N.J. Admin. Code § 8:8-4.2

Current through Register Vol. 56, No. 21, November 4, 2024

Section 8:8-4.2 - Standard operating procedures

(a) All policies and procedures developed for use in the blood bank and required by this chapter shall be detailed in a manual(s) of SOP.

(b) Each procedure shall have a current pertinent literature reference.

(c) The actual test procedures used shall coincide with the manufacturers' current product insert or written documentation from the manufacturer.

(d) The most current edition of the manufacturer's product inserts shall be available.

(e) The manual(s) of SOP shall be reviewed by the blood bank director annually and this review shall be documented by date and the blood bank director's signature.

(f) All significant changes to procedures shall be reviewed, dated and signed by the blood bank director.

N.J. Admin. Code § 8:8-4.2

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 reporting requirements previously at this location recodified to N.J.A.C. 8:8-5.2.
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 the rule heading, substituted "Standard operating procedures" for "Procedures"; in (a), deleted "written procedure" following "detailed in a" and added "(s) of SOP" to "manual"; in (e), deleted "procedure" preceding "manual" and added "(s) of SOP" to "manual".