Current through October 31, 2024
Section 493.63 - Notification requirements for laboratories issued a certificate of accreditationLaboratories issued a certificate of accreditation must:
(a) Notify HHS and the approved accreditation program within 30 days of any changes in- (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.