StacksVerified U.S. regulatory reference

42 CFR §493.63

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
Laboratories issued a certificate of accreditation must:
  1. (a)Notify HHS and the approved accreditation program within 30 days of any changes in—
    1. (1)Ownership;
    2. (2)Name;
    3. (3)Location; or
    4. (4)Director.
  2. (b)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.
  3. (c)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.