§ 7 — Clinical laboratory director

Section 7. Every person licensed to maintain a clinical laboratory under this chapter shall appoint an individual, who shall bear the title "clinical laboratory director'', with responsibility for the direction of the technical and scientific operation of such laboratory, including the examination of specimens and the making of reports thereon; provided, that no individual so appointed shall serve as clinical laboratory director for more than three months unless the department within such period shall certify that such person (1) is a physician who is certified in anatomical or clinical pathology by the American Board of Pathology or in at least one laboratory speciality by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, or other national accrediting board acceptable to the department, or who possesses qualifications which the department considers equivalent to any such certification; or (2) holds an earned doctoral degree, with a chemical, physical, or biological science as his major subject, from an accredited educational institution, and he is certified in at least one laboratory speciality by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, or other national accrediting board acceptable to the department, or he possesses qualifications which the department considers equivalent to any such certification; or (3) has been responsible for direction of the technical and scientific operation of a clinical laboratory for at least twelve consecutive months at any time during the calendar years of nineteen hundred and seventy-one through nineteen hundred and seventy-five, and he meets one of the following requirements: (i) he holds an earned master's degree, with a chemical, physical, or biological science as his major subject, from an accredited educational institution and has had at least four years experience since graduation in a clinical laboratory, or (ii) he holds an earned bachelor's degree, with a chemical, physical, or biological science as his major subject, from an accredited educational institution and has had at least six years experience since graduation in a clinical laboratory, or (iii) he has passed an examination conducted by or under the sponsorship of the United States Public Health Service, and approved by the department as evidence of competence to direct the technical and scientific operation of a clinical laboratory; provided, however, that when a clinical laboratory is maintained by more than two physicians exclusively in connection with the diagnosis and treatment of patients, and the director is one of the physicians who maintains the laboratory, and the laboratory performs only procedures approved by the commissioner, the department, by regulation, may limit such educational requirements by providing that, as a minimum, said director holds a bachelor's degree with a chemical, physical or biological science as his major subject and has had since graduation at least one year of related experience in a clinical laboratory.[ Second paragraph effective until April 8, 2025. For text effective April 8, 2025, see below.]The department may, in regulations, set conditions as to the employment of individuals as clinical laboratory directors, including a minimum number of hours per week required in such position; provided, that in no event shall any individual accept employment as a clinical laboratory director at more than three clinical laboratories during the same period. The department may revoke its confirmation of an appointment for cause shown but not otherwise.[ Second paragraph as amended by 2024, 343, Sec. 70 effective April 8, 2025. For text effective until April 8, 2025, see above.]The department may, in regulations, set conditions as to the employment of individuals as clinical laboratory directors, including a minimum number of hours per week required in such position; provided, that in no event shall any individual accept employment as a clinical laboratory director at more than 5 clinical laboratories during the same period. The department may revoke its confirmation of an appointment for cause shown but not otherwise.