Laboratories issued a certificate of compliance must meet the following conditions:

1. (a) Notify HHS or its designee within 30 days of any change in—

   1. (1) Ownership;
   2. (2) Name;
   3. (3) Location;
   4. (4) Director; or
   5. (5) Technical supervisor (laboratories performing high complexity only).
2. (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.
3. (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.

[57 FR 7143, Feb. 28, 1992, as amended at 60 FR 20046, Apr. 24, 1995]