, or risk thereof. Serious injury
specifically includes loss of limb or function. The phrase risk thereof includes any process
variation for which a recurrence would carry a significant chance of serious adverse outcomes.

(1) Sentinel Events signal the need for immediate investigation and response. Immediate
investigations may be an RCA, or, in the case of an intentionally unsafe act, administrative
action.

(2) Some Sentinel Events are considered reviewable and include the following (see App.
A.):

(a) Hemolytic transfusion reaction involving administration of blood or blood products


having major blood group incompatibilities,

(b) Surgery on the wrong patient or wrong body part,

(c) Unintended retention of a foreign object in a patient after surgery or other procedure, and

(d) Prolonged fluoroscopy with cumulative dose >1500 rads to a single field or any delivery
of radiotherapy to the wrong body region or >25 percent above the planned radiotherapy dose.

NOTE: The Joint Commission (TJC) updated its document describing the required responses to
sentinel events in July 2007. In general, events considered to be reviewable Sentinel Events
are included in the catastrophic severity category of the SAC matrix (see App. B).

9. IDENTIFICATION AND REPORTING OF ADVERSE EVENTS, SENTINEL


EVENTS, AND CLOSE CALLS AND HOW TO ADDRESS INTENTIONALLY
UNSAFE ACTS

a. Each VISN must ensure that its designated facilities report at least the following events to
NCPS (and to the local VISN, if this is the VISN policy):

(1) Adverse Events (see subpar. 4a).

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(2) Close Calls (see subpar. 4c).

(3) Sentinel Events (see par. 8).

b. Facility staff must report, as per local policy, any unsafe conditions of which they are
aware, even though the conditions have not yet resulted in an adverse event or close call to the
Patient Safety Manager (PSM).

c. Adverse events and close calls must be reported within the facility to the PSM, or acting
PSM.

d. Any report of an adverse event or close call as defined in subparagraphs 4a, 4c, and
paragraph 8, received by the PSM, is protected from disclosure under 38 U.S.C. 5705, as part of
a medical quality assurance program. The only exceptions to this protection are in cases of an
intentionally unsafe act as defined as a criminal act; a purposefully unsafe act; an act related to
alcohol or substance abuse by an impaired provider or staff; or events involving alleged or
suspected patient abuse of any kind (see subpar. 4d).

e. If in the course of conducting an RCA, it appears that the event under consideration is the
result of an intentionally unsafe act, the RCA team must refer the event to the facility Director
for appropriate further consideration as described in subparagraph 4d. In such a situation the
RCA team discontinues their efforts, since the facility Director has assumed the responsibility for
any further fact finding or investigation.

(1) The RCA team still maintains the information it has already collected confidentially (as
per 38 U.S.C. 5705). This means that members of the RCA team must not serve on an AI team
that might be convened by the facility Director to consider this particular issue.

(2) All facilities must maintain a record of all events that have been referred to top
management for consideration and the final disposition of the case. RCAs that are discontinued,
as described in subparagraph 4d are to be recorded as such by using the Halted function in the
WebSPOT software application.

(3) After an AIB is completed in response to an adverse event or close call that had been
initially referred for RCA, that AIB is to be reviewed by the facility PSM. The PSM is to consult
with the RCA team, if one had been initially convened to review the adverse event or close call.
If the PSM and RCA team are not satisfied that the AIB has identified systems issues for follow-
up, then the PSM needs to communicate with the facility Director to recommend that an RCA
Team be convened or reconvened. The purpose of the ensuing RCA is to identify any systems
issues that may not have been identified in the AIB.

f. If a crime is suspected to have been committed, appropriate officials (e.g., facility


Director, VA Police and Security) must be notified as soon as possible by management
consistent with 38 C.F.R. 1.203. NOTE: Specific guidance on safeguarding evidence is
provided in VA Handbook 0730, Security and Law Enforcement. To the greatest degree possible,
the surrounding area must not be disturbed so that evidence is available for review by the police

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and other authorities. However, care needed by the patient must always be provided for, as
quickly as possible, regardless of the effect on the potential evidence.

(1) As required by 38 C.F.R. Section1.203, information regarding actual, or possible,


violations of criminal laws related to VA programs, operations, facilities, or involving VA
employees, where the violation of criminal law occurs on VA premises, must be reported by VA
management officials to the VA police component with responsibility for the VA station or
facility in question.

(2) As required by 38 CFR Section1.204, criminal matters involving felonies must be


immediately referred to the Office of Inspector General (OIG), Office of Investigation. VA
management officials with information about possible criminal matters involving felonies must
ensure (and be responsible for) prompt referral to the OIG. Examples of felonies include, but are
not limited to: theft of Government property valued over $1,000; false claims; false statements;
drug offenses; crimes involving information technology; and serious crimes against a person, i.e.,
homicides, armed robbery, rape, aggravated assault, and serious physical abuse of a VA patient.

(3) In accordance with 38 C.F.R. Section 1.205, VA police or the OIG, whichever has the
primary responsibility within VA for investigation of the offense in question, is responsible for
notifying the appropriate United States Attorney's office, pursuant to 28 U.S.C. 535.

(4) Notification must be given to the Deputy Assistant Secretary for Security and Law
Enforcement and to the VISN office. The VISN Director, or designee, must inform the Deputy
Under Secretary for Health for Operations and Management (10N).

g. If a crime is suspected to have been committed, facility security and medical staff may
need to assist law enforcement agencies with preserving evidence (e.g., blood alcohol levels,
weapons, controlled substances, etc.). Local policies and procedures for maintaining the chain of
custody of evidence apply in these instances (for specific guidance regarding the safeguarding of
evidence see VA Handbook 0730).

h. Staff who submit close call and adverse event reports that result in an RCA must receive
feedback on the actions being taken as a result of their report. The feedback is to be of a timely
nature and come from the PSM, or other appropriately designated party. Prompt feedback to
those reporting adverse events has been credited in other reporting systems with being one of the
cornerstones that establishes trust in the system. It demonstrates the seriousness and
commitment on the part of the organization to the importance of the reporting effort. Reporters
must be made acutely aware that their effort of reporting was not just a paperwork drill.
Feedback must only be given to individuals who remain on staff at the time when the information
from the RCA is available.

i. Each VISN and facility must adopt strategies to encourage and advocate identification and
reporting of adverse events and close calls. Emphasis is to be placed on the value of close calls
in identifying needed system redesigns. Identification and reporting of adverse events and close
calls, including those that appear to result from practitioner error, need to be a part of routine
practice. Employees must understand that events that are often referred to as human errors are

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commonly due to system problems. They must especially understand that even the most
conscientious, knowledgeable, and competent professionals can make mistakes and that the goal
is to understand these in order to prevent them from causing harm to patients.

j. Responding to adverse events that occur in the course of research, rather than during
ordinary patient care described in VHA Handbook 1058.01, Research Compliance Reporting
Requirements. An adverse event in research is any untoward physical or psychological
occurrence in a human subject participating in research. An adverse event in research can be
unfavorable and unintended event, including an abnormal laboratory finding, symptom, or
disease associated with the research or the use of a medical investigational test article. An
adverse event in research reportable to the Office of Research Oversight (ORO) may also be
reportable to the VA facility PSM in accordance with the procedures described in this handbook.
RCAs conducted consistent with the guidance in this Handbook and current VHA policy are not
available to, and are not for use by, ORO for compliance oversight activities, nor are they to be
released under clinical research agreements.

k. VA medical facilities with a Nuclear Regulatory Commission (NRC) license, or other


authorization to use radioactive materials, must ensure compliance with the license and pertinent
regulations. The VHA National Health Physics Program (NHPP) is to be contacted for
assistance, if needed, to clarify license or regulatory requirements. NOTE: The NHPP can be
contacted by e-mail at vhconhpp@med.va.gov.

l. Laboratory-related incidents must be handled in accordance with the policy and regulatory
guidelines identified in VHA Directive 1106, Pathology and Laboratory Medicine Service, and
VHA Handbook 1106.01, Pathology and Laboratory Medicine Service Procedures. Serious
laboratory-related incidents must be reported to the local Pathology and Laboratory Medicine
Service (P&LMS) Regional Commissioners office or the P&LMS National Enforcement
Program Office as defined in these policies. The regional and national points of contact are
identified on the P&LMS national Web site at: http://vaww.lab.med.va.gov/. NOTE: This is an
internal Web site and is not available to the public.

m. WebSPOT must be used to track and monitor reported events. Data concerning the
reported events must be entered into WebSPOT by designated staff at VA medical facilities to
ensure the accuracy of the data recorded. NOTE: This may also avoid translation and
transcription errors that could occur if others performed this function.

10. REVIEW AND ANALYSIS OF REPORTED EVENTS

a. A procedure has been established so that the review and analysis system for handling
reports proceeds in an understandable manner and takes into account the various requirements
of VHA and accrediting organizations. The RCA process is detailed schematically in App. C,
which provides a detailed view of the RCA process. The following description will describe the
event evaluation and reporting process:

(1) When an adverse event or close call occurs, VA personnel may use any available or
locally accepted method to notify the PSM and begin the facilitys consideration of the event.

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The first step taken by the PSM after any required immediate action is to assign actual and
potential SAC score (see App. B) that then defines what further actions are necessary.

(2) Events receiving an actual and potential SAC score of one or two are to be addressed
appropriately by the facility. These actions can range from performing an RCA to no further
action required.

(3) All events receiving an actual or potential SAC score of three receive either an individual
RCA or must be included in an Aggregated Review as described in subparagraph 4b; and the
initial report of the event must be entered into WebSPOT. Events with a potential SAC score of
three that occur in the required Aggregated Review areas (i.e. medications, falls and missing
patients), may receive either an Aggregated Review or an individual RCA. Events that receive
an actual SAC score of three, and those with a potential SAC score of three that are not in the
aforementioned three categories, must have an individual RCA completed; an Aggregated
Review may not be used.

(4) An Aggregated Review may be used for selected events as described in paragraph 13.
The use of aggregated analysis serves two important purposes, it:

a. Provides a greater utility of the analysis at the facility level as systems vulnerabilities,
trends, or patterns not noticeable in individual case analysis are more likely to show up as the
number of cases increases.

b. Makes wise use of the RCA team's time and expertise. NCPS compares this information
with other data and uses it to determine if any immediate action, such as issuing a Patient Safety
Alert, is indicated. NOTE: Any event may be subjected to an individual RCA if this course of
action is thought to be appropriate, even though it is in a category that permits an Aggregated
Review.

(5) If the event in question is an actual adverse event meeting TJC definition of Reviewable
Sentinel Event, the facility must make the determination as to whether they care to report it to
TJC. Reporting to TJC is optional and is not required by the VHA Patient Safety Program.
Reporting to TJC may entail consultation with other entities, such as the VISN as defined by
local policy. NOTE: Additional information on TJC policy can be found at:
http://www.jointcommission.org/Sentinel_Event_Policy_and_Procedures/

(6) The greatest benefit of the RCA process is realized after all the proper steps have been
completed and corrective actions defined and implemented, to prevent future occurrences of
similar events. Individual corrective actions can eliminate, control, or accept identified system
vulnerabilities. Once implemented, a plan for evaluating the effectiveness of the implemented
change must be enacted to ensure that changes have the desired effects. The subsequent results
must also be communicated to the VISN and NCPS through entry in WebSPOT. NOTE: APP.
D provides a simplified view of the RCA process.

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11. RCA PROCESS REQUIREMENT FOR AGGREGATED REVIEWS AND


INDIVIDUAL RCAs

a. To reduce harm to patients, and with input from key VISN and VA medical facility
personnel, minimum annual requirements for Aggregated Reviews and individual RCAs that
must be completed by each VA medical facility and reported to NCPS have been established.
The primary purpose for setting minimum requirements is to encourage facilities to identify and
mitigate vulnerabilities in their systems of care and to share their experiences, analysis, and new
knowledge gained with the broader VA community. NOTE: These minimum requirements are
subject to modification by the Chief Patient Safety Officer in consultation with the Deputy Under
Secretary for Health for Operations and Management.

b. The requirement for a total of eight RCAs and Aggregated Reviews is a minimum
number, as the total number of RCAs i