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

Department Of Health

October 23
10:03 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:

  • on or before day 2 only
  • on or before day 2 and on and after day 8

In this guidance, when we talk about eligible arrivals, we mean those who are eligible to follow the rules for people who have been fully vaccinated under an approved vaccination programme.

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

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

The day 2 and day 8 COVID-19 PCR tests described in this guidance are not for arrivals from red list countries. Providers must not sell these tests to people who have been in a red list country in the 10 days before arriving in England.

By law, all tests privately provided for international arrivals must meet and maintain the minimum standards from 12 November 2021. The standards for day 2 and day 8 PCR testing are outlined below. There is separate guidance on the day 2 lateral flow tests for international arrivals: minimum standards for providers.

People arriving from countries not on the red list who have a legal duty to self-isolate for 10 days may be able to opt in to Test to Release for international travel to see if they can 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 day 2 and day 8 PCR 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 there is a change to any information submitted in their self-declaration, the provider 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 enforcement action and the resultant 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 as soon as possible to the consumer.

Minimum standards that apply to day 2 and day 8 PCR tests

1. Requirement for a medical director and clinical 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 clinical 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 day 2 and day 8 PCR 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 30 June 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 the test being received by the lab for processing.

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 (only needed for positive and inconclusive results)
  • telephone number (only needed for positive and inconclusive results)
  • COVID-19 vaccination status

Together with data required to be reported under The Health Protection Regulations 2010, 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:

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