N.J. Admin. Code § 8:44-3.4

Current through Register Vol. 56, No. 11, June 3, 2024

Section 8:44-3.4 - Supervision

(a) A limited purpose laboratory shall be supervised by a person, designated as the general supervisor, who can be, but is not limited to being, a physician, professional registered nurse, counseling and testing site coordinator, or health educator, approved by the laboratory director, who, under the general direction of the laboratory director, supervises testing personnel and the report of findings, and in the absence of the laboratory director, is responsible for the proper performance of all laboratory procedures.

1. Limited purpose laboratory records including, but not limited to, patient accession, testing, test results, quality control and temperature monitoring, shall be reviewed at least monthly by the laboratory director, general supervisor, or qualified designee of the laboratory director.

(b) The rapid FDA licensed point-of-care test for Human Immunodeficiency Virus (HIV) shall be performed by personnel, such as professional registered nurses, technicians or non-professionals, who have been trained in accordance with the provisions of the Centers for Disease Control and Prevention (CDC) Quality Assurance Guidelines for Testing using the OraQuick Rapid HIV-1 Antibody Test, hereinafter known as the CDC Quality Assurance Guidelines, which are incorporated herein by reference, as amended and supplemented, and available at http://www.cdc.gov/hiv/rapid testing/materials/QA-Guide.htm. The laboratory director shall develop testing and operational protocols, which meet or exceed those issued by the CDC.

(c) The laboratory director shall revise quality assurance, testing, and operational protocols and provide training of testing personnel and supervisors, for any new additional point of care rapid HIV test authorized by the Department for use in limited purpose laboratories subsequent to the adoption of these regulations.

N.J. Admin. Code § 8:44-3.4