N.J. Admin. Code § 8:8-12.1

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

Section 8:8-12.1 - General provisions

(a) A facility that intends to perform out-of-hospital transfusion shall obtain a blood bank license to offer the service in New Jersey.

(b) Any facility that issues blood and blood components to an Out-of-Hospital Transfusion (OOHT) service shall be a blood bank licensed in accordance with this chapter to perform "Transfusion Services" and "Processing (Routine)".

(c) The OOHT service and the New Jersey licensed "Transfusion Service" shall have a written agreement that specifies the division of responsibilities for assuring compliance with this chapter. If the OOHT service performs no function other than transfusion of the blood, the New Jersey licensed transfusion service shall agree in this written document to perform recipient testing required in 8:8-9.1 and 8:8-9.2, and to provide technical consultation when necessary.

(d) Blood banks wishing to employ the techniques set forth in this subchapter shall file their protocol and a request in writing with the Department, prior to initiation of the procedure.

(e) Such techniques shall only be employed upon receipt of written approval from the Department.

(f) The procedures used shall be acceptable to the Department and ensure that there is compliance with this Chapter.

N.J. Admin. Code § 8:8-12.1

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).
Rewrote the section.