CLIA UPDATE

1. CLIA UPDATE

2. Current National Statistics • Total Number of Laboratories: 209,499 • - Compliance 19,261 • - Accredited 16,238 • - Waived 129,219 • - Provider Performed Microscopy 38,383 • - Exempt 6,398 • *NY 3,133 • *WA 3,265

3. Louisiana Stats • - Total Number 3822 • - Compliance 310 • - Accredited 376 • - Waived 2411 • - PPMP 725

4. Mississippi Stats • Total Number 2281 • - Compliance 428 • - Accredited 187 • - Waived 1286 • - PPMP 380

5. CMS’ Top Condition Level Deficiencies • - Mod Complexity lab director qualif/respons • - Successful PT participation • - Analytic Systems (QC) • - Sufficient staffing • - High Complexity lab director qualif/respons • - Technical consultant qualif/respons

6. CMS’s Top 10 Deficiencies - Policy for proper reagent storage - Verify accuracy non-PT’d tests - Analytic Systems’ (QA) - Follow mfgr’s instructions - Procedure manual

7. CMS’ Top 10 Deficiencies • - LD responsibility-QA plan • - General lab systems QA • - Use of expired reagents • - Required elements for test reports • - Mod complexity director qualif/response

8. Louisiana Top 10 Def • - Lab Director: mod complexity • - Following manufacturers instructions • - Establishing quality control ranges • - QA for Analytic Systems • - Procedure Manual • - Expired Items

9. Louisiana Top 10 (cont) • - Performance verification • - Specimen collection, processing, integrity • Manufacturer instructions for Water, Temp, Humidity and protection of equipment from fluctuations with electricity • Corrective Action

10. Mississippi Top 10 Def • - Technical Consultant responsibilities • - Evaluation of PT performance • - Successful participation • - Following manufacturer instructions • - Maintenance and function checks

11. Mississippi Top 10 (cont) • - Manufacturer instructions for Water, Temp, Humidity and protection of equipment from fluctuations with electricity • - Specimen collection, processing and integrity • - Retention of Analytic Records • - calibration/cal verif • - Documentation of QC

12. Current CMS Survey Approach • - Survey approach remains educational, but deficiencies identified are cited. • - In 2006 GAO: survey consistency concerns • - Accelerated enforcement for repeat offenders • - Slight increase in citations occurred

13. Changes in QC Regulations- Analytic systems - 2003 • - Verification of performance specifications • - Clarification of calibration verification (checks) • - QC procedures: 2 levels of ext QC or EQC req’d • - Initially all 3 were educational • - Pertinent CMS brochures on CLIA web site

14. Discontinue as Educational/must be met • - Test method verification • - Maintenance & Function Checks • - Calibration and Cal. Verif.

15. PT Referral WARNING • - Review & learn CLIA PT regs, Subpart H • * DO NOT send a PT sample or partial sample to another lab for testing • * DO NOT communicate with another lab about PT results • - Report to CMS any PT samples received in your lab from another lab

16. PT Referral WARNING • - PT includes analytes NOT Listed in the regulations • - PT referral results in the most serious CLIA penalties. • Loss of CLIA certificate for one year • Includes cancellation of Medicare/Medicaid payment • Lab Dir can’t direct any lab for 2 years • Listing on CLIA annual Lab Registry – CMS website

17. Where to Find Info • CMS CLIA Web site: - www.cms.hhs.gov/clia/ - Brochures, state contacts, application, guidelines