A member of the CBBS e-network wanted input regarding the high wastage of unused thawed FFP on their transfusion service. This occurs under two situations:

1. The FFP has been dispensed by the laboratory, but is returned (typically less than several hours after thaw). In this case, if the plasma has been out of refrigeration for more than 30 minutes and then returned to the lab, it is considered to be an automatic discard.
2. In other cases the FFP is ordered but is not picked up. The transfusion service holds the thawed FFP in their refrigerator for up to 24 hours before discarding it.

What about the FFP which has been dispensed by the laboratory and then returned? There are studies showing that 24 hour room temperature storage of whole blood (Transfusion 1999; 39:488-91) or thawed FFP (Transfusion 1980; 20:546-8) have quite good stability of factors V and VIII over this interval. If FFP is returned to the laboratory and put back into refrigeration, is it permissible to give this plasma a 24 hour outdate? (See final response below.)

What follows are the replies of several e-Network Forum members.

1. One member replied that their approach is to try to limit the number of units thawed at any one time. This member's blood bank advises the requesting physician that units will be thawed quickly when actually needed. This approach seems to help avoid thawing plasma that is not actually needed. When an order is received, this blood bank inquires of the ordering physician how many units they want to give immediately, and thaws only that number of units - often only one unit at a time. For more units the blood bank requires about twenty minutes advance notice and units will be thawed as they are needed. Wasted units and follow-up with the ordering physician are documented through the Transfusion Committee.

(Editor's NOTE: While this approach may work in some settings, limiting access to FFP to one unit at a time, with a 20-minute delay per unit, may not be practical in other settings, such as a trauma center.)

2. A second member replied that his institution monitors ordering by physician. All units of FFP that are ordered, thawed, and not used are included in their blood utilization review. This physician-specific data is used for purposes of recredentialing. The member reports that they have only rare units that are thawed and not used.

3. A third member replied that in his area, the wastage of FFP often happens on TTP patients whose exchange gets canceled or postponed. This member's blood bank relabels the product as "Liquid Plasma", storing it a 4^oC until the next scheduled plasma exchange, as described in the AABB Technical Manual. The new expiration date is 5 days from the time the product was thawed.

4. A fourth member's blood bank routinely uses FFP which has been thawed but not issued. After 24 hours the FFP is relabeled as thawed plasma and used up to 5 days. This has been very convenient for trauma patients. Using this inventory management approach the blood bank saved $3,300 in 1999.

5. A fifth member commented that she was concerned about another issue, besides the viability of the product. Her concern was why are all these products being requested and not used? Her blood bank has had success with educating the nursing staff and, with their Blood Bank director, addressing the issue through Medical committees. The member works at a transplant center, where about a year ago their monthly statistics showed that a significant number of units of FFP were wasted each month. They identified that the transplant MDs were requesting up to 10 units of FFP to be thawed for each case and not using the product. This was discussed in their Transfusion Committee and then the issue was taken up with the specific Medical committee. The result was that the pre-op ordering routine was changed to reduce the number of FFP units prepared for surgery for these patients.

6. A sixth member commented that when she was in the hospital environment, her blood bank set up an ordering system where they were able to distinguish between a "hold this in case I need it" order (in which case the blood bank would not thaw) and a "transfuse this on this date" order (in which case the blood bank would thaw). In this member's opinion, relabeling and trying to "recover" the plasma wasn't going to prevent the waste. She felt education might help.

7. A seventh member stated it was their policy for FFP that has been thawed and refrigerated to issue it as FFP, provided it is used within 24 hours of thawing. After 24 hours the unit is discarded. As for products issued and kept at room temperature for an extended period of time, it is their policy to return them to the Blood Bank for discard.

8. An eighth member had this to offer. Blood components leaving the blood bank and laboratory for an extended period of time create problems with regard to how they are stored and how storage conditions are documented. Some hospitals have O.R. refrigerators dedicated to holding blood components (RBC's and FFP) until they are needed. If the components are not used they can be returned at any reasonable time (within expiration dates or times), provided that proper re-identification procedures are followed on the components after their return to the blood bank. The medical center at which I worked used this system for around the last five years in their open heart surgery rooms. The refrigeration also inhibits bacterial contamination of FFP and RBC's. The problems arise when you have more than one patient with more than one type of unit/component and so on. The program at this medical center has low numbers of such cases, so there is less risk of errors resulting from this kind of practice. This member believes there is a far greater wastage of FFP and blood in the E.R., other operating rooms, and ICU's where there can be many units transfused and/or "wasted". In these areas it can be difficult to apply this kind of policy/procedure, due to cost and respective practicality. As for FFP, there is an alternative with SD-Plasma (Plas+SD). This component has been sterile-filtered and post thaw is good for 24 hours at room temperature. Therefore returns after 30 minutes should not be a problem. This member is interested in finding out how much standard FFP is wasted due to this 30-minute return limit at major surgical and trauma centers. It could be an added reason to use SD-Plasma, even though unit costs are higher.

9. Finally, in response to the question about post thaw stability of 'labile' coagulation factors a member stated there is published data that factor V has reasonable levels at 5 days post thaw, but levels of factor VIII drop lower. The FDA has been willing to accept a notation that, based on cited studies in the literature a label of thawed plasma can be used, and the plasma can used for up to 5 days post thaw, provided it has been refrigerated. The caveat is that the "thawed plasma" will not be used for factor VIII replacement. Since most hospitals use factor VIII concentrates for such replacement, this limitation is not necessarily a problem.

10. Editor's Note: The following information was provided to me by Kay Gregory of the AABB who states that the new Circular of Information (if approved by the FDA) will address thawed plasma - in a fashion very similar to that in the current edition. The circular addresses the approved uses. Here is what it says:

Description
Other Plasma components may be made from whole blood collected in all approved anticoagulants or by apheresis. These components contain stable coagulation factors such as factor IX and fibrinogen in concentrations similar to that of FFP, but reduced amounts of factors V and VIII. The volume is indicated on the label.

Actions
These components serve as a source of defective or deficient plasma proteins except for Factor V and factor VIII.

Indications
As for FFP, except that these components should not be used to treat coagulation factor deficiences of factor V and factor VIII:C

Contraindications
Do not use Plasma, Thawed Plasma, or Liquid Plasma for replacement of coagulation factors V and VIII. Otherwise, the contraindications are the same as for FFP.

Dosage & Administration
Same as for FFP.

Side Effects and Hazards
Same as for FFP.

Components Available

1. Thawed Plasma is derived from FFP prepared in a closed system, thawed at 30-37 C, and maintained at 1-6 C for 1-5 days.
2. Plasma Frozen Within 24 Hours After Phlebotomy must be separated and placed at -18 C or below within 24 hours from whole blood collection.
3. Plasma; Liquid Plasma is separated no later than 5 days after the expiration date of the Whole Blood. Plasma may be stored at minus 18 C or below. Liquid Plasma is stored at refrigerator temperature (1-6 C).

Please submit comments to the e-Network Forum.

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