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

2. STATISTICS CLIA Certification
Certificates
Region IX
Nation
Waived
22,171
73%
181,270
71%
PPMP
4,311
14%
36,255
Compliance
2,073 7%
19,553 8%
Accreditation
1,712 6%
16,683
TOTAL
30,267
253,761
CLIA

3. STATISTICS Self-Determined Laboratory Types
Region IX
Nation
POL
50%
48%
Pharmacy 4%
Nursing Facility 6%
Home Health Agency
Hospital 3%
Community Clinic
Independent 2%
CLIA

4. STATISTICS CLIA Certification - POL
Certificates
Nation
Waived
72,131
61%
PPMP
29,017
24%
Compliance
12,289
10%
Accreditation
5,856 5%
TOTAL
119,293
CLIA

5. STATISTICS CLIA Certification of Accreditation
Organization
Nation
COLA
44%
CAP
39%
TJC
15%
AABB 1%
ASHI
0.4%
AOA
0.6%
CLIA

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

7. IQCP CLIA 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. IQCP Policies
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. IQCP Education 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. IQCP Educational 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. IQCP Educational 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 CLIA
January 2016 revision:
Removal of EQC
Addition of IQCP
CLIA

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

15. CLIA Interpretive Guidelines Removal 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 § 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 Referral Category 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 Referral Category 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 Referral Category 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 Referral Narrow 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 Referral Narrow Exception
CMS will consider the referral to be improper, but not intentional, and subject to alternative sanctions in accordance with 42 CFR § (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 Referral Narrow 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 Referral Narrow 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 Referral Narrow 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 CLIA information can be found at the CMS Website:
IQCP Mailbox:
CLIA Interpretive Guidelines Mailbox:
CLIA