GovWire

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

Department Of Health

October 4
03:00 2021

Introduction

Everyone entering England from abroad must take one or more tests for coronavirus (COVID-19).

Depending on their vaccination status, people whove entered England from abroad need to take a test on either:

  • day 2 only
  • day 2 and day 8

There are different rules for people whove been in a country on the red list during the 10 days before they arrive.

Read an overview of the rules for travelling to England from abroad and find out who needs to take which tests.

By law, all tests privately provided on day 2 and day 8 for international arrivals must meet minimum standards as outlined in the guidance below.

People arriving from abroad who have a legal duty to quarantine for 10 days can opt in to Test to Release for international travel to shorten their quarantine period. Providers for Test to Release must meet separate minimum standards.

Self-declaration

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 laboratories completing the self-declaration will self-declare on behalf of themselves and all of the organisations theyre working with to provide these tests. They will need to list all organisations that they will be working with (whether by sub-contract or otherwise) in order to carry out this service. They will also need to list any organisations they 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 with to provide 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.

Penalties and offences

If a private provider does not meet the standards required, they may be committing an offence and subject to a penalty.

Problems with test kits and results

Where a test kit is broken, is not delivered or gives an inconclusive or invalid test result, the provider should offer a replacement kit.

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 48 hours of them becoming available.

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

At booking, the provider (or sub-contractor, if relevant) must 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 reside in England (if different)
  • email address
  • telephone number
  • COVID-19 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
  • the sample specimen ID number prefixed by the laboratory ID
  • COVID-19 vaccination status
  • the purpose of the test this must include the vaccination status of the person taking the test, and whether the test was an eligible non-red day 2 test, a non-eligible non-red day 2 test or a non-eligible non-red day 8 test
  • test booking reference
  • passport number or travel document reference number

The following additional data must also be reported by the laboratory conducting genome sequencing:

  • the same sample specimen ID and laboratory ID reported by the diagnostic laboratory
  • whether a variant of concern (VOC) has been identified
  • whether a variant under investigation (VUI

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