N.J. Admin. Code § 8:8-2.2

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

Section 8:8-2.2 - Blood bank director

(a) The blood bank director and the licensee shall be responsible for compliance with 26:2A-2 et seq. and the rules set forth in this chapter.

(b) The blood bank director shall administer the licensed activities of the blood bank as follows:

1. The director shall be responsible and shall have authority for all procedures and policies relating to all phases of donor and recipient testing as well as the collection, processing, storage, and distribution of all blood and blood components. Procedures and policies for the administration of blood and blood components shall be established in consultation with the blood bank director.

2. The director shall not individually serve as director or co-director of more than three blood banks, laboratories or one health system. If the blood bank is an integral part of the clinical laboratory, this shall be considered one facility.

3. The director shall spend an adequate amount of time in the blood bank to direct and supervise the technical performance of the staff. The director shall be readily available for personal or telephone consultation.

4. The director shall be responsible for the blood bank personnel's in-service training and their adherence to established policies and procedures.

5. If the director is to be absent, the director must arrange for a qualified substitute director.

6. The director may delegate his or her responsibilities for administering the licensed activities of the blood bank to a properly qualified and trained designee. If the director appoints a designee, the director shall be responsible for the proper performance of all the designee's duties and these duties shall be outlined in the SOP.

(c) Qualifications of the blood bank director shall be as follows:

1. The blood bank director shall be a physician licensed to practice medicine in the State of New Jersey. The physician requirement shall be waived for industrial manufacturers and/or brokers.

2. The blood bank director shall have four years of fulltime experience and/or training appropriate to the services provided by the blood bank, as described in (c)3 below. For new and developing procedures performed by the blood bank, the blood bank director shall have at least two years of relevant experience.

3. Appropriate experience shall include, but shall not be limited to:

i. Evaluation of donor suitability;

ii. Donor and recipient testing;

iii. Blood and blood component collection, preparation, storage, processing and distribution; and

iv. Administration of blood and blood components for therapeutic purposes.

N.J. Admin. Code § 8:8-2.2

Amended by R.1994 d.350, effective 8/1/1994.
See: 26 N.J.R. 1057(a), 26 N.J.R. 3171(a).
Recodified from N.J.A.C. 8:8-2.1 and amended by R.2005 d.283, effective 10/3/2005.
See: 36 N.J.R. 4261(a), 37 N.J.R. 3815(a).
Former N.J.A.C. 8:8-2.2 recodified as N.J.A.C. 8:8-2.3.
Rewrote the section.