Blood Bank System FDA Validation Requirements

[sbrodbeck]

Are any of you recieving orders and providing results for ABO and Rh in the general LIS just of a mechanism of pushing and pulling information? All work; patient history, reactions, blood transfusion history, unit disposition, etc would be done manually (no system for FDA validation requirments).

[Deny Morlino]

As we do not have the blood bank module from Soft this is the situation we are in. We do not report any blood bank results through the LIS. The chart copy of the blood bank requisition is the "official" copy. It was felt that we ran a risk with the documentation in the LIS / HIS you describe. Nursing units would access this elecrtonic version vs going to the medical record. For this primary reason we do not "key" results to the LIS. I agree with this stance even though I can see the value of the information flow you are describing. The chances are high enough for mistakes to occur in a paper system. Adding a layer to the process with "another place" to maintain the information is just asking for an error to occur. I dread / look forward to the day we go with the soft bank system. Life will be very different.

[bduff]

I agree with Deny. To put that extra layer of entering in the results is just asking for an error to occur. I would try to stay away from doing that as long as you can. Deny, I hope you get to experience the soft bank system soon! It is a great system!

[David Saikin]

If your system does not have any truth tables and you are only reporting interps . . . this is not considered a Medical Device by the FDA, hence, no validation requirements (since there is nothing to validate). I would say you have no choice but to enter results into your system, as, I assume, that is how your results go to the pt care areas. It is probably prudent to review a certain percentage of computer entry for correctness.

[BLipkin]

This was how we did things for over six years while we were without a blood bank system. We enetered the Type and Screen results into the LIS in order to not only generate reports, but also to generate charges to the billing system. We never had any major issues because of this. The key for us to always go to the paper patient/transfusion history when doing any testing/product selecting on a patient, and not to consult the results in the LIS.