§493.63. Notification requirements for laboratories issued a certificate of accreditation.
42 C.F.R. § 493.63
Laboratories issued a certificate of accreditation must:
Notify HHS and the approved accreditation program within 30 days of any changes in—
Ownership;
Name;
Location; or
Director.
Notify the approved accreditation program no later than 6 months after performing any test or examination within a specialty or subspecialty area that is not included in the laboratory's accreditation, so that the accreditation organization can determine compliance and a new certificate of accreditation can be issued.
Notify the accreditation program no later than 6 months after of 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 accreditation.
Notes, amendments, and revision history
Source
Source: 57 FR 7144, 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.