Colleagues in Florida and in California both wonder what other institutions are doing regarding the use of selected outdated (expired) antibody identification (panel) red cells, including any quality control to assure the cells are working properly.

The current practice in the Floridian’s hospital is to test each selected expired panel cell to prove that the corresponding antigen is still present. The Floridian questioned her staff to see if they had ever observed an expired panel cell that did not give expected results with commercial antisera, and the answer was NO. Of interest, the Floridian acknowledged that they do not perform any quality control on ‘indate’ panels. Her personal experience prior to coming to this institution was to run a cell with each expired panel that would be expected to reactive positively, to show that the red cell panel had not deteriorated.

The California colleague reports that his hospital’s written SOP ‘allowed’ them to use outdated panel cells. However, at a recent inspection (May 2004) they were told that current CLIA rules do not allow them to use outdated (expired) panel red cells for identification of red cell antibodies. The California colleague wonders if this advice is actually correct?

(The Editor believes that the previous discussion in 2002 makes some points that are germane to the current question. However, the current discussion should focus on the most recent CLIA regulations and their enforcement.

The following responses have been received.

ADDENDA Oct. 7, 2004

1. A colleague in the Pacific Northwest reports that at his AABB Accredited Immunohematology Reference Laboratory (IRL) they follow AABB Standards for IRLs. Specifically Standard 5.1.4.2 which states that "The criteria for the use of non-FDA-licensed reagents (including expired reagents) shall be defined." He adds that their SOP states that in-date, licensed reagents are to be used when available. If the only example of a red cell used for 'rule-outs' is expired, the technologists must reconfirm the reactivity of the antigen that is being ruled out. He suggests that colleague go to the FDA's Guide to Inspections of Blood Banks, page 11 of 24, Part B - Laboratory, ABO and Rh Testing, and RBC Antibody Screening, paragraph 6. It states that "Rare reagents, e.g., anti-Jk(b), anti-Le(b), etc.. are sometimes used beyond the expiration date: this is acceptable only if adequate controls are used and the reactivity and specificity of the reagents are documented." His facility has interpreted the aforementioned to include panel red cells as well.

ADDENDA Aug. 19, 2005

2. A colleague in Wisconsin reports that her lab is in currently defining QC requirements for use of outdated typing sera (rare reagents). They wonder how other members handle this issue. They are considering recording the reactivity of freshly received antisera and then would consider it acceptable if when the reagent outdated it had nearly similar reactivity. They are also wondering if anyone employs an absolute time limit on how outdated an antisera can be and still be used. They thought that six months might be reasonable, but they wonder if others go beyond that.

Editor's Note: AABB Standards for Immunohematology Reference Laboratories (3rd Edition, 2003) 5.1.4.2 states that "The criteria for the use of non-FDA-licensed reagents (including expired reagents) shall be defined." In addition, the FDA's Guide to Inspections of Blood Banks, page 11 of 24, Part B - Laboratory, ABO and Rh Testing, and RBC Antibody Screening, paragraph 6 states that "Rare reagents, e.g., anti-Jk(b), anti-Le(b), etc. are sometimes used beyond the expiration date: this is acceptable only if adequate controls are used and the reactivity and specificity of the reagents are documented."

ADDENDA Aug. 28, 2005

3. A colleague in Nevada is of the opinion that there are very few instances (if any) where the use of expired red cell panels are of any value. He believes that a patient's phenotype will provide more information than testing old panel cells. He comments that in his experience the use of red cell separation techniques, red cell treatments (DTT, Enzymes, etc.) and adsorptions are extremely valuable, as is crossmatching with in-date known donor phenotyped units. He also believes that if extremely rare red cells are required, you won't find them in the expired panel cells, but in a library of cells preserved by liquid nitrogen at a local Reference Laboratory. It is his opinion that "people hold on to their expired reagent cells mostly out of habit, not of necessity". He advises that "if you can't perform the techniques above, throw away your expired red cell panels and send the specimen to your local Reference Laboratory."

Editor's NOTE: I must admit that our local reference laboratory is excellent. Thank you Dr. Garratty!!!

ADDENDA Aug. 30, 2005

4. An experienced immunohematologist in Michigan suggests that crossmatching blood that is negative with a commercially prepared antibody of the same specificity that cannot be excluded is an alternative approach to doing "rule outs" with expired reagent red cells. This is acceptable practice, as indicated by AABB IRL Standard 5.4.1. He reports that his laboratory does not use expired panel cells, but will exclude antibodies based on testing frozen red cells that had their red cell phenotype determined before being frozen. He acknowledges that such an approach might cause them to miss an unexpected antibody if the corresponding antigen deteriorated (they do not QC the thawed red cells for their phenotype at the time of thawing) or if the frozen reagent red cell cell had been mistyped initially. However, since RBC units set up for the patient would require an antiglobulin crossmatch, they would still detect a serologic incompatibility when doing the indirect antiglobulin test.

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Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator