PRINT-DoD Clinical Laboratory Improvement Program

Center for
Clinical Laboratory Medicine
DoD Clinical Laboratory Improvement Program

Armed Forces Institute of Pathology Pamphlet (AFIP) 40-24
Presenter Cathy Leppiaho, COL, MS, USA Assoc Director, Center for Clinical Laboratory Medicine (202) 782-2514 DSN 662 FAX: 6022 cathy.leppiaho@afip.osd.mil or Cathy.Leppiaho@us.army.mil CCLM web site: http://www.afip.org/consultation/CCLM/index.html
Center for
Topics for Discussion

History of CLIA, CLIP and CCLM Test Categorization CLIP Certificate Complexity Levels and Types CLIP Program Requirements Proficiency Testing Quality Control Review (if time allows) References Useful Websites Contact Information
2
Center for
History
Clinical Laboratory Improvement Act of 1967
Regulated any laboratory engaged in interstate commerce Had little impact on the laboratory community as a whole
Beginning in1987
Adverse publicity regarding PAP smear mills and concerns about physician office laboratory testing (POL) Concern regarding the number of laboratories that were not subject to either Federal or State regulations
Center for
History (cont)
Response of Congress in October 1988
Enacted PL 100-578 - the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88)
Revised Section 353 of the Public Health Service Act
Expanded HHS authority from regulation of labs that only accepted and tested specimens in interstate commerce to the regulation of any lab that tested specimens for the diagnosis, prevention, or treatment of any disease or impairment of , or the assessment of the health of human beings.
February 28, 1992 CLIA 88 final rule (42 CFR Part 493) published in the Federal Register
implementation date of September 1, 1992
4
Center for
History (cont)
493.3(c) Federal Laboratories
Laboratories under the jurisdiction of an agency of the Federal Government are subject to the rules of this part, except that the Secretary may modify the application of such requirements as appropriate Allowed DoD to modify the application of the CLIA rule to accommodate the unique mission requirements within the DoD that are not found within the civilian sector
Center for
History of the Clinical Laboratory Improvement Program (DoD CLIP)

Meeting of representatives from the three Services to draft original plan from CLIA 88 in April 1992 DOD Clinical Laboratory Improvement Advisory Committee met in Washington, DC, from 20-23 July 1992 and developed final draft of CLIP. Coordinated through Service Surgeon Generals on 29 September 1992 DODI 6440.2 Clinical Laboratory Improvement Program 20 April 1994 42 CFR starting at part 430 was revised October 2006 September 2007 New AFIP Pam 40-25
Center for
CLIP - Basis of Requirement

Clinical Laboratory Improvement Amendments of 1988 (CLIA 88; 42 CFR 493)
Oversight provided by the Centers for Medicare and Medicaid Services (CMS), Department of Health and Human Services Federal law that sets forth the conditions that all laboratories must meet to be certified to perform testing on human specimens
Laboratory a facility that examines materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings
7
Center for
DoD Compliance with CLIA 88

DoDI 6440.2 - Clinical Laboratory Improvement Program (CLIP)
OASD(HA) has responsibility for program oversight and policy review on the implementation of CLIA comparable regulations Established the DoD CLIP office at the Armed Forces Institute of Pathology (AFIP)
8
Center for
DoD Compliance with CLIA 88 (cont)

Per DoDI:
CLIA requirements modified only as may be required to meet unique aspects of DoD missions, training, and preparations during peace, contingency, and war time operations which preclude compliance with CLIA
Center for

CLIP office responsibilities (per DoDI 6440.2)
Serves as the DoD CLIA program manager Develops and issues, with the approval of OASD(HA), the triservice CLIP regulations (AFIP Pam 40-24) Identifies, registers, and certifies all appropriate clinical laboratory testing sites within the DoD Provides information on clinical laboratory accreditation and proficiency testing performance or deficiencies to the appropriate Service Surgeon General for resolution
10
Center for

Implied Responsibilities of Managers/Supervisors Providing Oversight of Labs
Identify and register all clinical laboratories and laboratory testing sites Renew CLIP registration of laboratories every 2 years Ensure the complexity of testing performed is within the scope of the CLIP certificate held by the lab Ensure the lab is inspected or inspected/accredited (with some minor exceptions) Ensure enrollment in a PT program for each of the specialties and subspecialties in which testing is performed Make required notifications within allowed time frame
11
Center for
AFIP Pam 40-24

The CLIA 88 rules, as modified per consultation with CMS, are specified in AFIP Pam 40-24
Current MOA between DoD and CMS runs for a 6-year period beginning 14 January 2009
12
Center for
AFIP Pam 40-24 (cont)

Other modifications allowed:
During declared or undeclared wars, or when under a period of mobilization, OASD(HA), the Services Surgeons General (TSG), or subordinate medical commanders may temporarily modify these rules as required. OASD(HA) or TSG may modify these rules as required for laboratories which are components of deployable operational forces. OASD(HA) or TSG may modify these rules as required for laboratories which are located in overseas locations.
REMINDER: Per DODI 6440.2, CLIA 88 rules may be modified ONLY when circumstances PRECLUDE compliance with those rules
13
Center for
CLIP Excepted Functions (para 2-1b of Pamphlet)

Site only performs testing for forensic purposes Research labs that do not report patient specific results Drug testing labs (regulated by DoDI 1010.16; testing other than the regulated drug testing is subject to the Pamphlets requirements) Deployable medical units or laboratories that perform limited human testing in a field environment for military training purposes
DEPLOYED MEDICAL UNITS OR LABORATORIES PERFORMING THEIR MISSION ARE SUBJECT TO CLIP!!!
14
Center for
Test Categorization
Four categories of test complexity as determined by the Food and Drug Administration (FDA):
Minimal Complexity (commonly referred to as waived testing) Provider Performed Microscopy (a subcategory of moderate complexity testing) Moderate Complexity High Complexity
15
Center for
Test Categorization (cont)

Minimal Complexity (Waived)
Test systems are simple laboratory examinations and procedures which:
Are cleared by the FDA for home use; Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or Pose no reasonable risk of harm to the patient if the test is performed inaccurately
Examples: dipstick or tablet reagent urinalysis (non-automated); fecal occult blood; ovulation tests by visual color comparison; urine pregnancy tests by visual color comparison tests; non-automated ESR; hemoglobin by copper sulfate method; blood glucose by glucose monitoring devices cleared by the FDA specifically for home use; spun hematocrit; etc.
16
Center for

Provider Performed Microscopy (PPM)
Are a subcategory of moderate complexity tests
Primary instrument for performing the test is the microscope, limited to bright-field or phase-contrast microscopy Specimen is labile or a delay in performing the test could compromise the accuracy of the test result Control materials are not available to monitor the entire testing process Limited specimen handling or processing is required Must be personally performed by a physician, a midlevel practitioner (physician assistant, nurse practitioner, nurse midwife), or a dentist
All direct wet mount preparations for the presence or absence of bacteria, fungi, parasites, and human cellular elements; all potassium hydroxide (KOH) preparations; pinworm examinations; fern tests; post-coital direct, qualitative examinations of vaginal or cervical mucous; urine sediment examinations; nasal smears for granulocytes; fecal leukocyte examinations; qualitative semen analysis (limited to the presence or absence of sperm and detection of motility) 17
Center for

Moderate and High Complexity Tests
All tests that do not meet the criteria for minimal (waived) complexity tests PPM tests revert back to their moderate complexity categorization when performed by personnel other than a physician, midlevel practitioner, or dentist A higher level of specimen manipulation is required prior to analysis and/or interpretation is required to determine the test result
18
Center for

High Complexity is the default categorization
A test system, assay, or examination that has not been categorized is considered to be high complexity until it is categorized
if modify a test, i.e., deviate from the manufacturers specifications/instructions for use, the test becomes a high complexity test
19
Center for

Performed by the FDA Tests scored on 7 criteria required to perform the test to determine complexity categorization (42 CFR 493.17)
Knowledge; training & experience; reagents and materials preparation; characteristics of operational steps; calibration, quality control, and proficiency testing materials; test system troubleshooting and equipment maintenance; and interpretation and judgment
Database and other CLIA-related information maintained at http://www.fda.gov/cdrh/clia/index.html

Direct link to complexity database is: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Search.cfm
20
Center for
Center for
22
Center for
23
Center for
Center for
Center for
Center for
27
Center for
CLIP PROGRAM REQUIREMENTS
All laboratories must be registered with the CLIP office BEFORE laboratory testing is initiated
28
Center for
Chapter 16 - Deployable Medical Units

If performing health care testing on a routine basis while in garrison during peace time are required to meet the requirements of CLIP, except for PT, and units must obtain CLIP registration Units that do not perform lab testing on a routine basis when in garrison are subject to minimum CLIP requirements (i.e., 16-3a) Deployed units will adhere to minimum CLIP requirements (i.e., 163a(1) (3)) unless they are temporarily modified in writing by OASD(HA), the Services Surgeons General, or subordinate medical commanders. Naval shipboard laboratories (including those on U.S. Cost Guard assets when deployed as a component of Naval Forces), either in port or underway, are considered deployed medical units supporting the ships operational mission
29
Center for
Deployable Lab Requirements

Chapter 16 lists minimum CLIP requirements for deployed labs
Maintain verification of training and competency of personnel Maintain an SOP for each test performed Maintain and document QC, QA, and maintenance programs Validate all procedures with the supporting MTF laboratory Participate in continuing education offered by the supporting MTF
30
Center for
Chapter 16 MTF Support to Deployable Labs

Assign a technical consultant to each unit Conduct an annual assistance visit to each unit Provide training as necessary Establish internal proficiency testing, as needed Verify a deployable units ability to perform all listed procedures
31
Center for
CLIP Certificate Complexity Levels

Complexity levels of CLIP certificates correspond to the complexity of testing performed
Minimal Complexity Provider Performed Microscopy Moderate Complexity High Complexity
POCT can be of any complexity level of testing!
32
Center for
CLIP Certificate Complexity Levels (cont)

Higher complexity certificates allow the performance of tests of lower complexity without the need to obtain another CLIP certificate
Labs with a high complexity certificate can perform any mix of tests of high, moderate, or minimal complexity Labs with a moderate complexity certificate can perform any mix of tests of moderate or minimal complexity Labs with a PPM certificate can also perform minimal complexity tests
Must administratively control the segregation of testing personnel as to who is allowed to do what testing - PPM must be limited to performance by providers ONLY
Labs with a minimal complexity certificate are restricted to performance of minimal complexity tests only
33
Center for
Types of CLIP Certificates

Certificate for Minimal Complexity
Chapter 3
Certificate for Provider Performed Microscopy

Chapter 4, specifically para 4-3
34
Center for
Types of CLIP Certificates (cont)

Registration Certificate
Chapter 4, specifically para 4-2 Chapter 5, specifically para 5-2
Required of all laboratories seeking a Certificate of Accreditation
Certificate of Compliance
Chapter 4, specifically para 4-4
Certificate of Accreditation
Chapter 5
35
Center for
Certificate for Minimal Complexity

Per Chapter 2, paragraph 2-3e, minimal complexity testing sites must:
Follow the manufacturers instructions for performing the test(s); Meet the requirements in Chapter 3, Certificate for Minimal Complexity Analyze and document the results of controls for the test(s) as recommended by the test manufacturer (retain records for 2 years) Ensure that training to properly perform the test(s) is documented for each employee (new employee requirement training and documentation of competency required initially, at 6 month point, and at 12 months post-hire; documentation of training for new requirements and annual competency assessment for all tasks performed required thereafter; retain records for term of employment plus two years; includes providers if testing involves use of instrumentation) Participate in a proficiency testing program when a program for the test(s) performed is commercially available (NEW requirement in 1 Sep 2007 revision to AFIP Pam 40-24; retain records for 2 years)
36
Center for
Certificate for Provider-Performed Microscopy

Tests are a subcategory of moderate complexity tests Must be performed by a provider (i.e., physician, PA, NP, nurse midwife, or dentist) during the patients visit
Competency assessment is required for all testing personnel, including physicians
CAP (POC.09600) annual competency assessment is not required; frequency is at the discretion of the laboratory director TJC (HR.3.10) all staff who perform testing, including all physicians, dentists, and midlevel practitioners performing PPM, must participate in competence demonstrations
37
Center for
Certificate for Provider-Performed Microscopy (cont)

If PPM tests are to be performed by anyone NOT a provider:
PPM tests are a subcategory of moderate complexity tests When performed by other than a provider, the tests revert back to their moderate complexity categorization i.e., a moderate complexity level certificate IS REQUIRED
38
Center for
Certificate of Registration
Allows start of testing for a new moderate or high complexity laboratory Is not renewable Must subsequently obtain a Certificate of Compliance or Certificate of Accreditation Laboratories performing only minimal complexity tests, PPM procedures, or any combination of these tests are not required to obtain a registration certificate
By CLIA/CLIP (AFIP Pam 13-3a) A laboratory that has been issued a certificate for minimal complexity or a certificate for provider-performed microscopy is not subject to biennial inspections
39
Center for
Certificate of Compliance
Must be obtained before Certificate of Registration expires Compliance inspection performed by CLIP Office or designee using conditions and standards as stated in AFIP Pam 40-24 Seldom (if ever) used
40
Center for
Certificate of Accreditation
Must be obtained
Within 11 months of the issuance of a Certificate of Registration, or Prior to the expiration of a Certificate of Compliance
Accreditation inspection performed by a CMSapproved, private, non-profit accreditation organization (as listed on the CMS CLIA web page, e.g., CAP, TJC, COLA, AABB, etc.)
41
Center for
CLIP Certificates (cont)

Good for a 2-year period of time NO EXCEPTIONS!!!
42
Center for
CLIP Certificates (cont)

Notify CLIP and accreditation program within 30 days of changes in:
Director of laboratory Name or physical location of laboratory Test menu
CAP Standards for Laboratory Accreditation

Laboratories undergoing a change in directorship, location, ownership, or scope of service are subject to inspection and reevaluation in accordance with applicable policy.
43
Center for
44
Center for
45
Center for
46
Center for
Single or Multiple Labs per CLIP Certificate?

A lab must file a separate certificate for each lab location Exceptions to the single lab per certificate rule:
Labs not in a fixed location may be covered under the certificate of a designated primary site or home base, using its address
health screening fairs, mobile vans, other temporary testing locations
Labs engaged in limited public health testing

No more than a combination of 15 moderate or minimal complexity tests per certificate
Labs under a single hospital/clinic commander and supervised by a single laboratory director may file a single application or multiple applications
Used most often with POCT multiple waived testing sites or PPM sites in a hospital listed on one CLIP certificate
47
Center for
Single or Multiple Labs per CLIP Certificate?

A laboratory director may direct no more than 5 laboratories performing moderate complexity testing (including the subcategory of PPM procedures), high complexity testing, or a combination of moderate (including PPM) and high complexity testing
Laboratories in this case means certificates Contact your Service CCLM representative for special circumstances
48
Center for
Application Requirements - Initial Application

Registration
Initial snapshot of facility
Type of laboratory (complexity) Director, by name (NOTE: Lab Director named on CLIP certificate is the same as the Lab Director identified to the accrediting organization; position of Medical Director is not recognized within CLIA/CLIP) Identification of numbers of testing personnel by educational level Test volume and methodology
49
Center for
Application Requirements - Initial Application (cont)

Use forms on AFIP CCLM webpage: http://www.afip.org/consultation/CCLM/index.html Cover sheet of the Registration Form signed by:
The laboratory director (i.e., individual whose name will be placed on the CLIP certificate and identified to the accreditation agency as the lab director) The commander of the hospital or clinic Signature attests that the laboratory will be operated in accordance with AFIP Pam 40-24
50
Center for

Information in Section I of the Cover Sheet of the Registration Form is to provide demographic information for the ORGANIZATION having oversight of the testing site/sites that will be listed on the CLIP certificate
The remaining sheets/sections of the Registration Form collect information specific to the testing site/sites that will be listed on the certificate
Different buildings?
Should be the same ONLY IF in the same physical location
Different telephone numbers?

Should be the same ONLY IF a central point-of-contact is to be used for all communications
51
Center for

Provide all required information most importantly,
Complete lab director information; name, physical address, and telephone number of lab; identification of tests performed and the methodology used; total annual testing volume of all tests performed; and testing personnel information
52
Center for
Application Requirements Renewal Application

A Certificate of Registration is NOT renewable
Must transition to Certificate of Accreditation
Use forms on AFIP CCLM webpage:

http://www.afip.org/consultation/CCLM/index.html
Signed by the laboratory director and the commander of the hospital or clinic Provide all required information
53
Center for
Application Requirements Renewal Application (cont)

Submit verification of CLIP compliance
Copy of accreditation letter from CAP, TJC, COLA, AABB, etc.
Required for ALL moderate or high complexity certificates TJC
recognizes CAP and COLA accreditation in lieu of their own laboratory survey but does not grant dual accreditation does NOT accredit PPM or waived testing sites
Navy autogenerates renewal process upon receipt of accreditation notice from accrediting agency
54
Center for

Submit verification of CLIP compliance (cont)
For TJC inspected Certificate for PPM or Certificate for Minimal Complexity sites (i.e., are not accredited by CAP or COLA)
memorandum signed by the commander (or his/her designee) stating that the laboratory is in compliance with the provisions of the CLIP Copy of TJCs
Accreditation letter for the MTF/Health Care Organization (HCO) Accreditation Quality Report for the MTF/Health Care Organization (shows all sites in the HCO that were surveyed) Documentation that these sites were identified to TJC surveyors (copy of survey application, etc.)
TJC inspects, but does not accredit, PPM or waived testing sites
55
Center for

Submit verification of CLIP compliance (cont)
For non-accredited, non-TJC inspected Certificate for Minimal Complexity sites (i.e., MEPS, ANG, etc.)
memorandum signed by the commander (or his/her designee) stating that the laboratory is in compliance with the provisions of the CLIP a completed self-assessment checklist (NEW requirement is in the 1 Sep 2007 revision to AFIP Pam 40-24)
56
Center for
57
Center for
Specific Certificate Registration Form Submission Requirements

Minimal Complexity
Cover Sheet (Worksheet 1) and Minimal (Worksheet 2)
PPM
Cover Sheet and PPM (Worksheet 3)
Moderate and High Complexity

Cover Sheet, Mod High Site Info (Worksheet 4), Mod High Test Personnel (Worksheet 5), and Mod High Test Volume (Worksheet 6)
Mod High Site Info page (Worksheet 4) required only if multiple sites will be listed on the certificate Mod High Test Personnel and Mod High Test Volume pages are submitted as a set for each testing site to be listed on the certificate
58
Page 1 Cover page

Must be completed for all applications for initial registration/re-registration Contains general info about the laboratory When submitted, must be signed by director and organization commander One cover sheet submission equals/corresponds with one CLIP certificate action. You cannot combine different complexities under one cover sheet.
Page 2 Minimal application
Application must have cover page and minimal complexity page
A certificate may have more than one site

Must enter lab information for each site There is no limit to the number of minimal complexity sites that one director can direct
Page 3 PPM application
Application must have cover page and PPM page A certificate may have more than one site
Must enter lab information for each site
Page 4 Multiple sites (Mod/High complexity)

Used only for a mod or high certificate with multiple sites Must enter lab information for each site
Page 5 Moderate or High Complexity

- Application must have cover page, page 5 and 6 (single site), or pages 4, 5, 6 (multiple sites) - This page addresses testing personnel information and educational qualifications (Personnel Information sections currently not required) - Applications must also be accompanied with a CV for the director
Center for
Page 6 Moderate or High Complexity

This page addresses specialties, test volumes, and analytes/instrument/methods
Page 5 and 6 are submitted as a set for each testing site listed on a moderate or high complexity CLIP certificate
Center for
Inspection Requirements
A laboratory issued a Certificate for Minimal Complexity or Certificate for PPM is not subject to biennial inspections, BUT for MTFs surveyed by TJC, all minimal complexity and PPM testing sites must be:
inspected/accredited by an accrediting organization granted deeming authority by TJC (i.e., CAP, COLA) inspected (TJC does not accredit minimal complexity or PPM labs) by TJC during the MTFs survey as one on the services provided by the MTF
MUST ensure TJC surveyors are aware of all such non-accredited testing sites MUST correctly answer laboratory service-related questions in the MTFs JC survey application to ensure the surveyors are aware
65
Center for
Inspection Requirements
Moderate and High complexity testing sites must be inspected biennially
If elect to have your PPM and Minimal Complexity testing sites inspected/accredited by CAP or COLA, then they are also inspected biennially
Accrediting organizations have moved to unannounced inspections
66
Center for
CLIP Program Requirements

Personnel standards defined qualifications within each category of testing (with the exception of minimal complexity)
PPM (lab director and testing personnel) Moderate (lab director, technical consultant, clinical consultant, and testing personnel) High (lab director, technical supervisor, clinical consultant, cytology general supervisor/general supervisor, and cytotechnologist/testing personnel)
Role of all personnel in laboratory should be defined in writing

Specify highest role an individual qualifies for he/she then qualifies for any role below that level (clinical consultant an exception to this)
67
Center for
CLIP Program Requirements (cont)

Facility Administration (facility requirements; requirements for transfusion services; retention requirements for records, slides, blocks, and tissues) Quality System (general laboratory systems; preanalytic systems; analytic systems; and postanalytic systems)
68
Center for

Procedure Manuals
Clinical Laboratory Standards Institute (formerly NCCLS) GP2-A5 is mentioned as a reference in the notes to CAP checklist questions pertaining to procedure manuals
CAP states that The specific style and format of procedure manuals are at the discretion of the Laboratory Director
69
Center for

Proficiency Testing
Mandatory for moderate and high complexity tests (nonwaived testing as specified in CLIA; PPM is nonwaived testing)
Required for minimal complexity sites in 1 Sep 2007 revision to AFIP Pam 40-24
Need to ensure are compliant with accrediting organization requirements for minimal complexity testing sites (CAP differs from TJC in their requirements)
70
Center for

Type of Laboratory Minimal Complexity
Requirements Registration, PT (NEW as of Sep 07), and good laboratory practices (see para 2-3e of Pam) Registration, PT, Facility Admin, Quality Systems, Personnel (PPM restricted to providers; somewhat limited qualifications for Moderate; stringent qualifications for High), & Inspection (with the exception of PPM)
71
Moderate (including PPM) & High Complexity
Center for

Sanctions (Chapter 14 of Pamphlet) - if a laboratory is determined to be non-compliant with CLIP requirements:
TSG may impose principal sanctions (limitation, suspension, or revocation of a CLIP certificate) TSG or the CLIP office may impose alternative sanctions (directed plan of correction or directed onsite monitoring)
72
Center for
Revocation/Suspension/Limitation of Certificate
Failure to:
Meet requirements of CLIP Meet accreditation requirements Meet proficiency testing requirements Permit complaint inspections Correct deficiencies
73
Center for
Revocation/Suspension/Limitation of Certificate (cont)

Other actions of concern:
Performing, or representing the laboratory as entitled to perform, a lab examination or other procedure that is not within a category of lab examinations or other procedures authorized by it DoD CLIP certificate Intentional referral of PT samples to another laboratory
Process samples to the extent/scope are capable and report that result DO NOT refer the sample to another laboratory for analysis, even if that is what you would normally do with a patient sample (e.g., from an outlying clinic lab to a hospital lab)
74
Center for
Program Funding
CCLM centrally contracts for:
Accreditation inspection costs Proficiency testing (surveys)
Excluding linearity and educational (Army)
75
Center for
Approved Accrediting Organizations (i.e., granted Deeming Authority by CMS)

The Joint Commission (TJC) College of American Pathologists (CAP) Commission on Laboratory Accreditation (COLA) American Association of Blood Banks (AABB) American Osteopathic Association American Society for Histocompatibility and Immunogenetics Exempt States (Washington and New York) http://www.cms.hhs.gov/home/regsguidance.asp
76
Center for
Proficiency Testing (PT)

All laboratories must enroll in a PT program
CLIA requires PT participation for all non-waived testing (including PPM) and specifies regulated analytes CLIP follows CLIA BUT added the requirement in the 1 September 2007 version of the Pam that minimal complexity testing sites must also enroll in PT when commercially available
For each specialty, subspecialty, and analyte or test Required only for the test system, assay, or examination used as the primary method for patient testing during the PT event
Enrollment strongly encouraged by all Services to cover non-regulated analytes and back-up methods (i.e., non-primary method) for standardization
77
Center for
Proficiency Testing (cont)

PT consists of:
The testing of unknown samples sent to a laboratory by a CMS approved PT program - most sets of PT samples are sent to participating laboratories three times per year. After testing the PT samples in the same manner as its patient specimens, the laboratory reports its sample results back to their PT program. The program grades the results using the CLIA grading criteria and sends the laboratory scores reflecting how accurately it performed the testing.
78
Center for

PT is a tool the laboratory can use to verify the accuracy and reliability of its testing
Routine reviews of PT reports by the lab staff will alert them to areas of testing that are not performing as expected and also indicate subtle shifts and trends that, over time, would affect their patient results.
79
Center for

Must maintain at least 80% acceptable performance for each analyte or test procedure (e.g., if 5 challenges are provided per survey event for an analyte or test procedure, must have acceptable performance for 4 of the 5 challenges)
Some immunohematology PT requires 100% acceptable performance ABO group & D (Rho) typing, compatibility testing
80
Center for

Chapter 14 of the CLIP Pamphlet (14-11b) requires that:
Upon failure to successfully participate in proficiency testing, the laboratory will take immediate action which may include voluntary cessation for the specialty, subspecialty or analyte that was failed. The accuracy of testing will be verified within 5 days of receiving the proficiency testing results.
81
Center for

1st time failure to achieve 80% (or 100%) acceptable performance
Internal investigation to determine cause of inaccurate results and implementation of necessary corrective action
82
Center for

Failure in 2 consecutive or 2 out of 3 consecutive events
Cease testing for the failed analyte or test procedure (immediately upon receipt of survey evaluation from the PT provider) Investigation conducted to determine cause of the inaccurate results and implementation of necessary corrective actions Conduct testing to demonstrate that the corrective actions are effective and accurate results can be achieved (split sample testing with another laboratory is the most effective proof) Provide documentation of the investigation and all conclusions, the implementation of corrective action, and the ability to achieve accurate results to the next higher level MTFs regional pathology or lab consultant Regional pathology or lab consultant will authorize restart of testing upon agreement that all issues surrounding the proficiency test failure have been appropriately resolved Provide copy of all supporting documentation to the CCLM
83
Center for

Failure in 3 consecutive or 3 out of 4 consecutive events
Cease testing for the failed analyte or test procedure (immediately upon receipt of survey evaluation from the PT provider) Investigation conducted to determine cause of the inaccurate results and implementation of necessary corrective actions Conduct testing to demonstrate that the corrective actions are effective and accurate results can be achieved (split sample testing with another laboratory is the most effective proof) Provide documentation of the investigation and all conclusions, the implementation of corrective action, and the ability to achieve accurate results to the next higher level MTFs regional pathology or lab consultant and the CCLM CCLM, in coordination with the MEDCOM Laboratory Program Manager, will authorize restart of testing upon agreement that all issues surrounding the proficiency test failure have been appropriately resolved
84
Center for

Frequent causes of proficiency testing failure (other than an outright incorrect answer)
Failure to monitor timely receipt of surveys and resultant degradation of survey materials Failure to prepare survey materials for analysis per survey kit instructions Failure to provide correct methodology and/or instrument code (instrument may be Visual) and other administrative errors Failure to return results to proficiency testing provider within the required time frame
85
Center for

Do (paragraph 7-1b in 1 Sep 2007 revision of AFIP Pam 40-24)
Monitor survey shipment dates and be proactive concerning delivery (i.e., check with Mail Room each day beginning two days after scheduled survey shipment date) Rotate testing among all personnel who routinely perform patient testing Treat survey samples in the same manner as patient specimens (i.e., must be examined or tested with the labs regular workload by personnel who routinely perform the testing in the lab, using the labs routine methods and must test the samples the same number of times that it routinely tests patient samples) Document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples; maintain documentation for a minimum of two years
86
Center for

Dont (paragraph 7-1b in 1 Sep 2007 revision of AFIP Pam 40-24)
Do not communicate with other laboratories regarding the results of proficiency testing until after the date by which the laboratory must report proficiency testing results to the proficiency testing provider Do not send proficiency testing samples or portions of samples to another laboratory for any analysis for which a lab is certified to perform in its own laboratory (corollary precaution: report PT result to the extent/scope of the capabilities of your lab dont refer PT specimen further!) Do not appoint a supervisor or one individual as the sole individual allowed to perform testing on proficiency test samples (see previous slide; however, one individual may be appointed to prepare the samples for testing and/or to complete the proficiency testing report) Do not perform duplicate or repeat testing on proficiency testing specimens unless patient specimens are treated in a like manner
87
Center for
Quality Controls
Used to:
Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance, environmental conditions, and variance in operator performance
Performed as specified in manufacturers instructions (identifies control materials to be utilized and the minimum frequency of use) Over time, rotate control material testing among all personnel who perform the test Test control materials in the same manner as patient specimens Proper preparation/handling of control materials is critical
88
Center for
Quality Controls Documentation

Document quality control testing (control information lot number, expiration date, etc.; reagent/kit information lot number, expiration date, etc.; results obtained - initial and any re-runs required; assessment as to whether the control results were within the acceptable range; any corrective actions taken to resolve out-ofcontrol instances; testing personnel identification) Conduct and document supervisory review
89
Center for
Out-of-control corrective actions (in sequence order until resolved)

Re-run with same control material Re-run with new control material Re-run with new reagents Try controls/reagents received in a different shipment Review testing personnel performance to ensure test is being performed correctly Investigate possible instrument malfunctions Seek manufacturer or other assistance Dont perform tests on patient specimens until test system is demonstrated to be in control EXCEPT FOR THE FIRST TWO ACTIONS LISTED ABOVE, ALL PATIENT TEST RESULTS OBTAINED IN THE UNACCEPTABLE TEST RUN AND SINCE THE LAST ACCEPTABLE TEST RUN MUST BE EVALUATED TO DETERMINE IF PATIENT TEST RESULTS HAVE BEEN ADVERSELY AFFECTED
90
Center for
References
Public Law 100-578 - CLIA-88 42 CFR Part 493 Centers for Medicare and Medicaid Services, HHS Laboratory Requirements DODI 6440.2, 20 April 1994 CMS/DOD MOA dated 14 Jan 2009 AFIP Pamphlet 40-24 dated 1 September 2007 (DOD CLIP provides current guidance)
Center for
Useful Websites
CMS CLIA web page: http://www.cms.hhs.gov/CLIA/ FDA CLIA web Page: http://www.fda.gov/cdrh/clia/index.html FDA CLIA test complexity db: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm CDC CLIA web page: http://wwwn.cdc.gov/clia/default.aspx AFIP web page: http://www.afip.org/ CCLM web page: http://www.afip.org/consultation/CCLM/index.html CAP web page: http://www.cap.org/apps/cap.portal TJC web page: http://www.jointcommission.org/ COLA web page: http://www.cola.org/
92
Center for
General CCLM Office Info

Address: ARMED FORCES INSTITUTE OF PATHOLOGY ATTN: AFIP-ZCL (Center for Clinical Laboratory Medicine) Bldg 54, Room G134 6825 16TH Street NW Washington, DC 20306-6000 Homepage: http://www.afip.org/consultation/CCLM/index.html FAX: (202) 782-6022 DSN: 662-6022
93
Center for
94
Center for
95
Center for
96
Center for
97
Center for

PRINT-DoD Clinical Laboratory Improvement Program

Uploaded by

Document Information

Original Description:

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

PRINT-DoD Clinical Laboratory Improvement Program

Uploaded by

Copyright:

Available Formats

Center for

Clinical Laboratory Medicine

DoD Clinical Laboratory Improvement Program

Topics for Discussion

History of the Clinical Laboratory Improvement Program (DoD CLIP)

CLIP - Basis of Requirement

DoD Compliance with CLIA 88

DoD Compliance with CLIA 88 (cont)

DoD Compliance with CLIA 88 (cont)

DoD Compliance with CLIA 88 (cont)

AFIP Pam 40-24

AFIP Pam 40-24 (cont)

CLIP Excepted Functions (para 2-1b of Pamphlet)

Test Categorization (cont)

Test Categorization (cont)

Test Categorization (cont)

Test Categorization (cont)

Test Categorization (cont)

Database and other CLIA-related information maintained at http://www.fda.gov/cdrh/clia/index.html

CLIP PROGRAM REQUIREMENTS

Chapter 16 - Deployable Medical Units

Deployable Lab Requirements

Chapter 16 MTF Support to Deployable Labs

CLIP Certificate Complexity Levels

POCT can be of any complexity level of testing!

CLIP Certificate Complexity Levels (cont)

Types of CLIP Certificates

Certificate for Provider Performed Microscopy

Types of CLIP Certificates (cont)

Certificate for Minimal Complexity

Certificate for Provider-Performed Microscopy

Certificate for Provider-Performed Microscopy (cont)

CLIP Certificates (cont)

CLIP Certificates (cont)

CAP Standards for Laboratory Accreditation

Single or Multiple Labs per CLIP Certificate?

Labs engaged in limited public health testing

Single or Multiple Labs per CLIP Certificate?

Application Requirements - Initial Application

Application Requirements - Initial Application (cont)

Application Requirements - Initial Application (cont)

Different telephone numbers?

Application Requirements - Initial Application (cont)

Application Requirements Renewal Application

Use forms on AFIP CCLM webpage:

Application Requirements Renewal Application (cont)

Application Requirements Renewal Application (cont)

Application Requirements Renewal Application (cont)

Specific Certificate Registration Form Submission Requirements

Moderate and High Complexity

Page 1 Cover page

Page 2 Minimal application

Application must have cover page and minimal complexity page

A certificate may have more than one site

Page 3 PPM application

Must enter lab information for each site

Page 4 Multiple sites (Mod/High complexity)

Page 5 Moderate or High Complexity

Page 6 Moderate or High Complexity

Accrediting organizations have moved to unannounced inspections

CLIP Program Requirements

Role of all personnel in laboratory should be defined in writing

CLIP Program Requirements (cont)