---
kind: "section"
citation: "42 C.F.R. § 493.1777"
title: "42"
number: "493.1777"
heading: "Standard: Inspection of laboratories that have requested or have been issued a certificate of compliance."
url: "https://uscodex.org/cfr/42/493.1777"
---

# §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).

## Notes

### Amendments

[63 FR 26738, May 14, 1998]

### Source

Source: 57 FR 7184, Feb. 28, 1992, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).

### Source

Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.

### Amendments

[63 FR 26738, May 14, 1998]