N.J. Admin. Code § 8:8-8.15

Current through Register Vol. 56, No. 23, December 2, 2024

Section 8:8-8.15 - Cytapheresis

(a) Facilities that perform cytapheresis procedures shall obtain a blood bank license before offering the service.

(b) Facilities shall submit SOP to the Department and receive written approval prior to initiation of the service.

(c) A licensed physician on the premises shall supervise the performance of manual cytapheresis collection. This requirement shall not be applicable to automated cytapheresis collection which meets the following conditions:

1.8:8-8.2, Donor's emergency care, shall be strictly followed;

2. Donor emergency care personnel, as required under 8:8-2.3(d), shall be on the premises; and

3. A contingency plan to assure that a physician is available for emergency purposes during the procedure shall be in use. The physician response time shall be no longer than 15 minutes.

(d) The interval between procedures shall be at least 48 hours, and the amount of plasma collected shall not exceed the amount cleared by the FDA for the device.

(e) If a cytapheresis donor donates a unit of whole blood, at least eight weeks shall elapse before a subsequent cytapheresis procedure unless the extracorporeal red cell volume of the apheresis machine does not exceed 100 ml.

(f) If it becomes technically impossible to return the donor's red blood cells during apheresis, at least eight weeks shall elapse before a subsequent apheresis procedure, unless the red cell loss was less than 200 ml.

(g) The blood bank or transfusion service shall ensure that donor red cell losses during any eight-week period, as well as the preceding 12 months, do not exceed the loss of red cells permitted for whole blood collections.

(h) Donors may receive drugs before or during leukapheresis.

1. Such drugs shall not be used for donors whose medical history suggests that they may exacerbate previous intercurrent disease.

2. The blood bank director is responsible for setting appropriate written guidelines in such circumstances.

(i) For a two-unit red cell collection, the volume of red cells removed from apheresis donors shall not exceed a volume predicted to result in donor hematocrit of less than 30 percent or hemoglobin of less than 10 grams per deciliter (g/dL) after volume replacement, and no additional collections shall be performed in the following 16 weeks.

(j) In the case of multiple concurrent apheresis collections, the volume limits of red cells and plasma removed from the donor shall follow the FDA-cleared device criteria.

N.J. Admin. Code § 8:8-8.15

Recodified from 8:8-7.12 and amended by R.1989 d.246, effective 5/15/1989.
See: 21 N.J.R. 407(a), 21 N.J.R. 1412(a).
Cytapheresis waiver requirements added.
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, except for (h).