N.J. Admin. Code § 8:8-9.1

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

Section 8:8-9.1 - General provisions

(a) The requirements in this section shall apply to both hospital and out-of-hospital transfusion of blood for therapeutic purposes.

(b) Forms and request for blood and blood components and forms accompanying recipient blood samples shall have sufficient information for the positive identification of the recipient.

(c) The recipient's full name, as it appears on the identification band, and a traceable identification number are required. If more than one identification number is needed to establish the positive identification of the recipient, all the numbers shall be documented on all blood bank documents used for recipient testing.

(d) Incomplete or illegible forms shall not be accepted.

(e) The intended recipient and the blood sample shall be identified at the time of collection by a mechanism which positively identifies the recipient. Use of an armband is considered the method of preference. The Department shall approve any other method prior to use.

(f) The sample for compatibility testing shall be:

1. Identified by a label firmly attached to the sample before leaving the side of the recipient;

2. Labeled at the time of the collection with at least the recipient's full name, as it appears on the identification band, traceable identification number, the identity of the person drawing the sample and the date the sample was drawn;

3. Obtained within three days of the scheduled transfusion when the recipient has been transfused or pregnant in the preceding three months or this information is not known;

4. Examined by a qualified person, before a specimen is used for typing or compatibility testing, to confirm that all information on the request form is in agreement with that on the specimen label. In the case of a discrepancy or doubt, another specimen shall be obtained and used for these procedures; and

5. Labeled so that if it is necessary for the blood bank to affix a second label, the second label could be peeled off so that personnel performing the compatibility testing can verify that the information on the original and secondary labels match. The second label shall be affixed in a manner that it does not obscure the full name of the recipient and the traceable identification number.

(g) Testing of the recipient's blood shall include at least the following:

1. Determination of ABO group:

i. ABO grouping shall be performed on each sample of recipient blood as in 8:8-7.2(g).

ii. For neonates, only anti-A and Anti-B reagents are required.

2. Rh typing:

i. Anti-D reagent shall be used to determine whether the recipient shall receive Rh positive or Rh negative blood.

ii. The test for weak D is unnecessary when testing recipient red cells.

iii. To avoid incorrect designation of an Rh negative recipient as Rh positive, a control system appropriate to the Anti-D reagent in use is required.

3. Detection of unexpected antibodies:

i. Each blood sample submitted with a request for potential transfusion shall be tested prior to, or concurrently with, the performance of compatibility testing.

ii. Methods for testing for unexpected antibodies shall be those which demonstrate clinically significant antibodies and shall include an antiglobulin test.

4. Compatibility testing:

i. Compatibility testing requirements shall be consistent with the most recent Code of Federal Regulations and shall include a method to verify the ABO group of the donor unit and the recipient.

ii. For compatibility testing, the sample used shall be from an originally attached Whole Blood or Red Blood Cell component segment.

iii. If a computer system is used to detect ABO incompatibility, the following requirements shall be met:

(1) On-site validation of the computer to ensure that only ABO compatible whole blood and red blood cells components are selected for transfusion.

(2) Performance of two determinations of the recipient's ABO group as specified in 8:8-7.2(g). One of the determinations shall be on a current sample and the second shall be by one of the following methods: retesting the same sample; testing of a second current sample; or comparison with previous records.

(3) The computer system shall contain the donor unit number, component name; ABO group and Rh type of the component, the confirmed ABO group, the two unique recipient identifiers, recipient ABO group, Rh type, and antibody screening results.

(4) The computer system shall contain logic to alert the user to discrepancies between the donor ABO group and Rh type on the unit label and those determined by blood group confirmatory tests, and ABO incompatibility between the recipient and the donor unit.

(5) There shall be a method to verify correct entry of data before release of blood and blood components for transfusion.

5. A control system using red blood cells sensitized with IgG shall be used with each negative antiglobulin test.

(h) Selection of compatible blood and blood components for transfusion for special circumstances shall follow AABB Standards, as amended and supplemented.

1. There shall be a mechanism to ensure that patients with special transfusion requirements receive the correct component as clinically indicated.

2. The blood bank shall have a policy regarding transfusion of cellular components selected or processed to reduce Cytomegalovirus (CMV) transmission and transfusion of irradiated components for patients at risk for transfusion-associated graft-vs-host disease.

N.J. Admin. Code § 8:8-9.1

Recodified from 8:8-8.1 and amended by R.1989 d.246, effective 5/15/1989.
See: 21 N.J.R. 407(a), 21 N.J.R. 1412(a).
Labeling requirements added to (e). Control requirements added to (f).
Rule on issue of blood recodified to N.J.A.C. 8:8-10.1.
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 the section, except for (a) and (d).