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CLIA - Clinical Laboratory Improvement Amendments

  • Vijayarani Sivakumar

    • Published On - August 28, 2023

    CLIA – Clinical Laboratory Improvement Amendments

    What is CLIA?

    CLIA regulations include federal standards that are applicable to any US Facility that performs laboratory testing on specimens derived from humans for the purpose of providing information for:

    <!--[if !supportLists]-->o   <!--[endif]-->Diagnosis or treatment of disease or impairment

    <!--[if !supportLists]-->o   <!--[endif]-->Health assessments

    The objective of CLIA is to ensure the accuracy, reliability, and timeliness of test results regardless of where the test is performed

    Clinical laboratory testing helps health care providers screen for or monitor specific diseases or conditions. It also helps assess patient health to make clinical decisions for patient care. The Clinical Laboratory Improvement Amendments (CLIA) of 1988 (42 USC 263a) and the associated regulations (42 CFR 493) provide the authority for certification and oversight of clinical laboratories and laboratory testing.  Under the CLIA program, clinical laboratories are required to have the appropriate certificate before they can accept human samples for testing. There are different types of CLIA certificates, as well as different regulatory requirements, based on the types and complexity of clinical laboratory tests a laboratory conducts.

    CLIA CERTIFICATIONS:

    Certificate of Waiver This certificate is issued to a laboratory to perform only waived tests.

    Certificate for Provider-Performed Microscopy Procedures (PPMP) This certificate is issued to a laboratory in which a physician, midlevel practitioner or dentist performs no tests other than the microscopy procedures. This certificate permits the laboratory to also perform waived tests.

    Certificate of Registration This certificate is issued to a laboratory that enables the entity to conduct moderate or high complexity laboratory testing or both until the entity is determined by survey to be in compliance with the CLIA regulations.

    Certificate of Compliance This certificate is issued to a laboratory after an inspection that finds the laboratory to be in compliance with all applicable CLIA requirements.

    Certificate of Accreditation This is a certificate that is issued to a laboratory on the basis of the laboratory's accreditation by an accreditation organization approved by CMS.

    Three federal agencies are responsible for administering the CLIA program: the Centers for Medicare & Medicaid Services (CMS), the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC). Each agency has a unique role.

    CMS

    • Issues laboratory certificates
    • Collects user fees
    • Conducts inspections and enforces regulatory compliance
    • Approves private accreditation organizations for performing inspections, and approves state exemptions
    • Monitors laboratory performance of Proficiency Testing (PT) and approves PT programs
    • Publishes CLIA rules, regulations, and guidance

    FDA

    • Categorizes tests based on complexity
    • Reviews requests for CLIA Waiver by Application
    • Develops rules/guidance for CLIA complexity categorization

    CDC

    • Provides analysis, research, and technical assistance
    • Develops technical standards and laboratory practice guidelines, including standards and guidelines for cytology
    • Conducts laboratory quality improvement studies
    • Monitors proficiency testing practices
    • Develops and distributes professional information and educational resources
    • Manages the Clinical Laboratory Improvement Advisory Committee (CLIAC)

     A surgical pathology, gross and microscopic examination was performed for a colorectal polyp by a CLIA waived lab. How is this coded?

     

    <!--[if !supportLists]-->A.   <!--[endif]-->88305

    <!--[if !supportLists]-->B.   <!--[endif]-->88305QW

    <!--[if !supportLists]-->C.   <!--[endif]-->88307

    <!--[if !supportLists]-->D.   <!--[endif]-->88307QW

     

    A surgical pathology, gross and microscopic examination performed for a colorectal polyp will be coded with 88305. Since the service was performed in a CLIA waived lab, and 88305 requires modifier QW to denote a waived test, 88305QW is the appropriate CPT® code.

     

    Which CLIA certification allows labs to perform 12 microscopic procedures in addition to waived tests?

     

    <!--[if !supportLists]-->E.   <!--[endif]-->Certificate of Waiver

    <!--[if !supportLists]-->F.   <!--[endif]-->Certificate of Provider Performed Microscopy Procedures

    <!--[if !supportLists]-->G.   <!--[endif]-->Certificate of Registration

    <!--[if !supportLists]-->H.   <!--[endif]-->Certificate of Compliance

     

    In addition to the CLIA waived tests, the Certificate of Provider Performed Microscopy Procedures (PPMP) allows a lab to perform an additional 12 microscopic tests




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