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

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

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

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

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

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

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

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

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

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

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

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

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

CLIA Interpretive Guidelines Removal 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

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

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

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

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

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

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

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

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

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

Proficiency Testing Referral Narrow Exception CMS will consider the referral to be improper and subject to alternative sanctiosn in accordance with 42 CFR 493.1804© but not intentional if: Not a repeat proficiency testing referral Limited to reflex, confirmatory, or distributive testing CLIA

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 § 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

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

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

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

CLIA 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