what you need to know about waived testing ......what you need to know about waived testing &...
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What You Need to Know About Waived Testing & Competency
Assessment for Non-waived Testing
CLIA
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Objectives • General overview of CLIA
• Guidance on regulations regarding waived testing
• Guidance on regulations regarding competency assessment for non-waived testing
CLIA
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What is “CLIA”?
• Clinical Laboratory Improvement Amendments
• Federal program that establishes quality laboratory standards to protect patient safety and improve health care
CLIA
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CLIA Program Responsibilities
CMS
CDC FDA
Clinical Laboratory Oversight
Scientific Consultation
Test Categorization
CLIA
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The CLIA regulations….. • Established uniform quality standards
for all laboratory testing to ensure accuracy, reliability and timeliness of patient test results regardless of where the test was performed
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CLIA Definition of Laboratory
• Any facility that examines human specimens for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings
CLIA
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All clinical laboratories…..
• that perform testing on patient specimens must: • apply for a CLIA certificate • pay appropriate fees and • follow applicable CLIA
requirements
CLIA
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Test Complexity • Waived • Moderate complexity including the
subcategory of Provider Performed Microscopy (PPM)
• High complexity
Laboratories are certified at the highest level of testing performed
CLIA
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CLIA Certificate Types
• Certificate of Compliance (COC) • Certificate of Accreditation (COA) • Certificate for PPM procedures
(PPMP) • Certificate of Waiver (CoW)
CLIA
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Current Enrollment Statistics
• Total Number of Laboratories: 244,564
oCompliance Labs: 18,959 oAccredited Labs: 16,081
oWaived Labs: 165,058 oPPM Labs: 36,784
CLIA
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Waived Tests…. • Simple laboratory examinations and
procedures
• Cleared by FDA for home use;
• Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or
• Pose no reasonable risk of harm to the patient if the test is performed incorrectly.
CLIA
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Certificate of Waiver (CoW) • Enroll in the CLIA program • Pay biennial certificate fees • Only perform tests categorized as
waived • Not subject to routine inspections • Must follow manufacturer’s instructions
CLIA
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CoW Personnel Requirements • Must have a Laboratory Director
o There are no educational and experiential requirements for LD
• There are no other personnel requirements
CLIA
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CoW Site Visits • Announced, designed to help educate
on sound laboratory practices
• Surveyors determine: o Testing being conducted in manner that
protects patient safety o Regulatory compliance o Performing tests appropriate for a CoW
lab
CLIA
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CDC Educational Materials oCDC has published “Ready, Set, Test”
booklet - describes recommended practices for physicians, nurses, medical assistants and others performing patient testing under a CLIA Waiver Certificate
oCDC also offers an on-line training course corresponding to “Ready, Set, Test”.
CLIA
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Educational booklet with job aids
Poster and postcards
Good Laboratory Practices for Waived Testing Sites
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Non-waived Testing • Includes moderate and high complexity tests • Must follow:
oAll manufacturer’s instructions and oApplicable CLIA requirements oAO requirements o State requirements (ex. Maryland, New
York)
When in doubt, always follow the most stringent requirements
CLIA
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New FDA BGM Limitation • FDA required limitation in manufacturer’s
BGM instructions/pkg inserts that prohibit use of meter for critically ill patients.
• CMS only recently made aware of this limitation being placed in instructions/inserts.
CLIA
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What does this limitation mean?
• Devices used outside of the manufacturer’s requirements are considered to be test modification/off label use.
• This is not a new CLIA regulation!
19 CLIA
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Test modification/off label use • Any change to a test system/device or
manufacturer’s instructions or intended use that affects the test’s performance specifications for accuracy, precision, sensitivity or specificity.
• Modified tests become high complexity tests under CLIA
CLIA
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If using meters with the “critically ill” limitation:
• Define “critically ill” for their specific patient populations
• Establish performance specifications (42 CFR §493.1253)
21 CLIA
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If using meters with the “critically ill” limitation
• Obtain a CLIA Certificate of Compliance (COC) or Certificate of Accreditation (COA), pay applicable fees
• Meet all other high-complexity requirements (ex. Proficiency Testing, Personnel requirements)
22 CLIA
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Definition of “Critically Ill”
• Due to myriad of factors, circumstances and patient populations, it is up to each laboratory/facility to define “critically ill” for its specific patient populations.
• FDA and CMS will not define “Critically Ill”
23 CLIA
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Other Laboratory Options
• Use POC test systems without the “critically ill” limitation
• Send glucose tests to main laboratory • Presents patient care issues due to
volume of blood required, need for frequent testing
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Performance Specification Resources
• 42 CFR §493.1253 of the CLIA Interpretive Guidelines (IG)
• CLIA Brochure #2, “Verification of Performance Specifications” on the CLIA/CMS website owww.cms.hhs.gov/CLIA
25 CLIA
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CLIA
CLIA Personnel & Competency Policies
Topics for Discussion CLIA Personnel Policies Rationale for Policies
Outcomes Goal of Discussion
Competency Assessment
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High Complexity Personnel
• Laboratory director (LD) • Technical Supervisor (TS) • Clinical Consultant (CC) • General Supervisor (GS) • Testing Personnel (TP)
CLIA
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Moderate Complexity Personnel
• Laboratory director (LD) • Clinical consultant (CC) • Technical consultant (TC) • Testing personnel (TP)
CLIA
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CLIA
CLIA Personnel Policies
• Use CMS Interpretive Guidelines (IG) & S & C Letter 10-07-07-CLIA as a guide
• Qualification evaluations are done @ highest level of academic achievement for the position
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CLIA
CLIA Personnel Policies • All required positions & a sample of TP are
reviewed once. • Review add’l. TP on subsequent surveys
along w/ any changes or new personnel • If a LD changes, quals. are reviewed by
the appropriate AO/SA upon notification prior to approval.
• LD responsibilities correspond to all quality standards
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CLIA
CLIA Personnel Policies • Phlebotomists, micro plating personnel, clerks,
reagent & specimen prep, etc. who do not test are NOT reviewed.
• MT(ASCP) & nursing licenses alone aren’t acceptable.
• Even if certification is required by CLIA; e.g., CT, degrees & transcripts, etc. are still required.
• If a State license is required by CLIA, it alone is acceptable. Most States do an extensive review.
• Surveyor may still request documentation.
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CLIA
CLIA Personnel Policies • Consider test complexity when evaluating
credentials. • Agency evaluations aren’t acceptable,
except for foreign credentialing equivalency purposes.
• Foreign educated individuals must be evaluated by a nationally recognized agency for equivalency.
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CLIA
CLIA Personnel Policies • If an individual doesn’t meet education,
training or experience requirements, position not filled or responsibilities not met, a condition level deficiency is cited.
• Competency is assessed per the regulations for TC/TS.
• Solo practitioners are not assessed.
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CLIA
CLIA Personnel Policies: Rationale • Individuals download qualifications from the
Web, use fraudulently to obtain CLIA certificates, and bill Medicare for millions of $$.
• More than 100 false applications recorded so far. Many shell labs caught by pre-approval review of application credentials.
• ASCP has changed its credentialing process after discovering individuals who submitted false credentials for their certification.
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CLIA
CLIA Personnel Policies: Rationale • There is great risk to CLIA & patients if an
individual in a regulated position is ID’d 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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CLIA
CLIA Personnel Policies: Rationale • Offshore operation upgrades degrees for a
fee; diploma mills; quickie degrees. • TP (with only 10th grade education) not
following mfgr’s. instructions for intended use (endocervical) - testing males for GC/Chlamydia
• Lab w/ all personnel unqualified for high complexity micro testing it performed.
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CLIA
CLIA Personnel Policies: Rationale • Immediate Jeopardy found in lab
where GS had no foreign equivalency done.
• TP w/ no HS degree or GED – test results impacted.
• POL w/ repeated deficiencies –MD’s high school age son performing testing.
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CLIA
CLIA Personnel Policies - Goals
1. All oversight agencies have and enforce consistent personnel policies.
2.Patients are protected by qualified personnel at all levels.
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CLIA
CLIA Competency Assessment • Competency is required for all
technical, supervisory & testing personnel (TP).
• Requires 6 elements for all tests for TP.
• Various related requirements are interspersed throughout the regulations.
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CLIA
CLIA Competency Assessment • Competency is NOT the same as a
performance evaluation/training.
• Quality management includes personnel, processes, & procedures, as does competency.
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CLIA
CLIA Competency Assessment • Studies indicate that more education & training
produce higher quality results. • The means to confirm training effectiveness is
competency evaluation. • In CLIA, laboratory director’s qualifications are
stringent due to overall quality responsibility. • But qualifications for testing personnel are
minimal, based on test complexity.
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CLIA
CLIA Competency Assessment
• CLIA survey experience indicates many problems caused by personnel errors which may have a patient impact.
• Routine competency evaluations help prevent errors; highlight importance of competency, regardless of education.
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CLIA
CLIA Competency Assessment: Key Requirement
Technical Consultant/Supervisor Responsibilities (§493.1413(b)(8)(9) and §493.1451(b)(8)(9)) • Evaluating the competency of all testing
personnel & assuring that the staff maintain their competency to perform test procedures & report test results promptly, accurately, & proficiently.
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CLIA
CLIA Competency Assessment
Must Include: 1. Direct observation of routine patient test
performance, including patient preparation, if applicable, specimen handling, processing & testing.
2. Monitoring the recording & reporting of test results
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CLIA
CLIA Competency Assessment
Must Include:
3. Review of intermediate test results or worksheets, QC records, PT results, & preventive maintenance records
4. Direct observation of performance of instrument maintenance & function checks
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CLIA
CLIA Competency Assessment Must Include:
5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external PT samples; and
6. Assessment of problem solving skills
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CLIA
Competency Assessment Tips • Operator training prior to testing is critical &
required • Competency assessments must be
documented • Individual conducting competency
assessments must be qualified (TS/GS or TC)
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CLIA
Competency Assessment Tips • Competency assessment is not PT! • PT can be used to meet some elements of
competency, but not all! • Pathologists should be evaluated by the
laboratory director as technical supervisors.
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CLIA
Competency Assessment Tips • Competency records should match the
laboratory’s actual procedures performed by its personnel.
• When observing test performance, use the procedure manual (PM) /package insert (PI) to ensure PM is current.
• Competency for clinical & technical consultants & supervisors is based on their regulatory responsibilities.
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CLIA
Competency Assessment Tips • Laboratory director is not subject to
competency requirements, but is accountable. Responsibilities checked on surveys.
• Do not have to do all at one time; can combine elements.
• Can often combine analytes on multichannel analyzers.
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CLIA
Competency Assessment Tips • Can use competency assessment for QA
when confirming tests ordered match reported/charted results.
• Follow up on QC corrective actions will demonstrate problem solving ability.
• Checklists are only minimally ok.
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CLIA
Competency Assessment Tips • Competency evaluations must be done
for Provider Performed Microscopy (PPM) individuals.
• Personnel performing pre & post analytic activities, but not in regulatory positions are not subject to competency, but it’s good QA.
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Resources: • CLIA Website
o http://www.cms.gov/CLIA o http://www.accessdata.fda.gov/scripts/cdrh
/cfdocs/cfCLIA/search.cfm
o http://www.cdc.gov/mmwr/pdf/rr/rr5413.pdf
• CDC: Ready, Set, Test booklet o http://www.cdc.gov/dls/waivedtests
CLIA