Despite the title of this blog, and the onerous task that it is, a gap analysis is actually a very useful tool. Whether you intend to go for POCT accreditation anytime soon or not, I would urge you to complete one, - even if just as an audit exercise. 

Knowing where to start was daunting but fortunately, we had a few templates on hand from the Blood Sciences ISO 15189 accreditation process. This gave me an overview of the documentation required, processes to look at and how I would present it all to UKAS when the time came. 

I started by using a simple Excel spreadsheet - there are a number of free templates available online that may make the gap analysis look prettier, but if I’m honest, they looked quite complex and this was going to be a big enough task as it was. So, down the left hand side of the spreadsheet I named all of our devices. Although currently we are only going for accreditation with Blood Gas, Glucose and Ketones, we decided we might as well have a look and see where all the devices are placed. This will be useful in the future when we are adding to our scope.

I then put along the top of the spreadsheet, in each column, the name of each piece of documentation needed: 

• Was the equipment on the equipment/asset register in Q-Pulse
• Verification/validation data
• SOP and ward based SOP for the users
• Internal Quality Control
• External Quality Assurance
• COSHH and Risk assessments
• Training logs
• Competency assessments
• Minor incident reporting procedures
• Reagent pre-acceptance protocols
• IT connectivity to Electronic Patient Record
• Service Level Agreements between POC user and laboratory
• Regular auditing, both scheduled and risk based.

Contact Us if you have any ideas for other documentation which should be included.  

It’s a big list, and that’s if I haven’t forgotten anything! Finding old verifications and trawling through documentation to put it all in one place, albeit labour intensive and a bit of a dry task, was a brilliant way of getting our house in order.  In particular it gave me the opportunity to put all our documents under POC nomenclature in Q-Pulse so everything was easy to find especially when a UKAS assessor is asking to see a particular document.

I discovered that we had misplaced verification data for our glucose meters which had been carried out at the time, but since then people had left or retired and the documentation had been lost in the ether. So, we completed a retrospective verification instead, which was a reassuring task that proved our glucose meters were still fit for purpose. Extra work maybe, but given that accreditation provides reassurance to your users, being able to demonstrate the analysers are fit for purpose is the crucial evidence that we need.

Over time, we’ve managed to fill the gaps. It’s been long and slow but we are getting there. Once complete and everything is in place, we’ll be on to the next daunting task: the application.

I’ll tell you all about it in the New Year.

Robyn x