COVID-19

Delivering public confidence in private providers of Covid-19 testing – the ongoing role of UKAS Accreditation

UKAS is the National Accreditation Body for the United Kingdom. UKAS is appointed by Government, to assess and accredit organisations that provide a variety of services including certification, testing, inspection and calibration based on compliance with international standards and demonstration through objective evidence of competency and impartiality in the performance of defined activities.

At the beginning of the pandemic reliable testing was quickly identified as a key component in our effort to control the spread of the virus. UKAS has been part of that effort, working with government to provide advice on quality assurance and accreditation of laboratories performing COVID-19 testing including laboratories that have been supporting the national testing provision (NHS Test and Trace) and private providers of sampling and testing.  This work continues as the pandemic, and resulting restrictions and requirements continue to evolve.

The sampling and testing provided by private providers quickly became a vital part of the testing provision, where testing being performed for general population i.e. work-based testing, was required as well as testing prior to and following travel to or from England. Accreditation was recognised as playing a vital role in assuring the quality of the sampling and testing services offered. To support this work UKAS has worked with the Department for Health and Social Care (DHSC) to develop a 3-staged accreditation process for private providers of COVID-19 sampling and testing consisting of a self-declaration –  stage 1, key area assessment – stage 2 and then a full assessment of activities – stage 3. The self-declaration is reviewed by UKAS to ensure standards are being met. UKAS does not conduct any monitoring of those organisations who only ‘sell’ the testing service and do not perform sampling and/or testing.

This process has been developed to assist providers gain some early recognition by DHSC while they were progressing towards accreditation within the timescales required by the regulations established for England for ‘Testing to Release for International Travel’, Day 2 and 8 testing, and for any providers of private COVID-19 testing requiring accreditation for their services. Bespoke support for private providers was also produced via a number of eLearning modules which take the reader through the entire process as well as weekly drop-in webinar sessions led by accreditation specialists throughout the spring and summer of 2021 where any and all questions were addressed.

To date, UKAS has received over 500 applications/extensions to scope requests and has accredited over 50 public sector laboratories and over 200 private providers of COVID-19 sampling and/or testing.  It is recognised that many laboratories do not sell the tests directly to the consumer and that tests are provided through intermediaries that interact with and sell directly to the public.  The regulations that apply to private providers of covid-19 tests in England require that all organisations selling private Covid-19 testing kits/services (to be used at home or for self-swabbing) must make a declaration to the Department of Health that they comply with certain minimum standards. The details of the organisations which have made this declaration are published on gov.uk (unless the provider has opted out of appearing on the public lists). The legislation allows that organisations may take up to 8 months to achieve accreditation.

Government holds overall authority over which organisations are listed on gov.uk. DHSC utilise information gathered from a variety of sources, including information about the status of UKAS application stage and accreditation to maintain the information up to date. Please note that not all organisations on the gov.uk listed are yet accredited and may not be required to be accredited (i.e. whether it only sells tests or carries out sampling and/or testing) or the status of accreditation of the organisation or its chosen subcontractor(s). However, details of all UKAS accredited services can be found on www.ukas.com

Lateral flow tests

On 30 November 2021 Government announced that lateral flow tests would not be acceptable for Day 2 international arrivals due to the omicron variant of concern.

In the event that the requirements are revised to allow the use of LFTs for Day 2 tests, providers need to meet published minimum standards that will be evaluated via the self-declaration form on the gov.uk site. Providers who supply kits for self-swab and self-test will not be UKAS accredited and UKAS is not conducting the assessment of this activity.

Any enquiries about the process for approving providers for self-tests need to be directed to [email protected]. Providers that perform sampling and point-of-care testing (POCT) for international arrivals are required to apply for and gain accreditation following the staged process that is described above.

UKAS accreditation of the providers that perform sampling and testing will confirm their competence to perform their activities and provide assurance to consumers that test results are reliable. UKAS accredited organisations are subject to ongoing surveillance assessment.