The laboratory director must be qualified to manage and direct the laboratory personnel and the performance of PPM procedures as specified in §493.19(c) and must be eligible to be an operator of a laboratory within the requirements of subpart R of this part.

(a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if the licensing is required.

(b) The laboratory director must meet one of the following requirements:

(1) Be a physician, as defined in §493.2.

(2) Be a midlevel practitioner, as defined in §493.2, authorized by a State to practice independently in the State in which the laboratory is located.

(3) Be a dentist, as defined in §493.2.