Minimum standards for private-sector providers of COVID-19 testing for ‘Test to Release for international travel’

Question 1

New testing, self-isolation and quarantine rules from 15 February

Accepted Answer

From 15 February, all travellers who in the 10 days prior to their arrival have been in a country with a travel ban to the UK will be required to quarantine in government-managed facilities. All international arrivals will be required to take a mandatory coronavirus test on day 2 and day 8 of their quarantine period.

International arrivals who have been in a ‘red list’ country in the 10 days prior to their arrival may not opt-in to Test to Release. The Test to Release scheme will remain available to international arrivals who have only been in non-red-list countries in the 10 days prior to their arrival.

Guidance for arrivals from ‘red list’ countries

Guidance for arrivals from non ‘red list’ countries

More information on the minimum standards for day 2 and day 8 mandatory tests can be found in the guidance for private providers.

As a consequence of these measures, it is important that Test to Release providers place warnings on their booking page to highlight that international arrivals to England who have been in a red-list country in the 10 days prior to their arrival cannot opt-in to Test to Release.

Question 2

Introduction

Accepted Answer

From 15 December 2020, international arrivals are able to opt in to ‘Test to Release’.

The government has published this guidance for private providers of ‘Test to Release for international travel’.

By law, all tests used for the purpose of shortening the self-isolation period for international arrivals must meet certain minimum standards.

Providers must also complete a declaration that their tests meet these standards.

Start the private sector provider self-declaration process to complete this declaration and request to be added to the GOV.UK list of providers of Test to Release for international travel.

This will include providing some additional information to support our due diligence checks.

Once you have completed your self-declaration and it has undergone the required due diligence, you may choose for your organisation to appear on the GOV.UK list of private providers for Test to Release, subject to your organisation meeting the required minimum standards.

For further information on providing tests for ‘Test to Release for international arrivals’, please contact globaltraveltaskforce@dft.gov.uk.

Read further information on the UKAS (UK Accreditation Service) appraisal and accreditation process on the UKAS website

Question 3

Minimum standards

Accepted Answer

1. Requirement for a medical director and healthcare scientist

The provider of the test 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 ‒ registered with the General Medical Council.

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. The individual must be a registered medical practitioner or a healthcare scientist, registered with the Health and Care Professions Council. The same individual may fulfil both roles (medical and clinical), providing they are duly registered.

2. Requirement for effective system of clinical governance

The provider of the test must have an effective system of clinical governance in place, which includes appropriate standard operating procedures in relation to the carrying out of the tests being provided for ‘Test to Release for international travel’.

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
for laboratory testing, 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
for laboratory testing, working to containment level CL3 or CL2+ with Health and Safety Executive (HSE) approval
systems, processes and record management to support the delivery of safe and reliable service

3. The test device 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 regulation 39(2) of those regulations

This requirement is to ensure that the testing device used in relation to ‘Test to Release for international travel’ have a CE marking (or, following the UK’s exit from the European Union, a UK marking) and do not benefit from a derogation from those standards.

A CE mark is a logo that is placed on IVD medical device to show that it conforms to the requirements of the In Vitro Diagnostic Medical Devices Directive 98/79/EC. A CE mark shows that the testing device is fit for its intended purpose stated and meets legislative requirements relating to safety.

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

Further information is available on CE marking, UKCA marking and in-vitro diagnostic medical devices.

4. Use of tests that meet minimum performance characteristics

The provider must use test devices that use an established molecular detection method and have the following performance characteristics as a minimum:

sensitivity greater than 95% (with 95% 2-sided confidence interval entirely above 90%)
specificity greater than 95% (with 95% 2-sided confidence interval entirely above 90%)
limit of detection less or equal to 1,000 SARS-CoV-2 copies per millilitre (≤1000 Copies/ml)

In addition, test devices must have been independently validated as having the required sensitivity and specificity using at least 150 positive clinical samples and 250 negative clinical samples against a laboratory-based RT-PCR test that is itself within the performance specification of the target product profile published by the Medicines and Healthcare Products Regulatory Agency (MHRA) for laboratory-based SARS-CoV-2 PCR tests.

Independent validation must have been conducted, no more than 18 months before the test is provided, by one of:

an independent lab which is accredited by UKAS to ISO 15189 or 17025
a scientific committee which is overseen by the Department of Health and Social Care, including the Technologies Validation Group or the Lateral Flow Device Oversight Group

Further guidance explaining how both virus and antibody tests work has been published by the Medicines and Healthcare products Regulatory Agency (MHRA).

5. Use of age-appropriate test devices

The test device should be age-appropriate, so it must be suitable to administer or provide a test to a person of the same age as the international arrival.

6. Reporting of coronavirus test results, as a notifiable disease

The provider must have a system in place for reporting positive, negative and inconclusive test results cases in accordance with their obligations under public health legislation.

More information is available in the PHE guidance for reporting notifiable diseases.

At booking, the provider (or sub-contractor, if relevant) must, therefore, collect the following data fields from international arrivals:

full name
sex
date of birth
NHS number (if known and applicable)
ethnicity
home address, including postcode, and the address at which they intend to self-isolate (if different)
email address
telephone number
vaccination status

Together with data required to be reported under public health legislation, the provider (or their subcontractor, if relevant) will need to have a system in place to collect from the international arrival and report the following additional data fields:

the date of their arrival in the UK
their coach number, flight number or vessel name (as appropriate)
the date on which they arrived in England from country or territory outside of the Common Travel Area
the country or territory they were travelling from when they arrived in the UK, and any country or territory they transited through as part of that journey

Additionally, the provider must collect the international arrivals’ passport number or ID card reference number, and include this information on the notification of result, and confirm this to the police upon request.

7. 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.

For more information, go to MHRA COVID-19 Yellow Card portal

8. For lab-based testing

Providers must be or use a UKAS applicant laboratory to either ISO 15189 (Medical Laboratories – requirements for quality and competence) or ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories).
Additionally, samples must be taken by a provider (or sub-contractor, if relevant) applicant to ISO standard ISO15189 or ISO/IEC17025.

UKAS (UK Accreditation Service) accreditation provides an assurance of the competence, impartiality and integrity of laboratories. This accreditation is an important element in establishing and maintaining confidence in a testing service.

For polymerase chain reaction (PCR) or other lab-based testing, all samples must be processed by a UKAS applicant laboratory (the laboratory has applied for UKAS accreditation but has not yet achieved it) and have quality management systems operating according to ISO 15189 and/or ISO/IEC 17025. Samples must also be taken by or under the instruction of, a provider (and their sub-contractors, if relevant) that is applicant to ISO 15189 and/ or ISO/IEC 17025. This requirement does not prevent issue of tests which are self-swabbed or self-administered since those samples would be taken under instruction from the person responsible for taking the samples.

UKAS appraisal status (‘stage 2’) will become mandatory for providers of ‘Test to Release for international travel’ (or their sub-contractors, if relevant) and commercial providers COVID-19 testing on 4 weeks after they become a UKAS applicant. UKAS appraisal status is an assessment of compliance with the requirements published by UKAS in relation to the relevant ISO standard. UKAS accreditation (‘stage three’), which is full accreditation to the relevant ISO standard, will become mandatory for providers of ‘Test to Release for international travel’ (or their sub-contractors, if relevant) and commercial COVID-19 testing by 1 July 2021, or 4 months after they have gained UKAS appraisal status.

Read more information on UKAS accreditation and appraisal, ISO 15189 and ISO 17025.

9. For point of care testing: providers must be applicant to ISO 15189 and 22870 (point-of-care testing – requirements for quality and competence)

UKAS accreditation provides confidence in the competence, impartiality and integrity of point of care test providers to provide a safe and reliable point of care testing service.

For point of care testing, all providers (or sub-contractors, if relevant) must be applicant to ISO 15189 and 22870. Providers are encouraged to adhere to ISO 22583 “Guidance for supervisors and operators of point-of-care testing devices”.

UKAS appraisal status (‘stage 2’) will become mandatory for providers of point of care tests for ‘Test to Release for international travel’ (or their sub-contractors, if relevant) and commercial providers COVID-19 testing 4 weeks after they become a UKAS applicant. UKAS appraisal status is an assessment of compliance with the requirements published by UKAS in relation to the relevant ISO standard. UKAS accreditation (‘stage 3’), which is full accreditation to the relevant ISO standard, will become mandatory for providers of point of care tests for ‘Test to Release for international travel’ (or their sub-contractors, if relevant), and commercial COVID-19 testing by 1 July 2021, or 4 months after they have gained UKAS appraisal status.

More information on ISO 22870 and ISO 22583.

10. Date tests can be provided or administered

Providers may only provide or administer tests to international arrivals on or after the fifth full day after arrival. The provider should base the day of arrival on the day the international arrivals declares on their booking form, meaning that the day of arrival is day 0.

The international arrival will therefore take the test on or after the fifth full day after they arrive.

11. Reference number

At the time the test is booked the test provider must provide a test reference number to the person booking the test. This booking reference number should include the first 5 letters of the provider name.

12. Sub-contractors

If the test provider arranges with another provider or person (for example a sub-contractor) to carry out any element of the single end-to-end testing service on their behalf, the test provider must ensure that such person complies with the following requirements, as relevant to the carrying out of that element of the service:

requirement for a medical director and healthcare scientist (standard 1)
requirement for system of clinical governance (standard 2)
requirement to report data to PHE (standard 6)
requirement for systems in place to report issues (standard 7)
requirement to be an applicant, to have reached appraisal status or to be accredited to the relevant ISO standard (standard 8,9)
requirement to not administer the test before the end of the fourth day after the traveller has departed from a non-exempt country (standard 10)
requirement to provide results within 24 hours and in a set format (standard 13)

13. Notification of test result: providers must issue the result of tests in a set notification which instructs the international arrival on whether they are required to self-isolate

Test providers must notify the international arrival taking the test within 24 hours of their result becoming available by email, text message, letter or secure web portal. Providers must issue test results in a set notification, to ensure that the international arrival receives the relevant public health advice and notifications are recognisable.

The set format must include the international arrival’s name and date of birth and passport or ID card number, as provided at booking, the name and contact details of the test provider and the reference number for the test. The provider must also provide the same unique reference number at test booking to enable the international arrival to complete the passenger locator form.

The notification of the international arrival’s test result should be conveyed including the following form of words, as appropriate.

Form A: negative test result

Your coronavirus test result is negative. You did not have the virus when the test was done. If you were self-isolating as an international arrival you may stop self-isolating.

You should self-isolate if:

you get symptoms of coronavirus (you should get an NHS coronavirus test and self-isolate until you get the results)
you’re going into hospital (self-isolating until the date you go in)
someone you live with tests positive
you’ve been traced as a contact of someone who tested positive

For advice on when you might need to self-isolate and what to do, go to www.nhs.uk/conditions/coronavirus-covid-19 and read ‘Self-isolation and treating symptoms’.

It’s a legal requirement to self-isolate when you arrive in the UK from a non-exempt country, territory or region. If you’re contacted by the enforcement authorities or the police after you have received this negative result please show them this notification.

Form B: positive test result

Your coronavirus test result is positive. You had the virus when the test was done.

If you have not had symptoms of coronavirus, you must self-isolate for 10 days from the day after your test date. If you have symptoms of coronavirus, you must self-isolate for 10 days from the day your symptoms started, if earlier than when you took your test. (The day after symptom onset or test date is counted as the first full day of self-isolation.)

People you live with or are travelling with should also self-isolate for 10 days from the day after you took a test.

You may be contacted for contact tracing and to check that you, and those who you live or are travelling with, are self-isolating.

You must not travel, including to leave the UK, during self-isolation.

Contact 111 if you need medical help. In an emergency dial 999.

Form C: unclear test result

Your coronavirus test result is unclear. It’s not possible to say if you had the virus when the test was done.

You must, by law, continue self-isolating for the remainder of your self-isolation period as an international arrival travelling to the UK from a non-exempt country, territory or region. You may be contacted to check that you are self-isolating.

If you want to shorten your self-isolation period you will need to take another test for international arrivals. For more information, go to https://www.gov.uk/guidance/coronavirus-covid-19-test-to-release-for-international-travel.

14. Corroborate test results with the police (by exception and on request)

By law, international arrivals who travel to England from a destination not on the travel corridors list are required to self-isolate for 10 days. As part of compliance investigations, the police may request confirmation of the international arrival’s test result, to decide whether they must still to self-isolate.

Test providers must, on request, provide a constable with the following information:

an arrival’s passport number or travel document reference number (as collected at booking)
an arrival’s test result
the date on which an arrival took their test
the date on which the test result was notified or made available to the arrival (as collected at booking)

The Information Commissioner’s Office (ICO) has set out FAQs on data collection and data protection relating to COVID-19 that provide further information, including GDPR considerations:

Minimum standards for private-sector providers of COVID-19 testing for ‘Test to Release for international travel’

New testing, self-isolation and quarantine rules from 15 February

Introduction