N.J. Admin. Code § 8:8-4.3

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

Section 8:8-4.3 - Documented review

(a) When blood or blood components are collected and/or prepared, a key individual in the operation of the blood bank shall conduct a documented review prior to the release and final labeling of blood and blood components to ensure that blood from unsuitable donors shall not be distributed for transfusion or further manufacture. If this function is performed by computer, validation of the computer programs, as outlined in 8:8-5.1(e) shall be performed. This review procedure shall be in writing and the procedure shall include tracking of all collected and/or prepared blood and blood components, to assure that:

1. The sequence of the numbers of the blood and blood components drawn are verified and donor numbers for which no donations are available are accounted for;

2. All required testing, as outlined in 8:8-7.2, Testing, is performed on all blood and blood components, with specimens drawn from the donor at the time of collection, before release for transfusion. For granulocytes, the specimen may be drawn up to 10 days prior to collection;

3. Blood or blood components with positive or questionable test results are not released for allogeneic transfusions;

4. Blood or blood components collected from donors that shall be deferred are not released for allogeneic transfusion or for further manufacture;

5. If required tests are performed by the blood bank, the testing is performed correctly and properly interpreted as determined by at least the following criteria:

i. Personnel are following the blood bank's established procedures for the test;

ii. Equipment is correctly set-up for test method specific adjustments;

iii. Test results on the machine printout can be traced to the worklist;

iv. Test runs, that are unacceptable by the criteria specified in the manufacturers' product insert, are repeated;

v. Appropriate repeat testing is performed; and

vi. Review of the interpretation of all final test results to assure that the interpretation complies with state requirements, when applicable, or the manufacturers' product insert;

6. If required tests are performed by personnel outside the blood bank, the criteria used to determine a final reactive or nonreactive result coincides with the blood bank's own policy of interpreting results used to discard blood and blood components for transfusion; and

7. That all blood and blood components from donations that have positive or questionable test results are quarantined until their final disposition is determined or they are destroyed.

(b) Final disposition/destruction of records shall be completed at the time of disposition/destruction and documented review shall verify that records accurately reflect that disposition/destruction.

N.J. Admin. Code § 8:8-4.3

New Rule, R.1989 d.246, effective 5/15/1989.
See: 21 N.J.R. 407(a), 21 N.J.R. 1412(a).
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 (a), substituted "individual" for "person" following "a key" and substituted "(e)" for "(d)" following "N.J.A.C. 8:8-5.1 in the introductory paragraph, added ". For granulocytes, the specimen may be drawn up to 10 days prior to collection;" following "transfusion" in 2, and substituted "allogeneic" for "homologous or directed" in 3 and 4.