What is the purpose of quality in pathology?

I have opened a thread for us to discuss what we all feel is the purpose/ role of 'quality' within pathology, it would be great if you joined in- regardless of your profession.

I find that unless I understand how a clause/ reference in both ISO 15189 or GPGs relates back to the patient, staff or safety of the blood supply ( which is basically the patient), then it would feel meaningless, and I would lose the will. Luckily my team are far more persevering and patient than I am :o. For everything we do I believe we need to understand the [I]'why'[/I] we are meant to do this, and simply stating that it's part of the Standards etc- isn't helpful and contributes to hours of discussions, extra work that has little added value, and is unachievable to maintain.

Can anyone think of a UKAS Standard or other non-conformance that has been cited, that appears to be somewhat meaningless and that we could discuss. Maybe we could even agree on a standard approach to addressing these issues?

bw

Rashmi

Excellent Thread. Discussions like this are going on all the time at the Research Quality Association, a not-for-profit professional association for quality professionals ([url]www.theRQA.com[/url])

Many thanks.
So, one I have heard about is the supposed need (UKAS) to regularly test [I]patient samples[/I] containing known antibodies across analysers within a pathology network.
Doesn't NEQAS/ EQA testing fulfill this criteria ?

How can using a patient sample be right?- consider the following:
[LIST][*]antibody strength is unknown, so may or may not react across the platforms- what does this demonstrate?[*] transport conditions and time could adversely affect the sample, leading to different results between labs.... then we end up having to waste more time addressing this.[*]the patient sample is probably needed in the lab for 7days for issuing blood, and using the plasma may lead to having to re-bleed/re- test the patient.[*]what are the ethics in taking this approach?[*]I gather that other pathology disciplines are even more so distressed in having to do this with their numerous tests[/LIST]

Some clarification would be helpful. If we understand the rationale, then it might not cause so much angst- but we still need to consider the ethics involved.

bw

Thank you, I also wanted to talk about NEQAS / EQA. I haven’t conducted any tests myself yet, but I plan to do it.

Hi olyberse,
I have forwarded the question to a UKAS assessor for formal clarification and hopefully I will receive a reply within a couple of weeks, that I will post.
bw

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

[I]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]

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.

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

[QUOTE=Rashmi;6033]Hi olyberse, please see response below from a UKAS technical assessor
bw
Rashmi
_______________________________________________________________________
[B]Reply:[/B]
I think you are referring to clause 5.6.4 – Comparability of examination results.

[I]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]

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.[/QUOTE]

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

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