Citation, commencement and application

1.–(1) These Regulations may be cited as the Health Protection (Notification) Regulations 2010 and shall come into force–

(a) for the purposes of all regulations except regulation 4 on 6th April 2010; and

(b) for the purposes of regulation 4 on 1st October 2010.

(2) These Regulations apply in relation to England only.

Duty to notify suspected disease, infection or contamination in patients

2.–(1) A registered medical practitioner (R) must notify the proper officer(2) of the relevant local authority where R has reasonable grounds for suspecting that a patient (P) whom R is attending–

(a) has a notifiable disease;

(b) has an infection(3) which, in the view of R, presents or could present significant harm to human health; or

(c) is contaminated(4) in a manner which, in the view of R, presents or could present significant harm to human health.

(2) The notification must include the following information insofar as it is known to R–

(a) P´s name, date of birth and sex;

(b) P´s home address including postcode;

(c) P´s current residence (if not home address);

(d) P´s telephone number;

(e) P´s NHS number;

(f) P´s occupation (if R considers it relevant);

(g) the name, address and postcode of P´s place of work or education (if R considers it relevant);

(h) P´s relevant overseas travel history;

(i) P´s ethnicity;

(j) contact details for a parent of P (where P is a child);

(k) the disease or infection which P has or is suspected of having or the nature of P´s contamination or suspected contamination;

(l) the date of onset of P´s symptoms;

(m) the date of R´s diagnosis; and

(n) R´s name, address and telephone number.

(3) The notification must be provided in writing within 3 days beginning with the day on which R forms a suspicion under paragraph (1).

(4) Without prejudice to paragraph (3), if R considers that the case is urgent, notification must be provided orally as soon as reasonably practicable.

(5) In determining whether the case is urgent, R must have regard to –

(a) the nature of the suspected disease, infection or contamination;

(b) the ease of spread of that disease, infection or contamination;

(c) the ways in which the spread of the disease, infection or contamination can be prevented or controlled; and

(d) P´s circumstances (including age, sex and occupation).

(6) This regulation does not apply where R reasonably believes that the proper officer of the relevant local authority has already been notified with regard to P and the suspected disease, infection or contamination by another registered medical practitioner in accordance with this regulation.

(7) In this regulation–

"child" means a person under the age of 18 years;

"notifiable disease" means a disease listed in Schedule 1;

"parent" has the meaning given to it by section 576 of the Education Act 1996(5); and

"relevant local authority" means the local authority within whose area R attended P on the occasion of forming a suspicion under paragraph (1).

Duty to notify suspected disease, infection or contamination in dead persons

3.–(1) A registered medical practitioner (R) must notify the proper officer of the relevant local authority where R has reasonable grounds for suspecting that a person (P) whom R is attending has died whilst–

(a) infected with a notifiable disease;

(b) infected with a disease which, in the view of R, presents or could present, or presented or could have presented (whilst P was alive), significant harm to human health; or

(c) contaminated in a manner which, in the view of R, presents or could present, or presented or could have presented (whilst P was alive), significant harm to human health.

(2) The notification must include the following information insofar as it is known to R–

(a) P´s name, date of birth and sex;

(b) P´s date of death;

(c) P´s home address including postcode;

(d) P´s place of residence at time of death (if different from home address);

(e) P´s NHS number;

(f) P´s occupation at time of death (if R considers it relevant);

(g) the name, address and postcode of P´s place of work or education at the time of death (if R considers it relevant);

(h) P´s relevant overseas travel history;

(i) P´s ethnicity;

(j) the disease or infection which P had or is suspected of having had or the nature of P´s contamination or suspected contamination;

(k) the date of onset of P´s symptoms;

(l) the date of R´s diagnosis; and

(m) R´s name, address and telephone number.

(3) The notification must be provided in writing within 3 days beginning with the day on which R forms a suspicion under paragraph (1).

(4) Without prejudice to paragraph (3), if R considers that the case is urgent, notification must be provided orally as soon as reasonably practicable.

(5) In determining whether the case is urgent, R must have regard to–

(a) the nature of the suspected disease, infection or contamination;

(b) the ease of spread of that disease, infection or contamination;

(c) the ways in which the spread of the disease, infection or contamination can be prevented or controlled; and

(d) P´s circumstances (including age, sex and occupation).

(6) This regulation does not apply where R reasonably believes that the proper officer of the relevant local authority has already been notified with regard to P and the suspected disease, infection or contamination by another registered medical practitioner in accordance with this regulation or regulation 2(1).

(7) In this regulation–

"notifiable disease" has the same meaning it has in regulation 2; and

"relevant local authority" means the local authority within whose area R attended P on the occasion of forming a suspicion under paragraph (1).

Duty to notify causative agents found in human samples

4.–(1) The operator of a diagnostic laboratory must notify the Health Protection Agency(6) in accordance with this regulation where the diagnostic laboratory identifies a causative agent in a human sample.

(2) The notification must include the following information insofar as it is known to the operator of the diagnostic laboratory–

(a) name and address of the diagnostic laboratory;

(b) details of the causative agent identified;

(c) date of the sample;

(d) nature of the sample;

(e) name of person (P) from whom the sample was taken;

(f) P´s date of birth and sex;

(g) P´s current home address including postcode;

(h) P´s current residence (if not home address);

(i) P´s ethnicity;

(j) P´s NHS number; and

(k) the name, address and organisation of the person who solicited the test which identified the causative agent.

(3) The notification must be provided in writing within 7 days beginning with the day on which the causative agent is identified.

(4) Without prejudice to paragraph (3), if the operator of the diagnostic laboratory considers that the case is urgent, the notification must be provided orally as soon as reasonably practicable.

(5) In determining whether the case is urgent, the operator of the diagnostic laboratory must have regard to –

(a) the nature of the causative agent;

(b) the nature of the disease which the causative agent causes;

(c) the ease of spread of the causative agent;

(d) the ways in which the spread of the causative agent can be prevented or controlled; and

(e) where known, P´s circumstances (including age, sex and occupation).

(6) This regulation does not apply where the operator of the diagnostic laboratory reasonably believes that the Health Protection 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.

(7) For the purposes of paragraph (1), a diagnostic laboratory identifies a causative agent where–

(a) the diagnostic laboratory identifies the causative agent; or

(b) the causative agent is identified by another laboratory under an arrangement made with that diagnostic laboratory.

(8) Where paragraph (7)(b) applies, the day on which the causative agent is identified for the purposes of paragraph (3), is the day on which the diagnostic laboratory became aware of the identification by the other laboratory.

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

(10) 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.

(11) In this regulation–

"causative agent" means–

"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–

"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.

Duty to provide information to the Health Protection Agency

5.–(1) This regulation applies where a notification has been made by the operator of a diagnostic laboratory to the Health Protection Agency under regulation 4.

(2) The Health Protection Agency may request that the person (R) who solicited the laboratory test which identified the causative agent to which the notification relates, provide to it the information listed at regulation 4(2) insofar as that information was not included in the notification.

(3) R must provide the information requested under paragraph (2) insofar as it is known to R.

(4) The information must be provided in writing within 3 days beginning with the day on which the request is made.

(5) Without prejudice to paragraph (4), if the Health Protection Agency considers the case to be urgent and informs R of this fact when making the request, the information must be provided orally as soon as reasonably practicable.

(6) In determining whether the case is urgent, the Health Protection Agency must have regard to–

(a) the nature of the causative agent to which the notification relates;

(b) the nature of the disease which the causative agent causes;

(c) the ease of spread of the causative agent;

(d) the ways in which the spread of the causative agent can be prevented or controlled; and

(e) where known, the circumstances of the person from whom the sample was taken (including age, sex and occupation).

Duty on the relevant local authority to disclose notification to others

6.–(1) This regulation applies where the proper officer of a local authority has received a notification under regulation 2 or 3.

(2) The proper officer of the local authority must disclose the fact of the notification and its contents to–

(a) the Health Protection Agency;

(b) the proper officer of the local authority in whose area P usually resides (if different); and

(c) the proper officer of the port health authority or local authority in whose district or area a ship, hovercraft, aircraft or international train is or was situated from which P has disembarked (if known to the disclosing proper officer and if that officer considers disclosure appropriate).

(3) The disclosure must be made in writing within 3 days beginning with the day that the proper officer receives the notification.

(4) Without prejudice to paragraph (3), if the disclosing proper officer considers that the case is urgent, disclosure must be made orally as soon as reasonably practicable.

(5) In determining whether a case is urgent, the disclosing proper officer must have regard to–

(a) the nature of the disease, infection or contamination or the suspected disease, infection or contamination notified;

(b) the ease of spread of the disease, infection or contamination;

(c) the ways in which the spread of the disease, infection or contamination can be prevented or controlled; and

(d) where known, the patient´s circumstances (including age, sex and occupation).

Electronic communications

7.–(1) This regulation applies to–

(a) notifications provided under regulation 2(1), 3(1) and 4(1);

(b) information provided under regulation 5(3);

(c) disclosures made under regulation 6(2);

(d) lists provided under regulation 3 of the Health Protection (Local Authority Powers) Regulations 2010(7) (requirement to provide details of children attending school); and

(e) reports provided under regulations 10(1) (duty to report Part 2A applications) and 11(1) (duty to report variations or revocations of Part 2A orders) of the Health Protection (Part 2A Orders) Regulations 2010(8).

(2) Notifications, information, disclosures, lists and reports, which are required to be in writing, may be communicated electronically if–

(a) the recipient has consented in writing to receiving the notification, information, disclosure list or report (as the case may be) by an electronic communication; and

(b) the communication is sent to the number or address specified by the recipient when giving that consent.

Revocations

8. The regulations listed in Schedule 3 are revoked.

Regulation 2(7)

SCHEDULE 1 Notifiable Diseases

Regulation 4(11)

SCHEDULE 2 Causative Agents

Regulation 8

SCHEDULE 3 Revocations

1. The Public Health (Prevention of Tuberculosis) Regulations 1925(9).

2. The Public Health (Infectious Diseases) Regulations 1988(10).

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations place obligations on various persons to disclose information to specified third parties for the purpose of preventing, protecting against, controlling or providing a public health response to the incidence or spread of infection or contamination.

Regulation 2 obliges registered medical practitioners to notify the local authority if a patient they are attending is believed to have a disease listed in Schedule 1 or is otherwise infected or contaminated in a way that may cause significant harm to others. Regulation 3 extends this obligation to cover notification of suspected disease, infection or contamination in a dead body. Regulation 6 obliges the local authority to disclose notifications under regulations 2 or 3 to other specified bodies with a health protection role.

Regulation 4 obliges the operators of diagnostic laboratories to notify the Health Protection Agency (HPA) if they identify a causative agent listed in Schedule 2, or evidence of such an agent, in a human sample. Regulation 5 enables the HPA to approach the person who solicited the laboratory tests for certain information not provided by the operator of the diagnostic laboratory and obliges that person to provide the information where known.

Regulation 7 enables specified documents to be sent electronically where certain conditions are met.

Regulation 8 revokes 2 sets of regulations.

A full impact assessment of the effect that this instrument will have on the costs of business, the voluntary sector and the public sector is available from the Department of Health, Room 514, Wellington House, 133-155 Waterloo Road, London, SE1 8UG and is annexed to the Explanatory Memorandum which is available alongside the instrument on the OPSI website (www.opsi.gov.uk).