N.J. Admin. Code § 8:8-7.2

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

Section 8:8-7.2 - Testing

(a) All laboratory tests shall be made on specimens of blood taken from the donor at the time of phlebotomy in properly identified tubes. For granulocytes, the specimen may be drawn 10 days prior to collection.

(b) When available, FDA licensed reagents shall be used for screening tests.

(c) Required infectious disease testing includes a serologic test for syphilis (STS), Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis C Virus (HCV), HCV RNA, Hepatitis B Core Antibody (HBcAb), antibody to Human Immunodeficiency Virus Type I (HIV-1), HIV-1 RNA, antibody to Human Immunodeficiency Virus Type 2 (HIV-2) and antibody to Human T-Lymphotrophic viruses I/II (HTLV I/II).

(d) Testing shall be performed as required in 8:8-7.2 and shall adhere to FDA regulations.

(e) The blood or blood components shall not be used for therapeutic purposes unless results of test(s) are clearly negative except where delay occasioned by testing may result in serious threat to the health and well-being of the recipient.

(f) In instances where untested units are transfused, the attending physician shall attest in writing to the existence of an emergency and if the test is subsequently positive, the recipient's physician shall be notified.

(g) Determination of ABO group shall be as follows:

1. Each container of blood shall be properly identified and labeled as to its blood group.

2. The ABO group of each blood donation shall be determined by testing the red cells of the donor using known Anti-A and Anti-B reagents, and by testing the serum or plasma for expected antibodies using known A1 and B red blood cells. The two methods of testing shall be recorded and be in complete agreement before any label or release can be effected for the unit of blood.

3. All Anti-A and Anti-B reagents shall meet the Code of Federal Regulations minimum requirements, and the procedures used shall follow the manufacturer's directions.

4. Previous records of ABO group shall not serve as identification of units subsequently given by the same donor. New determinations shall be made for each collection.

(h) Determination of Rh type shall be as follows:

1. The Rh type of each container of donor blood shall be determined with Anti-D reagent.

2. If the blood is Rh negative, it shall be tested using a technique designed to detect weak D.

3. Only reagents meeting the Code of Federal Regulations minimum requirements for the products shall be used and the technique of typing shall be that recommended by the manufacturer.

(i) Determination of antibodies shall be as follows:

1. Each container of blood shall be tested for unexpected antibodies using a screening cell suspension which meets the Code of Federal Regulations minimum requirements.

2. The techniques employed shall be those which shall detect clinically significant antibodies and shall include the anti human globulin test.

3. Blood in which antibodies are found shall be used in a manner not detrimental to the recipient.

(j) Repeat testing: The facility at which the transfusion is administered shall confirm the ABO group, on a sample obtained from the integral attached segment, of all units of whole blood and red blood cells, and the Rh type of all Rh negative units of whole blood and red blood cells.

(k) Performance of any additional testing for product quality and patient safety is permitted under this chapter. This testing shall comply with all applicable requirements of this chapter.

N.J. Admin. Code § 8:8-7.2

Amended by R.1987 d.111 effective 2/17/1987.
See: 18 N.J.R. 2280(a), 19 N.J.R. 356(b).
(b)3 added; old (b)3.-7. renumbered (b)4.-7.
Recodified from 8:8-6.2 and amended by R.1989 d.246, effective 5/15/1989.
See: 21 N.J.R. 407(a), 21 N.J.R. 1412(a).
Compliance with CFR and industry standards added. Surrogate testing for non-A, non-B Hepatitis added. Rule on medical contingency plan recodified to N.J.A.C. 8:8-8.3.
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).
Rewrote (a)-(d) and (f)-(j).
Administrative correction.
See: 38 N.J.R. 2800(b).