105 CMR 180.060
Standard - Laboratory Director: Qualifications
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
accreditingboard 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 atleastone
laboratory specialty by the American Board of MedicalMicrobiology, 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 educationalinstitutionand 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 ofits ownpatients 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.