N.J. Admin. Code § 8:8-13.3

Current through Register Vol. 56, No. 24, December 18, 2024

Section 8:8-13.3 - Personnel

(a) The licensee shall be responsible for obtaining a qualified HPC blood bank medical director, laboratory director and qualified technical staff.

(b) The medical director shall:

1. Be a physician who is appropriately licensed to practice medicine in New Jersey and is board certified in one or more of the following specialties: Hematology; Oncology; Pediatric Hematology/Oncology; Immunology and/or Pathology;

2. Have at least two years of documented experience or training in the relevant field, and have supervised at least 10 HPC collection and/or transplantation procedures for which they have direct authority;

3. Acquire proficiency in new procedures as they are developed with appropriate study, training, supervision, and/or certification;

4. Be responsible and have the authority for providing oversight of the entire HPC process, and shall specifically assure that each portion of the collection, processing, administration and storage comply with this subchapter;

5. Be responsible for adherence with N.J.S.A. 26:2A-2 et seq. and this subchapter;

6. Be responsible for the employment of qualified HPC personnel, their in-service training and their adherence to established policies and procedures.

7. A qualified medical director may serve in the dual capacity of medical director and laboratory director with full responsibility for all HPC services and duties listed in this subchapter and (c) below.

(c) The Laboratory director shall:

1. Hold a doctoral degree in a biological science;

2. Have one year of HPC processing training or two years of HPC processing experience, and shall have supervised at least 10 processing procedures for which he or she has direct authority;

3. Provide written confirmation of his or her training or experience from the Director of the Program of the department or institution in which he or she obtained his or her training or experience. The laboratory director shall acquire proficiency in new procedures as they are developed with appropriate study, training, supervision, and/or certification;

4. Be responsible for all administrative operations of HPC processing facility, including compliance with this chapter;

5. Be responsible for supervision of the technical staff, and for ensuring that the staff shall have capabilities and training appropriate to the services offered;

6. Have the responsibility and authority for all technical aspects of those portions of the program that he or she supervises;

7. Be responsible for adherence with N.J.S.A. 26:2A-2 et seq. and this subchapter;

8. Be responsible for the employment of qualified HPC personnel, their in-service training and their adherence to established policies and procedures; and

9. Where the laboratory director does not qualify as the medical director, there shall be a medical director in accordance with (b) above.

(d) The following concern HPC technical staff:

1. The HPC blood bank shall have one or more supervisors who under the general direction of the medical director and/or laboratory director supervise all functions related to HPC, and in the absence of the medical director or laboratory director shall be responsible for proper performance of these procedures set forth in this chapter.

2. There shall be a sufficient number of properly trained and qualified technical staff per the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) P.L. 100-578, amending 42 U.S.C. § 263a and N.J.A.C. 8:44 to meet the volume and complexity of technical procedures performed by the HPC blood bank.

3. All other personnel associated with the functions related to the collection, processing, testing, cryopreservation, storage and distribution of HPCs shall be suitably trained and supervised in the performance of their prescribed tasks with training records available for review.

4. Personnel shall qualify as the general supervisor.

N.J. Admin. Code § 8:8-13.3