CLIA OVERVIEW

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CLIA OVERVIEW

• Virginia Wanamaker
• Deputy Director
• Division of Laboratory Services
• Centers for Medicare Medicaid Services

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CLIA OVERVIEW

• Impetus for Clinical Laboratory Improvement
  Amendment (CLIA)
• Deaths from inaccurately read Pap smears.
• Proliferation of black box technology with no
  oversight in physicians offices.

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CLIA OVERVIEW

• Congress passed the Law in 1988
• Regulates all testing on humans for health
  purposes using minimum quality standards
• To ensure accurate testing regardless of
  location
• Includes research when results returned and
  specimens have unique ID

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CLIA OVERVIEW

• Final Regulations published Feb. 1992
• Five major quality standards based on test
  complexity
• The more complex the test, the more stringent the
  standards

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CLIA OVERVIEW

• Surveys
• Performed biennially and are announced
• The first survey is information-sharing unless
  risk to patient safety is found
• Survey process looks at outcomesresults
• Lab is given credit for what they do right

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CLIA OVERVIEW

• Labs must enroll and meet all major CLIA quality
  requirements
• Personnel
• PT
• Quality control (Analytic Systems)
• Patient test management (Pre Analytic and Post
  Analytic Systems)
• Facility Administration
• Quality Assessment

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How does CMS look at laboratories?

• Outcome-Oriented Survey Process

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CLIA OVERVIEW

• CLIA Surveys
• State Agency Med. Techs. trained by CMS
• Approved accrediting organizations with
  equivalent standards e.g. CAP, JCAHO
• Educational, outcome-oriented with QA focus
• Data indicates improved lab performance over time
  with more labs than ever enrolled in CLIA

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CLIA OVERVIEW

• Survey Process
• Perform entrance interview
• Tour lab
• Observe testing
• Interview personnel

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CLIA OVERVIEW

• Survey Process
• Review records, data/information
• Assess outcomes and determine compliance
• Conduct exit conference and generate survey
  report
• Lab develops plan of correction if problems found

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CLIA OVERVIEW

• CLIA State Surveyors
• Professional and knowledgeable about CLIA,
  laboratory practices and quality assessment
• Evaluate labs overall ability to provide
  accurate results rather than individual standards
• Receive periodic training by CMS and experts

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CLIA OVERVIEW

• Without specific G.T. training a CLIA surveyor
  can
• Review lab directors qualifications and
  responsibilities
• Evaluate QC, instrument maintenance and
  analytical test validation and PT data
• Interview testing personnel observe test
  procedures

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CLIA OVERVIEW

• Without specific G.T. training a CLIA surveyor
  can
• Verify specimen integrity, identification,
  handling, audit trail, confidentiality, etc.
• Assess labs plan to assure accuracy internally
  and externally and solve problems check
  turnaround time
• Assist the lab to meet applicable CLIA
  requirements.

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CLIA COMPLIANCE for GENETIC TESTIANG

• CLIA experience with G.T. research labs
• Much of what lab does to verify test works and
  results are correct facilitates meeting CLIA
• Existing documentation and data are useful
• Organizational materials are acceptable e.g. job
  descriptions, safety plans, etc.
• There are G.T. research labs in compliance with
  CLIA!!

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CLIA COMPLIANCE for GENETIC TESTING

• Quality control
• Examples of alternative control procedures
• Split samples with another lab
• Include previously tested patient samples as
  surrogate controls
• Test each patient specimen in duplicate
• Test multiple specimen types from same patient

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CLIA COMPLIANCE for GENETIC TESTING

• Proficiency Testing (PT)
• No PT program samples available
• At least twice a year lab needs to verify
  accuracy of test
• Some examples to accomplish verification
• Blind testing of materials with known values
• Correlation of patient results with clinical
  symptoms
• Split samples with another laboratory

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QUALITY ASSESSMENT PROGRAM

• Establish and follow policies/procedures
  addressing ongoing QA activity
• Take corrective actions as necessary
• Review their effectiveness
• Revise policies/procedures as necessary to
  prevent recurrence
• Communicate to staff
• Document all assessment activities

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GENETIC TESTING UPDATE

• Currently CLIA has no specific standards
  addressing genetic testing
• Molecular amplification procedures are included
  in Final Quality System Rule
• Notice of Proposed Rulemaking (NPRM) under
  development by CDC and CMS
• NPRM is on CMS regulation schedule

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CLIA and HIPAA

• HIPPA Privacy Rule yields to CLIA
• CLIA limits release of test results by a
  laboratory only to persons authorized under State
  law to receive test results
• CLIA yields to State requirements

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MYTH and FACT

• MYTH
• A CLIA certified lab may send a specimen to a
  research lab. If the CLIA lab confirms the test
  results of the research lab, then the research
  lab does not need a CLIA certificate.
• FACT
• Both labs need CLIA certificates. The CLIA
  certified lab has referred a specimen to another
  lab that should also be CLIA certified.

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MYTH and FACT

• MYTH
• If a physician sends a patient sample to a
  foreign lab, it is considered practice of
  medicine and the foreign lab does not have to be
  CLIA certified.
• FACT
• It does not matter whether the physician or a
  CLIA lab sends the specimen, it is laboratory
  testing and falls under CLIA. The foreign lab
  needs to be CLIA certified.

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MORE INFORMATION

• www.cms.hhs.gov/clia
• CLIA Application
• State Agency Contacts
• Guidelines for Surveyors and Laboratories
• General Information about CLIA

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