1. CLIA COMPLIANCE

2. What is CLIA? In 1988 Congress turned its attention to deficiencies in the quality of services provided by the nation’s laboratories

3. Clinical Laboratory Improvement Amendment of 1988 To ensure accurate, reliable tests delivered in reasonable time, wherever the tests are performed

4. CLIA Applies to laboratories that examine human specimens for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of---- human beings. Specifies performance requirements, based on test complexity and risk factors related to erroneous test results.

5. CLIA Seeks to improve quality in all lab testing by setting standards has specifications for quality control, quality assessment, patient testing management, personnel and proficiency testing. Sets minimum standards for lab practice and quality these are federal guidelines, states may establish requirements more stringent than CLIA

6. CLIA exceptions…………………………. CLIA does not apply to facilities only performing testing for forensic purposes Research labs that test human specimens but do not report patient specific results for the assessment of the health of individual patients.

7. CLIA also does not apply to labs under the jurisdiction of an agency of the Federal Government, except that the Secretary of HHS (Health and Human Services) may modify the application of such requirements as appropriate.

8. CLIA is jointly administered by CMS(centers for Medicaid/medicare services), FDA, and CDC CMS: Implementation of the program and monitoring regulatory compliance, including survey and certification of laboratories, enforcement, and financial management of the program. CDC: Assists in providing technical expertise. FDA: Test complexity categorization, including rules and guidance for CLIA complexity categorization.

9. All labs performing testing must file a separate application for each laboratory location. EXCEPT: labs not in a fixed location. Certain not-for-profit or Federal, State or local government labs. Labs within a hospital that are located at a contiguous building on the same campus and under common direction

10. Types of Certification under CLIA Certification of Registration—an initial certificate provided to all labs except those performing only waived and/or Provider Performed Microscopy Procedures (PPM). Valid for no more than two years or until such time as an inspection to determine program compliance can be conducted, whichever is shorter.

11. Waived tests are defined to employ methodologies so simple and accurate as to render the likelihood of erroneous results negligible. They pose no reasonable risk of harm to the patient if the test is performed incorrectly, and they are cleared by the Food and Drug Administration for home use.

12. More Certification Types Certificate of Waiver—labs that perform only waived tests. Certificate of PPM-tests largely performed by Physician Office Labs (POLS) Certificate of Compliance-issued after lab(other than waived and/or PPM procedures) demonstrates CLIA compliance. Certificate of Accreditation-for labs seeking certification via accreditation agency requirements deemed by CMS to be equal to, or more stringent than CLIA.

13. o Non- waived labs must apply for CLIA certification and meet all 5 major CLIA quality requirements: personnel quality control proficiency testing patient test management quality assessment

14. All personnel in the office must have qualifications for each responsibility on file Quality assurance controls that assure accurate tests each and every day Patient identification and privacy control for all patients and tests

15. Periodic testing using samples from a Proficiency Testing Program. The Program grades the samples and reports back to the Laboratory. These are used to prove the lab is continually upgrading their quality controls, and their testing is accurate.

16. The complexities of the test are what CLIA looks at for certification standards. Waived Moderate High CLIA certifies laboratories/clinical laboratory practices, not the people in the lab or the tests themselves. Labs must demonstrate analytical validity. ×

17. Waived Tests Simple lab procedures that pose no reasonable risk of harm if performed incorrectly

18. Moderate Complexity Moderate complexity (including the subcategory of Provider Performed Microscopy Procedures (PPM) these are mostly tests done in the doctors office (lab) or a test essential for immediate care.

19. High complexity *Risk of erroneous results is substantial because testing methodologies are often complex, usually involving multiple steps, and are characterized by complicated reagent preparation or requires special reagents *equipment which requires multiple steps complicated maintenance and troubleshooting *Controls that require special materials and/or analyst interpretation

20. Why? High complexity tests are (usually) not automated and require more knowledge and training to perform/interpret the results. High Complexity Tests have the most stringent standards.

21. http://www.fda.gov/cdrh/clia/ FDA website lists all waived analytes and tests Links to CMS, CDC websites CLIA database

22. High Complexity Testing & Personnel Requirements More rigorous than those for other testing, the testing is more complicated. Personnel conducting high complexity testing are required to have more education and experience.

23. Only moderate and high complexity labs are subject to routine, announced biennial surveys (The Survey Process) The lab has the choice of: State Agency MTs trained by CMS, or CMS-approved accrediting organizations with equivalent standards It is an outcome-oriented survey with Quality Assurance focus

24. The Survey Process *entrance interview *tour lab *observe testing *interview personnel *review records, data/information *assess outcomes and determine compliance *conduct exit conference and generate survey report *if problems are found, the lab develops a correction plan

25. What type lab are you? More than half of all labs are Waiver Next comes the Provider performed Microscopy Compliance labs come next followed by Accredited Labs

26. Reference Websites http://www.fda.gov/cdrh/clia/ http://www.phppo.cdc.gov/clia/default http://www.phppo.cdc.gov/clia/regs http://www.phppo.cdc.gov/clia/default