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INCIDENT REPORTING AND INVESTIGATION POLICY VERSION 9.
1
RATIFIED BY: BISE
RATIFIED DATE: OCTOBER 2010
REVIEW DATE: OCTOBER 2013
Page 1 of 49

Incident Reporting and Investigation Policy

ID # 2010 183
Authors name Pooja Sharma
Authors job title Risk and Patient Safety Manager
Division Corporate
Department
Clinical Governance & Risk
Management
Version number 9.1
Ratifying Committee
Business Integrated Standards
Executive Committee (BISE)
Ratified date October 2010
Review date October 2013
Name of manager responsible for
review
Patricia Duncan
J ob title of manager responsible for
review
Assistant Director of Clinical
Governance & Risk
Email address for this manager Patricia.Duncan@whht.nhs.uk
Source of evidence (if applicable) N/A
Level of evidence indicated N/A
Referenced (Yes/No) Yes
Key words (to aid searching)
Incident, Accident, Safety, Injury,
Investigation, NPSA, Reporting
User Group All Staff
The Trust is committed to promoting an environment that values diversity. All staff
are responsible for ensuring that all patients and their carers are treated equally
and fairly and not discriminated against on the grounds of race, sex, disability,
religion, age, sexual orientation or any other unjustifiable reason in the application
of this policy, and recognising the need to work in partnership with and seek
guidance from other agencies and services to ensure that special needs are met.
INCIDENT REPORTING AND INVESTIGATION POLICY VERSION 9.1
RATIFIED BY: BISE
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CHANGE HISTORY

Version Date Author Reason
Ratification
Required
8.0 J une 2008
Nicola Havutcu

Yes
8.1 November 2008
Updated by
Nick Egginton
Updated based on new SUI
reporting process
No
8.2 May 2009
Updated by
Nick Egginton
MHRA reporting process added No
8.3 J uly 2009
Updated by
Sirajul Islam
Updated based on
organisational changes in
governance structure
No
8.4 September 2009
Updated by
Nick Egginton
Changes to Training section
and SUI reporting process.
No
8.5 J anuary 2010
Updated by
Nick Egginton
Small changes to supporting
staff
No
9.0 October 2010
Sonia Cabezas
Snchez
Revision due. Internal audit
recommendations (August
2010)
Yes
9.1 April 2012 Pooja Sharma Update RIDDOR reporting No

CONTENTS

1.0 Introduction .............................................................................................................................. 3
2.0 Purpose .................................................................................................................................... 4
3.0 Incident Reporting Procedure (process for reporting) ............................................................ 10
4.0 Actions to be Taken Immediately Following an Incident ......................................................... 11
5.0 Incidents Involving Drugs ....................................................................................................... 11
6.0 Process for Reporting to External Agencies .......................................................................... 12
7.0 Incident Grading & Investigation Procedures ......................................................................... 16
8.0 Levels of Investigation ............................................................................................................ 17
9.0 Supporting Staff ..................................................................................................................... 17
10.0 Communication ...................................................................................................................... 19
11.0 Incident Analysis & Sharing of Lessons .................................................................................. 21
12.0 Process by which to raise concerns ....................................................................................... 21
13.0 Disciplinary Action .................................................................................................................. 21
14.0 Training ................................................................................................................................... 22
15.0 Monitoring & Review of Incident Reporting & Investigation Policy ......................................... 22
16.0 References .............................................................................................................................. 23
Appendix 1a Immediately Reportable Injuries to the HSE under RIDDOR 1995 ............................ 24
Appendix 1b Types of RIDDOR Incidents ....................................................................................... 25
Appendix 2 Reportable Incidents .................................................................................................... 27
Appendix 3a Incident Reporting Form ..................................................................................... 28
Appendix 3b DatixWeb Incident Reporting Form ............................................................................ 29
Appendix 4 Investigation Process / Level ....................................................................................... 31
Appendix 5 List of External Stakeholders ....................................................................................... 33
Appendix 6 Medical Devices Incident Reporting Procedure (to MHRA) ......................................... 34
Appendix 7 7 Day Report Template ................................................................................................ 38
Appendix 8 Guidelines for Staff: Statement Writing ........................................................................ 44
Appendix 9 Human Tissue Authority Serious Incident Notification Form ........................................ 45

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1.0 Introduction
1.1 West Hertfordshire Hospitals NHS Trust (WHHT) recognises the need for
comprehensive and systematic incident reporting as an integral part of Clinical
Governance & Risk Management, the aim of which is to collect information about
adverse incidents, including near misses, ill health and hazards, which will help to
support wider organisational learning and improvement. Robust incident reporting
and management are key elements of the NPSAs 7 Steps to Patient Safety. These
7 steps provide a simple checklist to help NHS organisations plan their activities and
measure performance in patient safety.

7 Steps to Patient Safety:
1. Build a safety culture.
2. Lead and support your staff.
3. Integrate your risk management activity.
4. Promote reporting.
5. Involve and communicate with patients and the public.
6. Learn and share safety lessons.
7. Implement solutions to prevent harm
1.2 It is WHHTs policy that all incidents:
Are reported electronically using the Datix system incident form.
Include a grading derived using the Trust risk assessment tool
Are investigated appropriately and robustly according to grading and an
action plan put in place
Are reported to external bodies (including statutory agencies) in the
timescales required when necessary.
1.3 The Trust will:
Have systems for monitoring and reporting incidents to the Trust board.
Participate in the NPSA's National Reporting and Learning System (NRLS).
Encourage all individuals directly or indirectly involved in its work to report
incidents without fear of repercussions or disciplinary action. (See Section
13, Disciplinary Action of this policy.)
Ensure compliance with Care Quality Commission (CQC), NHS Litigation
Authority Scheme for Trusts (NHSLA) and NPSA incident reporting
requirements.
Enhance the standard and quality of patient care provided through
monitoring all incidents, taking appropriate action and learning lessons and
minimising likelihood of recurrence.
Seek to minimise loss to the Trust resulting from clinical negligence or other
claims or complaints made against the Trust by learning from incidents.
Facilitate and promote learning from incidents and near misses.
Ensure that where incidents arise which require external agency reporting
then this is carried out according to Trust policy and the requirements of the
external agency.
Improve the range of data for the purpose of trend analysis (see Policy for a
Systematic and Aggregated Approach to Complaints, Litigation, Incident and
PALS Management & Encouraging Learning and Promoting Improvements in
Practice).
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Provide information, instruction and training to the workforce in order that
staff are aware of their duties and responsibilities under current regulations.
Ensure staff are appropriately supported if required as a result of an incident.
Ensure staff follow the principles of Being Open following an incident.
1.4 This Policy applies to all Trust staff and contractors working on Trust premises,
including staff on honorary contracts.
1.5 The policy should be read in conjunction will the following policies / guidance:
Being Open Policy
Raising Concerns Policy and Procedure (Whistleblowing)
Policy for a Systematic and Aggregated Approach to Complaints, Litigation,
incidents and PALS and Encouraging Learning and Promoting Improvements
in Practice
Risk Management Strategy
DatixWeb reporting guidance for managers and Staff.
Serious Incidents Requiring Investigation Policy (SIRIP)
The Health and Safety Policy
Fire Policy
Moving and Handling Policy
Medical Equipment Management Policy
Security Policy
Policy for the Management of Safety Alerts

2.0 Purpose

2.1 The policy describes the Trusts arrangements for the reporting of incidents and
near misses. The aim is to minimise injury to all, by ensuring that any lessons
learned from any injury, near miss, disease or dangerous occurrence are acted on
so that a similar recurrence is avoided or consequence minimised. It also ensures
that required information is passed on to appropriate authorities and affected
person(s) in a proper and timely manner.

2.2 The Trust promotes an open, positive and fair blame culture towards incident
reporting. The Trust has also adopted an open practice policy to encourage staff
and services to learn from when things go wrong. It is imperative that the incident
reporting system is used as a proactive mechanism for risk management.

2.3 Disciplinary action will only be considered in accordance with the Disciplinary
Policy. The Trust positively encourages staff to raise their concerns about health
care matters, malpractice, and a breach of legal obligations or damage to the
environment and encourages staff to use additional internal mechanisms for
reporting.
2.4 Definitions

An Incident

Adverse incidents can be defined as any unexpected or untoward event that has
a short or long-term detrimental effect on patients, visitors, staff and the
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organisation. If an incident specifically relates to a patient or patients care then it
may be known as a Patient Safety Incident.

Near Miss
A near miss event is a free lesson for the Trust. A near miss is where a
serious accident or incident could have occurred but did not occur due to one or
more factors.
3.0 Responsibilities

Chief Executive
The Chief Executive is responsible for ensuring that an incident reporting and
investigation process is established, implemented and maintained in accordance
with this policy. This includes ensuring the Trust meets relevant statutory
requirements and that it complies with best practice as described by the
Department of Health, NPSA and CQC.

Director of Patient Safety, the Medical Director
The Director of Patient Safety, the Medical Director has Executive responsibility
for Patient Safety and Clinical Governance and Risk Management. The Director
of Patient Safety, the Medical Director reports directly to the Board and the Chief
Executive on all matters relating to incidents and Serious Incidents.

Executive Directors
Executive Directors are responsible to the Board for:
- Implementing this policy on behalf of the Chief Executive;
- Promoting a responsible culture, which encourages individuals to
report all types of incidents;
- Delegating responsibility to local managers for the policys
implementation at local level;
- Ensuring sufficient resources are available, as far as reasonably
practicable, to deal with identified hazards and risks that might
lead to an adverse incident.

Assistant Director of Clinical Governance and Risk
On behalf of the Director of Patient Safety, the Medical Director, the Assistant
Director of Clinical Governance and Risk is responsible for ensuring that all of
the clinical governance systems and processes, including incident reporting are
fit for purpose and are implemented in practice. Where processes are deemed
insufficient, to make recommendations as appropriate to the Clinical Quality
Committee (CQuaC). The role reports to and is accountable to the Director of
Patient Safety, the Medical Director.

Risk and Patient Safety Manager
The Risk and Patient Safety Manager is responsible for the operational
management of this Policy and will oversee the incident reporting processes
Trust wide. The Risk and Patient Safety Manager will ensure:
- Mandatory training courses, including incident reporting training,
takes place
- Manage the Risk Systems Administrator who is responsible for the
maintenance of the Datix and DatixWeb systems
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- Manage the incident reporting process, ensuring divisions are
aware of these processes (including timelines) and ensuring that
all incidents that may potentially be identified as a reportable
Serious Incident are escalated in accordance with the Serious
Incidents Requiring Investigation Policy (SIRIP).
- Ensuring that the appropriate incident reports are provided for the
appropriate committees
- Provide support on the incident reporting process to Divisional
Risk Leads.

Risk Systems Administrator
The Systems Administrator is responsible for the day-to-day management of the
Datix and DatixWeb system and for producing incident data for trend analysis
and reporting internally and externally (to NPSA).

Health and Safety Manager
The Health and Safety Manager or Occupational Health Manager will, when
required, complete RIDDOR F2508 or F2508A forms respectively and send
them to the Health and Safety Executive (HSE). The Health and Safety
Manager will offer assistance and training regarding the Trusts RIDDOR
responsibilities. The Health and Safety Manager will also keep records of all
reportable incidents under RIDDOR, and investigate as appropriate, with regular
reports to the Health and Safety Committee

The Radiation Radiology Supervisor and Radiology Manager
The Radiation Protection Supervisor will be responsible for notifying the
Radiation Manager of all radiology related incidents where patients have
received a dose greater than intended in accordance with the Ionising Radiation
(Medical Exposure) Regulations 2000 (IR(ME)R). The Radiology Manager will
review the dose received by the patient against the criteria issued by the Health
and Safety Executive (PM77 2
nd
Ed 1998) and will complete an IR(ME)R
incident report and submit this electronically to the Care Quality Commission.

Transfusion Nurse Specialist
The Transfusion Nurse Specialist (TNS) will review all blood product related
incidents against the Serious Hazard of Transfusion (SHOT) and Serious
Adverse Blood Reactions and Events (SABRE) reporting criteria and report
accordingly to Denrite (for SHOT) and MHRA (for SABRE). In the absence of
the TNS, the Consultant Haematologist for Transfusion or the other two
members of the Hospital Transfusion Team will initiate external reporting as
required. Reports should be posted within 3 weeks of the event occurring.

Local Security Management Specialist
The Local Security Management Specialist (LSMS) will review all reported
incidents of actual and attempted physical assault against staff, verbal abuse
and aggression towards staff, theft or criminal damage to NHS property and
equipment against the Security Management Service (SMS) reporting criteria
and upload incident records via the Security Incidents Reporting System (SIRS)
within 72 hours of the incident occurring. (See: Security Policy).

Designated individual /pathology Services Manager
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The Designated Individual for the Trust must be notified of all potential incidents
meeting the Human Tissue Human Tissues Authority (HTA) criteria for Serious
Untoward Incidents (SUIs) in the post mortem sector. The Designated
Individual will be responsible for reporting the incident to the HTA. In the
absence of the Designated Individual, the Pathology Services Manager will take
responsibility for reporting the incident to the HTA.

Divisional Managers, Service Managers and Heads of Nursing
Divisional Managers, Heads of Nursing & Service Managers are responsible for
ensuring that staff at all levels understand the need to report all incidents, near
misses and clinical incidents as per this policy. They will be responsible for
ensuring incidents (including serious incidents) and / or trends are reviewed and
investigated at a local level and escalated for review by the Divisional Board as
required and to the Divisional Integrated Standards Executive.

Divisional Managers, Service Managers and Heads of Nursing are responsible
for ensuring the Clinical Governance and Risk Department and Executive
Director are informed of any major/catastrophic incidents that may need to be
escalated as a serious incident requiring investigation. (See Serious Incidents
Requiring Investigation Policy SIRIP)

Departmental Ward Managers / Matrons / Sisters
All Departmental Ward Managers / Matrons / Sisters are responsible for:

- Ensuring that the Incident reporting form is properly processed in
accordance with the requirements outlined in this policy.
- Reviewing all incident reports in a timely manner, ensuring they
are properly and fully completed on the DATIXWEB system no
later than week after the incident occurred.
- Carrying out investigations relevant to the severity of the incident,
which occur within their area of responsibility.
- Immediate post incident support for staff involved in the incident
and record any actions taken to support staff in the incident report.
- Refer members of staff involved to Occupational Health if deemed
appropriate or other employee support services (See Section 9.0,
Supporting Staff of this policy)
- Ensuring that all members of their staff receive sufficient training
so that they fulfil their individual responsibility in meeting the policy
requirements.
- Ensuring the Being Open Policy is adhered to and communication
with patients and their family/carer following an adverse incident is
undertaken and documented.

Divisional Risk Leads
Divisional Risk Leads are responsible for:
- Ensuring incidents are appropriately investigated within the
divisions and spend no longer than 14 days on the DatixWeb
system awaiting final approval.
- Maintaining an appropriately robust system for the management of
DatixWeb incidents for the division.
- Ensuring appropriate feedback mechanisms are in place to ensure
learning
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- Ensuring statistical incident data is presented at the local meeting
responsible for incidents.
- Providing incident information for the Complaints, Litigation,
Incident and PALS (CLIP) report specifically on the actions taken
and lesson learnt following incidents: green (negligible), yellow
(minor) and orange (moderate) severity incidents.
- Ensuring investigations are carried out following significant
incidents (red/major) or Serious Incidents (red/catastrophic)
incidents, which are reported and reviewed at DISE and also via
the Serious Incident Review Group.
- Providing training to staff on the incident reporting process.
- Ensure the Being Open process is followed as outlined in the
Being Open Policy.

Employees Responsibilities
Each employee has a legal duty to report an accident, incident or near miss
whether it involves staff, patients or visitors to the site as soon as is reasonably
practicable after the incident via DATIXWeb.

Where an employee is unable to report the incident, i.e. as a result of injury or
other factor affecting ability to report, the responsibility for reporting will rest with
their manager.

Employees will have a responsibility for recognising their own distress, stress or
changes in their normal life patterns after experiencing an adverse event.

Contractors, Volunteers, students, work experience placements
Contractors, Volunteers, students, work experience placements etc: are required
to report any incident to a member of staff who will then have the responsibility
for reporting (See Contractors Working Within Trust Premises).

Committees and Groups Responsibilities

Trust Board
The Trust Board is ultimately accountable for effective risk management within
the Trust including ensuring that all incidents, including Serious Incidents are
reported and where appropriate, fully investigated and that action is taken to
prevent reoccurrence. The Trust board will receive CLIP summary report for
review on a quarterly basis. This will include incident trend analysis, SIs reported
and a summary of the actions taken and lessons learnt. The Trust Board will
receive an annual report on all SIs and the actions taken.

Audit Committee
The Audit Committee is responsible for providing assurance to the Board that
the Trust has a sound system for managing risks and incidents and has
adequate plans, processes and systems for minimising risk and incidents. It
agrees the annual internal audit programme and reviews and monitors
recommendations made following audit of the incident reporting processes.

Clinical Quality and Committee (CQuaC)
CQuaC will review reports concerning specific incident trends identified, (i.e.
pressure sores, patient falls). It will also be responsible for reviewing external
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high-level incidents and reports for learning purposes. CQuaC will be notified of
SIs reported through the BISE minutes/report.

Business Integrated Standards Executive (BISE)
The BISE receives details of issues that prevent the robust application of this
policy, including issues relating to the use of DATIXWEB, incident management
training and other matters as raised by the Clinical Governance and Risk Team
or the Divisional Integrated Standards Executives.

Divisional Integrated Standards Executive (DISE)
The DISE will:
- Monitor the investigation of catastrophic incidents (serious
incidents) and major incidents (significant incidents) and progress,
including implementation of risk management actions and
recommendations
- Review incident trends and analyses.
- Review reports to external agencies as relevant to the division.

Serious Incident Review Group (SIRG)
The SIRG will ensure review of all catastrophic (Serious) and major (Significant)
incidents

Complaints, Litigation, Incident and PALS (CLIP) Group
The CLIP report will be presented at the CLIP group, which will review the
actions taken for trends identified in green (negligible), yellow (minor) and
orange (moderate) severity incidents.

Local Divisional Meetings
Each division has a meeting where they review incidents that occurred within the
division and the actions taken. When necessary the incidents may be escalated
to the Divisional Board and DISE where there may be trends emerging or
implications for the division. These local meetings should also be used to
review internal and external reports that relate to incident reporting trends and
analyses, for example:

- CLIP Report
- NPSA Feedback Report
- Quarterly Medication Incident Report
- Medical Devices Annual/Quarterly Incident Report
- Health and Safety Reports

Reporting Committees
Each of the reporting committees listed above (but not limited to) has a
responsibility for reviewing incident trends or serious incidents that relate to the
committees scope and remit. The Clinical Governance and Risk department will
provide these reports according to a schedule agreed with the chair of the
committee:
- Medical Devices Committee
- Medication Safety Committee
- Infection Control Committee
- Thrombosis & Anticoagulation Group
- Safeguarding Adults Group
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- Safeguarding Childrens Group
- Information, Implementation and Governance Group
- Hospital Transfusion Committee
- Resuscitation Committee

3.0 Incident Reporting Procedure (process for reporting)

3.1 When an adverse incident or near miss occurs, a clear record of events must be
written. An incident form must be completed using the DatixWeb system. Each
incident will require a review to establish why it happened, steps taken to resolve the
incident and to prevent recurrence.

3.2 Guidance is available to staff and managers on using the DatixWeb incident reporting
systems and is available on the incident reporting web page.

http://wghintra01/risk_management/documents/User%20Manual%20DIF%201.doc

http://wghintra01/risk_management/documents/User%20Manual%20DIF%202.doc

3.3 All incidents must be reported using DatixWeb, if the system is unavailable or the
individual reporter is unsure how to report using the system then a paper incident
form must be completed. The Divisional Risk Lead must be informed if the above
circumstances arise. If the Datix system is unavailable, the Divisional Risk Lead will
maintain a written record of incidents reported in the period and ensure they are
reviewed and approved.

3.4 A generic list of Incidents for Reporting can be found at Appendix 2. This list is not
exhaustive but should be used for guidance. In addition, local specific trigger lists
should be developed to further assist staff with the identification of adverse incidents.

3.5 All information given, including written statements must accurately state the facts,
without expressing personal opinion or allocating blame. Guidance on statement
writing can be found at Appendix 8

3.6 All sections of the DatixWeb/Paper incident report form should be completed as fully
as possible for all types of incidents.

3.7 The initial incident report must be submitted as soon as possible following the
incident and within 24 hours.

3.8 Once the form has been completed it should be submitted / given to the appropriate
manager for review and investigation as appropriate. Appropriate leads should also
be notified of the incident (e.g. Health and Safety Advisor for RIDDOR related
incidents)

3.9 All Negligible (Green), Minor (Yellow), Moderate (Amber) incidents and Major (red)
incidents will be reviewed and given final approval within 14 days of the incident.

3.10 Red (Catastrophic) incidents are likely to be serious incidents requiring investigation
and will follow timescales set out in the Serious Incidents Requiring Investigation
Policy (SIRIP).

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3.11 The manager has 7 days to carry out any necessary investigation for significant
(red/major) incidents using the 7 Day Report Template at Appendix 7.

3.12 Each division has a tailored process for managing the final approval process, which
meets the Divisions specific requirements. In the Division of Surgery the final
approval is given by the Divisional Risk Lead and in the Division of Medicine the ward
sister. All local processes adopted ensure incidents are appropriately reviewed,
investigated and reported within timescales.

3.13 All incidents will be treated with the appropriate degree of sensitivity and
confidentiality. The Trust will also comply with all requirements of the Data Protection
Act.

4.0 Actions to be Taken Immediately Following an Incident

4.1 Some incidents will require prompt and specific action to deal with the problem.
This may include the following:

Emergency medical care
Summoning assistance
Ensuring all at risk; patients, staff, visitors and others, are moved to a safe
environment
Treating/caring for others affected
If the incident could recur, take immediate action to prevent this
If equipment / machinery is involved, removing it from service (marking it clearly
out of order) and contacting the Clinical Engineering Department.
Notifying senior members of staff on duty
Where appropriate notifying a patients family and considering the need to make
an apology to the patient and family; an apology invariably improves relations
and communications and is not an admission of liability (Being Open Policy)
Recording the action taken in the patients medical records. Records might not
be at hand, but they should be found and either tracked or made secure.
Member of staff to report the incident via DatixWeb (or paper form if DatixWeb
unavailable)

4.2 The Department Manager/Sister should then ensure the following:

Ensure an Incident Reporting Form has been completed and dispatched to the
Divisional Risk Lead/other appropriate lead for immediate notification.
Ensure that all reasonable steps have been taken to prevent a recurrence, make
any enquiries or investigations relevant to the case, review the incident report,
check severity grading and update the actions taken and lessons learnt
sections. Depending on the incident severity it maybe necessary to obtain
witness statements.

5.0 Incidents Involving Drugs

5.1 All incidents involving Controlled Drugs must be reported directly to the Trust
Accountable Officer for Controlled Drugs who is the Chief Pharmacist as well as
following the reporting procedures outlined within this policy.

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6.0 Process for Reporting to External Agencies

6.1 Reporting Incidents Involving Medical Devices to the Medical Health products
Regulatory Agency (MHRA)

6.1.1 All incidents involving medical devices (including single use devices) need to be
reported through DatixWeb following the incident reporting process outlined in
section 5. Once the incident has been submitted to the Divisional Risk Lead, the
Divisional Risk Lead must liase with the Clinical Engineering Department and
determine whether the medical device involved meets MHRA medical device
reporting requirements for clinical engineering products. If a clinical engineering
product, the Clinical Engineering Department will report the incident to the MHRA
directly and inform the Divisional Risk Lead of outcomes.

6.1.2 If the incident relates to a non-clinical engineering device then the Divisional Risk
Lead will report the incident to the MHRA.

6.1.3 All incidents reported to the MHRA must be communicated to the Clinical
Governance and Risk Department by the Divisional Risk Lead so that a central
record can be kept by the department. They must be provided with all
correspondence and updated regularly on progress. Any such incidents will be
followed up at the Divisional Integrated Standards Executive (DISE) and a report
will be submitted to the Medical Devices Committee on a quarterly basis.

6.2 Incidents Involving Patients receiving a Radiation dose much greater than
intended

6.2.1 All incidents involving patients receiving a radiation dose much greater than
intended need to be reported through DatixWeb following the incident reporting
process outlined in section 5.

6.2.2 The incident should be reported to the Radiation Protection Supervisor (RPS) who
will notify the Radiology Services Manager (RSM) or in their absence a
superintendent radiographer. The RSM will be responsible for investigating the
incident in accordance with the Ionising Radiation (Medical Exposure) Regulations
2000 (IR(ME)R). The RSM will obtain an estimate of radiation dose received by the
patient. If exposure was considered to be much greater than intended based on the
criteria issued by the Health and Safety Executive (PM77 2
nd
Ed 1998) then the
RSM will complete an IR(ME)R incident report and submit this electronically to the
CQC. A copy of the report will be forwarded to the patients clinician with an
explanatory letter.

6.2.3 A copy of the incident report and subsequent investigation will be kept by the
Radiology Department and forwarded to Clinical Governance and risk to attach to
the Datix record.

6.2.4 Any incidents involving radiation or IR(ME)R reportable incidents will be reviewed at
the Trust Radiation Protection Committee and will be followed up at the DISE.

6.2.5 The full process is documented in the: Procedure to ensure that the probability and
magnitude of accidental exposure to patients are reduced (EP11 WHHT IR(ME)R
Employers Procedures.
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6.3 Incidents Involving Blood Products (SHOT and SABRE)

6.3.1 All incidents involving blood products need to be reported through DatixWeb
following the incident reporting process outlined in section 5. Using the trigger on
the incident form for reporting blood product incidents the Transfusion Nurse
Specialist (TNS) will receive an automatic notification of the incident. The TNS will
review the incident to confirm if it is a Serious Hazard of Transfusion (SHOT) or
Serious Adverse Blood Reactions and Events (SABRE) related incident.

6.3.2 If the incident is reportable as a SHOT incident then the TNS will then log onto the
SHOT (Dendrite) website and report the incident and will inform the Divisional Risk
Lead to update the Datix record. The TNS also keeps hard copy of the form/report.

6.3.3 If the incident is reportable as SABRE then the TNS will log onto the MHRA website
and report the incident and will inform the Divisional Risk Lead to update the Datix
record. The TNS keeps a hard copy of the form/report. The Trust will receive an
acknowledgment to the incident, the acknowledgment email will ask for a full report
to be sent. Any incidents that are SHOT/SABRE reportable will be reviewed at the
Hospital Transfusion Committee. (See Blood Transfusion Policy)

6.4 Reporting of Injuries, Diseases and Dangerous Occurrences Regulations
(RIDDOR) 1995

6.4.1 The Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995
(RIDDOR) require employers, the self-employed, such as contractors and those in
control of work premises to report certain accidents and diseases that arise out of or
in connection with work to the Health and Safety Executive (HSE).

In cases of death or major injuries, you must notify the enforcing authority without
delay, most easily by reporting online
(http://www.hse.gov.uk/riddor/report.htm#online)

Alternatively, you can telephone 0845 300 9923. Cases of over-seven day injuries
must be notified within fifteen days of the incident, using the appropriate online
form.

Cases of disease should be reported as soon as a doctor notifies you that your
employee suffers from a reportable work-related disease using the online form
Report of a case of disease (https://extranet.hse.gov.uk/lfserver/external/F2508AE).

Immediately Reportable Incidents
This includes death or major injury to a member of staff, patient or visitor (which
arises out of or in connection with our work activities) or major injury which occurs
at a hospital.

Over Seven day injuries
Over seven day injuries must be reported to the HSE within 15 days of the
injury occurring. A record of all over three day injuries will also be kept by
the Health and Safety Manager. Over seven days incapacitation means that
the person was unable to attend work, or was unable to perform their normal
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duties as would reasonably be expected of them for over seven days (not
including the day of the accident).

Diseases
Under RIDDOR, the Trust must report to the Health and Safety Executive (HSE)
certain cases of diseases and ill health associated with work activities.

Dangerous Occurrences
Under RIDDOR the Trust is required to report certain dangerous occurrences.

Should any of the above incidents occur the following process must be followed:

1. All potential RIDDOR incidents need to be reported through DatixWeb
following the incident reporting process outlined in section 5.On the incident
form there is a specific RIDDOR prompt, if this is completed then the Health
and Safety Manager automatically receives notification of the potential
RIDDOR incident.
2. If staff are uncertain of what constitutes a RIDDOR incident then there is a
quick explanation on DatixWeb and a contact number for the Health and
Safety Manager/Advisor.
3. Potential RIDDOR incidents should be escalated through the review and
checking process within 24hrs.
4. Upon receipt of the incident form the Health and Safety Manager prepares
an incident report, which includes the basic RIDDOR information and
contacts the RIDDOR Incident Contact Centre to report the incident.
5. The Health and Safety Advisor receives a confirmation email from the
Incident Contact Centre (essentially a copy of the F2508 form)
6. The Health and Safety Manager maintains a record.
7. Where reports are overdue (due to late identification of a work related injury
or illness) then the incident still needs to be reported via DatixWeb.
8. The Health and Safety Committee monitors RIDDOR incidents.

6.5 Incidents Reportable directly to the Care Quality Commission (CQC)

6.5.1 Under the Health and Social Care Act 2008 and specifically the CQC Essential
Standards of Quality and Safety Outcomes the following incidents need to be
reported directly to the CQC.

Outcome 19: Notification of death or unauthorised absence of a person who
is detained or liable to be detained under the Mental Health Act 1983.
Outcome 20: Notification of other incidents. Applications to deprive someone
of their liberty under the Mental Capacity Act

6.5.2 Forms are available on the CQC website to be completed and submitted following
such incidents.

6.6 Reporting To The National Patient Safety Agency (NPSA)

6.6.1 The NPSA was established to ensure that the NHS learns from Adverse Patient
Incidents involving patients so that improvements to the delivery of healthcare and
the systems supporting care can be made for the benefit of patients in the future.

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6.6.2 All patient safety incidents, which are reported via DatixWeb or the paper forms are
uploaded to the NPSA via the National Reporting and Learning System (NRLS).
The Risk Systems Administrator will upload all patient safety incidents to the NPSA
on monthly basis. Performance against this process is monitored through the NPSA
six monthly feedback reports. These reports are reviewed at various committees.

6.7 SIRS
6.7.1 All reported incidents of actual and attempted physical assault against staff, verbal
abuse and aggression towards staff, theft or criminal damage to NHS property and
equipment are reviewed by the Local Security Management Specialist (LSMS).
Incidents meeting Security Management Service reporting criteria are uploaded on
a monthly basis and monitored at Health and Saftey Group.

6.8 Her Majestys Coroner
6.8.1 If the incident results in an unexpected or unnatural death, the Coroner may decide
it warrants an Inquest to establish the cause of death. If an Inquest is opened the
Coroner may request statements from specific named staff he believes can assist
him in his enquiry. The Litigation and Claims Manager is the point of liaison with
the Coroners Office and will support staff in writing their statements and prepare
them for attendance in Court if they are called as witnesses to the Inquest. Legal
representation will be arranged if necessary.

6.9 Involving and Informing the Police
6.9.1 The Police should be informed and involved in violent incidents or breaches of
security or if some other criminal act is thought to have occurred. The Police should
also be informed in the event of an unnatural death, as they have a duty to
investigate these on behalf of the Coroner. In such cases the scene of the incident
should not be disturbed before the Police arrive.

6.10 Safeguarding Children Incidents
6.10.1 Safeguarding Children Incidents are reported and dealt with rigorously through the
arrangements in place with the Hertfordshire Local Safeguarding Children Board
(HLSCB). This is a multi agency body with responsibility for reviewing all
safeguarding children issues in Hertfordshire. Where issues require a Serious
Case Review, this will be dealt with in accordance with HLSCB processes.
However all incidents relating to children occurring or involve the services of WHHT
that warrant a Serious Case Review should also be reported as Serious Incidents
and investigated accordingly (See Serious Incidents Requiring Investigation Policy).
This enables the Trust to undertake its own review to ensure that any immediate
findings can be addressed in advance of the outcome of the Serious Case Review.
All such incidents should be immediately notified to the Lead Nurse for
Safeguarding Children and the Director of Nursing, Patient Champion.

6.11 Safeguarding Adults incidents
6.11.1 Safeguarding adult incidents are reported and dealt with rigorously through the
arrangements in place with the Hertfordshire Safeguarding Adult from Abuse Board
(HSAAB), a multi agency body with responsibility for reviewing all safeguarding
adult issues in Hertfordshire. All such incidents should be notified to the Lead
Nurse for Safeguarding Adults and the Director of Nursing, Patient Champion.

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6.12 Notifying the Human Tissues Authority (HTA) of Serious Untoward Incidents
(SUIs) in the post mortem sector
6.12.1 From 1 May 2010, the Human Tissues Authority must be notified of all Serious
Untoward Incidents (SUI) that occur at establishments in the post mortem sector
holding an HTA licence. Incidents that must be notified to the HTA are listed below
(near-misses are to be included as incidents):

Discovery of an organ or tissue following post-mortem examination and
release of body
Loss of an organ
Disposal or retention of an organ against the express wishes of the family
Disposal or retention of a whole fetus or fetal tissue (gestational age greater
than 24 weeks) against the express wishes of the family
Post-mortem examination of the wrong body
Post-mortem examination conducted was not inline with the consent given or
the PM examination proceeded with inadequate consent
Removal of tissue from a body without authorisation or consent
Release of the wrong body
Major equipment failure
Serious security breach
Incident leading to the temporary unplanned closure of a mortuary resulting
in an inability to deliver services
Any incident that could result in adverse publicity that may lead to damage in
public confidence
Discovery of an additional organ(s) in a body on evisceration for a second
post- mortem examination
Accidental damage to a body before or after post-mortem examination

6.12.2 The Designated Individual for the Trust must be notified of all potential incidents
meeting the above criteria. The Designated Individual will be responsible for
reporting the incident to the HTA using the HTA SUI notification form found at
Appendix 9. In the absence of the Designated Individual, the person designate will
take responsibility for reporting the incident to the HTA (those named are detailed
in the HTA return lodged in the Histopathology Department). Notifications of SUIs
to the HTA must be submitted without delay via email to
pm.incident.report@hta.gov.uk quoting the Trust's HTA licence number (12082)
and the date of the incident in the subject line. Notification forms can also be
faxed to 0207 2113430.

7.0 Incident Grading & Investigation Procedures

7.1 All incidents are graded according to the actual impact or near miss on the person
involved. If there is an ongoing risk to the Trust then a risk assessment should be
completed and the risk managed on the appropriate risk register depending on
rating (See Risk Management Strategy). All incidents are graded by the initial
reporter; the grading is then reviewed by the ward sister / Matron prior to final
approval.

7.2 Appendix 4 summarises the process for the investigation of incidents, following up,
implementation and monitoring of recommendations and action plans. The Clinical
Governance and Risk Department is available to advise and support with this
process.
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8.0 Levels of Investigation
It is unrealistic to suggest that all incidents should be investigated to the same
degree, or at the same level within the Trust.

8.1 Negligible (Green), Minor (Yellow), Moderate (Amber) Incidents

All Negligible (Green), Minor (Yellow), Moderate (Amber) incidents should provide a
summary of the immediate action taken following the incident by the initial reporter.
All Negligible (Green), Minor (Yellow), Moderate (Amber) incidents should have the
investigation section (which includes lessons learnt and actions taken) of the DIF2
DatixWeb form completed by either the ward manager or matron reviewing the
incident. Incident trends, the lessons learnt and actions taken will be reviewed
through the CLIP report for all Negligible (Green), Minor (Yellow), Moderate
(Amber) incidents.

8.2 Major Incidents (Red)

8.2.1 All major incident investigations will be led by an investigation lead nominated
(usually the ward manager) by Head of Nursing, Divisional Manager or Clinical
Director.

8.2.2 The investigation lead has 7 days to carry out any necessary investigation for
significant (red/major) incidents using the 7 Day Report Template at Appendix 7.

8.2.3 All major incidents and their action plans should be reviewed at the DISE and
appropriate divisional group or committee with risk responsibilities.

8.2.4 It is the responsibility of the relevant service / senior manager where the incident
occurred to ensure that all learning points and safety improvements are
appropriately identified and action plans drawn up, implemented, monitored and
reviewed.

8.3 Catastrophic incidents (Red/Serious Incident)

8.3.1 Incidents reported as having a catastrophic severity are likely to be Serious
Incidents Requiring Investigation and are reportable externally. (See Serious
Incidents Requiring Investigation Policy for the procedural guidelines).

9.0 Supporting Staff
Line Managers are expected to support their staff through traumatic and stressful
situations; offering immediate support following a stressful event. Line managers
should provide a supportive style of management and be fully aware of the action to
take if one of their staff members is experiencing difficulty. They need to be
confident of seeking advice from senior managers and directors and to know that
they can refer a member of staff to occupational health and confidential staff
counselling service when greater levels of support are deemed necessary.

The following support be offered for staff involved in incidents:

9.1 Immediate Support
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During or immediately after an incident has occurred it may be necessary to provide
support for any staff involved.

It will be the role of the Divisional Managers and Heads of Nursing, including on-call
managers, to be alert to those factors, which may necessitate and provide the
necessary resources for this to take place. The welfare of any staff involved in a
serious incident must be considered particularly in relation to psychological trauma
or stress.

9.2 Personal Debrief
The personal debrief is where the manager and the staff member involved sit in
private and discuss the incident in an uncritical atmosphere. The location of this
debrief should be discussed and could include a private office, at the staff
members home or in a neutral location.

It is a good idea (with the permission of the staff member) to write some notes e.g.
on the incident and how this has affected staff and what assistance has been
offered by the manager.

The Trust's confidential staff counselling service can also provide critical debriefing.
Debriefing can be set up via the 24/7 free phone number 0800 328 1437.

For Significant (red/major) incidents and Serious Incidents (red/catastrophic)
incidents, details of what staff support has been offered should be included in the 7
Day Report.

9.3 Leave Arrangements
In some incidences, staff may wish to return to work e.g. after a couple of hours. A
personal debrief should always take place before the member of staff returns to
work, even if they return to work shortly after the incident. This will ensure that
both the member of staff and manager are in agreement they can return and make
any necessary changes to their duties.

When the member of staff is not ready to return to work, they should be allowed to
go home. Due to Health & Safety Executive reporting requirements regarding
incidents at work, all subsequent leave will need to be taken as sick leave and this
incident will then become RIDDOR reportable (if a period of absence of three days
or more).

If the member of staff and manager disagree as to whether the member of staff is
ready to return to work, advice should be sought from the Occupational Health
Department as a matter of urgency.

9.4 Actions for managers or individuals to take if a staff member is experiencing
difficulties associated with the event
If an individual has a concern about another member of staff who is experiencing
difficulties as a result of being involved in an incident they can raise the concern
with the appropriate line manager. The line manager should recommend the staff
member contact the Employee Assistance Programme.

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The Trust provides an Employee Assistance Programme (EAP) that includes
confidential counselling for staff affected by stress caused by either work or external
factors. Confidentiality will be maintained. Employee Assistance Programme can be
accessed on telephone 0800 328 1473.

9.5 Ongoing Support
Where a member of staff is affected by an incident the appropriate line manager will
ensure liaison between staff and occupational health and consider identifying a
supervisor or colleague to support and monitor the affected staff member for an
extended period of time.

At this time all supportive options should be considered when necessary over time
to ensure that a staff member affected by a traumatic/stressful incident has every
opportunity to access the support appropriate to the resolution of their needs. This
should include practical as well as psychological support.

It is also important for staff to be kept fully informed of the progress of an
investigation with which they have had clear associations. This will be the
responsibility of the manager undertaking the review or chair of any investigation
team. In particular staff must be kept aware of progress and when the report has
been completed, the findings, recommendations and action to be taken should be
relayed to them, giving them the opportunity to ask questions.

9.6 Occupational Health Service

The Occupational Health Department offers a confidential service for all employees,
providing care, preventing illness and promoting health and safety in the workplace.

Useful Contacts

The Watford Occupational Health Department
Situated in front of the Administration Block (through Main Gate off
Vicarage Road, next to football ground). Tel: 01923 217304.
Hours of opening: 8.00 am - 4.00pm Monday to Friday

The Hemel Hempstead Occupational Health Department
Situated in the Main Block, Level 2. Tel: 01442 287576.
Hours of opening: 8.00 am to 4.00 p.m. Monday to Friday

9.7 Monitoring compliance with the supporting staff processes
Details of the immediate support offered to staff should be detailed on the incident
form and also for Significant (red/major) incidents and Serious Incidents
(red/catastrophic) incidents, in the 7 Day Report. A summary report of the contact
made by staff to the Employee Assistance Programme (EAP) reviewed at H&S
committee.

10.0 Communication

10.1 Communication with the affected individual (including patients)

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Every effort must be made to inform the individual involved as soon as possible
before any media contact is made and in line with the Being Open Policy.

The individual will receive treatment, care and support, and be given full information
on the incident, including the outcome of the investigation. If the individual is
incapacitated then next of kin and or significant other, must be informed in lieu of
the patient. Where the incident has led to death or serious injury, the individuals
next of kin must be informed before any media contact is made. The Executive
Director will be responsible for delegating these tasks where appropriate.

10.2 Communication with many affected individuals

It is acknowledged that on occasion, particularly where many patients have been
involved or the incident has come to light some months later, it may not be possible
to inform the individuals affected prior to the media becoming aware, although it will
be the responsibility of the Executive Director to ensure every effort to do has been
demonstrated.

There may be circumstances where there are multiple enquiries needing to be
responded to, or a complex, high profile incident needing well co-ordinated action
planning and implementation. In these events hotline arrangements will be
implemented.

10.3 Communication with Staff

It will be the responsibility of the manager in charge of the area where the incident
occurred (Lead Investigating Officer, in the case of a Significant or Serious Incident)
to ensure that relevant senior clinical and management staff are informed.

It will be the responsibility of the Lead Investigating Officer to ensure full feedback
on completion of the investigation.

10.4 Communications with other interested parties

At any stage during the investigation, the Director of Nursing / Medical Director will
consider whether or not it is appropriate to report the incident to the relevant
professional or statutory body e.g. NMC, GMC.

It will also be the responsibility of the Director of Nursing / Medical Director to
determine whether other external bodies are to be involved in the investigation,
based on the detail of the incident itself. It will be the responsibility of the Lead
Director to inform and involve any organisation as appropriate; this may include one
or more of the following (this list is not exhaustive):

GPs (particularly if the incident involves many patients)
The Strategic Health Authority, Primary Care Trusts, other Trusts and
Department of Health where applicable.
Community Health Councils / Patient Advice and Liaison Services (PALS)
NHS Litigation Authority
Police
Coroner
Social Services
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Medicines and Healthcare products Regulatory Agency (MHRA)
Health and Safety Executive
Public Health Bodies
Trust legal Advisors
Local Supervising Authorities for a maternal death
Child Protection Agency

10.5 Communications with other people involved in the incident

Incidents may involve anyone, visitors, the general public or staff from other
agencies. All those involved in the incident will be offered support.

10.6 Communications with Media

In circumstances where there is actual or anticipated media interest in an incident,
then the Associate Director of Communications will be responsible for dealing with
the Trusts response to the media, in conjunction with the Chief Executive and the
Communications team. It will be the responsibility of the Associate Director of
Communication to make every effort to ensure staff are briefed on how to deal with
the media should they be approached.

11.0 Incident Analysis & Sharing of Lessons

Detailed information is available in the Policy for a Systematic and Aggregated
Approach to Complaints, Litigation, Incident and PALS management and
encouraging learning and promoting improvements in practice.

12.0 Process by which to raise concerns

Where an incident investigated raises concerns about the performance of a
particular member of staff, the Trusts Raising Concerns Policy and Procedure
should be followed.

13.0 Disciplinary Action

The Trust recognises that the most incidents occur as a result of an accumulation of
a number of factors and events all conspiring together. Staff should be encouraged
to report incidents without fear of disciplinary action in a culture of learning and fair
blame. Fear of disciplinary action may defer staff from reporting a serious incident.

The view of the Trust is that disciplinary action should not form part of a response to
an incident except in cases where one or more of the following apply:

Where in the view of the Trust, and / or any professional registration body, the
actions causing the incident / arising from the incident were far removed from
acceptable practice
Where there was intent to harm and / or criminal offence has taken place
Where there is failure to report an incident in which the member of staff was
either involved or about which they were aware

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If, prior to or during the investigation, the matter to be investigated is considered to
involve gross misconduct or if it is considered that allowing the employee to
continue working will jeopardise patient care and safety whilst the investigation is
conducted, the employee may be suspended from work for as short a period as
possible.

Suspension is a neutral action and does not imply guilt. The employee will receive
full pay and will lose no rights whilst the investigation proceeds apart from in
exceptional circumstances. Suspension processes outlined in the Trusts
Disciplinary Policy & Procedures should be followed.

No disciplinary process will be commenced as a result of an incident until at least
the initial report of the investigation has been completed and agreed by the
Associate Director for Integrated Governance / Assistant Director for Clinical
Governance and Risk.

To ensure a robust and consistent approach to incident investigation, the Trust
must use the NPSAs Incident Decision Tree (IDT) which can be found at
http://www.msnpsa.nhs.uk/idt2/(d5vvderjryty2f552oxkrr55)/index.aspx

The Incident Decision Tree helps NHS managers and senior clinicians decide initial
action to take with staff involved in a patient safety incident. It is intended to
promote a consistent and fair approach, avoiding unnecessary and costly
suspensions and exclusions.

This process can be facilitated by the Associate Director for Clinical Governance
and Risk in conjunction with the Lead Investigation Officer and Head of Nursing /
Divisional Director.

14.0 Training

All new members of staff will be introduced to the principles of risk management,
including incident reporting procedures, during their induction training (corporate
and local induction) and all staff will receive mandatory update training on incident
reporting as part of risk management training.

Staff identified through the Training Needs Analysis will be provided with training in
the investigation of Incidents, Complaints and Claims, this will be provided on a
rolling basis every 3 years.

15.0 Monitoring & Review of Incident Reporting & Investigation Policy

The Incident reporting and Investigation Policy will be monitored for effectiveness
by the following processes:

Quarterly incident trend analysis reports to the CLIP Group.
CLIP summary reports to the Trust Board.
Quarterly incident trend analysis reports to the Medicines Safety Committee
Review of NPSA Feedback Reports
Incident reviews at DISE
Internal Audits of the Incident Reporting Process

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16.0 References

Risk Management Strategy
Serious Incidents Requiring Investigation Policy
Raising Concerns Policy and Procedure (Whistleblowing)
Being Open Policy
Risk Management Intranet Site
Procedure for A Systematic Approach To Incidents, Complaints and Claims
Management, Analysis and Sharing Safety Lessons
Seven Steps to Patient Safety National Patient Safety Agency (2003)
Root Cause Analysis Toolkit National Patient Safety Agency (2004)
Building a Safer NHS National Patient Safety Agency (2002)
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Appendix 1a Immediately Reportable Injuries to the HSE under RIDDOR 1995

Under RIDDOR it is an offence to fail to report a reportable event or to fail to report within
the specified periods.

Immediately Reportable Events

The following accidents are to be notified by the Health and Safety Manager to the Health
and Safety Executive (HSE) by the fastest practicable means, i.e. by telephone or via the
internet

The death of any person as a result of an accident arising out of or in connection
with work
Any person suffering any of the following injuries or conditions as a result of an
accident arising out of or in connection with work:
Fracture of any bone (other than fingers, thumbs or toes)
Amputation (including a finger, thumb or toe, or any part thereof if the joint or
bone is completely severed)
Dislocation of the shoulder, hip, knee or spine
Loss of sight (temporary or permanent)
Penetrating injury to an eye, or a chemical or hot metal burn to an eye
Injury resulting from an electric shock from any electrical circuit or equipment,
whether or not due to direct contact (including burns) leading to loss of
consciousness or requiring resuscitation or hospitalisation for more than 24
hours
Any other injury leading to hypothermia, heat induced illness or
unconsciousness, or requiring resuscitation or hospitalisation for more than 24
hours
The loss of consciousness caused by asphyxia or exposure to a harmful
substance(s) or biological agent(s)
Either of the following conditions which result from the absorption of any
substance by inhalation, ingestion or through the skin
(a) Acute illness requiring medical treatment; or
(b) Loss of consciousness
Acute illness which requires medical treatment where there is reason to believe
that this resulted from exposure to a biological agent or its toxins or affected
material.
Any person, other than staff, suffering injury as a result of an accident and is
taken from the scene to a hospital for treatment (or where occurring in a
hospital, would otherwise be taken to hospital).
Any injury received by staff as a result of physical violence, or as a result of an
accident, which requires treatment at a hospital or, if sustained in a hospital,
would otherwise require removal to an hospital and detained for 24 hrs or more.
The death of an employee if this occurs some time after a reportable injury
which led to that employees death, but not more than one year afterwards.

In addition, all staff should note that, where sickness or a reduction in normal duties is
related to an incident at work, whether or not it is immediately following the incident, the
incident must be reported via the incident reporting process.
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Appendix 1b Types of RIDDOR Incidents

Death or Major Injury Over Three Day Injury Disease Dangerous Occurrence
If there is an accident at work and:
Employee, or self employed person
working on Trust premises is killed or
suffers a major injury
A member of the public is killed or
taken to hospital as a result of a major
injury
If there is an accident connected with work
(including an act of physical violence) and the
employee, or a self employed person working
on Trust premises, suffers an over- seven-day
injury. Please note that whilst over three day
injuries do not have to be reported to the HSE,
they still need to be recorded by the Health and
Safety Manager.
If a doctor notifies an employee that they
are suffering from a work-related disease
then this needs to be reported.
If something happens which does not
result in a reportable injury but could
have. It may be a dangerous
occurrence, which must be
immediately reported to the enforcing
authority

Example definitions of a Major Injury
Fracture other than to fingers, thumbs
or toes
Amputation
Dislocation of the shoulder, hip, knee,
or spine
Injury resulting from an electric shock
or electric burn leading to
unconsciousness or requiring
resuscitation or admittance to hospital
for more than 24 hours
Loss of sight (whether temporary or
permanent).
A chemical or hot metal burn to the
eye or any penetrating injury to the
eye.

Definition of an over-three-day injury
An injury which is not major, but results in
the injured person being away from work or
unable to do the full range of their normal
duties for more than sevendays (including
any days they wouldnt normally be
expected to work such as weekend, rest
days, or holidays) not counting the day of
the injury itself.
There may be cases when reportable
injuries or conditions resulting from an
accident will either be:
A) Unrecognisable without medical
examination, which is conducted after
some time
B) Delayed for some time after the
accident
For example if a member of staff has an
incident and comes back to work for a day,
but then goes sick or cannot carry out their
full range of duties as a direct result of the
incident for 7 or more days.

Example definitions of a Disease
Inflammation, ulceration or malignant
disease of the skin due to ionising
radiation.
Physically demanding work causing
severe or prolonged friction or
pressure on the hand.( Bursitis or
subcutaneous cellulites)
Physically demanding work, frequent
or repeated movements, constrained
postures or extremes of extension or
flexion of the hand or wrist. (Traumatic
inflammation of the tendons)
Carpal tunnel syndrome.
Hand-arm vibration syndrome.
Infections due to biological agents
Hepatitis.
Legionellosis
Infections due to biological agents

Example definitions of a Dangerous
Occurrence
The collapse of, the overturning of,
or the failure of any load-bearing
part of any crane, lift, hoist, access
platform etc
Failure of any closed vessel /
pressure system
Electrical Short circuit overload
Malfunction of radiation generators
(fixed or mobile radiology
equipment)
Collapse of Scaffolding
Incidents in respect of a pipeline or
pipeline works
Any accident or incident which
resulted or could have resulted in
the release or escape of a biological
agent likely to cause severe human
infection or illness.
Collapse of building or structure
(unintended collapse or partial
collapse)
Escape of flammable substances
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Appendix 1c Divisional RIDDOR Incident Flowchart

Di vi si onal RIDDOR Incident Reporting Fl owchart
Accident occurs Refer to RIDDOR guidance sheet.
If applicable, escalate to
H&S Advisor
Incident / DatixWeb form to be
completed by person affected or
person/involved or witness,
RIDDOR box to be ticked
By ti cking the RIDDOR box on
the Dati xWeb i nci dent form the
Healt h and Saf et y Manager wi ll
automati call y receive a copy of
the i nci dent.
Important not e:
All personal details of the Person
affected MUST be provided.
These include:
J ob Title (if staff), title, full name,
date of birth, address, postcode,
personal telephone contact.
Pass/submit completed incident
form to
Ward / Dept manager
Ward/dept manager to ensure
all personal details, descriptions
of the incident,
treatment/medical referral
and total number of days taken as
Absence / light duties are
documented
Pass/submit incident form to senior manager
within 48 hours for logging onto main Datix
Important not e:
If the total number of days taken
as absence / light duties is not
known, dont delay passing the
incident report to your Ward/dept
manager . You will be contacted at
a later date to confirm this
information.
Divisional Risk Lead to identify any incidents that are RIDDOR reportable
that have not been escalated to the Health and Safety Manager
If i n doubt, contact Trust Heal th and Safety Manager
Tel: 01442 287189 (Ext 2189 HHGH); Mobile: 07760172701
Email sam.walker@whht.nhs.uk
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Appendix 2 Reportable Incidents

An incident or near miss can include (but not limited to) the following events:
Theft, vandalism, intrusion or missing or damaged property
Work related ill health (including over three/seven day injury). The definition
of work-related ill health used by the Health and Safety Executive is "any
illness, disability, or other physical problem which reduces, either temporarily
or permanently, the functioning of an individual and which has been caused,
in whole or part, by the working conditions of that individual". This can also
include musculo-skeletal disorders.
Any incident of fire or explosion regardless of cause within the Trust.
Violence, sexual abuse, harassment and bullying affecting staff within the
Trust.
Any breach or potential breach of information/data security, physical or
computer-related. Information Security breaches include internet misuse and
abuse, e-mail misuse and abuse.
Patient Falls
Medication Errors (dispensing, administration, prescribing)
Staffing Shortages
Lack of medical equipment or failure of equipment
Failure to monitor patient / Failure to act on deteriorating patient
Absconded or missing patients
Pressure Sores
Inappropriate transfer / discharge and or delay

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Appendix 3a Incident Reporting Form
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Appendix 3b DatixWeb Incident Reporting Form

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Appendix 4 Investigation Process / Level

Process / Objective

SI
Catastrophic
Red
Major
Amber
Moderate
Yellow
Minor
Green
Negligible
Investigation Team Nominated by the
Director of Nursing /
Medical Director.

Investigation Team
should have a lead
investigating officer
and be supported by
the Head of Nursing
and Divisional
Manager

Nominated by the Head
of Nursing / Divisional
Manager and Clinical
Director. Usually the
ward manager

Nominated by a Senior
Manager where the
incident occurred and will
comprise of:

Department / Ward / Line
Manager (from where the
incident occurred)

These should
normally be
investigated and
reviewed locally in
the ward or
department in which
the event occurred.

The investigation
lead will normally be
the ward /
department / line
manager.
These should
normally be
investigated and
reviewed locally in
the ward or
department in
which the event
occurred.

The investigation
lead will normally
be the ward /
department / line
manager.
Plan and conduct
investigation - Collect
facts, knowledge and
physical items related to
the incident as soon as
possible
See Serious Incidents
Requiring Investigation
Policy.
Notification to
SHA/PCT within 24
hours.
72 hour Report if
requested by PCT.

7 Day Report
completed.
45 Day Report
7 Day Report completed
within 7 days.

DIF and DIF2 completed
on DATIX. Within 14 days

DIF and DIF2
completed on
DATIX. Within 14
days.

DIF and DIF2
completed on
DATIX within 14
days.
Implementation of
Action Plans
Monitored by Serious
Incident Review
Group.
Monitored by Divisional
Integrated Standards
Executive (DISE)

Monitored by Complaints,
Litigation, Incident and
PALS (CLIP) Group

Monitored by
Complaints,
Litigation, Incident
and PALS (CLIP)
Group

Monitored by
Complaints,
Litigation, Incident
and PALS (CLIP)
Group
Incident / Near Miss Occurs Grade Incident Establish Severity
RATIFIED BY: BISE

Appendix 5 List of External Stakeholders

External Agency Type of Incident Timescale Policy to be
followed
Coroner Death from industrial diseases
Cot death and postnatal deaths
Suicides
Where death may be linked to an accident
(whenever it occurred).
Death after operation or before full
recovery from anaesthetic
Death due to abortion
Cause of death unknown or within 24
hours of admission
Possibility of complaint about any medical
care (Negligence)
Neglect or self-neglect
Any violent, suspicious or unnatural death
Drug related deaths
Death of anyone currently or recently
detained in Police / Prison custody
Immediate Incident
Investigation &
Reporting Policy
and Litigation and
Claims Policy
Health & Safety
Executive (HSE)
Death, major injury or dangerous
occurrence
Over three day injuries
Immediate

Seven days
See point 7.2.2
above
NHS Litigation
Authority
(NHSLA)
Incidents where Trust becomes aware
that litigation will result
Immediate Litigation & Claims
Policy
Professional
Regulatory
Bodies
Incidents where there appears to have
been a breach of the professional code of
conduct
When the
breach
becomes
apparent

Medicines & Healthcare
products Regulatory
Agency (MHRA)
Incidents involving injury or risk of serious
injury involving healthcare products and
equipment
Within 24
hours
Medical Devices
Policy and
Safety Alert
Broadcasting Policy
Serious Hazards of
Transfusion (SHOT)
Serious Adverse Blood
Reactions and Events
(SABRE)
Any incident involving transfusion of blood
products
As soon as it
is identified
Blood Transfusion
Policy
Area Child Protection
Committee
Any incident involving serious harm to a
child
Immediate Child Protection
Policy
Commission for Social
Care Inspection/
Healthcare
Commission
Any serious incident As soon as
possible
SUI Policy
Environmental
Health/Food Standards
Agency/Health
Protection Agency
Incident involving contaminated food
products resulting in illness
Immediate Food Hygiene
Policy and
Procedure
Counter Fraud and
Security Management
Service (CFSMS)
Any incident involving serious assault on
someone in connection with the provision
of health and social care services
All non-serious incidents
24 hours

As soon as
Possible
(Liase with Trust
Counter Fraud
Specialist)
Mental Health Act
Commission
Any serious incident involving a detained
patient
As soon as
Possible
MCA Policy
Local Supervising
Authority Midwifery
Officer
Any serious incidents involving any
midwives or for maternal deaths
As soon as
Possible
Incident
Investigation &
Reporting Policy
RATIFIED BY: BISE

Appendix 6 Medical Devices Incident Reporting Procedure (to MHRA)
Reporting a defect or incident

In the event of an accident, incident or defect concerning medical equipment the Trust
Incident Reporting and Investigation Policy must be followed. The user must ensure that
the equipment is withdrawn from service immediately, quarantined, labelled Defective Do
Not Use and handed over to Clinical Engineering Department for further investigation.
Whenever practicable the device controls and settings should remain in the same position
as when the incident occurred and all relevant information must be documented.

If the medical device does not fall under the remit of Clinical Engineering (i.e. a single use
device) then the incident still needs to be reported via the incident reporting process.

Reporting a medical device defect or incident to the MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) is the executive
agency of the Department of Health charged with protecting and promoting public
health and patient safety by ensuring that medicines, healthcare products and medical
equipment meet appropriate standards of safety, quality, performance and effectiveness,
and that they are used safely. One way they aim to achieve this is by investigating reports
of adverse incidents involving medical devices and, where appropriate, instigating
corrective actions to reduce the risk of recurrence.
Definition

An adverse incident is an event that causes, or has the potential to cause, unexpected or
unwanted effects involving the safety of device users (including patients) or other persons.

Example of a medical device: this list is not exhaustive
Anesthetic equipment
Blood warming cabinets
Blood gas analysers
Blood glucose meters
Catheters (e.g. urinary, cardiac)
Dental equipment and materials
Dressings
Endoscopes
Examination gloves
Hospital beds
Hoists and slings
Implants powered (e.g. implantable defibrillators, pacemakers) and non-powered
(e.g. heart valves, orthopaedic implants, bone cements)
Incontinence products
IV administration sets and pumps
Ophthalmic equipment
Patient monitoring equipment (e.g. cardiac monitors)
RATIFIED BY: BISE

Pathology analysers/equipment
Physiotherapy equipment
Resuscitators
Radiotherapy equipment (brachytherapy, external beam)
Sphygmomanometers
Slider boards and standing aids
Stretchers and trolleys
Surgical instruments and equipment
Syringes and needles
Thermometers
Urine drainage systems
Wheelchairs
X-ray systems, ultrasound imagers and CT/MR scanners

Examples of POCT medical devices: this list is not exhaustive
Blood Glucose meters
Bayer Clinitek and Status urine analysers
IL GEM Blood Gas analysers
Roche Coaguchek INR Meters
HemoCue total haemoglobin meters
Pfaff Bilimeter 3
Hettich Microcentrifuge
Siemens hCG pregnancy test kits
Bayer Urinalysis strips
i-Stat blood gas analyser
Sysmex Haematology analyser
Sure-Screen drugs of abuse screening kits
Lion intoximeter (breath alcohol)
Medisense Ketone meter
Bayer DCA 2000 and 3000 HbA1c analysers

Causes of adverse incidents involving devices may include:
design or manufacturing problems
inadequate servicing and maintenance
inappropriate local modifications
unsuitable storage and use conditions
selection of the incorrect device for the purpose
inappropriate management procedures
poor user instructions or training (which may result in incorrect user practice)

What needs to be reported to the MHRA
Any adverse incident involving a device or its instructions for use should be reported to
MHRA, especially if the incident has led to or, were it to occur again, could lead to:
death, life-threatening illness or injury
deterioration in health or permanent impairment of body structure or function
the necessity for medical or surgical intervention (including implant revision)
hospitalisation or prolongation of existing hospitalisation
RATIFIED BY: BISE

unreliable test results and associated risk of mis-diagnosis or inappropriate
treatment
fetal distress, fetal death, congenital abnormality or birth defect
ongoing faults that successive service/maintenance visits have failed to rectify
no diagnosis for the patient that is due to medical device failure that results or could
result in serious harm to the patient.

What do I do with devices that have been involved in incidents?

Medical devices that have been involved in an incident should be quarantined.

Until the MHRA has been given the opportunity to carry out an investigation, they should
not be:
Discarded
Repaired
Returned to the manufacturer

They should be:
Clearly identified and labelled
Stored securely

How reporting should be carried out?

If the device falls under the remit of Clinical Engineering then they should be contacted to
ensure that the proper details are included and that any urgent action needed within the
Trust can be taken in a timely fashion. The Clinical Engineering Manager is then
responsible for reporting the incident to the MHRA. Any such reports will be copied to the
Divisional Risk Lead and Clinical Governance & Risk Management Department where a
central record will be kept.

If a device incident needs to be reported to the MHRA, but the equipment/device involved
is not part of the Clinical Engineering remit, the user needs to report this directly to the
divisional risk lead who will review the incident with the clinical governance and risk
department and report it to the MHRA.

If it were an incident involving any of the Radiology kit it would need to be reported directly
to the MHRA and manufacturer. The Radiology Manager must also be informed.

Forms for reporting medical device incidents can be found at
http://www.mhra.gov.uk/Safetyinformation/Reportingsafetyproblems/Devices/index.htm

Whilst the MHRA would like the initial report of an incident to contain as much relevant
detail as possible, submission should not be unnecessarily delayed. However, it is
important that names and contact details of persons who may be contacted for further
information should be included on the form.

Serious cases must be reported to MHRA by the fastest means available.

RATIFIED BY: BISE

Dealing with the manufacturer

The manufacturer or supplier should be informed promptly of incidents and, if
accompanied by an appropriate person, may be allowed to inspect the items. To facilitate
an investigation, it may be possible to provide the manufacturer with a sample of unused
stock from a large batch. However, until advised to the contrary by the MHRA, the
manufacturer must not be allowed to exchange, interfere with, or remove any part of the
product implicated in the incident as this might prejudice our investigations, or those of
other official bodies.
RATIFIED BY: BISE

Appendix 7 7 Day Report Template

This report should be completed using the principles of Root Cause Analysis for all Significant
Incidents and Serious Incidents by the investigator nominated by the by Head of Nursing,
Divisional Manager or Clinical Director.

This template aims to give the investigation a structure to identify the true cause(s) of the incident
and the actions necessary to eliminate it. The report will seek to identify the contributory factors
leading to the incident and the immediate actions necessary to reduce the likelihood of the incident
recurring.

All sections of the report should be completed in full. All abbreviations must be given in full on first
reference.

The NPSA RCA toolkit is available here:
http://www.nrls.npsa.nhs.uk/resources/collections/root-cause-analysis/?locale=en

1. Incident Reported By:
Division:
Speciality:
Site:
Datix
Reference:

2. Incident Overview:
Date of
Incident:
DD - MM - YYYY Time of Incident: -- : -- (24 hour)
Brief outline of
the nature of
incident:

(Further detail
will be included
in the
Chronology)

Is this incident subject to external investigation by the Police/other organisation? YES/NO

3. Patient Profile:
Name: NHS no.:
Date of Birth: DD - MM - YYYY Sex: Male/Female
Relevant history:
Primary
Diagnosis:

RATIFIED BY: BISE

3. Patient Profile:
Reason for
accessing
service /
treatment:

Name of
Consultant:

Degree of harm
sustained by
individual
adversely
affected:
No Harm / Low Harm / Moderate Harm / Severe Harm / Death
(Delete as appropriate)

4. Chronology of Incident
Give a succinct account of the events leading to the incident and immediate action taken following
the incident by date and time.
Date Time Event
dd-mm-yy -- : --
dd-mm-yy -- : --
dd-mm-yy -- : --
dd-mm-yy -- : --
dd-mm-yy -- : --
dd-mm-yy -- : --
dd-mm-yy -- : --
dd-mm-yy -- : --
dd-mm-yy -- : --
dd-mm-yy -- : --
dd-mm-yy -- : --
dd-mm-yy -- : --
dd-mm-yy -- : --
dd-mm-yy -- : --
dd-mm-yy -- : --
dd-mm-yy -- : --
dd-mm-yy -- : --
dd-mm-yy -- : --
dd-mm-yy -- : --
dd-mm-yy -- : --
dd-mm-yy -- : --
dd-mm-yy -- : --
dd-mm-yy -- : --
dd-mm-yy -- : --

RATIFIED BY: BISE

5. Initial Analysis of Contributory Factors
Consider factors such as:
P Pa at ti ie en nt t f fa ac ct to or rs s
I In nd di iv vi id du ua al l f fa ac ct to or rs s
T Ta as sk k f fa ac ct to or rs s
C Co om mm mu un ni ic ca at ti io on ns s f fa ac ct to or rs s
T Te ea am m a an nd d s so oc ci ia al l f fa ac ct to or rs s
E Ed du uc ca at ti io on n a an nd d t tr ra ai in ni in ng g f fa ac ct to or rs s
W Wo or rk ki in ng g c co on nd di it ti io on ns s f fa ac ct to or rs s
O Or rg ga an ni is sa at ti io on na al l a an nd d m ma an na ag ge em me en nt t f fa ac ct to or rs s
Consider in your analysis:
Was there a failure to adhere to/apply any Trust policies
Was the risk assessment and management of the individual involved in the
incident appropriate and robust? When was the last review or assessment had
frequent reviews been undertaken?
Were adequate treatment and equipment arrangements in place?
Was there adequate communication between the patient, their carers and the
Trust, health professionals and external agencies (if applicable)?
How compliant was the service user with their treatment plan?

RATIFIED BY: BISE

6. Good Practice
Highlight any areas of good practice.

7. Findings/Recommendations

8. Lesson Learned

RATIFIED BY: BISE

9. Further Actions Taken/To Be Taken
Has the immediate risk been assessed for impact and likelihood of recurrence? YES/NO
If Yes, what measures if any have been put in place/will be put in place to minimise the risk of
reoccurrence? These should clearly link to any gaps identified during analysis of contributory
factors and recommendations.
Action To Be Taken
Designation of
Responsible
Officer
Completion
Deadline
Date
completed
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
Which group will oversee the implementation of
this action plan?

RATIFIED BY: BISE

9. Being Open
Detail communication with the patient or family/carer. What has been explained to them about the
cause of the incident?

10. Supporting Staff
Detail the support offered to staff involved in the incident? Was there a debrief, or a referral made
or was the staff member signposted to Employee Assistance Programme?

11. Investigating Officer:
Name:
Designation:
Date:

12. Approval at Divisional Level:
Name:
Designation:
Date:

RETURN YOUR COMPLETED REPORT TO:
Wherts-tr.sui@nhs.net
RATIFIED BY: BISE

Appendix 8 Guidelines for Staff: Statement Writing

1. Before providing a written statement, particularly if it relates to an incident,
complaint or claim that occurred some time ago, make sure that you have
access to all relevant records.

2. Give brief biographical details at the beginning of the statement:

Full name and professional address
Post held and grade
Qualifications (years experience in the relevant profession)

3. Confirm the date, time and location of the incident.

4. The report must be as accurate as possible and above all, factual.

5. Describe exactly what was done (or not done) in relation to the incident in as
much detail as possible and include timings, if available.

6. Explain the reasons for what was done (or not done).

7. Detail the events in chronological order, giving dates and times where
possible.

8. Do not include any of the following in the written statement:

Hearsay (someone elses views or version of events although it is acceptable
to include what you were told directly by someone else)
Speculation or hypothesis
Views on causes
Opinions on quality of work provided by other staff
Derogatory comments about what happened

9. Avoid jargon and clichs. It is acceptable to use technical words, but you
should try to explain these in lay terms wherever possible.

10. Abbreviations should only be used if the full terminology is given the first time
the phrase is used followed by the conventional abbreviation in brackets.

11. Statements should be legible, preferably typed and carefully checked before
being signed.

12. Sign and date the statement at the foot of each numbered page.

13. Remember to keep a copy for your own records.
RATIFIED BY: BISE

Appendix 9 Human Tissue Authority Serious Incident Notification Form

Serious Untoward Incident (SUI) notification form

A guidance document for completing this form is available on the HTA website

http://www.hta.gov.uk/licensingandinspections/reportingtothehta/seriousu
ntowardincidentreporting.cfm

SECTION 1: YOUR DETAILS

Title:

First name:

Last
name:

Your contact details: Telephone number(s): Email address:

Address:

What is your role at the
establishment?

Designated Individual Person Designated

Other, please specify:

If you are not the Designated
Individual (DI), has the DI
been informed of the SUI?
Yes No

SECTION 2: ESTABLISHMENT DETAILS

HTA licence number:

12082
RATIFIED BY: BISE

Full name of establishment:

SECTION 3: SUI DETAILS

Date SUI occurred
(DD/MM/YYYY)

Details of the person who
reported the SUI to you:
(Name and job title)

Has the family been made aware?

Yes No N/A
Where did the SUI occur?

Description of relevant material
involved (where appropriate), e.g.
body, brain, tissue block

SUI CLASSIFICATION* Indicate all that are relevant:

Discovery of an organ or tissue following post-mortem examination and release of
body
Loss of an organ
Disposal or retention of an organ against the express wishes of the family
Disposal or retention of a whole fetus or fetal tissue (gestational age greater than
24 weeks) against the express wishes of the family
Post-mortem examination of the wrong body
Post-mortem examination conducted was not inline with the consent given or the
Post-mortem examination proceeded with inadequate consent
Removal of tissue from a body without authorisation or consent
Release of the wrong body
Major equipment failure
Serious security breach
Incident leading to the temporary unplanned closure of a mortuary resulting in an
RATIFIED BY: BISE

inability to deliver services
Any incident that could result in adverse publicity that may lead to damage in public
confidence
Discovery of an additional organ(s) in a body on evisceration for a second post-
mortem examination
Accidental damage to a body before or after post-mortem examination

* Refer to the HTA guidance document for further information on SUI
classification.

SECTION 4: FURTHER DETAILS

To whom has the SUI been reported?
e.g. Trust or County Council,
professional body, Strategic Health
Authority

Has an internal investigation been
initiated?

Yes No *

If yes, what is the anticipated conclusion date?

What is the internal reference for the
SUI?
e.g. incident number

Description of SUI

RATIFIED BY: BISE

* If there is no formal internal investigation, provide details on the reason for this

Preliminary information/findings on why the SUI occurred

Actions taken in immediate response to the SUI

RATIFIED BY: BISE

Completed Serious Untoward Incident notification forms should be submitted to:

Email: pm.incident.report@hta.gov.uk

Fax: 020 7211 3430, attention Miss Stacey Last, Regulation Officer

Next steps:

You will receive email confirmation that the SUI notification has been
received

A Regulation Manager will be assigned to review the SUI and will contact
the DI. In the DIs absence, the Regulation Manager may contact the
Licence Holder / Corporate Licence Holder named contact and / or the
individual who submitted the notification

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INCIDENT REPORTING AND INVESTIGATION POLICY VERSION 9.

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