Notification requirements for laboratories issued a certificate of accreditation.

Laboratories issued a certificate of accreditation must: (a) Notify HHS and the approved accreditation program within 30 days of any changes in— (1) Ownership; (2) Name; (3) Location; or (4) Director. (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. (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.