One persons SABRE is another ones Normal practice

[Chris Robbie]

Bear with me, as it will be very difficult to address some of these points without risk of being misinterpreted!

The BSQR exists to ensure quality and safety of the component and that it meets the requirements of the patient without risk of harm, and not specifically to ensure that guidelines are met. It is up to each BB to decide how to meet the guidelines, or to risk assess and justify why they might not meet the guidelines.

Your entire QMS is made up of numerous parts to ensure compliance. For example the existence or non-existence of flags or warnings is not the be all and end all of ensuring the correct component is selected. If the process is robust enough to ensure the correct component is selected, that would be acceptable. However, often processes are not totally robust and flags and warnings are deemed to be necessary. Unfortunately it is not one-size-fits-all.

When it comes to "error reporting" (I won't say "SABRE" reporting as that is another chapter entirely) it would depend on whether a process/SOP was deviated from.

If your SOP states that "Patient requires X, you must supply X" then you supply X or it is an error
If it states "Patient requires X, you must supply X unless X is not available, or cannot be supplied in time, then it is acceptable to supply Y" and Y is supplied that is not an error.

When investigating the first situation, you may decide that is too rigid and an improvement can be made to change the process to the second example. If you are concerned that situation 2 is too flexible and open to misuse, then a robust deviation process that is used to manage the process of deviations from strict procedures is also acceptable.

So, I think it is true that different blood banks might be doing different things to interpret guidelines and meet compliance, but whether something is an error or not depends on what the SOP says and how you deviate from it.