902 KAR 11:040 - Specialty test procedure
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.
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.
Notes
STATUTORY AUTHORITY: KRS 194.050
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