N.J. Admin. Code § 8:44-3.14

Current through Register Vol. 56, No. 21, November 4, 2024

Section 8:44-3.14 - Quality control and quality assurance

(a) Quality controls imposed on and practiced by the limited purpose laboratory shall provide for and include written records to assure the following:

1. Preventive maintenance, periodic inspection, and testing for proper operation of equipment as may be appropriate based on the frequency of the testing sessions and on the number of tests performed; evaluation of reagents; surveillance of results; and remedial action to be taken in response to detected defects;

2. Adequacy of facilities, equipment, and methods for performance of the procedures for which licensure is approved; proper lighting for accuracy and precision; convenient location of essential utilities; monitoring of temperature-controlled spaces and equipment to assure proper performance; and evaluation of analytical measuring devices with respect to all critical operating characteristics;

3. Labeling of all reagents and solutions to indicate identity, recommended storage requirements, expiration date, and other pertinent information. Materials of substandard reactivity and deteriorated materials shall not be used. All outdated material shall be discarded immediately;

4. The availability at all times, in the immediate bench area of personnel engaged in examining specimens and performing related procedures, of current laboratory manuals or other complete written descriptions and instructions relating to:

i. The methods used by those personnel, properly designated and dated to reflect the most recent supervisory reviews;

ii. Reagents; and

iii. Control procedures;

5. Written approval by the laboratory director of all changes in laboratory procedures;

6. Maintenance and availability of records to laboratory personnel and to the Department, reflecting dates and, where appropriate, the nature of inspection, validation, remedial action, monitoring, evaluation and changes and dates of changes in laboratory procedures; and

7. Acceptance by the limited purpose laboratory of only specimens that have been properly collected, labeled, processed, in such a manner as to assure identity of the specimen with respect to the requested tests.

(b) Provision shall be made for an acceptable quality assurance program that follows the CDC Quality Assurance Guidelines for rapid FDA licensed point-of-care tests for HIV or, if developed by the laboratory director, is equal to or more stringent than the CDC Quality Assurance Guidelines which are available at http://www.cdc.gov/hiv/rapid testing/materials/QA-Guide.htm. The quality assurance program shall verify and evaluate the accuracy and precision of the testing process and be able to detect errors in the testing process.

N.J. Admin. Code § 8:44-3.14