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]
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