Just  to throw in a thought or two [some of which may just be me playing devil's advocate!]

QC - crudely,  to evidence that process [getting sample into "analyser" - technique, performance of cartridge/cassette, output - ?interface] is producing expected result on a sample, with known value and tolerance.

How many labs either just QC a reagent lot [they are all of course CE marked] on receipt in lab, then just use it without performing any further QC?
Why do we act differently if it POCT?
 The same clinical judgments and actions may be taking place on the result produced, shouldn't we be adopting the same approach in our quality assurance process?

If you are taking responsibility for the POCT provision, I know I would be v uneasy about standing up in front of a coroner [and believe me from experience it's not something I like repeating even when I am confident that processes were correct] and proving that on the day of the incident that I can evidence that the "meter" was giving results that were fit for purpose

"So Dr James, you can evidence that 3 weeks prior to Mr X's unfortunate death, the lot of cassettes/strips was found by experienced lab staff to capable of producing an analytically correct result [add and QC was OK 6 days before incident if appropriate], yet all you can say about the day of the incident is that you believe everything was OK, but have no evidence that it was"

We do daily QC on our POCT

I know manufacturers may not like that approach - "there's an optical check/"electric cartridge etc - you don't need to do it"

Is that missing point of what IQC is for?? Happy to run with manufacturers recommendations when manufacturer will take liability for provision of testing, including offering to stand in witness box and defend recommended practice.

Quote from Pathology Quality Assurance Review [section 1.8]. Review looks at Quality in a v holistic way, putting patient at focus of quality

"The current system was fi t for the purpose for which it was designed, but
it is not fi t for the future, nor does it meet the emerging requirement for
transparency and well-evidenced quality assurance. Therefore, the Review and the
recommendations it makes will attempt to bring these features of the system into
sharper focus, strengthening existing structures to ensure these gaps are filled."

I think the key phrase here is "well-evidenced quality assurance"

Just my view

Dave James


-----Original Message-----
From: ACB Point-of-Care Testing [mailto:[log in to unmask]] On Behalf Of James Emma (RW3) CMFT Manchester
Sent: 29 January 2014 15:28
To: [log in to unmask]
Subject: Re: I-stat qc

Hi Peter
We use the same schedule as Lisa-Marie
Best wishes
Emma


Emma James
POCT Coordinator/Chief BMS
Point of Care Testing
Laboratory Medicine
4th Floor, SMH
Central Manchester University Hospitals NHS Foundation Trust Oxford Road, Manchester M13 9WL Office phone: 0161 701 2259

POCT Team: 0161 276 4891
Manchester Royal Infirmary
Royal Eye Hospital
CMFT Satellite Sites

www.cmft.nhs.uk  Central Manchester University Hospitals NHS Foundation Trust includes: Manchester Royal Infirmary, Manchester Royal Eye Hospital, Royal Manchester Children's Hospital, Saint Mary's Hospital, University Dental Hospital of Manchester, Trafford Hospitals and Community Services.


-----Original Message-----
From: ACB Point-of-Care Testing [mailto:[log in to unmask]] On Behalf Of Button Lisa-Marie (RVW) Pathology
Sent: 29 January 2014 14:47
To: [log in to unmask]
Subject: Re: I-stat qc

Hi Peter,

Our SOP states that the external simulator should be run daily. External liquid controls are run weekly. This was recommended by the rep.

Regards,

Lisa-Marie

Lisa-Marie Button
POCT Manager
North Tees and
Hartlepool NHSfT

-----Original Message-----
From: ACB Point-of-Care Testing [mailto:[log in to unmask]] On Behalf Of peter taylor
Sent: 29 January 2014 14:25
To: [log in to unmask]
Subject: I-stat qc

---
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Hi just writing an SOP for the I-STAT device, what do people recommend for a QC schedule, I get them to run a QC for each new lot number. but should they also QC weekly ?

Thanks

Peter


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