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Detailed guide: Day 2 and day 8 testing for international arrivals: minimum standards for providers

Department Of Health

February 22
17:17 2021

Introduction

All international arrivals to England must quarantine for 10 days, unless they have a job that qualifies for an exemption.

From 15 February 2021, all international arrivals in quarantine are required to take a test on or before day 2 (of their quarantine period), for variant surveillance, and a test on or after day 8 (of their quarantine period).

By law, all tests privately provided testing on day 2 and day 8 for international arrivals must meet minimum standards as outlined in the guidance below. The first section sets out minimum standards that apply for both day 8 and day 2 tests. The second section sets out additional specific standards for day 2 tests and the third section sets out additional specific standards for day 8 tests.

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

This self-declaration must only be completed by laboratories that will be conducting diagnostic test evaluation for mandatory coronavirus (COVID-19) testing for international arrivals.

The laboratory completing the self-declaration will self-declare on behalf of themselves and all of the organisations theyre working with to provide these tests. You will need to list all organisations that you will be working with (whether by sub-contract or otherwise) in order to carry out this service. You will also need to list any organisations you will be working with (whether by sub-contract or otherwise) to carry out genomic sequencing. If you wish to change the list of organisations you are working in providing the service and/or genomic sequencing, you will need to notify the Department of Health and Social Care (DHSC) of the nature of the arrangement and the name of this organisation.

International arrivals who have arrived from countries that do not have a travel ban (amber list countries) will still be able to opt in to Test to Release for international travel to shorten their isolation period. Providers for Test to Release must also meet certain minimum standards.

Minimum standards that apply to day 2 and day 8 tests

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 mandatory testing for international arrivals.

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 has a CE marking (or, following the UKs 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 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. 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:

4. 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. All results of tests for this purpose must be reported within 24 hours of them becoming available.

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

At booking, the provider (or sub-contractor, if relevant) will need to have a system in place to 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 quarantine (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 last departed from or transited through a country or territory outside 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, for sequenced samples the provider must report a sorted BAM file containing all reads aligning to the SARS-CoV-2 reference genome with unaligned reads removed and human reads removed.

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. Medicines & Healthcare productsRegulatory Agency (MHRA) has a dedicated coronavirus (COVID-19) yellow card portal to report adverse incidents with medicines, medical devices and diagnostics.

6. Use of ag

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