Kentucky Administrative Regulations › Title 902 - CABINET FOR HEALTH AND FAMILY SERVICES - DEPARTMENT FOR PUBLIC HEALTH › Chapter 11 - Medical Laboratories › Section 902 KAR 11:050 - Equipment, methods, and samples

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO: KRS Chapter 333
NECESSITY, FUNCTION, AND CONFORMITY: KRS Chapter 333 directs
				that all medical laboratories in Kentucky shall establish a quality control
				program acceptable to the Cabinet for Human Resources, and authorizes the
				cabinet to adopt reasonable rules and regulations to effectuate the purposes of
				KRS Chapter 333, including standards of performance in the examination of
				specimens. This administrative regulation is to ensure accuracy of test results
				by control of medical laboratory equipment, methods, and samples.
Section 1. Quality Control; General
			 Practices. Each medical laboratory shall establish a quality control program
			 covering all types of analyses performed by the laboratory for verification and
			 assessment of accuracy, measurement of precision, and detection of error. The
			 program shall provide for the following:
(1)
			 Preventive maintenance, periodic inspection, and testing for proper operation
			 of equipment and instruments as may be appropriate; validation of methods;
			 evaluation of reagents; surveillance of results; and remedial action to be
			 taken in response to detected defects.
(2) Adequacy of facilities, equipment,
			 instruments, and methods for performance of the procedures or categories of
			 procedures for which a license application is filed or granted; proper lighting
			 for accuracy and precision; monitoring of temperature-controlled spaces and
			 equipment, including water baths, incubators, sterilizers, and refrigerators,
			 to ensure proper performance; evaluation of analytical measuring devices, such
			 as photometers and radioactivity counting equipment, with respect to all
			 critical operating characteristics.
(3) Labeling of all reagents and solutions to
			 indicate identity and, if significant, titer, strength or concentration,
			 recommended storage requirements, preparation or expiration date, and other
			 pertinent information; assure that material of substandard reactivity or
			 deteriorated materials are not used.
(4) The availability at all times, in the
			 immediate bench area in which staff is engaged in examining specimens and
			 performing related procedure within a category (e.g., clinical chemistry,
			 hematol-ogy, and pathology) of current laboratory manuals or other complete
			 written descriptions and instructions relating to:
(a) The analytical methods to be used by the
			 staff, properly designated and dated to reflect the most recent supervisory
			 reviews;
(b) Reagents;
(c) Control and calibration procedures;
			 and
(d) Pertinent literature
			 references. Textbooks may be used as supplements to the written descriptions
			 but may not be used in lieu thereof.
(5) Written approval by the director or
			 supervisor of all changes in laboratory procedures.
(6) Maintenance and availability to
			 laboratory personnel and to the cabinet of records, reflecting dates and, if
			 appropriate, the nature of inspection, validation, remedial action, monitoring,
			 evaluation, and changes and dates of changes in laboratory
			 procedures.
(7) Solicitation
			 designed to provide for the collection, preservation, and transportation of
			 specimens sufficiently stable to provide accurate and precise test results
			 suitable for clinical interpretation.