What is the purpose of quality in pathology?

[Rashmi]

Hi olyberse, please see response below from a UKAS technical assessor
bw
Rashmi
__________________________________________________ _____________________
Reply:
I think you are referring to clause 5.6.4 – Comparability of examination results.

There shall be a defined means of comparing procedures, equipment and methods used and establishing the comparability of results for patient samples throughout the clinically appropriate intervals. This is applicable to the same or different procedures, equipment, different sites, or all of these……

I’m not sure why your colleagues think that they have to send out patient samples. As you have described, there are alternatives available, they just need to be able to explain and justify their approach to the assessor. The key thing is that comparability of examination results is being formally documented and reviewed on a regular basis and any spurious results are acted upon and users notified. This may be different to your normal EQA activity.

I have observed many labs which are compliant with this clause and don’t send out patient samples. It could be that your colleagues are possibly not meeting some other aspect of the clause such as the documentation of comparison and review? Hope this helps.

[Q4Quality]

Hi Rashmi,
Based on UKAS response, do you notify your service users on every spurious EQA failures?
In my lab we just raise that as aNC and conduct the investigation. we don't necessarily inform the service users. Should we be notifying service users on failed EQA.

Thanks

Hi olyberse, please see response below from a UKAS technical assessor
bw
Rashmi
__________________________________________________ _____________________
Reply:
I think you are referring to clause 5.6.4 – Comparability of examination results.

There shall be a defined means of comparing procedures, equipment and methods used and establishing the comparability of results for patient samples throughout the clinically appropriate intervals. This is applicable to the same or different procedures, equipment, different sites, or all of these……

I’m not sure why your colleagues think that they have to send out patient samples. As you have described, there are alternatives available, they just need to be able to explain and justify their approach to the assessor. The key thing is that comparability of examination results is being formally documented and reviewed on a regular basis and any spurious results are acted upon and users notified. This may be different to your normal EQA activity.

I have observed many labs which are compliant with this clause and don’t send out patient samples. It could be that your colleagues are possibly not meeting some other aspect of the clause such as the documentation of comparison and review? Hope this helps.

[Rashmi]

Hi Q4Quality,
No- we do exactly as you, and it would depend on investigation findings as to whether service users are informed. If it shows there is a system-wide problem that may have impacted on patient testing eg staff may have been regularly misinterpreting results that could affect clinical decisions, that would be reported.
Also, our monthly Pathology Quality Report would show any failures, and these would also be Datix'd for transparency.

bw