902 KAR 11:030.

Personnel standards.

 

      RELATES TO: KRS

Chapter 333

      STATUTORY

AUTHORITY: KRS 194.050

      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 full-time 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 subspecialty 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 cytotechnology 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. (3 Ky.R. 198; eff.

5-4-77; Am. 20 Ky.R. 2181; 2637; eff. 3-14-94.)