Regulation 4 Duty on the operators of diagnostic laboratories to notify the United Kingdom Health Security Agency of causative agents found in human samples and of SARS-Cov-2 , respiratory syncytial virus or influenza virus tests processedF37F38F39

The operator of a diagnostic laboratory must notify F1the United Kingdom Health Security Agency in accordance with this regulation where the diagnostic laboratory F2—

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The operator of a diagnostic laboratory must also notify F8the United Kingdom Health Security Agency in accordance with this regulation where the diagnostic laboratory—

The notification must include the following information insofar as it is known to the operator of the diagnostic laboratory—

F17A notification under paragraph (1)(a) where the causative agent identified is not SARS-CoV-2 must be provided in writing within 7 days beginning with the day on which the causative agent is identified.

F19A notification under paragraph (1A) must be provided in writing within 7 days beginning with the day on which the diagnostic laboratory becomes aware of the test result.

A notification under paragraph (1)(a) where the causative agent identified is SARS-CoV-2, must F20... be provided in writing within 24 hours of the causative agent being identified.

F21A notification under paragraph (1)(b) must be provided in writing within 24 hours of the diagnostic laboratory becoming aware of the test result.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Without prejudice to F23paragraphs (3) and (3A), if the operator of the diagnostic laboratory considers that F24a particular case to which one of those paragraphs applies is urgent, the notification must be provided orally as soon as reasonably practicable.

In determining whether the case is urgent, the operator of the diagnostic laboratory must have regard to —

This regulation does not apply where the operator of the diagnostic laboratory reasonably believes that F25the United Kingdom Health Security Agency has already been notified in accordance with this regulation by the operator of another diagnostic laboratory in relation to the same causative agent being found in a sample from the same person.

For the purposes of F26paragraph (1)(a), a diagnostic laboratory identifies a causative agent where—

For the purposes of paragraphs (1)(b) and (1A), a diagnostic laboratory processes a test where—

Where paragraph (7)(b) applies F28—

Where paragraph (7A)(b) applies—

It is an offence for the operator of a diagnostic laboratory to fail without reasonable excuse to comply with this regulation.

Any person who commits an offence under this regulation is liable on summary conviction to a fine not exceeding level 5 on the standard scale.

In this regulation—

• F32“carer” has the meaning given in section 10 of the Care Act 2014;

• “causative agent” means—

  1. (a)

     a causative agent listed in Schedule 2, or

  2. (b)

     evidence of an infection caused by such an agent;

• F33“child” has the meaning given in regulation 2(7);

• “diagnostic laboratory” means an institution (or facility within an institution) which is equipped with apparatus and reagents for the performance of diagnostic tests for human infections;

• “director of a diagnostic laboratory” means—

  1. (a)

     the clinical microbiologist, consultant pathologist or other registered medical practitioner or other person in charge of a diagnostic laboratory, or

  2. (b)

     any other person working in the diagnostic laboratory to whom the function of making a notification under this regulation has been delegated by the person mentioned in paragraph (a); F34...

• F35“disability” has the same meaning as in the Equality Act 2010 (see section 6 of, and Schedule 1 to, that Act);

• “guardian” has the meaning given in section 107 of the Children and Young Persons Act 1933;

• “operator of a diagnostic laboratory” means the corporate body that operates the diagnostic laboratory or, if there is no such body, the director of the diagnostic laboratory;

• F36“parent” has the meaning given in regulation 2(7).