N.J. Admin. Code § 8:8-8.14

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

Section 8:8-8.14 - Plasmapheresis

(a) Facilities that perform plasmapheresis 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) The procedures used shall include as a minimum the following requirements:

1. Within one week prior to the first plasmapheresis, the donor shall be examined and certified to be in good health by a clinical practitioner.

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

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

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

iii. 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.

3. Prior to each procedure, records shall be made and maintained of the major pertinent elements of each donor's physical condition and shall also include a determination of the donor's total protein.

4. A donor shall not serve as a source of plasma unless his or her total protein is within normal limits.

5. Quality control records of the total protein determinations shall be maintained.

6. If a second plasmapheresis is to be performed within 30 days of the first procedure, laboratory tests shall be done on samples of the donor's serum to determine that the protein level and ratio of the various protein components, as shown by electrophoresis, fall within normal limits.

7. A donor shall not serve as a source of plasma while there is any significant change in his health, or in the values of these initial determinations.

8. Periodic determinations shall be made as frequently as necessary and at least every four months to monitor these evaluations.

9. The amount of plasma withdrawn shall be consistent with the current Code of Federal Regulations.

10. A plasmapheresis donor may donate a unit of whole blood if 48 hours have lapsed since the last plasmapheresis, but at least eight weeks shall elapse after a regular whole blood donation before starting a donor in a plasmapheresis program.

11. Plasmapheresis donors shall, on each occasion of plasmapheresis satisfy all requirements of whole blood donors outlined in N.J.A.C. 8:8-6, Criteria for Donor Selection.

(d) Plasmapheresis shall be performed in accordance with AABB standards.

N.J. Admin. Code § 8:8-8.14

Recodified from 8:8-7.11 by 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).
In rule heading, substituted "Plasmapheresis" for "Routine plasmapheresis"; rewrote section, adding (d).