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Title 42 Part 493 → Subpart C → §493.51

Title 42 → Chapter IV → Subchapter G → Part 493 → Subpart C → §493.51

Electronic Code of Federal Regulations e-CFR

Title 42 Part 493 → Subpart C → §493.51

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

Title 42Chapter IVSubchapter GPart 493Subpart C → §493.51


Title 42: Public Health
PART 493—LABORATORY REQUIREMENTS
Subpart C—Registration Certificate, Certificate for Provider-performed Microscopy Procedures, and Certificate of Compliance


§493.51   Notification requirements for laboratories issued a certificate of compliance.

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]