A colleague who works for the nation's largest blood collection agency recently received an inquiry about the acceptability (or not) of completing the transfusion of a unit of blood (any type of component) beyond the date and time of the unit's stated expiration. Example: A unit of RBCs is issued by a Transfusion Service at 2240 hours on June 20, 2003 and the infusion is begun at 2300 hours on the same day. The unit is ordered to be given “slowly” and is only partially infused by midnight. Unfortunately, the unit has an expiration date of June 20, 2003, and according to the hospital's policy, the unit is considered outdated at the stroke of midnight. Therefore, at 0002 hours on June 21, 2003, the patient’s RN dutifully discontinues the unit, per hospital policy, even though more than a small fraction of the unit remains untransfused. The Transfusion Service physician would like to know what others would do in situations like this. The inquiring colleague personally knows of hospitals that allow such a unit to be completed, even though the official unit expiration date and time has passed, so long as the unit was "issued" before the unit formally expired.

The following responses have been received.

ADDENDA July 2, 2003

1. A transfusion medicine physician in Pennsylvania reminds us that where a slow infusion rate is needed, it is common to split the transfusion product. If the second aliquot of a unit is not requested until after it has outdated, the second aliquot would not be issued (he hopes), even though it represents half of a unit that was recently infused. Likewise, in his opinion the blood remaining in a component bag after the unit's expiration is beyond the limits of use set by the product labeling. He adds that in his practice, ONLY in the setting of product scarcity would it be acceptable to transfuse beyond the expiration date, and then only with the appropriate documentation and sign offs, including the approval of the patient's clinician and the consent of the patient. The Pennsylvanian concludes with (verbatim) "Finally, rejoice when you find a nurse who works at midnight and reads labels! She will probably save someone's life by detecting a mix-up someday. She should be honored, not pilloried."

2. A transfusion medicine physician in Sacramento, California is of the opinion that from a compliance perspective, he believes either approach (i.e. (1) stopping the transfusion exactly at the time the unit officially outdates or (2) allowing the unit to be transfused in its entirety, even following its outdate) may be taken, as he cannot find any definitive regulation that rules one way or the other. That said, he goes on to comment from a clinical perspective (verbatim) "I strongly believe it would be unconscionable to stop a transfusion (especially if doing so would risk consigning the patient to additional donor exposure) due merely to a pedantic interpretation of the regulations/standards. In short, because there exists no significant safety downside to allowing the blood to flow to completion, and because the upsides (in many cases) would include reduced donor exposure and blood wastage, I would recommend that the hospital allow for the complete transfusion of units issued prior to their outdate."

3. In the opinion of very experienced transfusion medicine physician in Nevada, the question of should a transfusion of blood continue "after the stroke of midnight" when the unit technically expires at midnight, the answer is clear (verbatim): "the only role of physicians and nurses is to take care of patients. Their role is not to be compliance officers, hospital attorneys, or government inspectors. It would therefore be foolish to (1) run the unit faster so as to have all of it transfused before midnight (and risk volume overload, CHF, etc.) or (2) to expose the patient to two units, and the risks attendant thereto, when only one unit was needed. When common sense, compliance, and patient care considerations are seemingly at odds, patient care always trumps the other two."

4. A blood bank colleague in Pennsylvania is of the opinion that the answer to the question under discussion depends on one's definition of "acceptable". For a number of years she operated under the impression that the expiration date of a product was based on the maximum allowable storage time for a product and followed the practice that if the transfusion was started before the expiration date of the product it was okay to continue transfusion to completion (which generally would occur within 4 hours or less). With heightened awareness of product inserts, manufacturer's recommendations, etc. facilities may want to refer to the Circular of Information for the Use of Human Blood and Blood Components (page 5, #12) which she quotes as stating 'Transfusion should be completed within 4 hours and prior to component expiration.' Perhaps in the decision-making process it's worth considering the scenario where a product is collected on the east coast (EST) and is being transfused on the west coast (PST) ... at which midnight is the product officially considered to have "expired"?

ADDENDA July 3, 2003

5. A transfusion medicine physician in New York agrees with those who have stated that, from the scientific and clinical standpoints, interrupting or refusing to fully transfuse a unit issued before outdate, but not completely transfused at the stroke of midnight, represents a triumph of the administrative/legal model of medicine over common sense and clinical/scientific judgment. He laments (verbatim), 'We are now virtual slaves to largely unscientific and political rule-making and that is the regulatory and legal reality.' In order to avoid the situation of a unit expiring during its transfusion, his facility has chosen to not issue any component without at least four hours left on the outdate at the time of issue. They figure that they are not going to be wasting too many products by this policy, which allows them to be compliant with the strictest interpretation of the regulations. It also should make life slightly easier for the nursing staff. If they are asked whether one can prolong infusion for short periods of time (minutes to an hour or two) beyond the almost entirely arbitrary four hours allowed by regulation/standards, they almost always answer "YES."

ADDENDA July 7, 2003

6. A colleague in Denver concurs that reasonable decisions within the context of the practice of medicine should prevail. She ponders (verbatim) "Are we going to waste a pool of cryoprecipitates, or an apheresed platelet, or a deglycerolized unit of autologous red cells because the expiration time passes during the infusion? There are many instances where circumstances such as unsuccessful attempts to start an IV cause delay in issuing a product, preventing completion of the infusion within the established time-frame."

ADDENDA July 9, 2003

7. A transfusion medicine physician at a Texas hospital reports that in the scenario of a product expiring prior to completion of the infusion, and the blood bank gets called to ask what to do, he always makes a medical decision to complete transfusion for all the reasons listed by others above. He sees no medical reason to discontinue the unit that is being infused, and to transfuse another unit, as long as the unit in question will be transfused within 4 hours of being spiked.

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