§493.51. Notification requirements for laboratories issued a certificate of compliance.
42 C.F.R. § 493.51
Laboratories issued a certificate of compliance must meet the following conditions:
Notify HHS or its designee within 30 days of any change in—
Ownership;
Name;
Location;
Director; or
Technical supervisor (laboratories performing high complexity only).
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.
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.
Notes, amendments, and revision history
Amendments
[57 FR 7143, Feb. 28, 1992, as amended at 60 FR 20046, Apr. 24, 1995]
Source
Source: 57 FR 7143, Feb. 28, 1992, unless otherwise noted.
Authority
Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).
Source
Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.
Amendments
[57 FR 7143, Feb. 28, 1992, as amended at 60 FR 20046, Apr. 24, 1995]