Cms 2567 05-13-08

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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED

CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
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NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
700 S JOHN REDDITT
LUFKIN DIALYSIS CENTER
LUFKIN, TX 75904
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)

PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
V 000 INITIAL COMMENTS V 000
An entrance conference was conducted at this

end stage renal disease (ESRD) facility on April
28, 2008, 2008 at 12:50 p.m. with the facility's
Regional Director and the Medical Director. The
purpose of the survey and the survey process
was explained. An opportunity was provided for
questions and answers.
An onsite unannounced complaint investigation

for TX#00093935, TX#00094614 and
TX00093224 was conducted per Section 2278,
2700-2764, and Appendix H of the State
Operations Manual (CMS Pub. 100-7) to
determine the ESRD facility's compliance with the
requirements at 42 CFR 405, Subpart
U-Conditions for Coverage of suppliers of ESRD
services using the applicable survey report form.
Complaint #00094614 and TX#00093935 were

found to be substantiated with related deficiencies
cited and an immediate jeopardy was identified.
The facility voluntarily closed on a temporary
basis effective the last shift on 4/28/08, removing
the threat to the patient safety. The facility
successfully transferred all patients on 4/29/08.
This finding was considered an immediate
jeopardy on 4/28/08 and the immediate jeopardy
was removed with the voluntary closure of the
facility on 4/28/08 after the last patient shift.
Recommend 90 day termination. The following

Conditions for Coverage were not met. Governing
Body, (405.2136); Medical Records(405.2139);
Physician Director of an ESRD Facility
(405.2161); and Staff of a renal dialysis facility
(405.2162).
Complaint # TX 00093224 was found to be

LABORATORY DIRECTOR'S OR PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE TITLE (X6) DATE
Any deficiency statement ending with an asterisk (*) denotes a deficiency which the institution may be excused from correcting providing it is determined that
other safeguards provide sufficient protection to the patients. (See instructions.) Except for nursing homes, the findings stated above are disclosable 90 days
following the date of survey whether or not a plan of correction is provided. For nursing homes, the above findings and plans of correction are disclosable 14
days following the date these documents are made available to the facility. If deficiencies are cited, an approved plan of correction is requisite to continued
program participation.
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: INPH11 Facility ID: 820110 If continuation sheet Page 1 of 41
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V 000 Continued From page 1 V 000

unsubstantiated.
Note: The Statement of Deficiencies is an official,

legal document. All information must remain
unchanged except for entering the plan of
correction, correction dates, and the signature
space. If information is inadvertently changed by
the provider, you should notify the State Survey
Agency. If the State Agency notices any
discrepancy in the information related to scope
and severity assigned or the deficiency citation(s),
the State Agency will report this occurrence to the
Department. The Department will make a referral
of possible fraud to the Office of the Inspector
General (OIG).
Definitions and Abbreviations:
Access- An access is a route into the

bloodstream that allows enough blood flow for
hemodialysis. For permanent access, a surgeon
connects a vein to an artery. For temporary
access, a catheter may be placed in a large
central vein, such as the internal jugular vein in
the neck.
Administer (ADM) to give to a patient
Adverse Occurrence Report: (AOR): reports

required to be completed by facility policy for
certain events including emergency transfers
from the facility to the hospital.
As Needed (PRN) - to administer as needed, as

directed by the physician.
Blood Flow Rate (BFR)- The blood pump pulls

and returns the blood from the patient via the
arterial and venous needles. The pump speed
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and the resulting blood flow rate is adjustable
from zero to about 600cc/min. The physician
prescribes the BFR for each patient.
Blood Pressure (B/P)- According to the

Contemporary Nephrology Nursing: Principles
and Practice, Second Edition, Copyright 2006,
page 257 states the following on blood pressure
management: " The National Kidney Foundation
Kidney Disease Outcomes Quality Initiative
Clinical Practice Guidelines (NKF-K/DOQI) on
Blood Pressure Management and use of
Antihypertensive Agents in Chronic Kidney
Disease (2004) state the goals of
antihypertensive therapy in CKD (Chronic Kidney
Disease) are to lower BP, slow the progression of
kidney disease, and reduce the risk of
CVD(cardiovascular disease)....Patients with CKD
should have a BP <(less than) 130/80 mmHg."
The Core Curriculum for the Dialysis Technician,
Third Edition, page 327, states "Hypotension is
low blood pressure. In dialysis patients,
hypotension occurs most often when too much
fluid is removed during dialysis, or when patients
take too many blood pressure drugs. Symptoms
include severe muscle cramps, headache; feeling
warm, restless, dizzy, faint, or nauseated; or
having visual disturbances. The Trendelenburg
position (raising the feet higher than the heart)
and giving fluids(i.e. normal saline) help return
blood pressure to normal."
c/o-complains of
Clonidine- an oral medication used to treat

elevated blood pressure during dialysis.
CVC- Central Venous Catheter, used as vascular

access for dialysis
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Dialysate - Dialysate is a precise mixture of

treated water, acid (electrolytes) and bicarbonate.
It is used in dialysis to create a gradient so waste
can be removed from the blood.
Dialyzer- An artificial kidney used to filter out

waste and fluid from the blood of patients.
Dry weight- The estimated weight of a patient if all

excess fluid is removed by dialysis. Also referred
to as "target weight" or "goal weight."
Epogen- a medication used in the anemia

management.
Hemoglobin- The red, oxygen-carrying pigment of

red blood cells. Measuring hemoglobin levels is a
way to diagnose and assess the management of
anemia.
Hematocrit is a measure of red cells in the blood.
Heparin - A blood thinner used during dialysis so

blood will flow freely through the blood lines and
dialyzer without clotting
Hemostasis - Stopping the bleeding
Hypertension - High or elevated blood pressure.

Uncontrolled high blood pressure could result in
stroke. Failure to notify physician of uncontrolled
high blood pressure would prevent the physician
from making a clinical decision to adjust
/change/or add medication in order to treat the
patient's high blood pressure.
Hypotension - Low blood pressure
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Infiltration - an abnormal leakage of a fluid (saline
or blood) out of a blood vessel into body tissue
Kilograms (kg)-a measurement of weight, each

kg equals 2.2 pounds
Licensed Vocation Nurse (LVN)- A vocational

nurse licensed by the State of TX (Texas) or
Compact State
Lisinopril- A medication used in the control of high

blood pressure.
ml/min -milliliters per minute
Narvasc- A medication used in the control of high

blood pressure.
Nitroglycerin- A medication used to treat chest

pain.
Normal Saline (NS) sterile intravenous fluid that

contains 0.9% sodium chloride, the solution is
equal to the concentration of sodium chloride
found in blood. It is used in dialysis to clear the
blood lines and dialyzer of air or germicide prior to
treatment and for fluid replacement during
treatment.
Patient (PT)- A patient of the facility
Patient Care Technician (PCT) an unlicensed

person who provides direct patient care in the
dialysis facility, including initiating and completing
dialysis treatments.
PO- to take by mouth
Prescription (Rx) the order given by a physician
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Reprocessing (Reuse)-Reprocessing is cleaning

and disinfecting dialyzers to be used again by the
same patient. Done carefully, reprocessing
reduces the cost of dialyzers and offers some
benefit to patients. The hazardous chemicals
used must be handled with care by staff and there
are a number of regulations and guidelines in
place to protect patients and staff.
Registered Nurse (RN) a registered nurse by the

State of Texas or Compact State.
Sublingual (SL)- a route that medication is

administered under the tongue
Treatment (TX) - the administration of an ordered

dialysis prescription to a patient
Ultra Filtration (UF) - a method to use pressure to

remove excess fluid weight from a patient during
dialysis treatment
Ultra Filtration Rate (UFR) - the rate at which fluid

moves from the blood into the dialysate.
V 110 405.2136 GOVERNING BODY AND V 110
MANAGEMENT
The ESRD facility is under the control of an

identifiable governing body, or designated
person(s) so functioning, with full legal authority
and responsibility for the governance and
operation of the facility.
This CONDITION is not met as evidenced by:

Based on record review and interview the
governing body failed to monitor the care being
provided to patients in the facility and did not
immediately detect an increase in adverse events
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impacting health and safety. Patient harm had
occurred, and there was potential for harm to all
patients in the facility. Immediate jeopardy was
identified on April 28 at approximately 1:30 p.m.
and removed by the facility by voluntarily closing
on a temporary basis and transferring all patients
at the end of the treatment day on April 28, 2008.
Refer to Tag V112, V146, V424 and V431 for

details
V 112 405.2136 GOVERNING BODY: HEALTH AND V 112
SAFETY
The governing body adopts and enforces rules

and regulations relative to the health care and
safety of patients.
This STANDARD is not met as evidenced by:

governing body failed to monitor mortality,
emergency transports from the facility and
adverse occurrence reports to ensure safe
delivery of care. Patient harm had occurred and
all patients were placed at risk for harm.
Findings:
1. A review of the facility's Quality Improvement

and Facility Management Meeting Minutes on
May 1, 2008 for the period of September 21,
2007 through April 18, 2008 found that reviews of
patient deaths did not include evidence the
reasons for the deaths were trended and
analyzed in order for the facility to evaluate any
potential relationship between the deaths and the
delivery of care in this facility. There was no
evidence of any root cause analysis, nor any
evaluation of the potential existence of systemic
issues.
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A review of the Meeting Minutes and the required

Death Notification Forms(CMS 2746) and hospital
information received during the onsite survey
facility visit found that there were a total of 19
deaths from December 1 - April 28, 2008 and 25
deaths from January 1-2007 through December
31, 2007.
According to the 2007 Dialysis Facility Report

provided to the facility in September 2007, the
facility had a 27% mortality rate which was
greater than the State Average of 19.9%. There
was no evidence that 2007 Dialysis Facility
Report had been reviewed and analyzed by
facility management including the Medical
Director to improve patient outcomes or that any
plan had been developed, adopted, and
implemented to correct poor outcomes.
2. During an interview with employee #14 on May

5, 2008 at 3:00 p.m. in her office, she reported
that she was responsible for completing the
required Death Notifications(Form CMS 2746)
and the facility's "ESRD Patient Death Review
Form." She reported this process as starting
when she would be notified by a nurse that a
patient had died, this employee would then call
the hospital or place of death and obtain the
cause and date of death, usually from the hospital
staff person responsible for Medical Records.
She would then complete the forms and give
them to the Facility Administrator. An interview
with the employee #2 on May 6, 2008 at 4:30 p.m.
found that she reports the information on the form
in the Quality Improvement and Facility
Management Meetings. She reported that the
patient dialysis treatment records were not
reviewed or analyzed for delivery of care issues
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and that the committee reviewed the forms as the
mortality review. As there was no root cause
analysis, these meetings failed to provide for the
adoption or implementation of a plan to improve
the health care and safety of patients being
treated here.
3. Refer to tag V146 for additional information

V 146 405.2136(d)(2) PERSONNEL P/P: INCIDENTS V 146
REVIEWED
The governing body, through the chief executive

officer of the ESRD facility, is responsible for
maintaining and implementing written personnel
policies and procedures that ensure that reports
of incidents and accidents to patients and
personnel are reviewed to identify health and
safety hazards.

governing body failed to ensure that reports of
adverse incidents involving patients were
completed, tracked, analyzed and interventions
put into place to identify trends and improve care
and remove health and safety hazards. The
facility's incomplete process placed all patients of
the facility at risk for harm.
Findings:
1. A review of the facility's Adverse Occurrence

Reports (AOR) on May 5, 2008 for the period of
September 1, 2007 through April 28, 2008 found
a total of 114 recorded. On interview 5/6/08 in
the treatment room at 4:30 p.m. employees # 2,1
and 4 of the facility stated all of the AOR's for the
period of September 1, 2007 through April 28,
2008 were provided to the surveyors. Review of
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the emergency transfer logs obtained from the
two ambulance services available found 68
emergency transports from the facility which were
not reported as AOR's as required by facility
policy.
2. Review of the two local emergency transport

services "Call List Detail Reports" on May 5, 2008
found that the two services had transported
patients from the facility to the emergency room
who were not listed on an AOR by the facility, as
follows:
September 2007 -8 patients were transported
with no AOR's completed.
October 2007-8 patients were transported with 1
AOR that was completed..
November 2007-7 patients were transported with
7 AOR's completed.
December 2007- 15 patients were transported
with no AOR's completed.
January 2008-11 patients were transported-with 2
AOR's completed.
February 2008- 11 patients were transported with
3 AOR's completed.
March 2008- 8 patients were transported with 2
AOR's completed.
April 1st-26th - 34 patients were transported with
19 AOR's completed.
There were a total of 102 patients transported

from the facility to the emergency room from
September 1, 2007 through April 26, 2008.
Sixty-eight patient transfers (67%) did not have a
completed AOR.
3. On April 30, 2008 a review of the facility's

policy titled Adverse Occurrence Report Policy
#13-01-02 origination date June 2006, found that
the policy instructed facility employees to
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complete an Adverse Occurrence Report for any
unexpected event that is inconsistent with the
routine operation of a dialysis facility. Transport
of patients to the emergency room from the
dialysis facility was not an expected outcome in
the routine operation of dialysis and all transports
should have had an AOR completed, as outlined
in facility policy.
4. A review of a facility policy titled Continuous

Quality Improvement Program Policy # 1-02-01,
origination date of September 2007 revealed that
the facility was to monitor Adverse Occurrence
Reports and mortality indicators and identify
areas for improvement, develop appropriate plans
of corrections and evaluate effectiveness of the
plans once implemented. There was no evidence
the facility followed this policy.
5. A review of the facility's Quality Improvement

and Facility Management Meeting Minutes on
May 3, 2008 found the meeting minutes dated
October 19, 2007(reviewing data for September
2007) stated that all AOR's were reviewed and
staff would "continue to monitor." A review of the
meeting minutes dated October 19, 2007,
November 16, 2007, December 2007, January
25, 2007, February 22, 2008 March 21, 2008
found the minutes stated that all AOR's were
reviewed and staff would "continue to monitor."
There was no evidence that AOR's were tracked,
trended, or analyzed in order for the facility to
identify trends and improve patient adverse
outcomes. During an interview with employee # 2
in the Peritoneal Dialysis Area on 5/2/08 at 2:30
p.m., she reported that an AOR should be
completed for any patient requiring transport to
the emergency room from the facility She also
reported that she was instructed to not include
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anything in the Quality Improvement and Facility
Management Meeting Minutes about Adverse
Occurrence Reports except that they were
"discussed and will monitor." There was no
evidence facility policy requiring the development
of an appropriate plan to improve care was
followed related to the AOR's.
V 230 405.2139 MEDICAL RECORDS V 230
The ESRD facility maintains complete medical

records on all patients (including self-dialysis
patients within the self-dialysis unit and home
dialysis patients whose care is under the
supervision of the facility) in accordance with
accepted professional standards and practices.
A member of the facility's staff is designated to
serve as supervisor of medical records services,
and ensures that all records are properly
documented, completed, and preserved and that
they are completely and accurately documented,
readily available, and systematically organized to
facilitate the compilation and retrieval of
information.

Based on record review and interview the facility
failed to ensure that the medical record was
completely and accurately documented,
preserved, readily available, and systematically
organized to facilitate the compilation and
retrieval of information. These findings had the
potential to adversely impact the care to all
patients receiving care at the facility due to the
facility's inability to provide complete and accurate
records, to any clinician who would rely on clinical
information, to adequately evaluate and treat a
patient needing care.
1. A total of 24 facility records were reviewed
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during this survey. Of the 24 patients, 17 were on
the facility's dialyzer reuse program. Seventeen
of seventeen records of patients on the reuse
program did not include accurate documentation
of treatments with a reused dialyzer. The daily
treatment sheets of patients treated prior to April
17, 2008 did not contain the documentation that
the staff had tested the dialyzer to verify that the
germicide used in the disinfection process was
removed from the dialyzer by running normal
saline through the dialyzer. The space on the
daily treatment records that is used by the facility
for recording that two staff persons had verified
that there was no residual germicide present in
the dialyzer, was completed with the words
"non-reuse."
Interview with employee # 1 in the conference
room of the facility on May 1, 2008 confirmed that
these 17 patients were treated with reuse
dialyzers prior to April 17, 2008.
Interview of Employee # 1 revealed that the

facility suspended their reuse program on April
17, 2008, and made a facility-wide change to the
computer system in use for the patient records to
indicate non-reuse. When this change was
made, apparently the computer system replaced
the previously entered data including staff
identification and times of verification of the
absence of residual germicide with the statement
" non-reuse " in all records of patients treated in
the facility that were on reuse prior to April 17.
These changes to the record were not noted on
the electronic record or on the printed copy, This
"automatic" retrospective change compromised
the integrity of the medical record.
Interview with employee # 1 on May 3, 2008 at
approximately 10 :00 a.m., confirmed that the
records erroneously stated non-reuse" on the
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treatment sheets on 17 out of 17 patient medical
records reviewed of patients that were on the
reuse program. This alteration of the record had
not been identified by the facility.
2. In review of records in the facility conference

room the week of April 30, 2008 -May 3, 2008,
complete medical records for 24 patients were
requested on numerous occasions. The portion
of the record specifically requested included 6
month cumulative laboratory reports, all
physicians orders, all treatment records for the
time specified, and all nursing and medical staff
documentation. In review of the records it was
discovered that the records provided had missing
or changed documentation , such as the removal
of the reuse status on the patients on reuse and
missing nursing notes due to the notes being
entered in a wrong field. Over the course of the
week numerous requests were made to staff # 1,
2, 4, and 19 for the missing pieces of
documentation. Staff members were not in each
case able to retrieve the requested information.
During the course of the week it was discovered
that the computerized record utilized by the
facility, did not have an option to print an entire,
integrated and easily retrievable record. None of
the staff were able to print a complete record on
request. Failure to provide a complete record
could potentially cause harm to a patient when
the needed information is needed in a timely
manner and the information provided is
incomplete or inaccurate.
Employee # 1 confirmed that the computerized

record utilized by the facility was not integrated
and easily retrievable.
3. Review of 24 medical records during the
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survey found changes in patient conditions that
were not reported to a licensed nurse or
physician. There was no evidence the nurse or
the physician had reviewed these records, or
would have been able to easily retrieve the
information to use in caring for the individual
patient or in identifying patient care issues which
posed risks to patients health and safety. The
issues identified in this review are detailed at
V420 and V430.
V 420 405.2161 DIRECTOR OF A RENAL DIALYSIS V 420
FAC
Treatment is under the general supervision of a

Director who is a physician. The
physician-director need not devote full time as
Director but is responsible for planning,
organizing, conducting, and directing the
professional ESRD services and must devote
sufficient time to carrying out these
responsibilities. The director may also serve as
the Chief Executive Officer of the facility.

Based on record review and interview the Medical
Director failed to ensure there was adequate
monitoring of patients and the dialysis process
and that appropriate policies were in place to
guide staff to monitor patients safely. The
Medical Director failed to direct the quality
assurance program to analyze and trend adverse
patient outcomes. These deficient practices did
not provide a system to ensure patient safety,
patients had been harmed, and there was
potential for any patient receiving treatment at this
facility to be harmed. Immediate jeopardy was
identified on April 28 at approximately 1:30 p.m.
and removed by the facility by voluntarily closing
on a temporarily basis and transferring all patients
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at the end of the treatment day on April 28, 2008
Findings:
1. The Dialysis Facility Report for 2007, provided

to the facility in September 2007 reported a 27%
mortality rate as compared to the state average of
19.9%. There was no evidence the Medical
Director had reviewed this report or taken action
to use the report as a step in a quality
improvement action.
Cross refer V 112
2. Review of the quality management materials

found a lack of evidence the Medical Director
reviewed each death of a facility patient for
possible relationship to treatment here.
Cross refer to V 112.
3. Review of the quality management materials

and records of ambulance services here found
each emergency transfer to hospital was not
reported as an AOR to allow accurate trending
and analysis.
4. Review of quality management materials found

reported AORs were not analyzed for root causes
or used as a way to identify needed
improvements in care.
5. Multiple interviews with employees #2,4, and

#19 during the onsite investigation found that the
Medical Director had not developed standing
orders or protocols for nurses to use as guidance
in reporting, monitoring or treating patients with
abnormal findings during dialysis treatment.
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6. Review of clinical records found staff did not
follow the prescribed orders for treatment and did
not report changes in patient condition to a
responsible nurse or physician.
Cross refer to V 424 and V 431.
V 424 405.2161(b)(3) RESPONSIBILITIES: V 424
MONITORING PROCESS
The responsibilities of the physician-director

include but are not limited to assuring adequate
monitoring of the patient and the dialysis process,
including, for self-dialysis patients, assuring
periodic assessment of patient performance of
dialysis tasks.

Based on record review and interview the Medical
Director did not ensure that patients and the
dialysis process were monitored to ensure safe
care was delivered and deviations from the
ordered care were reported to allow corrective
actions, citing 18 of 24 records reviewed.
Findings:
1. A review of patient records on May 5-9, 2008

found the following:
a. A review of patient # 2's Post Treatment Sheet

dated 2/11/08 found on the post assessment
documentation the patient had post treatment
bleeding from the venous needle site lasting 1.5
hours after treatment. The records documented
"Hemostasis achieved at 17:25. Pt. instructed to
call 911 if bleeding occurred after getting home."
There was no evidence in the patient's chart that
any physician was notified of the prolonged
bleeding. A review of the physician's order found
no evidence of an order for a
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hemoglobin/hematocrit after the prolonged
bleeding. On 02/12/08 a physician's order for the
Epogen dose was adjusted downward to 2200
units every treatment from a previous order dated
1/22/08 for 3000 units every treatment. There was
no evidence the physician had knowledge of the
blood loss on 2/11/08 to be able to consider the
impact of the loss of the patient's hemoglobin and
indicated dose of Epogen.
b. Review of patient # 3's Post Treatment Sheet

dated 3/11/08, found pretreatment sitting blood
pressure at 11:12 was 211/106 and post
treatment B/P at 15:45 was 223/114 and
remained elevated during treatment with the
highest B/P recorded at 13:38 being 262/129.
There was no evidence on the post treatment
record or in the patient event notes that indicated
that the nurse notified the physician of the
elevated B/P. A review of the Kardex(current
physician's orders) found the PRN physician
order dated 2/14/08 read as "Clonidine 0.10 mg
for elevated blood pressure." The order did not
give parameters for the B/P, how often to give the
Clonidine, how often to monitor the B/P or when
to report to the physician.
A review of patient #3's Post Treatment Sheets
dated 3/13/08, 3/15/08, 3/20/08, 3/22/08, 3/25/08,
3/27/08, 3/29/08, 4/1/08, 4/3/08, 4/5/08, 4/10/08,
4/12/08 and 4/17/08 found elevated blood
pressures of greater than 200/100 and no
evidence that the physician was notified or the
PRN Physician order dated 2/14/08 "Clonidine
0.10 mg for elevated blood pressure" was given
to the patient to control the blood pressure.
A review of the Kardex PRN orders printed on
5/3/08 found an order reading as "Blood Glucose
Testing 1 each do weekly checks and prn(as
needed) for diabetics." The order date was
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2/07/07 and the order had not been discontinued.
There was no evidence in the patient event notes
or the post treatment sheet dates reviewed from
the period of 3/11/08 through 4/17/08 found no
evidence of blood glucose testing results. An
interview with employee #1 on May 8, 2008 at
9:15 am on the treatment floor revealed that the
physician's order was to perform weekly blood
glucose testing and that the results would be
documented on the post treatment sheets and/or
the patient event notes.
c. A review of patient # 4's Post Treatment Sheet

dated 12/18/07 found on the post assessment
documentation the patient had prolonged arterial
bleeding for 80 minutes after treatment. The
patient was sent to the Emergency Room. There
was no evidence in the patient's chart that the
physician was notified. A review of the
physician's orders found no evidence of an order
for a hemoglobin/hematocrit. On 12/20/07 the
nurse's notes read "Pt had prolonged bleeding
with last treatment. Heparin adjusted. Left upper
arm bruised and swollen. Used CVC only today."
There was no evidence in the patient's record that
the physician was notified or the physician
ordered the heparin adjusted or the use of the
catheter site for dialysis treatment.
d. A review of patient #7's nursing notes dated

2/29/08 found that the RN documented that the
"Patient reports he has had continual bleeding
from access puncture site from 2/27/08
treatment. The dressing over the site shows
evidence of bright red bleeding. Heparin infusion
held." There was no evidence that the physician
was notified. On the patient's post treatment
sheets dated 11/20/07, 11/23/07, 11/26/07,
11/28/08, 11/30/07, 12/3/07, 12/5/07, 12/7/07,
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12/10/07, 12/14/07, 12/17/07, 12/19/07, 12/21/07,
12/26/07, 12/28/07, the patient had elevated
blood pressures of greater than 200/100 with the
highest being 271/138. There was no evidence
that the physician was notified. On the patient's
treatment record dated 12/31/07, the patient's
blood pressure at 6:11 was recorded as 277/138.
There was documentation that the LVN gave
Clonidine at 0600. The nursing notes read that
the patient's B/P remained elevated the entire
treatment. The physician was notified and an
order to give 0.1 mg of Clonidine was obtained
and if no response repeat the dose in 30 min. 0.1
mg of Clonidine was given at 11:30 and repeated
at 12:00: and the patient was sent to the
Emergency Room with elevated B/P. The record
stated the patient returned to the center later that
day for removal of dialysis needles. It is contrary
to standard of practice to allow a patient to leave
a dialysis facility with dialysis needles in place as
those. These needles have the potential to
become dislodged and cause harm by
hemorrhaging from the access site.
e. A review of patient's #14 's post treatment

sheet dated 3/22/08 found at 6:01 the patient's
B/P was 179/107 as documented by the RN at
the initiation of treatment. The patient's blood
pressure remained elevated throughout the
treatment and at 9:18 the B/P was documented
by the RN as 179/105. There was no evidence
that the physician was notified of the patient's
condition.
A review of the patient's post treatment sheet
dated 4/5/08 found at the initiation of treatment at
5:31 the patient's B/P was 187/113 and pulse rate
was 101. The patient's blood pressure and pulse
remained elevated throughout the treatment and
at 9:44 the patient's B/P was 172/105 and the
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pulse was 105. There was an RN assessment at
5:35 that documented that the "patient has
increased BP will notify physician." There was no
other documentation in the record to indicate if
the physician was notified and if any orders were
given by the physician.
A review of the physician's prn orders found that
blood glucose testing was to be done weekly and
prn for diabetes. Order start date was 2/7/07 and
was still current. There was no evidence in the
medical record that weekly blood glucose testing
was performed.
f. A review of patient # 16 's Post Treatment

Sheet dated 04/12/08 found that at 12:16 the RN
documented that the patient "complained of chest
pain. 1000 ML of Normal Saline was given to the
patient." The patient was alert but " groaning,
states his chest pain has not improved." A
review of the patient's prn orders found a
physician's order as follows:
" Nitroglycerin 0.4 mg SL (sublingual) Chest pain."
There was no evidence that the patient was given
the Nitroglycerin. The treatment sheet
documented that the patient was transported to
the emergency room by ambulance.
A review of the patient #16's PRN orders found a
physician order to do weekly blood glucose
checks and prn for diabetes dated 2/07/07.
There was no evidence in the medical record that
blood glucose testing was done.
A review of the patient's post treatment sheet
dated 3/22/08 found the patient's pretreatment
B/P documented at 11:09 as 138/107 and the
patient's post treatment B/P was documented at
15:09 as 162/104. There was no evidence in the
medical record to indicate the physician was
notified.
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g. A review of patient #17's Post Treatment
Records dated 3/22/08, 3/25/08, 3/27/08,
3/29/08,4/1/08, and 4/3/08 found the patient had
elevated blood pressures from initiation of
treatment through the end of treatment with the
B/P diastolic greater than 100. There was no
evidence that the physician was notified on any of
those dates. A review of the physician's prn
orders found that on 04/05/08 the patient's B/P
was recorded at 6:33 as 178/114. There were
nursing notes that reported the patient presented
with elevated B/P of 187/114 . The patient had
taken 10 mg of Narvasc and 40 mg of Lisinopril
pre-treatment. The physician was notified and
the physician ordered 0.1 mg of Clonidine.
Clonidine was given at 7:59 and again 8:57. The
physician's prn order reads "Clonidine 0.10 mg
PO give for elevated B/P (blood pressure)" order
effective 4/05/08. On 4/8/08 the patient initiated
dialysis at 6:12 with a B/P of 182/110 and the B/P
remained elevated throughout the treatment.
There was no evidence that the physician was
notified, that Clonidine was given, or that
clarification of the order was requested. The
physician's prn orders did not indicate how often
to give the Clonidine, or what the parameters of
blood pressure would merit giving Clonidine.
h. A review of patient # 23's medical record found

that on 04/08/2008 the patient had a post
treatment bleed. The record did not contain
evidence of a RN assessment prior to the
patient's transport to the emergency department,
or any documentation of monitoring of the
patient's condition during the 4.5 hours the patient
remained in the clinic after treatment with
uncontrolled bleeding. There was no evidence
documented in the clinic record that the physician
ordered a hemoglobin and hematocrit after the
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patient had the prolonged bleeding on
04/08/2008.
i. A review of patient # 22's medical record found

that on 12/18/08 the post treatment sheet
documented the treatment ended at 15:09 and
the blood was rinsed back. The patient's record
documented in a space identified in the record as
discharge status, that the patient was sent to the
emergency department There was no time of
transfer recorded in the facility record or nursing
assessment prior to transfer, or monitoring of the
patient condition during the time between the
treatment ending and the transfer of the patient
by ambulance. The ambulance transfer record
from the local ambulance service documented
that the ambulance was dispatched to the dialysis
facility at 17:02, two hours after the dialysis
treatment was documented as ending. The
ambulance record indicated the patient was
transported to the emergency department due to
severe bleeding On 02/26/08 the record
indicated the patient remained in the facility with
bleeding from an infiltrated vascular access site
for 2 hours prior to being transported to the
emergency department. During the 2 hours there
was no monitoring or assessment of the patient's
condition documented in the patient's medical
record.
In review of this record for the dates of 12/18/07
and 02/26/08 there was no evidence that the
physician was made aware of the bleeding to be
able to consider ordering a hemoglobin and
hematocrit to assess the level of blood loss after
the episodes of bleeding that occurred on both
days.
2. Multiple interviews with employees #2,4, and

#19 during the onsite investigation found that the
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physician had no standing orders or protocols for
nurses to use as guidance in reporting,
monitoring or treating patients with abnormal
medical conditions.
3. Refer to V 431 for additional findings

V 430 405.2162 STAFF OF A RENAL DIALYSIS V 430
FACILITY
Properly trained personnel are present in

adequate numbers to meet the needs of the
patients, including those arising from medical and
nonmedical emergencies.

Based on record review and interview nursing
staff did not demonstrate compentence in
monorting patients during treatment, alerting
nurses or physicians of changes to a patients
condition, and following the physicians orders for
the dialysis treatment. Examples cited form
mores than 75 treatments sheets in 18 of 24
records reviewed. Patient harm had occurred
and there was potential for harm to all patients
receiving care at the facility. Immediate jeopardy
was identified on April 28 at approximately 1:30
p.m. and removed by the facility by voluntarily
temporarily closing on a temporary basis and
transferring all patients at the end of the
treatment day on April 28, 2008.
Refer to V 431 for examples and details

V 431 405.2162(a) REGISTERED NURSE V 431
The dialysis facility employs at least one full time

qualified nurse responsible for nursing service.
(See 405.2102.)
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Based on staff interviews and clinical record
review, direct staff did not report changes in
patient condition to the responsible nurse or
physician; indicated nursing assessments were
not completed; and physician ' s orders for the
dialysis prescription were not followed, citing
more that 75 treatments records in 18 of 24
records reviewed. (Records # 2, 3, 6, 7, 8, 10,
13, 14, 15, 16, 18, 19, 20, 21, 22, 23, and 24).
All records reviewed in the facility office on April

30th through may 3rd, 2008.
Patient # 2's: The treatment dated 1/25/08 found

the post treatment sitting B/P was 133/113 at
15:15. There was no documentation that the
physician was notified on the patient event notes
or the patient treatment record for this change in
patient conditions.
The treatment record dated 1/28/08 found the

BFR was recorded as 350/ml/min with no
documentation as to why physician ' s order of
400 ml/min was not followed.

patient's blood pressure at 11:15 was 126/106, at
11:30 was 134/115, and at 14:04 was 131/116.
There was no documentation that a licensed
nurse was notified or assessed the patient for the
change in patient condition.
The treatment sheet dated 02/04/08 found the

pretreatment sitting B/P to be 138/115 with no
evidence that the physician was notified. The post
treatment vitals recorded the sitting B/P was
156/70 at 15:35, which was different from the B/P
recorded as part of the dialysis treatment
monitoring at 15:31, when the B/P was
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documented as 156/104. There was no
explanation or indication the staff member noted
these differences or of the elevated B/P at 15:31.
The treatment sheet for 2/1/08 found the

pretreatment sitting B/P to be 210/107. There
was no evidence that the physician was notified
for this change in patient condition.
The treatment record dated 3/17/08 found at

15:10 the blood pressure on the post treatment
vitals to be recorded as 165/105 on the record
treatment of treatment and as 105/60 for the
same time on another place on the same record.
There was no evidence the discrepancy was
noted or that the findings were reported to the
Charge Nurse and no evidence that the patient
was assessed by a licensed nurse.
The treatment record dated 3/19/08 found the B/P

at 15:00 to be 83/45 and no evidence that the
patient was assessed by a licensed nurse for this
low B/P.

patient's B/P at 15:10 to be 99/44, and PCT notes
saying "Pt feeling hot, UF off, BP Down, 150 ml
NS (normal saline) given." There was no
evidence that a licensed nurse assessed the
patient for this change in condition.

at 14:32 was 90/43 which was a drop from the
initial B/P at 11:09 from 117/87. There was no
evidence in the record that a licensed nurse
assessed the patient for this change in condition.
The treatment record sheet dated 4/11/08 found

the B/P at 15:36 was 101/48 which was a drop
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from the initial B/P of 150/70 at 12:26. There was
no evidence in the record that a licensed nurse
assessed the patient until 17:30, also most two
hours after the change in condition.
Interview with employee # 4 at 10:55 on May 2,

2008 a.m., in the conference room of the facility
found that all documentation in the record is typed
in by staff members and the computer which
operates the automatic blood pressure cuffs does
not interface with the medical record.
Patient # 3's: The treatment record dated 3/11/08

found the pretreatment sitting B/P at 11:12 was
211/106 and post treatment B/P at 15:45 was
223/114 and had remained elevated during
treatment with the highest B/P recorded at 13:38
of 262/129. There was no evidence on the post
treatment record or in the patient event notes that
indicated that the nurse notified the physician of
the elevated B/P. A review of the Kardex found
the PRN physician order dated 2/14/08 read as
"Clonidine 0.10 mg for elevated blood pressure."
The order did not give parameters for the B/P,
how often to give the Clonidine, how often to
monitor the B/P and when to report a change to
the physician. The Clonidine was not given as
ordered for the change in the B/P.
The treatment Sheet dated 3/13/08 had a

pretreatment sitting B/P at 12:07 was 228/113
and a post treatment sitting 215/118 at 15:35.
notified or the clonidine given as ordered.
The treatment Sheet dated 3/15/08 had a

and post treatment sitting B/P of 205/90 at 15:41.
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notified for the elevated B/P or that clonidine was
given as ordered.
The treatment sheet dated 3/20/08 had a

pretreatment standing B/P at 11:17 was 175/146
and post treatment sitting B/P of 219/115 at
15:32. There was no evidence that the physician
was notified for the elevated B/P or that clonidine
was given as ordered.

and post treatment sitting B/P of 212/112 at
15:45. There was no evidence that the physician
was notified for the change in the patient B/P or
that clonidine was given.

pretreatment sitting B/P of 162/110 at 11:24 and
post treatment B/P of 226/101 at 15:45. There
was no evidence that the physician was notified of
the elevated B/P or the clonidine was given.
The treatment sheet dated 3/27/08, pretreatment

sitting B/P was 200/102 at 11:59 and post
treatment B/P was 209/110 at 16:16. There was
no evidence that the physician was notified or the
clonidine was given as ordered.
The post treatment Sheet dated 3/27/08,

pretreatment sitting B/P was 200/102 at 11:59
and post treatment B/P 209/110 at 16:16. There
was no evidence that the physician was notified
for the elevated blood pressure or that clonidine
was given as ordered.
The treatment Sheet dated 3/29/08, pretreatment

sitting B/P was 204/89 at 10:57 and post
treatment B/P was 229/104 at 15:17. There was
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no evidence that the physician was notified for the
elevated blood pressure or that clonidine was
given as ordered.
The post treatment sheets for 4/1/08, 4/3/08,

4/5/08. There as no evidence the physician was
notified for the elevated or that clonidine was
given.
The treatment records for give 4/10/08, 4/12/08,

4/17/08, found elevated blood pressures at each
treatment and there was no evidence the
physician was notified or that clonidine was given.
The only day the patient was given clonidine was
on 04/08/08 and 04/19/08 as require by the
physicians.
A review on 05/03/08 of the prn orders read as "

Blood Glucose Testing" do weekly checks and
prn(as needed) for diabetics." The order date
was 2/07/07 and the order had not been
discontinued. Review of the record for the
treatment times from 3/11/08 through 4/17/08
found no evidence of blood glucose testing
results. An interview with employee #1 on May 8,
2008 at 9:15 am on the treatment floor revealed
that the physician's order was to perform weekly
blood glucose testing and that the results would
be documented on the post treatment sheets
and/or the patient event notes.
Patient # 4 ' s: Review of patient # 4's treatment

record dated 11/24/07 found the patient's B/P was
recorded at 15:59 as 222/101 by a PCT and no
patient for this elevated B/P...

was 93/47 at 13:04 documented by the PCT. The
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B/P had dropped from the patient's initial
pretreatment blood pressure of 154/77 and there
was no evidence that a licensed nurse was
notified or assessed the patient for this change in
condition.

13:03 the patient's B/P was 83/54, which had
dropped from the patient's initial pre-treatment
B/P of 183/80. The PCT documented the " UF
turned off NS given pt c/o feeling dizzy light
headed." There was no evidence in the record
that a licensed nurse assessed the patient for this
change in condition. At 14:20 the patient's B/P
was recorded 84/45 and the PCT documented
that the "UF turned off Low B/P NS given." The
amount of saline give was not recorded, and
there was no evidence in the record that a
licensed nurse assessed the patient change in
condition.
The treatment record on 12/13/07 found the

patient's pre-treatment weight to be 97.8 kg
(kilograms) and the patient's post treatment
weight to be 97.9 kg. The patient had a weight
gain of 0.1kg rather than the expected weight loss
and there was no evidence this finding was noted
or brought to the attention to the responsible
nurse to allow assessment of the patient '
condition. In addition, the record on 12/13/07
revealed the patient's catheter dressing was not
changed and the documentation read "pt clothing
prevented changing of dressing. Pt has been
instructed to wear proper clothing multiple times
before." There was no evidence that the
patient's catheter site was assessed for redness,
draining or other possible signs of infection.
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The treatment record the BFR on 12/15/07 was
recorded as 200ml/min from the beginning of the
patient ' s treatment at 11:34 until 15:53. The
physician order for the BFR was 300 ml/min.
There was no evidence as to why the physician ' s
order was not followed.

11:32 the patient's B/P was 82/37 documented by
a PCT which had dropped from the patient's initial
pretreatment B/P of 108/57. There was no
evidence that a licensed nurse was notified of the
low B/P or assessed the patient. At 12:02 the
patient's blood pressure was 70/38 and the PCT
documented that she gave the patient 200 ml of
normal saline due to low B/P and the ultra
filtration rate was turned off. There was no
evidence that a licensed nurse was notified or
assessed the patient ' s change in condition.
Patient # 6's: The treatment record found on

3/11/08 at 12:29 and 13:50 the PCT gave a 200
ml bolus of normal saline without an assessment
of the patient by a licensed nurse. Initial B/P was
recorded as 107/48, at 12:29 the B/P was
recorded at 116/40 and at 13:49 the B/P was
recorded as 102/38 there was no evidence the
nurse was aware of the patient ' s change in
condition.
The treatment record for 03/29/2008 found that

the patient complained of shortness of breath and
the B/P was recorded at 86/39. The PCT turned
off the UF and documented giving a 100 ml
normal saline bolus without evidence that a
licensed nurse was notified and assessed the
patient ' s change in condition.
The treatment record found the PCT on
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03/01/2008 at 13:05 documented decreasing the
blood blow rate to 350 from the physician ordered
400 without a documented notification to a
licensed nurse of a change to the change to the
treatment order. In addition the treatment record
found that the PCT documented giving the patient
a 200 ml bolus of NS for a B/P of 62/32 and
turning off the UF without notifying a licensed
nurse to assess the patient for this change in
condition.
Patient # 7 ' s: The treatment record dated 3/3/08

found at 10:05 the
Patient ' s B/P was 192/105 at the end of the
patient's treatment documented by the PCT which
was an increased from the patient's initial
pretreatment blood pressure of 191/88. There
was no evidence that a licensed nurse was
notified or assessed the patient for this high B/P.

07:33 the patient's B/P was 108/62. The patient's
initial pretreatment blood pressure was 186/98. At
7:33 the PCT documented the patient was feeling
bad and she turned down the UF and gave 150
cc of Normal Saline. There was no evidence that
a licensed nurse was notified or assessed the
patient. At 09:25 the patient's blood pressure was
72/50 and the PCT documented the UF off and
B/P down. 200cc of Normal Saline given. There
was no evidence that a licensed nurse assessed
the patient or was aware of the very low B/P.
The treatment record dated 3/14/08 found at 8:40

the PCT documented the patient was cramping
and she gave 200cc of Normal Saline and the UF
was turned off. There was no evidence that a
licensed nurse was notified or assessed the
patient ' s changed condition.
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The treatment record dated 3/24/08 at 5:40; the

PCT recorded the B/P to be 221/109. At the end
of treatment the PCT recorded the B/P to be
199/109. There was no evidence that a licensed
nurse or the physician was notified for the
elevated B/P.

09:41 the patient ' s B/P was 100/56. The patient '
s initial pretreatment blood pressure was 161/80.
The PCT documented "B/P down, UF off, patient
feeling bad, 200 cc Normal Saline." There was no
evidence that a licensed nurse was notified or
assessed the patient change in condition.
Patient # 8 ' s: The treatment record for 3/05/08

found the BFR was set to run 250ml/min instead
of the ordered 350. On 4/17/2008 the BFR was
set to run at 300 ml/min instead of the ordered
350 without documentation to indicate why the
rate was changed or the charge nurse was
notified.
Patient #10's The treatment records for

03/19/2008, 03/21/08, 03/24/08 and 03/28/08
revealed the blood flow rate was set to run at
400ml/min versus the ordered 350 without a
documented reason for the change.
Patient # 13 ' s The treatment records dated

03/25/2008 and 04/03/2008 revealed the blood
flow rate was set at 450 verses the ordered 400
without a reason documented for not following the
order or evidence the charge nurse was notified
of a reason the ordered BFR could not be
provided.
The treatment record revealed evidence that on
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03/20/2008 at 0830 the UF was turned off by the
PCT for a recorded blood pressure of 91/47
without notifying a licensed nurse for this change
in patient condition. .
Patient # 14's: The treatment record dated

3/1/08 found at 6:44 the patient's B/P was
181/107 as documented by the PCT at the
initiation of treatment. There was no evidence
that a licensed nurse assessed the patient or the
physician was notified for the elevated B/P. At
8:33 the patient's B/P was 178/101 and there was
no evidence that a licensed nurse assessed the
patient or the physician was notified of the
continuing high B/P. Uncontrolled high B/P can
result in stroke.

the patient's B/P was 185/108 as documented by
the PCT at the initiation of treatment. There was
patient or the physician was notified. At 6:00 the
patient's B/P was 185/111; at 6:38 the patient's
B/P was 185/111; at 7:03 the B/P was 179/116;
and at 7:38 the BP was 193/121. There was no
patient or the physician was notified of the high
B/P to allow treatment to be ordered or changed.

the patient ' s B/P was 181/107 as documented
by the PCT at the initiation of treatment. The
patient's blood pressure remained elevated
throughout the treatment and at 9:59 the B/P was
documented by the PCT as 179/108. There was
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B. WING _____________________________
452639 05/13/2008
700 S JOHN REDDITT
LUFKIN, TX 75904

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DEFICIENCY)

the patient's B/P was 180/105 as documented by
the PCT at the initiation of treatment. The
patient's blood pressure remained elevated
throughout the treatment and at 9:57 the B/P was
documented by the PCT as 182/93. There was no
Patient # 15's: The treatment records for

03/21/2008 and 03/26/08 and 04/28/08 found the
blood flow rate was set to run at 300ml/min
instead of the ordered 350. On 04/02/2008 and
04/23/08 the blood flow rate was set to run at
250ml/min instead of the ordered 350. There is
no documentation indicating why the rate was
changed or that the charge nurse being notified of
this change of the physician ' s ordered
prescription for treatment.
Patient # 16's: The treatment record dated

3/13/08 found that the physician had prescribed a
BFR of 400 ml/min and the patient ran the entire
treatment from 11:28 through 15:33 at 300 ml/min
with no reason documented in the medical record
as to why the physician's order was not followed.
The medical record dated 3/20/08 found that the

physician had prescribed a BFR of 400 ml/min
and the patient BFR ran at 350 for the entire
treatment with no reason documented in the
medical record as to why the physician's order
was not followed.
The treatment record dated 04/12/08 found that

at 12:16 the RN documented that the patient
complained of chest pain. 1000 ML of Normal
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LUFKIN, TX 75904

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Saline was given intravenously to the patient. The
patient was alert but " groaning states his chest
pain has not improved." A review of the patient's
prn orders found a physician's order as follows: "
Nitroglycerin 0.4 mg SL (sublingual) Chest pain. "
There was no evidence that the patient was given
the Nitroglycerin as instructed in the physicians
order. This patient was transferred form the
facility by ambulance to the emergency
Department.
The physician orders included an order for blood

glucose testing weekly and as needed for
diabetes dated 2/07/08. There was no evidence
in the medical record that blood glucose testing
was done.
Patient # 18 ' s The treatment record dated

04/09/2008 found the PCT documented she did
not give the ordered heparin dose due to
cannulation problems and the blood flow rate was
set at 350 verses the ordered 400. There was no
evidence in the record she notified the charge
nurse or that the physician was notified. On
04/14/2008 at 0941 the PCT documented that the
UF was turned off and a bolus of 100 ml normal
saline was given due the drop in B/P. There was
no B/P recorded and no evidence the charge
nurse was notified of patients change in condition.
Patient # 19 ' s The treatment record dated

11/26/2007, 11/28/2007 and 12/05/07 found the
blood flow was reduced to 350 from the ordered
400 by the PCT without notifying the charge
nurse. On 12/07/2007 the PCT documented the
blood flow rate was reduced at 09:05 to
350ml/min, the UF was turned off and the patient
was given 200 ml of normal saline for a recorded
B/P of 100/64 without notifying the charge nurse
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B. WING _____________________________
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LUFKIN, TX 75904

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for the change in the condition.
Patient # 20's: The treatment record dated 3/6/08

at 14:31 found the patient's B/P to be 139/24
which had dropped from the initial BP was of
125/68. The PCT recorded " Pt complains of
sweating and nausea B/P low UF off given 200 ml
saline RN notified. " There was no evidence of a
licensed nurse assessment for this patient's
change in condition.
The treatment record dated 3/1/08 and 04/08/08

found that the physician's order for the BFR was
350/ml/min. The record indicated the BFR was
set for 200/ml/min with no evidence as to why the
physician's order was not followed.
The treatment record dated 3/11/08 found no post

assessment documentation of the patient's pulse
or temperature. At 14:33 the PCT documented
the patient's B/P to be 96/56, which had dropped
from the initiation of treatment at 11:09 of 129/74.
The PCT infused 200 ml of normal saline for the
low B/P and there was no evidence that a
licensed nurse assessed the patient for the
patient ' s changed condition. There was also no
evidence that this patient was assessed after
treatment which ended at 14:49. The patient's
B/P of 91/57 was recorded without an
assessment of the patient's cardiac, mental
status, mobility, gastrointestinal status, fluid
retention, or respirations prior to discharge which
would put the patient at risk for complications at
home.
The treatment record dated 3/15/08 at 14:22

found the patient's B/P to be 61/22, a drop from
the patient's initial B/P of 112/57. The PCT
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B. WING _____________________________
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LUFKIN, TX 75904

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recorded " Pt complains of dizziness, BP low UF
off given 200 ML Saline RN Aware." There was
no evidence of a licensed nurse assessment for
this patient's change in condition.
Patient # 21's: The treatment record for

03/06/2008 revealed the blood flow rate was set
to run at 300ml/min instead at the ordered 400
without documentation indicating why the rate
was changed or the charge nurse being notified.
blood flow rate was set to run at 300 instead of
the ordered 400 without documentation indicating
why the change or that the charge nurse was
notified.

treatment ended at 10:17 and the blood was
rinsed back, the patient's record under "discharge
status" that the patient was sent to the
Emergency department. There was no time of
assessment prior to transfer. There was no post
dialysis weight recorded. The standard of
practice is to have a nursing assessment for a
change in patient condition, there is no indication
the patient was assessed prior to being sent the
emergency department or the reason for the
transfer.
Patient ' s # 22's: The treatment record dated

12/18/08 found the treatment ended at 15:09 and
the blood was rinsed back, with "the discharge
status" completed with the entry was sent to the
emergency department. There was no time of
assessment prior to transfer, or monitoring of the
patient condition during the time between the
treatment ending and the transfer of the patient
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B. WING _____________________________
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LUFKIN, TX 75904

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by ambulance. The ambulance transfer record
from the local ambulance service documented
that the ambulance was dispatched to the dialysis
facility at 17:02, two hours after the dialysis
treatment was documented as ending. The
ambulance record indicated the patient was
transported to the emergency department due to
severe bleeding. Standard of care requires
patient status be monitored during active care;
since the patient continued to require care for the
prolonged bleeding, the expectation would include
a record of care. In addition the treatment record
found no documentation to support that a nurse
was notified to assess the patient for a decrease
in weight from his normal 66kg " dry weight " to
a recorded pretreatment weight of 55. 8 kg. (A
loss of 10.2 kg or 22.4 pounds from Saturday to
Tuesday) prior to initiation of dialysis. In addition,
there was no evidence the patient was weighed
post dialysis treatment or that they were unable to
weigh the patient due to the patient's condition.
It is contrary to the Standard of Practice to
dialysis a patient without a nursing assessment
for a loss prior to initiation of treatment.
The treatment record dated 02/26/08 found

documentation the patient remained in the facility
with post infiltrated access site bleeding for 2
hours prior to being transported to the emergency
department. During the 2 hours, there was no
monitoring or assessment of the patient's
condition documented in the patient's medical
record.

staff member decreased the patient's dialysis
treatment time from the physician' order of 240
minutes to 180 minutes without a documented
reason for the decrease or notifying the charge
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B. WING _____________________________
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LUFKIN, TX 75904

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nurse. On 02/26/08 the facility decreased the
patient's dialysis treatment from the physician's
order of 240 minutes to 190 minutes without a
documented reason for the decrease.
Patient # 23's : The treatment record revealed

that on 04/08/2008 the patient had a post
treatment bleed. The record did not contain
evidence of a RN assessment prior to transport to
the emergency department, or any documentation
of monitoring of the patient's condition during the
4.5 hours the patient remained in the clinic
bleeding from the vascular site. The standard of
care requires patient ' s status to be monitored;
since the patient continued to require care for the
prolonged bleeding the expectation would include
a record of that care.
Patient # 24: The treatment record for

12/27/2007 documented the patient's B/P
dropped to 73/49 at 15:05, 94/58 at 15:33 and
67/43 at the end of the treatment at 16:02. The
patient was discharged without any evidence in
the record the PCT notified the charge nurse of
the drop in blood pressure. To allow assessment
of the change in patient condition
The treatment record for 1/1/08 found the

patient's pretreatment weight before treatment
was 64.8 kg and after treatment weight was 72.8
kg (a gain of 8 kg.) There was no evidence the
nurse was notified or that a licensed nurse
assessed the patient's weight gain (rather than an
expected loss of fluid weight during treatment)
prior to the patient discharge. The patient was
transferred back to the nursing home post
treatment and later transferred to the hospital
where he died on 01/03/08. There was no
evidence in the record that the staff noted this
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A. BUILDING ______________________
C
B. WING _____________________________
452639 05/13/2008
700 S JOHN REDDITT
LUFKIN, TX 75904

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DEFICIENCY)

critical gain in weight, which, if accurate, would
mean that the patients gained more that 17
pounds of fluid during treatment, and would result
in respiratory distress for excess fluid prior to his
next scheduled treatment.
Interview with staff # 1 confirmed that the PCT

are required to notify a licensed nurse to assess
the patient for any change in conditon including
but not limited to, administration of a bolus of NS
for correction of hypotension, weight loss
pretreatment, bleeding post treatment, weight
gain at the completion of the treatment verses the
expected weight loss, and hypertension .

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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED

(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)

V 000 INITIAL COMMENTS V 000

An entrance conference was conducted at this

An onsite unannounced complaint investigation

Complaint #00094614 and TX#00093935 were

Recommend 90 day termination. The following

Complaint # TX 00093224 was found to be

(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)

V 000 Continued From page 1 V 000

Note: The Statement of Deficiencies is an official,

Definitions and Abbreviations:

Access- An access is a route into the

Administer (ADM) to give to a patient

Adverse Occurrence Report: (AOR): reports

As Needed (PRN) - to administer as needed, as

Blood Flow Rate (BFR)- The blood pump pulls

(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)

V 000 Continued From page 2 V 000

Blood Pressure (B/P)- According to the

Clonidine- an oral medication used to treat

CVC- Central Venous Catheter, used as vascular

(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)

V 000 Continued From page 3 V 000

Dialysate - Dialysate is a precise mixture of

Dialyzer- An artificial kidney used to filter out

Dry weight- The estimated weight of a patient if all

Epogen- a medication used in the anemia

Hemoglobin- The red, oxygen-carrying pigment of

Hematocrit is a measure of red cells in the blood.

Heparin - A blood thinner used during dialysis so

Hemostasis - Stopping the bleeding

Hypertension - High or elevated blood pressure.

Hypotension - Low blood pressure

(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)

V 000 Continued From page 4 V 000

Kilograms (kg)-a measurement of weight, each

Licensed Vocation Nurse (LVN)- A vocational

Lisinopril- A medication used in the control of high

ml/min -milliliters per minute

Narvasc- A medication used in the control of high

Nitroglycerin- A medication used to treat chest

Normal Saline (NS) sterile intravenous fluid that

Patient (PT)- A patient of the facility

Patient Care Technician (PCT) an unlicensed

PO- to take by mouth

Prescription (Rx) the order given by a physician

(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)

V 000 Continued From page 5 V 000

Reprocessing (Reuse)-Reprocessing is cleaning

Registered Nurse (RN) a registered nurse by the

Sublingual (SL)- a route that medication is

Treatment (TX) - the administration of an ordered

Ultra Filtration (UF) - a method to use pressure to

Ultra Filtration Rate (UFR) - the rate at which fluid

The ESRD facility is under the control of an

This CONDITION is not met as evidenced by:

(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)

V 110 Continued From page 6 V 110

Refer to Tag V112, V146, V424 and V431 for

The governing body adopts and enforces rules