RELATES TO: KRS Chapter 333
NECESSITY, FUNCTION, AND CONFORMITY: KRS Chapter 333 directs
that the Cabinet for Human Resources may require medical laboratory directors
to submit reports concerning selected test results and medical laboratory
operations. KRS Chapter 333 authorizes the Secretary for Human Resources to
adopt rules and regulations to effectuate the provisions of KRS Chapter 333,
including standards of construction of medical laboratories, sanitary
conditions within the medical laboratory and its surroundings, and licensure of
medical laboratories. This administrative regulation sets out the contents of
the required reports, standards of health and safety for medical laboratories,
and a provision relating to licensure.
Section
1. Reporting of Information Concerning Operations. The medical
laboratory director shall submit to the cabinet reports of operation as the
cabinet may require.
Section 2.
Medical Laboratory Space, Facilities, and Personnel Health. Conditions in the
medical laboratory shall be adequate to ensure proper performance of services
within the laboratory. The following requirements shall be met:
(1) Workbench space within the laboratory
shall be ample, well-lighted, and situated to facilitate the use of necessary
sinks, water, gas, suction, and electrical outlets.
(2) Work areas shall be arranged to minimize
problems in transportation and communication.
(3) The laboratory shall be properly
ventilated.
(4) Volatile chemicals
and inflammable solvents shall be properly stored in areas where they are
unlikely to ignite.
(5) Temperature
and humidity within the laboratory shall be controlled within the limits
required for proper performance of tests and operation of instruments affected
by these variations.
(6) Fire
precautions and occupational safety rules shall be posted and observed to avoid
physical, chemical, and biological hazards.
(7) Appropriate sterilization and
disinfection techniques shall be used for tests performed on potentially
contaminated material. Pipettes, Petri dishes, and other disposable items shall
be appropriately discarded immediately after use. Each sterilizing cycle shall
contain a recording thermometer or other device indicating the point of proper
sterilization. Records of temperature readings shall be kept at least two (2)
years. Proper operation of the autoclave shall be checked monthly with viable
spores or appropriate indicator.
Section 3. Provisions for Acceptance by
National Licensing or other Accrediting Bodies. With the exception of
902 KAR
11:030 and Section 1 of this administrative
regulation, medical laboratories inspected and certified pursuant to
42 USC
263a, Public Health Service Act, and medical
laboratories which have been inspected and accredited by the commission on
inspection and accreditation of the College of American Pathologists or by any
other national accreditation body approved by the cabinet, shall be deemed to
meet all of the requirements for licensure, if the standards applied by the
commission or body in determining accreditation of the medical laboratory are
equal to, or more stringent than, the provisions of KRS Chapter 333 and the
rules and regulations issued pursuant to KRS Chapter 333; and there is adequate
provision for assuring the standards continue to be met by the
laboratory.
Section 4. Compliance
with State, Federal, and Local Laws. All medical laboratories shall comply with
any other applicable state, federal, and local laws and regulations.
