A transfusion medicine physician in New England reports that his hospital is migrating from a "home-grown" blood bank information system to a commercial system for which the FDA has issued a 'Substantially Equivalent 510(k) Device Information' notification. He adds that their home-grown system used a format for their blood product unit numbers that cannot be used with their new information system. Thus, in order to "import" historical unit information into their new system, they need to convert old unit numbers into new unit numbers. The inquiring New Englander is concerned about compliance implications of reassigning unit numbers to historical units, and he would like to know how other institutions that have changed information systems have dealt with this issue. He reports that he reviewed the information in Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application (PDF) but could not find a clear answer to his question in this document.

ADDENDA May 20, 2005

The following comments have been received.

1. A transfusion medicine physician at a hospital in one of the five boroughs of New York reports that in their experience there are two issues that need to be considered when embarking on a conversion of unit information for the purpose of switching from a home-grown to commercial computer system:

• archiving transfusion recipient transfusion history
• tracing specific units in order to conduct recalls or product withdrawal follow ups

For archiving transfusion recipient transfusion histories, the information needed would include the kind of components that a patient received, a converted unique identifier for each component that the patient received, and the date and (perhaps) time each component was issued. For the aforementioned purpose a converted unit number should not be problematic, provided the converted unit number can be traced back to the original unit number.

For the purpose of tracing specific units to specific recipients based on an ID code provided by the supplier (as in recalls, lookback, etc), a change from an original to a converted identifier could present a challenge. One possible solution might be to create a freestanding database (using MS Access or some other program) of all transfusion information that is in the legacy system, so that the data can be searched using the supplier's original unit identification number, which then links to the converted number. The New Yorker's institution reports having created such a database to resolve another data conversion problem, that the process was not a large undertaking, and that the processes worked for them.

2. A colleague in Spain reports that his institution is changing to a new information system that will be compliant with code ISBT 128. This change in information systems and barcode symbology presents them with the challenge of converting from old donation codes (codabar 8 digits) to newer more complex codes. In order to maintain traceability of products that have already been dispensed, and to avoid needing to relabel all of their "in-date" stock (which can be particularly complex for FFP), they can take advantage of the fact that their new information system can handle older donation codes by adding a series of zeroes to the left of the original donation number. i.e. number 12345678 changes to 000012345678, and they will keep a separate record of each product description for reference if necessary for the coming years.

3. A blood bank supervisor at a hospital in the San Fernando Valley reports that when making major changes in their blood bank computer systems, they have never attempted to capture old blood product information into the new system databases. Rather, the old product histories were either maintained on an archived system or saved onto a disk, readable in MS Word. The only blood products that they have included in a new system were products that were actually "in-date" at the time of the conversion, which would be available to be crossmatched or dispensed once the new system was implemented. When necessary to track old products (e.g., lookbacks, recalls, market withdrawals), they have always been able to retreive final disposition data using their archived data. On the other hand, patient histories (i.e., patient group and type, comments, transfusion requirements, and antibodies), have always been transferred from their old to new systems, sometimes with much difficulty.

Please submit comments to the e-Network Forum.

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