Alabama Administrative Code › Title 420 - ALABAMA STATE BOARD OF HEALTH › Chapter 420-5-8 - INDEPENDENT CLINICAL LABORATORIES › Section 420-5-8-.04 - Management

Current through Register Vol. 42, No. 9, June 28, 2024
(1) Personnel.
(a) The laboratory shall be under the
			 direction of a director and shall provide the number of other qualified
			 personnel commensurate with the volume and type of tests performed.
(b) The laboratory shall perform only those
			 laboratory procedures and tests that are within the specialties or
			 subspecialties in which the laboratory director, supervisors, or persons
			 engaged to perform tests are qualified.
(c) The laboratory may perform laboratory
			 procedures and tests in all specialties provided that the director or
			 supervisor is a pathologist certified or eligible for certification in both
			 anatomical and clinical pathology by the American Board of Pathology or
			 American Osteopathic Board of Pathology.
(d) In circumstances where AAC Rule
			 420-5-8.04(1) (c) is not met, the following criteria shall be used to establish
			 qualifications of laboratory personnel to perform each specialty:
1. Microbiology, including serology - The
			 laboratory engages the services of an individual who holds an earned doctoral
			 degree or master's degree in microbiology from an accredited institution or is
			 a licensed practitioner of the healing arts with two years of experience in
			 microbiology.
2. Hematology - The
			 laboratory engages the services of an individual who holds a master's or
			 bachelor's degree in biology, immunology or microbiology from an accredited
			 institution and has had at least four years experience in hematology or is a
			 licensed practitioner of the healing arts with pertinent experience.
3. Immunohematology - The laboratory engages
			 the services of a licensed physician with specific experience in this field or
			 an individual with a master's or bachelor's degree in biology, immunology or
			 microbiology from an accredited institution and has four years of experience in
			 immunohematology.
4. Chemistry -
			 The laboratory engages the services of an individual who holds an earned
			 doctoral degree or master's degree in chemistry or biochemistry from an
			 accredited institution or is a licensed practitioner of the healing arts with
			 two years experience in clinical chemistry.
5. Histopathology - The laboratory engages
			 the services of a licensed practitioner in the healing arts who is certified in
			 anatomic pathology or is eligible for certification by the American Board of
			 Pathology or the American Board of Osteopathic Pathology or possesses
			 qualifications which are equivalent to those required for certification by
			 these Boards.
6. Cytotechnology -
			 The laboratory engages the services of a licensed practitioner of the healing
			 arts who is certified in anatomic pathology or is eligible for certification by
			 the American Board of Pathology or the American Osteopathic Board of Pathology
			 or is certified by the American Society of Cytology to practice cytopathology
			 or who possesses qualifications which are equivalent to those required for
			 certification by these Boards.