DoD Clinical Laboratory Improvement Program (DoD-CLIP)

1. DoD Clinical Laboratory Improvement Program (DoD-CLIP) Presented By: HMC Gerry S. Rapisura, USN, MT(ASCP) Navy Program Manager, DoD-CLIP MSgt Gary Brown, USAF Air Force Program Manager, DoD-CLIP Center for Clinical Laboratory Medicine (CCLM)

2. Topics for Discussion • Overview of CCLM • CLIP Program and certificates • CAP surveys and inspections • CAP PT failures • Useful websites • Contact Information

3. History • Clinical Laboratory Improvement Act of 1967 • Applied only to laboratories involved in interstate commerce. • Had little impact on the laboratory community • Adverse publicity regarding PAP smears and physician office laboratory testing (POL) • Response of Congress (amends PL 100-578) • The Clinical Laboratory Improvement Amendments of 1988 • Published March 1992 • Included Federal Facilities (DOD facilities not exempt)

4. CLIA'88 • Purpose: To improve the quality of any testing conducted for medical purposes. • Broadly applicable: Congress required every testing site examining “materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease…” to be regulated.

5. CLIA'88 • Revised and superseded CLIA'67 • The Centers for Medicare &/Medicaid Studies (CMS) provides oversight for the program • Incorporated four separate sets of rules for implementation • DOD allowed to develop separate plan with certain restrictions

6. History Clinical Laboratory Improvement Program (DoD-CLIP) • Meeting of representatives from the three services to draft original plan from CLIA 88 - Code of Federal Regulations 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 92

7. DOD Program • To be called Clinical Laboratory Improvement Program (DoD-CLIP). • AFIP PAM 40-24 – DOD-CLIP Program • Very much like CLIA with certain exceptions to meet military operational requirements. • Office of Clinical Laboratory Affairs (OCLA), Center for Clinical Laboratory Medicine (CCLM) in AFIP staffed by tri-service personnel and provides oversight for the program.

8. Registration Required for all DoD Clinical Testing Sites • Based on complexity of testing • Minimally Complex (Waived) • Moderate • Provider-Performed Microscopy (PPM) • High • Currently have 1251 certificates issued with 2471 testing sites

9. Complexity Definitions • Minimal Complexity (Waived) tests are those laboratory examinations and procedures that employ accurate but simple methodologies (mostly FDA approved home tests) • Moderate Complexity tests are those defined as moderate complexity by the Centers for Medicare & Medicaid Studies (CMS) and published by the Center for Disease Control (CDC)

10. Complexity Definitions • High Complexity tests are those defined as high complexity by CMS and published by CDC (also includes non-FDA approved procedures) • Any deviation from the manufacturers instructions automatically classifies a test as high complexity • CDC Web site lists all tests by complexity (www.fda.gov/cdrh/CLIA/index.html)

11. Program Requirements • Personnel Standards - Defined for each category of testing (director, clinical consultant, technical consultant, general supervisor, and testing personnel) • Quality Control (QC) - monitors the actual analytical testing process • Quality Assurance (QA) - all phases of the testing process are monitored • Procedure Manuals - meeting National Committee for Clinical Laboratory Science (NCCLS) GP2-A3 format

12. Program Requirements • Patient Test Management Process (Pre, Analytical, Post) • Proficiency Testing - Mandatory for PPM, moderate and high complexity sites (even for waived sites, test accuracy must be verified at least twice annually) • Inspections and Sanctions - testing privileges are suspended or revoked for facilities out of compliance

13. Type of Laboratory Minimal Complexity Moderate Complexity PPM High Complexity Requirements Registration and good laboratory practice QC, QA, PT, Limited Personnel, Accreditation QC, QA, PT, Stringent Personnel, Accreditation Overview of DoD CLIP Requirements

14. Accrediting Organizations (Deemed Status) • Joint Commission on Accreditation of Healthcare Organizations (JCAHO) • College of American Pathologists (CAP) • Army, Air Force and Navy has a centralize contract for PT and Accreditation • Commission on Office Laboratory Accreditation (COLA) • Certain States also have deemed status • Etc.

15. Registration Process • Registration: http://www.afip.org/OCLAB/index.html • Initial snapshot of facility • Type of laboratory (complexity) • Director, by name • List of personnel and education • Test volume and methodology • Certificates are valid for two years • Discuss in details on later presentation.

16. Types of Certificates • Registration Certificate • Certificate for Minimal Complexity Testing • Certificate for Provider-Performed Microscopy • Certificate of Compliance • Certificates of Accreditation

17. DoD-CLIP LAP/PT Funding • OCLA, CCLM centrally contracts for: • Accreditation inspection (LAP) costs for CAP accredited laboratories • Proficiency testing (surveys) through CAP • Means CCLM will pay your LAP and PT • Non-CAP LAP and PT are self pay. • Nice to know: Not all CAP PT are funded by CCLM. Check with your corresponding service Program Manager for exemption

18. QUESTIONS THANK YOU FOR LISTENING AND YOUR TIME

19. DoD-CLIP, CCLM • Established with an MOA between the DoD and DHHS • Purpose is to establish standards and policy for implementation of quality clinical laboratory testing within the DoD

20. DoD - Clinical laboratory Improvement Program(CLIP) What is it? • Military equivalent of CLIA 88 (Clinical Laboratory Improvement Amendments of 1988) • Sets forth the minimum conditions that all laboratories must meet to be certified to perform testing under the DoD CLIP • Laboratories under DoD jurisdiction are subject to the rules of this program

21. DoD-CLIP - Exceptions • During declared or undeclared wars, or period of mobilization • Testing for forensic purposes only • Research laboratories that test human specimens, but do not report patient results for diagnosis • Some laboratories performing drug testing • Medical laboratories assigned to field medical units that perform limited human testing • Navy Ship’s Laboratories

22. CLIP - Complexities Tests are categorized as one of the following: • Minimal complexity (Waived) • Non-Waived • Moderate complexity, including subcategory provider performed microscopy (PPM) • High complexity

23. CLIP – Laboratories performing minimally complex tests Definition of minimally complex: • A test cleared by the FDA for home use • employs methodologies that are simple and accurate • pose minimal risk of harm to the patient if performed incorrectly

24. CLIP – Laboratories performing minimally complex tests • Laboratory qualifies for a certificate of minimal complexity if it restricts its tests to minimal complexity • Sites with minimal complexity certificates are normally your outlying point of care testing sites • Examples: Urine HCG, fecal occult blood, urine dipstick, glucose, cholesterol

25. CLIP – Laboratories performing minimally complex tests • Laboratories eligible for a certificate of minimal complexity must: • Follow manufacturer’s instructions • Analyze and document controls • Ensure training and competency is documented • Verify accuracy and reliability at least twice a year

26. CLIP – Laboratories performing minimally complex tests A laboratory performing minimally complex tests must file a separate certificate for each laboratory location Exceptions: • Lab not in a fixed location, i.e. health screening fair or mobile van • Labs engaged in public health testing • Labs under a single hospital/commander may file a single (one certificate for all hospital’s waived testing sites) or multiple applications

27. CLIP – Laboratories performing Provider Performed Microscopy (PPM) Definition of PPM • A test personally performed by one of the following practitioners: 1. Physician 2. Midlevel practitioner (nurse practitioner, midwife, physician assistant) 3. Dentist • The procedure must be classified as moderately complex • The primary instrument is the microscope • The specimen is labile • Control materials are not available to monitor the entire testing process • Limited specimen handling or processing is required

28. CLIP – Laboratories performing Provider Performed Microscopy (PPM) • Laboratory qualifies for a certificate of PPM (not more than five sites per certificate) if it restricts its tests to Provider Performed Microscopy procedures and Waived tests. • PPM is a subcategory of Moderate complexity • Examples of tests: All direct mount preparations, KOH preparations, Fern tests, Urine sediment examinations

29. CLIP – laboratories performing tests of moderate and high complexity Definition of high/moderate (Non-waived) complexity testing: • A test system, assay, and examination categorized as high/moderate complexity by the Federal Register (define by CMS and published by CDC)

30. CLIP – laboratories performing tests of moderate and high complexity Requirements for a certificate of high/moderate complexity (at a minimum): • Must have a procedure manual • Must follow manufacturers instructions • Must run a control • Must enroll in proficiency testing (PT) • Must identify and resolve problems • Must be accredited

31. Application for a certificate of registration • Application must be made on form prescribed by OASD(HA) designee • Be signed by commander of the hospital or clinic • Describe characteristics of laboratory: • Test procedures and volume • Methodologies for each lab test • Qualifications of personnel • See Attachment (A) pages 1- 6

32. Application for a certificate of registration • Certificate is valid for two years. • Must obtain certificate before performing and reporting results • The laboratory must meet all CLIP standards • May undergo unannounced inspections by TSG or their designee

33. Minimal Complexity and PPM: Must submit renewal application every 2 years Must demonstrate compliance with CLIP: testing and reporting is performed correctly not performing tests not listed on application correct specimen procurement and processing Application for a certificate of registration

34. Application for certificate of registration High and Moderate Complexity • Valid for two years • Must provide proof of accreditation: • within 11 months of issuance of registration • If proof of accreditation is not provided, suspension, revocation or limitations of laboratory registration testing will occur

35. CLIP CERTIFICATE REGISTRATION • PLEASE SEE ATTACHMENT (A) pages 1-6 (DoD Registration Form CLIP) for reference for the next slides presentation • PLEASE SEE ATTACHMENT (B) – Key to Registration Certificates • PLEASE SEE ATTACHMENT (C) – Instruction for Completing Registration Forms

36. CCLM website: www.afip.org/OCLAB

37. Page 1 – Cover page Must accompany all applications or registration Contains general information about the laboratory When submitted, must be signed by director and organization commander Each site must have its own cover sheet. You cannot combine different complexities under one cover sheet.

38. 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

39. Page 3 – PPM application Application must have cover page and PPM page A certificate may have more than one site (5 max) Must enter lab information for each site

40. Page 4 – Multiple sites (Mod/High complexity) Used for a certificate with multiple sites Must enter lab information for each site Can direct no more than a combination of FIVE high/moderate complexity sites (includes PPM)

41. 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 Applications must also be accompanied with a CV for the director

42. Page 6 – Moderate or High Complexity This page addresses specialties, test volumes, and methods

43. Notification requirements Laboratories must notify CLIP within 30 days of any changes in: • name • location • Director • New test – need PT order Notify accreditation program • Changes in “Activity Menu” -new tests, deletion of tests • Director change

44. Revocation of certificate A certificate of registration may be revoked or suspended due to failure to: • Meet requirements of CLIP • Meet accreditation requirements • Meet proficiency testing requirements • Permit complaint inspections • Correct deficiencies

45. Certificate of registration Questions?

46. Proficiency Testing (PT) All high/moderate complexity laboratories must enroll in a proficiency testing program Must enroll in an approved PT program for each specialty, subspecialties, analyte or test Used for the primary method for patient testing

47. Proficiency Testing (PT) Definition: A method of establishing and maintaining the accuracy and reliability of its testing procedures.

48. Proficiency Testing (PT) • Required for all analytes listed in your Activity Menu • PT samples are sent from the approved PT provider (CAP) in each of three shipments (events) per year • Samples must be treated the same as regular patient samples (no special handling) • General acceptable score is 80% or better for each event except Blood Bank which is 100%

49. Proficiency Testing (PT) Do’s • Enrollment • Participation • Evaluation of results • Investigation of failures • Corrective actions • Maintenance of record

50. Proficiency Testing (PT) Don’ts • Test sample differently than patient specimens • Have same Tech (or Supervisor) always do the testing • Refer samples to another lab/Accept referred PT samples: Result in accreditation revocation, suspension and/or monetary fine • Discuss results before reporting