902 KAR 11:040. Specialty test procedure

Link to law: http://www.lrc.ky.gov/kar/902/011/040.htm
Published: 2015

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      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.)