Department Of Health
The government has published this guidance on the minimum standards for private sector providers of COVID-19 testing.
To request to be added to the indicative list of providers on GOV.UK, providers must declare that they meet these minimum standards by completing the form, as well as providing some additional information to support our due diligence checks.
The government envisages that UKAS (UK Accreditation Service) accreditation will become a minimum standard for all private sector providers of COVID-19 testing at a future stage and is planned to be established by September 2021.
Further information on the UKAS accreditation process is available on the UKAS website.
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 or clinical practices undertaken by the provider and responsibility for reporting medical/clinical issues. The individual shall be registered with a clinical regulatory body, for example, the General Medical Council, Health and Care Professions Council, etc.
Additionally, the provider shall employ a regulated healthcare scientist who is registered with the Health and Care Professions Council. These can be the same individual, providing both roles are satisfied
2. Use of CE-marked tests that have a UK/European-based authorised representative and are registered in the country where that representative is based
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: it is an offence under the Consumer Protection Act 1987 to place a device on the market or supply with without a CE mark, unless a derogation has been obtain from MHRA under regulation 12(4) of 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.
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.
- MHRA guidance
- government guidance on the suite of antibody tests (the antigen TPPs once published will be published here)
4. Public Health England (PHE) data reporting system
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 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 June 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:
- clear governance and lines of accountability such as senior responsible officer, clinical lead, quality lead, training lead
- staff are appropriately trained and there is evidence of competency assessment and participation in relevant external quality assessment (EQA)
- liability and indemnity cover for staff
- a verification report for the laboratory element of the test (known as the assay), in line with national protocols for laboratory-based testing
- information management systems to monitor sample delivery and tracking
- systems to meet the provisions for handling, transportation and analysis of test samples
- working to containment level CL3 or CL2+ with Health and Safety Executive (HSE) approval for laboratory-based testing
- systems, processes and record management to support the delivery of safe and reliable service
Private providers must tell employers of any positive results for COVID-19, and employers must inform relevant staff to self-isolate. For more information on what employers should do in the case of a positive test result, please see employer g