N.J. Admin. Code § 8:8-6.5

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

Section 8:8-6.5 - AIDS screening requirements

(a) All blood and blood components collected in New Jersey are subject to the requirements of this section.

(b) Educational material shall be given to the blood donors prior to the collection of blood which will allow donors to determine whether or not they have engaged in high risk behavior.

(c) All donors including those utilized in hemapheresis, shall be screened by history for the early signs and symptoms of AIDS.

(d) The collecting agency shall ensure that all blood and blood components collected in New Jersey, including those obtained by hemapheresis, be tested for HIV-1 and HIV-2 as specified in 8:8-7.2. Laboratory tests not performed by the collecting facility shall be referred to a blood bank or laboratory licensed to perform HIV testing by the Department as specified in 8:8-3.1(c)2. It shall be the responsibility of the receiving blood bank to assure that any blood brought in from out-of-state sources shall be tested for HIV types 1 and 2 in accordance with testing methods specified in AABB Standards and FDA regulations. If the blood is used for allogeneic transfusion, it shall be tested as all other blood and blood components.

(e) Blood and blood components that are positive, as defined by Centers for Disease Control (CDC) in the "Morbidity and Mortality Weekly Report" of August 14, 1987, in "Laboratory Evidence for or Against HIV Infection," as amended and supplemented, incorporated herein by reference, to serologic tests for HIV types 1 and 2 or collected from a donor known to be positive to serologic tests for HIV types 1 and 2 shall either be discarded or used for research purposes only.

(f) Prior to a donation of blood or blood component each donor shall be notified in writing and shall have signed a written statement confirming that:

1. The blood or blood components shall be tested for evidence of the probable causative agent of acquired immune deficiency syndrome.

2. Donors found to have serologic evidence of HIV shall be placed on a confidential internal deferral list and may, if deemed appropriate by the Department, a confidential statewide deferral list.

3. The donor shall be notified of the test results in accordance with requirements described in (i) below.

4. Blood or blood components shall not be donated for transfusion purposes by a person if the person has reason to believe that he or she has engaged in high risk behavior.

(g) All blood banks shall notify the donor of results when there is serologic evidence of the probable causative agent of AIDS as currently outlined by the Department.

(h) Reactive donors shall be notified and counseled in person. Every effort shall be made to accomplish face to face notification and counseling.

(i) Blood banks shall maintain records pertaining to all HIV requirements and test results. These records shall be kept in a confidential manner.

(j) Testing facilities shall participate in a proficiency program acceptable to the Department.

N.J. Admin. Code § 8:8-6.5

New Rule, R.1987 d.111, effective 2/17/1987.
See: 18 N.J.R. 2280(a), 19 N.J.R. 356(b).
Recodified from 8:8-5.5 and amended by R.1989 d.246, effective 5/15/1989.
See: 21 N.J.R. 407(a), 21 N.J.R. 1412(a).
Requirement to test autologous blood deleted. Self-deferral system requirements added.
Requirement to produce HIV statistics added.
Amended by R.1994 d.350, effective 8/1/1994.
See: 26 N.J.R. 1057(a), 26 N.J.R. 3171(a).
Amended by R.2005 d.283, effective 10/3/2005.
See: 36 N.J.R. 4261(a), 37 N.J.R. 3815(a).
In (b), (c), (g)-(i), substituted "shall" for "must"; rewrote (d) and (e); in (h), also substituted "counseling" for "counselling".