How to become a private provider of COVID-19 testing바카라 사이트�바카라 사이트�
Guidance for prospective providers바카라 사이트痮n how to be listed as a testing provider for바카라 사이트痝eneral바카라 사이트痯opulation testing.
Thank you for your continued support throughout the UK바카라 사이트檚 response to COVID-19.바카라 사이트� In line with the Living with COVID-19 strategy, we have reviewed the contents of the legislation.聽Subject to parliamentary approval, from 1 January 2024, clinical COVID-19 testing services (diagnostic laboratories, point of care testing and sample collection) will be required to be accredited as per these draft regulations to trade: .
Private providers must comply with the timetable set out within the current regulations 바카라 사이트� the final date for new applications to the current system (self-declaration against minimum standards followed by achieving accreditation from the United Kingdom Accreditation Service (UKAS)) is 31 December 2023. Anyone wishing to progress with their current accreditation must contact UKAS before 31 December.
All commercial providers of COVID-19 testing services must meet the appropriate legal requirements as set out below.
Self-declaration
For general population testing, including tests used for the purpose of entering another country, the end-to-end testing provider (the organisation that customers approach to access testing services and whose name appears on these lists) is responsible for completing the바카라 사이트�.바카라 사이트繏�
The UK Health Security Agency (UKHSA) must also be provided with a list of all organisations that are involved (whether subcontracted or otherwise) in carrying out the testing service, indicating the nature of the service that each organisation provides. This list should be updated as appropriate.
The provider must use the appropriate self-declaration form for their service. If an organisation completes the incorrect self-declaration form their evidence will not be reviewed and they will have to submit the correct self-declaration form.
Any changes to the original self-declaration must be communicated to UKHSA through privateproviderselfdecqueries@dhsc.gov.uk
The declaration is a mandatory requirement for providers with effect from 1 January 2021, or before providers begin testing (whichever is later).바카라 사이트繏�
Any organisation which intends to run a commercial COVID-19 testing service or carry out an element of that service on behalf of an end-to-end provider,바카라 사이트痬ust meet the relevant legal minimum standards for their role in the testing process. The test provider must document in the self-declaration form if they subcontract elements of the testing process.바카라 사이트繏�
It is the overall responsibility of the test provider to ensure that the services comply with the government바카라 사이트檚 minimum standards.
UKAS accreditation
The organisation providing sample collection and/or sample testing바카라 사이트痵ervices will need to undergo UKAS accreditation to the relevant ISO standards.바카라 사이트繏�
There is a charge for the accreditation process. See information on the .바카라 사이트繏�
There are 3 stages to the UKAS accreditation process:바카라 사이트�바카라 사이트�
Stage 1
Organisations that provide sample collection and/or sample testing (including laboratory testing and point of care testing services) must바카라 사이트�.바카라 사이트繏�
For general population testing, the test provider (the customer-facing organisation) must submit a바카라 사이트痵elf-declaration form, as detailed above, to show they meet the minimum standards for their provision of testing.
General population testing: minimum standards바카라 사이트�바카라 사이트痬ust be met as soon as testing services are provided.
The self-declaration is바카라 사이트痵ubsequently바카라 사이트痳eviewed to ensure standards are being met. At this point, private providers can offer testing services and appear on the appropriate 바카라 사이트 list once they have successfully completed stage 1.바카라 사이트�
Getting listed on 바카라 사이트 may require further checks.
Stage 2
The organisation undergoing바카라 사이트�UKAS바카라 사이트痑ccreditation must undertake UKAS appraisal within 4 weeks of completing stage 1 바카라 사이트� that is, the date on which the organisation made a valid application for accreditation.바카라 사이트�
Detailed guidance on the stage 2 UKAS바카라 사이트痑ppraisal process is .
Contact바카라 사이트�medlabscustomerservice@ukas.com바카라 사이트痜or more information.바카라 사이트�
Stage 3
The organisation undergoing UKAS accreditation must undertake a full assessment of activities in line with the relevant ISO standards.
For stage 3, organisations must:바카라 사이트�바카라 사이트�
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Achieve a positive recommendation from바카라 사이트�UKAS within 4 months after completing stage 2 (that is, the date on which the organisation submitted evidence to바카라 사이트�UKAS바카라 사이트痙emonstrating compliance with the UKAS appraisal requirements).
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Achieve full accreditation within 6 months after completing stage 2 UKAS appraisal.
The set out the stages of and deadlines for obtaining accreditation and state that test providers must stop selling tests if they do not meet those deadlines.
Full guidance on the accreditation process can be found on the바카라 사이트�UKAS바카라 사이트痺ebsite. For further queries contact바카라 사이트�covid@ukas.com
For further information, contact privateproviderselfdecqueries@dhsc.gov.uk
Get listed on 바카라 사이트바카라 사이트�
Once the submitted self-declaration form has been reviewed and any outstanding queries are resolved, you바카라 사이트檒l be contacted by UKHSA, who will confirm in writing when they consider that standards have been met for their provision of testing. At this point, they will request that your organisation provides up to date information for 바카라 사이트 listing.바카라 사이트�
Please note it will take a minimum of 2 working days for your information바카라 사이트痶o be published바카라 사이트痮n the relevant 바카라 사이트 list as UKHSA conducts due diligence checks on the information supplied.바카라 사이트繏�바카라 사이트�
UKHSA may remove your listing from 바카라 사이트.
Reasons why this may occur include:
- no longer meeting the minimum standards for your provision of testing
- failing to meet your statutory reporting duties
- being subject to specific compliance and enforcement actions due to low quality or dangerous service바카라 사이트痯rovision
- failing to meet the stipulated timelines required by the UKAS accreditation process (if applicable)
You may also ask to be removed from the 바카라 사이트 list, or to not be listed, at any time. Your organisation must ask to be delisted if you run out of stock or stop providing the relevant testing services. Removal requests will be acted on within 2 working days.바카라 사이트�
UKHSA will remove your organisation where we identify your organisation no longer has stock or has stopped providing the relevant testing services.
See a list of and information on private providers compliant with the government바카라 사이트檚 minimum standards.
Further requirements
Private providers should provide clear, easy to understand information for their customers about:
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the benefits and drawbacks of testing바카라 사이트�바카라 사이트�
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how reliable the results will be, and what the limitations are바카라 사이트�바카라 사이트�
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what a test result means, in non-medical language바카라 사이트�바카라 사이트�
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how they are following the measures set out in this guidance바카라 사이트�바카라 사이트�
It is important to be aware that self-declaring against the government바카라 사이트檚 minimum standards and/or UKAS accreditation itself does not discharge a private provider바카라 사이트檚 general legal obligations in relation to the provision of testing services.
It is a provider바카라 사이트檚 responsibility to understand what legislation and regulations they will need to follow, including around consumer and data protection law, patient confidentiality, mandatory reporting to UKHSA in accordance with public health legislation and how they will meet these as required.바카라 사이트繏�
Private providers offering COVID-19 testing services should keep up to date with:
- relevant minimum standards and applicable regulations
- deadlines for accreditation where appropriate and reporting of data
- the latest government guidance on restrictions, testing, isolation and specific advice on travel obligations
Compliance and enforcement
The purpose of the legislation governing private testing is바카라 사이트痶o ensure that the UK has a continued supply of high-quality providers of testing services for COVID-19. This is specifically by ensuring that providers must continue to meet the minimum standards set out in legislation, which includes continuing to meet accreditation deadlines바카라 사이트痑nd ensuring their actions do not degrade public trust in the testing schemes.바카라 사이트繏�
UKHSA바카라 사이트檚 goal is to focus on supporting providers, encouraging best practice and improving compliance. However, when we do not receive appropriate and timely responses to requested changes and improvements, we may engage with key regulatory bodies to pursue legal action for a breach of standards and obligations.바카라 사이트繏�
UKHSA carefully monitors issues raised by the public and will reach out to organisations directly, taking action where appropriate.바카라 사이트繏�
National regulatory enforcement bodies may also intervene in instances where providers fail to comply with their general obligations under consumer law or other legal requirements such as data protection. For example, on 25聽August 2021, the Competition and Markets Authority (CMA) sent an open letter to PCR test providers warning that a range of harmful practices in the sector could breach consumer protection law. The CMA also sent letters to 25 PCR providers, warning them to review their terms and conditions 바카라 사이트� and other practices 바카라 사이트� or risk facing enforcement action.
Private providers should seek legal advice if they are unclear on which regulations apply to their business. The Laboratory and Testing Industry Organisation (LTIO), which provides support for its members who provide PCR testing services, has published a in the sector. 바카라 사이트�
UKHSA may also act if we believe there is a public health concern or risk of fraudulent or illegal behaviour.바카라 사이트繏�
UKHSA may remove a private provider from 바카라 사이트 during this process and pass collected information through to key regulatory bodies. UKHSA will make every effort to ensure that the process is being followed and reasoning for any decision is communicated to you in a timely manner. However, in some situations UKHSA may be unable to communicate all of the details.
Note: tests remain valid if providers are removed from the list. Private providers will be instructed directly when they can no longer provide testing services.바카라 사이트繏�
Once compliance or enforcement action has concluded, which may include the private provider being removed from the private provider lists on 바카라 사이트, UKHSA바카라 사이트痺ill consider any evidence-based submissions which shows that the provider is바카라 사이트痗omplaint with the process or evidence of corrective action the provider has taken.
This evidence should be sent to privateproviderselfdecqueries@dhsc.gov.uk
UKHSA will review and consider all evidence and decide on whether바카라 사이트痑 provider should be kept바카라 사이트痮ff or reinstated to the 바카라 사이트 list as appropriate.
Updates to this page
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Updated notice about upcoming requirements.
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Added note on legislation and guidance being under review.
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Updated to reflect end of international travel testing.
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Updated guidance around self-isolation.
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Updated to reflect new rules for international arrivals in England from 11 February 2022.
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Updated to add a link for the self-declaration form for providers of day 2 lateral flow tests for international arrivals.
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First published.