Guidance: Self-declare as a private COVID-19 testing provider

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The government has published this guidance on the minimum standards that private providers of COVID-19 testing services are expected to meet when offering services to organisations or members of the public.

A list of self-declared private providers of COVID-19 testing will be published on GOV.UK. This is also the first stage of UKAS accreditation (UKAS Applicant stage). To complete this stage and to be published on the GOV.UK list of private providers, you must declare that your service meets these minimum standards by completing the form.

To be published on the list you will also need to provide some additional information to support our due diligence checks and this will be reviewed by UKAS.

To become an accredited test provider, please visit the UKAS website and complete an application form before making a self-declaration.

Requirements

The current minimum standards are summarised as follows (more detail is provided in the form):

1. Requirement of a clinical or medical director or equivalent and healthcare scientist

The provider must have a designated resourced role that has oversight and approval of medical practices undertaken by the provider and responsibility for reporting medical issues. The individual must be a registered medical practitioner.

The provider must also have a designated resourced role that has oversight of clinical practices undertaken by the provider and responsibility for reporting clinical issues. This individual must be a registered medical practitioner or a healthcare scientist, registered with the Health and Care Professions Council.

The same individual can fulfil both roles (medical and clinical) providing they are duly registered.

2. The test product must be permitted to be put into service in accordance with part 4 of the Medical Devices Regulations 2002, other than solely by virtue of an authorisation made under regulation 39(2) of those regulations.

This requirement is to ensure that the test product has a CE marking (or, once the UK leaves the European Union on December 31st, a UKCA marking).

A CE mark is a logo that is placed on an in vitro diagnostic (IVD) medical device to show that it conforms to the requirements of the In Vitro Diagnostic Medical Devices Directive 98/79/EC, as implemented by the Medical Devices Regulations 2002 (note: its currently an offence under the Consumer Protection Act 1987 to place a device on the market or supply without a CE mark, unless a derogation has been obtained from MHRA under the Medical Devices Regulations 2002).

A CE mark shows that the device is fit for its intended purpose stated and meets legislative requirements relating to safety.

From 1 January 2021, tests with a UKCA mark can be used. Tests with a CE mark can be used until July 2023.

3. Alignment to DHSC MHRA target product profile scope

The Medicines and Healthcare products Regulatory Agency (MHRA) has published target product profiles (TPPs) for different types of test, setting out the scope of what that test should be used for, including target use, target user and target use settings.

The provider must declare that theyre using the test in line with its published scope. MHRA has set out guidance explaining how both virus and antibody tests work.

Note: this standard only applies to providers solely providing COVID-19 testing services for domestic purposes. Providers of Testing to Release for International Travel (or their sub-contractors, if relevant) must adhere to the more stringent minimum standard Use of tests which meet minimum performance characteristics. See the minimum standards for these services.

4. Reporting of coronavirus test results

The test provider must have a system in place for reporting positive, negative, inconclusive (indeterminate) and void test results to PHE in accordance with public health legislation.

Providers who use a laboratory to process test results are not under a legal requirement to report but should ensure they pass all relevant information to their laboratory for the laboratory to report. Where data sharing is not possible to allow the laboratory to report to PHE, then the provider should submit the relevant information to PHE, alongside the laboratory reporting the test result to PHE.

Point-of-care testing (POCT)

POCT providers using NHS Test and Trace or government-provided kits should report results online.

For those using privately acquired POCT kits, please contact the POCT support team on poct.contact@phe.gov.uk. This data must follow a specific format, and the template is available from the PHE POCT support team. Read the full guidance on COVID-19 and influenza point-of-care testing results: how to report.

It is a requirement that POCT providers transfer the following information to PHE, insofar as it is known to the test provider.

In relation to the person being tested:

  • first name
  • surname
  • sex
  • date of birth
  • NHS number (if known)
  • ethnicity
  • current address (including postcode)
  • telephone number (only in the case of SARS-CoV-2 positive or indeterminate results)
  • email address (only in the case of SARS-CoV-2 positive or indeterminate results)

In relation to the test:

  • name of the test provider
  • the type of establishment of the test provider (for example school)
  • test result code (such as COVID-19 +ve/-ve or influenza A +ve/-ve)
  • specimen identification number (if applicable)
  • specimen type
  • specimen date
  • date the test was performed
  • test method (for example PCR)
  • name of the testing equipment manufacturer

Positive and indeterminate COVID-19 test results should be reported to PHE as soon as they are available from the test device and, at the latest, within 24 hours, which will be the statutory requirement.

Negative and void COVID-19 test results, and positive, indeterminate, negative and void influenza test results, can be sent to PHE within 7 days of testing.

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