Blood Component Donation Number Check Digit

[GMC]

We are continuing to test a new IT system for blood transfusion and have another query. The ward client view does not display the check digit for blood components and some clinical staff have not fated the blood component as the numbers do not match. We the HTT maintain that the check digit should be visible when staff fate blood components but we have been asked to provide the evidence:

'We need clear documented evidence that the check digit MUST be visible on the ward client screen.
Emails from colleagues or concerns it “could” be a risk won’t cut it Im afraid – I need something that clearly states it is a requirement'

[Orr]

I can't see anything in the BSH guidelines about the check digit being present. However, they do refer to the unit donation number , and not the unit donation number minus the check digit! So the HTT is right in maintaining that this number must be consistent across the system used.

Our clinical colleagues have enough challenges on the wards without having to deal with the situation where they are trying to check a number that is different from the bag to the screen and being told this is acceptable practice- would they be expected to do this with a patient hospital number? In next to no time it will be just check the first 4 digits and ignore the last 10.

This is basic GMP stuff, perhaps the MHRA inspectors could give us some words of wisdom on this please?

[Chris Robbie]

The Council of Europe Guidance talks about numbers throughout whether donation numbers, batch numbers, in relation to labeling, etc. At no time does it talk about part-numbers or incomplete numbers

https://www.edqm.eu/sites/default/fi...cember2016.pdf

e.g.

6.2.5. Systems of sterile blood bags used for the collection of blood and blood components and theirprocessing must be CE-marked or comply with equivalent standards if the blood and bloodcomponents are collected in third countries. The batch number of the bag must be traceablefor each blood component (Directive/2005/62/EC/Annex 6.2.2).

I would argue a batch number isn't traceable if it isn't complete.

[GMC]

I can't see anything in the BSH guidelines about the check digit being present. However, they do refer to the unit donation number , and not the unit donation number minus the check digit! So the HTT is right in maintaining that this number must be consistent across the system used.

Our clinical colleagues have enough challenges on the wards without having to deal with the situation where they are trying to check a number that is different from the bag to the screen and being told this is acceptable practice- would they be expected to do this with a patient hospital number? In next to no time it will be just check the first 4 digits and ignore the last 10.

This is basic GMP stuff, perhaps the MHRA inspectors could give us some words of wisdom on this please?

Thank you for your reply
GMC

[GMC]

Thanks Chris

[Orr]

So the requirement for this is under the BSQR ; The person responsible for the management of a hospital blood bank shall—
section 9 (1) (e): maintain, for not less than 30 years, the data needed to ensure full traceability of blood and blood components, from the point of receipt of the blood or blood component by the hospital blood bank;

If your colleagues still don't accept this affecting the unambiguous traceability of the units, then they have the responsibility to inform your CEO (as they are the responsible person for the hospital blood bank compliance) with reasons for deviating from the regulations and placing this at risk.

This is really interesting, please keep us updated on how things go as many of us are not getting the IT support we need for improvement projects.

bw