Kentucky Administrative Regulations › Title 902 - CABINET FOR HEALTH AND FAMILY SERVICES - DEPARTMENT FOR PUBLIC HEALTH › Chapter 11 - Medical Laboratories › Section 902 KAR 11:040 - Specialty test procedure

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO: KRS Chapter 333
NECESSITY, FUNCTION, AND CONFORMITY: KRS Chapter 333 authorizes
				the Cabinet for Human Resources to issue licenses to medical laboratories in
				Kentucky, and directs that licenses be issued only for the performance of those
				medical laboratory procedures which the particular laboratory, by virtue of the
				educational and experience background of its laboratory personnel, is competent
				to perform. The cabinet is authorized to adopt reasonable rules and regulations
				to effectuate the purposes and provisions of KRS Chapter 333. This
				administrative regulation establishes standards for determining the specialty
				of test procedures for which a laboratory may be licensed.
Section 1. Tests Performed. The medical
			 laboratory shall perform only those laboratory procedures and tests that are
			 within the specialties and subspecialties the laboratory director or supervisor
			 is qualified. The following standards shall apply:
(1) A laboratory may perform anatomical and
			 clinical laboratory procedures and tests in all specialties if the laboratory
			 director or a supervisor is a physician certified in both anatomical and
			 clinical pathology by the American Board of Pathology or the American
			 Osteopathic Board of Pathology or possesses qualifications equivalent to those
			 required for certification.
(2)
			 Unless otherwise exempted in subsection (1) of this section, a laboratory may
			 perform tests in the specialty of:
(a)
			 Microbiology, including the subspecialties of bacteriology, virology, mycology,
			 and parasitology if the director or a supervisor is a physician or holds an
			 earned doctoral or master's degree in microbiology from an accredited
			 institution and, subsequent to graduation, had two (2) years of experience in
			 clinical microbiology.
(b) Serology
			 if the director or a supervisor is a physician or holds an earned doctoral or
			 master's degree in biology, chemistry, immunology, or microbiology from an
			 accredited institution and, subsequent to graduation, had two (2) years of
			 experience in serology.
(c)
			 Hematology, including gross and microscopic examination of the blood, if the
			 director or a supervisor holds a master's or bachelor's degree in biology,
			 immunology, microbiology, chemistry, or medical technology from an accredited
			 institution and, subsequent to graduation, had two (2) years of experience in
			 hematology.
(d) Immunohematology if
			 the director or a supervisor is a physician with two (2) years of experience in
			 immunohematology subsequent to graduation.
(e) Clinical chemistry if the director or a
			 supervisor is a physician or holds an earned doctoral or master's degree in
			 chemistry from an accredited institution and, subsequent to graduation, had two
			 (2) years of experience in clinical chemistry approved by the
			 cabinet.
(f) Radiobioassay if the
			 director or a supervisor is a physician or holds an earned doctoral, master's,
			 or bachelor's degree in chemistry, physics, biology, or medical technology from
			 an accredited institution and, subsequent to graduation, had two (2) years of
			 experience in radiobioassay approved by the cabinet.
(g) Tissue pathology, limited to skin
			 pathology, if the director or a supervisor is a physician certified in
			 dermato-pathology by the American Board of Dermatology or possesses
			 qualifications equivalent to those required for certification.
(h) Diagnostic cytology if the director or a
			 supervisor is a physician who is certified by the American Society of Cytology
			 to practice cytopathology or possesses qualifications equivalent to those
			 required for certification. The laboratory shall be qualified to perform the
			 tests only on that anatomic site for which the director or supervisor is
			 certified.
(i) Oral pathology if
			 the director or supervisor is a dentist or physician who is certified in oral
			 pathology by the American Board of Oral Pathology or possesses qualifications
			 equivalent to those required for certification.
(3) Unless otherwise exempted in subsections
			 (1) and (2)(d) of this section, a laboratory may perform tests in the
			 immunohematology subspecialties of ABO grouping and Rh typing, antibody
			 detection, identification, and titering if the director or a supervisor holds a
			 master's or bachelor's degree in biology, immunology, microbiology, chemistry,
			 or medical technology from an accredited institution and, subsequent to
			 graduation, has two (2) years of experience in immunohematology.
(4) A laboratory may perform tests in the
			 specialty of tissue pathology if the director or a supervisor is a physician
			 who is certified in anatomical pathology by the American Board of Pathology or
			 possesses qualifications equivalent to those required for
			 certification.