DoD Clinical Laboratory Improvement Program

1. DoD Clinical Laboratory Improvement Program Armed Forces Institute of Pathology Pamphlet (AFIP) 40-24 Presenter Dan Harms, COL, MS, USA Assoc Director, Center for Clinical Laboratory Medicine (202) 782-2514 DSN 662 FAX: 6022 Dan.Harms@afip.osd.mil or Dan.E.Harms@us.army.mil CCLM web site: http://www.afip.org/consultation/CCLM/index.html

2. Topics for Discussion • History of CLIA and CCLM • CLIP Program and Certificates • Inspection Requirements • CLIP Program Requirements • Proficiency Testing • Quality Control Review (if time allows) • References • Useful Websites • Contact Information

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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)

9. 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

10. DoD Compliance with CLIA ’88 (cont) • 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

11. DoD Compliance with CLIA ’88 (cont) • 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

12. 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

13. AFIP Pam 40-24 (cont) • 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

14. 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 trainingpurposes • DEPLOYED MEDICAL UNITS OR LABORATORIES PERFORMING THEIR MISSION ARE SUBJECT TO CLIP!!!

15. 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

16. 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

17. DoD and CLIP • 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

18. DoD and CLIP (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.

19. DoD and CLIP (cont) • 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)

20. DoD and CLIP (cont) • 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

21. DoD and CLIP (cont) • 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

22. DoD and CLIP (cont) • Test Categorization • 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

31. DoD and CLIP (cont) • All laboratories must be registered with the CLIP office BEFORE laboratory testing is initiated • 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.

32. 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

33. 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!

34. 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

35. Types of CLIP Certificates • Certificate for Minimal Complexity • Chapter 3 • Certificate for Provider Performed Microscopy • Chapter 4, specifically para 4-3

36. 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

37. 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)

38. 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

39. 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

40. 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

41. 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

42. 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.)

43. CLIP Certificates (cont) • Good for a 2-year period of time – NO EXCEPTIONS!!!

44. 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.

48. 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

49. 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 • Each testing site listed on a certificate is considered a ‘laboratory’ • A single lab director could hold up to 5 CLIP certificates when only one testing site is listed on each certificate • A single lab director could hold only 1 CLIP certificate and come up against this limitation if five testing sites are listed on any one non-waived certificate (i.e., PPM, Moderate, or High) • Contact your Service CCLM representative for special circumstances

50. 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