Following what may have felt like a slow uptake of voluntary third-party laboratory testing support during the fight against the COVID-29 pandemic, Lorraine Turner explains how UKAS has fast tracked accreditation and continues to assess and onboard laboratories at unprecedented rates…
From the outset of the COVID-19 pandemic, the government recognised the important role that testing would play in both managing the disease and planning for an eventual return to ‘normal’ life. It is often said that a bad test is worse than no test, so whilst the rapid expansion of COVID-19 testing methods and capacity was encouraged, this could not be at the expense of ensuring the accuracy of the results.
No corners have been cut, or assessment criteria compromised, including the need to witness testing activities (usually via a live stream)
Q: So many labs offered to help. Why the delay?
A: Helping laboratories deliver high quality, reliable tests remains a priority for UKAS. Given the relative novelty of the COVID-19 disease, it was vital that all aspects of any new test methods and procedures are rigorously evaluated and verified if patients, regulators, and the public are to trust them. By assessing the technical competence of laboratory staff and the facilities, equipment and testing methods used, accreditation generates confidence in the quality and reliability of test results.
Q: How are UK COVID testing standards set?
A: Laboratories are awarded accreditation that demonstrates they are competent to perform a defined scope of activities, which are described on each laboratory’s Schedule of Accreditation. The most relevant standards for COVID-19 testing are ISO 15189 Medical laboratories — Requirements for quality and competence and ISO/IEC 17025 – General requirements for the competence of testing and calibration laboratories. Both standards are appropriate for accreditation of PCR (polymerase chain reaction) tests and the choice of standard very much depends on the type of laboratory performing the testing. Accreditation to ISO 15189 is more suited to medical laboratories as it ensures the competence of the whole process, including pre- and post-examination activities.
Q: How was accreditation fast tracked for this pandemic?
A: Owing to the emergency and high public health demand it was accepted that testing for COVID-19 had to commence before accreditation was in place. Acknowledging the pressure that healthcare, scientific and diagnostic services were facing at this challenging time, UKAS worked with Department for Health and Social Care (DHSC) to develop accreditation processes that are adjusted to current conditions without compromising standards. As a result, two new streamlined UKAS assessment processes have been introduced specifically for laboratories seeking to become accredited for COVID-19 testing.
Every laboratory is different in terms of its facilities, equipment, personnel, the testing procedures it performs and which of those (if any) are already covered by its scope of accreditation. For laboratories that are already accredited to either ISO/IEC 17025 or ISO 15189, UKAS developed a fast-track process to extend their scope to cover testing for COVID-19. In June 2020, the first labs granted accreditation under this process were St Helen’s & Knowsley NHS Trust (ISO 15189) for general patient diagnosis and the Metropolitan Police (ISO/IEC 17025) for testing its own staff. UKAS has since conducted over 80 assessments of both public sector and private laboratories using this process, with over 30 being granted accreditation to date.
Q: What types of testing are covered?
A: In line with the government’s priorities on diagnosing the number of cases in the community, the majority of these accreditations have been for COVID-19 antigen testing. This appears as “Detection of SARS CoV-2 virus RNA (COVID-19) specific gene sequences” on the laboratory’s Schedule of Accreditation. UKAS has also seen a number of applications for COVID-19 antibody testing.
Q: How have assessment standards been maintained?
A: Understanding the capability of new test methods takes time, and laboratories have had to work hard to gather evidence and data to demonstrate their capability at the same time as having to test large volumes of patient samples. Although the pandemic has necessitated UKAS conducting the majority of its assessments remotely since March 2020, the objectives and standards of performance have remained the same. No corners have been cut, or assessment criteria compromised, including the need to witness testing activities (usually via a live stream).
Q: How is UKAS onboarding private test providers?
A: As scientific knowledge progressed and exemptions for restrictions on movement evolved, the number of private providers offering COVID-19 testing increased dramatically. To ensure quality standards continued to be applied, in November 2020 DHSC announced that private providers of COVID-19 testing wishing to offer general population testing and/or participate in the ‘Testing to Release for International Travel’ scheme would have to meet certain minimum standards and gain UKAS accreditation under a new three-stage evaluation process.
The staged approach has been developed to enable progress towards accreditation to be tracked and to enable users to understand where providers are on their journey towards UKAS accreditation. ‘Stage 1: UKAS Application’ involves completing a self-declaration registration form which is reviewed by UKAS. Successful applicants then move onto ‘Stage 2: UKAS Appraisal’, which covers the implementation of 13 key requirements relating to clinical expertise, facilities and equipment, test methods and validation, and governance and documentation. Stage 2 is designed to ensure providers are capable of reaching the required standards of performance and competency, as well as prepare them for a full UKAS accreditation assessment under ‘Stage 3: UKAS Accreditation’.
The COVID-19 pandemic has highlighted that the need for competent, reliable and valid testing is as important as it has ever been. Making UKAS application and subsequent appraisal a compulsory requirement for private providers is a crucial steppingstone on the path to meeting the government’s aim that approved providers of COVID-19 testing gain UKAS accreditation by summer 2021.
Author: Lorraine Turner is Accreditation Director and leads the delivery of accreditation in laboratories, healthcare and developing areas for UKAS www.ukas.com