Re-issuing thawed plasma products that have been returned to the blood bank more than 30 minutes after being issued

A senior technologist at a hospital in the midwest reports that the policy at her current hospital permits nursing staff to keep thawed FFP on the wards at room temperature for as long as 6 hours before initiating the transfusion of thawed FFP (which is kept at room temp). From time to time, a unit of thawed FFP is returned to the blood bank unopened. When that occurs, the thawed FFP is placed into the refrigerator at 1 to 6 C and available for reissue to another patient, provided the FFP is used within a 24 hour outdate from the initial time of thawing. The hospital at which the inquiring colleague previously worked would routinely discard thawed FFP if the product was returned to the lab more than 30 minutes after it was originally issued. The inquiring colleague acknowledges that she "could not find anything in the standards or the FDA regulations that allows thawed FFP to be kept outside the blood bank at room temperature for 6 hrs and still be re-issued", so she wanted to know how other hospitals handled these situations. If the aforementioned practice is not appropriate, she would like to see it changed to a practice that is.

Editors' note: Colleagues might find the discussions below to be germane to the above question.

• How best to manage plasma products that are returned unused and how to minimize wastage of plasma products
• Minimizing Wastage of Unused Thawed FFP

The following comments have been received in response.

ADDENDA May 18, 2010

1. A colleague with considerable knowledge of California regulations and application of AABB Standards in California reports that AABB standards and the Circular of Information indicate that FFP must be used immediately after thawing or be stored at 1-6 deg C. for up to 24 hours. Transport is allowed at 1-10 deg C. While there is no mention of Factor requirements, the thawed FFP could be relabeled as thawed plasma and stored at 1-6 deg C. for up to five days. Unless a facility has validation documentation of the efficacy of thawed FFP held at room temperature, there does not appear to be a provision in standards to allow usage of this product if held at room temperature or to accept it for reissue. The responding colleague agrees with the editor of the 13th edition of the technical manual that if thawed FFP was issued on ice or maintained at proper storage or transport temperatures (documented), it could be accepted for reissued as FFP within 24 hours of thawing or relabeled appropriately. Additionally, it would be prudent to follow FDA or AABB current technical manual requirements, if available and/or more stringent.

ADDENDA June 11, 2010

2. A colleague is concerned about using an upper limit of 6C as a temperature above which dispensed Fresh Frozen Plasma cannot be reissue if a product is returned unused. This concern stems from the observation that the temperature of freshly-thawed plasma is probably not between 1-6C. They often issue plasma within minutes after thawing and the temperature of the thawed products can be as high as 20C on completion of the thawing process. How does one use a temperature of 1-6C (or even 1-10C) as a criteria for reissue of returned product, if the temperature at issue is 20C?

ADDENDA Aug. 6, 2010

3. Stephen Apfelroth, MD, Director of the Blood Bank at Jacobi Medical Center, Einstein College of Medicine, (attribution used with permission), writes: The suitability of FFP stored at room temperature for up to 24 hours should not be an issue from point of view of bacterial growth/contamination as cryoprecipitate or platelet products are routinely held at room temperature for similar periods. Solvent-detergent plasma, when it was available, was specifically labeled for 24 hours storage at 20 degrees. Studies related to this issue have shown that factor content in FFP as well as SDP is preserved at least as well at 20 degrees as at 4 degrees for 24 hours storage, and perhaps as long as 5 days (Transfusion 2002:42:1581).

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