N.J. Admin. Code § 8:8-13.6

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

Section 8:8-13.6 - Reporting requirements

(a) Any error in collection, processing, testing or administration of HPC that results in an adverse clinical event shall be reported on forms provided by the Department within 15 working days of occurrence.

(b) All prospective donors found to test positive for hepatitis B surface antigen and hepatitis C virus antibody shall be reported to the Department within 10 calendar days on forms provided for this purpose. These donors shall be considered ineligible for transplantation purposes as long as they continue to be identified on current lists of interdicted donors supplied by the Department, unless approved by the medical director and the recipient's physician.

(c) All prospective donors who test positive for communicable diseases shall be reported to the Department in accordance with N.J.A.C. 8:57.

(d) Corrective actions shall be documented and reviewed promptly by the medical director/laboratory director dependent upon whether the corrective action in this case is of medical or technical nature.

(e) Any errors, as set forth in 8:8-4.4(a), that result in the availability of unsuitable HPC products shall be reported to the Department on forms provided for that purpose.

N.J. Admin. Code § 8:8-13.6