Regulations of Connecticut State Agencies (Last Updated: June 14,2023) |
Title19a Public Health and Well-being |
SubTitle19a-36-A1_19a-36-d38. Reportable Diseases and Laboratory Findings |
Sec.19a-36-D33. Qualifications of director
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No person shall be the director of a clinical laboratory unless he meets the educational, training and/or experiential requirements identified in this section.
(a) For laboratories performing tests categorized as high complexity, the director shall:
(1) be a physician licensed to practice medicine in Connecticut who is certified in anatomic and/or clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or meets all of the education, training or experience requirements to take the examination but has not actually taken and successfully completed the examination; or
(2) hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and:
(A) be certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, the American Board of Medical Laboratory Immunology or other board deemed comparable by the Commissioner; or
(B) have at least two (2) years of laboratory training or experience, or both, and at least two (2) years of experience directing or supervising high complexity testing; or
(3) have a combination of education, training and experience in the clinical laboratory specialty, which, in the judgment of the commissioner, qualifies the individual to direct a laboratory whose services are limited to that specialty.
(b) For laboratories performing tests categorized as moderate complexity, the director shall:
(1) meet the qualification standards identified in subsection (a) of this section; or
(2) hold an earned doctoral degree in medicine or dentistry or in chemical, physical or biological sciences from an accredited institution and have at least one (1) year of experience directing or supervising non-waived laboratory testing; or
(3) have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution and have at least one (1) year of laboratory training or experience, or both, in non-waived testing and at least one (1) year of supervisory laboratory experience in non-waived testing; or
(4) have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution and have at least two (2) years of laboratory training or experience, or both, in non-waived testing and at least two (2) years of supervisory laboratory experience in non-waived testing.
(Adopted effective June 4, 1996)