Guidance

LFD Testing Agreement: England, Northern Ireland and Wales terms and conditions for COVID-19 testing in eligible high-risk settings

Updated 29 January 2024

This guidance was withdrawn on 8 March 2024

This content is now available at COVID-19: guidance and support.

This Agreement is entered into between The Secretary of State for Health and Social Care as part of the Crown through the UK Health Security Agency (UKHSA) of Nobel House, 17 Smith Square, London SW1P 3HX, UK and the organisation which has agreed to participate in the testing programme described in this Agreement (‘Participating Organisation’) on the earliest of the following (the ‘Commencement Date’):

• the date on which a representative of the Participating Organisation confirms their agreement to these terms and conditions as part of registering the Participating Organisation with the UKHSA for the Testing Programme defined below (‘Registration’) through UKHSA Testing Programme online portal (‘Portal’); or
• the date on which the Participating Organisation commences any participation in the Testing Programme (including without limitation by accepting delivery of Testing Kits and/or distributing Testing Kits to the Test Subjects (as defined below)) and by any such participation, the Participating Organisation confirms their agreement to the terms and conditions of this Agreement.

This Agreement is formed of:

• these UKHSA terms and conditions for coronavirus (COVID-19) testing; and
• the ‘Clinical Framework Standard Operating Procedure for Testing with Lateral Flow Antigen Testing Devices in High-risk Department of Levelling Up Housing and Communities Settings’ applicable to the relevant UK country in which the testing is to be carried out, as made available by UKHSA to the Participating Organisation from time to time (the ‘SOP’)

As part of UKHSA’s wider efforts to combat the COVID-19 pandemic, UKHSA is supporting the Participating Organisation in running a COVID-19 self-testing programme, where the relevant lateral flow device (‘LFD’) self-test kits as identified in the SOP (‘Testing Kits’) are distributed by the Participating Organisation to Test Subjects (defined below) for Self Testing (defined below) with the aim of identifying asymptomatic or symptomatic individuals who have COVID-19 (‘Testing Programme’). UKHSA and the Participating Organisation have agreed to co-operate in the Testing Programme.

A Participating Organisation may only participate in the above workstreams of the Testing Programme as agreed with UKHSA as part of its Registration, or any later update via the Portal.

Certain provisions of this Agreement are modified for Participating Organisations in the public sector (see clause 15) and Crown Bodies (see clause 16).

1. Basis of the Testing Programme

1.1 UKHSA will provide Testing Kits to the Participating Organisation, and the Participating Organisation will distribute them to such employees, volunteers and other service users, in each case, as identified in the SOP as being covered by the Testing Programme and who volunteer, and any other category of individual which UKHSA agrees in writing can be included in the Testing Programme (together ‘Test Subjects’), enabling the Test Subjects to self- administer tests.

1.2 To the extent set out in the SOP, UKHSA will provide instructions for use for the Testing Kits together with the Testing Kits (the latest version of which provided to the Participating Organisation in accordance with this Agreement being the ‘Instructions for Use’).

1.3 The Participating Organisation agrees to make available for collection from the Participating Organisation’s premise(s) and to distribute, in each case in accordance with the SOP, Testing Kits and the Instructions for Use to Test Subjects to enable them to test themselves for COVID-19 (whether such testing by the Test Subjects takes place onsite at the Participating Organisation’s premise(s) or elsewhere) (‘Self Testing’).

2. Participating Organisation responsibilities

2.1 Promptly after receipt of the Testing Kits from UKHSA under this Agreement, the Participating Organisation shall inspect the Testing Kits to confirm that the expected quantity and type of Testing Kits have been delivered.

2.2 Following receipt of the Testing Kits, the Participating Organisation shall:

2.2.1 store the Testing Kits safely and securely in accordance with the SOP; and

2.2.2 distribute the Testing Kits (with the current Instructions for Use) to Test Subjects in accordance with the SOP from the locations agreed with UKHSA at the time of Registration (unless otherwise agreed with UKHSA in writing).

2.3 The Participating Organisation shall:

2.3.1 facilitate the Self-Testing in accordance with the SOP and distribute the Testing Kits to Test Subjects free of charge and solely for the purpose of the Self Testing by Test Subjects pursuant to this Agreement and not make any other use of the Testing Kits or distribute the Testing Kits to anyone other than the Test Subjects or otherwise distribute the Testing Kits for commercial gain;

2.3.2 distribute the Testing Kits to Test Subjects with the Instructions for Use, and the Participating Organisation shall not do anything to modify, obscure or contradict the Instructions for Use;

2.3.3 promptly on request return any unused or surplus Testing Kits to UKHSA which have not been dispatched to Test Subjects;

2.3.4 report any problems or incidents with the Testing Kits to UKHSA as soon as reasonably practicable in accordance with any processes notified to the Participating Organisation by UKHSA;

2.3.5 comply with any further reporting obligations set out in the SOP;

2.3.6 be responsible for obtaining any necessary consents from Test Subjects, or from parents or legal guardians, in respect of the Testing Programme in accordance with the applicable SOP;

2.3.7 advise the Test Subjects to promptly report their test results from the Testing Kits (whether positive, negative or void) via the NHS Test and Trace (or equivalent body in a devolved administration) digital solution and to promptly inform their line manager or other appropriate contact at the Participating Organisation of any positive test results;

2.3.8 undertake and deliver all communications in relation to the Self Testing in accordance with the SOP and other UKHSA guidance, including the communication of the Self Testing and impact of the results of Self Testing to potential Test Subjects;

2.3.9 unless otherwise notified by UKHSA in writing:

2.3.9.1 be required, as a minimum, to keep and maintain a log (in such format as the Participating Organisation, acting reasonably, deems appropriate) of the information relating to the distribution of Testing Kits as may be specified in the SOP from time to time (without recording any personal data relating to Test Subjects); and

2.3.9.2 retain the log compiled in accordance with clause 2.3.9.1 for the period specified in the SOP; and

2.3.10 in the event of any product recall in relation to Testing Kits, provide any assistance reasonably requested by UKHSA in identifying the location of the impacted Testing Kits, returning or destroying impacted Testing Kits, and/or contacting the relevant Test Subjects.

2.4 On written request by UKHSA, Participating Organisations shall co-operate and assist UKHSA with such evaluation and quality assurance activities (including without limitation dual testing with polymerase chain reaction (PCR) testing kits) as may be specified in the SOP from time to time (‘Evaluation and QA Activities’). Participating Organisations shall carry out any such Evaluation and QA Activities in accordance with the SOP.

3. UKHSA responsibilities

3.1 UKHSA shall arrange for delivery of an appropriate volume of Testing Kits to the Participating Organisation as determined by UKHSA (subject to the availability of UKHSA supplies of the same), to each of the locations agreed between the parties at the time of Registration. The supply of Testing Kits shall be at UKHSA’s sole discretion (save that UKHSA will use its reasonable endeavours to meet any delivery timeframes notified to the Participating Organisation).

3.2 UKHSA shall be responsible for ensuring that:

3.2.1 the SOP (including the Instructions for Use) is appropriate for Self Testing (and, where applicable, any Evaluation and QA Activities), in accordance with this Agreement and applicable law and regulation;

3.2.2 the Testing Kits are appropriate for use by Test Subjects to carry out the Self Testing in accordance with the SOP and this Agreement; and

3.2.3 the Testing Kits are of the necessary quality and standard to enable Test Subjects to carry out the Self Testing and are free from material defects. Subject to clause 3.1, if the Participating Organisation notifies UKHSA that any Testing Kits have material defects, UKHSA shall endeavour to provide replacements.

3.3 Where UKHSA requires Participating Organisations to take part in Evaluation and QA Activities, UKHSA shall provide to Participating Organisations such instructions and applicable testing kits (including PCR testing kits) and such or other equipment or materials, in all cases, as may be specified in the SOP.

Standard Operating Procedure (SOP)

4.1 The Participating Organisation has been provided with access to the SOP which sets out general guidance for the Self Testing and ancillary responsibilities that are to be carried out by each party under this Agreement.

4.2 Each party agrees to comply with the roles and responsibilities assigned to it under the SOP and to co-operate with the other party in order to achieve the objectives set out in the SOP.

4.3 The parties shall each ensure that their own relevant personnel are aware of the applicable provisions of the SOP and comply fully with the SOP.

4.4 UKHSA may update the SOP from time to time. The updated SOP shall apply from the date on which it is notified to the Participating Organisation (which shall include for these purposes UKHSA making the updated SOP available at the relevant web address). Participating Organisations should check the web address regularly for any updated documentation.

4.5 In the event of conflict between the SOP and the terms of this Agreement, the terms of this Agreement shall prevail.

5. Term

5.1 The Testing Programme shall continue for the duration of this Agreement, which shall (unless earlier terminated in accordance with the terms of this Agreement) be from the Commencement Date until the later of the date: (i) of the notice from UKHSA to the Participating Organisation that the Testing Programme is ending; and (ii) on which the Participating Organisation’s stock of the Testing Kits delivered by UKHSA pursuant to clause 3.1 has been exhausted and no further Testing Kits are available for it to distribute to the Test Subjects (‘Term’), at which point this Agreement shall expire unless any extension is agreed in writing between the parties.

5.2. Any work such as training or preparation for the Testing Programme by either party prior to the Commencement Date shall be treated as having been performed under the terms and conditions of this Agreement. Unless expressly agreed otherwise, this Agreement shall supersede any existing terms and conditions between UKHSA and the Participating Organisation which apply to the Testing Programme.

6. Data protection

6.1 Each party will process personal data under or in connection with this Agreement. Each party will be a controller in respect of the information that it processes under or in connection with this Agreement.

6.2 Without limitation to the foregoing, the parties intend that:

6.2.1 the Participating Organisation shall be the controller in respect of the personal data it collects from Test Subjects (including in arranging the attendance of Test Subjects at the locations to collect the Testing Kits);

6.2.2 UKHSA shall be the controller in respect of any personal data processed through the NHS Test and Trace (or equivalent body in a devolved administration) digital system.

6.3 The parties do not intend to disclose or share any personal data to each other under or in connection with this Agreement (including without limitation in relation to the Test Subjects). To the extent that the parties each process personal data relating to the Test Subjects, each will do so as separate independent data controllers.

6.4 UKHSA does not intend to disclose any results obtained from the Self Testing directly to the Participating Organisation under this Agreement.

6.5 In carrying out its obligations under this Agreement, each party shall comply with its obligations under the Data Protection Act 2018 and any other applicable laws and regulations relating to the protection of personal data and the privacy of individuals (all as amended, updated or re- enacted from time to time).

7. Confidential information

7.1 For the purposes of this Agreement, ‘Confidential Information’ shall mean information, data and material of any nature, including personal data, which either party may receive or obtain in connection with the conclusion and/or operation of this Agreement which is designated as confidential by either party or that ought reasonably to be considered as confidential (however it is conveyed or on whatever media it is stored) and, for the purposes of this Agreement, shall include any data created in the course of the Testing Programme (‘Testing Data’). Where the parties have entered into a non-disclosure agreement in relation to the Testing Programme and/or UKHSA’s testing strategy, any information disclosed under such non-disclosure agreement shall be deemed to be Confidential Information under this Agreement.

7.2 Each party shall take all proper steps to keep confidential all Confidential Information of the other party which is disclosed to or obtained by it under or as a result of this Agreement, and shall not disclose the same to any third party and shall allow access to the same to its own employees only on a need-to-know basis, except to the extent that any such Confidential Information becomes public through no fault of that party and except for use reasonably necessary for the performance of this Agreement.

7.3 Notwithstanding clause 7.2, UKHSA shall be entitled to disclose Confidential Information received from the Participating Organisation to its contractors or other third parties to the extent necessary to enable them to support the Testing Programme in accordance with this Agreement, provided that such contractors or other third parties have entered into a contract containing confidentiality provisions no less onerous than those contained in this Agreement.

7.4 Upon termination of this Agreement, where possible and on written request, save as expressly provided in this Agreement, each party shall return to the other party or securely destroy any Confidential Information (without retaining copies) provided for the purposes of this Agreement, save that this shall not apply to any Testing Data in the possession of UKHSA and/or any Confidential Information held on backup IT systems (provided that any such information shall remain subject to the obligations of confidentiality in this clause 7.

7.5 The Participating Organisation shall not use any Testing Data or other relevant Confidential Information as part of any form of research project, or otherwise publish any Testing Data, without the prior written consent of UKHSA.

7.6 Notwithstanding the termination or expiry of this Agreement for whatever reason, the obligations and restrictions in this clause shall be valid for a further period of 3 years from the date of termination or expiry of this Agreement.

7.7 Nothing in this Agreement shall restrict or prevent UKHSA from disclosing the name of the Participating Organisation, the address of any Facility, and information on the volumes of tests, to any Crown Body, local government entity, or any other organisation involved in the UKHSA COVID-19 testing programme.

8. Freedom of Information Act

8.1 The Participating Organisation acknowledges that UKHSA is subject to the Freedom of Information Act 2000 and the Environmental Information Regulations 2004 (together ‘FOIA’) and shall assist and co-operate with any reasonable written requests from UKHSA to enable it to comply with the requirements of FOIA in relation to this Agreement.

8.2 The Participating Organisation further acknowledges that UKHSA may be obliged to disclose any information (including Confidential Information) which it holds in response to a request received under FOIA, and that the extent, content and format of the disclosure is UKHSA’s decision. Where possible, prior to any such disclosure involving Confidential Information disclosed to UKHSA by the Participating Organisation, the Participating Organisation shall be consulted by the UKHSA.

8.3 The Participating Organisation shall permit UKHSA to inspect such records as are maintained by the Participating Organisation in relation to its performance of this Agreement as reasonably requested in writing from time to time during the Term of this Agreement.

8.4 In no event shall the Participating Organisation respond directly to a Request For Information (as defined in the Freedom of Information Act 2000, and such term shall include its equivalent under the Environmental Information Regulations 2004) related or otherwise connected to UKHSA or this Agreement unless expressly authorised to do so by UKHSA.

9. Liability

9.1 Neither party shall be liable to the other party for loss of profits, business, goodwill or anticipated savings, or any indirect or consequential loss or damages suffered or incurred by a party under or in connection with this Agreement.

9.2 Subject to clauses 9.1 and 9.3, the total liability of the Participating Organisation to UKHSA under or in connection with this Agreement, whether in contract, tort (including negligence) or otherwise, shall in no circumstances exceed £100,000.

9.3 Nothing in this Agreement shall limit or exclude either party’s liability for:

9.3.1 death or personal injury caused by negligence on the part of the relevant party or its employees, contractors or agents; or

9.3.2 any matter in respect of which it would be unlawful to exclude or restrict liability.

10. Costs

10.1 Each party shall bear its own costs in relation to the Testing Programme and carrying out its responsibilities under this Agreement.

11. Termination

11.1 Either party may terminate this Agreement on not less than 7 days’ notice in writing to the other party.

11.2 On termination or expiry of this Agreement, the Participating Organisation shall, at UKHSA’s request, promptly return to UKHSA or destroy (in accordance with the SOP) all equipment, materials and property that UKHSA has supplied to the Participating Organisation under this Agreement, including any test kits which the Participating Organisation has not used or distributed to Test Subjects.

11.3 The termination of this Agreement shall be without prejudice to the rights and remedies of a party which survive or may have accrued at the date of termination.

12. Publicity

12.1 Neither party shall make any press announcement in relation to, or publicise, this Agreement or any part of it in any way, without the prior written consent of the other party. Consent from any Government Department shall constitute consent by UKHSA for these purposes. This clause shall not restrict or prevent any announcement or publicity by a Government Department other than UKHSA.

12.2 Subject to clause 12.3, clause 12.1 shall not prevent publicity issued by the Participating Organisation in order to promote the Self Testing to potential Test Subjects in accordance with this Agreement.

12.3 The Participating Organisation shall only publicise the availability of Self Testing to potential Test Subjects who are not employees, consultants, directors, contractors or sub-contractors of the Participating Organisation where such publicity is permitted by and in accordance with any relevant guidance issued by UKHSA.

12.4 Nothing in this Agreement shall prevent or restrict any information disclosure, publication or announcement required by applicable law or regulation.

13. Governing Law and Jurisdiction

13.1 This Agreement shall be considered as a contract made in England and shall be subject to the laws of England.

13.2 Both parties agree that the courts of England and Wales shall have exclusive jurisdiction to hear and settle any action, suit, proceeding or dispute in connection with this Agreement and irrevocably submit to the jurisdiction of those courts.

14. General

14.1 Capitalised terms used in this Agreement shall have the meaning set out in these terms and conditions.

14.2 In the event of the transfer of all or a substantial part of UKHSA’s relevant activities to one or more government bodies, UKHSA’s rights and obligations shall, notwithstanding any provision to the contrary in this Agreement, automatically transfer to such other government body.

14.3 Except as provided elsewhere in this Agreement, a person who is not a party to this Agreement shall not have any rights under or in connection with it.

14.4 If any part of this Agreement is prohibited by law or judged by a court to be unlawful, void or unenforceable, it must be read as if that part was removed from this Agreement as much as required and rendered ineffective as far as possible without affecting the rest of this Agreement, whether it is valid or enforceable.

14.5 UKHSA may amend this Agreement at any time by issuing a notification to the Participating Organisation that these terms and conditions have been amended and making a copy of the amended terms and conditions available to the Participating Organisation. Such amendments shall be effective 7 days following the date of receipt by the Participating Organisation of such notification in the absence of receipt by UKHSA within such 7 days of notice from the Participating Organisation to terminate this Agreement.

14.6 Notices under this Agreement for UKHSA shall be sent to the following email address: jacqui.pude@ukhsa.gov.uk

14.7 For the Participating Organisation, notices under this Agreement shall be sent to the email address supplied by the Participating Organisation at the time of Registration or such other address as the relevant party may give notice to the other party for the purpose of service of notices under this Agreement. For the purposes of this Agreement ‘in writing’ includes email.

14.8 This Agreement (including the SOP) is the entire agreement between the parties relating to its subject matter, and replaces all previous statements and agreements whether written or oral.

15. Public sector organisations only

15.1 Where the Participating Organisation is named in the Public Sector Classification Guide as published and amended from time to time by the UK Office for National Statistics, the following provisions of this clause 15 shall apply:

15.1.1 Where the Participating Organisation is subject to FOIA, or to the Freedom of Information (Scotland) Act 2002 or the Environmental Information (Scotland) Regulations 2004 (together ‘FOISA’), the reciprocal of clauses 8.1 and 8.2 shall also apply such that ‘Participating Organisation’ is replaced by ‘UKHSA’, ‘UKHSA’ is replaced by ‘Participating Organisation’, and references to ‘FOIA’ are replaced by ‘FOIA or FOISA as applicable’. Clauses 8.3 and 8.4 shall not apply under this clause 15.1.1.

15.1.2 Nothing in this Agreement shall be interpreted as limiting, superseding, or otherwise affecting any party’s normal operations in carrying out its statutory, regulatory or other duties.

16. Crown bodies only

16.1 Where the Participating Organisation is a Crown Body, where ‘Crown’ means the government of the United Kingdom (including the Northern Ireland Assembly and Executive Committee, the Scottish Ministers and the National Assembly for Wales), including, but not limited to, government ministers and government departments and particular bodies, persons, commissions or agencies from time to time carrying out functions on its behalf, and ‘Crown Body’ means any department, office or executive agency of the Crown (including without limitation any Government Department or Executive Agency of such a Department), the following provisions of this clause 16 shall apply in addition to clause 15.1.2:

16.1.1 This Agreement has the status of a Memorandum of Understanding between the parties, in that it is not intended to be legally binding and no legal obligations or legal rights shall arise between the parties from the provisions of the Agreement. Notwithstanding the above, the parties enter into this Agreement intending to honour their obligations.

16.1.2 This Agreement establishes the responsibilities of the parties and the general principles for their cooperation.

16.1.3 The following clauses of this Agreement shall not apply: clauses 7, 8, 9, 11.3, 12, 13 and 14.