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

CLIACLIA

CLIA Hot TopicsCLIA Hot Topics

Gary YamamotoGary Yamamoto

Centers for Medicare & Medicaid ServicesCenters for Medicare & Medicaid Services

San Francisco Regional OfficeSan Francisco Regional Office

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STATISTICSSTATISTICSCLIA CertificationCLIA Certification

CertificatesCertificates Region IXRegion IX NationNation

WaivedWaived 22,17122,171 73%73% 181,270181,270 71%71%

PPMPPPMP 4,3114,311 14%14% 36,25536,255 14%14%

ComplianceCompliance 2,0732,073 7%7% 19,55319,553 8%8%

AccreditationAccreditation 1,7121,712 6%6% 16,68316,683 7%7%

TOTALTOTAL 30,26730,267 253,761253,761

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STATISTICSSTATISTICSSelf-Determined Laboratory Self-Determined Laboratory

TypesTypes

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TypesTypes Region IXRegion IX NationNation

POLPOL 50%50% 48%48%

PharmacyPharmacy 4%4% 4%4%

Nursing FacilityNursing Facility 4%4% 6%6%

Home Health AgencyHome Health Agency 6%6% 6%6%

HospitalHospital 3%3% 4%4%

Community ClinicCommunity Clinic 3%3% 3%3%

IndependentIndependent 3%3% 2%2%

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STATISTICSSTATISTICSCLIA Certification - POLCLIA Certification - POL

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CertificatesCertificates NationNation

WaivedWaived 72,13172,131 61%61%

PPMPPPMP 29,01729,017 24%24%

ComplianceCompliance 12,28912,289 10%10%

AccreditationAccreditation 5,8565,856 5%5%

TOTALTOTAL 119,293119,293

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STATISTICSSTATISTICSCLIA Certification of CLIA Certification of

AccreditationAccreditation

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OrganizationOrganization NationNation

COLACOLA 44%44%

CAPCAP 39%39%

TJCTJC 15%15%

AABBAABB 1%1%

ASHIASHI 0.4%0.4%

AOAAOA 0.6%0.6%

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IQCPIQCP

• Individualized Quality Control Plan Individualized Quality Control Plan (IQCP)(IQCP)

• Replaces Equivalent Quality Replaces Equivalent Quality Control (EQC)Control (EQC)

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IQCPIQCP

• Pursuant to 42 CFR § 493.1256(d):Pursuant to 42 CFR § 493.1256(d):– Unless CMS approves a procedure Unless CMS approves a procedure

specified in Appendix C of the State specified in Appendix C of the State Operations Manual (CMS Pub. 7), that Operations Manual (CMS Pub. 7), that provides equivalent quality testing, provides equivalent quality testing, the laboratory must. . .”the laboratory must. . .”

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IQCP IQCP FactsFacts

• Education and transition period Education and transition period started on January 1, 2014started on January 1, 2014

• On January 1, 2016, laboratories On January 1, 2016, laboratories must be in compliance with their must be in compliance with their quality control choice or quality control choice or deficiencies will be citeddeficiencies will be cited

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IQCPIQCPPoliciesPolicies

• Applies to CMS-certified, non-Applies to CMS-certified, non-waived laboratories, covering all waived laboratories, covering all phases of the testing processphases of the testing process

• May or may not reduce QC amount May or may not reduce QC amount or frequencyor frequency

• IQCP is optional; default is IQCP is optional; default is regulationsregulations

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IQCPIQCPEducation and Transition PeriodEducation and Transition Period

• CLIA certified laboratories should:CLIA certified laboratories should:– Continue to follow existing quality Continue to follow existing quality

control protocolscontrol protocols– Decide to implement IQCP or default Decide to implement IQCP or default

quality controlquality control– Plan and complete their transition Plan and complete their transition

accordingly, phasing out EQC, if accordingly, phasing out EQC, if applicableapplicable

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IQCPIQCPEducational OutreachEducational Outreach

• Brochure 11Brochure 11: CLIA Individualized : CLIA Individualized Quality Control Plan IntroductionQuality Control Plan Introduction

• Brochure 12Brochure 12: Considerations When : Considerations When Deciding to Develop an IQCPDeciding to Develop an IQCP

• Brochure 13Brochure 13: What is IQCP?: What is IQCP?

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IQCPIQCPEducational OutreachEducational Outreach

• CMS, in collaboration with the CDC, CMS, in collaboration with the CDC, released the IQCP Workbookreleased the IQCP Workbook– Geared primarily towards physician Geared primarily towards physician

office laboratories (POL) and other office laboratories (POL) and other smaller laboratoriessmaller laboratories

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CLIA Interpretive CLIA Interpretive GuidelinesGuidelines

• Revised guidelines published on Revised guidelines published on the CLIA website January 9, 2015the CLIA website January 9, 2015

• Summary of major changes Summary of major changes included in S&C Memo 15-17-CLIAincluded in S&C Memo 15-17-CLIA

• January 2016 revision:January 2016 revision:– Removal of EQCRemoval of EQC– Addition of IQCPAddition of IQCP

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Removal of CLSI Microbiology Removal of CLSI Microbiology ReferencesReferences• For the following requirements, For the following requirements,

references to CLSI documents references to CLSI documents have been removed:have been removed:– 42 C.F.R. § 493.1256(e)(4) 42 C.F.R. § 493.1256(e)(4) [Media QC][Media QC]

– 42 C.F.R. § 493.1261(b)(1 – 2) 42 C.F.R. § 493.1261(b)(1 – 2) [Susceptibility][Susceptibility]

• For additional information, refer to For additional information, refer to S&C Memo 15-07-CLIAS&C Memo 15-07-CLIA

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Removal of CLSI Microbiology Removal of CLSI Microbiology ReferencesReferences• With the 01/09/2015 publication of With the 01/09/2015 publication of

the revised IG, microbiology the revised IG, microbiology laboratories will have 2 options for laboratories will have 2 options for CLIA quality control:CLIA quality control:– Follow all applicable CLIA quality Follow all applicable CLIA quality

control regulationscontrol regulations– Implement IQCPImplement IQCP

• CLIA surveyors will cite CLIA surveyors will cite laboratories for non-compliancelaboratories for non-compliance

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TEST Act – HR 6118TEST Act – HR 6118

• TEST Act – Taking Essential Steps for TEST Act – Taking Essential Steps for Testing Act of 2012Testing Act of 2012

• Amendment to the CLIA statute Amendment to the CLIA statute signed by the President on December signed by the President on December 4, 20124, 2012– Clarifies that proficiency testing samples Clarifies that proficiency testing samples

to be tested in the same manner as to be tested in the same manner as patient specimens, EXCEPT that no patient specimens, EXCEPT that no proficiency testing samples shall be sent proficiency testing samples shall be sent to another laboratory for analysisto another laboratory for analysis

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• Allows the Secretary enforcement Allows the Secretary enforcement discretion for:discretion for:– Revocation of a laboratory’s CLIA Revocation of a laboratory’s CLIA

certificate for proficiency testing certificate for proficiency testing referralreferral

– Imposition of the 2-year Imposition of the 2-year owner/operator prohibition when the owner/operator prohibition when the laboratory is sanctioned for laboratory is sanctioned for proficiency testing referralproficiency testing referral

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• Regulations required to implement Regulations required to implement the TEST Act published May 2, the TEST Act published May 2, 2014, and effective July 1, 20142014, and effective July 1, 2014

• Final rule details hierarchical Final rule details hierarchical adverse actions for proficiency adverse actions for proficiency testing referrals by seriousnesstesting referrals by seriousness

• Defines when discretion will be Defines when discretion will be applied and when revocation will applied and when revocation will be imposedbe imposed

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• Adds definition to 42 CFR § 493.2 for Adds definition to 42 CFR § 493.2 for “repeat” proficiency testing referral“repeat” proficiency testing referral– A second instance in which a proficiency A second instance in which a proficiency

testing sample, or a portion of a sample, testing sample, or a portion of a sample, is referred, for any reason, to another is referred, for any reason, to another laboratory for analysis prior to the laboratory for analysis prior to the laboratory’s proficiency testing program laboratory’s proficiency testing program event cut-off date within the period of event cut-off date within the period of time encompassing the two prior survey time encompassing the two prior survey cycles.cycles.

– Applies to all CLIA certificate typesApplies to all CLIA certificate types

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Proficiency Testing Proficiency Testing ReferralReferralCategory 1Category 1

• Repeat PT referral or laboratory sends Repeat PT referral or laboratory sends PT samples to another laboratory and PT samples to another laboratory and reports that laboratory’s test results as reports that laboratory’s test results as it’s ownit’s own– CMS must impose:CMS must impose:

• Revocation of the laboratory’s CLIA certificateRevocation of the laboratory’s CLIA certificate• Civil Money Penalty (CMP)Civil Money Penalty (CMP)

– CMS may impose:CMS may impose:• Owner prohibitionOwner prohibition

– Includes a provision for discretion in exempting the Includes a provision for discretion in exempting the owner from the prohibitionowner from the prohibition

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• Laboratory sends PT samples or the results Laboratory sends PT samples or the results of PT samples to another laboratory prior to, of PT samples to another laboratory prior to, or on, the event cut-off dateor on, the event cut-off date

• Referring laboratory reports its own PT Referring laboratory reports its own PT sample resultssample results– CMS must impose:CMS must impose:

• Suspension/Limitation of the laboratory’s CLIA Suspension/Limitation of the laboratory’s CLIA certificatecertificate

• Civil Money Penalty (CMP)Civil Money Penalty (CMP)• Directed Plan of CorrectionDirected Plan of Correction

– CMS may impose:CMS may impose:• Any other alternative sanctions, as appropriateAny other alternative sanctions, as appropriate

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• Laboratory sends PT samples to another Laboratory sends PT samples to another laboratory but no test results were laboratory but no test results were receveid prior to the event cut-off datereceveid prior to the event cut-off date– CMS must impose:CMS must impose:

• Civil Money Penalty (CMP)Civil Money Penalty (CMP)• Directed Plan of CorrectionDirected Plan of Correction

– CMS may impose:CMS may impose:• Any other alternative sanctions, as appropriateAny other alternative sanctions, as appropriate

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Proficiency Testing Proficiency Testing ReferralReferral

Narrow ExceptionNarrow Exception• One-time, narrow exception carve-out One-time, narrow exception carve-out

for intentional PT referralfor intentional PT referral• Clarifies intentional PT referral carve-out Clarifies intentional PT referral carve-out

with addition of the following with addition of the following terms/definitions:terms/definitions:– Reflex testingReflex testing– Confirmation testingConfirmation testing– Distributive testingDistributive testing

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Narrow ExceptionNarrow Exception• CMS will consider the referral to be CMS will consider the referral to be

improper and subject to alternative improper and subject to alternative sanctiosn in accordance with 42 CFR sanctiosn in accordance with 42 CFR 493.1804© but not intentional if:493.1804© but not intentional if:– Not a repeat proficiency testing referralNot a repeat proficiency testing referral– Limited to reflex, confirmatory, or Limited to reflex, confirmatory, or

distributive testingdistributive testing

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Narrow ExceptionNarrow Exception• CMS will consider the referral to be CMS will consider the referral to be

improper, but not intentional, and improper, but not intentional, and subject to alternative sanctions in subject to alternative sanctions in accordance with 42 CFR § 493.1804(c):accordance with 42 CFR § 493.1804(c):– If the referral is not a repeat proficiency testing If the referral is not a repeat proficiency testing

referralreferral– It the referral is limited to reflex, confirmatory, or It the referral is limited to reflex, confirmatory, or

distributive testingdistributive testing– If the sample was a patient specimen, the referral If the sample was a patient specimen, the referral

would have been in full conformance with written, would have been in full conformance with written, legally accurate and adequate standard operating legally accurate and adequate standard operating procedures for the laboratory’s testing of patient procedures for the laboratory’s testing of patient specimensspecimens

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Narrow ExceptionNarrow Exception• Reflex TestingReflex Testing

– Confirmatory or additional laboratory Confirmatory or additional laboratory testing that is automatically requested by a testing that is automatically requested by a laboratory under its standard operating laboratory under its standard operating procedures for patient specimens when the procedures for patient specimens when the laboratory’s findings indicate test result that laboratory’s findings indicate test result that are abnormal, are outside a predetermined are abnormal, are outside a predetermined range, or meet other pre-established criteria range, or meet other pre-established criteria for additional testingfor additional testing

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Narrow ExceptionNarrow Exception• Confirmatory TestingConfirmatory Testing

– Testing performed by a second analytical Testing performed by a second analytical procedure that could be used to procedure that could be used to substantiate or bring into question the substantiate or bring into question the results of an initial laboratory testresults of an initial laboratory test

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Narrow ExceptionNarrow Exception• Distributive TestingDistributive Testing

– Laboratory testing performed on the same Laboratory testing performed on the same specimen, or an aliquot of it, that requires specimen, or an aliquot of it, that requires sharing it between two or more laboratories sharing it between two or more laboratories to obtain all data required to complete an to obtain all data required to complete an interpretation or calculation necessary to interpretation or calculation necessary to provide a final reportable result for the provide a final reportable result for the originally ordered testoriginally ordered test

– When such testing occurs at multiple When such testing occurs at multiple locations with different CLIA certificates, it is locations with different CLIA certificates, it is considered distributive testingconsidered distributive testing

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CLIA information can be foundCLIA information can be foundat the CMS Website:at the CMS Website:www.cms.gov/clia

IQCP Mailbox: IQCP Mailbox: [email protected]

CLIA Interpretive Guidelines Mailbox: CLIA Interpretive Guidelines Mailbox: [email protected]

http://www.cms.gov/clia

mailto:[email protected]

mailto:[email protected]

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

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