Since the beginning of the pandemic, UKAS has been working with government to provide advice on quality assurance and accreditation of laboratories performing COVID-19 testing. To date, UKAS has received over 80 applications/extensions to scope requests and has accredited nearly 30 public and private sector laboratories.
As demand for testing and the number of private providers of testing continues to grow, the need for the public to have confidence in the testing remains as important as ever. Recognising the time it takes to establish a reliable testing service and gain accreditation, UKAS has agreed to provide some preliminary assessment that can be used to provide information about the competence of these testing services that are being established, through necessity, at pace.
UKAS has been working with the Department for Health and Social Care (DHSC) to develop a three stage UKAS accreditation process for private providers of COVID-19 testing. This scheme will be used for ‘Testing to Release for International Travel’ and for any providers of private COVID-19 testing requiring accreditation for their services.
From 15 December, international arrivals will be able to opt-in to ‘Testing to Release’. The government has published guidance for private providers of ‘Testing to Release for International Travel’. By law, all tests used for the purpose of shortening the self-isolation period for international arrivals must meet certain minimum standards.
Providers, including those for ‘Testing to Release for International Travel’ must self-declare that their service meets minimum standards through the gov.uk self-declaration process. This includes the requirement for test providers to at least be a UKAS applicant for the relevant international standard – ISO 15189 or ISO/IEC 17025 for lab-based providers and ISO 15189 and ISO 22870 for point of care testing providers.
Quality assurance has been a key driver in the establishment of these minimum requirements, and as the National Accreditation Body for the UK, UKAS will be involved in this stage of the process by assessing each provider’s self-declaration form, and if UKAS is confident that these requirements are met will recommend to DHSC that the provider be added to the government’s published list of providers.
Stage two of the registration process requires a the provider to complete a gap analysis against the requirements for accreditation and provide information that demonstrates the minimum requirements have been met. UKAS will conduct an appraisal of this information l to confirm that providers are progressing towards accreditation. The 13 key requirements contained within this appraisal can be found on the UKAS website.
Laboratory based providers must have gained UKAS appraisal for ISO/IEC 17025 or ISO 15189 and point of care testing providers to ISO 15189 and ISO 22870 by 18th January, or four weeks after they have completed Stage One.
Once the UKAS appraisal stage has been completed, applicants will be able to progress to full UKAS accreditation for either ISO 15189 or ISO/IEC 17025 or, for point of care testing, ISO 15189 and ISO 22870.
UKAS accreditation must be achieved by June 2021, or four months after providers have gained UKAS appraisal.