Laboratories performing one or more tests listed in §493.15 and no others must notify HHS or its designee—

(a) Before performing and reporting results for any test or examination that is not specified under §493.15 for which the laboratory does not have the appropriate certificate as required in subpart C or subpart D of this part, as applicable; and

(b) Within 30 days of any change(s) in—

(1) Ownership;

(2) Name;

(3) Location; or

(4) Director.

[57 FR 7142, Feb. 28, 1992, as amended at 60 FR 20045, Apr. 24, 1995]