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.
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 provider must have a system in place for reporting positive, and negative and inconclusive test results cases to PHE in accordance with public health legislation.
5. Relevant systems in place to report adverse test incidents
The provider must be able to demonstrate that it has systems in place to identify any adverse incidents or quality control issues in respect of the test device and be able to report them in a timely manner to the relevant regulatory body. MHRA has a dedicated COVID-19 Yellow Card portal to report adverse incidents with medicines, medical devices and diagnostics.
6. Samples shall be taken by a provider meeting or working towards ISO standard ISO15189 or ISO/IEC17025
MHRA has published target product profiles (TPPs) for different types of test, which outlines who should collect test samples under the Target User description.
The provider must have relevant competency-based trained test operators undertaking or overseeing sample collection dependent on test sample collection requirements.
The ISO standard and technical specifications set out the key components that should be considered to provide safe and reliable sample collection service.
It is expected that UKAS accreditation to ISO 15189 or ISO/IEC 17025 will become a mandatory minimum standard by summer 2021.
Sampling can be accredited as part of a wider lab-based activity, or sampling can be the scope of a standalone, separately accredited legal entity.
7. Clinical governance
The provider must have clear clinical governance procedures in place. For example: