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CMS CLIA Update 2010For CAP Annual Policy Meeting

May 2010

Harriet Walsh, Deputy Director, Division of Laboratory Services, Centers for Medicare &

Medicaid Services

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CLIA Update

Topic Areas• General Status Update• Focus Areas• Activities for Immediate Future

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CLIA Update

General Status Update (Our numbers and on-going activities)

• Current CMS CLIA Statistics • CMS Top Survey Deficiencies • CMS Enforcement Data• Cytology PT NPRM• CLIAC & Partners

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Current Statistics

Total Number of Laboratories: 214,875– Compliance 19,178– Accredited 16,095– Waived 134,778– Provider Performed Microscopy 38,509

– Exempt 6,315• NY 3,103• WA 3,212

CMS data base 10/2009

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Current Statistics

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Current Statistics

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CLIA Update - General

October 2009October 20099

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CLIA Update - General

October 2009October 200910

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CMS’ Top 10 Condition Level Deficiencies

Citation % Labs Cited Mod. complexity LD qual./resp.-----------------4.4%Successful PT participation-----------------------4.1%PT enrollment------------------------------------—1.9%Analytic Systems (QC)----------------------------1.9%Mod. complexity TP-------------------------------1.5%

Source: CMS CLIA Database 10/09

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CMS’ Top 10 Condition Level Deficiencies

Citation % Labs Cited High complexity director qual./resp.------------1.2%Technical consultant qual./resp.------------------0.9%Hematology-----------------------------------------0.6%Bacteriology----------------------------------------0.4%Gen. Lab Systems----------------------------------0.3%

CMS CLIA Database 10/09

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CMS 2009 Enforcement Data551 labs had sanctions proposed

Principal---372 sanctionsCertificate limitation, suspension, revocation

Alternative---806 sanctionsDPOC, on-site monitor, CMP, T&TA, cancel

/suspend Medicare141 labs had sanctions imposed

Principal---76 sanctionsAlternative---183 sanctions59 Immediate Jeopardy

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2008 Annual Lab Registry

• CLIA requires public listing of all enforcement actions• >300 total listings for 2008 (some >1X)

– 94 labs --certificate revoked &/or lost Medicare• IJ, Cond. Noncompliance, POC bad, PT referral

– 63 labs -- certificate limited• Unsuccessful PT performance

– 86 -- Directed POC – 14 -- CMP– 81 accredited labs rec’d. probation, cease

testing/limitation, or were denied accreditation.• Lab types correspond to proportions of total lab pop.

– POLs, independent, hospitals most entries

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Cytology PT

Cytology PT Proposed Regulation:• Proposed rule considered 17 CLIAC recommendations.• Pub. by CMS Jan. ‘09; comments closed Mar. ‘09• Joint CDC/CMS collaboration.• Contains questions; solicits comments & suggestions• 5,193 comments received from 660 submissions • Comments are analyzed• Stay tuned!

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Cytology PT

Comparison of PT Performance, 1st Test2005 91% passed

2006 95% passed

2007 96% passed

2008 97% passed

2009 97% passed

Value of cytology PT:

-Identifies those who shouldn’t screen.

-Demonstrates high quality of those who do

Clinical Laboratory Improvement Advisory Committee (CLIAC)

Scientific and technical advice & guidance to the Secretary on matters involving clinical laboratory standards– Needed revisions

– Impact on medical and laboratory practice

– Modifications for technological advances

Meetings held twice per year, Atlanta– Announced through FRNs

– Open to Public

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CLIAC

20 members selected by the Secretary and deemed Special Government Employees– Professional authorities in laboratory medicine

– Representatives from fields of Medical Technology, Public Health, and Clinical Practice

– Consumer representatives

– Three voting ex officio members or designees• Director of CDC

• Commissioner of FDA

• Administrator of CMS

Serve overlapping terms of up to 4 years for continuity

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CLIAC

• Updates from all three agencies responsible for regulation of clinical laboratories – FDA

– CDC

– CMS

• Workgroup and Subcommittee reports• Any current events or issues related to clinical

laboratory testing• Meeting and committee information:

http://wwwn.cdc.gov/cliac/default.aspx

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Partners

• CMS has been meeting with Partners in Laboratory Oversight since 2004

• Membership: – CMS CO&RO– AOs, Exempt States, and SAs with Licensure– DoD– VA

• Meet approximately every 9 months

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Partners

• Common Goal: – Quality Laboratory Testing

• Mutual Commitments:– Improved communication mechanisms– Enhanced information-sharing opportunities– Greater understanding of each entity’s relevant

activities and policies– Establishment of more effective oversight

programs

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Partners Performance Measures Workgroup

• Third Partners Meeting May 2005– Volunteers from Partners

• First meeting February 2006– Open sharing and brainstorming– Agreement to develop performance indicators

• Subsequent conference calls and meetings– Workgroup Purpose & Objective of Indicators– Final Plan developed May 2009

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Partners Performance Measures Workgroup

Purpose and Objective– Joint development of performance indicators– Promote optimal & effective performance by all

laboratory oversight entities• Strengthened oversight

• Improved quality of laboratory testing

• Common means of assessment

• Joint initiatives

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Partners Performance Measures Workgroup

• Indicators Considered– Most Frequently Cited Deficiencies (in

development)– PT Monitoring (evaluated)– Survey Timeliness (on-going)– Repeat Deficiencies (info-gathering)– Complaints (info-gathering)– Survey Validations (evaluated)

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Quality System Essentials(Partners Data from 2007/2008)

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Survey Category Deficiency Data2007 and 2008

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Survey Timeliness

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CLIA Update

Focus Areas• New Complaint Brochure & Complaint Data

• Validation Surveys

• Personnel

• PT Referral

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New Complaint Brochure

• Hot off the press!• Result of GAO CLIA audit• Provides simple mechanisms for anyone to file a

complaint • Will be distributed to all labs over next 2 yrs.• On CLIA web site• Will be available at professional meetings

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CMS 2009 Complaint Data

• 81 complaints received; 27% substantiated– 20 Compliance labs– 52 Accredited labs– 3 Waived labs– 6 PPM labs

• All complaints investigated; most complaints generate an on site survey

Validation Surveys

• CLIA Statute (after formal AO Approval)– Evaluation of AO Performance - annually

– Report to Congress on Results – annually

• Why?– Ensure equivalency (equal to or more stringent than)

• How many?– Approximately 350 nationwide annually divided proportionately

– AABB, AOA, ASHI – selected by CO

– CAP, COLA, JC – selected by RO with SA input

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Validation Surveys

• CLIA Surveyor Role – Determine if the laboratory is in compliance with CLIA

– Simultaneous surveys may require reassurance of AO surveyors

• CLIA CO Role– Team reviews every condition-level deficiency on the

CLIA survey report in comparison to the AO inspection report

– Reaches consensus on each report

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Validation Surveys

• Question to be answeredIf the CLIA survey hadn’t occurred, would the laboratory have known from the AO inspection that the deficiency was present and needed correction?

Yes = match

No = disparity

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Validation Surveys

• Disparity rate calculation

Total # disparities

Total # validation surveys

• Threshold 20%• Reports sent to each AO followed by a formal

Report to Congress in the CMS Financial Report

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Validation Surveys

FY2006 FY2007 FY2008

CAP 6 7 12

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Recent Disparity Rates

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Validation Surveys

• What have we noticed?• Increased Mandatory Personnel Qualification

Citation Discrepancies– Surveyor Training (10/2007 and 11/2009)– Policy Memo (S&C Letter 10-07)– Misunderstandings

• Acceptance of ASCP certifications• Contracting out review of qualifications

• This does NOT mean that we have an increase in unqualified personnel in laboratories!

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Validation Surveys

Outcomes Related to Personnel Policy Changes:• AOs have condition level citations on CMS

validation surveys & increased disparity rates

• 3 yrs. of data reflects personnel as high % of validation citations—20% of surveys

• Impacts credibility & re-approval of AOs

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Personnel Policies

Applicable Regulations

Subpart M-Covers mod., PPM & high complexity• §493.1351-§493.1495

• Laboratory Director (LD)

• Clinical Consultant (CC)

• Technical Consultant & Supervisor (TC/TS)

• General Supervisor (GS)

• Testing Personnel (TP)

• Cytology General Supervisor (CGS)

• Cytology Technologist (CT)

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Personnel Policies

• Use CMS Interpretive Guidelines (IG) & S & C Letter 10-07 as a guide

• Qualification evaluations are done @ highest level of academic achievement for the position

• All required positions & a sample of TP are reviewed once

• Review additional TP on subsequent surveys along w/ any changes or new personnel

• If a LD changes, qualifications are reviewed by the appropriate AO/SA upon notification prior to approval

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Personnel Policies

If education, training or experience requirements aren’t met by the individual, the position isn’t filled or position’s responsibilities not met, a condition level requirement must be cited

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Personnel Policies

Rationale:• Individuals downloaded qualifications from the

Web, used them fraudulently to obtain CLIA certificates & billed Medicare for millions $$

• Number of false applications recorded so far: 70!!• ASCP discovered individuals who submitted false

credentials for their certification• Surveyors must always evaluate credentials per

policy to ensure consistency

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Personnel Policies

Rationale:• Mandatory citations also facilitate consistency—a fall

out of GAO Report in 2006. Individuals are qualified or not; this isn’t considered educational.

• There is great risk to CLIA & patients if an individual in a regulated position is ID as unqualified & quality issues are also found.− Lab w/ multiple, consecutive PT failures had TP w/

falsified HEW card. All lab results had to be reviewed.

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Personnel PoliciesRationale:• Offshore operation upgraded degrees for a fee; diploma

mills; quickie degrees.• TP with 10th grade education was not following

manufacturer’s instructions for intended use and was testing males for GC/Chlamydia with kit for endocervical specimens.

• Lab w/ all personnel unqualified for high complexity micro testing it performed.

• VA discovered falsified degrees.

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Personnel PoliciesRationale:

• Many shell labs caught by pre-approval review of application credentials 

• IJ in lab where GS had no foreign equivalency done

• TP w/o HS or GED – test results impacted

• POL w/ repeated deficiencies w/ MDs son without HS degree performing testing

• Etc., etc., etc.

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Personnel Policies

Outcomes:• Increase in CMS condition level deficiencies

cited for personnel• CMS’ policy now provides time frame to obtain

documentation• Huge patient safety risk• Medicare/Medicaid defrauded of significant

sums

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Personnel Policies

GOAL:

All oversight agencies will have & enforce consistent personnel policies

PT Referral

The “CLIA” Law (42 USC 263a)

(i)(4) Improper referrals

Any laboratory that the Secretary determines intentionally refers its proficiency testing samples to another laboratory for analysis shall have its certificate revoked for at least one year and shall be subject to appropriate fines and penalties as provided for in subsection (h) of this section.

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PT Referral

The Regulations 42 CFR 493

•Sec. 493.801 Condition: Enrollment and testing of samples.

(b)(3) Laboratories that perform tests on proficiency testing samples must not engage in any inter-laboratory communications pertaining to the results of proficiency testing sample(s) until after the date by which the laboratory must report proficiency testing results to the program for the testing event in which the samples were sent.

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PT ReferralThe Regulations 42 CFR 493

•Sec. 493.801 Condition: Enrollment and testing of samples.

(b)(4) The laboratory must not send PT samples or portions of samples to another laboratory for any analysis which it is certified to perform in its own laboratory. Any laboratory that CMS determines intentionally referred its proficiency testing samples to another laboratory for analysis will have its certification revoked for at least one year. Any laboratory that receives proficiency testing samples from another laboratory for testing must notify CMS of the receipt of those samples.

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PT Referral

CMS Central Office Message:

We want to be notified of anything that even looks like it could be considered PT Referral.

We’re trying to develop enough case reviews to give full consideration to any changes we may need to make in how we approach determinations and enforcement.

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CLIA Update

Activities for Immediate Future• CLSI EP-23: Alternative QC for Laboratories

• PT Regulation• CMS Waived Project• Electronic Health Records (EHR)

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Status Alternative QC Development

• 2005 CLSI meeting discussed “QC for the Future”

– Labs need more info from manufacturers

– One-size-fits-all QC not good for different test systems/labs

• 2 CLSI Evaluation Protocol (EP) QC documents

– EP-23: Alternative, Custom QC for Labs (Jim Nichols)

– EP-22: ISO Risk Mgt. for Manufacturers (Greg Cooper)

• Document development process uses consensus process & includes all constituencies

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Status Alternative QC Development

CMS is working w/ CLSI and Partners – Goal is for standard policies– Possible companion products

Labs should begin to learn & plan now!

Will be phased in by CMS– Interpretive Guidelines will be revised accordingly

– Have not determined if EQC will remain

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PT Regulation• 2008 CLIAC recommendation

• PT programs met November 2008• CLIAC WG met March 2010• Evaluating regulations– mechanisms for analyte /test selection– target values,– grading criteria – PT referral– alternative assessment– genetic tests

• Requires a proposed rule w/ comment & final

• WG will report to CLIAC in September 2010

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Waived Testing

• By CLIA definition…..Waived tests are:

“…..simple laboratory examinations & procedures which –

Employ methodologies that are so simple & accurate as to render the likelihood of erroneous results negligible;

Pose no reasonable risk of harm to the patient if the test is performed incorrectly”.

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Since 1992……

• CLIA-waived tests have increased from 8 to about 100 tests.

This represents 1000’s of test systems!

• The number of laboratories issued a CW has grown exponentially from 20% to 65% of the >214,000 laboratories enrolled.

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Waived Testing

• Offers timely, efficient, convenient patient care• The only standard for CW laboratories is to follow

manufacturer’s instructions & register w/ CMS. • Issues:

Testing personnel less-trained; may not ID problems No routine oversight w/ no funding/resources Minimal mfr. required QC=quality issues Pre & post analytical issues

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Growth of Waived Labs vs.Non-waived Labs

Non Exempt by Application Type

0

25,000

50,000

75,000

100,000

125,000

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175,000

200,000

225,000

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2007

Year

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mb

er

of

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Accred/Comp

PPMP

Waiver

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CMS CERTIFICATE OF WAIVER (CW) PROJECT DATA

1999 Pilot Project: • CO & OH each visited 100 CW & PPMP

laboratories• 50% had quality problems!

• As a result of findings in CO & OH, CMS expanded the pilot to the 8 other States

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CMS CW Project DataFY 2006

Initial visits

Of 1947 labs visited, 69% were following the manufacturer’s instructions.

Follow-up visits Of 414 labs revisited for not following manufacturer’s instructions, 353 or 85% improved upon revisit.

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CMS CW Project– IJ Risk of Harm

• FY 2005: 6 out of 1678 surveys or <1%

• FY 2006: 6 out of 1938 surveys or <0.5%

• FY 2007: 2 out of 1737 surveys or <0.20%

• FY 2008: 3 out of 1902 surveys or <0.16%

Consider if you extrapolate to the total CW population of labs!

0.2% of 135,000 = ??

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CW Labs Not Performing Required QC On Follow Up Visit

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CMS Plan for Waived Testing

Short term

• Continue CW project

• Provide educational materials : new applications, web site, on-site visits, etc.; update clearinghouse

• More comprehensive test menu collection

• Collaborate w/ Partners/CDC to ID opportunities

• Seek support of medical, manufacturer, & patient advocacy orgs.

• Solicit data from AO/ES w/ CW standards

• Coordinate w/ FDA on overlapping issues

Long term

• Change the CLIA law to improve level of oversight

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Electronic Health Records

• CLIA requires reporting to State authorized person– Or individual who will use them– Or referring laboratory

• CLIA requires certain data elements• CLIA requires accurate, timely, reliable & confidential

transmission regardless of mechanism• Issues: State laws, incompatible systems &

terminology, lab responsibilities, oversight of EHRs & HIEs

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Electronic Health Records

Misperception: CLIA doesn’t permit patients to receive test results directly; CLIA regulations should be changed to permit patients to receive their results.

Clarification: Depending on State law, patients may be able to order & receive test results or the authorized person may request a copy for the patient when ordering the test. (493.1241 & 493.1291) This area of the regulations still under discussion with ONC.

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Electronic Health Records

• Newly clarified CMS CLIA Interpretive Guidance for EHRs released Mar. 1 !!– Contains expanded information, guidance &

regulatory interpretations for test ordering, record retention & result reporting

– Under the current regulations!• Accompanied by corresponding FAQs.• http://www.cms.hhs.gov/SurveyCertificationGenI

nfo/downloads/SCLetter10-12.pdf

Electronic Health Records

An agent is an individual or entity legally acting on behalf of the authorized person to receive test results

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Electronic Health Records

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Electronic Health Records

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Electronic Health Records

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Electronic Health Records

• Regulations are unchanged• Interpretive Guidance revised for specific regulations

• Survey Process remains the same

• Laboratories must make sure that all the required data elements are in their test reports

• Laboratories must confirm the accuracy/timeliness of their data transmissions

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Where to Find Info:

CMS CLIA Web site:– www.cms.gov/clia/

– NEW FEATURE: “Lab Demographic Look- Up”

– Brochures, state contacts, application, guidelines, data

CMS Central Office, Baltimore – 410-786-3531

Judy Yost’s email:– Judith.yost@cms.hhs.gov

Harriet Walsh’s email:– Harriet.Walsh@cms.hhs.gov

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THE END

THANK YOU!!! THANK YOU!!! QUESTIONS???QUESTIONS???