Kentucky Administrative Regulations
Title 902 - CABINET FOR HEALTH AND FAMILY SERVICES - DEPARTMENT FOR PUBLIC HEALTH
Chapter 11 - Medical Laboratories
Section 902 KAR 11:030 - Personnel standards
Universal Citation: 902 KY Admin Regs Service 11:030
Current through Register Vol. 51, No. 3, September 1, 2024
RELATES TO: KRS Chapter 333
NECESSITY, FUNCTION, AND CONFORMITY: KRS Chapter 333 authorizes the Cabinet for Human Resources to license and regulate medical laboratories in Kentucky, including the setting of qualifications for medical laboratory personnel. This administrative regulation establishes personnel standards for medical laboratory directors, supervisors, technologists, and technicians.
Section 1. Medical Laboratory Director.
(1) A medical laboratory
director shall, in addition to the responsibilities specified in KRS Chapter
333, be responsible for the following:
(a)
Technical and scientific operation of the laboratory;
(b) Performance of tests made in the
laboratory;
(c) Reporting of
findings of laboratory tests; and
(d) Employment of qualified laboratory
personnel and their in-service training.
(2) The director may serve the laboratory on
a full-time or regular part-time basis.
(a) A
director may not serve more than three (3) medical laboratories on a regular
part-time basis, unless the director provides for an associate, qualified
according to the standards in subsection (4) of this section, in each
additional laboratory to serve as assistant director in each
laboratory.
(b) An assistant
director shall not serve more than three (3) laboratories.
(3) Commensurate with the laboratory
workload, the director shall spend adequate time in the laboratory to
effectively direct and supervise its technical operation. The director shall be
available for personal or telephone consultation. If the director is to be
continuously absent from the laboratory for more than one (1) month, the
director shall make arrangements for a qualified substitute director.
(4) To qualify as a medical laboratory
director, a person shall meet one (1) of the following requirements:
(a) Is a physician certified in anatomical or
clinical pathology by the American Board of Pathology or the American
Osteopathic Board of Pathology, or possessing qualifications equivalent to
those required for the certification.
(b) Is a physician certified by the American
Board of Pathology or the American Osteopathic Board of Pathology in at least
one (1) of the laboratory specialties.
(c) Is a physician certified by the American
Board of Medical Microbiology, the American Board of Clinical Chemistry, the
American Board of Bioanalysis, or any other national accrediting board in one
(1) of the laboratory specialties.
(d) Is a physician certified by the American
Society of Cytology to practice cytopathology or possessing qualifications
which are equivalent to those required for certification.
(e) Is a physician who, subsequent to
graduation, has two (2) years of experience in a medical laboratory approved by
the cabinet.
(f) Holds an earned
doctoral degree from an accredited institution with a chemical, physical, or
biological science as a major subject; and
1.
Is certified by the American Board of Medical Microbiology, the American Board
of Clinical Chemistry, the American Board of Bioanalysis, or any other national
accrediting board acceptable to the cabinet in one (1) of the laboratory
specialties; or
2. Subsequent to
graduation has two (2) years' full-time experience in one (1) of the laboratory
specialties.
(5) A dentist certified by the American Board
of Oral Pathology or possessing qualifications equivalent to those required for
certification may serve as director of a medical laboratory specializing in the
area of oral pathology only.
(6) An
individual responsible for the direction of a medical laboratory for twelve
(12) months between January 1, 1968, and May 4, 1977, may continue to serve as
a medical laboratory director if one (1) of the following requirements is met:
(a) Holds a master's degree from an
accredited institution with a chemical, physical, or biological science as a
major subject and, subsequent to graduation, has four (4) years of pertinent
full-time laboratory experience.
(b) Holds a bachelor's degree from an
accredited institution with a chemical, physical, or biological science as a
major subject, and subsequent to graduation, has six (6) years of pertinent
full-time medical laboratory experience.
(c) Has achieved a satisfactory grade through
an examination approved by the cabinet.
Section 2. Medical Laboratory Supervisors.
(1) Each medical laboratory shall have a
general supervisor and a technical supervisor. A general supervisor may be a
technical supervisor in those specialties in which requirements of competency
are met as provided in 902 KAR Chapter 11.
(2) The general supervisor shall be present
on the laboratory premises during all hours in which tests are being
performed.
(3) The technical
supervisor shall spend adequate time in the laboratory to supervise the
technical performance of the staff in the specialty and shall be available for
personal or telephone consultation.
(4) Emergency procedures implemented outside
regularly scheduled hours of duty may proceed without the general supervisor
being on the premises if the technologist performing the tests is qualified to
do so. The supervisor who is responsible for the result of the work shall
review the tests during the next duty period, and a record shall be maintained
reflecting the actual review.
(5)
To qualify as a general supervisor, a person shall meet one (1) of the
following requirements:
(a) Is a physician, or
has earned a doctoral degree from an accredited institution with a major in one
(1) of the chemical, physical, or biological sciences and, subsequent to
graduation, has two (2) years of experience in one (1) of the laboratory
specialties in a medical laboratory approved by the cabinet.
(b) Holds a master's degree from an
accredited institution with a major in one (1) of the chemical, physical, or
biological sciences and, subsequent to graduation, has three (3) years of
pertinent fulltime laboratory experience of which two (2) years have been spent
working in the designated laboratory specialty in a medical laboratory approved
by the cabinet.
(c) Is qualified as
a medical laboratory technologist pursuant to Section 3 of this administrative
regulation and, subsequent to the date of qualifying as a medical laboratory
technologist, has four (4) years of pertinent full-time laboratory experience
of which two (2) years have been spent working on the designated laboratory
specialty in a medical laboratory approved by the cabinet.
(6) To qualify as a technical supervisor, the
person shall meet competency requirements provided in 902 KAR Chapter
11.
(7) To serve as general
supervisor of medical laboratory personnel specializing in the area of
diagnostic cytology, a person shall qualify as a cytotechnologist pursuant to
Section 3 of this administrative regulation and, subsequent to the
qualification, have four (4) years of full-time experience as a
cytotechnologist in a laboratory directed or supervised by a pathologist or
other physician recognized as a specialist in diagnostic cytology within the
preceding ten (10) years.
(8) A
person not meeting the training and experience requirements of subsection
(5)(a),(b), and (c) of this section may qualify as a medical laboratory general
supervisor if the person:
(a) Was performing
the duties of a medical laboratory general supervisor anytime between January
1, 1968, and May 4, 1977; and
(b)
Has fifteen (15) years of pertinent full-time medical laboratory experience. A
minimum of thirty (30) semester hours of credit from an approved school of
medical technology or toward a bachelor's degree from an accredited institution
with a chemical, physical, or biological science as a major subject shall be
considered equivalent to two (2) years of experience. Additional education
shall be equated to the rate of fifteen (15) hours of credit for one (1) year
of experience.
(9) An
individual serving as a medical laboratory supervisor in Kentucky for a period
of one (1) year prior to May 4, 1977, may continue to supervise the laboratory
unless otherwise exempted in subsections (5), (6), (7), and (8) of this
section. The cabinet may require, in the interest of the health, safety, and
welfare of the people of this state and as a condition to issuance of an
original or renewal license, the individual to satisfactorily demonstrate the
ability to perform medical laboratory examinations and supervise a medical
laboratory.
Section 3. Medical Laboratory Technologists and Cytotechnologists.
(1) Medical laboratory technologists and
cytotechnologists shall be in sufficient number to adequately supervise the
work of technicians or trainees.
(2) An individual qualifying as a medical
laboratory technologist shall:
(a) Perform
tests requiring the exercise of independent judgment and responsibility with
minimal supervision by the director or supervisors only in those specialties or
subspecialties in which the technologists are qualified by education, training,
and experience.
(b) Perform tests
only under the direct supervision of the laboratory supervisor or qualified
technologist in those specialties in which the medical laboratory technologist
is not qualified by education, training, or experience.
(3) To qualify as a medical laboratory
technologist, a person shall meet one (1) of the following requirements:
(a) Earn a bachelor's degree in medical
technology from an accredited university or college.
(b) Successfully complete three (3) years of
academic study (a minimum of ninety (90) semester hours or equivalent) in an
accredited college or university which meet the specific requirements for
entrance into a school of medical technology accredited by an accrediting
agency approved by the cabinet and successfully complete completed a course of
training of twelve (12) months in a school of medical technology.
(c) Earn a bachelor's degree in one (1) of
the chemical, physical, or biological sciences, with an additional one (1) year
of pertinent full-time laboratory experience or training in the specialty or
sub-specialty in which the individual performs.
(d) Successfully complete three (3) years (a
minimum of ninety (90) semester hours or equivalent) in an accredited college
or university with the following distribution of courses:
1. For those whose training was completed
prior to September 15, 1963, the course work shall include twenty-four (24)
semester hours in chemistry and biology courses of which six (6) semester hours
are in inorganic chemistry, and three (3) semester hours are in other chemistry
courses, and twelve (12) semester hours are in biology courses pertinent to the
medical sciences; or
2. For those
whose training was completed after September 14, 1963, the course work shall
include sixteen (16) semester hours in chemistry courses which include six (6)
semester hours in inorganic chemistry acceptable toward a major in chemistry,
sixteen (16) semester hours in biology courses which are pertinent to the
medical sciences and are acceptable toward a major in biology, and three (3)
semester hours of mathematics; and
3. Has experience or training covering
several fields of medical laboratory work of one (1) year and of a quality to
provide education and training in medical technology equivalent to that
described in paragraphs (a) and (b) of this subsection.
(e) A person not meeting the training and
experience requirements defined in paragraphs (a), (b), (c), or (d) of this
subsection may qualify as a medical laboratory technologist if the person:
1. Was performing the duties of a medical
laboratory technologist any time between January 1, 1968, and May 4, 1977;
and
2. Had ten (10) years of
pertinent medical laboratory experience prior to May 4, 1977. A minimum of
thirty (30) semester hours of credit from an approved school of medical
technology or toward a bachelor's degree from an accredited institution with a
chemical, physical, or biological science as a major subject shall be
considered equivalent to two (2) years of experience. Additional education
shall be equated to the rate of fifteen (15) hours of credit for one (1) year
of experience.
(f) Has
achieved a satisfactory grade in a proficiency examination approved by the
cabinet. After December 31, 1978, initial qualification as a technologist shall
be in accordance with the requirements of paragraphs (a), (b), (c), or (d) of
this subsection.
(4) To
qualify as a medical laboratory cytotechnologist, a person shall meet one (1)
of the following requirements:
(a)
Successfully complete two (2) years in an accredited college or university with
twelve (12) semester hours in science, eight (8) hours of which are in biology;
and
1. Complete twelve (12) months of training
in a school of cytotechnology accredited by an accrediting agency approved by
the cabinet; or
2. Has received six
(6) months of formal training in a school of cytotechnology accredited by an
accrediting agency approved by the cabinet and six (6) months of full-time
experience in cytotech-nology in a laboratory acceptable to the pathologist who
directed the formal six (6) months of training.
(b) Has, prior to May 4, 1977:
1. Graduated from high school;
2. Completed six (6) months of training in
cytotechnology in a laboratory directed by a pathologist or other physician
recognized as a specialist in cytotechnology; and
3. Completed two (2) years of full-time
supervised experience in cytotechnology.
(c) Has achieved a satisfactory grade in a
proficiency examination approved by the cabinet. After December 31, 1978,
initial qualification as a cytotechnologist shall be in accordance with the
requirements of paragraphs (a) or (b) of this subsection.
(5) An individual qualifying as a
cytotechnologist solely under subsection (4) of this section may supervise
technicians and trainees only in the specialty of cytology.
(6) An individual serving as a laboratory
technologist or cytotechnologist in Kentucky for a period of one (1) year prior
to May 4, 1977, may continue to serve the laboratory in a capacity unless
otherwise exempted in subsections (3) and (4) of this section. The cabinet may
require, in the interest of the health, safety, and welfare of the people of
this state and as a condition to issuance of an original or renewal license,
the individual to satisfactorily demonstrate the ability to perform medical
laboratory functions under supervision.
Section 4. Medical Laboratory Technicians and Trainees.
(1) Medical laboratory technicians
shall:
(a) Perform only medical laboratory
procedures which require a degree of skill commensurate with their education,
training, and technical abilities, and which involve limited exercise of
independent judgment.
(b) Perform
procedures only in the presence of a qualified medical laboratory technologist,
supervisor, or director.
(2) A medical laboratory technician trainee
shall perform only repetitive procedures which require a minimal exercise of
independent judgment. These procedures shall be performed only under the
personal and direct supervision of a qualified supervisor or
technologist.
(3) To qualify as a
medical laboratory technician, a person shall meet one (1) of the following
requirements:
(a) Successfully complete sixty
(60) semester hours of academic credit, including chemistry and biology, and a
structured curriculum in medical laboratory techniques at an accredited
institution, or possess an associate degree based on a course of study
including those subjects from an accredited institution.
(b) Be a high school graduate or equivalent
and have completed one (1) year in a technician training program in a school
accredited by an accrediting agency approved by the cabinet.
(c) Be a high school graduate or equivalent
and have two (2) years of pertinent full-time laboratory experience as a
technician trainee in a medical laboratory approved by the cabinet.
(d) Be a high school graduate or equivalent,
have successfully completed an official military medical laboratory procedures
course of fifty (50) weeks and have held the military enlisted occupational
specialty of Medical Laboratory Specialist (Laboratory Technician).
(e) A person not meeting the training and
experience requirements defined in paragraphs (a), (b), (c), or (d) of this
subsection may qualify as a medical laboratory technician if the person:
1. Was performing the duties of a medical
laboratory technician any time between January 1, 1968, and May 4, 1977;
and
2. Had five (5) years of
pertinent medical laboratory experience prior to May 4, 1977.
(f) An individual serving as a
laboratory technician in Kentucky for a period of one (1) year prior to May 4,
1977, may continue to serve the laboratory unless otherwise exempted in
paragraphs (a), (b), (c), (d), and (e) of this subsection. The cabinet may
require, in the interest of the health, safety, and welfare of the people of
the state and as a condition to the issuance of an original or renewal license,
the individual to satisfactorily demonstrate the ability to perform medical
laboratory functions under supervision.
(g) Has achieved a satisfactory grade in a
proficiency examination approved by the cabinet. After December 31, 1978,
initial certification as a technician shall be in accordance with paragraphs
(a), (b), (c), or (d) of this subsection.
Section 5. Personnel Policies. Each laboratory shall create and maintain written personnel policies, practices, and procedures that support sound laboratory practice. Work assignments shall be consistent with qualifications. The laboratory shall maintain written employment records which include:
(1) A resume
of each employee's initial and continued training, experience, duties, and date
or dates of employment.
(2)
Evidence of adequate health supervision of employees, including results of
preemployment physical examinations, including chest X-rays, immunization
records, and records of all illnesses and accidents occurring on
duty.
STATUTORY AUTHORITY: KRS 194.050
Disclaimer: These regulations may not be the most recent version. Kentucky may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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