PAPER NSG 16
THE PUBLIC HEALTH ETC. (SCOTLAND) ACT 2008
Draft 1: Guidance to health boards, registered medical practitioners and diagnostic
laboratories
1.
Whilst the electronic issues concerning notification have yet to be fully addressed, I
thought that it would be useful to draw together the work undertaken by the group to date, so
that it can be considered within an overall framework. The following documents (which I
have attached to this for ease of reference) comprise:
-
-
A covering guidance note to Health Boards (both to ensure that they comply with
their statutory notification duties, but also to issue the other guidance to registered
medical practitioners and diagnostic laboratories in their areas);
Paper 1 – guidance to registered medical practitioners;
Paper 2 – guidance to health boards;
Paper 3 – guidance to diagnostic laboratories.
2.
You will wish to consider how I have incorporated the guidance to date on HRSs,
nurse-led clinics, ‘urgent’ notifications, case definitions and other general information,
including governance and offences. I have tried to be as brief as possible. Lorna is currently
considering further advice relating to organisms to try to ensure consistency of notification
timescales (within the statutory deadline), and she’ll be able to speak about that at the
meeting.
3.
In the meantime, it would be useful to have your views on what has been developed,
particularly on clarity, bearing in mind that this is still very much work in progress. I think
that it also re-inforces the need for the group to consider the communication needs around the
implementation of Part 2 of the Act.
Molly Robertson
Public Health Act Implementation Team
March 2009
Part 2 General HB guidance – Draft 1 – March 2009
PUBLIC HEALTH ETC. (SCOTLAND) ACT 2008
IMPLEMENTATION OF PART 2: NOTIFIABLE DISEASES, ORGANISMS AND
HEALTH RISK STATES
Purpose
1.
This paper advises that Part 2 and Schedule 1 of the Public Health etc.
(Scotland) Act 2008 comes into effect on [1 January 2010] and provides supporting
guidance to health boards, registered medical practitioners and directors of
diagnostic laboratories on their obligations under the Act with regard to the
notification of infectious diseases, organisms and health risk states.
Current
responsibilities under the Public Health (Notification of Infectious Diseases)
(Scotland) Regulations 1988 and the Infectious Disease (Notification) Act 1889
cease to apply on [31 December 2009].
2.
Part 2 and Schedule 1 of the Act are replicated in Annex A.
Guidance
3.
Guidance is contained in the following papers, attached:
Paper 1:
Notifiable diseases and health risk states: duties on
registered medical practitioners
Paper 2:
boards
Notifiable diseases and health risk states: duties on health
Paper 3:
Notifiable organisms: duties on directors of diagnostic
laboratories
4.
Health boards should ensure that they meet their new statutory
obligations on 1 January 2010 (Paper 2).
They are also invited to note the
guidance to registered medical practitioners (Paper 1) and diagnostic laboratories
(Paper 3) in their areas which have implications for the work within the boards’ health
protection teams.
5.
In addition, health boards are requested to issue the relevant advice to
registered medical practitioners and laboratories in their areas to ensure a
smooth transition to the new arrangements. The guidance would also be useful
to those registered nurses leading clinics or out of hours services or working in
isolated communities without immediate access to a registered medical practitioner.
The guidance should be augmented, before issue, by the provision of local Health
Protection Team contact details for notifications, where appropriate, including urgent
notifications and for inquiries.
Methods of notification
[ISSUES AROUND THE ELECTRONIC TRANSMISSION ARRANGEMENTS ETC]
2
Part 2 General HB guidance – Draft 1 – March 2009
6.
Further
detailed
information
on
the
Act
is
http://www.scotland.gov.uk/Topics/Health/NHS-Scotland/publicact
3
available
at
Part 2 General HB guidance – Draft 1 – March 2009
ANNEX A
[COPY OF PART 2 AND SCHEDULE 1 TO BE INSERTED]
4
Part 2 guidance – paper 1, draft 1 – March 2009
PAPER 1
PUBLIC HEALTH ETC . (SCOTLAND) ACT 2008
NOTIFIABLE DISEASES AND HEALTH RISK
REGISTERED MEDICAL PRACTITIONERS
STATES:
DUTIES
ON
Diseases notifiable under the Public Health etc. (Scotland) Act 2008 from [1
January 2010]
*Anthrax
*Meningococcal disease *Severe Acute Respiratory
Syndrome (SARS)
*Botulism
Mumps
*Smallpox
Brucellosis
*Necrotizing fasciitis
Tetanus
*Cholera
*Paratyphoid
Tuberculosis (respiratory or
non-respiratory
*Clinical syndrome due to *Pertussis
*Tularemia
E.coli 0157 infection
*Diphtheria
*Plague
*Typhoid
*Haemolytic Uraemic
*Poliomyelitis
*Viral haemorrhagic fevers
Syndrome (HUS)
*Haemophilus influenzae *Rabies
*West Nile fever
Type b (Hib)
*Measles
Rubella
Yellow Fever
Case definitions can be accessed online at [
].
Notification of health risk states

As well as those diseases above which are notifiable in their own right,
medical practitioners are obliged to notify any case suffering from a ‘health
risk state’ (HRS), and anyone likely to have been exposed to such a case with
an HRS, or the same risk factor. Further guidance is contained in Annex A.
Please note that we would expect notification of a health risk state to be
an exceptional occurrence.
Further requirements and supporting guidance




Notification is on grounds of reasonable suspicion that a patient whom the
practitioner is attending has a notifiable disease/HRS.
Practitioners must notify their health board, in writing (which includes
electronic transmission) within 3 days of suspicion, unless he/she has
reasonable grounds to believe that another practitioner has notified the
disease/HRS. This does not include the potential notification by a laboratory
of the organism which causes the disease.
Separate notification
arrangements are in place for diagnostic laboratories.
For the purposes of electronic notification, a document is to be taken to be
received on the day of transmission.
If the case is ‘urgent’, notification should take place by telephone as soon as
reasonably practicable. The need to notify urgently is determined by the
registered medical practitioner, having regard to the nature of the disease, the
5
Part 2 guidance – paper 1, draft 1 – March 2009


ease of transmission of that disease, the patient’s circumstances and any
guidance issued by Scottish Ministers.
It is suggested that those diseases above marked with an * may require
urgent notification, i.e. within same working day. However, there may be
other circumstances where immediate notification might be necessary, e.g. if
there are a cluster of cases. Further guidance on the need for telephone
notification may be provided locally from time to time, based on changing
epidemiology or particular local circumstances.
It is recognised that there may be nurses leading clinics or out of hours
services, or working in isolated communities who may well form a suspicion
that a patient has a notifiable disease etc., which requires immediate action.
If such a nurse were to communicate a suspicion by telephone to a registered
medical practitioner, the practitioner may choose to commence notification
procedures immediately on this basis. Should there be delay in contacting a
registered medical practitioner to facilitate notification, for any reason, the
registered nurse should call the local health protection team directly to inform
them of their suspicion. However, this does not constitute a formal notification
under the Act. The registered nurse should continue to pursue formal
notification through the relevant registered medical practitioner.
Information to be notified (in so far as it is known)

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
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

the patient’s name;
the patient’s address and postcode;
the patient’s occupation (if the practitioner considers that it is relevant);
the name, address and postcode of the patient’s place of work or education (if
the practitioner considers that it is relevant);
the patient’s sex;
the patient’s date of birth;
the suspected disease; and
the patient’s NHS identifier, i.e. the patient’s community health index number
or where that number is not known, the NHS identification number, or where
neither of these numbers are known, any other number of other indicator
which is used to identify a patient individually.
Method of notification
[GUIDANCE ON ELECTRONIC REPORTING ARRANGEMENTS, INCLUDING
FORM]
Local contacts
The Act requires notification to the Health Board for the area in which the practitioner
works.
For [
[
] NHS Board, the contacts are:
]
6
Part 2 guidance – paper 1, draft 1 – March 2009
Further information





The list of diseases has been considerably reduced from existing statutory
notification requirements and only contains diseases which may prompt
urgent public health action. For example, food poisoning and chickenpox,
which constitute about 80% of current notifications, have been removed.
The fee to registered medical practitioners has been removed, recognising
that notification of the significant diseases on the list will become an unusual
event for a medical practitioner and should be undertaken under his/her
general duty of care to protect public health.
Non-notification is a governance issue which falls to the health board for
employed doctors, and for GPs as independent contractors, through their own
clinical governance systems, and ultimately through the GMS contractual
requirement in paragraph 114 of the GMS regulations, i.e. the contractor shall
comply with all relevant legislation; and have regard to all relevant guidance
issued by the health board and the Scottish Ministers.
Scottish Ministers may amend the list set out above, by regulation, by adding
to or removing an item from the list, and varying the description of an item in
the list.
Scottish Ministers may also, by regulation, amend any other aspect of the
notification arrangements.
Further
detailed
information
on
the
Act
is
http://www.scotland.gov.uk/Topics/Health/NHS-Scotland/publicact
7
available
at
Part 2 guidance – paper 1, draft 1 – March 2009
Annex A
NOTIFICATION OF HEALTH RISK STATES
Why is it necessary to notify suspected 'health risk states'?
The aim of notifying suspected health risk states is to identify diseases or conditions
which are not notifiable in their own right but which pose or may pose a significant
risk to public health.
Pubic health authorities need to be able to identify and respond quickly to new and
emerging public health threats, even when a condition is identified from its symptoms
and epidemiology and the causative organism is not yet identified. This is particularly
relevant in the modern world of global travel and trade. For example, urgent public
health action was required in the early stages of the SARS (Severe Acute
Respiratory Syndrome) outbreak in 2003, even before the causative agent was
known.
Other examples from the past of conditions that would fulfil the criteria of a health
risk state include the initial five cases of Pneumocystits carinii pneumonia heralding
the AIDS epidemic, avian flu, Polonium exposure and poisoning in the Litvinenko
case.
What should be notified?
If a novel serious condition occurs at home or abroad, it may be designated an HRS
by the Scottish Government's Chief Medical Officer (CMO), who will provide a case
definition for exactly what should be notified.
In the absence of a definition from the CMO, medical practitioners should notify as
an HRS any condition which is:
1. Serious:
A case must be very ill or have died, or be likely to become very ill or die.
AND
2. Be potentially serious to others.
The three principal ways in which a HRS might be serious for others are if it is:
(i) infectious;
(ii) the result of contamination with, for example, a radioactive material;
(iii) the result of a toxin or poison to which others may be exposed.
An HRS is likely to be new, rare, unexplained, or difficult to diagnose. Obviously, the
more serious the condition, and the greater the likelihood of spread, the more
important it is for the medical practitioner to notify it. The more cases the medical
practitioner sees within a given period of time, the more likely is the potential for
spread, but an HRS presenting in a single case may still have the potential to affect
others.
8
Part 2 guidance – paper 1, draft 1 – March 2009
Notifications of a ‘health risk state’ will be an exceptional occurrence and should only
be made on the basis that the registered medical practitioner considers that there is
a risk of significant public health implications of the condition. If in doubt whether to
notify a condition, on grounds of either its seriousness or potential to affect others,
the medical practitioner should discuss the condition with their CPHM (CD&EH).
How to notify
Immediate oral notification by telephone would be expected in these circumstances,
followed up in writing with the required information within 3 days of forming the
suspicion of the health risk state.
9
Part 2 guidance – paper 2, draft 1 – March 2009
PAPER 2
PUBLIC HEALTH ETC. (SCOTLAND) ACT 2008
NOTIFIABLE DISEASES AND HEALTH RISK STATES: DUTIES ON HEALTH
BOARDS
Requirements and supporting guidance


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
Where a health board receives a notification of a disease or health risk state
from a registered medical practitioner and the patient to whom the information
relates usually resides in that health board area, the board must send a
return, in writing (which includes electronic transmission), to
Health
Protection Scotland (HPS), containing the information set out below.
The return should be sent by the end of the working week in which the
information is received (i.e. by close of play on Friday of that week), or, if it is
not practicable to do so, as soon as practicable afterwards.
For the purposes of electronic transmission of data, a document is to be taken
to be received on the day of transmission.
If the patient to whom the information relates does not usually reside in that
health board area, the board must without delay transmit the information to
the health board for the area in which the person usually resides.
Where a health board receives information from another health board about a
patient who usually resides in its area, that board must send the return, in
writing, to HPS, by the end of the working week in which it is received (i.e. by
close of play on Friday of that week) or, if it is not practicable to do so, as
soon as practicable afterwards.
Information to be included in return to HPS (in so far as it is known)

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the patient’s postcode;
the patient’s occupation;
the patient’s sex;
the patient’s date if birth;
the suspected disease or suspected health risk state; and
the patient’s NHS identifier, i.e. the patient’s community health index number
or where that number is not known, the NHS identification number, or where
neither of these numbers are known, any other number or other indicator
which is used to identify a patient individually.
Method of notification
[[GUIDANCE ON ELECTRONIC REPORTING ARRANGEMENTS ETC]
10
Part 2 guidance – paper 3, draft 1 – March 2009
PAPER 3
PUBLIC HEALTH ETC. (SCOTLAND) ACT 2008
NOTIFIABLE ORGANISMS: DUTIES ON DIRECTORS
LABORATORIES
OF
DIAGNOSTIC
The Public Health etc. (Scotland) Act 2008 places a new statutory obligation on
directors of diagnostic laboratories in Scotland to notify the organisms set out
in Annex A, with effect from [1 January 2010].
Requirements and supporting guidance

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The director of a diagnostic laboratory in Scotland must notify the organisms
set out in Annex A to the health board in whose area the laboratory is
situated and Health Protection Scotland (HPS).
Notification must take place, in writing (which includes electronic
transmission), within 10 days of identification.
For the purposes of electronic notification, a document is to be taken to be
received on the day of transmission.
If the case is ‘urgent’, notification should take place by telephone as soon as
reasonably practicable. ‘Urgency’ is determined by the director of the
laboratory, having regard to the nature of the organism, the nature of the
disease caused by the organism, the ease of transmission, the patient’s
circumstances (where known) and any guidance issued by Scottish Ministers.
It is suggested that those organisms marked with an * merit notification as a
matter of urgency.
However, there may be circumstances where notification well within the 10
day period would be appropriate, but might not necessarily merit immediate
telephone notification, or where organisms might need to be notified to health
boards before formal identification. Laboratories should therefore ensure that
they have mutually agreed Standard Operating Procedures or other
agreements in place with local health boardS, which clarify these issues and
take into account their new statutory obligations.
Where a diagnostic laboratory requires, under an arrangement, to send a
sample to another laboratory for analysis, e.g. to a specialist facility in
Scotland or elsewhere in the UK), statutory notification is required from the
originating laboratory. In these cases, the day of identification for the
purposes of notification will be the day on which the first diagnostic laboratory
becomes aware of the identification by the other laboratory with which it has
the arrangement.
Information to be notified (in so far as it is known)

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the name of the person to whom the identification relates;
the person’s address;
the person’s sex;
the person’s date of birth;
the organism which has been identified; and
11
Part 2 guidance – paper 3, draft 1 – March 2009

the person’s NHS identifier, i.e. the patient’s community health index number
or where that number is not known, the NHS identification number, or where
neither of these numbers are known, any other number or other indicator
which is used to identify a patient individually.
Method of notification
[CURRENT ELECTRONIC NOTIFICATION ARRANGEMENTS/ VIA ECOSS
etc]
Local contacts
[
]
Further information




‘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 –
- the clinical microbiologist, consultant pathologist or other registered medical
practitioner or other person in charge of a diagnostic laboratory; or
- any other person working in the diagnostic laboratory to whom the function
of making a notification under this section has been delegated by the person
mentioned above.
Scottish Ministers may amend the list of organisms to be notified, by
regulation, by adding to or removing an item from the list, and varying the
description of an item on the list.
Scottish Ministers may also, by regulation, amend any aspect of the
notification arrangements.
Offences

It is an offence for the director of a diagnostic laboratory to fail, without
reasonable excuse, to comply with the duty of notification. Where the director
of a diagnostic laboratory commits an offence and is employed by a body
corporate, the body corporate also commits the offence. There is a defence
of due diligence and that all reasonable steps were taken to avoid committing
the offence, both for a director of the diagnostic laboratory and a body
corporate, or its employee or agent.
Further
detailed
information
on
the
Act
is
http://www.scotland.gov.uk/Topics/Health/NHS-Scotland/publicact
12
available
at
NOTIFIABLE ORGANISMS
ANNEX A
*Bacillus anthracis
Bacillus cereus
*Bordetella pertussis
Borrelia burgdorferi
Brucella genus
*Campylobacter genus
Chlamydia psittaci
*Clostridium botulinum
Clostridium difficile
Clostridium perfringens
*Clostridium tetani
*Corynebacterium diphtheriae (toxigenic strains)
*Corynebacterium ulcerans
*Coxiella burnetii
*Crimean-Congo haemorrhagic fever virus
*Cryptosporidium
Dengue virus
*Ebola virus
Echinococcus genus
*Verocytotoxin-producing E.coli (VTEC)
*Francisella tularensis
*Giardia lamblia
*Guanarito virus
*Haemophilus influenzae type b (from blood, cerebrospinal fluid or other normally
sterile site)
Hantavirus
*Hepatitis A virus
*Hepatitis B virus
Hepatitis C virus
Hepatitis E virus
Influenza virus (all types, including *those caused by a new sub-type)
13
*Junín virus
*Kyasanur Forest disease virus
*Lassa virus
*Legionella genus
Leptospira genus
*Listeria monocytogenes
*Machupo virus
*Marburg virus
*Measles virus
Mumps virus
*Mycobacterium bovis
*Mycobacterium tuberculosis complex
*Neisseria meningitidis
Norovirus
*Omsk haemorrhagic fever virus
Plasmodium falciparum, vivax, ovale and malariae
*Polio virus
*Rabies virus
Rickettsia prowazekii
*Rift Valley fever virus
*Rubella virus
*Sabia virus
*Salmonella (all human types)
*SARS-associated coronavirus
*Shigella genus
Enterotoxigenic Staphylococcus aureus
Staphylococcus aureus (all blood isolates)
Methicillin-resistant Staphylococcus aureus (MRSA)
*Streptococcus pyogenes (from blood, cerebrospinal fluid or other normally sterile
site)
Streptococcus pneumoniae (from blood, cerebrospinal fluid or other normally sterile
site)
Toxoplasma gondii
14
Trichinella genus
Varicella-zoster virus
*Variola virus
*Vibrio cholerae
*West Nile fever virus
*Yellow Fever virus
*Yersinia enterocolitica
*Yersinia pestis
*Yersinia pseudotuberculosis
Case definitions can be accessed online at [
15
]