Point-of-care testing (POCT) UKAS ISO 15189 accreditation is still in its infancy.
Very few sites are accredited due to the complexity of multiple POCT locations, analysers and personnel – which all stretch beyond a traditional lab environment. As the UK’s largest UKAS ISO 15189:2012 and ISO 22870:2016 accredited POCT service, South West London Pathology (SWLP) provides a near-unique example of how POCT can be considered a safe and clinically effective pathology discipline in its own right. We spoke with Haval Ozgun, POCT Manager and Network Lead at SWLP, to find out how he achieved this.
SWLP is the largest UKAS ISO 15189:2012 POCT blood gas accredited site in the UK. Serving a population of >3.5m people, the hub for this POCT pathology service is based at St George’s Hospital, Tooting, overseeing four other hospital sites and many community settings, with >10,000 service users.
To achieve this complex, large-scale accreditation, Haval Ozgun decided to view POCT as a ‘laboratory without walls’, requiring quality assurance and governance to ensure the safe and effective management and use of POCT analysers across all care settings.
Haval explained, “One of the biggest problems in POCT is that it’s seen as out of the scope of the main pathology department because activities take place outside the laboratory. We’ve changed that. We’ve brought all POCT in-house and started setting it up as a standalone pathology discipline within SWLP to ensure the necessary governance.”
From one POCT Manager (Haval) in 2018, the SWLP POCT pathology department has now grown to a team of 22 in 2023 after achieving accreditation in 2021.
“We were a newly formed network of three acute hospitals in south west London. So even before accreditation, our focus had to be on service harmonisation, starting with the largest service, blood gas,” said Haval. “Three different types of analysers were being used across the network, and contracts and finances were not in place, or not being monitored. Essentially, there was no proper governance around POCT. So, our starting point was to put in place the building blocks for POCT governance. Harmonisation using a single type of analyser across our network was one of these blocks.”
Achieving harmonisation
Key to harmonisation was choosing the right blood gas analysers, plus associated IT systems and customer support. Several devices were assessed as part of the tender process.
“There were many reasons for choosing Radiometer as the right partner for us, but a key one was the great uptime with minimal calibration and QC requirements compared to other analysers. This means the analysers are always readily available to our clinicians at the point of need,” detailed Haval.
“Pre-analytics were a big consideration too. Radiometer’s safePICO syringes and the sample mixing port on its analysers ultimately generate more reliable results by eliminating one of the main pre-analytical errors in blood gas analysis.”
Also essential, is putting the right devices in the right places based on clinical needs and ensuring they make a real difference to patient pathways and care. Haval noted that this was especially important for certain patient cohorts, such as paediatrics and neonatal ICUs. “Radiometer’s ABL90 FLEX PLUS analysers were the right choice for us. For example, the small sample volume of just 45 µL is very important for neonatal patients.” For SWLP’s Emergency Department patients, the availability of creatinine, urea and eGFR with the ABL90 FLEX PLUS analysers was also of paramount importance to certain patients.
IT connectivity and integration with electronic patient records were also high priority. “Radiometer’s AQURE middleware system is very good and has met our needs in many ways. It’s enabled us to easily connect POC analysers and interface them with patients’ electronic records. Having results available electronically—and importantly results’ trends, especially for ICU patients requiring several blood gas measurements a day—really helps clinicians in managing their patients.”
Harmonisation of devices also proved hugely beneficial during the pandemic because the clinical users who rotated between the five hospitals in the SWLP network could all use the same type of analyser.
Haval explained, “Clinician and nurse users were frequently moving between sites in south west London, and they were able to use the same instruments wherever they went. We received very positive feedback that this was really helpful for efficiency and reduced training needs.”
Achieving accreditation
After harmonising its blood gas service, SWLP could then undertake POCT accreditation with the support of Radiometer. “For accreditation we grew our team significantly” said Haval. “Preparing for accreditation, this growing team performed a gap analysis to identify areas in need of change or improvement – governance and risk management being key. Within six months we were able to close all the gaps and were in a position to obtain POCT accreditation as the largest accredited blood gas service in the country.”
He added, “Achieving accreditation was a testament to the hard work and dedication of the SWLP POCT team and the amazing collaboration of our medical, nursing and midwifery colleagues who use our services in their departments.”
Haval noted that Radiometer also played a central role. “Firstly, Radiometer’s was the right analyser for us, due to all its safety features covering pre-analytical and analytical processes. They also provided the customer and technical support we needed, from installation to their ongoing support now, and helped us with the verification works. Then, training was important, which they also facilitated. We could use Radiometer documentation as a precursor for our training certification which they developed with us.”
Having achieved accreditation, SWLP must maintain this status, “Radiometer continue to support us with the ongoing training and deliver on-site training monthly to new and existing staff,” said Haval. “They also provide IT support for their AQURE middleware system and setting up interfaces, as well as assistance with the reports we get from AQURE, such as QC analysis and analyser uptime. We also use the data insights available via Radiometer’s software for our monthly quality report required by UKAS inspectors.”
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