Raising Standards

31 May, 2017

Elaine Holgado and David Ricketts discuss the importance of accreditation to ISO standards for all pathology service providers

Walking along the seafront on a sunny day in Southend, the last thing you might expect to see is a Church group offering on-the-spot blood glucose and cholesterol testing for the passing public. Yet as Dr David Ricketts, Head of HSL Laboratory Process Improvement, points out, these sights are becoming increasingly familiar. And they are becoming more popular too – why not have a quick cholesterol check instead of waiting two weeks for a GP appointment?

Point-of-care testing (POCT) has a number of advantages over laboratory testing, primarily in terms of creating more efficient patient pathways. An immediate result helps drive an immediate clinical decision, which makes the whole diagnostic process quicker, leaner and less stressful for the patient. However, until relatively recently there was very little effort to bring the quality of POCT in line with laboratory standards. “This is fundamentally unsafe,” says Dr Ricketts, who was closely involved in the creation of ISO standards 15189 and 22870: internationally agreed standards of quality and competence for medical laboratories and POCT respectively. “People empirically believe a number if it is generated by an analyser. Yet without any form of quality control, there is no way of ensuring the accuracy of these results.”

In Lord Carter’s 2008 review of NHS pathology services in England, he recommended that all pathology service providers, including those providing POCT, should be subject to mandatory accreditation. In the UK, accreditation to ISO standards is still not obligatory, although the vast majority of pathology labs are accredited to ISO standard 15189 (Medical Laboratories). Accreditation gives patients and staff the confidence that the quality of the service has been independently and objectively verified. As Dr Ricketts states, “If a laboratory is following ISO standards, then it will be running a quality service. The power of accreditation lies in the role of peer-review – it’s an external and unbiased confirmation that you are achieving what the standard sets out.”

Elaine Holgado understands this issue better than most. Not only is she Consultant Clinical Scientist for Molecular Genetics at HSL, she also works part-time as a peer assessor for UKAS. She spends around eight days a year assessing molecular genetics laboratories around the country, checking whether they meet the criteria for accreditation. “HSL has been very supportive of my role as a UKAS peer assessor”, she says. “Assessing the procedures and processes of different laboratories gives great insight into new ways of doing things, as well as providing an opportunity to network and meet new people.”

HSL’s substantial support of both Dr Ricketts and Ms Holgado in these roles highlights an unwavering commitment to improving the quality and safety of pathology services worldwide. Only with HSL’s support can Dr Ricketts attend the international meetings where ISO standards are set. “It is vital that we get people with a pathology background to these meetings – otherwise the only representatives are those from industry or the accreditation boards themselves. HSL are very supportive of this and understand that to create truly international standards we need to ensure the UK has a voice at these meetings.”

Uptake of POCT accreditation is still much lower than that of its parent standard, ISO 15189, but the tide is starting to turn. It is now possible to use the same paperwork for both standards, which makes accreditation both easier and simpler to achieve. But how can we guarantee the quality and competence of POCT outside the clinical setting? Dr Ricketts is currently working on a document outlining the standards for a quality POCT service written in non-scientific language. This is intended to help those with no links to an accredited laboratory to deliver safe, high-quality POCT. Given the growing prevalence of POCT, the importance of accreditation to ISO standards cannot be overstated. As Dr Ricketts states, “Our goal is to raise awareness of this issue, and ensure that all point-of-care tests are carried out with the same degree of quality as those done in a laboratory.” Until then, maybe think twice before getting your cholesterol checked on the Southend seafront.

HSL is a partnership between The Doctors Laboratory, Royal Free London NHS Foundation Trust (the Royal Free London) and University College London Hospitals NHS Foundation Trust (UCLH)

Health Services Laboratories
Health Services Laboratories
Health Services Laboratories