Sec. 10.10.13.07. Director Requirement, Qualifications, and Responsibilities

A. Director Requirement. A permittee that offers to perform or performs a first-tier, supplemental, or second-tier test shall employ a director.

B. Director Qualifications. The director shall:

(1) Meet the qualifications for a medical laboratory director set forth at COMAR 10.10.07.04; and

(2) Possess a current license as a laboratory director issued by the state in which the laboratory is located if:

(a) The laboratory is not located in Maryland; and

(b) Licensing is required by the state in which the laboratory is located.

C. Director Responsibilities. The director is responsible for:

(1) The overall operation and administration of the laboratory, including the employment of a sufficient number of competent personnel;

(2) Ensuring that each first-tier, supplemental, or second-tier test conducted is performed accurately and reliably in all aspects of the testing process, including the preanalytic, analytic, and post-analytic phases of the total testing process; and

(3) Ensuring compliance with:

(a) This chapter;

(b) The applicable parts of COMAR 10.10.01- 10.10.08; and

(c) COMAR 10.52.12.