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42 C.F.R. § 493.553

Approval process (application and reapplication) for accreditation organizations and State licensure programs.

§ 493.553 Approval process (application and reapplication) for accreditation organizations and State licensure programs.

(a) Information required. An accreditation organization that applies or reapplies to CMS for deeming authority, or a State licensure program that applies or reapplies to CMS for exemption from CLIA program requirements of licensed or approved laboratories within the State, must provide the following information:

(1) A detailed comparison of the individual accreditation, or licensure or approval requirements with the comparable condition-level requirements; that is, a crosswalk.

(2) A detailed description of the inspection process, including the following:

(i) Frequency of inspections.

(ii) Copies of inspection forms.

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