ISBT requirements to assign a unique number to a pool of blood components
A colleague wonders about any ISBT requirements to assign a unique number to a pool of blood components. For example, is there a requirement to label a pool of 5-6 single donor cryoprecipitate components? Does any regulation mandate the use of an ISBT number to designate a pooled product? According to the inquiring colleague, at least one computer system currently assigns an automatically generated pool number when 5-6 single cryo units are physically pooled.
Editors' NOTE: The ISBT website makes a comment about pooling blood components. Reproducing here: "9. (Question): If I pool products that are collected from another facility, whose facility identification number is supposed to appear on the ISBT 128 label and where? Answer: Pooled products should be assigned a unique identification number by the modifying facility. This number will include the facility identification number of the pooling facility and be placed at the top of the upper left quadrant of a 4"x 4" label. Beneath this number should appear the name and location of the pooling facility. Records of the units used in the pool should be maintained by the pooling facility."
The following comments have been received.
ADDENDA Jan. 23, 2009
- A blood banker from Ohio writes:
ISBT products can be pooled at facilities other than where collected. An example may be seen at http://freeisbt.googlepages.com under "Pooled Platelets with further processing".
Some systems will create sequential pool numbers, such as P1234, followed by P1235. These numbers will not be ISBT compliant, but they must be printed as a barcode to meet FDA requirements. If these pooled platelets are not shipped, it is not mandatory to be ISBT compliant, and so the unit can be labeled with that number. I have tested one system (Sunquest) which generates pool numbers. The system allows you to scan the ISBT format product codes, etc, but will still allow barcode scanning of the pool number printed with Code 39 or Code 128.
One workaround I have seen is to "ship the unit out" to your own facility. Then receive it back in with the ISBT pool number. For example, if the transfusing hospital had a facility number "W1234" and creates a pool number "P2501" and the creation date is 2/1/09, the unit could be brought back in as pool number W123409002501 (the 6th and 7th digit being the year and the last 4 digits being the pool sequence number).
Submit comments to the e-Network Forum at enetworkforum@cbbsweb.org
Ira A. Shulman, MD
CBBS e-Network Forum Senior Editor & Moderator
W. Tait Stevens, MD
CBBS e-Network Forum Editor & Moderator
Elizabeth M. St. Lezin, MD
CBBS e-Network Forum Associate Editor & Moderator
The e-Network Forum is supported in part by the California Blood Bank Society (CBBS) and the American Red Cross Blood Services (ARCBS) and endorses collegial discussion among blood banking and transfusion medicine professionals. However, neither the CBBS nor the ARCBS in any way endorse the specific views and opinions expressed in the forum. The forum is not intended as a substitute for medical or legal advice and the content should not be relied upon for any medical or legal purposes. Readers should make their own determinations as to: (i) what constitutes appropriate medical, technical, and administrative practices, and (ii) how best to comply with laws and regulations relevant to their questions. For the latter, they should consider consulting, as to any medical matters, a qualified physician, and, as to any legal matters, an attorney familiar with related state and federal laws. The user of the forum, by accessing same, assumes all risks arising out of such use and releases CBBS and their respective members, directors, officers and agents from and against any loss, damage, claim or liability arising out of such use of the Forum.