Section 19.2 - Clinical laboratory or blood bank; qualifications of laboratory director

19.2 Clinical laboratory or blood bank; qualifications of laboratory director. A director and any assistant director of a clinical laboratory or blood bank shall possess training and/or experience acceptable to the department, obtained within the previous six years, in one or more categories.  Additionally, the applicant must meet one of the following requirements:

(a) be a physician who is currently certified by:

(1) the American Board of Pathology in:

(i) clinical pathology; or

(ii) anatomic pathology; or

(iii) dermatopathology; or

(2) the American Osteopathic Board of Pathology in:

(i) laboratory medicine; or

(ii) anatomic pathology; or

(iii) dermatopathology; or

(b) be a physician in the State of New York who: 

(1) is currently certified by the American Board of Pathology in Blood Banking and Transfusion Medicine; or

(2) is currently certified by the American Board of Pathology in Clinical Pathology or the American Board of Internal Medicine in Hematology, and possesses six months of training and/or experience in transfusion services; or

(3) possesses four years of training and/or experience in an acceptable laboratory including two or more years of training and/or experience in transfusion services and in general laboratory management.

(c) be a dentist who is currently certified by the American Board of Oral and Maxillofacial Pathology; or

(d) be a physician, or hold an earned doctoral degree from an accredited institution with a relevant chemical, physical or biological science major, and:

(1) is currently certified by one of the following boards and meets any supplemental requirements for experience as specified by the department:

(i) the American Board of Bioanalysis as a High Complexity Laboratory Director, provided the applicant has obtained a minimum of four years of post-doctoral experience equivalent to paragraph (2) of this subdivision; or

(ii) the American Board of Clinical Chemistry in clinical chemistry; or

(iii) the American Board of Clinical Chemistry in toxicological chemistry; or

(iv) the American Board of Dermatology; or

(v) the American Board of Forensic Toxicology, provided the applicant has an earned doctoral degree; or

(vi) the American Board of Internal Medicine in hematology or hematology and medical oncology; or

(vii) the American Board of Medical Laboratory Immunology; or

(viii) the American Board of Medical Microbiology; or

(ix) dual certification by the American Board of Pathology in either Anatomic Pathology or Clinical Pathology, and Molecular Genetic Pathology; or

(x) the American Board of Pathology in Medical Microbiology; or

(xi) the National Registry for Certified Chemists, provided the applicant has obtained a minimum of four years of post-doctoral experience equivalent to paragraph (2) of this subdivision; or

(2) subsequent to receiving a doctor of medicine, doctor of osteopathic medicine or earned doctoral degree has had, and has documented to the department, four years of training and/or experience in an acceptable laboratory, including two or more years of training and/or experience in methods and techniques currently in use in the certificate category or categories sought and in general laboratory management, or an equivalent combination of training and/or experience as verified by the department.

Effective Date: 
Wednesday, June 12, 2019
Doc Status: 
Complete