C.F.R. » Title 42 » CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER G—STANDARDS AND CERTIFICATION › PART 493—LABORATORY REQUIREMENTS › Subpart C—Registration Certificate, Certificate for Provider-performed Microscopy Procedures, and Certificate of Compliance

42 C.F.R. § 493.51

Notification requirements for laboratories issued a certificate of compliance

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Laboratories issued a certificate of compliance must meet the following conditions:

(a) Notify HHS or its designee within 30 days of any change in—

(1) Ownership;

(2) Name;

(3) Location;

(4) Director; or

(5) Technical supervisor (laboratories performing high complexity only).

(b) Notify HHS no later than 6 months after performing any test or examination within a specialty or subspecialty area that is not included on the laboratory's certificate of compliance, so that compliance with requirements can be determined.

(c) Notify HHS no later than 6 months after any deletions or changes in test methodologies for any test or examination included in a specialty or subspecialty, or both, for which the laboratory has been issued a certificate of compliance.

[57 FR 7143, Feb. 28, 1992, as amended at 60 FR 20046, Apr. 24, 1995]
Notes of Decisions
Cited in 1 case (1 in the last 5 years), 2022–2022 · leading case: Smalley v. Becerra (E.D. Mo. 2022).
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Smalley v. Becerra (E.D. Mo. 2022). “See 42 C.F.R. § 493.51 , 63. CMS is tasked with regulating clinical laboratories through its survey and certification process.”
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