Surely the ISO standard for acceptance testing is trying to ensure that the new product has arrived in a state suitable for use. This should be validated before the old stock is used up. If the on analyser validation of the latest delivery fails and you haven't got a cassettes from a previous delivery to fall back on then the service will suffer whilst you wait for a new delivery of cassettes.
So, on analyser validation seems to be OK as long as it is done soon after the delivery has arrived with cassettes from an old delivery in-hand if it fails.
Stephen Brown CSci FIBMS
POCT Manager, The Pathology Partnership
-----Original Message-----
From: ACB Point-of-Care Testing [mailto:[log in to unmask]] On Behalf Of ACB-POCT automatic digest system
Sent: 28 April 2016 00:01
To: [log in to unmask]
Subject: ACB-POCT Digest - 25 Apr 2016 to 27 Apr 2016 (#2016-55)
There are 5 messages totaling 1906 lines in this issue.
Topics of the day:
1. EasyCheck Pregnancy kit
2. GEM 4000 pre-acceptance testing (4)
----------------------------------------------------------------------
Date: Wed, 27 Apr 2016 03:11:57 +0000
From: S&SEl-Jack <[log in to unmask]>
Subject: EasyCheck Pregnancy kit
Hello everybody
does anyone have any experience with the EasyCheck POCT pregnancy kit?
we found a couple false negatives with it.
any experience/outcome of past evaluation would be appreciated.
cheers
samarina
------------------------------
Date: Wed, 27 Apr 2016 14:43:05 +0000
From: "Bennett Michelle (BFWH)" <[log in to unmask]>
Subject: GEM 4000 pre-acceptance testing
Hi All
Of those of you that are currently using the GEM 4000 blood gas analysers, do any of you have a process in place for pre-acceptance testing, and if so would you be willing to share? Any responses would be greatly appreciated.
Best wishes
Michelle
Michelle Bennett
Point of Care Coordinator
Blackpool Teaching Hospitals NHS Foundation Trust Pathology Department | Blackpool Victoria Hospital
* 01253 (95) 7511
* [log in to unmask]<mailto:[log in to unmask]>
[Dot_not_touch[1]]Stop and think - are you trained on a medical device? If not, don't touch!
------------------------------
Date: Wed, 27 Apr 2016 15:00:30 +0000
From: Michelle Miller <[log in to unmask]>
Subject: Re: GEM 4000 pre-acceptance testing
Hi Michelle
No we aren't doing anything for the GEMS, but we are for other POCT such as glucose strips etc. I really don't see the need to validate a validation product!
We are monitoring the temperature of the packs/CVP in storage before use to ensure integrity but I really don't see why this isn't enough for ISO.
Michelle
Michelle Miller
Biochemistry Laboratory and POCT Manager Biochemistry Department University Hospital of South Manchester [log in to unmask]
0161 291 4783
[cid:2F051E97-6C52-46C8-A0E5-171AE0EB25DC@local]
From: ACB Point-of-Care Testing [mailto:[log in to unmask]] On Behalf Of Bennett Michelle (BFWH)
Sent: 27 April 2016 15:43
To: [log in to unmask]
Subject: GEM 4000 pre-acceptance testing
Hi All
Of those of you that are currently using the GEM 4000 blood gas analysers, do any of you have a process in place for pre-acceptance testing, and if so would you be willing to share? Any responses would be greatly appreciated.
Best wishes
Michelle
Michelle Bennett
Point of Care Coordinator
Blackpool Teaching Hospitals NHS Foundation Trust Pathology Department | Blackpool Victoria Hospital
* 01253 (95) 7511
* [log in to unmask]<mailto:[log in to unmask]>
[Dot_not_touch[1]]Stop and think - are you trained on a medical device? If not, don't touch!
------------------------------
Date: Wed, 27 Apr 2016 15:02:03 +0000
From: "HOLLOWOOD NICKY (RCD) PATHOLOGY" <[log in to unmask]>
Subject: Re: GEM 4000 pre-acceptance testing
HI Michelle,
We "receive" and document this receipt of our blood gas cartridges on arrival. As they are individually wrapped all we can do when they arrive in the lab is check the condition and storage requirements and record receipt. We then complete the verification process once the cartridge is put on the analyser and CVP'd. This was acceptable to UKAS at our recent POCT inspection.
Hope this helps.
Thanks
Nicky Hollowood
POCT Manager
*Post: Harrogate and District NHS Foundation Trust, POCT Department, Pathology, Fewston Wing, Lancaster Park Road, Harrogate, HG2 7SX
*Tel: 01423 555858 *Fax: 01423 553081 *e-mail: [log in to unmask]<mailto:[log in to unmask]>
[Trust_Banner_LEFT_RGB]
From: ACB Point-of-Care Testing [mailto:[log in to unmask]] On Behalf Of Bennett Michelle (BFWH)
Sent: 27 April 2016 15:43
To: [log in to unmask]
Subject: GEM 4000 pre-acceptance testing
Hi All
Of those of you that are currently using the GEM 4000 blood gas analysers, do any of you have a process in place for pre-acceptance testing, and if so would you be willing to share? Any responses would be greatly appreciated.
Best wishes
Michelle
Michelle Bennett
Point of Care Coordinator
Blackpool Teaching Hospitals NHS Foundation Trust Pathology Department | Blackpool Victoria Hospital
* 01253 (95) 7511
* [log in to unmask]<mailto:[log in to unmask]>
[Dot_not_touch[1]]Stop and think - are you trained on a medical device? If not, don't touch!
------------------------------
Date: Wed, 27 Apr 2016 15:02:17 +0000
From: "Bennett Michelle (BFWH)" <[log in to unmask]>
Subject: Re: GEM 4000 pre-acceptance testing
Hi Michelle
That's great, thanks. I appreciate any responses that also suggest that it might not be an essential process for these analysers. Do you store consumables centrally in the lab?
Thanks
Michelle
From: ACB Point-of-Care Testing [mailto:[log in to unmask]] On Behalf Of Michelle Miller
Sent: 27 April 2016 16:01
To: [log in to unmask]
Subject: Re: GEM 4000 pre-acceptance testing
Hi Michelle
No we aren't doing anything for the GEMS, but we are for other POCT such as glucose strips etc. I really don't see the need to validate a validation product!
We are monitoring the temperature of the packs/CVP in storage before use to ensure integrity but I really don't see why this isn't enough for ISO.
Michelle
Michelle Miller
Biochemistry Laboratory and POCT Manager Biochemistry Department University Hospital of South Manchester [log in to unmask]<mailto:[log in to unmask]>
0161 291 4783
[cid:2F051E97-6C52-46C8-A0E5-171AE0EB25DC@local]
From: ACB Point-of-Care Testing [mailto:[log in to unmask]] On Behalf Of Bennett Michelle (BFWH)
Sent: 27 April 2016 15:43
To: [log in to unmask]<mailto:[log in to unmask]>
Subject: GEM 4000 pre-acceptance testing
Hi All
Of those of you that are currently using the GEM 4000 blood gas analysers, do any of you have a process in place for pre-acceptance testing, and if so would you be willing to share? Any responses would be greatly appreciated.
Best wishes
Michelle
Michelle Bennett
Point of Care Coordinator
Blackpool Teaching Hospitals NHS Foundation Trust Pathology Department | Blackpool Victoria Hospital
* 01253 (95) 7511
* [log in to unmask]<mailto:[log in to unmask]>
[Dot_not_touch[1]]Stop and think - are you trained on a medical device? If not, don't touch!
------------------------------
End of ACB-POCT Digest - 25 Apr 2016 to 27 Apr 2016 (#2016-55)
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