N.J. Admin. Code § 8:8-4.1

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

Section 8:8-4.1 - Quality control and quality assurance

(a) All blood banks shall have quality control and quality assurance programs which shall be in compliance with these rules, and shall be sufficiently comprehensive to ensure that blood and blood components, reagents and equipment perform as expected.

(b) The quality control and quality assurance programs shall include at least the following:

1. Written procedures that include all policies and procedures developed for use;

2. Evidence of validation of methods;

3. Evidence of periodic evaluation of reagents and equipment including the date of performance;

4. Evidence of periodic evaluation of blood and blood components in accordance with, whichever is more stringent, the Code of Federal Regulations and/or the AABB Standards ;

5. Evidence of periodic evaluation to determine that policies and procedures are appropriate and are followed;

6. Evidence of daily review of computer maintained error correction records by the blood bank director or supervisor.

7. Evidence of appropriate and timely corrective action;

8. Review by the supervisor or the director;

9. Evidence of self-evaluation of the clinical appropriateness of licensed activities; and

10. Documented evidence of monitoring of the transfusion which shall include:

i. The type of the component;

ii. The blood unit identification number;

iii. The pre-transfusion, 15-minute and post-transfusion vital signs;

iv. The volume transfused;

v. The identities of the transfusionist and the reviewing staff; and

vi. Notation of any suspected transfusion reaction.

(c) The requirements of (b)10iii and iv above shall not apply to blood and blood component transfusions performed in the operating room or under emergency situations as that term is defined at 8:8-9.4(a).

N.J. Admin. Code § 8:8-4.1

New Rule, R.1989 d.246, effective 5/15/1989.
See: 21 N.J.R. 407(a), 21 N.J.R. 1412(a).
Rule on records previously at this location recodified to N.J.A.C. 8:8-5.1.
Amended by R.1994 d.350, effective 8/1/1994.
See: 26 N.J.R. 1057(a), 26 N.J.R. 3171(a).
Amended by R.2005 d.283, effective 10/3/2005.
See: 36 N.J.R. 4261(a), 37 N.J.R. 3815(a).
In (b), added "and timely" following "appropriate" and deleted "and" following "action;" in 7, substituted ";" for "." following "director" in 8, and added 9 and 10i through vi; added (c).

Amended by 56 N.J.R. 2233(c), effective 11/18/2024