Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories
Section 180.060 - Standard - Laboratory Director: Qualifications

Universal Citation: 105 MA Code of Regs 105.180

Current through Register 1531, September 27, 2024

The minimum qualifications for a Clinical Laboratory Director shall be as follows:

(A) A physician who is certified in anatomical or clinical pathology by the American Board of Pathology or in at least one laboratory specialty by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Dermatology, or other national accrediting board acceptable to the department, or who possesses qualifications which the department considers equivalent to any such certification except that physicians certified by the American Board of Dermatology are restricted to director of a dermatology laboratory; or

(B) An individual who 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 atleast one laboratory specialty 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

(C) An individual who has been responsible for direction of the technical and scientific operation of a clinical laboratory for at least 12 consecutive months at any time during the calendar years of 1971 through 1975, and who meets one of the following requirements:

(1) 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; or

(2) 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

(3) 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; or

(4) A physician who meets the following requirements:
(a) is a member of the group practice which is maintaining the laboratory exclusively in connection with the diagnosis and treatment of its own patients and the laboratory is performing only those test procedures which are included on the approved limited license test list;

(b) holds an earned bachelor's degree with a chemical, physical, or biological science as his/her major subject; and

(c) has at least one year of pertinent experience subsequent to graduation in a clinical laboratory with the range of testing at least as broad as the testing in the current laboratory.

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