N.J. Admin. Code § 8:8-5.2

Current through Register Vol. 56, No. 24, December 18, 2024

Section 8:8-5.2 - Reporting requirements

(a) Blood banks shall report transfusion reactions to the Department as follows:

1. Hemolytic and/or delayed hemolytic and other known or suspected life threatening transfusion reactions within 10 days of the occurrence, using the Transfusion Reaction Report form (CL-44) at chapter Appendix A, incorporated herein by reference; and

2. Known and/or suspected fatal transfusion reactions by telephone call to (609) 718-8084 by the next working day after the day the event occurs, with written follow-up within 10 days of the occurrence, using the Transfusion Reaction Report form (CL-44) at chapter Appendix A, incorporated herein by reference.

(b) Blood banks shall report in writing to the Blood Bank Program, Clinical Laboratory Improvement Service, of the Department, at PO Box 361, Trenton, NJ 08625-0361, known and/or presumed cases of HIV infection and/or AIDS associated with a transfusion within 10 days of the date on which the case is brought to the attention of the blood bank.

(c) Blood banks shall report prospective donors testing positive for hepatitis B, hepatitis C, syphilis and infectious diseases that are reportable pursuant to N.J.A.C. 8:57-1 to the Communicable Disease Service of the Department or the local health agency in accordance with N.J.A.C. 8:57-1.

(d) Blood banks shall report prospective donors testing positive for HIV-1 and/or HIV-2 to the Division of HIV, STD, and TB Services of the Department in accordance with N.J.A.C. 8:65.

(e) Blood banks shall report to the Department the occurrence of errors and accidents described at N.J.A.C. 8:8-4.4 within 15 working days of the recognition of the error, using the Error/Accident Report form (CL-21) at chapter Appendix B, incorporated herein by reference.

(f) Blood banks shall report to the Department the occurrence of errors and accidents that result in the wrong blood or blood component being transfused that results in no harm to the recipient within 15 working days of the recognition of the error, using the Error/ Accident Report form (CL-21) at chapter Appendix B, incorporated herein by reference.

(g) Appendices A and B are available on request from the Blood Bank Program of the Clinical Laboratory Improvement Service of the Department and are available for download from the Department's forms page at http://nj.gov/health/forms.

N.J. Admin. Code § 8:8-5.2

Recodified from 8:8-4.2 and amended by R.1989 d.246, effective 5/15/1989.
See: 21 N.J.R. 407(a), 21 N.J.R. 1412(a).
Rule on medical history, physical exam and bleeding limitations previously at N.J.A.C. 8:8-5.2 recodified to N.J.A.C. 8:8-6.2. Requirements added for the reporting of transfusion-associated AIDS and of errors in shipment.
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), added "to the Department" following "reported" in the introductory paragraph, rewrote 1, and added "known or suspected" preceding "fatal transfusion" in 2; in (b), recodified 2 as (c) and added "and antibody to hepatitis C virus" following "surface antigen"; recodified former (c) and (d) as (d) and (e) and substituted "15 working" for "10" in both subsections.
Amended by R.2008 d.352, effective 11/17/2008.
See: 40 N.J.R. 1951(a), 40 N.J.R. 6605(a).
Rewrote the section.

Amended by 56 N.J.R. 2233(c), effective 11/18/2024