Laboratories issued a certificate of compliance must meet the following conditions:
(a) Notify HHS or its designee within 30 days of any change in -
(4) Director; or
(5) Technical supervisor (laboratories performing high complexity only).
(b) 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.
(c) 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.