N.J. Admin. Code § 8:8-13.4

Current through Register Vol. 56, No. 11, June 3, 2024

Section 8:8-13.4 - Quality management

(a) HPC collection, processing, and administration service(s) shall establish and maintain a program or programs for quality control, quality assurance and quality assessment, which shall be in accordance with 8:8-4.1. The ultimate responsibility for the implementation of an adequate quality management program shall reside with the medical director.

1. There shall exist a written method for evaluating product specifications, specimen collection, storing, processing, usage, administration policies, and ability of services to meet patient needs.

(b) HPC collection, processing, storage and administration service(s) shall maintain a SOP manual or manuals describing, in a standardized format, all policies and procedures for activities performed by those services.

1. Policies and procedures shall include, but not be limited to, all aspects of the operation. When the following activities are performed, policies and procedures shall be available for them: donor screening, consent, collection, processing, quality control and proficiency testing, storage, labeling, dispensing, transportation, preparation for and actual administration of HPC and clinical research protocols.

(c) HPC collection, processing, and administration services shall have a system for detecting, evaluating, documenting, and reporting errors, accidents, suspected adverse reactions, nonconformance and deviations from the SOP manual(s).

1. Any deviations from standards, regulations, or the SOP manual(s) shall be documented and reviewed subsequently by the medical director and/or laboratory director dependent upon whether the deviation is medical or technical in nature.

2. Corrective actions shall be documented and reviewed promptly by the medical director and shall be made available to the patient's physician and all directors of facilities separately cooperating in provision of services.

3. If HPC has been transplanted prior to recognition of the error or accident, the medical director shall take immediate appropriate action to resolve the problem. If the error or accident has resulted in the transplantation of the HPC that could result in infectious disease or other harmful consequences, appropriate staff shall notify the patient/recipient's physician. Thorough and complete documentation shall be made as to these actions.

N.J. Admin. Code § 8:8-13.4