1 clia cms clia update 2010 for cap annual policy meeting may 2010 harriet walsh, deputy director,...
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1CLIACLIA
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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2CLIACLIA
CLIA Update
Topic Areas• General Status Update• Focus Areas• Activities for Immediate Future
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3CLIACLIA
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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4CLIACLIA
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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CLIACLIA
CLIA Update - General
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CLIACLIA
CLIA Update - General
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7CLIACLIA
Current Statistics
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8CLIACLIA
Current Statistics
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CLIACLIA
CLIA Update - General
October 2009October 20099
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CLIACLIA
CLIA Update - General
October 2009October 200910
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11CLIACLIA
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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12CLIACLIA
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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13CLIACLIA
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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14CLIACLIA
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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15CLIACLIA
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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16CLIACLIA
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
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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)
CLIACLIA
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Survey Category Deficiency Data2007 and 2008
CLIACLIA
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Survey Timeliness
CLIACLIA27
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28CLIACLIA
CLIA Update
Focus Areas• New Complaint Brochure & Complaint Data
• Validation Surveys
• Personnel
• PT Referral
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29CLIACLIA
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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30CLIACLIA
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
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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
CLIACLIA 34
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Validation Surveys
FY2006 FY2007 FY2008
CAP 6 7 12
CLIACLIA
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!
CLIACLIA 36
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37CLIACLIA
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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38CLIACLIA
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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39CLIACLIA
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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40CLIACLIA
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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41CLIACLIA
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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42CLIACLIA
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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43CLIACLIA
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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44CLIACLIA
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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45CLIACLIA
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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46CLIACLIA
Personnel Policies
GOAL:
All oversight agencies will have & enforce consistent personnel policies
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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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51CLIACLIA
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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52CLIACLIA
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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53CLIACLIA
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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54CLIACLIA
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
150,000
175,000
200,000
225,000
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
Year
Nu
mb
er
of
La
bo
rato
rie
s
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
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Electronic Health Records
An agent is an individual or entity legally acting on behalf of the authorized person to receive test results
CLIACLIA 67
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Electronic Health Records
CLIACLIA 68
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Electronic Health Records
CLIACLIA 69
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Electronic Health Records
CLIACLIA 70
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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:– [email protected]
Harriet Walsh’s email:– [email protected]
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THE END
THANK YOU!!! THANK YOU!!! QUESTIONS???QUESTIONS???