N.J. Admin. Code § 8:8-13.13

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

Section 8:8-13.13 - Testing of donors

(a) For products originating in the United States, all required tests on the prospective donors prior or at the time of the donation shall be performed by a New Jersey licensed laboratory/blood bank and/or CMS certified laboratory. This information shall be available to the recipient's physician and the cell processing laboratory.

(b) All allogeneic donors are subject to the testing required by the Food and Drug Administration (FDA).

(c) The blood bank director shall communicate abnormal results in writing to the donor.

(d) Prior to the collection/transplantation, the transplant physician shall review the results to determine compatibility.

(e) Current results shall be compared with previous results, if any, for ABO group, Rh type and HLA type. Any discrepancies shall be resolved prior to issue of the HPC.

(f) The following tests shall be performed:

1. ABO group and Rh type;

2. Major histocompatibility antigens, HLA-A; -B and -DR (For allogeneic donors only);

3. Tests for unexpected antibodies to red cell antigens. Serum or plasma from donors with a history of transfusion or pregnancy shall be tested for unexpected antibodies to red cell antigens using methods that demonstrate clinically significant red cell antibodies within 30 days of donation. (For allogeneic donors only); and

4. Required infectious disease testing for allogeneic and autologous transplantation include a serologic test for syphilis (STS); Hepatitis B Surface Antigen (HBsAg); antibody to Hepatitis C Virus (HCV); Hepatitis B Core Antibody (HBcAb); antibody to Human Immunodeficiency Virus type 1 (HIV-1) and type 2 (HIV-2); antibody to Human T-Lymphotropic Viruses I/II (HTLV I/II); Cytomegalovirus (CMV) for allogeneic only, and any other tests licensed by the FDA for donor testing within 30 days of availability.

i. This testing is waivable only in accordance with 21 CFR Part 1271 -Human Cells, Tissues, and Cellular and Tissue-Based Products, incorporated herein by reference, as amended and supplemented.

(g) Cord blood testing shall be done on a sample from donor's birth mother within 48 hours of cord blood collection.

N.J. Admin. Code § 8:8-13.13