(a) A clinical laboratory shall be under the direct and personal supervision of a laboratory director.
(b) To qualify as a laboratory director, a person shall meet the applicable qualifications as specified in rules issued pursuant to § 44-213 and shall:
(1) Hold a doctor of science degree or its equivalent in one of the basic sciences of chemistry, biology, or microbiology, including professional degrees in public health, medicine, osteopathy, pharmacy, dentistry, or veterinary medicine from a college or university recognized by the National Committee of Regional Accrediting Agencies; and
(2)(A) Have a minimum of 4 years of experience in a clinical laboratory acceptable to the Mayor; or
(B) Be certified by the American Board of Pathologists, the American Board of Osteopathic Pathology, the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or other accrediting board acceptable to the Mayor in one of the laboratory specialties.
(c) The laboratory director shall be responsible for the proper performance of all tests in a clinical laboratory. The laboratory director shall direct and supervise the testing of specimens and be responsible for the continuous application of quality control procedures to the clinical laboratory work in accordance with the rules issued pursuant to this chapter. The laboratory director shall be responsible for the work of subordinates. Clinical laboratory records of all work performed shall indicate the name of the laboratory director and be signed by or otherwise indicate the person who actually performed the test.
(d) The laboratory director shall be accessible to the laboratory to provide onsite, telephone, or electronic consultation, as needed. If the laboratory director cannot be accessible on a short-term basis for a period of time to be determined by the Mayor, the laboratory director shall designate, in writing, a substitute laboratory director who is qualified to be director in accordance with rules issued pursuant to § 44-213.
(e) No person may serve as a director of more than 5 clinical laboratories.
(Mar. 16, 1989, D.C. Law 7-182, § 4, 35 DCR 7718; Oct. 20, 2005, D.C. Law 16-33, § 5012(c), 52 DCR 7503; Mar. 2, 2007, D.C. Law 16-191, § 5(s)(1), 53 DCR 6794.)
Prior Codifications1981 Ed., § 32-1503.
Effect of AmendmentsD.C. Law 16-33, in subsec. (b), substituted “a person shall meet the applicable qualifications as specified in rules issued pursuant to § 44-213 and shall:” for “a person shall meet:”; in subsec. (e), substituted “5” for “2”; and rewrote subsec. (d), which had read as follows: “(d) The laboratory director shall be present for a reasonable period of each working day in each clinical laboratory for which he or she is director. If the laboratory director cannot be present on a short-term basis for a period of time to be determined by the Mayor, the laboratory director shall designate, in writing, a substitute laboratory director who meets the qualifications of subsection (b) of this section.”
D.C. Law 16-191 validated a previously made technical correction in (b).
Emergency LegislationFor temporary (90 day) amendment of section, see § 5012(c) of Fiscal Year 2006 Budget Support Emergency Act of 2005 (D.C. Act 16-168, July 26, 2005, 52 DCR 7667).