The Health Protection (Notification) (Amendment) (Coronavirus) Regulations 2020

Insertion of new regulation 4A

4.  After regulation 4 insert—

“Duty on test providers to notify results of tests for the detection of SARS-CoV-2 or Influenza virus to Public Health England

4A.— (1) This regulation applies where a test provider carries out on a person (“P”) a valid point of care test for the detection of SARS-CoV-2 or influenza virus.

(2) For the purposes of this regulation—

(a) a point of care test is a diagnostic test which is not carried out in a diagnostic laboratory; and

(b) a point of care test is valid if it is carried out in accordance with the instructions provided by the manufacturer of the testing equipment.

(3) The test provider must notify Public Health England of the result of the test, in accordance with paragraphs (4) to (6).

(4) A notification must be provided in writing—

(a) within 24 hours of the time when the test result is received by the test provider, in the case of the result of a test for the detection of SARS-CoV-2 being positive or indeterminate;

(b) within 7 days beginning with the day on which the test result is received by the test provider, in the case of—

(i) the result of a test for the detection of SARS-CoV-2 being negative or void; or

(ii) the result of a test for the detection of influenza virus.

(5) A notification must include the following information, insofar as it is known to the test provider—

(a) in relation to P, their—

(i) first name;

(ii) surname;

(iii) sex;

(iv) date of birth;

(v) NHS number (if known);

(vi) ethnicity;

(vii) current address (including postcode);

(viii) telephone number, where the test is for the detection of SARS-CoV-2 and the result is positive or indeterminate,

(ix) email address, where the test is for the detection of SARS-CoV-2 and the result is positive or indeterminate;

(b) in relation to the test, the—

(i) name of the test provider;

(ii) nature of establishment;

(iii) specimen identification number (if applicable);

(iv) specimen type;

(v) specimen date;

(vi) test method;

(vii) result of test;

(viii) date on which the test was carried out;

(ix) name of the testing equipment manufacturer.

(7) Where P is a child, or a person with a disability who is unable for that reason to provide the information set out in paragraph (5)(a) to the test provider, the test provider must provide Public Health England with, insofar as it is known to the test provider—

(a) the information set out in paragraph (6)(a)(i) to (vii) in relation to P, having obtained it from an appropriate parent, guardian or carer of P (“X”); and

(b) where the test is for the detection of SARS-CoV-2 and the result is positive or indeterminate, X’s telephone number and email address.

(8) It is an offence for a test provider to fail without reasonable excuse to comply with this regulation.

(9) A test provider that commits an offence under this regulation is liable on summary conviction to a fine.

(10) In this regulation—

“carer”, “child”, “disability”, “guardian”, and “parent” have the meanings given in regulation 4;

“test provider” means a company, partnership, charity, corporation, unincorporated association, or other organisation or body, whether public or private, or sole trader, carrying out point of care tests for the detection of SARS-CoV-2 or influenza virus.”.