Under new UK Government legislation, private providers of commercial coronavirus testing will no longer need to obtain CQC registration. Providers will instead apply under the end-to-end accreditation scheme run by the United Kingdom Accreditation Service (UKAS) that will cover all providers of coronavirus testing.
The UKAS accreditation scheme offers commercial providers of COVID-19 testing the following benefits:
- A government endorsed end–to-end accreditation scheme.
- A simplified, accessible process for providers.
- A means of communicating high-quality service standards to consumers.
- Inclusion on a list of approved testing providers on the gov.uk and www.ukas.com websites.
Impact of the Testing Regulations on commercial Covid testing services
- Commercial Covid testing services will not need the services to be registered with CQC (assuming that the services they provide are limited to purely Covid testing services);
- They will, however, in order to trade lawfully:
2.1 In accordance with regulation 4, need to ensure that any device used:
(a) can be put into service in accordance with Part 4 of the Medical Devices Regulations 2002; and
(b) has been validated within 18 months of being used.
2.2 In accordance with regulation 5 need to ensure:
(a) that a registered medical practitioner has oversight of the medical practises undertaken;
(b) that there is an effective system of clinical governance in place (including standard operating procedures); and
(c) that a registered clinical scientist has oversight of clinical practices undertaken.
2.3 In accordance with regulation 6, must, before providing any further applicable tests, make a valid application to UKAS and declaration (“stage one of the accreditation process”), and then complete stages two and three of the accreditation process within the prescribed timescales.
What is the cost of an application?
This depends on the size of the organisation. It will vary, but £1500 is the standard UKAS application cost. The cost depend on the number of sites in a location, and the size of the organisation. It also depends whether the applicant is just a sample collection provider. If so, then the effort is relatively smaller so there is a lower cost. Determination will be based on contract review regarding the particular organisation. An estimate will be given once the application is provided.
The three stage process to accreditation
- Stage One: UKAS Application: This is a self-declaration against the minimum standards required.
- Stage Two: UKAS Appraisal: This is a form of interim appraisal to demonstrate that providers are progressing towards full accreditation, and also understanding the relevant international standards.
- Stage Three: Full UKAS Accreditation: This provides accreditation to particular standards depending on the setting of the relevant tests:
- Lab-based testing: Accreditation to ISO 15189 or ISO/IEC 17025
- Point of care testing: Accreditation to ISO 15189 and ISO 22870
Stage One: UKAS Application Requirements:
To complete Stage One, providers must apply to UKAS and then complete a ‘self-declaration against minimum standards’ form which can be found at the www.gov.uk website.
This sets out the minimum standards, and also requests further information to support due diligence checks.
N.B: Part of the aim of this stage is to determine exactly how the end-to-end process functions, and how many bodies are involved in the provider chain from sample collection to submission.
If the actual sample collection is delivered by a different provider (e.g: a provider collecting from drive through testing centres at car parks) then this must be stated on the form and the collecting provider must also apply to UKAS. However, they will not be required to complete the self-certification form.
If providers want more information on this stage, they can contact email@example.com
Stage One: Requirements:
There are 10 requirements that must be fulfilled under Stage One.
1. Requirement of a clinical or medical director or equivalent healthcare scientist:
- The same individual can fulfil both roles, provided they are duly registered.
2. The testing product must be put into service in accordance with Part 4 of the Medical Devices Regulations 2002, and not solely by virtue of an authorisation made under Reg 39(2) of those Regulations.
- This is specifically to ensure that the product has a CE marking (or UKCA marking post EU withdrawal).
3. Declaration that the test product will be in line with the MHRA’s ‘target product profiles’ for that particular type of test.
- This sets out what the test is used for, its target user, and the target use settings.
4. Reporting of coronavirus test results:
- The provider must have a system in place for reporting positive, negative, and inconclusive test results to Public Health England (PHE).
5. Systems in place to report adverse test incidents:
- This applies to both adverse incidents, and quality control issues for test products.
6. Confirmation that the samples shall be taken by a provider meeting or working towards either ISO 15189 or ISO/IEC 17025.
- Part of this is to ensure that the provider is collecting samples using competency trained operators.
7. Clinical Governance: The provider must declare that the following governance procedures are in place:
- Lines of accountability: E.G: senior responsible officer, clinical lead, quality lead, training lead, etc.
- Appropriately trained staff.
- Staff liability and indemnity cover.
- Verification report (assay) for the laboratory.
- Information management systems to monitor sample delivery and tracking.
- Appropriate systems for handling, transportation, and analysis of test samples.
- Health and Safety Executive (HSE) approval that labs are working to CL3 or CL2+ containment standards.
- Robust record management systems.
8. For lab-based testers: The laboratory must be rated to either ISO 15189 or ISO/IEC 17025
- These are the standard requirements for PCR testing.
9. For point-of-care based testers: providers must meet ISO 15189 and ISO/IEC 22870
- The samples must actually then be processed by a UKAS accredited (or applicant) provider.
10. Applicants must be compliant with all legal and regulatory requirements for sample collection, processing and sharing of results including the requirements of data protection legislation.
- This includes GDPR considerations.
Stage Two: UKAS Appraisal Requirements:
There are 13 requirements providers must meet to pass Stage Two:
- Provider must obtain a copy of the relevant ISO standard for accreditation and conduct a gap analysis.
- Provider must have defined its governance and management structure with clear definition of the reporting lines and responsibilities.
- Provider must have adequate liability insurance.
- Provider shall have access to relevant clinical expertise (N.B: expectations shall vary depending on which ISO standard is adopted).
- Provider shall have sufficiently trained and competent staff with records of their training.
- Provider shall use validated technical methods and prove that they can reach the required performance characteristics.
- Provider shall have documented procedures for sample collection, transportation, storage, and analysis.
- Provider shall implement appropriate IQC and have registered in a suitable EQA scheme or ILC.
- Provider shall have and maintain suitable facilities that meet the containment level requirements.
- Provider shall have appropriate interpretation criteria.
- Provider shall have appropriate procedures in place to ensure testing is performed five days post self-isolation and/or for other agreed turnaround times, and for reporting the outcome of these tests.
- Provider shall have appropriate procedures in place to resolve and report adverse incidents.
- Provider shall have appropriate procedures to dispose of clinical waste safely.
Submitting the Stage Two Application:
UKAS will provide a report on whether the 13 requirements have been met. Providers will need to address any gaps identified.
Once Stage Two has been completed, UKAS will set out the next steps for initial assessments for Stage Three full accreditation.
If providers need more information on the Stage Two process, they can contact: firstname.lastname@example.org
Stage Three: Full UKAS Accreditation
Once the UKAS appraisal stage has been completed, applicants will be able to progress to full UKAS accreditation for either ISO 15189 or ISO/IEC 17025 or, for point of care testing, ISO 15189 and ISO 22870.
UKAS accreditation must be achieved by June 2021, or four months after providers have gained UKAS appraisal.
Contact addresses for general queries:
Our Bevan Brittan team is here to advise on every stage of the UKAS accreditation process.
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