POLICY FOR THE CARE OF PATIENTS KNOWN,
SUSPECTED OR AT RISK OF HAVING CREUTZFELDT
JACOB DISEASE (CJD) v5
IC 07
Version Number:
Version 5
Issued Date:
January 2014
Review Date:
January 2017
Sponsoring Director:
Prepared By:
Directors of Nursing
NHS North Durham, NHS Darlington, NHS Durham Dales,
Easington and Sedgefield (DDES) Clinical Commissioning
Groups (CCGs)
Lead Infection Prevention and Control Nurse
Consultation
Process:
Members of Health and Social Care Health Care
Associated Infection (HCAI) Assurance Group
Document History
Version
1
2
3
4
Date
June 2005
June 2007
June 2009
July 2011
5
Jan 2014
Significant Changes
*
*Reviewed
*Reviewed
Update with new guidance issues January 2011question on
page 7 to be asked of all patients undergoing an endoscopy.
*None
POLICY VALIDITY STATEMENT
This policy is due for review on the latest date shown above. After this date, policy
and process documents may become invalid.
Policy users should ensure that they are consulting the currently valid version of the
documentation.
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EQUALITY IMPACT ASSESSMENT STATEMENT
Audit Assessment
Date
Result
Risk Audit
14.01.2014
Risks identified and risk assessment included
at Appendix 1
Equality Audit
14.01.2014
No or very low potential for discrimination
Human Rights Audit
14.01.2014
No breach of Human Rights
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POLICY FOR THE CARE OF PATIENTS KNOWN,
SUSPECTED OR AT RISK OF HAVING CREUTZFELDT
JACOB DISEASE (CJD) v4
Contents
Section Title
Page
1
Introduction
2
Definitions
3
Care of Patients Known, Suspected or At Risk of Having
Creutzfeldt Jacob Disease
4
Duties And Responsibilities
5
Implementation
6
Training Implications
7
Documentation
8
Monitoring, Review And Archiving
9
Equality Analysis
4
5
5
11
12
12
13
14
14
Appendices
1
Risk Assessment
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POLICY FOR THE CARE OF PATIENTS KNOWN,
SUSPECTED, OR AT RISK OF HAVING CREUTZFELDT
JACOB DISEASE (CJD) v4
1.
Introduction
NHS North Durham, Darlington and DDES CCGs aspire to the highest
standards of corporate behaviour and clinical competence, to ensure that
safe, fair and equitable procedures are applied to all organisational
transactions, including relationships with patients, their carers, public, staff,
stakeholders and the use of public resources. In order to provide clear and
consistent guidance, NHS County Durham and Darlington will develop
documents to fulfil all statutory, organisational and best practice requirements
and support the principles of equal opportunity for all.
Transmissible Spongiform Encephalopathy’s (TSE) are a group of diseases
which can occur in both people and animals. The diseases are characterised
by degeneration of the nervous system and are invariably fatal.
Classical CJD is the commonest form of the human TSEs but is still rare.
There is no obvious cause in the majority of cases but in the past 1% have
been transmitted as a result of medical treatments such as human pituitary
growth hormone injections, corneal transplants and brain surgery involving
contaminated instruments.
In 1996, the National CJD Surveillance Unit identified a form of CJD that
differed from previously recognised types of the disease. The patients were
younger, their symptoms were different and the appearance of the brain was
not the same as in the classical form of CJD. The disease was initially labelled
as new variant CJD (nvCJD) and is now known as variant CJD (vCJD).
The precise nature of the agent, which causes either type of CJD, is not
known but it is presumed to be an abnormal form of a prion, a protein
distributed throughout nature and which is found in the tissues of healthy
people and animals. It is believed that prions can cause disease when they
become altered in shape by folding in an abnormal way. This abnormally
shaped protein then influences the normal prion proteins to alter their shape
and it is the accumulation of this altered prion protein which causes
destruction of nervous tissue and the clinical manifestations of the disease.
Classical CJD is thought to only affect the central nervous system and so
brain, spinal cord and eyes are thought to be potentially infectious.
Variant CJD as well as affecting the central nervous system has also been
detected in lymphatic tissue such as tonsil and appendix. It is therefore
believed that vCJD poses a greater potential risk of person to person spread
in health care settings than classical CJD.
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The Government’s Spongiform Encephalopathy Advisory Committee (SEAC)
concluded that the most likely explanation for the emergence of vCJD was
that it had been transmitted to people through exposure to Bovine Spongiform
Encephalopathy (BSE).
1.1
Status
This policy is an Infection Prevention and Control policy.
1.2
Purpose and scope
.
This guidance applies to healthcare workers involved in the management and
care of patients with known, suspected or who are at risk of developing, CJD
within NHS North Durham, Darlington and DDES CCGs. It would be good
practice for this policy to be adopted by external contractors.
2.
Definitions
The following terms are used in this document
CJD: Creutzfeldt Jacob Disease
TSE: Transmissible Spongiform Encephalopathy
vCJD: Variant CJD
Prion: A protein distributed throughout nature and which is found in the
tissues of healthy people and animals
BSE: Bovine Spongiform Encephalopathy
3.
Care of Patients known, suspected or at risk of having
Creutzfeldt Jacob Disease
3.1
Summary
For patients known, suspected or at risk of classical CJD there are no
special precautions that need to be taken for surgical instruments
coming into contact with tissues other than brain, the spinal cord, the
eye or olfactory epithelium.
For patients known, suspected or at risk of vCJD there are no special
precautions that need to be taken for surgical or dental instruments coming
into contact with tissues other than the brain, the spinal cord, the eye, the
olfactory epithelium or lymphoid tissue. Affected tissue has been
detected in the tonsil, appendix, lymph node, spleen, thymus, adrenal
gland and rectum of vCJD patients.
.
In most routine clinical contact no additional precautions are needed for the
care of patients in the risk groups (Table 1). However, when certain invasive
interventions are performed, there is the potential for exposure to the agents
of TSEs. In these situations it is essential that control measures are in place
to prevent the spread of infection.
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In general it is not possible to identify specific risk groups for the iatrogenic
transmission of vCJD. However, the CJD Incidents Panel may identify
individual patients who have been exposed to vCJD and advise them to
inform clinicians in the event of needing surgery. Decisions on whether
instruments can be reprocessed will be made on the basis of type of tissues
previously encountered. This decision will be made on an individual patient
basis by the Clinician in charge of that patient following consultation with the
consultant microbiologist.
3.2
Infection Control and CJD
The epidemiological evidence to date does not suggest that, in the majority of
situations with CJD patients, there is need for particular precautions beyond
those that should be used as standard for other patients.
The use of routine standard infection control precautions will minimise the
exposure of individuals involved in the healthcare of patients who have, or
may develop, a TSE and protect them from the very remote possibility of
infection.
When considering measures to prevent transmission to patients or staff in the
healthcare setting, it is useful to make a distinction between symptomatic
patients, i.e. those who fulfil the diagnostic criteria for definite, probable or
possible CJD or vCJD, and asymptomatic patients, i.e. those with no clinical
symptoms, but who are potentially at risk of developing one of these diseases,
i.e. having a medical or family history which places them in one of the risk
groups.
Table 1 below details the classification of the risk status of symptomatic and
asymptomatic patients.
Table 1 Creutzfeldt Jacob Disease
Patient groups
Symptomatic patients
Patients ‘at increased
risk’ from genetic
forms of CJD
• Patients who fulfil the diagnostic criteria for definite, probable or
possible CJD or vCJD;
• Patients with neurological disease of unknown aetiology, who do
not fit the criteria for possible CJD or vCJD, but where the diagnosis
of CJD is being actively considered.
• Individuals who have been shown by specific genetic testing to be
at significant risk of developing CJD;
• Individuals who have a blood relative known to have a genetic
mutation indicative of genetic CJD;
• Individuals who have or have had two or more blood relatives
affected by CJD or other prion disease.
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Patients identified as
‘at increased risk’ of
CJD/vCJD through
iatrogenic exposures
• Recipients of hormone derived from human pituitary glands, e.g.
growth hormone, gonadotrophin. In the UK the use of humanderived gonadotrophin was discontinued in 1973, and use of
cadaver-derived human growth hormone was banned in 1985.
However, use of human-derived products may have continued in
other countries after these dates.
• Individuals who underwent intradural neurosurgical or spinal
procedures before August 1992. These patients may have received
a graft of human-derived dura mater and should be treated as being
‘at increased risk’ unless evidence can be provided that humanderived dura mater was not used. Patients who received a graft of
human-derived dura mater before August 1992 are ‘at increased
risk’ of transmission of sporadic CJD.
• Individuals who have had surgery using instruments that had been
used on someone who went on to develop CJD/vCJD, or was ‘at
increased risk’ of CJD/vCJD;
• Individuals who have received an organ or tissue from a donor
infected with CJD/vCJD or ‘at increased risk’ of CJD/vCJD;
• Individuals who have been identified prior to high risk surgery as
having received blood or blood components from 80 or more donors
since January 1980;
• Individuals who have received blood from someone who went on
to develop vCJD.
Recipients of ocular transplants, including corneal transplants, are not considered to
be ‘at increased risk’ of CJD/vCJD.
In most routine clinical contact, no additional precautions are needed for the
care of patients in the risk groups. However, when certain invasive
interventions are performed, there is the potential for exposure to the agents
of TSEs. In these situations it is essential that control measures are in place
to prevent the iatrogenic transmission of TSEs.
GPs are asked to record their patients’ CJD/vCJD risk status in their primary
care records. The GP should also include this information in any referral letter
should the patient require surgical, medical or dental procedures.
3.3
All patients for endoscopy
This guidance is taken from Transmissible Spongiform Encephalopathy
Agents: Safe Working and the Prevention of Infection Annex J in Appendix E
16 July 2009 which gives further background and detail.
Recommendations for all patients undergoing surgery or endoscopy
(including rigid sigmoidoscopy)
All patients about to undergo any elective procedure or emergency or
endoscopic procedure should be asked the question,
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‘Have you ever been notified that you are at increased risk of CJD or
vCJD for public health purposes?’
Based on the patient’s response actions should be taken as outlined below
Patient’s response:
NO
Surgery or endoscopy should proceed using normal infection control
procedures unless the procedure is likely to lead to contact with high risk
tissue.
YES
Please ask the patient to explain further.
The Consultant Microbiologist in the Local Foundation Trust should be
consulted before any procedure is undertaken for advice, as special infection
control precautions are necessary for all surgery or endoscopy involving
patients at risk of CJD or vCJD.
The patient’s response should be recorded in their medical notes for future
reference.
Patient unsure
Surgery or endoscopy should proceed using normal infection control
procedures unless the procedure is likely to lead to contact with high risk
tissue. If the procedure is likely to lead to contact with high risk tissue please
contact the Consultant Microbiologist for advice.
3.4
Care of patients in the community defined in Table 1
Procedures
Available epidemiological evidence does not suggest that normal social or
routine clinical contact with a CJD or vCJD patient presents a risk to
healthcare workers, relatives or others in the community.
Body Fluids
At present, there is no evidence of infectivity in saliva, body secretions or
excreta. Although abnormal prion protein has not been detected in the
Cerebrospinal Fluid (CSF) in either sporadic or variant CJD in the main, most
infectivity is likely to be concentrated in the central nervous tissue. In vCJD,
infectivity is also likely to be present in lymphoid tissue, albeit at a lower level.
It is important to ensure that only professionals, aware of the hazards, carry
out invasive procedures involving body fluids that may lead to contact with
infective tissue.
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Invasive Medical/Surgical Procedures and Specimen Labelling
Because of the unusual resistance to destruction of the TSE agents, singleuse disposable equipment should be used wherever practicable, and all other
items of equipment contaminated whilst obtaining specimens should be
destroyed by incineration.
Blood and biopsy specimens from patients defined in Table 1 should only be
taken by trained personnel who are aware of the hazards involved.
The collection of blood specimens should involve the same precautions used
for all work of this type with any patient i.e. avoidance of sharps injuries and
other forms of parenteral exposure, and the safe disposal of sharps and
contaminated waste in line with the Safe Disposal of Sharps and Waste
Policy.
Samples should be marked with a ‘Biohazard’ label and it is advisable to
inform the laboratory in advance that a specimen is being sent. Patient
confidentiality must be maintained, do not write ‘CJD’ on the card.
Spillages
The infectious agent associated with TSEs is unusually resistant to
inactivation techniques. Dilution is the most important element in cleaning up
spillages. Exposure to high-concentration (10,000 ppm available chlorine)
sodium hypochlorite for one hour is known to be effective. Although its use is
unlikely to be practical in any clinical environment or other care setting, since
it is highly corrosive to many surfaces, it can be used in exceptional
circumstances to clean up spillages of high-risk material, e.g. CSF.
Therefore, standard infection control precautions should be followed to clear
up spillages in primary care including spillages of blood. Potentially infectious
materials should be removed using absorbent material, and any waste
disposed of as hazardous waste, in line with policy. Disposable gloves and
an apron should be worn when removing such spillage(s), goggles should be
worn if there is a risk of splashing and disposed of as hazardous waste.
For spillages of large volumes of liquid, absorbent material should be used to
absorb the spillage, for which a number of proprietary absorbent granules are
available.
Disposal of Waste
General guidance on the safe management of clinical waste is given in the
Department of Health’s guidance document Health Technical Memorandum
07-01: Safe Management of Healthcare Waste, available at
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPo
licyAndGuidance/DH_063274.
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According to this guidance, ‘Waste known or suspected to be contaminated
with transmissible spongiform encephalopathy (TSE) agents, including CJD,
must be disposed of by high temperature incineration in suitable authorised
facilities’. Additional guidance on the management of TSE-infected waste is
given in the Department of Health’s Transmissible spongiform
encephalopathy: Safe working and the prevention of infection.
The ACDP TSE Working Group have considered the disposal of clinical
waste, and have agreed that tissues and contaminated materials such as
dressings and sharps, from patients with, or ‘at increased risk’ of, CJD/vCJD,
should be disposed of as in the following table:
Table 4b Disposal of clinical waste from patients with,
or ‘at increased risk’ of, CJD or vCJD
Diagnosis of CJD
High or medium risk
tissue *
Low risk tissue and
body fluids**
Definite
Incinerate
Normal hazadrous
waste disposal
Probable
Incinerate
Normal hazardous
waste disposal
‘At increased risk’
Incinerate
Normal hazardous
waste disposal
* High or medium risk tissues are highlighted in section 3.1 of this policy
** Tissues and materials deemed to be low risk include body fluids such as
urine, saliva, sputum, blood, and faeces. Blood from vCJD patients is
considered to be low risk except when transfused in large volumes.
Bed Linen
Bed linen can be washed in domestic washing machines in patients’ own
homes at the highest temperature the fabric can withstand.
Occupational Exposure
Although cases of CJD/vCJD have been reported in healthcare workers, there
have been no confirmed cases linked to occupational exposure. However, it
is prudent to take a precautionary approach. The highest potential risk in the
context of occupational exposure is from exposure to high infectivity tissues
through direct inoculation (e.g. as a result of ‘sharps’ injuries, puncture
wounds or contamination of broken skin), and exposure of the mucous
membranes (e.g. conjunctiva).
Compliance with standard infection control precautions will help to minimise
risks from occupational exposure.
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Healthcare personnel, who work with patients with definite, probable or
possible CJD or vCJD, or with potentially infected tissues, should be
appropriately informed about the nature of the risk and relevant safety
procedures.
For any accident involving ‘sharps’, or contamination of abrasions with blood
or body fluid(s), wounds should be gently encouraged to bleed, gently washed
(avoid scrubbing) with warm soapy water, rinsed, dried and covered with a
waterproof dressing, or further treatment given appropriate to the type of
injury. Splashes into the eyes or mouth should be dealt with by thorough
irrigation. The accident should be reported to your manager and the
Management of Potential Exposure to Blood and Body Fluid Policy followed.
4.
Duties and Responsibilities
4.1
Accountable Officer
The accountable officer has overall responsibility for the
strategic direction and operational management, including ensuring that CCG
process documents comply with all legal, statutory and good practice
guidance requirements.
4.2
Director of Nursing
The Director of Nursing is the sponsoring director for this document and is
responsible for ensuring that:

4.3
arrangements are in place to manage infection prevention and control
including the risks from managing patients known, suspected or at risk of
having CJD. In addition the Director of Nursing is responsible for ensuring
that the policy is drafted, approved and disseminated in accordance with the
‘Policy for the Development and Approval of Policies’. The necessary training and
education needs and methods to implement this document are identified and
resourced. Mechanisms are in place for the regular evaluation of the
implementation and effectiveness of this document.
Lead Infection Control Nurse
The Lead Infection Control Nurse will:

update the policy and all supporting documents;

ensure the policy is taken to members of Health and Social Care HCAI
Group for comment;

monitor the effectiveness of this policy and its procedures through audit;
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4.4

provide support and advice to staff on decontamination of equipment;

deliver training to clinical staff on the procedures and processes laid
out in the policy through training.
Title of any relevant officers
None.
4.5
All Staff
All staff, including temporary and agency staff, are responsible for:

compliance with relevant process documents. Failure to comply may result in
disciplinary action being taken;

co-operating with the development and implementation of policies and
procedures as part of their normal duties and responsibilities;

identifying the need for a change in policy or procedure as a result of
becoming aware of changes in practice, changes to statutory requirements,
revised professional or clinical standards and local/national directives, and
advising their line manager accordingly;

identifying training needs in respect of policies and procedures and bringing
them to the attention of their line manager;

attending training / awareness sessions when provided.
5.
Implementation
5.1
This policy will be available to all Staff for use.
5.2
All managers are responsible for ensuring that relevant staff within their own
directorates and departments have read and understood this document and
are competent to carry out their duties in accordance with the procedures
described.
6.
Training Implications
It has been determined that there are no specific training requirements
associated with this policy/procedure.
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7.
Documentation
7.1
Other related policy documents
None.
7.2
Legislation and statutory requirements
Department of Health (2011) (part 4) Infection control of CJD, vCJD and other
human prions diseases in healthcare and community settings.
Department of Health (2011) Annex J Assessment to be carried out before
surgery and/or endoscopy to identify patients with or at increased risk of CJD
or vCJD.
7.3
Best practice recommendations
None.
7.4
References
Department of Health (2005). Transmissible spongiform encephalopathy
agents: safe working and the prevention of infection. Guidance from the
Advisory Committee on Dangerous Pathogens and the Spongiform
Encephalopathy Advisory Committee. London. DH.
Department of Health (2006). Health Technical Memorandum 07-01: Safe
Management of Healthcare Waste. London. DH.
Department of Health (2006). The Health Act 2006, Code of Practice for the
Prevention and Control of Health Care Associated Infections. London.
DH.
Department of Health (2011) Infection control of CJD,vCJD and other
human prions diseases in healthcare and community settings. (part 4).
London. DH.
Department of Health (2011). Annex J Assessment to be carried out
before surgery and/or endoscopy to identify patients with or at
increased risk of CJD or vCJD. London. DH.
Health Protection Agency (2009). Letter to Clinical Groups – Pre-surgical
risk assessment for variant Creutzfeldt-Jakob Disease (vCJD) risk in
patients undergoing neurosurgery, neuro-endoscopy and eye surgery.
London. HPA.
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8.
Monitoring, Review and Archiving
8.1
Monitoring
The Director of Nursing as sponsoring director will agree with the Lead
Infection Prevention and Control Nurse a method for monitoring the
dissemination and implementation of this policy. Monitoring information will be
recorded in the policy database.
8.2
Review
8.2.1 The Director of Nursing will ensure that each policy document is reviewed in
accordance with the timescale specified at the time of approval. No policy or
procedure will remain operational for a period exceeding three years
without a review taking place.
8.2.2 Staff who become aware of changes in practice, changes to statutory
requirements, revised professional or clinical standards and local/national
directives that affect, or could potentially affect policy documents, should
advise the sponsoring director as soon as possible, via line management
arrangements. The sponsoring director will then consider the need to review
the policy or procedure outside of the agreed timescale for revision.
8.2.3 Whether or not the review results in changes to the document, the author will
inform the Policy and Corporate Governance Lead who will schedule the
revised policy for the next appropriate policy group meeting. Following reapproval the policy will be re-issued under the next ‘version’ number.
8.2.4 For ease of reference for reviewers or approval bodies, changes should be
noted in the ‘document history’ table on the front page of this document.
NB: If the review consists of a change to an appendix or procedure document,
approval may be given by the sponsoring director and a revised document
may be issued. Review to the main body of the policy must always follow the
original approval process.
8.3
Archiving
The Policy and Corporate Governance Lead will ensure that archived copies
of superseded policy documents are retained in accordance with Records
Management: NHS Code of Practice 2009.
9.
Equality Analysis
The tables below summarise reviews with respect to:



Strategic and operational risks, including risks to health and safety.
Current equality and diversity legislation.
Rights under the European Convention on Human Rights.
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9.1
Risk Audit
Risk Audit for
RISK CATEGORIES
1
2
3
4
5
6
7
8
Risks relating to organisational objectives
Risks to patient experience/outcome
Risk to or from service/business interruption
Risks relating to staffing and competence
Financial risks
Risks to compliance with inspection/audit standards
General risks to organisational reputation
Specific health and safety (inc fire) risks to persons
(staff, patients, public, etc)
a
Location (access, environment, working
conditions)
b
Equipment (medical, electrical, other)
c
Hazardous substances
d
Lone working
e
Moving and handling
f
Potential to cause undue stress
g
Anti-social behaviour (violence, harassment,
theft)
Significant Risks
Identified Yes/No
Yes
Yes
No
Yes
No
Yes
Yes
No
No
No
No
No
No
No
No
OUTCOME (tick appropriate box)
ACTION
No significant risks
identified
Significant risks identified
Proceed with ratification process.
There is some doubt about
whether risks are significant
or relevant.

Complete a full risk assessment form and
action plan for all risks identified. Include in
the Appendices – see Appendix 8.
Take further advice from appropriate
directorate or department. If unresolved,
refer to Governance and Assurance
Committee.
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9.2
Equality Audit
Equality Audit for
QUESTION
RESPONSE
What is the purpose of the proposed policy document
(or changes to policy document)?
Care of Patients known,
suspected or at risk of
having Creutzfeldt Jacob
Disease (CJD)
Correct patient
management and safety
No
Who is intended to benefit, and how?
Will the proposals involve, or have consequences for,
the people the CCGs serve and employ?
Is there any reason to believe that people could be
affected differently by the proposals, for example in
terms of access to a service, or the ability to take
advantage of proposed opportunities?
Is there any evidence that any part of the proposals
could discriminate unlawfully, directly or indirectly,
against any section of the population?
Is the proposed policy likely to affect relations between
certain groups of people, for example because it is
seen as favouring a particular group or denying
opportunities to another?
Is the proposed policy likely to damage relations
between any particular group(s) of people and the
CCG?
No
No
No
No
OUTCOME (tick appropriate box)
Potential for discrimination
is very low or non-existent
Potential for discrimination
exists
There is doubt about the
potential for discrimination

Proceed with ratification process.
Amend the document as appropriate to
clarify exceptions or remove potential. If this
is not possible, take further advice from
Corporate Services Manager and/or the
Equality Lead Manager (HR Department)
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9.3
Human Rights Audit
Human Rights Audit for
QUESTION
RESPONSE
Does the policy document interfere with a Convention
right?
Could the actions described in the policy document
touch on one of the Convention rights?
Is there a victim?
Are there circumstances where the right can
legitimately be limited or interfered with?
Does the interference meet the general criteria
established by the Strasbourg authorities, ie:

The action is prescribed by law

It pursues a legitimate aim.

It is necessary in a democratic society.
No
No
No
No
No
OUTCOME (tick appropriate box)
No rights affected
Potential to affect a right
has been identified
There is doubt about the
potential to affect a right.

Proceed with ratification process.
Amend the document as appropriate to
clarify exceptions or remove potential. If this
is not possible, take further advice from
Corporate Services Manager/Legal Advisers.
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APPENDIX 1
Risk Assessment
There is a risk of non-compliance with all infection control policies which would in turn
increase the risk of patients acquiring healthcare associated infections (HCAI), the
organisation not achieving national targets on HCAI and not complying with inspection
audits.
These policies are designed to provide a framework to reduce those risks.
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