42 CFR 493.39 – Notification requirements for laboratories issued a certificate of waiver
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Laboratories performing one or more tests listed in § 493.15 and no others must notify HHS or its designee—
(a) Before performing and reporting results for any test or examination that is not specified under § 493.15 for which the laboratory does not have the appropriate certificate as required in subpart C or subpart D of this part, as applicable; and
(b) Within 30 days of any change(s) in—
(1) Ownership;
(2) Name;
(3) Location; or
(4) Director.