Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 10 - LABORATORIES
Chapter 10.10.07 - Medical Laboratories-Personnel
Section 10.10.07.04 - Permitted Laboratory Other than a POL or POCL - Director
Universal Citation: MD Code Reg 10.10.07.04
Current through Register Vol. 51, No. 19, September 20, 2024
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.
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