CLIA Hot Topics

1. CLIA Hot Topics Gary Yamamoto Centers for Medicare & Medicaid Services San Francisco Regional Office CLIA

2. STATISTICSCLIA Certification CLIA

3. STATISTICSSelf-Determined Laboratory Types CLIA

4. STATISTICSCLIA Certification - POL CLIA

5. STATISTICSCLIA Certification of Accreditation CLIA

6. IQCP • Individualized Quality Control Plan (IQCP) • Replaces Equivalent Quality Control (EQC) CLIA

7. IQCP • Pursuant to 42 CFR § 493.1256(d): • Unless CMS approves a procedure specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must. . .” CLIA

8. IQCP Facts • Education and transition period started on January 1, 2014 • On January 1, 2016, laboratories must be in compliance with their quality control choice or deficiencies will be cited CLIA

9. IQCPPolicies • Applies to CMS-certified, non-waived laboratories, covering all phases of the testing process • May or may not reduce QC amount or frequency • IQCP is optional; default is regulations CLIA

10. IQCPEducation and Transition Period • CLIA certified laboratories should: • Continue to follow existing quality control protocols • Decide to implement IQCP or default quality control • Plan and complete their transition accordingly, phasing out EQC, if applicable CLIA

11. IQCPEducational Outreach • Brochure 11: CLIA Individualized Quality Control Plan Introduction • Brochure 12: Considerations When Deciding to Develop an IQCP • Brochure 13: What is IQCP? CLIA

12. IQCPEducational Outreach • CMS, in collaboration with the CDC, released the IQCP Workbook • Geared primarily towards physician office laboratories (POL) and other smaller laboratories CLIA

13. CLIA Interpretive Guidelines • Revised guidelines published on the CLIA website January 9, 2015 • Summary of major changes included in S&C Memo 15-17-CLIA • January 2016 revision: • Removal of EQC • Addition of IQCP CLIA

14. CLIA Interpretive GuidelinesRemoval of CLSI Microbiology References • For the following requirements, references to CLSI documents have been removed: • 42 C.F.R. § 493.1256(e)(4) [Media QC] • 42 C.F.R. § 493.1261(b)(1 – 2) [Susceptibility] • For additional information, refer to S&C Memo 15-07-CLIA CLIA

15. CLIA Interpretive GuidelinesRemoval of CLSI Microbiology References • With the 01/09/2015 publication of the revised IG, microbiology laboratories will have 2 options for CLIA quality control: • Follow all applicable CLIA quality control regulations • Implement IQCP • CLIA surveyors will cite laboratories for non-compliance CLIA

16. TEST Act – HR 6118 • TEST Act – Taking Essential Steps for Testing Act of 2012 • Amendment to the CLIA statute signed by the President on December 4, 2012 • Clarifies that proficiency testing samples to be tested in the same manner as patient specimens, EXCEPT that no proficiency testing samples shall be sent to another laboratory for analysis CLIA

17. TEST Act – HR 6118 • Allows the Secretary enforcement discretion for: • Revocation of a laboratory’s CLIA certificate for proficiency testing referral • Imposition of the 2-year owner/operator prohibition when the laboratory is sanctioned for proficiency testing referral CLIA

18. TEST Act – HR 6118 • Regulations required to implement the TEST Act published May 2, 2014, and effective July 1, 2014 • Final rule details hierarchical adverse actions for proficiency testing referrals by seriousness • Defines when discretion will be applied and when revocation will be imposed CLIA

19. TEST Act – HR 6118 • Adds definition to 42 CFR § 493.2 for “repeat” proficiency testing referral • A second instance in which a proficiency testing sample, or a portion of a sample, is referred, for any reason, to another laboratory for analysis prior to the laboratory’s proficiency testing program event cut-off date within the period of time encompassing the two prior survey cycles. • Applies to all CLIA certificate types CLIA

20. Proficiency Testing ReferralCategory 1 • Repeat PT referral or laboratory sends PT samples to another laboratory and reports that laboratory’s test results as it’s own • CMS must impose: • Revocation of the laboratory’s CLIA certificate • Civil Money Penalty (CMP) • CMS may impose: • Owner prohibition • Includes a provision for discretion in exempting the owner from the prohibition CLIA

21. Proficiency Testing ReferralCategory 2 • Laboratory sends PT samples or the results of PT samples to another laboratory prior to, or on, the event cut-off date • Referring laboratory reports its own PT sample results • CMS must impose: • Suspension/Limitation of the laboratory’s CLIA certificate • Civil Money Penalty (CMP) • Directed Plan of Correction • CMS may impose: • Any other alternative sanctions, as appropriate CLIA

22. Proficiency Testing ReferralCategory 3 • Laboratory sends PT samples to another laboratory but no test results were receveid prior to the event cut-off date • CMS must impose: • Civil Money Penalty (CMP) • Directed Plan of Correction • CMS may impose: • Any other alternative sanctions, as appropriate CLIA

23. Proficiency Testing ReferralNarrow Exception • One-time, narrow exception carve-out for intentional PT referral • Clarifies intentional PT referral carve-out with addition of the following terms/definitions: • Reflex testing • Confirmation testing • Distributive testing CLIA

24. Proficiency Testing ReferralNarrow Exception • CMS will consider the referral to be improper, but not intentional, and subject to alternative sanctions in accordance with 42 CFR § 493.1804(c): • If the referral is not a repeat proficiency testing referral • It the referral is limited to reflex, confirmatory, or distributive testing • If the sample was a patient specimen, the referral would have been in full conformance with written, legally accurate and adequate standard operating procedures for the laboratory’s testing of patient specimens CLIA

25. Proficiency Testing ReferralNarrow Exception • Reflex Testing • Confirmatory or additional laboratory testing that is automatically requested by a laboratory under its standard operating procedures for patient specimens when the laboratory’s findings indicate test result that are abnormal, are outside a predetermined range, or meet other pre-established criteria for additional testing CLIA

26. Proficiency Testing ReferralNarrow Exception • Confirmatory Testing • Testing performed by a second analytical procedure that could be used to substantiate or bring into question the results of an initial laboratory test CLIA

27. Proficiency Testing ReferralNarrow Exception • Distributive Testing • Laboratory testing performed on the same specimen, or an aliquot of it, that requires sharing it between two or more laboratories to obtain all data required to complete an interpretation or calculation necessary to provide a final reportable result for the originally ordered test • When such testing occurs at multiple locations with different CLIA certificates, it is considered distributive testing CLIA

28. CLIA CLIA information can be found at the CMS Website: www.cms.gov/clia IQCP Mailbox: IQCP@cms.hhs.gov CLIA Interpretive Guidelines Mailbox: CLIA_IG@cms.hhs.gov CLIA