CMS CLIA Update 2010
For 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
• NY
• WA
6,315
3,103
3,212
CMS data base 10/2009
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CLIA Update - General
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CLIA Update - General
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Current Statistics
CLIA Labs by Certificate Type
(Non-Exempt Only)
Accreditation
Provider Performed
Microscopy
Compliance
9%
8%
18%
65%
Waiver
Source: CMS CLIA database 10/22/2009
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Current Statistics
Physician Office Laboratories
by CLIA Certificate Type
(Non-Exempt Only)
Provider Performed
Microscopy
Accreditation
Compliance
6%
11%
28%
55%
Source: CMS CLIA database 10/22/2009
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Waiver
CLIA Update - General
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October 2009
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CLIA Update - General
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October 2009
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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 Data
551 labs had sanctions proposed
Principal---372 sanctions
Certificate limitation, suspension,
revocation
Alternative---806 sanctions
DPOC, on-site monitor, CMP, T&TA,
cancel /suspend Medicare
141 labs had sanctions imposed
Principal---76 sanctions
Alternative---183 sanctions
59 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 Test
2005
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
•
•
•
•
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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)
9000
8000
7000
6000
5000
4000
3000
2000
1000
0
Docs/Recs
6.1
# Labs 2007
428
# Labs 2008
443
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Proc.Imp
6.10
562
789
Cust.Serv
6.11
0
16
Facil/Safe
6.12
891
730
Organ.
6.2
1836
1982
25
Person.
6.3
3782
2049
Equip.
6.4
15
8
Proc.Cont
6.6
6796
7883
Assess.
6.9
488
354
Survey Category Deficiency Data
2007 and 2008
60
50
2007
2008
40
30
20
10
0
2007
Enroll.
Test
12.1
2008
11.3
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12.5
38.1
Spec.
SubSp
9.9
13.2
34.5
7.8
Succ.
Part
Gen.Lab
Pre-An
An
Post-An
Pers.-LD
Pers. Other
11.7
52.6
15.4
22.7
16.4
13.2
55.1
19.8
24
4.3
26
Survey Timeliness
100
90
80
70
60
2007
50
2008
40
30
20
10
0
AAB
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AOA
ASHI
CAP
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COLA
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NY
TJC
WA
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
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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 answered
If 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
Recent Disparity Rates
CAP
CLIA
FY2006
6
FY2007
7
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FY2008
12
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 1007 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 Policies
Rationale:
• 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 Policies
Rationale:
• 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
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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 Referral
The 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:




CLIA
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
225,000
Number of Laboratories
200,000
175,000
150,000
Accred/Comp
125,000
PPMP
100,000
Waiver
75,000
50,000
25,000
Year
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2007
2006
2005
2004
2003
2002
2001
2000
1999
1998
1997
1996
1995
1994
1993
0
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 Data
FY 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, onsite 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
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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!!!
QUESTIONS???
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