N.J. Admin. Code § 8:8-13.11

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

Section 8:8-13.11 - Processing

(a) The medical director of the facility shall approve HPC processing procedures in writing.

(b) The facility shall use methods known to result in acceptable viability, recovery, and sterility.

(c) Cryopreservation, manipulation or other processing procedures shall be performed as per the SOP that are well established in the medical literature or, if experimental, shall be approved by an institutional review board.

(d) Aseptic techniques shall be used to prevent bacterial contamination.

(e) Appropriate quality control tests and measures shall be in place to demonstrate adequate targeted cell yields, microbial sterility and viability of the product.

(f) After processing, the product shall be stored at acceptable temperatures in accordance with 8:8-13.16.

(g) Relevant information that can affect the safety, efficacy and potency of the product shall be communicated to the recipient's physician.

(h) The licensee shall ensure that the HPC are not exposed to gamma irradiation, inappropriate temperatures and other conditions known to compromise the safety or the efficacy of the HPC unit.

(i) The facility shall maintain records of:

1. Lot numbers and expiration dates of all disposables and reagents used in processing;

2. Processing procedures for each unit and the identity of the person performing each procedure; and

3. Processing tests performed on each unit prior to cryopreservation, which shall include CD34 or a comparable analysis, total nucleated cell count, percent viability, ABO group, Rh type, final HPC unit volume and microbial cultures.

(j) The processing record for each unit shall be reviewed by the medical or laboratory director in a timely manner after completion of processing.

N.J. Admin. Code § 8:8-13.11