N.J. Admin. Code § 8:44-2.3

Current through Register Vol. 56, No. 21, November 4, 2024

Section 8:44-2.3 - Laboratory director

(a) The clinical laboratory shall be under the direction of a qualified person.

(b) The director shall administer the technical and scientific operation of the laboratory including the reporting of findings of laboratory tests.

1. The director shall serve the laboratory full time, or on a regular part-time basis. The director shall not individually serve as director or Co-director of more than three laboratories.

2. Commensurate with the laboratory workload, the director shall spend an adequate amount of time in the laboratory to direct and supervise the technical performance of the staff and shall be readily available for personal or telephone consultation.

3. The director is responsible for the proper performance of all tests made in the laboratory.

4. The director is responsible for the employment of qualified laboratory personnel and their inservice training.

5. If the director is to be absent, the director must arrange for a qualified substitute director.

(c) The laboratory director shall hold a valid, current license as a bioanalytical laboratory director issued pursuant to L.1953, c.420 (45:9-42.1 et seq.), and, in addition, shall meet one of the following requirements:

1. Is a physician certified in anatomical and/or clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possesses qualifications which are equivalent to those required for such certification (board eligible);

2. Is a physician who:

i. Is certified by the American Board of Pathology or the American Osteopathic Board of Pathology in at least one of the laboratory specialties; or

ii. Is certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or other national accrediting board in one of the laboratory specialties; or

iii. Is certified by the American Society of Cytology to practice cytopathology or possesses qualifications which are equivalent to those required for such certification, (under this provision the individual may qualify as a director only in the specialty of Cytology); or

iv. Subsequent to graduation has had 4 or more years of full-time general laboratory training and experience of which at least 2 years were spent acquiring proficiency in one of the laboratory specialties in an approved clinical laboratory;

3. Holds an earned doctoral degree from an accredited institution with a chemical, physical, or biological science as a major subject and:

i. Is certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or other national accrediting board acceptable to the Department of Health in one of the laboratory specialties; or

ii. Subsequent to graduation has had 4 or more years of full-time general clinical laboratory training and experience of which at least 2 years were spent acquiring proficiency in one of the laboratory specialties in an approved clinical laboratory; or

4. The requirements of (c)1, 2 and 3 above do not apply to individuals who qualified as a bioanalytical director and were licensed pursuant to L.1953, c.420 (45:9-42.1 et seq.) as amended prior to adoption of these regulations.

N.J. Admin. Code § 8:44-2.3

As amended, R.1983 d.498, effective 11/7/1983.
See: 15 N.J.R. 995(a), 15 N.J.R. 1862(b).