New Jersey Administrative Code › Title 8 - HEALTH › Chapter 44 - CHAPTER IV OF THE STATE SANITARY CODE › Subchapter 2 - OPERATION OF CLINICAL LABORATORIES › Section 8:44-2.8 - Quality control

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Quality controls
				imposed and practiced by the laboratory must provide for and include written records
				to assure the following:
1. Preventative
				maintenance, periodic inspection, and testing for proper operation of equipment and
				instruments as may be appropriate; validation of methods; evaluation of reagents and
				volumetric equipment; 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 licensure is approved; proper
				lighting for accuracy and precision; convenient location of essential utilities;
				monitoring of temperature-controlled spaces and equipment, including water baths,
				incubators, sterilizers, and refrigerators, to assure proper performance; evaluation
				of analytical measuring devices, such as photometers and radioactivity counting
				equipment, with respect to all critical operating characteristics. Records must
				reflect actual readings obtained both before and after any adjustments have been
				made.
3. Labeling of all reagents and
				solutions to indicate identity, and when significant, titer, strength, or
				concentration, recommended storage requirements, preparation or expiration date, and
				other pertinent information. Materials of substandard reactivity and deteriorated
				materials may not be used. All outdated material must be discarded
				immediately.
4. The availability at all
				times, in the immediate bench area of personnel engaged in examining specimens and
				performing related procedures within a category (e.g., clinical chemistry,
				hematology), of current laboratory manuals or other complete written descriptions
				and instructions relating to:
i. The analytical
				methods used by those personnel, properly designated and dated to reflect the most
				recent supervisory reviews;
ii.
				Reagents;
iii. Control and calibration
				procedures; and
iv. Pertinent current
				literature references. Textbooks may be used as supplements to such 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 Department of Health records reflecting dates and, where
				appropriate, the nature of inspection, validation, remedial action, monitoring,
				evaluation, and changes and dates of changes in laboratory procedures.
7. A laboratory shall accept only specimens which
				have been properly collected, labeled, processed, stored and transported in such a
				manner as to assure identity and the stability of the specimen with respect to the
				requested tests or analyses; or if a specimen's stability has not been assured the
				laboratory report shall clearly state that the results may be invalid due to an
				unsatisfactory sample.