N.J. Admin. Code § 8:8-8.13

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

Section 8:8-8.13 - Therapeutic phlebotomy

(a) Any person who performs a therapeutic phlebotomy shall obtain a blood bank license before offering the service.

(b) Therapeutic phlebotomy shall be done only at the written request of the patient's physician or clinical practitioner, whichever is more consistent with AABB Standards.

(c) There shall be a written procedure describing the technique used.

(d) Records shall be maintained which include patient identification, diagnosis, therapeutic procedure, volume of plasma and cells removed, volume replaced, nature of the replacement fluids, any adverse actions, and a record of the administered medications.

(e) Informed consent of the patient shall be obtained.

(f) There shall be provisions for the management of reactions.

(g) If therapeutic phlebotomy procedures and recordkeeping are not entirely performed by blood bank personnel, there shall be a written agreement that specifies the division of responsibilities for assuring compliance with this chapter.

(h) Any blood or blood component withdrawn from a patient for therapeutic purposes shall be clearly indicated as such on the blood label.

(i) Blood or blood components obtained from therapeutic phlebotomy may be used for allogeneic transfusion using the following criteria:

1. Waiver approval from the FDA shall be received and the approved procedures and protocols shall be followed;

2. It shall be performed at no expense to the donor;

3. The donor diagnosis shall be hereditary hemochromatosis; and

4. The donor shall meet all the allogeneic donation criteria except for donation interval and hematocrit.

N.J. Admin. Code § 8:8-8.13

Recodified from 8:8-7.10 and amended by R.1989 d.246, effective 5/15/1989.
See: 21 N.J.R. 407(a), 21 N.J.R. 1412(a).
Requirement for written physician's request added to (a), and notation of adverse reaction added to (c).
Amended by R.2005 d.283, effective 10/3/2005.
See: 36 N.J.R. 4261(a), 37 N.J.R. 3815(a).
Rewrote section, adding (h) and (i).