Instruments drawn to the special attention of the House
Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment) Regulations 2021 (SI 2021/682)
Date laid: 8 June 2021
Parliamentary procedure: negative
Previous Regulations set a deadline for private providers of coronavirus tests to meet relevant ISO standards by 30 June 2021. These Regulations extend that deadline to 31 August 2021 to allow more firms to complete the assessment process. A recent article published by Which? has questioned the way the Government select the private test providers they list on their official website, raising questions about the clarity of pricing and the capacity of some of the firms listed to provide the service advertised. The House may wish to ask the Minister whether DHSC has taken action, and if so what, to ensure that test package pricing is shown in a standardised way that reflects the Government’s wider policies for the protection of consumers.
Whatever disclaimer the Government may publish, the public is likely to regard a company listed on the Gov.uk website as in some way “official”. The House may wish therefore to ask the Minister whether self-declaration is an adequate basis for inclusion on the list of providers and how frequently DHSC checks non-ISO-accredited firms’ compliance with “the minimum standards”. These Regulations extend the assessment period to six months, lengthening the period during which firms can offer tests before they meet the ISO standard. We are already concerned however about the potential threat to public health from inaccurate test results if firms are operating before they have gained full accreditation.
These Regulations are drawn to the special attention of the House on the grounds that they are politically or legally important and give rise to issues of public policy likely to be of interest to the House.
1.The Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 20201 set the criteria that private providers of coronavirus tests must meet. They required, in particular, that all private test providers work towards the relevant International Organisation for Standardisation (ISO) accreditation by 30 June 2021. The Department for Health and Social Care (DHSC) states that this instrument extends that deadline to 31 August 2021 to allow more firms to complete the assessment process. The delay allows the United Kingdom Accreditation Service (UKAS), which must check the evidence submitted, more time to work with applicants many of which do not have previous experience in this field.
Background
2.Private providers who offer sample collection or sample testing services (whether this is in laboratory or point of care testing) must apply for full UKAS accreditation by the stipulated deadlines. There are different standards for those who are offering general population testing and those who are offering tests that comply with international travel legislation. Criteria to be met also depend on whether the applicant is a laboratory actually conducting diagnostic tests or a customer-facing organisation that subcontracts the diagnostic testing.
- Stage 1: To be included on the list of test providers, firms “self declare” that they meet the specified standards2 and that declaration is subsequently reviewed by UKAS.
- Stage 2 (within four weeks of completing Stage 1—that is, the date on which the organisation made a valid application for accreditation): Firms must submit evidence demonstrating their compliance with 13 points, which include, for example, explanation of their methods for avoiding contamination of samples, and how they will dispose of clinical waste.3 This submission is subsequently reviewed by UKAS to ensure standards are being met.
- Stage 3: The organisation must complete full UKAS accreditation within the deadline set. This involves a full assessment of a laboratory’s activities in line with ISO 15189 or ISO/IEC 17025. For point of care testing providers, this would be ISO 15189 and ISO 22870. Under the existing Regulations the deadline is 30 June 2021 or four months after completing Stage 2. These new Regulations extend the assessment deadline until 31 August 2021 or six months after completing Stage 2.
Concerns from Which?
3.A recent article published by Which?4 has questioned the way the Government select the private test providers they list on their official website.5 The article raises questions about the clarity of pricing for travel tests (cheaper prices listed were found to be per test rather than per package of two tests, some prices were for tests to be taken at a specified venue rather than a home test).The article also raises concerns about the capacity of some of the firms listed to provide the service advertised at all.
4.The article notes that when Which? contacted DHSC about certain companies whose performance was in question, they were immediately removed from the Government list. The Government webpage states that “Organisations may be taken off the lists if they are at any time found to be non-compliant with any of the minimum standards for the test service they are providing”, but on the Gov.uk webpage the focus is on meeting the ISO technical standards rather than the normal consumer standards in relation to the service and its pricing.
5.DHSC did not respond to our request for comment on the Which? article. The House may therefore wish to ask the Minister whether DHSC has taken action to ensure test package pricing is shown in a standardised way, that reflects the Government’s wider policies for the protection of consumers.
Grounds for inclusion on the Government list
6.We asked DHSC about the criteria for including firms on the list on the Gov.uk page. They said:
“The self-declaration is subsequently reviewed by the United Kingdom Accreditation Service (UKAS) to ensure standards are being met. When private providers have successfully completed due diligence for their provision of testing, they can then begin to offer testing services and appear on the appropriate Gov.uk pages.
All measures are kept under review and further action will be taken to protect the public if needed.
Anyone who has concerns about the trading standards of an individual company may wish to contact their local trading standards office.”
7.Although the Gov.uk website does say that “the government does not endorse, recommend or approve any private test provider”, it also says that, while not fully UKAS accredited, providers listed “have demonstrated compliance with the applicable minimum standards”. Which?’s findings suggest that some of the firms included on the Government list have not had the basic capacity to offer coronavirus tests either technically or commercially. The House may therefore wish to ask the Minister whether self-declaration is an adequate basis for inclusion on the list of providers.
Conclusion
8.Whatever disclaimer the Government may publish, the public is likely to regard a company listed on the Gov.uk website as in some way “official”. The House may therefore wish to ask the Minister how frequently, if at all, DHSC checks non-ISO-accredited firms’ compliance with “the minimum standards”.
9.If a firm offering Test to Release tests to travellers incorrectly returns a negative result, an infected traveller could mix freely with the general population. These Regulations propose extending the assessment period from four to six months, lengthening the period during which firms can offer tests before they meet the ISO standard. We are already concerned about the potential threat to public health from inaccurate test results if firms are operating before they have gained full accreditation.
1 Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 2020 (SI 2020/1549).
2 See for example: DHSC, ‘Day 2 and day 8 testing for international arrivals: minimum standards for providers’ (14 February 2021): https://www.gov.uk/guidance/testing-on-day-2-and-day-8-for-international-arrivals [accessed 15 June 2021] or DHSC, ‘Self-declare as a private COVID-19 testing provider’ (20 October 2021): https://www.gov.uk/guidance/self-declare-as-a-private-sector-covid-19-testing-provider [accessed 15 June 2021].
3 See UKAS, ‘C19-Stage2 UKAS appraisal’: https://www.ukas.com/c19-stage2-ukas-appraisal/ [accessed 15 June 2021].
4 ‘The cheap testing firms that can’t provide tests at the top of the government’s day two and day eight provider list’, Which? (10 June 2021): https://www.which.co.uk/news/2021/06/the-cheap-testing-firms-that-cant-provide-tests-at-the-top-of-the-governments-day-2-and-day-8-provider-list/ [accessed 15 June 2021].
5 DHSC, ‘Private providers of COVID-19 testing: what you need to know’ (15 June 2021): https://www.gov.uk/government/publications/list-of-private-providers-of-coronavirus-testing/list-of-private-providers-of-coronavirus-testing [accessed 15 June 2021].