57 FR 7184, Feb. 28, 1992, unless otherwise noted.
(a) Each laboratory issued a CLIA certificate must meet the requirements in § 493.1773 and the specific requirements for its certificate type, as specified in §§ 493.1775 through 493.1780.
(b) All CLIA-exempt laboratories must comply with the inspection requirements in §§ 493.1773 and 493.1780, when applicable.
[63 FR 26737, May 14, 1998]
(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]
(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.
(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 § 493.1773.
[63 FR 26737, May 14, 1998]
(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 § 493.1773.
[63 FR 26738, May 14, 1998]
(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 § 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 § 493.1773.
[63 FR 26738, May 14, 1998]