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Subpart Q--Inspection

Section
493.1771 Condition: Inspection requirements applicable to all CLIA-certified and CLIA-exempt laboratories
493.1773 Standard: Basic inspection requirements for all laboratories issued a CLIA certificate and CLIA-exempt laboratories
493.1775 Standard: Inspection of laboratories issued a certificate of waiver or a certificate for provider-performed microscopy procedures
493.1777 Standard: Inspection of laboratories that have requested or have been issued a certificate of compliance
493.1780 Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a certificate of accreditation
 
 Subpart Q--Inspection
      
    Source: 57 FR 7184, Feb. 28, 1992, unless otherwise noted.
            
      [[Page 986]]
      
      Sec. 493.1771  Condition: Inspection requirements applicable to all
          CLIA-certified and CLIA-exempt laboratories.
      
    (a) Each laboratory issued a CLIA certificate must meet the
      requirements in Sec. 493.1773 and the specific requirements for its
      certificate type, as specified in Secs. 493.1775 through 493.1780.
    (b) All CLIA-exempt laboratories must comply with the inspection
      requirements in Secs. 493.1773 and 493.1780, when applicable.
      
      [63 FR 26737, May 14, 1998]
      
      Sec. 493.1773  Standard: Basic inspection requirements for all
          laboratories issued a CLIA certificate and CLIA-exempt
          laboratories.
      
    (a) A laboratory issued a certificate must permit CMS or a CMS
      agent to conduct an inspection to assess the laboratory's compliance
      with the requirements of this part. A CLIA-exempt laboratory and a
      laboratory that requests, or is issued a certificate of accreditation,
      must permit CMS or a CMS agent to conduct validation and complaint
      inspections.
    (b) General requirements. As part of the inspection process, CMS or
      a CMS agent may require the laboratory to do the following:
    (1) Test samples, including proficiency testing samples, or perform
      procedures.
    (2) Permit interviews of all personnel concerning the laboratory's
      compliance with the applicable requirements of this part.
    (3) Permit laboratory personnel to be observed performing all phases
      of the total testing process (preanalytic, analytic, and postanalytic).
    (4) Permit CMS or a CMS agent access to all areas encompassed
      under the certificate including, but not limited to, the following:
    (i) Specimen procurement and processing areas.
    (ii) Storage facilities for specimens, reagents, supplies, records,
      and reports.
    (iii) Testing and reporting areas.
    (5) Provide CMS or a CMS agent with copies or exact duplicates of
      all records and data it requires.
    (c) Accessible records and data. A laboratory must have all records
      and data accessible and retrievable within a reasonable time frame
      during the course of the inspection.
    (d) Requirement to provide information and data. A laboratory must
      provide, upon request, all information and data needed by CMS or a CMS
      agent to make a determination of the laboratory's compliance with the
      applicable requirements of this part.
    (e) Reinspection. CMS or a CMS agent may reinspect a laboratory at
      any time to evaluate the ability of the laboratory to provide accurate
      and reliable test results.
    (f) Complaint inspection. CMS or a CMS agent may conduct an
      inspection when there are complaints alleging noncompliance with any of
      the requirements of this part.
    (g) Failure to permit an inspection or reinspection. Failure to
      permit CMS or a CMS agent to conduct an inspection or reinspection
      results in the suspension or cancellation of the laboratory's
      participation in Medicare and Medicaid for payment, and suspension or
      limitation of, or action to revoke the laboratory's CLIA certificate, in
      accordance with subpart R of this part.
      
      [63 FR 26737, May 14, 1998; 63 FR 32699, June 15, 1998]
      
      Sec. 493.1775  Standard: Inspection of laboratories issued a certificate
          of waiver or a certificate for provider-performed microscopy
          procedures.
      
    (a) A laboratory that has been issued a certificate of waiver or a
      certificate for provider-performed microscopy procedures is not subject
      to biennial inspections.
    (b) If necessary, CMS or a CMS agent may conduct an inspection of
      a laboratory issued a certificate of waiver or a certificate for
      provider-performed microscopy procedures at any time during the
      laboratory's hours of operation to do the following:
    (1) Determine if the laboratory is operated and testing is performed
      in a manner that does not constitute an imminent and serious risk to
      public health.
    (2) Evaluate a complaint from the public.
    (3) Determine whether the laboratory is performing tests beyond the
      scope of the certificate held by the laboratory.
      
      [[Page 987]]
      
    (4) Collect information regarding the appropriateness of tests
      specified as waived tests or provider-performed microscopy procedures.
    (c) The laboratory must comply with the basic inspection
      requirements of Sec. 493.1773.
      
      [63 FR 26737, May 14, 1998]
      
      Sec. 493.1777  Standard: Inspection of laboratories that have requested
          or have been issued a certificate of compliance.
      
    (a) Initial inspection. (1) A laboratory issued a registration
      certificate must permit an initial inspection to assess the laboratory's
      compliance with the requirements of this part before CMS issues a
      certificate of compliance.
    (2) The inspection may occur at any time during the laboratory's
      hours of operation.
    (b) Subsequent inspections. (1) CMS or a CMS agent may conduct
      subsequent inspections on a biennial basis or with such other frequency
      as CMS determines to be necessary to ensure compliance with the
      requirements of this part.
    (2) CMS bases the nature of subsequent inspections on the
      laboratory's compliance history.
    (c) Provider-performed microscopy procedures. The inspection sample
      for review may include testing in the subcategory of provider-performed
      microscopy procedures.
    (d) Compliance with basic inspection requirements. The laboratory
      must comply with the basic inspection requirements of Sec. 493.1773.
      
      [63 FR 26738, May 14, 1998]
      
      Sec. 493.1780  Standard: Inspection of CLIA-exempt laboratories or
          laboratories requesting or issued a certificate of
          accreditation.
      
    (a) Validation inspection. CMS or a CMS agent may conduct a
      validation inspection of any accredited or CLIA-exempt laboratory at any
      time during its hours of operation.
    (b) Complaint inspection. CMS or a CMS agent may conduct a
      complaint inspection of a CLIA-exempt laboratory or a laboratory
      requesting or issued a certificate of accreditation at any time during
      its hours of operation upon receiving a complaint applicable to the
      requirements of this part.
    (c) Noncompliance determination. If a validation or complaint
      inspection results in a finding that the laboratory is not in compliance
      with one or more condition-level requirements, the following actions
      occur:
    (1) A laboratory issued a certificate of accreditation is subject to
      a full review by CMS, in accordance with subpart E of this part and
      Sec. 488.11 of this chapter.
    (2) A CLIA-exempt laboratory is subject to appropriate enforcement
      actions under the approved State licensure program.
    (d) Compliance with basic inspection requirements. CLIA-exempt
      laboratories and laboratories requesting or issued a certificate of
      accreditation must comply with the basic inspection requirements in
      Sec. 493.1773.
      
      [63 FR 26738, May 14, 1998]

This page last reviewed: 7/7/2004
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