How best to manage plasma products that are returned unused and how to minimize wastage of plasma products

Several e-network members have expressed concern over wastage of plasma products and have asked for guidance from their e-network colleagues. Background to this problem can be found on related issues previously discussed on the e-Network: Expiration Date of Plasma Frozen Within 24 Hours? and Minimizing Wastage of Unused Thawed FFP.

The following questions are representative of what institutions have been asking:

1. A large transfusion service that provides blood products to a University Medical Center (including a major regional trauma center) reports that they dispense FFP and thawed frozen plasma interchangeably for trauma cases and most other O.R. cases (with some exceptions, e.g. liver transplants). Occasionally multiple units of plasma are returned to the blood bank unused, because ongoing anticipated hemorrhage did not occur, or because the patient died from their injuries. These returned units are discarded because the institution follows a "30-minute" rule for returned plasma (similar to how they manage returned RBCs). However, since patients who receive plasma transfusions often do not need plasma products to contain Factor VIII, the institution wonders if it would be acceptable for them to change their plasma return/reissue rule. They want to be able to place back into inventory thawed plasma that was maintained at room temperature for more than 30 minutes and to reissue these returned products. The institution believes that sterility of the product is no more of an issue than for room temperature stored platelets, so long as the container is intact. An additional consideration is that when plasma is required urgently, it is dispensed almost immediately after being thawed at 30C - 37C. In such a setting, even if the plasma has been out of the blood less than 30 minutes, it will be warm to the touch and be discarded. This institution is interested in knowing (1) what criteria others use for reissue of returned thawed plasma (2) what network members think is a reasonable time period at room temperature for thawed plasma to be reissued and (3) any regulatory implications of changing our practice. Their QA specialist has spoken to a representative of the FDA, who said that from the FDA perspective, the regulations for reissue (21CFR640.2(c)) apply to whole blood and red cells. The regulations for plasma (21CFR606.122(m)(2)ff) do not address time or temperature standards for reissue. Likewise, AABB Standard 5.17.3, Reissue of Blood and Components, specifies the acceptable temperature only for red cells. Thus, the inquiring institution believes that the available data support a more liberal criteria than a "30- minute rule" for reissuing thawed plasma that was returned to the blood bank, so long as the plasma is not used as a source of Factor VIII.
   
   
2. A transfusion service in a 360-bed hospital reports that their waste rate for FFP is higher than they would like. They have instituted various policies to try to minimize this waste. One thing they feel might help reduce waste is being able to thaw units more rapidly. Currently they use a plasma thawing bath by Precision with an additional pump to circulate the water. It takes about 30 minutes to thaw the units. Several years ago they tried a special microwave, but they had problems with hot spots and units exploding!

(Editor's note: According to the CAP Transfusion Medicine Checklist for Accreditation of Laboratories, compliance with Question TRM.44450 requires that if a microwave oven is used for thawing FFP, it should be FDA cleared as a Class III medical device (premarket approval), or data must be available showing acceptable preservation of labile coagulation factors and temperature maintained at less than or equal to 37C. REFERENCE: Department of Health and Human Services, Food and Drug Administration. Products used in establishments that manufacture blood and blood products. Federal Register, 1999(April 1):21CFR864.9205(b))". The inquiring institution wants to know if anyone is using equipment that can thaw 2 to 4 units in ten to fifteen minutes?

The above questions were referred to selected experts for their review prior to initiating a general e-network forum discussion.

Here is what some experts had to say:

1. The editor of the 13th edition of the AABB Technical Manual stated that a review of the Standards, Circular of Information and Technical Manual did not reveal any regulation or recommendation for storage time of thawed FFP that has been dispensed and later returned to the blood bank unopened, other than thawed FFP has a 24-hour shelf life when stored at 1-6C, and if shipped, thawed FFP must be maintained at 1-10C. Since there are no set regulations regarding the handling of unopened thawed plasma products that have been returned to the blood bank, she believes that it would be up to the facility to set a procedure, however she defers to the AABB Standards Committee for their interpretation.  She expressed the opinion that a 30-minute limit of having the thawed product out of refrigeration as a criterion for permitting the blood bank to place a returned thawed FFP back into inventory seems appropriate, but she wonders if the returned product should be relabeled as Frozen Plasma Thawed (as opposed to Fresh Frozen Plasma-Thawed), since the storage of the product in the patient treatment area may not have met the required temperature and was not controlled. Another option would be to issue the thawed FFP in a container with ice that would maintain the temperature within the 1-10C range for product shipping, (since the product is being transported to the patient care area). Accepting a plasma product back for the inventory after the product has been out of the blood bank for 30 minutes would not be a problem if the plasma was kept at 1-10C, and the facility should not need to relabel the thawed product until after 24 hours. Each facility has the option of using a Thawed Plasma product that has been stored at 1-6C in a closed system for up to 5 days from the time of thawing.
   
   
2. The editor of the upcoming 14th edition of the Technical Manual commented that at his institution, plasma is issued to the OR on ice in a cooler. Thus, returned plasma becomes thawed plasma (good for 5 days). Handling plasma in this fashion avoids having to interpret the 30-minute rule (which was validated for RBC units, not FFP). The argument about platelets being stored at 20-24C really does not apply, as this is a necessity of platelet survival. Since coagulation factors are more labile at 20-24C than at 1-6C, one could argue it is best to keep thawed plasma at 1-6C; this is particularly true when it is anticipated that these products may sit in the operating room for a few hours prior to infusion, e.g. a liver transplant. In many instances when plasma is urgently requested, the temperature of the bag as it is removed from the water bath is not 30-37C but <10C, since it is removed as soon as it is liquid. Thus, keeping thawed plasma on ice is similar to the plasma that is issued for emergency use. In terms of bacterial contamination with prolonged storage at room temperature, why place a recipient at risk when a simple method of minimizing the risk exists (keeping plasma on ice in a cooler)?
   
   
3. The Director of Regulatory Affairs of the AABB was willing to provide her own opinion on this topic (but she wanted to emphasize that her opinion does NOT necessarily represent AABB policy). She believes that facilities may institute their own policy for reissue of plasma, if the reissued plasma is not being used for Factor VIII. She was of the opinion if a facility did institute a policy allowing reissue of thawed plasma, that such a policy could be implemented so as to be compliant with current regulations.

ADDENDA Sept. 19, 2001

Here are the responses from the general membership of the e-Network Forum:

4. A blood banker from Anchorage, Alaska commented that she highly recommends the plasma thawer from Helmer. At her facility they are able to thaw plasma in eight to twelve minutes.

5. A hospital transfusion service supervisor in Nevada reports that his hospital does not use temperature controlled transport containers when issuing blood components for transfusion and enforces a policy of discarding an RBC unit that is returned to the blood bank more than 30 minutes after it was dispensed. On the other hand, their local policy requires that they discard an FFP or platelet unit if it is returned more than 2 hours after being issued from the blood bank. They want to re-evaluate their policy of discarding non-RBC components such as FFP, thawed plasma, and platelets that are returned to the blood bank. They wonder what other institutions do about such returned components.

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

W. Tait Stevens, MD
CBBS e-Network Forum Assistant Editor & Moderator