N.J. Admin. Code § 8:8-8.10

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

Section 8:8-8.10 - Autologous collection/transfusion

(a) Blood banks wishing to employ the techniques set forth in this section shall file their protocol and a request in writing to the Department, prior to initiation of the service.

(b) The techniques set forth in this section can be employed upon receipt of written approval from the Department.

(c) Autologous collection/transfusion shall be done only at the written request of the physician or clinical practitioner, whichever is more consistent with the AABB Standards. A telephone request shall be followed by written confirmation within seven calendar days.

(d) Testing and labelling requirements for autologous donations shall be consistent with, whichever is more stringent, this chapter or the Code of Federal Regulations.

(e) Donor processing for autologous transfusion shall be as follows:

1. Donor qualifications for autologous transfusion may vary from standard donor criteria but this entire procedure shall be arranged by consultation between the blood bank director and the donor-patient's physician or clinical practitioner, whichever is more consistent with the AABB Standards.

2. If the patient-donor and/or donated unit do not meet the criteria for donor selection listed in this chapter to protect the recipient, the unit shall be labeled "For Autologous Use Only", segregated, and used solely for this purpose.

3. "Crossing over" shall not be allowed.

4. Blood and blood components that test positive or abnormal and are transfused to the donor/recipient shall be labelled with a Biohazard label.

(f) Criteria for donation shall be as follows:

1. Volume of blood shall comply with the Code of Federal Regulations.

2. There are no age limits for autologous transfusion procedures.

3. The hemoglobin concentration of patient-donor shall be no less than 11 gms. per dl. The packed cell volume, if substituted, shall be no less than 33 percent.

4. Frequency of phlebotomy for autologous transfusion shall be determined by competent medical decision but blood shall not be collected from the patient within 72 hours of the anticipated procedure.

5. Phlebotomy concurrent with transfusion of previously collected autologous units shall not be undertaken more frequently than once every three days.

(g) Pretransfusion testing of blood and blood components for autologous transfusion shall be subject to the following:

1. ABO group shall be determined by the collection facility. If the transfusion facility is different from the collecting facility, the ABO group shall be confirmed.

2. Other factors tested for routine transfusion are optional.

3. Compatibility testing is optional.

(h) If "Autologous Use Only" blood is drawn, all satellite bags shall be labeled "Autologous Use Only" immediately prior to or at the time of the collection.

(i) Crossmatched autologous units that are tested can be stored on the same shelf with the crossmatched allogeneic and/or directed units for the same recipient.

N.J. Admin. Code § 8:8-8.10

Recodified from 8:8-7.8 and amended by R.1989 d.246, effective 5/15/1989.
See: 21 N.J.R. 407(a), 21 N.J.R. 1412(a).
Review and testing requirements for autologous blood processing added.
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).
Added "or clinical practitioner, whichever is more consistent with the AABB Standards" in (c) and (e)1; deleted "donor's-recipients" in (c); substituted "shall" for "must" and "should" throughout; rewrote "Chapter" as "chapter" in (e)2; deleted "must" preceding "shall be labeled", in (g)1; deleted "type" preceding "must group", and in (i); substituted "allogeneic" for "homologous".