How to perform periodic QC of antibody identification panel cells with an automated instrument?
A colleague at a small facility in California reports that his hospital transfusion service laboratory intends to bring antibody identification on-site (currently they send their antibody IDs to a reference laboratory). They do no manual testing (gel or tube). All pretransfusion testing is done by automated instruments that employ column agglutination technology. The manufacturer of the antibody identification panel cells states that for quality assurance the panel cells should be tested periodically with weak reactive antibodies. There was a previous discussion regarding QC of antibody identification panel cells on this website in 2005 with the last addenda written by Sheryl A. Kochman, Chief, Devices Review Branch (CBER/OBRR/DBA) who stated, "Show that you are following the QC instructions in the reagent red cells package insert." Has anyone addressed this issue, "How to perform periodic QC of antibody identification panel cells with an automated instrument?"
The following comments have been received.
ADDENDA Dec. 20, 2009
- Mr. Daniel Kettler, CLS, SBB, Blood Bank Supervisor at Delano Regional Medical Center in California (attribution used with permission) reports that he has developed a program configuration that enables periodic testing of antibody identification panels with weak reactive antibody on an automated testing platform (Ortho ProVue®). He states that the program configuration will not permit a user to run a panel on the automated platform if QC has not been done within defined time period. It will also generate a 'QC Pass' in the Batch Listing report. Interested individual may contact Mr. Kettler at kettd@drmc.com.
Submit comments to the e-Network Forum at enetworkforum@cbbsweb.org
Ira A. Shulman, MD
CBBS e-Network Forum Senior Editor & Moderator
W. Tait Stevens, MD
CBBS e-Network Forum Editor & Moderator
Elizabeth M. St. Lezin, MD
CBBS e-Network Forum Associate Editor & Moderator
The e-Network Forum is supported in part by the California Blood Bank Society (CBBS) and the American Red Cross Blood Services (ARCBS) and endorses collegial discussion among blood banking and transfusion medicine professionals. However, neither the CBBS nor the ARCBS in any way endorse the specific views and opinions expressed in the forum. The forum is not intended as a substitute for medical or legal advice and the content should not be relied upon for any medical or legal purposes. Readers should make their own determinations as to: (i) what constitutes appropriate medical, technical, and administrative practices, and (ii) how best to comply with laws and regulations relevant to their questions. For the latter, they should consider consulting, as to any medical matters, a qualified physician, and, as to any legal matters, an attorney familiar with related state and federal laws. The user of the forum, by accessing same, assumes all risks arising out of such use and releases CBBS and their respective members, directors, officers and agents from and against any loss, damage, claim or liability arising out of such use of the Forum.
