A transfusion service medical director at a 750 bed hospital reports that her hospital employs and supervises individuals who perform therapeutic plasma exchange (TPE) procedures. However, other hospitals in her community perform TPE services using a contracted commercial entity. At her hospital they do not pool the plasma that is used during TPE procedures and each plasma unit is 'hung' individually. On the other hand, at the neighboring hospitals the contracted TPE service requests that plasma used for TPE be pooled into a single large bag with a capacity to hold many liters. The expiration date for pooled plasma ranges from 4 hrs to 24 hrs, depending on local hospital policy. She acknowledges that if pooled plasma is prepared as a closed system using a sterile connecting device, one might argue that the pool would have an expiration similar to that of thawed plasma (up to five days after thawing if kept refrigerated at 1-6C). On the other hand, if the pooling is done in an open system, room temperature stored pools might expire in as few as 4 hours (similar to pooled random platelets). On the other hand, if pooled plasma was refrigerated at 1-6C, the pool might not expire for 24 hours. She wonders if others use pooled plasma for TPE procedures, and if so, how is the plasma pool prepared (open or closed system), how is the pool stored (refrigerated or at room temperature) and what expiration is assigned? She would also like to know the basis for each responding colleague's approach.

The following comments have been received.

ADDENDA May 4, 2005

1. A doctor and quality manager in Santander, Spain reports that he favors NOT pooling the plasma used in therapeutic plasma exchange for two main reasons:

• If the pooling bag breaks, you lose all the plasma.
• If an adverse reaction associated with the transfusion occurs, you can potentially limit the work-up to fewer implicated donor products.

ADDENDA May 5, 2005

2. A colleague in a Sunbelt State reports that her institution recently completed an FDA inspection during which the FDA investigator observed them pooling plasma for a TPE. The investigator reportedly had never seen plasma being pooled before, and this observation led to a conversation with CBER. To make a long story short, a series of email correspondences followed with CBER stating by email that: 1) her institution could pool plasma (but that this pooled product was not licensed nor regulated by the FDA; 2) her institution could assign a 24 hour shelf life to the pooled plasma provided it was stored at 1-6C (using the same rationale as for RBC units prepared in an open system); and that 3) her institution did not need to apply for a variance to pool plasma. Unfortunately, her institution was cited for pooling thawed cryoprecipitate-reduced plasma into the same container as units of thawed plasma. They called this hybrid pool "cryo reduced plasma". She acknowledges that her staff made the hybrid pool because they were trying not to waste products but forgot their GMP training! Based on the 483 citation, they intend to only pool like products and like types (O+ cryo reduced plasma in one bag, O Neg cryo reduced plasma in another bag, O+ plasma in a 3rd bag, etc). She adds that her contact at CBER recommended is that if one is going to pool plasma, the institution should document the thought process and rationale for doing this, the safety aspects, and how the process will be audited to assure control and detect if there are any problems, etc. One might extend such an approach to other reconstituted products, such as pooled RBCs with FFP for an exchange transfusion. The physicians at her institution feel that it is a safer practice for the blood bank staff to pool plasma rather than for the nurses to hang individual units on the floor. It is more labor intensive for the blood bank staff and once the pooling is done, the pooled product has a 24 hour outdate, instead of up to 5 days for thawed plasma or thawed cryo-reduced plasma.

ADDENDA May 10, 2005

3. A transfusion medicine physician in Texas sees no real advantage of pooling plasma for TPE. However, he can think of a few disadvantages:

1. If there is a reaction, it may be difficult to identify which unit caused the problem.
2. The product expiration date is changed from 5 days to 24 hrs, and this can potentially could lead to wastage if there is a delay in starting the procedure.
3. The blood bank is often asked to perform the pooling, using the time and labor of laboratory personnel.
4. The volume that can be pooled is limited, but may result in a 'heavy" product which may break.

The Texan acknowledges that he prefers using "jumbo plasmas" (~600 mL per container) to reduce the donor exposure and to reduce the amount of clerical work required by RNs to verify all information.

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