Responding to the COVID-19 pandemic, the role of accreditation

In this interview for the UKAS 2021 Annual Report, Chief Scientific Officer for NHS England, Sue Hill, shares her thoughts on the role accreditation plays during a global pandemic.

 

The Coronavirus pandemic presented us all with unique challenges that needed us to consider approaches that were far removed from the business as usual practices.

For me it was clear the initial priority was to ensure that there was sufficient COVID-19 testing to identify positive cases – and this initially meant laboratory capacity – to both enable hospitals to treat the critically unwell and then provide quick and timely diagnosis for those in the community.

From the very outset being able to build and rollout additional laboratory capacity was reliant on ensuring standards would be met, and systems and processes would enable processing to be undertaken at scale and pace.

As a result it was paramount the services would be working to the standards expected of accreditation and for those already UKAS accredited the current scope of practice extended to include COVID-19, so that testing across the country no matter where it was undertaken was homogeneous.  NHS, universities, private sector and Lighthouse labs would all deliver testing with the standards, systems and processes that ensured the results could be trusted.

Specifically working with colleagues across the NHS, DHSC and PHE, a staged approach was undertaken, working with accredited NHS laboratories and also some within universities, the provision was built for hospitals to ensure timely identification of COVID-19 positive cases and subsequent treatment of patients.

This was not without difficulties.  A worldwide shortage of consumables, completely new protocols to rollout, a need to diversify the supply chain, and with the constant introduction of new laboratory capacity, a requirement to make sure results could be uploaded and then communicated to clinicians, patients and public health colleagues.

Laboratories that came forward to undertake COVID-19 testing needed to have the necessary technical competence, equipment, methodology and quality management processes and systems in place to enable them to generate accurate results, which could be relied upon.

In order to maintain confidence in the quality and robustness of COVID-19 testing, PHE and the NHS’s policy was that laboratories undertaking COVID-19 diagnostic testing should already be accredited by UKAS and should apply for an extension of scope for COVID-19 testing

Speed, however, was key, it was clear early on that the UKAS accreditation process would take time, and the urgency of rolling out testing against the newness of the COVID-19 infection needed to be taken into consideration.

There is also the fact that is more difficult to accredit a new novel test method in a very short period, as there is little validation or evidence to support that it works.  Reliability of the tests needed to be understood and the NHS and the public needed to have confidence in the test.

The stringent requirements to demonstrate assay performance using accepted validation and acceptance criteria was essential and NHS laboratories needed to assure that they had undertaken this using internal (validation and verification) and external quality assurance (Lab Audit QA process), before offering this testing service to patients.

While we were working in exceptional circumstances, we still needed to maintain quality of service provided and provide that confidence.  UKAS became part of that critical validation path and process for on boarding of labs, utilising the expertise at UKAS (scientific and assessment) that could support decisions about validation of tests at PHE and in the NHS.

As more and more laboratory capacity was added from within and outside of the NHS/PHE laboratory network, being able to rely on and draw upon the UKAS accreditation process was vital.

We are always grateful for the willingness of UKAS to be part of broader discussions.  Our thanks to the team for being part of the Government’s’ advisory committee, assessing the various levels of performance and the plethora of testing methods proposed.

Leading on from this UKAS supported the establishment and growth of the testing capacity by providing expertise to consider the process of testing.  Importantly UKAS has been central to standing up a staged accreditation process for private sector providers of COVID-19 testing.