We have been through two UKAS assessments. We have a statement in our SOP for stock control that acceptance testing is done on the basis of calibration and IQC. If these are acceptable then we have performed acceptance testing. We've also produced a flow chart with prompts for staff to investigate if calibration fails or IQC is out; including is this a new batch of reagent? which delivery did the reagent arrive on? and so on. It was found to be acceptable by our assessor. I've found that with assessment against ISO 15189, it's incredibly easy to over-complicate and create more work for staff. Hope this helps,
helen
Helen Verrill
Consultant Clinical Scientist | North Tees and Hartlepool NHS Foundation Trust
T: 01642 624455| E: [log in to unmask]
www.nth.nhs.uk
-----Original Message-----
From: Clinical biochemistry discussion list [mailto:[log in to unmask]] On Behalf Of David James
Sent: 28 January 2016 10:01
To: [log in to unmask]
Subject: Re: UKAS - Acceptance testing
Really, is that what has been the experience of some labs? - I speak 4 languages, including English. I think key phrase in standard is:
"verified as performing satisfactorily before being used in conjunction with patient samples"
Unless UKAS are operating from a secret language interpretation guide, a process that verifies new lot is acceptable when it is brought out from store, prior to being used for patient samples meets that standard. You could do that on arrival, but I think it would need all reagents to go through process rather than a "sample"
I think we are all aware of "subjectivity" issues with accreditation processes, and hopefully common sense will prevail and labs will be assessed against the published standards
DJ
-----Original Message-----
From: Clinical biochemistry discussion list [mailto:[log in to unmask]] On Behalf Of SUBSCRIBE ACB-CLIN-CHEM-GEN Stephen Gibbons
Sent: 27 January 2016 13:04
To: [log in to unmask]
Subject: UKAS - Acceptance testing
Hello
We are currently developing a strategy to confirm to the UKAS acceptance testing standard.
‘5.3.2.3
Reagents and consumables - Acceptance testing: New lots/batches of reagents shall be verified as performing satisfactorily before being used in conjunction with patient samples. If the formulation changes then the performance should again be verified’
Would anyone, particularly those who have gone through the UKAS inspection, like to share how they went about this?
My understanding is that every batch, i.e. delivery will require testing before being ‘accepted’ and hence usable. This must be done on arrival, and not as the reagents are loaded as essentially the process ensures the reagents have been stored correctly etc. by the manufacturer/ during shipment.
We plan to quarantine all reagents on arrival, test a selection of assays with pre-prepared pooled serum, before moving the reagents to the ‘usable’ cold room. We are hoping testing a selection e.g 4 or 5 assays would be sufficient. To test all reagents from each delivery would be difficult to manage in practice.
Any advice would be appreciated
Thanks
Stephen
------ACB discussion List Information-------- This is an open discussion list for the academic and clinical community working in clinical biochemistry.
Please note, archived messages are public and can be viewed via the internet. Views expressed are those of the individual and they are responsible for all message content.
ACB Web Site
http://www.acb.org.uk
Green Laboratories Work
http://www.laboratorymedicine.nhs.uk
List Archives
http://www.jiscmail.ac.uk/lists/ACB-CLIN-CHEM-GEN.html
List Instructions (How to leave etc.)
http://www.jiscmail.ac.uk/
This message contains confidential information and is intended only for the individual named. If you are not the named addressee you should not disseminate, distribute or copy this e-mail. Please notify the sender immediately by e-mail if you have received this e-mail in error and delete this e-mail from your system. If you are not the intended recipient you are notified that disclosing, copying, distributing or taking any action in reliance on the contents of this information is strictly prohibited.
------ACB discussion List Information-------- This is an open discussion list for the academic and clinical community working in clinical biochemistry.
Please note, archived messages are public and can be viewed via the internet. Views expressed are those of the individual and they are responsible for all message content.
ACB Web Site
http://www.acb.org.uk
Green Laboratories Work
http://www.laboratorymedicine.nhs.uk
List Archives
http://www.jiscmail.ac.uk/lists/ACB-CLIN-CHEM-GEN.html
List Instructions (How to leave etc.)
http://www.jiscmail.ac.uk/
This email and its attachments are intended for the above named only and may be confidential. If they have come to you in error you must take no action based on them, nor must you copy or show them to anyone; please reply to this email and highlight the error.
The content of this email and its attachment(s) may be personal or contain personal opinions and unless expressly set out in this email, this email is not intended to form the basis of a binding agreement between North Tees and Hartlepool NHS Foundation Trust and you, or to be an expression of the Trust's position.
Although we have taken steps to ensure that this email and attachments are free from any virus, we advise that in keeping with good computing practice the recipient should ensure they are actually virus free.
------ACB discussion List Information--------
This is an open discussion list for the academic and clinical community working in clinical biochemistry.
Please note, archived messages are public and can be viewed via the internet. Views expressed are those of the individual and they are responsible for all message content.
ACB Web Site
http://www.acb.org.uk
Green Laboratories Work
http://www.laboratorymedicine.nhs.uk
List Archives
http://www.jiscmail.ac.uk/lists/ACB-CLIN-CHEM-GEN.html
List Instructions (How to leave etc.)
http://www.jiscmail.ac.uk/
|