1. A. Primary Standard. A licensee operating a permitted laboratory other than a POL or POCL shall employ a director who meets the applicable qualifications, responsibilities, and standards set forth in this chapter.

2. B. Standards.

   1. (1) Qualifications. In addition to applicable personnel standards set forth in this chapter, a director shall meet the applicable standards set forth in 42 CFR §493.1443.
   2. (2) Responsibilities. A director shall carry out the applicable responsibilities set forth in 42 CFR §§493.1407 and 493.1445.

   3. (3) Associate Director. A director shall designate another individual who qualifies as a director under this chapter to serve as an associate or substitute director when the director:

      1. (a) Will be away from the laboratory for a period of more than 30 days; or
      2. (b) Is unable to carry out the responsibilities set forth in §B(2) of this regulation.
   4. (4) Communications. A director shall communicate with the laboratory's supervisory personnel in person, in writing, or by telephone at least once a month regarding the performance and operation of the laboratory.
   5. (5) On-site Visits. A director of a laboratory shall conduct an on-site visit of the laboratory at least once a month.
   6. (6) Limitation. The director of a permitted laboratory may not serve as director or associate director, or both, of more than five medical laboratories at the same time.

Authority: Health-General Article, §§17-202, 17-203, 17-206, Annotated Code of Maryland

Effective date: December 13, 1999 (26:25 Md. R. 1897)

Regulation .01B amended effective July 24, 2000 (27:14 Md. R. 1340); June 1, 2009 (36:11 Md. R. 787)

Regulation .03 amended effective June 1, 2009 (36:11 Md. R. 787)

Regulation .05 amended effective July 24, 2000 (27:14 Md. R. 1340)

Regulation .05B amended effective June 1, 2009 (36:11 Md. R. 787)

Regulation .07B amended effective March 1, 2026 (52:24 Md. R. 1198)