N.J. Admin. Code § 8:44-3.1

Current through Register Vol. 56, No. 17, September 3, 2024

Section 8:44-3.1 - Limited purpose laboratory; definition and minimum protocols

(a) "Limited purpose laboratory" means a facility operated by a not-for-profit organization receiving grant funds from the Department of Health and Senior Services, hereinafter known as the Department, to operate a counseling and testing site to conduct rapid FDA licensed point-of-care tests for Human Immunodeficiency Virus (HIV).

(b) A limited purpose laboratory shall establish the following protocols at a minimum:

1. Follow-up protocols to ensure that Food and Drug Administration (FDA) approved confirmatory testing is performed;

2. A protocol for the review of test results by the laboratory director and general supervisor;

3. Protocols to ensure that individuals with abnormal results are referred to an appropriate source of medical care and prevention services; and

4. Personnel policies, practices and procedures that adequately support sound rapid FDA licensed point-of-care testing practices.

N.J. Admin. Code § 8:44-3.1