N.J. Admin. Code § 8:8-13.5

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

Section 8:8-13.5 - Records

(a) Suitable and legible records shall be maintained for a period of not less than five years. Records to trace a unit of HPC from source to final disposition shall be kept for at least 10 years after transplantation. Written records shall be prepared with indelible material. All records stored off-site shall be retrievable within 24 hours.

(b) All corrections made in the HPC records shall not conceal the original entry; shall document the reason for the correction; and shall include the date the change was made and the initials of the person making the change.

(c) Complete records for all aspects of HPC activities performed shall be maintained. Records shall include the identity of the personnel who performed each significant step, quality control and when applicable donor history, medical examination, consent, deferral, reactions and laboratory test results; storage temperature; labeling, issue, and administration of HPC and its final disposition.

(d) Records maintained on computer shall comply with all the requirements of this chapter as set forth in N.J.A.C. 8:8-5.1(e).

(e) All records of HPC donors that do not meet the donor suitability criteria shall be kept for a period of 10 years.

N.J. Admin. Code § 8:8-13.5