---
kind: "range"
citation: "42 C.F.R. §§ 493.1775–493.1780"
title: "42"
from: "493.1775"
to: "493.1780"
count: 3
url: "https://uscodex.org/cfr/42/493.1775..493.1780"
---

# §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.
  - (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](/cfr/42/493.1773.md).

# §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 [§ 493.1773](/cfr/42/493.1773.md).

# §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](/cfr/42/subpartE.md) of this part and [§ 488.11](/cfr/42/488.11.md) 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](/cfr/42/493.1773.md).