902 KAR 11:040.
Specialty test procedure.
RELATES TO: KRS
Chapter 333
STATUTORY
AUTHORITY: KRS 194.050
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.
Section 2.
Special Exceptions. (1) Unless otherwise exempted in Section 1(2)(a), (b), (c),
(e), or (f) of this administrative regulation, if an individual qualifies as a
medical laboratory director by reason of having served as director of a medical
laboratory for twelve (12) months between January 1, 1968, and May 4, 1977,
having attained a bachelor's degree from an accredited institution with a
chemical, physical, or biological science as a major subject, and, subsequent
to graduation, had six (6) years of pertinent full-time medical laboratory
experience, the laboratory may perform tests in the specialty of:
(a) Microbiology
if the director holds a bachelor's degree in a biological science and,
subsequent to graduation, had four (4) years of experience in microbiology.
(b) Hematology
if the director holds a bachelor's degree in biology, immunology, or microbiology
from an accredited institution and, subsequent to graduation, had four (4)
years of experience in hematology.
(c) Serology if
the director holds a bachelor's degree in biology, chemistry, immunology, or
microbiology and, subsequent to graduation, had four (4) years of experience in
serology.
(d)
Radiobioassay if the director, subsequent to graduation, had one (1) year of
experience in radiobioassay.
(e) Clinical
chemistry if the director holds a bachelor's degree in a chemical science or
its equivalent and, subsequent to graduation, had four (4) years of experience
in clinical chemistry.
(2) The
laboratory may perform tests in the subspecialties of blood grouping and Rh
typing, antibody detection, identification, and titering if the director holds
a bachelor's degree in biology, immunology or microbiology from an accredited
institution and, subsequent to graduation, had four (4) years of experience in
immunohematology.
(3) The
laboratory may perform tests in any of the specialties or subspecialties
mentioned in subsections (1) and (2) of this section if the director holds a
bachelor's degree in medical technology and, subsequent to graduation, had the
designated years of specialized experience.
Section 3.
Special Qualification by Examination. Unless otherwise exempted in Sections 1
and 2 of this administrative regulation, if an individual qualifies as a
medical laboratory director by reason of having served as director of a medical
laboratory for twelve (12) months between January 1, 1968, and May 4, 1977, and
has achieved a satisfactory grade through an examination approved by the
cabinet, the laboratory may perform tests in the laboratory specialties the
director achieved a satisfactory grade in an examination approved by the
cabinet. (3 Ky.R. 202; eff. 5-4-77; Am. 20 Ky.R. 2186; 2640; eff. 3-14-94.)
