Self-declare in 15 minutes

This guide walks you through how to complete the self-declaration form. You should read and understand the supplementary attachment so you are comfortable with the questions, answers and self-declaration.

Please note, as the form is a dynamic form the question order and numbering will change if you do not follow the recommended responses. 

Although you are self-declaring for Test to Release, you cannot offer Test to Release using Medicspot's kits. We are working on a process to allow pharmacies to sell Covid tests for Test to Release in the future.

Page 1 - Contact details

1. Name of your organisation

Enter your organisation name

2. Company number

Enter your company number

3. Primary contact full name

Enter your full name

4. Primary contact role at organisation

Enter your role

5. Primary contact telephone number

Enter your phone

6. Primary contact email address

Enter your email

7. Where did you hear about this form?

Select: [Other]

Enter:
Advised by Medicspot

8. Are you self-declaring to provide tests for:

Select:
[Both the general population and testing to release for international travel]

Note: We recommend that you also apply for Test to Release so you can choose to do this with Medicspot at a later date should you wish

GOV.UK listing contact details

9. Name of your organisation

Enter your organisation name

10. Website URL

Enter
https://www.medicspot.co.uk/covid-test

11. Contact email address

Enter your contact email for customers

12. Contact telephone number

Enter your contact phone for customers

Page 2 - Ability to meet relevant standards

13. Name

Enter
See Attachment 1 - Medicspot Testing Overview - Section 1

14. Role title

Enter
See Attachment 1 - Medicspot Testing Overview - Section 1

15. Email

Enter
covid@medicspot.co.uk

16. Telephone

Enter
0208 1546 955

17. Relevant clinical regulatory body / council

Enter
See Attachment 1 - Medicspot Testing Overview - Section 1

18. Relevant clinical regulatory body / council registration number

Enter
See Attachment 1 - Medicspot Testing Overview - Section 1

19. Any further details

Enter
See Attachment 1 - Medicspot Testing Overview - Section 1

20. Name

Enter
See Attachment 1 - Medicspot Testing Overview - Section 1

21. Role title

Enter
See Attachment 1 - Medicspot Testing Overview - Section 1

22. Email

Enter
covid@medicspot.co.uk

23. Telephone

Enter
0208 1546 955

24. Health and Care Professions Council registration number

Enter
See Attachment 1 - Medicspot Testing Overview - Section 1

25. Any further details

Enter
See Attachment 1 - Medicspot Testing Overview - Section 1

Page 3 - The test device

26. Please confirm the test (and its manufacturer) you will be providing. You should confirm each test and its manufacturer if you intend to use multiple tests

Enter
See Attachment 1 - Medicspot Testing Overview - Section 2

27. Please confirm that all test(s) your organisation will use are CE marked

Select: [I confirm]

28. Please select which TPP(s) are relevant to your product(s)

Select: [TPP Laboratory Molecular (Uniplex/Multiplex)]

29. I confirm that my organisation has satisfied itself that the manufacturers’ claimed performances reflect a published TPP

Select: [I confirm]

30. I confirm that my organisation has validated that the tests will meet our requirements

Select: [I confirm]

31. I confirm that if my organisation selects a new test to deploy into use then it commits to assessing this new test against the relevant TPP and validating that it meets our requirements.

Select: [I confirm]

32. Please confirm whether the test devices you will be providing has a viral load detection limit less than or equal to 1000 Copies/mL.

Select: [I confirm]

33. Please confirm whether the test devices you will be providing has test sensitivity of at least 97%.

Select: [I confirm]

34. Please confirm whether the test devices you will be providing has test specificity of at least 99%.

Select: [I confirm]

35. Please provide evidence of independent validation of the test devices, completed in the past 18 months

UPLOAD - [Attachment 1 - Medicspot Testing Overview]

36. Please confirm that, if relevant, you will only provide tests that are suitable to administer to a person of the same age as the international arrival

Select: [I confirm]

Page 4 - Reporting of coronavirus test results as a notifiable disease

37. Please confirm whether your organisation meets the above minimum standard for PHE data reporting system requirements

Select: [I confirm]

38. A display view of your PHE data reporting system

UPLOAD - [Attachment 1 - Medicspot Testing Overview]

39. An example output of your PHE data reporting system

UPLOAD - [Attachment 1 - Medicspot Testing Overview]

40. An example of an audit trail from the PHE data reporting system

UPLOAD - [Attachment 1 - Medicspot Testing Overview]

41. An example of your booking page to evidence that all required fields are captured

UPLOAD - [Attachment 1 - Medicspot Testing Overview]

42. Please confirm whether your organisation meets the above minimum standard for relevant systems being in place to report adverse test incidents.

Select: [I confirm]

43. A display view of your adverse incident reporting system

UPLOAD - [Attachment 1 - Medicspot Testing Overview]

44. An example output of your adverse incident reporting system

UPLOAD - [Attachment 1 - Medicspot Testing Overview]

45. An example of an audit trail from adverse incident reporting system

UPLOAD - [Attachment 1 - Medicspot Testing Overview]

Page 5 - Samples

46. Please confirm whether your organisation meets the above minimum standard for relevant competency based trained test operators undertaking or overseeing sample collection dependent on test sample collection requirements.

Select: [I do not confirm]

Note: You are not required to work towards these ISO standards if you are just selling self-swab Medicspot Covid testing kits for your customer's own use.

47. The organisation that will take samples is

Select: [A separate legal entity working on my organisation’s behalf]

Enter:
Medic Spot Limited

48. My UKAS registration number/ UKAS application reference is

Enter:
Medic Spot Limited Applicant Number (ISO15189) - 22183

49. The organisation is accredited by UKAS to ISO 15189

Select: [Yes]

The organisation is accredited by UKAS to ISO/IEC 17025

Select: [No]

51. Please confirm that you have appropriate and clear clinical governance procedures in place.

Select: [I confirm]

Page 6 - UKAS accreditation

52. My organisation is involved in PCR lab-based testing

Select: [No]

NoteYou are not responsible for anything other than selling the self-swab sample kit.

53. My organisation is involved in point of care testing

Select: [No]

Note: Medicspot self-swabs do not require ISO 22870 standards to be met for point of care testing.

Page 7 - Date of issue

54. Please confirm that your organisation understands and will comply with the requirement to only issue tests as part of the testing to release scheme on or after the 5th day after the international arrival left a non-exempt country or territory.

Select: [I confirm]

Note: Although you are self-declaring for Test to Release, you cannot offer Test to Release using Medicspot's kits. Medicspot is working on a process that should allow pharmacies to sell Covid tests for Test to Release in the future.

55. Please confirm you will provide a test reference number.

Select: [I confirm]

Note: Although you are self-declaring for Test to Release, you cannot offer Test to Release using Medicspot's kits. Medicspot is working on a process that should allow pharmacies to sell Covid tests for Test to Release in the future.

56. Please confirm that you will ensure any sub-contractor will comply with the requirements above

Select: [I confirm]

Note: Although you are self-declaring for Test to Release, you cannot offer Test to Release using Medicspot's kits. Medicspot is working on a process that should allow pharmacies to sell Covid tests for Test to Release in the future.

Page 8 - Notification of test result

57. Please provide an example of your organisation’s notifications for a positive, negative and unclear test result

UPLOAD - [Attachment 1 - Medicspot Testing Overview]

58. Please confirm whether your organisation has the capability to notify individuals of their test result via email, text message, letter or secure web portal.

Select: [I confirm]

Note: Medicspot manages all communication including results notification with the user.

59. Please confirm whether your organisation will provide the police with the necessary information outlined above, if and when you are contacted by the police.

Select: [I confirm]

Note: Medicspot will manage information release to the police as required.

Page 9 - Compliant with all legal and regulatory requirements

60. Please confirm that your organisation is compliant with all legal and regulatory requirements for sample collection, processing and sharing of results including the requirements of data protection legislation

Select: [I confirm]

Note: Medicspot is the ‘end-to-end’ provider of this service once the pharmacy has sold the test kit.

61. I declare, confirm and acknowledge the above statements

Select: [I confirm]

Note: Read the statements and provide explicit confirmation that you agree with the statements based on the [Attachment 1 - Medicspot Testing Overview] only if you are confident.

62. Authorised contact: Name

Enter your details

63. Authorised contact: Position in company

Enter your details

64. Authorised contact: Phone number

Enter your details

65. Authorised contact: Email address

Enter your details

66. Date of declaration

Enter today's date

Page 10 - Thank you

Thank you for your answers. If you need to amend any information, please click the back button below to return to the form. Otherwise, please click 'Submit' to submit your answers to DHSC.

Select: [Submit >>]