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Title 42 Part 493 → Subpart Q → §493.1777

Title 42 → Chapter IV → Subchapter G → Part 493 → Subpart Q → §493.1777

Electronic Code of Federal Regulations e-CFR

Title 42 Part 493 → Subpart Q → §493.1777

e-CFR data is current as of January 16, 2020

Title 42Chapter IVSubchapter GPart 493Subpart Q → §493.1777


Title 42: Public Health
PART 493—LABORATORY REQUIREMENTS
Subpart Q—Inspection


§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.

[63 FR 26738, May 14, 1998]