Sec. 10.10.07.04. Permitted Laboratory Other than a POL or POCL — Director

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.

B. Standards.

(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) Responsibilities. A director shall carry out the applicable responsibilities set forth in 42 CFR §§493.1407 and 493.1445.

(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:

(a) Will be away from the laboratory for a period of more than 30 days; or

(b) Is unable to carry out the responsibilities set forth in §B(2) of this regulation.

(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) On-site Visits. A director of a laboratory shall conduct an on-site visit of the laboratory at least once a month.

(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.