We currently run on manufacturers ranges which isn’t ideal. Going forward we are going to review all data across multiple lots and calculate SDs for L1 and L2. Then will any new change in lot we plan on changing the mean only. If the SD needs to widen this may indicate a deterioration of assay performance (specific to a meter or a specific strip lot). We will continue to review the SD's to ensure they are tight enough to reflect the assay performance as an ongoing review. We do this for assays in the lab but have not yet rolled this out to POCT but will do in the next 3 - 6 months hopefully
Helen Peat
Blood Sciences Laboratory Manager
BB: +44 (0)7826875875
Tel: 07826875875
Internal: 15963
Email: [log in to unmask]
Web: http://www.uhb.nhs.uk
Clinical Laboratory Services, Level -1, Office 8
Pathology - University Hospitals Birmingham NHS Foundation Trust
Queen Elizabeth Hospital Birmingham, Mindelsohn Way, Edgbaston
Birmingham, B15 2GW
-----Original Message-----
From: ACB Point-of-Care Testing [mailto:[log in to unmask]] On Behalf Of Glover Sarah [RCD]
Sent: 23 April 2018 09:51
To: [log in to unmask]
Subject: Re: UKAS Findings
Hi David,
Our glucose and ketone strips also have ranges associated with each lot. These do differ for each lot but are very similar. The way we approach this is to re-evaluate the QC limits every 6 months for each strip lot currently in use. Once we have calculated the range for each lot, we then establish an appropriate range which can be applied to all lots. This is done by setting the lower QC limit as the lowest limit of all strip lots and the higher QC limit as the highest upper limit of all strip lots.
Kind Regards
Sarah
Dr Sarah Glover PhD FRCPath
Consultant Clinical Biochemist & POCT Clinical Lead Blood Sciences, Biochemistry Harrogate and District NHS Foundation Trust H Tel: 01423 55 3056
e-mail: [log in to unmask]
-----Original Message-----
From: ACB Point-of-Care Testing [mailto:[log in to unmask]] On Behalf Of Ryder David (UHMB)
Sent: 17 April 2018 17:52
To: [log in to unmask]
Subject: [SPAM] Re: UKAS Findings
Hi,
Just out of interest, would you not have to calculate new qc ranges for each lot of QC/strips? (I say strips as our manufacturer prints their ranges on the strip canister.) How does this work? What are the assumptions made when calculating the QC ranges?
Kind Regards,
David Ryder, Point of Care Testing Coordinator
University Hospitals of Morecambe Bay NHS Foundation Trust Furness General Hospital Dalton Lane Barrow-in-Furness, Cumbria, LA14 4LF
External: 01229 491171 | Extension: 51171 | Mobile: 07580 818900
-----Original Message-----
From: ACB Point-of-Care Testing [mailto:[log in to unmask]] On Behalf Of Glover Sarah [RCD]
Sent: 12 April 2018 16:55
To: [log in to unmask]
Subject: Re: UKAS Findings
Hi Trish,
We have tightened our QC ranges for the glucose meters by calculating our own in-house QC limits as per Richard's approach.
We monitor the glucose meter QC by device on a monthly basis to detect any trends. This is a time consuming process (we have ~65 meters) however as the standard clearly states 'quality control data shall be reviewed at regular intervals...' I see no other way around this. UKAS are happy with our approach to QC review.
The standards do not define 'regular intervals' so that is down to the individual to decide upon. There may be some scope for less frequent monitoring however it would be hard to justify this for devices where the QC is run daily.
Kind Regards
Sarah
Dr Sarah Glover PhD FRCPath
Consultant Clinical Biochemist & POCT Clinical Lead Blood Sciences, Biochemistry Harrogate and District NHS Foundation Trust H Tel: 01423 55 3056
e-mail: [log in to unmask]
-----Original Message-----
From: ACB Point-of-Care Testing [mailto:[log in to unmask]] On Behalf Of KUA, Richard (PLYMOUTH HOSPITALS NHS TRUST - RK9)
Sent: 12 April 2018 16:32
To: [log in to unmask]
Subject: [SPAM] Re: UKAS Findings
Hello Trish
We would not be able to do this on our (UniPOC) software either.
My proposed solution is to calculate the true SD of the set of glucose meters from all the QC material run over a set time period.
Set the QC lock out more tightly that the 3SD normally allowed by our manufacturer.
The deviation permitted by the QC level should be less than an agreed maximum deviation set by users (in our case clinical leaders or POCT governance group).
This would in effect be a tighter level of control and should keep the deviation within a clinically insignificant range.
What do you think?
Kind Regards
Richard Kua
POCT Co-Ordinator
Derriford Hospital Plymouth
Tel- 01752 792299
-----Original Message-----
From: ACB Point-of-Care Testing [mailto:[log in to unmask]] On Behalf Of Patricia Lockett
Sent: 12 April 2018 10:12
To: [log in to unmask]
Subject: UKAS Findings
Hi,
During our recent UKAS inspection for Point of Care it was highlighted that there was no IQC trend analysis in place for every individual glucose meter (we have 281 meters).
Our glucose meters are linked to Cobas IT1000, but the IQC summaries are limited, and you are unable to produce results per site for every meter, just individual meters, which means this could be a very time consuming task every month.
Can anyone suggest a possible solution.
Trish
Patricia Lockett MSc (Clin Chem)
Senior Biomedical Scientist for Point of Care Testing and Laboratory Lead for the Bowel Cancer Screening Programme Hub Clinical Support & Screening Services | Gateshead Health NHS Foundation Trust Queen Elizabeth Hospital | Queen Elizabeth Avenue | Sheriff Hill | Gateshead NE9 6SX |
T: 0191 445 8563 | E: [log in to unmask] |
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