Last month, the SWLP POCT team received the exciting news that after two years of hard work, the blood gas and glucose meter service at St George’s was given full UKAS accreditation. It is the largest and most complex POCT service in the country to receive full accreditation, which proved challenging for both the POCT team and the UKAS accessors, as there was no blueprint to achieving accreditation anywhere at SWLP and on this scale. The service has 24 blood gas analysers and 160 glucose meters, and nothing of this size had been attempted before.
The process of getting the service accredited began in 2019 when the decision was made that the service should be accredited as part of an extension to scope for Clinical Blood Sciences. The first thing the team had to do was to carry out a retrospective validation and verification on all the blood gas analysers, which was no mean feat, especially as some analytes have no laboratory (gold standard) comparative method. The team were able to get some guidance from the clinical networks that they are a part of, however ultimately, they had to develop the acceptable criteria from scratch.
The POCT Quality Management System needed to be built as POCT had no presence on SWLP documentation. They had to begin work on integrating POCT into the CBS Quality Manual and drafting the relevant POCT policies on various aspects of ISO15189 and ISO22870. When this work began, there were just five POCT documents on QPulse – there are now over 300. A full and comprehensive gap analysis on both standards had to be performed before a Pre-Assessment visit by UKAS.
The team had to put special measures and processes in place to ensure a high standard of governance and quality assurance, as POCT tests are not carried out by staff in the lab. Managing training and competencies of thousands of clinical staff who run the tests is a crucial part of the work of the POCT team and, from a UKAS perspective, it is important that training records are kept up to date and stored somewhere they can be easily accessed. To ensure that these requirements would be met, the team carried out a retrospective audit of all 5,000 plus training and competency records and created a system of recording and storing them.
The UKAS assessment was carried out in two parts: the Quality Management System and the technical aspects. The team passed the technical elements with no findings. In fact, the assessor said, “I can’t think of anything you could have done better”. High praise indeed! For the Quality Management System, there was a modest four findings and one recommendation, which were easily dealt with and cleared.
POCT Manager Haval Ozgun says, “I am so proud to be part of the fantastic team that has worked tirelessly towards this accreditation. This has been a real journey into the unknown and, not only have the team had to work incredibly hard, they have also had think outside of the box to interpret guidelines and get all our systems and processes in place.”
POCT Quality Lead Faye Browne says, “I would like to thank every member of our very small team for their hard work and dedication. Each of them has played a big and crucial role in getting to this point.”
The next step for the team is to get POCT services at other SWLP sites accredited. While it will still be challenging, they will now have something to work from as they can refer back to all they have done at St George’s and look to replicate it. Watch this space!
