(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]