Вы находитесь на странице: 1из 64

Incident, Complaints and Claims

Reporting and Investigation Policy








This document is uncontrolled once printed.
Please check on the Trusts Intranet site for the most up to date version.



North West London Hospitals NHS Trust





Incident, Complaints and Claims
Reporting and Investigation Policy
(Includes Serious Incidents Reporting requirements)



Version 2
Ratified by Patient Safety and Quality Committee.
Date ratified March 2013
Name of Author Catherine Thorne, Director of Governance
Name of Ratifying Committee Patient Safety and Quality Committee
Date issued May 2013
Review Date May 2015
Target Audience All Trust Staff
Equality impact outcome Low
Associated documents Risk management strategy guidance and policy
Complaints policy
Claims policy
Supporting staff policy
Being open policy
Whistleblowing policy
Please note use the Interim Guidelines for
managing incidents in the NHS Bowel Screening
Programme, available on the Intranet.
Incident, Complaints and Claims
Reporting and Investigation Policy

2

Version Control


Version number Issue date Revision from previous issue
1 As per document date This is a new policy. It replaces the
Incident Reporting and SUI policy and it
incorporates the investigations aspect
from the Incident and Complaints
policy.
2 Provide guidance on management of
incidents relating to NHS Bowel
Screening Programme,


Incident, Complaints and Claims
Reporting and Investigation Policy

3

TABLE OF CONTENTS
Section Page

1. Introduction 5

2. Purpose 6

3. Scope of Policy 6

4. Definitions 6

5. Key Responsibilities and Duties 8

6. Policy Statements 13
6.1 General statement on the Incident, Complaints and
Claims Reporting and Investigation Policy
6.2 Statement on culture of openness
6.3 Statement on Fair Blame
6.4 Principles of effective communication, data protection &
Caldicott Principles

7. Policy Development and Consultation 15

8. Policy Implementation 15

9. Policy Monitoring, Review and Archiving 15

10. Specific Incidents, Complaints and Claims 16
10.1 Incidents, complaints and claims relating to
Safeguarding Children
10.2 Incidents, complaints and claims relating to a
Vulnerable Adult

11. Incidents, Complaints and Claims- Reporting and Immediate Action 17
11.1 Claims
11.2 Incidents and complaints
11.3 Being Open
11.4 Supporting staff involved in any incident, complaint or claim
11.5 Incidents involving more than one provider organisation
11.6 Process for involving and communicating with
external/internal stakeholders and of sharing lessons learnt

12. Incident, complaints and Claims grade and score 19




Incident, Complaints and Claims
Reporting and Investigation Policy

4

13. Actions to take following grading of an incident - (Reporting 20
and Lines of communication)
13.1 RED HIGH RISK - grade 5 or SUI
13.2 AMBER MODERATE RISKS Grade 4
13.3 YELLOW / GREEN LOW RISK - Grade 1-3 Incidents

14. Investigating Incidents, complaints and claims 22
14.1 Investigation procedures and general guidance
14.2 Meeting with staff, patients and relatives directly involved
in the incident or complaint

15 Investigating Serious Complaints 26

16 Investigating Serious Claims 26

17 Memorandum of Understanding 26

18. Learning lessons and making improvements as a 27
result of investigating incidents, complaints and claims

19. Recommendations and Monitoring of Action Plans 27

20. Feed back of Incident, Complaint or Claim Investigation Outcomes 28

21. Staff Training and Assistance with Incident, complaint 28
and claim investigation

22. Reporting to External Agencies. 28

23. References 29

24. Bibliography 30

25. List of Associated Policies 30
Appendices
1 Guide to incident form completion (DIF1) and managerial review (DIF2) 31
(Datix web reporting)
2 Reporting to External Agencies 37
3 Establishing and Running a Hotline 44
4 Log sheet for hotline calls 42
5 Standards for SUI Panel and Serious Complaints investigation 45
6 SUI Report Template 45
7 Witness Statements Guidance 63
8 Guidance for Staff writing a Statement 65
9 KEY AREAS OF ORGANISATIONAL RISK AND KEY CONTACTS 66
Incident, Complaints and Claims
Reporting and Investigation Policy

5

1. INTRODUCTION

This policy covers both clinical and non clinical incidents, complaints and claims. This
policy is best read in conjunction with the Trusts Risk Management Strategy, Policy and
Guidance document and NHS Londons SUI Reporting Policy available at
http://www.london.nhs.uk/webfiles/Corporate/Serious%20incidents/NHSL%20Serious%
20Incident%20Policy%20November%202010.pdf

When investigating a particular incident, the relevant Trust policy must also be
consulted, for example, Safeguarding Adults and Safeguarding Children Policies,
Complaints Policy and Procedure, Claims Handling Policy, Slips Trips and Falls
Policies, Medicines Management Policy, Incident Complaints and Claims: Analysis,
Learning Lessons and Improvements Policy, Supporting Staff Policy and Being Open
Policy.
Please note use the Interim Guidelines for managing incidents in the NHS Bowel
Screening Programme, available on the Intranet-

The Trusts risk management system is based on a proactive, fair blame approach
aimed at identifying things which can go wrong as part of a systematic approach to
incident management. This approach is in line with: An Organisation with a Memory
DH, 2000; Care Quality Commission requirements, National Health Service Litigation
Authority Risk Management Standards April 2010/11and the Management of Health and
Safety at Work Regulation 1999.

The Trust aims to establish the causes of incidents, complaints and claims, understand
these and make sure lessons are learnt and suitable improvements are made to
minimise any further recurrence.

This policy also outlines the arrangements for reporting Serious Untoward incidents
(SUIs) to NHS London and the commissioning Primary Care Trust for the purpose of
performance monitoring.

Serious untoward incidents relating to information governance are managed in line with
this policy and with consideration of Department of Health guidance and Checklist for
reporting, managing and investigating information governance serious untoward
incidents (Jan 2010) available on the Trust intranet.

The policy has drawn from the guidance produced by the NHSLA Risk Management
Standards and the National Patient Safety Agency; it includes Root Cause Analysis
guidance from the protocol used by the Association of Litigation & Risk Managers
(ALARM), which was developed by the University College London.
The policy also includes information on the requirements arising from the Health and
Social Care Act 2008 which means that organisations are required to notify the Care
Quality Commission (CQC) about events that indicate or may indicate risks to ongoing
compliance with the CQC registration requirements or that lead or may lead to changes
in the details about the organisation in the Commissions register.
Incident, Complaints and Claims
Reporting and Investigation Policy

6


2. Purpose
The policy aims to: -
Minimise human, organisational and financial impacts of incidents, complaints
and claims through effective management.
Ensure that, where appropriate, lessons are learnt to reduce risk and improve
patient care.
Identify practices, systems or equipment that is not contributing to the highest
standard of patient care and to correct them.
Maintain public confidence in the Trusts services.
Prevent any recurrence, by identifying the root causes in incidents complaints
and claims and minimise the risks from legal claims which divert funds and staff
away from patient care.
Provide information to the relevant managers for action or further investigation
and to enable local records to be kept for inspection and periodic review.
Enable the compilation of statistics for monitoring risk management performance.
Provide an archive of the essential facts for possible use by the Trusts legal
advisors/insurers.
Ensure compliance with all mandatory reporting schemes.

3. Scope of the Policy
This policy applies to all employees of North West London Hospitals NHS Trust. The
procedures for incident, complaint and claims reporting and investigation also apply to
other workers in the Trust who may be from another organisation working in the Trust
under a service level agreement. This includes all employees, bank, locum or agency
staff, contractors and volunteers.
The incident, complaints and claims reporting and investigation procedures apply to all
incidents/events occurring on Trust premises or connected with Trust activities.

4. Definitions
Adverse
event/incident

An adverse incident is an event which causes or has the potential to
cause unexpected or unwanted effects involving the safety of the patients,
users or other persons.
Hazard Something which has potential to cause harm e.g. substance, equipment,
method of work, other aspects of work
Accident An unexpected event that causes injury/damage
Serious d
Incident (S.I )
Something out of the ordinary or unexpected, with the potential to cause
serious harm and/or likely to attract public or media interest that occurs on
NHS premises or in the provision of NHS Commissioned services.
Harm Is defined as injury, (physical or psychological) disease, suffering or
death.
Injury Any wrong or damage done to a person, their rights, reputation or goods.
Patient Safety
Incident
Any unintended or unexpected incident(s) that could have or did lead to
harm for one or more patients receiving NHS funded healthcare.
Patient safety
event
Generic term applied to complaints claims and incidents
Incident, Complaints and Claims
Reporting and Investigation Policy

7

Non-clinical
Incident
events or omissions that cause a physical or psychological injury to any
person on Trust premises, such as verbal and/or physical abuse, theft,
sharps injuries, slips, trips etc
Near miss
applies to all of
above categories
A near miss is a situation in which an event or omission, or a sequence of
events or omissions, arising during clinical care fails to develop further,
whether or not as a result of compensating action, thus preventing injury.
Investigation Detailed systematic search to uncover facts and determine the truth of the
factors (who, what, when, where, why and how) of incidents.
Claim Allegations of negligence and/or demand for compensation made
following an untoward incident resulting in personal injury (to a member of
staff, a patient or a member of the public) or damage to property.
Complaint This is any expression of dissatisfaction, which requires a response. All
complaints whether oral or written, must receive a positive and full
response, with the aim of satisfying the complainant that his/her concerns
have been heeded, and offering an apology and explanation as
appropriate, referring to any remedial action that is to follow.
Root Cause
Analysis
A process for identifying the basic or causal factor(s) that underlies
variation in performance, including the occurrence or possible occurrence
of a sentinel event.
External Body /
Agency
An organisation that has an official advisory or regulatory role that has
been mandated to regulate the corporate and professional activities of
NHS Trusts.
Information
Governance SI
Any incident involving the actual or potential loss of personal information
that could lead to identity fraud or have other significant impact on
individuals must be considered as serious
(Dept of Health 20th Feb 2008 Gateway 9571)
RIDDOR Reporting of Injuries, Diseases and Dangerous Occurrences Regulations
1995 (RIDDOR), place a legal duty on employers to report
incidents/accidents
Never Events Never events are defined as serious, largely preventable patient safety
incidents that should not occur if the available preventative measures
have been implemented by healthcare providers.
To be a never event, an incident must fulfill the following criteria;
The incident has clear potential for or has caused severe
harm/death.
There is evidence of occurrence in the past (i.e. it is a known source
of risk).
There is existing national guidance and/or national safety
recommendations on how the event can be prevented and support for
implementation.
The event is largely preventable if the guidance is implemented.
Occurrence can be easily defined, identified and continually
measured
Further guidance on Never Events can be found by accessing
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsP
olicyAndGuidance/DH_124552

Incident, Complaints and Claims
Reporting and Investigation Policy

8

5. Key Responsibilities and Duties

Chief Executive Officer

The Chief Executive is accountable and responsible to the Board for ensuring that
resources, policies and procedures are in place to ensure the effective reporting,
recording, investigation and treatment of incidents, complaints and claims and that there
are suitable and sufficient arrangements for the support of those staff involved in any of
these events. In practice the Chief Executive may delegate the day-to-day responsibility
for this duty to Executive Directors and Heads of Departments.

Trust Board

The Trust Board collectively is responsible for ensuring the proper reporting, recording,
investigation and management of all incidents, complaints and claims.
The Trust Board delegates responsibility for receiving, assessing and acting upon
incidents, claims and complaints to two key committees, firstly the Patient Safety and
Quality Committee which in turn reports to the Governance Compliance and Risk
Committee, a formal subcommittee of the Trust Board.

Medical Director

The Chief Executive has nominated the Medical Director as the Executive Lead
responsible for Patient Safety and Clinical Risk. The Medical Director shares responsibility
for declaring SUIs with the Chief Executive Officer.

Director of Governance

The Director of Governance is responsible for ensuring the functioning and management
of corporate systems detailed within this policy related to incidents and claims and in the
support of identifying, recording, reporting to management, investigating and learning from
both. The Chief Executive has also nominated the Director of Governance as the
Executive responsible for Non-Clinical Risk Management (Health and Safety).
The Director of Governance is the designated Executive Director with responsibility for the
operational management of risk systems and is responsible for reporting and follow up of
serious incidents with the appropriate body within the appropriate timescales. They are
also responsible for ensuring that relevant staff are informed of incidents, including, as
appropriate, the Chief Executive and other members of the Executive team.

Director of Nursing

The Director of Nursing is responsible for corporate complaints management and the
operational delivery of the complaints system.
Incident, Complaints and Claims
Reporting and Investigation Policy

9


Executive Directors
All Executive Directors through their Managers ensure all staff within their sphere of
responsibility is aware of the policy and it is implemented effectively. Executive Directors
are responsible for ensuring that systems are in place to monitor incidents, complaints and
claims within Directorates and that they investigated according to Trust policy. Executive
Directors are also responsible for facilitating the learning of lessons from incidents,
complaints and claims ensuring that these are discussed at Divisional meetings. They
have a responsibility to ensure any lessons learnt from investigations, which involve
system errors, that may affect other areas are made known to other relevant Divisions to
prevent reoccurrence and to facilitate the review of these systems and policies with
operational managers. Executive Directors must ensure any formal complaints usually (but
not necessarily) written, are notified as per Trust policy

Divisional General Managers
It is the responsibility of the Divisional General Managers (DGMs) to ensure the
Directorate structure supports the systems for identifying, recording, reporting to
management, appropriately investigating and learning from incidents. They are
responsible and accountable for:
Enabling and ensuring staff attend Trust training in relation to the management of
patient safety events.
Ensuring that within their areas of responsibility this policy is followed and all
incidents and complaints are reported (Appendix 1) graded, investigated and
actions taken, to the level commensurate with the risk grading outlined in this policy
and that the investigation is documented.
Escalate incidents as detailed in this policy.
Ensuring that the impact of a patient safety event across the Trust is brought to the
attention of other Directorate and Senior Managers.
Ensuring that lessons learnt following the investigation of an incident, complaint or
claim, which may apply to areas outside of their remit are brought to the attention of
other Directorate and Senior Managers.
Ensuring patients and relatives are informed when patient safety events occur in
accordance with the Being Open policy. Where appropriate patient and relatives are
informed of the Trusts policy for investigating incidents complaints and claims.
Inviting discussion as appropriate to facilitate a positive outcome.
Ensuring that the Complaints policy is followed and facilitate the investigation of
complaints
Ensuring that modification to local policy and procedure are undertaken following
the results of incident, complaints and claims investigation. That these are brought
to the attention of their staff and any information, instruction or training required is
given.
Ensuring that risk assessments and the departmental risk registers are reviewed
regularly.
Provide information to the Medico - Legal Services Department in order to enable
the investigation of claims and apply any recommendations within their areas
following identification of lessons learnt as described in the Claims Policy
Incident, Complaints and Claims
Reporting and Investigation Policy

10


Line Managers

It is the responsibility of line managers to ensure that: -

Staff attend training as described in the Statutory and Mandatory training
Staff working in their area are aware of the incident reporting procedure, cooperate
in the investigation and know how to report an incident via Datix web (Appendix 1)
reporting or, where not available via an incident recording book.
Staff are guided through the incident reporting process and also guided, where
required, to provide information in relation to complaints and claims.
Staff are suitably supported following an incident, complaint or claim referring to
other support services as required e.g. Occupational Health, counselling services
Any incidents, complaints or claims which come to their attention which are graded
higher than low are reported to the appropriate Senior Manager.
Any formal complaints / concerns usually (but not necessarily) written, are reported
as per the Trust Complaints policy
The patient's clinician has informed the patient or relatives, of the incident, complaint
or claim in line with the Being Open Policy; this must be done before any media are
informed.
Appropriate liaison with the Governance (Risk and Medico legal services) and/or
Patient Relations Department takes place to identify which stakeholders need to be
informed of the incident/event and ensure they are informed.
All relevant documentation is gathered, completed and securely stored including
statements
Any equipment or scene of incident is appropriately quarantined

Governance Department

The nominated Risk Officers for Clinical Risk and Non Clinical risk are responsible and
accountable for:-

Facilitating the effective application of the incident reporting policy and associated
policies and procedures, supporting staff and managers alike.
Reviewing both non-clinical and clinical incident web reports and incident forms
received, in order to obtain an overview of the action taken.
Ensuring appropriate escalation through the Director of Governance or nominated
deputy to Medical Director or CEO of any red (high) graded incidents
Monitor the open incidents on the Datix web system until evidence of investigation
and action submitted online
Ensuring where necessary that statutory bodies have been notified within the
appropriate timescales.
The transfer of data to external databases as appropriate e.g. NPSA, MHRA
Analysing incidents and producing relevant reports to encourage and monitor
appropriate actions are taken to reduce the risk of a recurrent incident.
Incident, Complaints and Claims
Reporting and Investigation Policy

11

Liaising with the Patient Relations Department and the Legal Services Officer to
inform them of any potential claims and complaints arising from incident report forms
Identification and delivery of corporate training needs, developing training criteria
and training programmes and delivery of Risk Management, Health and Safety and
incident reporting training programmes to identified staff
Notification of the Health and Safety Executive, of any RIDDOR reportable incidents
(See Appendix 2)
Liaison with incident reporters regarding appropriate grading of an incident.
Production of regular and ad hoc reports as requested on incidents and action plans
where appropriate to the Divisional Governance meetings, The Patient Safety and
Quality Committee and the Governance, Compliance and Risk Committee

Head Of Patient Safety
Provides an operational link between the incident, complaints and claims management
systems and has management responsibility as lead officer for the Trusts Datix Risk
management system. They:-
Are responsible for day to day management of Clinical risk functions, liaising with
Medico legal and Patient Relations services as appropriate Ensures that systems
are in place to ensure action plans for incidents are submitted to and reviewed at the
by the Patient Safety and where appropriate the Governance Compliance and Risk
Committee or other suitable delegated Committee
Ensures that serious incidents are notified to the Director of Governance or
nominated deputy and that a panel of investigation is appointed in accordance with
this policy.
Ensures records of Serious incidents investigations are kept and updated
Ensure systems are in place and functioning to provide submission and collection of
incident data and to provide internal/external reports.


Head of Health Safety
Are responsible for day to day management of non - Clinical risk functions,
liaising with Medico legal services as appropriate. Ensures that systems are in
place to ensure action plans for incidents and claims are submitted to and
reviewed at the by the Health and Safety committee and where appropriate the
Governance Compliance and Risk Committee or other suitable delegated
Committee
Ensures that serious incidents are notified to the Director of Governance or
nominated deputy and that a panel of investigation is appointed in accordance
with this policy.
Ensures records of Serious incidents investigations are kept and updated
Ensure systems are in place and functioning to provide submission and collection
of incident data and to provide internal/external reports.





Incident, Complaints and Claims
Reporting and Investigation Policy

12

Complaints Department
Ensure that complaints are graded, recorded and investigations and responses are
carried out appropriately.
Provide regular update reports to the Patient Safety and Quality Committee and
Trust Board

Medico legal department
Claims are assessed and graded by the medico legal team who ensure appropriate
levels of investigation occur. They notify relevant external bodies where appropriate,
and, if applicable, monitor implementation of action plans.
Provide regular update reports to the Patient Safety and Quality Committee and
Trust Board


All Staff
There is a general requirement for employees:-
To take care of themselves whilst at work and not put patients or colleagues at risk
by any act or omission on their part.
To cooperate with their employer to enable their employer to comply with their
statutory duties.
To bring to the notice of their line manager any workplace health and safety risks ,
incidents
Work to resolve any concerns expressed by patients, their representatives, visitors
or other people concerned with the work of the Trust
Escalate to their managers and Pals, any concerns which cannot be resolved locally
or where the complainant indicates that they wish to make a complaint
Following an incident employees are specifically required to:-
where possible, make the situation safe for themselves and others bearing in mind
the retention of evidence and possible crime scene or scene of investigation
perform any treatment or first aid where competently trained to do so following an
incident
summon appropriate support where able following an incident
complete an incident report form including the grading section via Datix web
reporting (Appendix 1) or incident form within time-scales described in the main
procedure (this applies any member of staff who has knowledge of a particular
incident or event or who witnesses such an event.)
Provide a statement of events when requested by officers investigating an incident,
Complaint or claim


Governance, Compliance and Risk Committee
The Governance, Compliance and Risk Committee is the Trust Board sub-committee with
overall responsibility for risk management. The Committee meets six times a year with
the purpose of ensuring appropriate clinical, non-clinical and corporate governance,
compliance and risk management arrangements are in place.

Incident, Complaints and Claims
Reporting and Investigation Policy

13

The committee leads on ensuring implementation of both the Risk Management Strategy
and monitoring the risk management objectives and performance. It also reviews the risk
register at each meeting and the Trust receive an update on risk every month and a review
of the risk register quarterly.

Patient Safety & Quality Committee
The Patient Safety & Quality Committee is responsible for overseeing incidents, claims
and complaints activity and reports to the Governance, Compliance and risk committee. It
monitors themes and trends of incident reporting, claims and complaints (complaints now
quarterly) via a monthly Patient safety report. Action plans resulting from SUIs are
monitored for implementation via this committee. This committee is responsible for
approval of policy documents related to patient care.


Infection Control Committee
The Infection control committee are responsible for overseeing the incidents and
complaints related to infection control. The Committee reports to the Governance and
Compliance Risk Committee.


Healthcare Environment Committee
This committee oversees incidents related to health and safety issues and other and non
clinical issues within Trust. The committee reports to the Governance, Compliance and
Risk Committee.


Health and Safety Committee
The Health and Safety Committee has responsibility for the health, safety and welfare of
Trust staff and its users. It was convened under the Safety Committees and Safety
Representatives Regulations 1977, with members from recognised Trade Unions (safety
representatives) and Joint Staff representation. The committee reviews themes and trends
of non clinical incident reporting, RIDDOR reportable incidents and claims related to health
and safety claims. The committee is responsible for approval of health and safety related
policies.

6. Policy Statements

6.1 General statement on the Incident, Complaints and Claims Reporting and
Investigation Policy

North West London Hospitals NHS Trust considers incident and near miss reporting
investigation and analysis of incidents complaints and claims to be the foundation of an
effective risk management system. The systems in place for incident reporting and
incident complaints and claims investigation provide the Trust with tools by which to
identify problems implement changes and measure improvement. The Trust promotes
the development of a positive safety culture requires the creation of an open
Incident, Complaints and Claims
Reporting and Investigation Policy

14

environment in which healthcare professionals can feel safe and confident to report
adverse events and near misses.

6.2 Statement on culture of openness
The Trust encourages a culture of openness within the organisation through continuous
support and feedback to staff involved in incidents. The Trust realises that it is important
that staff understand that the purpose of reporting an incident is not to apportion
blame to any individual or group of people, but to identify problems and to remedy
them.

Without an open culture, the reporting of inappropriate care or the reporting of incidents
may not take place and it may be difficult to learn lessons thus preventing similar
situations.

In addition and in support of this policy the Trust has a Whistle blowing Policy which
provides an alternative avenue for staff to report inappropriate care if they do not feel
confident to report matters through the normal incident procedure.

6.3 Statement on Fair Blame
The Trust advocates a fundamental principle of Fair Blame. The Trust accepts that
many incidents, complaints and claims are caused by a combination of system failures
and seeks not to apportion individual blame without just reason. The Trust always seek
to improve its standards of risk management following any incident, complaint or claim
which on investigation concludes deficiencies in the provision of training, equipment,
guidelines, etc., or recommend changes in working practices.

If the circumstances surrounding an event are such that one or more members of staff
are to be the subject of a disciplinary investigation or hearing, this is conducted in
accordance with the Trusts established disciplinary procedures. The Trust advocates
use of the NPSA incident decision tree which is designed to guide managers and
ensure a fair and consistent approach with staff.

6.4 Principles of effective communication, data protection & Caldicott
Principles
Good communication is central to all aspects of incident, complaints and claims
reporting and investigation. In the majority of cases the Trust must comply with Caldicott
data protection and information governance requirements. When reporting serious
incidents individuals must not be referred to by name or give other identifiable
information and must restrict access to patient information by enforcing a strict need to
know basis for example the content of some reports must not contain the names of the
practitioner or the patients. Person identifiers must be documented separately.

However in the interests of public interest it may be necessary to identify an individual
for example in making a safeguarding alert. Whether communicating with staff or
patients and their families and carers, it is a fundamental part of the common core. It
involves listening, questioning, understanding and responding to what is being
communicated by the investigating staff.
Incident, Complaints and Claims
Reporting and Investigation Policy

15


It is important to be able to communicate both on a one-on-one basis and with other
team members and other members of the investigation team. Communication is not just
about the words used, but also your manner of speaking, body language and, above all,
effective listening. To communicate effectively it is important to take account of culture
and context, for example where English is an additional language.
Effective engagement of staff in the processes for reporting and investigation requires
consultation. A key part of effective communication and engagement is trust, between
those involved in the investigation.

Managers and those involved in the investigation process must remember that
information given to them in order to carry out the investigation is on a need to know
basis. Information must not be discussed with anyone outside of that individual incident
complaint or claim process and confidentiality should be maintained as far as is
possible. Information should only be passed on to managers where there could be an
adverse effect on patients or staff by failing to do so e.g. where the investigation
concludes that a member of staff had not had training, where a staff member has not
acted in accordance with that expected of their role.

7. Policy Development and Consultation

This policy was developed by the Director of Governance in conjunction with the
Governance and Patient Relations Department and key Trust risk committees.
It was circulated to members of the Patient Safety and Quality and Governance,
Compliance and risk committees for comments and appropriate amendments made
before ratification.

8. Policy Implementation

This policy is uploaded to the Trust Intranet. Staff are advised of any new policy version
by the Trusts Internal Communication system, In Brief. The policy is further
disseminated through discussion at Trust Induction and via incident reporting training
provided as outlined in the training needs analysis.

9. Policy Monitoring, Review and Archiving

Compliance with this policy will be monitored by the Patient Safety and Quality
Committee and reported up to the Governance, Compliance and Risk Committee via
the minutes and reporting template. This provides Board assurance. In addition the
Board receive a monthly review of SUI, RIDDOR and Security incidents and quarterly
report in respect to Complaints.

An Incident and Safety report is produced by the Director of Governance presented to
the Board monthly. This report monitors the requirements for SUI reports and
associated timescales. A similar report is produced quarterly by The Director of
Nursing for the monitoring of Complaints.

Incident, Complaints and Claims
Reporting and Investigation Policy

16

Incident final reports include information on
process for compiling report and investigating the incident
Involving and supporting staff, patients and others
Reporting to external agencies
Action plan

Complaints reports include
The number of complaints received in the quarter/ year and the Trust
performance in handling them
The number of complaints the Trust decided were upheld
The number of complaints referred to the Parliamentary and Health Service
Ombudsman
The report will also summarise:
The subject matter of complaints the Trust received
Actions taken to learn from complaints and to improve services as a
consequence of those complaints

Other monitoring mechanisms include,
Audit of the Datix and SUI process by the Internal Auditors as agreed by the
Audit Committee
The Trusts Executive Committee receive monthly information from the
incident, complaints (weekly Executive complaints summary is provided as
well as quarterly reports) and claims systems for analysis and review
Each Division will directly receive reports from Datix and is expected to
analyse and monitor these reports locally for Clinical Governance meetings
The Patient Safety and Quality Committee receive a monthly patient safety
report, produced by the Head of Patient Safety and Quality which includes
information related to patient safety events

Staff Training is monitored by the Education and Training Department in accordance
with the Trust Policy for Induction and Statutory and Mandatory Training.

The policy is to be reviewed in 2013; at each review all relevant comments from key risk
management committees are incorporated. Amendments are undertaken by the
Director of Governance. If monitoring indicates mechanisms outlined in the policy are
not being complied with or are failing to address issues, the policy may be reviewed
earlier.

The policy may also be reviewed as a result of recommendations from approved bodies
or the introduction of new legislation. Revised versions of the policy will be uploaded to
the Trust intranet following ratification and an archived copy kept in line with Trust
Policy.


The policy may also be reviewed as a result of recommendations from approved bodies
or the introduction of new legislation. Revised versions of the policy will be uploaded to
Incident, Complaints and Claims
Reporting and Investigation Policy

17

the Trust intranet following ratification and an archived copy kept in line with Trust
Policy.

10. Specific Incidents, complaints and claims

10.1 Incidents, complaints and claims relating to Safeguarding Children
Any incident, complaint or claim which specifically relates to a child protection concern
is also sent to the Named Doctor and/or Nurse for Child Protection and the Executive
Lead for Safeguarding Children.

10.2 Incidents, complaints and claims relating to an Adult at risk
Any incident or complaint which relates to the possible abuse of an adult at risk should
be sent to a Trust designated and responsible for safeguarding adults at risk
(Responsible) Manager who will assess the incident or complaint and decide whether
the Adult at Risk Policy needs to be invoked.
10.3 National Cancer Screening programme incidents
Any significant / major failures (e.g. fire, flood, effects to service greater than two days,
significant pathway deviations and or sustained loss of service) in the screening
services should be reported to the Director of Governance who will then inform the QA
Director for the specific programme at the SHA. Risk categories are defined by specific
programmes and include minor, intermediate, major and fatal. The Director of
Governance and the programme lead, for the trust, will then initiate the relevant
screening programme management of incident guidelines, referenced in Appendix 2.If
unsure regarding categorisation and requirement to inform the Director of Governance,
please contact either the Director or the Patient Safety Department for clarification.
Refer to appendix 9 Decontamination Incident management flowchart and key
screening Trust contact list.

Appendix 8 lists key areas of the organisation and the contact person for information or
advice with an incident or identified risk.

11. Incidents, complaints and claims Reporting and Immediate action
11.1 Claims
The immediate action on receipt of a claim differs from that required for a complaint or
incident in that it is often sometime since the original event. The Medico Legal Services
undertakes an initial review of the facts to determine the level of risk (as shown in
section 12) and establish if there may be any residual risk. This is followed by gathering
of information, statements for investigation.

11.2 Incidents and complaints
Following an incident or complaint the immediate needs of the patient, member of staff
or visitor must be attended to and remedial action must be taken to re-establish a safe
environment.

An incident form must be completed via Datix web by the person involved immediately
following any incident. The Datix system allows for designation of an incident handler,
this is usually the Departmental Manager, Matron, lead Consultant or General Manager
Incident, Complaints and Claims
Reporting and Investigation Policy

18

will ensure all immediate action required has been undertaken and is documented. Any
incidents categorised as High Risk (Red) (grade 5 / SUI) must be verified by the Line
Manager or the person in charge immediately following the incident. The line manager
must reassess the grade and where the incident grade remains high notify the
Governance department as soon as possible. Where the incident is out of hours see
section 13. A panel investigation will be undertaken for all SUI incidents.

Any complaints received which are considered to be high risk as defined by the Trusts
Risk matrix are notified to the Director of Nursing and Medical Director by the Patient
Relations Manager.

Where possible all evidence must be retained intact (subject to infection control
procedures) and in safe keeping for examination and any defective equipment, drugs or
other materials withdrawn from use.

The incident or complaint must be communicated to the relevant clinician or manager
who will undertake an investigation as described in section 14. An incident Datix web
report form must be completed for incidents as appropriate. Where the event was a staff
accident and there were witnesses present witness statements must be obtained.
Witness statements must also be obtained where applicable for all moderate and red
graded events. Witness statements must be obtained at the earliest opportunity.



11.3 Being Open
The Being Open Policy must be followed for any incident, complaint or claim.
Where the Being Open Policy indicates, the patient's clinician or the clinician's
delegated representative must inform the patient or next of kin and fully document this
in the relevant record.
The media must not be informed without the patient or next of kin first being informed of
any incident.

11.4 Supporting staff involved in any incident, complaint or claim
All staff are supported as appropriate by their line manager
Staff involved in a traumatic or stressful incident (usually grade 5 or SUI) are supported
by the line manager involved following the Supporting Staff Policy.

11.5 Incidents involving more than one provider organisation
If more than one organisation is involved in a serious incident the organisation that
identified the incident may make the initial notification to the PCT and other external
agencies.

Wherever possible this organisation must first make contact with the organisation where
the incident originated. The lead organisation must be identified at this point with the
others involved and clear roles and responsibilities agreed. Once the lead has been
agreed STEIS or local serious incident management systems need to be updated /
closed.
Incident, Complaints and Claims
Reporting and Investigation Policy

19





11.6 Process for involving and communicating with external/internal
Stakeholders and of sharing lessons learnt
As appropriate, information should also be communicated to external stakeholders in
order to ensure appropriate involvement in the investigation and to share lessons learnt
from incidents, complaints and claims. e.g. Primary Care Trust (PCT), Strategic Health
Authority (SHA), MHRA, National Patient Safety Agency (NPSA), and Health & Safety
Executive (HSE).

The GP will be notified by the relevant Department as appropriate.
Incidents & Claims - The Director of Governance or nominated Deputy is responsible for
ensuring the appropriate responses to external stakeholders this may be verbal
information but it is advisable to follow up with written clarification. For guidance on
external agencies see Appendix 2.

Complaints- the Patient Relations Manager is responsible for ensuring processes for
complaints as described in the Complaints policy.

Some information relating to incident and external stakeholders may be provided
electronically via agreed data submission.

12. Incident, complaint or claim grade and score

Not all patient safety events need to be investigated to the same extent or depth.
Categorising incidents, complaints and claims according to the actual impact and the
potential future risk to patients/ visitors/ staff and the organisation establishes the level of
local investigation and causal analysis that should be carried out.

Incidents
Ward/Departmental Managers/Supervisors are responsible for grading the incident, within
24hrs of the incident occurring, using the incident categorisation matrix below.

Complaints
The Patient Relations team will register complaints on DATIX and carry out an initial risk
grading .This will inform the investigation process including the level of investigation which
is initiated. If, following investigation, a complaint is more, or less, serious than initially
perceived, the risk grading can be altered. If the complaint raises issues that the Patient
Relations team are unable to risk grade, the complaint will be escalated to the divisional
lead.

Claims
Claims are categorised by the medico legal team using the matrix below. Categorisation of
claims usually informs the financial and safety risk to the organisation.

Incident, Complaints and Claims
Reporting and Investigation Policy

20

To categorise the patient safety event first, select the Most Likely Consequence or
outcome of the incident/complaint/claim.
What is the actual impact of the incident, complaint or claim? Is it catastrophic,
major, moderate, minor, or insignificant?
Secondly, identify the likelihood of a recurrence of the event. How likely will it
happen again?
potential degree of harm with the actual degree of harm that
occurred as this can affect the way in which the incidents are reported to the
NPSA for example grading near misses (where no harm occurred) as severe
harm.
degree of harm not the potential.
Where a patient dies following a patient safety incident grading must reflect
whether the patients death was directly attributable to the incident.


In terms of scoring incidents, complaints and claims the following grades are attached to
particular scores within the matrix:-
Very Low Risk
Grade 1-3
Low Risk
Grade 1-3
Moderate Risk
Grade 4
High Risk
Grade 5 / SUI
1-3 4-6 8-12 15-25

13. Actions to take following grading of a Patient safety event (Reporting and Lines
of communication)

13.1 RED HIGH RISK - grade 5 or SUI
Incidents
Incidents of this severity are subject to full Root Cause Analysis investigation and are
completed within NHS London defined reporting deadlines. It is recognised that the
effort involved in investigating this severity of incident that have not resulted in harm
may sometimes be less than that required for those resulting in harm.
The Medical Director (or nominated deputy) in conjunction with The Director of
Governance and/or nominated Deputy, identify an individual to co-ordinate the review
and also a panel chair.
Complaints
If a complaint is risk graded as High risk and events complained of are defined as a
SUI, the complainant is acknowledged and informed of the investigation process for
SUI. The complaint is then forwarded to the Clinical Governance team and The Medical
Incident, Complaints and Claims
Reporting and Investigation Policy

21

Director, Director of Nursing (or nominated deputy) in conjunction with the Director of
Governance and/or nominated Deputy, identify an individual to co-ordinate the review
and also a panel chair. (Please refer to the Complaints policy)



During normal working hours:
Inform the Governance / Risk Management team and Patient Relations Manager as
soon as is practically possible with details of the incident or complaint
Out of Hours:
Inform the Site Practitioner, who informs the on call General Manager and
Executive Director; immediate action(s) are then agreed.
Clear factual records of all detail (including times and dates) must be kept
locally and centrally by those dealing with the incident.
The patient/relative must be spoken with immediately by the most senior
clinician available and/or lead investigator to receive an explanation of the
incident and how the Trust will investigate it.
It is the responsibility of the lead investigator to inform the Governance and
Risk Department of the incident and any actions taken at soon as possible.


OUT of hours- Executive Director on call takes the following action:
Manage the incident or delegate its management to an appropriate person
Ensure the patient's clinician has informed the patient or relatives, this must be
done before any media are informed of the incident.
Provide an update to the Chief Executive and escalate to the PPCT and NHS
London as appropriate
Ensure as applicable that all media enquiries are handled according to Trust
Policy.
Liaise with the Governance department within normal hours to ensure that
relevant stakeholders are informed of the incident/event.
Establish a hotline if required (see Appendix 3)
Ensure that all documentation and equipment is gathered and securely stored.
Inform as necessary other relevant individuals/departments e.g. Occupational
Health, Human Resources.
An investigation panel is nominated & convened by the Chief Executive or
Medical Director

See Appendix 5 for Standards for the Panel Investigation of RED incidents
(Appendix 7 provides advice on witness statements and incident management).

Gathering of evidence and obtaining statements should be undertaken as soon
as possible when events are fresh in peoples minds and when staffs are still
allocated in the area. Where witnesses are recorded, statements must be
provided for all moderate and red investigations to substantiate the facts.
Incident, Complaints and Claims
Reporting and Investigation Policy

22

Witness statements must also be obtained and provided to any witnessed staff
accident/incident resulting in a RIDDOR.


13.2 AMBER MODERATE RISKS Grade 4

During Normal Working Hours, immediately report to: -
For clinical incidents,
The Senior Nurse and Consultant in charge of the patient.
In the event of a non-clinical incident
Seek assistance from the departmental manager and report the incident via Datix
web reports.
The Senior Manager will complete the appropriate documentation and obtain
witness statements if required.
Senior Managers should seek advice from the relevant Executive Director in the
event of any doubt or queries concerning the management of the incident.

Outside Normal Working Hours, immediately report to:-
For clinical incidents:
The Site Practitioner/Ward Manager who will inform the Senior Medical Staff on
duty. The Site Practitioner and senior clinician on duty liaise to decide whether
the incident needs reporting immediately to the Consultant in charge of the
patient. If the decision is that the incident does not need to be relayed to the
Consultant immediately provision must be made to inform them at the earliest
opportunity.

In the event of a non clinical incident, e.g. Major Electrical supply loss, loss of
Medical Gas Supply
Contact the Site Practitioner who will decide whether or not to contact the
Facilities / Estates Services on Call.
The Site Practitioner will contact the Senior Manager on call as appropriate.
The Governance department Risk Management leads must be informed of the
incident at the next practical opportunity within hours.
The Senior Manager on call will take the following action: -
Manage the incident or delegate its management to an appropriate person.
Provide an update to the Executive Director on call as appropriate / necessary.

It is the responsibility of the person in charge of an area/department to complete the
local investigation and ensure all necessary immediate remedial action is taken and
complete the documentation in the management section of the Incident reporting form
via Datix web reporting.
13.3 YELLOW / GREEN LOW RISK - Grade 1-3 Incidents

It is the responsibility of the person in charge of an area/department to complete a local
investigation and ensure all necessary immediate remedial action is taken and complete
Incident, Complaints and Claims
Reporting and Investigation Policy

23

the documentation in the management section of the Incident reporting form via Datix
web reporting.

Claims
Following the grading of a claim the legal team will start the investigation process as
stated below.


14. Investigating Incidents, complaints and claims
Adverse incidents and events must be given an appropriate level of investigation and
application of root cause analysis in order to identify the true reason for the problem.
Not all incidents, complaints or claims need to be investigated to the same extent or
depth. However all complaints and claims are required to be investigated to the level
that provides the complainant / claimant with a comprehensive/full response. Having
assessed each event against the risk grading matrix, the amount of investigation and
analysis effort should be expended in relation to the risk category. See following section
for guidelines on amount of time to be spent on investigation for each grade of event.

Green / Yellow (low) grade 1-3
Incidents
An aggregate review should be undertaken and investigated locally by the ward or dept
manager. Data should be reviewed by the DMT to identify any trends. These are
unlikely to warrant individual investigation, but root cause analysis of trends should be
undertaken, perhaps as part of a local working group, and a preventative risk
management strategy established to prevent recurrence. Local actions should be
documented on the incident form.


Complaints and Claims
Complaints and claims graded as low will still need to be fully investigated so that a
response can be made to the claimant or complainant. This includes notifying the
relevant department manager and collecting witness statements as outlined in both the
complaints and claims policies. For complaints the nominated lead investigator will have
responsibility of the actual investigation but the Patient Relations Manager facilitates the
investigation process. For claims the legal service Manager still has overall
responsibility of the investigation.

Amber (moderate) grade 4
Incident
A root cause analysis should be undertaken to identify contributor factors leading to the
incident. The use of experts may be relevant in order to learn lessons and to identify
actions required. These are managed locally and learning points and action plan
implementation is monitored through Divisional Governance meetings. The total
average time taken in investigation should be no more than 1-3 days. The lead
investigator/ investigating officer may find it useful although not essential to use the
guidance contributory factors Appendix 6

Incident, Complaints and Claims
Reporting and Investigation Policy

24

Complaints and Claims
The process highlighted above under grade 1-3 complaint or claims apply. In addition if
any recommendations are made and action plan will have to be completed and
monitored by the Divisional governance meeting. If they are trust wide
recommendations, the Patient Safety committee will be informed of the
recommendations through the divisional exception reports. The Patient Safety
Committee will then monitor the implementation of the recommended changes across
the trust.

Red (high) score grade 5 / SUI
Incidents
All red incidents will be investigated by a multi-professional panel of staff that have
either received full training in root cause analysis or have extensive experience in
incident or complaints investigations.
Where there is involvement of the police or Counter fraud service or a regulatory or
licensing organisation, consultation must take place with the organisation before
commencing a local investigation through the Director of Governance or nominated
Deputy.
The Trust should consider the requirements under the Memorandum of Understanding.
Where a local investigation is taking place and it becomes apparent that another
investigation is taking place then liaison should take place with the relevant body.

Appointment to the investigation panel will be made by the CEO, Medical Director
and/or nominated deputies.
Standards and timescales for the investigation of red incidents, are detailed in Appendix
5
The Trust has a specific investigation reports and action plan templates for RED
incidents and complaints. See Appendix 6.

Details and guidance on Witness statements can be found in Appendix 7. All
investigation reports on RED clinical incidents are reported to the Trust Board and
action plans monitored through the Patient Safety and Quality Committee.

See Appendix 6 for list of possible contributory factors which must be considered when
carrying out an investigation. In addition the NPSA Incident Decision Tree must be
considered to ensure fair blame. Available at:
https://report.npsa.nhs.uk/idt2/(S(ursyah45cpm3kde3bqhwca45))/login.aspx

STEIS reportable incidents (SUIs)
Serious Untoward Incidents must be managed and reported in line with NHS Londons
SUI reporting Policy

http://www.london.nhs.uk/webfiles/Corporate/Serious%20incidents/NHSL%20Serious%
20Incident%20Policy%20November%202010.pdf

They should also be reported to the relevant host Commissioner.

Incident, Complaints and Claims
Reporting and Investigation Policy

25

14.1 Investigation procedures and general guidance

Complaints
For complaints the lead investigator informs the Patient Relations team if there is
a potential delay in resolving the complaint, with the reason for the delay, so that
the complainant can be notified of when they can expect a response. However, in
line with the 2009 statutory regulations
1
all complainants obtain a written
response within the negotiated timeframe of the complaint.

Complaints graded as moderate or high risk must have an action plan in place to
manage the risk or prevent a recurrence. Divisional leads must ensure that
action plans are written, in collaboration with the named investigator, general or
service managers and clinicians. These action plans are recorded electronically
via the shared drive

Once the complaint response is completed and the complaint is deemed to be
upheld, the lead investigator will ensure that the action and learning plan is
developed, and shared with the Patient Relations Team and other appropriate
staff.
Completion of action plans relating to Parliamentary & Health Service
Ombudsman review is monitored by the Patient Safety & Quality Committee.
Other action plans are monitored by divisional governance boards, with feedback
to the Patient Safety & Quality Committee.
Incidents
Where work required to prevent the incident happening again is not immediate
an action plan is required. A copy of the initial action plan should be sent to the
Patient Safety and Quality Department. Following investigation of a moderate
Incident the action is monitored by the Patient Safety and Quality Committee. For
red Incidents the action plan will be submitted with the final report to the Patient
Safety and Quality Committee as well as the Trust Board.

In relation to actions which may have significance across a number of
departments, or divisions completed action plans will have the evidence and any
related new documentation embedded within the electronic plan for future
reference.

Contributory factors leading to a moderate/red incident will be identified and an
action plan learning the lessons will be prepared and implemented. The action
plan will be monitored and signed off by the relevant manager when all actions
have been completed. A copy of this should be returned to the Head of Patient
Safety for the central file.

1
The Local Authority Social & NHS Complaint (England) Regulations 2009.
Incident, Complaints and Claims
Reporting and Investigation Policy

26




When an investigation starts and at periods during the investigation it is good
practice to use the NPSA incident decision tree. This can help managers and
clinicians to decide whether it is appropriate to suspend staff from duty following
an incident and to consider alternatives and other possible measures as the
investigation continues. The incident decision tree is a web based tool and is
available
:https://report.npsa.nhs.uk/idt2/(S(ursyah45cpm3kde3bqhwca45))/login.aspx
Where patient safety has thought to be compromised due to concerns about
performance of an individual the correct Human Resources policies relating to
conduct and capability must be followed by the relevant managers to ensure
fairness and consistency across the organisation. In addition external reporting to
professional bodies and or other agencies needs to be carried out where
applicable.

14.2 Meeting with staff, patients and relatives directly involved in the incident or
complaints or Claims.
Consideration should be taken of the Trusts policy for Being Open.
If a meeting is arranged with the person directly involved in the patient safety event in,
the Lead Investigator/ Investigating Officer or Legal service manager ensures that an
appropriate time and setting for the meeting has been arranged, that enough time for
discussion has been allowed, that the person involved in the event has been advised
they can bring a friend, relative or member of an advocacy service to the meeting, and
that the relevant Trust personnel are present at the meeting.
The Lead investigator Investigating Officer, within 4 weeks maximum of the meeting,
provides a written record, summarising what was said and agreed, in the form of a letter
to the person involved in the patient safety event.
Meeting minutes are written and sent to the person involved for their approval re:
accuracy and completeness. Any suggested amendments are made and a final copy
sent to the person.
15. Investigating Serious Complaints
Serious clinical complaints are dealt with by way of in the establishment of an
investigation panel and production of a report and action plan overseen by the Patient
Safety and Quality committee. Serious complaints would be defined as those in which
there have been allegations of a major departure from accepted standards of diagnosis,
treatment or care.

See Appendix 5 for Standards for the Panel Investigation of RED incidents, complaints
or claims.

Note: This appendix also includes advice on witness statements, format of report and
template for action planning, possible contributory factors which give rise to the event.



Incident, Complaints and Claims
Reporting and Investigation Policy

27

16. Investigating Serious Claims
The processes for investigating serious claims differ from that of complaints or incidents
in that they are at this point subject to litigation and therefore led primarily by the Medico
Legal Manager and where applicable the Trusts solicitors.

Investigation/witness statement gathering will be required by the Trust or solicitors.
Claims may have been previously reported and investigated as an incident or complaint
and this is identified by the Medico Legal Services Department on receipt of the claim.

The Medico Legal Services Manager brings to the attention of the Director of
Governance and the Head of Patient and Safety & Quality together with the Patient
Safety and Patient Safety & Quality committee any relevant learning points and actions
required by the Trust following evidence gathering by the Solicitors and subsequent
investigation. These action points/ lessons learnt and improvements for claims are
discussed at the Patient Safety & Quality committee.
Serious claims would be defined as those in which there have been allegations of a
major departure from accepted standards of diagnosis, treatment or care or where there
has been a major departure from the accepted standards of Health and Safety.

17.Memorandum of Understanding
The 'Protocol for liaison between the NHS, Chief of Police and the Health and Safety
Executive' is a Memorandum of Understanding which sets out the general principles for
the NHS, Police and HSE to observe when liaising with one another. The protocol takes
effect in the event of an unexpected death or serious untoward harm, patient safety
incident. This will normally be the case if an incident has arisen from or involves
Criminal intent
Recklessness and or gross negligence
Or in the context of Health and Safety involves
A work related death or serious injury
Guidelines for the NHS in support of the Memorandum of Understanding along with a
link to the full Memorandum of Understanding document can be found on the
Department of Health website or by clicking this link:
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolic
yAndGuidance/DH_062975

18. Learning lessons and making improvements as a result of investigating
incidents, complaints and claims
The Trust requires investigations to be carried out in a timely and thorough way at a
level appropriate to the severity of the event in order to use Trust resources effectively
and to minimise recurrence of incidents, complaints and claims. Lessons should be
learnt both locally and organisationally from the outcomes following investigation. On an
individual basis each case investigated in accordance with the severity and action plans
put in place to correct any problems or to implement changes as a result. The Trust has
a separate policy on Incident, Complaints and Claims Analysis and Improvements which
looks at analysis and improvement of data and information as whole.

Incident, Complaints and Claims
Reporting and Investigation Policy

28

The results of Serious Untoward Incident investigations and actions taken must be
updated on the STEIS database by the Director of Governance or Assistant Director of
Governance.

19. Recommendations and Monitoring of Action Plans
After a serious clinical incident, or complaint the recommendations and action plan are
presented with the investigation report to the Patient Safety and Quality committee In
addition the Trust Board are presented with SUI reports and action plans and sign off
the recommendations and action plans, also considering whether further action is
required.

The Patient Safety and Quality Committee monitor the progress of relevant action plans.
The red incident or complaint remains active is not considered closed off until the
Committee is assured that actions have been completed.
Investigation reports and action plans from serious non-clinical incidents are discussed
at the Healthcare Environment and Amenities committee and/or the Governance
compliance and Risk Committee and Trust Board, depending upon the nature of the
incident. Outstanding action plans form part of the committees monthly agenda items,
and are required to be presented three monthly until fully implemented
The investigation reports from serious untoward incidents reported on STEIS are
monitored by NHS London according to their Incident Reporting Policy.
Where delays in investigation are unavoidable the Cluster are notified of the reason for
the delay via the Clinical Quality Group report.

Low graded incidents do not normally require an action plan (complaints do if they are
upheld) and immediate actions should be recorded on the web based incident form.
Recommendations and action plans from incidents which have been investigated at
moderate level Divisional or local level are monitored by the appropriate Divisional or
local manager and reported back into any appropriate Committees or Groups e.g.
clinical governance meetings.

20. Feed back of Incident, Complaint or Claim Investigation Outcomes
Incidents
The outcome of investigations into moderate or red investigations is fed back to those
who reported the incident and those who were involved in the investigation of the
incident.
Complaints and Claims
A copy of the final signed response letter is sent to the Lead investigator to share with
staff involved) or claim. In the case of complaints or claims the patient and their relatives
will receive feedback from the response letter or through the legal process.

21. Staff Training and Assistance with Incident, complaint and claim investigation
The training for investigation of claims, complaints and Incidents, is as outlined in the
Trusts Training needs analysis and enrolling and follow up as described in the statutory
mandatory training policy.

NPSA e-learning course on Root Cause Analysis
Incident, Complaints and Claims
Reporting and Investigation Policy

29

The National Patient Safety Agency (NPSA) has an e-learning course on root cause
analysis which can be accessed at any computer which has an internet link via-

http://www.npsa.nhs.uk/patientsafety/improvingpatientsafety/patient-safetytools-
and-guidance/rootcauseanalysis/
Follow instructions on using e-learning course provided.

22. Reporting to External Agencies.

A number of legal requirements are placed on the Trust to report incidents to external
agencies irrespective of the severity of the incident. When reporting to these agencies,
a Trust incident report form is required.
The responsible department for reporting to the external agency will also complete the
relevant submission forms required by the agency.
Appendix 2 provides a list of particular incidents and external agencies which need to
be informed.

The Care Quality Commission is informed of a number of incidents via the NPSA
incident reporting system (NRLS) or, where deemed appropriate in relation to the
incident severity, by the Director of Governance directly.
In addition Serious Untoward Incidents (SUIs) are reportable to the commissioners and
NHS London as described in Section 14.

























Incident, Complaints and Claims
Reporting and Investigation Policy

30

23. References

NHS London SUI Reporting Policy

NPSA Root Cause Analysis e-learning www.patientsafety.ucl.ac.uk.

Vincent CA, Adams S, Stanhope N (1998). A Framework for the Analysis of Risk and
Safety in Medicine. BMJ 316 1154-7

Vincent CA, Adams S, Hewett DH et al. (2000) How to investigate and analyse clinical
incidents: CRU & ALARM protocol. BMJ320, 777-781

NHSLA Risk Management Standards for Acute Hospitals, NHSLA.

'Memorandum of Understanding: Investigating patient safety incidents involving
unexpected death or serious untoward harm - A protocol for liaison and effective
communications between the National Health Service, Association of Chief Police
Officers and Health and Safety Executive' DoH Feb 2006

Information Resource to support the reporting of serious incident NPSA 2010/09

NPSA Never Events Framework Safely does it Implementing safer care for
Patients Healthcare Commission March 2009

Guidelines for Managing Incidents in the NHS Cervical Screening Programme
2
nd
Edition NHSCP Publication No 11

Guidelines for managing incidents in the Breast Screening Programme
3
rd
Edition NHSBSP Publication No 44

Bowel Screening: INTERIM Guidelines for Managing Incidents in the
NHS Bowel Cancer Screening Programme - NHS BCSP PUBLICATION NO 7 APRIL
2012
Incident, Complaints and Claims
Reporting and Investigation Policy

31


24. Bibliography

None


25. List of Associated Policies

This list is not exhaustive:

Whistle blowing Policy
Approved document for the management of a major incident
Management of claims Policy
Management of complaints Policy
Approved document for the management of media relations
Health and safety Policy
Infection control Policy
Risk Management strategy
Being open Policy




Incident, Complaints and Claims
Reporting and Investigation Policy

32

Appendix 1

Guide to incident form completion (DIF1) and managerial review(DIF2)
(Datix web reporting)

DIF 1 Incident form completion

Who to contact if there is a problem?
In event of queries please contact the Patient Safety Facilitator on ext (1) 3628 the
Patient Safety Assistant on ext (1) 2714

What do the red stars mean?
The red stars indicate the mandatory fields. The form does not save or submit if these
fields are not completed.

What do I do if my manager does not appear in the drop down list?
There is an option to select Datix Admin.
By selecting this option an alert is sent to Datix Web Incident reporting administrators
alerting them of the problem. The incident is reviewed and your manager contacted and
invited to attend a training session.

By selecting your manager you will be informing them of the incident.
The Datix Admin option can also be used if you wish to report an incident but do not
want your manager to be informed. In this event, the Datix Web administrator reviews
the incident and assesses who needs to be informed of the incident. The Datix
Administrator also ensures the correct manager is informed of the incident.

What are non-clinical incidents and patient safety incidents?
A non-clinical incident is what was formally known as a Health and Safety Incident. This
includes slips, trips and falls, sharps injury and any violence and aggression incidents.
Patient safety incidents are those where a patients safety is or could be compromised.

How to populate the directorate and speciality fields?
If the incident being submitted did not involve a patient, then these fields should be
populated with the directorate and speciality of the area the incident occurred. If the
incident involves a patient, these fields should be populated with the directorate and
speciality the patient was admitted under.

How to grade an incident?
Information regarding the scoring of risk is found in Section 12 of the Incident,
complaints and Claims reporting and Investigating Policy which can be found on the
Intranet.
This provides information for the reporter to select an initial grading for the incident
NB this is not the final incident grade. Circumstances may change and the original
grading could change during managerial review.


Incident, Complaints and Claims
Reporting and Investigation Policy

33


What to do if the hospital number is not known?
If the incident involves a patient a hospital number should always be entered. However,
if the incident does not involve a patient and therefore a hospital number is not relevant
this box should be populated with an X.

What to do if the date of birth is not know?
If the incident involves a patient the date of birth should always be entered. However, if
the incident does not involve a patient the date of birth is not relevant this box should be
populated with an X.

How to obtain feedback on the incident you have reported?
Once the incident has been submitted a reference number will appear and you will also
receive an email informing you of the reference number (subject to your email address
being entered in the first section of the form).
This reference number can then be quoted to the line manager you selected, or to the
Risk Department; either of these contacts will be able to provide feedback on actions
related to specific incidents where updated on Datix.


Dif 2 Managerial review

How do I know when I need to look at an incident?
As a manager you receive an email informing you that you have been allocated an
incident that needs to be reviewed. Click on the link included in the email which allows
you to log on and review the incident.

How do I access the incident?
There are two options to access an incident.
The first is by following the link that is included in the email notifying you that an incident
has been assigned to you. By clicking this link you will be taken to a log in screen.
When your log in details have been entered you will be taken into the incident from
which relates to the email received.

The second is by accessing an incident reporting form from the intranet. At the top of
the reporting form you can log in. Once you have logged on to Datix web you will need
to open the incidents section and select List incidents in the holding area awaiting
review option. This will then show you all incidents you have been informed of that you
have not yet reviewed.

Once the incident has been reviewed changing the approval status to still being
reviewed not yet sent for final approval will log that you have reviewed the incident. If
an incident is not reviewed within 7 days of the incident being submitted, or if the
approval status is not changed, the Risk Department will be alerted that an incident is
overdue.


Incident, Complaints and Claims
Reporting and Investigation Policy

34

The menu options

You will see a number of menu options within the Incident module. These will be:

Incidents in the holding area awaiting review
Incidents still being reviewed
Incidents awaiting final approval
List incidents with final approval status

The first time an incident is accessed it will be located in the Incidents in the holding
area awaiting review option. When an incident has been acknowledged or the save to
approve later button is selected the incident automatically moves to the Incidents still
being reviewed option. The incident remains here until next time it is accessed.

Once and incident investigation has been completed or the Approve button is selected
it automatically moves in to the Incident awaiting final approval option.

When the incident has reached this stage the Datix Administrator reviews the incident. If
further information is required the Datix Administrator will contact the handler/
investigator and the incident is moved back to the Incidents still being reviewed option.

If the Datix Administrator reviews the incident and no further information is required the
incident will be closed and moved the List incidents with final approval status option.
Only the Datix Administrator can moved incidents to this option.

Incidents can be accessed by the handler at all stages including when an incident has
final approval status.


Incident, Complaints and Claims
Reporting and Investigation Policy

35



Incident, Complaints and Claims
Reporting and Investigation Policy

36











Incident, Complaints and Claims
Reporting and Investigation Policy

37

What do the different screens do?
There is a menu down the left side of the form. Each screen on this menu holds a
different tool for a full incident investigation.
The details screen and investigation screens are covered above.

The feedback screen this screen can be used to feedback investigation results or to
communicate with the handler (using the drop down box) or to other members of staff
(using the free text additional recipients field) to provide an audit trail. All emails that
are sent using this screen are saved to the incident.

Equipment and medication screens this will be automatically populated from any
equipment and/or medication entered on the Dif 1 form.

Documents screen this screen allows you to attach any type of document to the
incident that has been saved to your PC or drive.

Notification sent screen this screen gives a full list of all staff that have been
informed of this incident.

Print screen this screen will allow you to print the entire incident including all screens
listed above.

NB Printed or paper incident forms should not be filed in medical records.
Incident, Complaints and Claims
Reporting and Investigation Policy


Appendix 2

Reporting to External Agencies

A number of legal requirements are placed on the Trust to report incidents, complaints
and claims to external agencies irrespective of the severity of the event. When
reporting incidents to external agencies, a Trust incident report form is required.
The responsible department for reporting to the external agency will also complete the
relevant submission forms required by the agency.

Medicines and Healthcare Products Regulatory Agency (MHRA)
The Patient safety department will report adverse incidents to the MHRA when the
incident involves a medical device. An adverse incident involving a medical device is
defined as an event, which causes, or has the potential to cause, unexpected or
unwanted effects involving the safety of patients, users or other persons.

The Pharmacy department will report any suspected Adverse Drug Reactions (ADR).
Where medicines are involved, reports should be made where a clinician suspects
that there is a causal link between the medicinal product and the suspected reaction
experienced.

Serious adverse reactions or events related to blood transfusion are reportable to the
MHRA. These incidents are reported via the Pathology Department manager.
.
Health and Safety Executive (H.S.E.)
The Health and safety department will report injuries or harm to the Health and Safety
Executive under RIDDOR. This is a legal requirement that requires the reporting of
work related accidents, diseases and dangerous occurrences. It applies to all work
activities, but not all incidents.
Patient accidents will be reported when significant injury (not related to healthcare)
has occurred to the patient. In addition any events leading to accidental death or
serious harm to staff, patients or visitors on NHS premises or involving NHS
equipment are reportable to the H.S.E. including screening and immunisation/radiation
errors serious injury or unexpected deaths of any individual to whom the organisation
owes a duty of care including staff visitor, contractor or any other person.
When reporting any of these incidents also consider the need to report to the Coroner
and Police.

National Blood Transfusion Service
Where there has been an incident or substantiated complaint or claim following
transfusion of blood and/or blood components, it will be reported by pathology
department under SHOT Serious Hazards of Transfusion. It will also be required to
be reported to the NPSA and it may also be necessary to report the incident to the
Medicines and Healthcare Products Regulatory Agency (MHRA).
Consideration should also be given to reporting to the European Blood Safety
Directives/Blood Safety Regulations (BSQR).

National Patient Safety Agency (NPSA)
The Governance Department report all patient incidents to the NPSA, irrespective of
the severity. This is undertaken using a direct electronic link from the Trusts incident
Incident, Complaints and Claims
Reporting and Investigation Policy


reporting system. Incidents are reported through the National Reporting and Learning
System (NRLS) to the National Patient Safety Agency (NPSA) that produces feedback
reports and benchmarking statistics. The NRLS reports are reviewed at the Patient
Safety and Quality Committee.

Strategic Health Authority (SHA)
The Governance department report all serious untoward patient incidents to the
Strategic Health Authority in accordance with STEIS guidelines by way of completing
an electronic report form to their Strategic Electronic Incident System (STEIS) this
includes serious untoward information governance incidents.

NHS Protect formerly Counter Fraud & Security Management Service (NHS
CFSMS)
The Local Security management Specialist reports any staff incidents involving
violence and aggression to the above authority in accordance with the guidance
produced.
All occasions where the Trust Emergency Plan/Major incident plan is invoked should
be reported to NHS Protect this includes any terrorist threats or incidents, potential or
confirmed chemical, biological radiological or nuclear incidents.

In addition reporting should take place where there is suspicion of fraud, malicious
activity such as tampering with equipment, serious damage to Trust property or
serious disruption to services i.e. such as evacuation of patients due to fire.
When reporting incidents consideration is given to informing the PCT/SHA, police,
Local transport Services, Local Ambulances Service. In cases of terrorism consider
informing the Armed Forces and Ministry of Defence.

Health Protection Unit
The Control of Infection Team will report to the Health Protection Unit any matters
relating to outbreaks of infections, communicable diseases and notifiable infections.
In addition consideration should be given to reporting communicable diseases and
health protection incidents to the Health and Safety Executive, Police, Local Council,
other healthcare organisations and other local bodies such as age concerns and local
Transport Services.

CEMACH
The Maternity unit report any maternal, stillbirth or neonatal death (within 12 months of
birth) to the NHS Confidential Enquiry into Maternal and Child Health.

Adults at Risk
Any incident which relates to the possible abuse of a vulnerable adult is reported by
The Trust designated Safeguarding Adults lead, Deputy Director of Nursing to the
Borough Safeguarding Adults Team.
In addition abuse of an adult is reportable to the CQC via the NPSA reporting system
consideration is also be given to reporting adult abuse events to the police and social
services and other partner agencies.

Safeguarding Children
The Trusts Safeguarding Childrens lead report relevant paediatric events to the local
Childrens Board and relevant Local safeguarding Boards.
Incident, Complaints and Claims
Reporting and Investigation Policy


Consideration should also be given to notifying Education Authority, Health Visitor,
School nurse, Centre for maternal and Child Enquires (CMACE), Confidential Enquiry
into patient outcome and death (CEPOD).

Professional Bodies
Advice on reporting to Professional Bodies should be sought from the Director of
Nursing in relation to Nurses; the Medical Director/Executive Director of Human
Resources in relation to Medical Staff; the Professional Head of Department/Executive
Director of Human Resources in relation to all other professions.

Radiation Protection
Incidents complaints and claims involving Ionising radiation should be reported and
investigated in accordance with this policy.
In addition they should immediately be reported to the Senior Superintendent
Radiographer who will inform the Radiology Manager and the Radiation Protection
Supervisor. They contact the appropriate external body i.e. CQC, Health & Safety
Executive. (The Trusts IRMER guidelines should be consulted)

National Health Service Litigation Authority (NHSLA)
The Trust must report claims in line with guidance from the NHSLA Summary of
NHSLA Clinical Negligence Reporting Requirements
Report relevant cases to the NHSLA within 2 months of request for records or
sooner if event is serious;
All letters of claim and Part 36 offers to be notified to the NHSLA immediately;
Acknowledge letters of claim within 14 days;
Detailed response due within 3 months;
All legal proceedings to be notified immediately.

Information Commissioner
Major Breaches of confidentiality such as the loss or theft of personal identifiable
records or information including missing case notes or incidents involving the actual or
potential loss of personal information which could lead to identity fraud should be
reported to the CQC via the NPSA reporting system the information Commissioner
and the police if applicable. The SIRO is responsible for these incidents.

Care Quality Commission (CQC)
The Care Quality Commission requires the reporting of certain events to them. For
Acute Trusts this is undertaken using the NPSA reporting system. There are a number
of events directly reportable, which include;
Homicide committed by an individual in receipt of mental health and or
learning disabilities.
Action of a patient which results in serious harm or injury to staff or which
place the lives of staff members in serious danger, staff death or serious
injury, a member of staff is a victim of abuse.

Coroner
Events reportable to the Coroner are:-
Clusters of unexplained or unexpected deaths
Maternity, maternal deaths neonatal deaths and unexpected still births
Incident, Complaints and Claims
Reporting and Investigation Policy


Suicide of any patient currently in receipt of NHS Services on or off NHS
premises or who has been discharged within the last 12 months.
Grade 3 or above pressure sores present on a deceased patient
In addition
Any events leading to accidental death to staff, patients or visitors on NHS
premises or involving NHS equipment.
Situations where a patient has required additional interventions as a result of
failures in the assessment or diagnosis process
Death where foul play is suspected
Abuse that has been perpetrated within the remit of the organisation, this may
be abuse by a member of staff visitor or member of the public

When reporting to the Coroner it should also be considered whether reporting to
professional bodies, local supervisor of Midwives and police is appropriate.

Commissioners
Local commissioning bodies must be informed of any incidents which occur which are
listed as Never events. In addition Serious Untoward Incidents are to be entered onto
the STEIS database system and should also be notified.

Professional Bodies and National Clinical Assessment Service
Consider reporting incidents, complaints or claims which identify concerns about
individuals or where there is a risk of adverse media interest.
Any serious criminal acts involving patients or staff
Suspicion of serious error or errors by a member of staff
Where a member of staff is suspected of abusing or harming patients
A serious drug error such as mal administered spinal injections
Where professional competence is in question (use the incident decision tree to
determine whether competence was a causative factor)
A serious breach of confidentiality
Where a member of staff is suspected of committing serious fraud (also report
to NHS Protect )
Where a member of staff shows gross disrespect for the dignity of a
patient/deceased patient
National Cancer Screening programme
The lead investigator for the cancer screening programme should ensure they follow the
relevant guidelines for managing the incident:
Cervical Screening,
Cervical Screening Programme Publication No 11
F000130_Guidelines for Managing Incidents in the NHS Cervical Screening
Programme.pdf

Breast Screening
Guidelines for managing incidents in the Breast Screening programme Publication No 44

Bowel Screening: INTERIM Guidelines for Managing Incidents in the NHS Bowel Cancer
Screening Programme - NHS BCSP PUBLICATION NO 7 APRIL 2012


Incident, Complaints and Claims
Reporting and Investigation Policy



Appendix 3

Establishing and running a Hotline Service - 24 hours

1 Introduction

For incidents where there is likely to be multiple enquiries from patients and
relatives, the Head of Communications or member of Communications Team,
in consultation with appropriate senior staff e.g. Chief Executive, Director of
Nursing, Medical Director, Director of Operations or Duty Director, will invoke
the Hotline Service.

The designated Hotline room is the A&E Conference Room at Northwick Park
Hospital. It is equipped with multiple telephone and data sockets to allow a
team to operate phones and computers at the same time. There are also white
boards on the wall to record key details of project progress.

Additional phone handsets are available to the Head of Communications at
short notice via the Telecoms Manager.

Depending on the nature of the incident and expected number of calls the
Hotline is may be operational for 24 hours a day, however generally it is
manned between 9.00am and 5.00pm. If some cover is needed overnight then
a member of staff will carry a bleep or mobile phone.

The Hotline service is staffed by those with the appropriate skills and
knowledge base; this knowledge base will be dependent on the specialty/
department involved. Staff are trained and provided with explanatory guidance
on the most likely questions likely to arise to ensure consistency of advice.

The numbers of staff required to man the Hotline Service is dependent on the
anticipated number of incoming calls. Should the number of calls exceed the
anticipated volume, additional staff (with the appropriate knowledge base) are
drafted in.

2 Head of Communications

The Head of Communications on behalf of the Executive Team ensures
appropriate structures are in place to allow the Trust to invoke a Hotline.

3 Role of Head of Communications or member of Communications Team

Before invoking a Hotline Service, the Head of Communications or Deputy will
ensure, in liaison with the lead Executive Director, that :

The designated Hotline room (in A&E at Northwick Park) is cleared and set
up for call centre use with phone handsets and computers as necessary.
Incident, Complaints and Claims
Reporting and Investigation Policy


Ensure appropriate and sufficient numbers of staff are available to man the
Hotline. Where possible staff are drawn from those staff groups with call
handling and counselling skills e.g. patient relations and PALS.
There is a common brief drawn up for staff members taking calls
Staff involved are aware of when, and from whom, they should seek further
advice
All staff manning the Hotline Service are provided with on the spot training
by the communications team in techniques for answering calls from
distressed/anxious members of the public (in the context of the reasons for
the Hotline being established).
IT support is available for the area which will hosts the Hotline
Additional needs are identified for postal arrangements.
The Post room is located a couple of minutes walk from the Hotline room.
When sending post, staff should be aware that the postal collection from
the post room is 4.30pm (Mon-Fri). A later 17.00 collection is available via
the post box outside the Social Club.

4 Training/Preparation brief for staff who will man the Hotline

The Head of Communications ensures staff members manning the Hotline
Service receive the following training/information before manning the
telephones:

Outline of the incident giving rise to the Hotline Service being invoked.
List of potential enquiries that callers to the Hotline Service may make.
List of potential/suggested answers that might be given to callers
Advice on how to deal with distressed callers to the Hotline Service.
Advice to be given to callers on the availability of a call-back service, (this
can be used if callers appear to be very distressed or appear to have
difficulty in assimilating the information provided.)
It may be appropriate that the call-back line is to an alternative member of
staff e.g. chaplaincy or more senior member of staff from a
specialty/department.
Staff maintain a written record of all calls and advice given see Appendix 4
and a letter of confirmation will follow all calls.
Instruction on the completion of log used to record the calls received by the
Hotline Service. This log is and stored for further reference.

Staff manning a Hotline will have been under great deal of pressure and may have
suffered some degree of stress. Counselling and support is made available to staff as
required.
Incident, Complaints and Claims
Reporting and Investigation Policy



Flowchart setting up hot-line service

SERIOUS INCIDENT
OCCURS
COMMUNICATIONS
MANAGER +
APPROPRIATE SENIOR
STAFF
MEDIA TO BE CONTACTED TO
FACILITATE PUBLICITY OF
INCIDENT AND HOTLINE
STAFF
INTERNAL/EXTERNAL
STAKEHOLDERS TO BE INFORMED
Red Alert Notice
Global e-mail
Target e-mail
HOTLINE TO BE SET UP
IN AGREED LOCATION
TELECOMMUNICATIONS
MANAGER
STAFF TO MAN HOTLINE SERVICE
APPROPRIATE NUMBERS/SKILLS
(Dependant on scale/type of incident)
SCRIPT TO BE WRITTEN
(By head of service)
STAFF TO BE PROVIDED WITH
APPROPRIATE
Training
Refreshments
Working Hours
ALL CALLS TO BE
LOGGED

ALL LOG SHEETS TO BE
ARCHIVED
(In health records library)
BANK OF TELEPHONES
DESIGNATED TELEPHONE
NUMBERS

Manned 24 hours or during working
hours with answer phone message
does this conflict with earlier timings..


STAFF TO BE OFFERED POST-
INCIDENT COUNSELLING
(via Occupational Health)
DECISION TAKEN AS TO
HOW LONG HOTLINE
SERVICE REMAINS IN
EXISTENCE
(by CE/Communications
Manager/Head of Service
ANSWERPHONE
MESSAGE TO BE LEFT
ON HOTLINE NUMBER
(Dependent on type of
incident)
Incident, Complaints and Claims
Reporting and Investigation Policy


Appendix 4
Log sheet for Hotline calls


NAME OF STAFF MEMBER: . SIGNATURE

TIME ON DUTY . TIME OFF DUTY

TIME
CALL IN
(24 hr
clock)
TIME
CALL END
(24 hr
clock)
DETAILS OF CALLER
(Name, address, telephone
number, relation to incident)
ISSUES RAISEDADVICE GIVEN FURTHER ACTION
AGREED WITH CALLER
























Appendix 5
Standards for the SUI Panel and serious Complaints Investigation

Introduction
This procedure describes the Trusts standard for incident and complaint
investigation and report writing when an SI event occurs.
When a SUI is declared or a serious complaint occurs, the Director of Nursing
(complaints) or the Director of Governance and/or the Medical Director (SUI)
establish an investigating panel with a nominated senior lead.

This panel must not include any one with direct involvement in the event thereby
ensuring external input. However, due consideration is given to the composition of
the team, given the nature of the incident or complaint to be investigated.
Assistance and administrative support to the investigation panel and process is
provided by the Patient Safety department for incidents and Patient Relations dept
for complaints.

1. Panel allocation
The investigation team is notified by the Head of Patient Safety and Quality/
Patient Safety dept of their involvement in the panel within one week of allocation
of the panel by the Director of Nursing/Medical Director/Director of Governance.

2. Initial handover meeting
At the initial handover meeting, the Patient Safety/Patient Relations Coordinator
(PSRC) informs the lead panel member (Chair) of the facts and assists in clarifying
the scope and direction of investigation. Further dates for investigation panel
meetings are planned by the panel lead.

3. Investigation Process
1. The PSRC meets with the Chair within one week of allocation of the panel and
case handed over.
2. The Chair arranges for the panel to meet as necessary to clarify the scope and
direction of the investigation, this is coordinated by the PSRC.
3. The PSRC and Chair organise the investigation to enable a draft report to be
available within reporting deadlines.
4. The report will incorporate the key headings set out in Appendix 6.
5 If the investigation panel wish to undertake interviews of staff, these are planned
at the start of the investigation where possible however the investigation may
uncover the need for further interview at a later date. A record of any interview
must be made, and all evidence collected must be sorted and catalogued
systematically..
7. Witness statements are called for & must be of good standard. See Appendix 7.
8. An action plan is drafted by the panel from the recommendations. The draft
action plan is finalised and formally ratified by the Trust Board and its
implementation overseen by the Patient Safety and Quality Committee.





4. Report and Action Plan Preparation
The report will follow the format prescribed in Appendix 6 and is prepared in line
with external reporting requirements.( For SUIs reported on STEIS report must be
completed within 45 working days from the date reported on STEIS.)

A draft report should be prepared for sign off by the investigating panel as follows
where possible:

a) Production of first draft report with panels recommendations to be drafted and
circulated to Panel members by the end of week 5.
b) Comments back to the Chair and PSRC by week 6.
c) The final draft report and proposed action plan, is presented to the next sitting of
the Trust Board.



Appendix 6
Report template





Report of the findings of the
Serious Incident (SI) Investigation


Incident:
Incident Date:
Incident Report date
STEIS Reference:
Author of report:



Executive approval
Date approved by Trust:


























1 Reasons for the inquiry - to include the incident severity,
how the incident was detected and the level of
Investigation

2
2 Incident Description and incident date

2
3 Initial report

2
4 Inquiry panels Terms of Reference
Members of the panel
4
5 Conduct of the Inquiry

4
6 Involvement and support of patient / relatives

5
7 Actual effect on patient / service

5
8 Clear, fact based chronology of events leading up to the
incident

5
9 Any Care and/or Service problems

7
10 Contributory factors

8
11 Root Causes

8
12 Lessons learnt

8
13 Conclusions

9
14 Recommendations

10
15 Arrangements for shared learning

10
16 Action Plan suggested time scales and leads















1. Reason for the inquiry ( this includes level of investigation)




2. Incident Description and incident date

3. Initial Report


4. Inquiry Panels Terms of Reference



Members of the Panel










5. Conduct of the inquiry and RCA investigation method
States method of RCA used, information and evidence gathered




6. Involvement and support of patient / relatives ( being open )





7. Actual effect on patient / service






8. Chronology of events leading up to the incident

9. Any Care and/or Service problems

10. Contributory factors

11. Root Causes

12. Lessons learnt

13. Conclusions

14. Recommendations

15. Arrangements for shared learning


16. Monitoring arrangements for actions


Action plan


Issue Action Lead Timescale Completed Monitoring
arrangements





















Possible Contributory Factors in an Incident, complaint or claim
Factor Definition Examples
Patient factors Physical, mental, emotional and
behavioural aspects of the patient that
contributed to the event.
May include DTs, hallucinations, sleep walking,
obesity, senility, the patient's response to
treatment, and any co-morbidity.
Includes the patient's choice to ignore
instructions.
Task factors Tasks performed or not performed by
any member of the care team that
contribute to the event. These factors
include all disciplines following policies
and procedures established in the Trust.
May include failure to undertake appropriate risk
assessment e.g. falls
Failure to follow surgical time out checklist
Failure to evaluate any patient's behaviour or
failure to act upon that assessment
Failure to formulate or implement properly a
standard plan of care from any discipline for the
specific needs of the patient.
Individual staff factors Those factors solely attributable to the
action of an individual
Failure to follow Trust Policy and protocols
attributable to an individual.
Issues of individual professional misconduct.
Team factors Failure of the members of the care team
to work together appropriately.
Failure of the staff to "speak-up" to the surgeon
prior to/during wrong site surgery.

Education and Training factors Failure to orient and train any staff
member in his/her job requirement and
Trust policies.
Failure to adequately oversee any staff
member in any discipline to ensure that
he/she is doing their job
Includes all staff groups
Equipment and Resource factors Any lack of or malfunction of equipment
including a medical device that causes
harm to the patient.
The adverse event may be due directly
May include IV pumps, ventilators, orthopaedic
drill bits, catheters, radiology equipment

Also may include stretchers, wheelchairs,


Factor Definition Examples
to malfunction of equipment, to use of
the equipment for an unapproved
purpose, or improperly used equipment.
among others.

Communication factors Failure of the staff to obtain and share
with the multi disciplinary team all
pertinent information related to the
comprehensive care of the patient in a
timely manner.
Failure to obtain all pertinent information
from the patient and the family about the
patient's status at home, recent
changes, and the current presentation of
symptoms and medical condition.
Failure of the staff to communicate with
the patient and family pertinent aspects
of care.
May include any type of communication
(written, oral or implied)

Working / Environmental factors Failure to maintain a physical
environment conducive to the proper
care of a patient

May include inappropriate lighting, inappropriate
noise level, inadequate space, clutter, alarms
that sound alike, or unfamiliar sounds to the
staff.
Lack of an appropriate staff taking into account
patient acuity as well as staff training and
experience.
Organisational / Strategic factors Failure of the Trust to facilitate and
support safety

May include lack of, or unclear policies or
protocols.
Lack of medical or nursing leadership.







Appendix 7

Standards for the Panel Investigation of incidents, complaints
Witness statements

Purpose
When a statement is requested, the purpose for which it is required must be made
clear. Access must be given to medical\nursing records if requested. In some
situations it may be wise for a witness to write down a brief account of the events
immediately.

Guidance
The person writing the statement can always seek advice from their professional
representative, their line manager or the governance staff.

Quality of witness statement
The investigation panel should only accept good quality statements. The panel
should look for the following points to be included in statements.

Accuracy
It is essential that only those facts which took place should be recorded. There
should be no exaggeration of minimisation.

Avoid hearsay
The statement should not repeat what someone else has seen or heard. The
statement should be a first-hand account of the person's personal involvement or
observation.

Facts Not Opinion
The statement should avoid value judgements and should keep to the facts.

For example, a health visitor might have formed the opinion that one of her clients
was lazy. If this is relevant to the statement it is of far more value if she were to
write down a description of the facts which led her to that opinion than to make
value judgements.
Thus there were 12 dirty milk bottles on the living room floor and piles of papers
on every seat, etc is more useful than expressing an opinion which may or may
not be acceptable and is not on its own very meaningful.

There are occasions where it is necessary to express opinions, especially where
they led one to act in a particular way. It is still necessary to record the facts which
led to those opinions.
For example: Because I felt she was a danger to herself I put the cot sides up.
This statement needs to be amplified in order to expand on what has caused the
nurse to believe that the patient was a danger to herself, for example, had she
fallen out of bed? Had she tried to leave the ward? Was she in a confused state
and if so, how did she show it?
Incident, Complaints and Claims
Reporting and Investigation Policy



Where concerns have been made regarding care management, the person raising
the concerns must give a detailed account of the situation.
For example, a health professional raises concerns about another health
professional's care of a patient. The person raising the concern must provide
specific details of how the care was lacking and in what way the care deviated from
normal protocol.

Facts made in a statement should be checked.
For example, a statement that a patient had a high temperature should be checked
against the patients record; similarly a description that the patient had been written
up for a particular form of medication should be checked against the drug card.

Sometimes it is helpful to obtain a sketch of the ward layout or where the patient
was found or where there is a need to identify the exact location.

Essential elements in a statement
date and time of incident; 24 hour clock, e.g., 4pm = 16.00hrs
full name of person completing the incident form, position, grade and
location;
full name of any person involved, e.g. patient, visitor, other staff.
a full and detailed description of the events which occurred;
date and time the statement was made;
signature AND PRINTED NAME

Incident, Complaints and Claims
Reporting and Investigation Policy



Appendix 8

Guidance for Staff Writing a Statement

The Statement should include the following detail:
INTRODUCTION
1. Your statement should begin with your full name, qualifications, job title and
area of employment.
2. Provide a chronological account of your involvement, from your first to your last
contact with the situation. You should pay particular attention to dates, times,
dosages of drugs etc. You should include where appropriate risk assessments,
and care plans/medication/referrals/second opinions obtained, to those risks.
Assume that the person reading the statement knows nothing about the
situation except for what you are writing.
3. What information did you have of the patients condition prior to this contact
with them? Had you previously cared for them? Did you receive a hand over
of the patients current condition?
4. State how patient presented to you upon your first contact. What were the
symptoms? Include any information received from other colleagues or from the
patient/family. State, were there any risks/concerns? What was the risk
management plan to those concerns? What was the medication regime?

Other Helpful Tips
1. Write your statement as soon after the event as possible while the facts are still
clear in your mind. You do not need the notes to write the statement.
2. Write in simple terms and avoid jargon or official language.
3. Stick to the facts and do not express subjective opinions unrelated to your area
of involvement.
4. When mentioning other professionals clearly include their name and status.
5. When describing hospital procedures explain what they are. Avoid general
statements such as routine observations recorded instead explain what this
included. If normal procedures were not followed, explain first what is normal
and then why there was departure from the accepted procedure.
6. If using abbreviations ensure that the full terminology is given at least once,
followed by the conventional abbreviation in brackets. Try and explain
technical terms in lay terms wherever possible.
7. Date your statement; where possible have your statement typed; if this is not
possible please write clearly in black ink or ballpoint pen as this statement will
probably be copied more than once.

Send a copy to the Patient Safety team Governance Division and
retain a copy for your information.
You may be requested to provide further information throughout
investigations



Incident, Complaints and Claims
Reporting and Investigation Policy


Appendix 8
Key Areas of Organisational Risk and Contacts
Area of Risk Contact person(s) & roles in relation to risk
Risk Management
Health and Safety
Head of Patient Safety and Quality
Head of Health &Safety
Asst Director for Occupational Health
In conjunction with the Director of Governance,
provides practical advice and support on the
assessment, treatment and management of risks
within the organisation. Provides expert source of
reference in the interpretation of Risk, Incident &
Health & Safety Policy.
Occupational Health Risk Manager (Health and Safety)
Director of Infection Prevention and control
Asst Director - Occupational Health
Provide advice on all areas relating to staff health,
including
illness, accidents, inoculation injuries, exposure
prone activities and inoculation status.
Buildings Divisional General Manager for Estates and
Facilities
Risk Manager (Health and Safety)
Provides expert advice on all areas of risk as they
relate to plant and the built environment
Complaints Patient Liaison Manager
In conjunction with Director of Nursing, manages an
effective complaints system including provision of
reports and statistics.
Supports staff involved in management
&investigation of complaints. Provides assistance in
the interpretation and implementation of local &
national complaints regulations & guidance.
Consent to Treatment Director of Nursing
Medico legal manager
Medical Director
Provide advice on the interpretation of consent
guidance in generic settings / specific cases.
Patient
Confidentiality/ Data
Protection Act 1998

Information Governance Officer
Medico legal Manager
In conjunction with Director of IM&T and Director of
Governance, provides systems for the safe and
confidential use of patient data.
Advises individuals, departments etc. on
implications of local and national guidance - works
with managers & clinicians to ensure compliance.
Medicines
Management

Chief Pharmacist
Provides an expert source of reference for all
issues relating to the
Incident, Complaints and Claims
Reporting and Investigation Policy


effective ordering, storage, prescription, dispensing
and administration of all medicines within the
hospital.
Contracted services (G4S)

Head of Facilities
Provides systems in which the quality and
effectiveness of contracted out services are
monitored. Deals with problems or issues arising
from or within the operation of such contracts
Emergency Preparedness

Assistant Director of Operations
Manages the production of the Trust Major Incident
Plan, facilitates the Trust Emergency Planning
Group, and has responsibility for ensuring that the
Trust has the infrastructure, resources and facilities
required to for optimal emergency preparedness in
collaboration with key managerial and clinical staff.
Fire

Head of Facilities
Risk Manager (Health and Safety)
Ensures that appointed Fire services provides
monitoring systems, training and advice on all
aspects of fire hazards/safety issues
Fraud

Director of Finance
Has overall responsibility for operation of counter
fraud Policy and
services.
Health Care Records

Health Care Records Manager
Ensures that Health Records are stored safely,
effectively, efficiently and in such as way as to
facilitate retrieval.
Advises managers and clinical staff on specific
issues of health records utilisation and disposal.
Incident Reporting

Head of Patient Safety and Quality
Operationally manages risk and incident reporting
systems and supports staff in their operation
Infection Prevention and
Control
Director of Infection Prevention and Control
Infection Control Doctor
Ensures that all of the Trust operates in such a way
as to prevent the spread of infection.
Provides advice to individuals and departments
regarding the
implementation of infection prevention and control
policies and guidance in both generic contexts and
in relation to specific infection control problems.

Information Management
and Technology

Director of IM&T
Ensures the operation of effective and safe data
systems. Acts as SIRO and advises the
management of information risks and preventive
action.
Incident, Complaints and Claims
Reporting and Investigation Policy


Security

Local Security Management Specialist
Provides guidance, training and specific advice and
guidance in relation to security risks
Works with managers in the investigation of
security incidents
Acts as link manager for police liaison
Safeguarding Children Director of Nursing Executive lead
Named doctor
Named Nurse
Named Midwife
Safeguarding Adults Director of Nursing Executive lead
Deputy Director of Nursing operational
lead
Violence & Aggression

Local Security Management Specialist
Risk Manager (Health and Safety)
Asst Director Occupational Health
Provide support, advice and specific interventions
in relation to specific incidents
Waste Management

Head of Facilities
Provides monitoring systems, training and advice
on all aspects of
hazards and safety issues relating to waste
procedures & materials.
Patient Care




Whistleblowing
Specific patient risk issues are brought to the
attention of ward managers, matron, Heads of
Nursing, Consultant leads or service heads, as
appropriate.
Incidents are reported via Datix and / or contact
Patient safety and Quality team. If in doubt contact
the Director of Nursing, Medical Director or Director
of Governance.
Director of Human Resources
Other Information
Governance issues,
including clinical record
keeping, corporate
records
Management (retention
periods) and Freedom of
Information Act requests
Information Security Officer
Provides advice on policy and operational queries
in these areas.

Training

Head of Education & Development
Provide monitoring systems and resources for
training and advises on aspects of risk in relation to
training




Appendix 9

Incident management: Endoscopy Services

Contact numbers:
Diagnostic Services Manager: 0208 235 4107

Endoscopy Decontamination Services manager 0208 869 5382

Exec team secretary/ Wolfson Unit: 0208 235 4225

Divisional General Manager / General Manager - secretary: 0208 235 4006
Site Manager: Bleep 013

Director of Governance: 07887 751826 - mobile

Head of Patient Safety: 0208 869 5848

Urology General Manager: 0208 869 3841 or 0208 869 3832
ENT General Manager 0208 869 4244 - CNS ENT x 3098

Endoscopy Sisters St Marks: Endoscopy Recovery 4141 /4142
Endoscopy Sisters ACAD: 6 8911/8828

Endoscopy Pre-assessment staff: 0208 235 2044 and 0208 235 4135

Programme Manager Bowel Cancer Screening: 0208 869 3543

Q Despatch: 0207 424 9559 (State need suitable transport to transport clean and dirty endoscopes)



Incident, Complaints and Claims
Reporting and Investigation Policy







Appendix 10

Root Cause Analysis Interviews

Preparation
Listening to the first-hand accounts from those involved in an incident as soon as
possible after it has happened will help the investigation team start to build a
picture of what happened and potentially highlight what other information will be
required.
The optimum time for holding an interview is between two1 and 72 hours after the
incident.2
The interviewer needs to establish who they want to interview and make
arrangements to do so as soon as possible. The identified staff should be invited to
attend; told the purpose of the interview; what to expect; and what preparation they
need to do. It is essential that the interviewer and the room are prepared prior to
the interview.

Inviting the member of staff to attend for an interview
Where appropriate, a written invitation to the interview can be provided and the
details below included. Where this is not practical due to the need to see staff as
soon as possible after the incident, staff should be advised in advance and be
given the following information verbally:
the purpose of the interview and details of the incident being investigated;
the time, place and estimated length of the interview;
who will be conducting the interview and their role;
how the cognitive interview will be conducted and the first-hand account recorded
(e.g. the interview will be informal, notes will be taken to inform the investigation,
but these will not act as a formal witness statement and do not need the
interviewees signature);
what documentary evidence will be available to them during the interview;
the fact that they can bring a friend or colleague for support (explanations need to
be given regarding the role of this friend/colleague e.g. confidentiality, their
involvement);
advice on what will happen after the interview.

Interviewer preparation
The interview should take place in a quiet, relaxed setting and, if possible, away
from the interviewees usual place of work and not at the scene of the incident. ).
Where possible, the interviewee should have the opportunity to attend the
interview in work time and arrangements may need to be made with their line
manager to ensure this.
Depending on the nature of the case or the interviewees personal involvement,
they may find the process of recounting the events either upsetting or disturbing.
The interviewer will need to have information available on staff support/counselling.
The interviewer should ensure they have all the relevant documentation available
at the interview.
Incident, Complaints and Claims
Reporting and Investigation Policy


It is important to remember in the cognitive interview to only interview one staff
member at once.
Conducting the interview
Introductions (where appropriate) should be made of those present in the room.
Include details on roles and an explanation of the sequence of the interview and
approximate length. The RCA process should be explained and an estimate given
of how long it will take to complete.
It is important to reinforce that this is not part of a disciplinary process. The
interviewer should explain that notes will be taken throughout, for the purpose of
informing the investigation. It must be stressed that these notes will not act as a
formal witness statement and therefore do not need the interviewees signature.
The interviewee should be asked to confirm they have understood all of the above
and should be reminded that they should offer only factual information, but include
everything regardless of whether they think it is relevant or not. The interviewee
should be discouraged from making off the record comments. The interviewee
should also be advised that the first-hand account and the final report will be
written with due anonymity to staff and the patient.

Completion of the interview
On completion, the interviewer should ensure the interviewee feels appropriately
supported and that any further support required is organised. The interviewer
should reconfirm what will happen with the information gained from the interview
and how this will be used in the RCA process.
Incident, Complaints and Claims
Reporting and Investigation Policy

Оценить