PRINT-DoD Clinical Laboratory Improvement Program

Center forClinical Laboratory Medicine

DoD Clinical Laboratory Improvement Program

Armed Forces Institute of Pathology Pamphlet (AFIP) 40-24

PresenterCathy Leppiaho, COL, MS, USA

Assoc Director, Center for Clinical Laboratory Medicine(202) 782-2514 DSN 662

FAX: [email protected] or [email protected]

CCLM web site: http://www.afip.org/consultation/CCLM/index.html


• 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

Topics for Discussion

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• 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

History

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• 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

History (cont)

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• 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

History (cont)

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• 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

History of the Clinical Laboratory Improvement Program (DoD CLIP)

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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


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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)


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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


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• CLIP office responsibilities (per DoDI 6440.2)– Serves as the DoD CLIA program manager– Develops and issues, with the approval of OASD(HA), the tri-

service 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


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• 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


• 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

AFIP Pam 40-24

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• Other modifications allowed:– During declared or undeclared wars, or when under a period of mobilization,

OASD(HA), the Service’s 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

AFIP Pam 40-24 (cont)

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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 Pamphlet’s 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!!!


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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


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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.


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• 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)


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• 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


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• 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 manufacturer’s specifications/instructions for use, the test becomes a high complexity test


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Test Categorization (cont)– 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



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CLIP PROGRAM REQUIREMENTS

All laboratories must be registered with the CLIP office BEFORE laboratory testing is initiated


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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., 16-3a(1) – (3)) unless they are temporarily modified in writing by OASD(HA), the Service’s 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 ship’s operational mission


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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


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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 unit’s ability to perform all

listed procedures


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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!


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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


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Types of CLIP Certificates

• Certificate for Minimal Complexity– Chapter 3

• Certificate for Provider Performed Microscopy– Chapter 4, specifically para 4-3


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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


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Certificate for Minimal Complexity

• Per Chapter 2, paragraph 2-3e, minimal complexity testing sites must:– Follow the manufacturer’s 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)


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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 patient’s 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


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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


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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


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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


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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 CMS-approved, private, non-profit accreditation organization (as listed on the CMS CLIA web page, e.g., CAP, TJC, COLA, AABB, etc.)


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CLIP Certificates (cont)

• Good for a 2-year period of time – NO EXCEPTIONS!!!


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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.


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• 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

Single or Multiple Labs per CLIP Certificate?

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• 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

Single or Multiple Labs per CLIP Certificate?

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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


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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


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– 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


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– 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


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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


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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


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– 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 TJC’s

» 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


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– 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)


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• 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

Specific Certificate Registration Form Submission Requirements

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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

Application must have cover page and PPM page

A certificate may have more than one site


Page 3 – PPM application

Used only for a mod or high certificate with multiple sites


Page 4 – Multiple sites (Mod/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

Page 5 – Moderate or High Complexity


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


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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 MTF’s 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 MTF’s JC survey application to ensure the surveyors are aware


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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


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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)


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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)


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• 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’


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• 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)


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CLIP Program Requirements (cont)Type of LaboratoryMinimal Complexity

Moderate (including PPM) & High Complexity

RequirementsRegistration, 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)


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• 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 on-site monitoring)


• Failure to: – Meet requirements of CLIP– Meet accreditation requirements– Meet proficiency testing requirements– Permit complaint inspections– Correct deficiencies

Revocation/Suspension/Limitation of Certificate

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• 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)

Revocation/Suspension/Limitation of Certificate (cont)

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Program Funding

• CCLM centrally contracts for:– Accreditation inspection costs– Proficiency testing (surveys)

• Excluding linearity and educational (Army)


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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


• 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

Proficiency Testing (PT)

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• 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.

Proficiency Testing (cont)

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• 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.


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Proficiency Testing (cont)• 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


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• 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.


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Proficiency Testing (cont)• 1st time failure to achieve 80% (or 100%) acceptable

performance– Internal investigation to determine cause of inaccurate results

and implementation of necessary corrective action


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• 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 MTF’s 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


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• 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 MTF’s 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


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• 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


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• 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 lab’s regular workload by personnel who routinely perform the testing in the lab, using the lab’s 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


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• Don’t (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 – don’t 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


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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 manufacturer’s 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


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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-of-control instances; testing personnel identification)

• Conduct and document supervisory review


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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• Don’t 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


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)


• 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/

Useful Websites

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Address:

ARMED FORCES INSTITUTE OF PATHOLOGYATTN: AFIP-ZCL (Center for Clinical Laboratory Medicine)Bldg 54, Room G1346825 16TH Street NWWashington, DC 20306-6000

Homepage: http://www.afip.org/consultation/CCLM/index.html

FAX: (202) 782-6022 DSN: 662-6022

General CCLM Office Info

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