Document

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Prepared by

Terry Service

Responsible Area: Risk Management

Approval Information:

Date Approved: COMMITTEE:-

Governance Committee 02.05.07

Approved By:

Sign

Print Name

Version No.: Three

Review date: April 2008

Reference to Standards for Better Health Domain

Department of Health 2004 Standards for Better Health First domain Safety Fourth domain Governance

Core/Development standard

Core Standard C1 C1B D1 C7B C8A

Performance indicators

1. Number of incidents reported. 2. Adherence to timescales 3. Reporting of incidents to SHA

SERIOUS UNTOWARD INCIDENT PROCEDURE

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Description: It is essential that all serious and untoward incidents that occur in the PCT are reported appropriately and handled effectively. This document covers the reporting arrangements and describes the actions that will be taken in terms of communication and follow up when a serious or untoward incident occurs. It will provide guidance to and is to be understood by all staff employed by the Trust. It is the responsibility of each manager to ensure that all staff are conversant with this policy and its contents.

Section Title Page number

1 PCT statement 2 2 Introduction 2 3 Standard Definitions 2-3 4 Information 4

5 Roles and Responsibilities 4-5 6 Fair Blame Culture 5 7 Links with supporting organisations (stakeholders). 5 8 Procedure for Serious Untoward Incidents (SUI) 5 9 Internal reporting 5-6 10 Immediate action 6-7

11 Action within 24 hours 7 12 Action within five working days 7-8 13 Action within eight weeks 8 14 Internal reporting and audit of actions 8 15 Reporting to the Strategic Health Authority. 8-9 16 Investigation. 9

17 Communication requirements 10 18 Communication with patients, their families and carers. 10 19 Communication with the media. 10 20 Incident room and help line 10 21 Staff support 11

App 1 List of supporting organisations (stakeholders) App 2 National enquiry reports

App 3 Examples of Serious Untoward Incidents App 4 PCTSUI report form. App 5 SHA report information. App 6 SHA suggested action plan App 7 SHA Exception report information App 8 SHA Good practice principles for incident management

App 9 Information on statement provision App 10 Information for staff App 11 References

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Kirklees Primary Care Trust

Serious Incident Policy and Procedure

1.0 PCT Statement

The Kirklees Primary Care Trust is committed to working together to improve services for patients, staff and the general public. Part of this philosophy is about ensuring that when things go wrong, events are reported and reviewed and that learning and action takes place.

2.0 Introduction

A robust system for identifying and managing serious incidents allows the PCT to investigate incidents quickly, to review practice and identify trends and patterns. This document lays out the process to be followed should a serious untoward incident occur. It is one of a set of documents that underpin the risk management and Clinical Governance programmes for the Trust. The PCT has a responsibility to work with statutory bodies such as the Police and this procedure does not supersede the normal legal requirements to notify other agencies of certain incidents. All serious untoward incidents must be reported to the Strategic Health Authority (Yorkshire and Humber) using the process outlined in this document. It is essential that all serious and untoward incidents that occur in the PCT are reported appropriately and handled effectively. This document covers the reporting arrangements and describes the actions that will be taken in terms of communication and follow up when a serious or untoward incident occurs. It will provide guidance to and be understood by all staff employed by the Trust. It is the responsibility of each manager to ensure that all staff are conversant with this policy and its contents. This policy should be read in conjunction with the following PCT documents:

• Incident reporting policies and procedures.

• Risk Management Strategy

• Incident, Complaint and Claims policies and procedures.

• Risk Assessment policies and procedures.

• Emergency Plan

• Whistle Blowing Policy

• Media Handling policies and procedures.

• West Yorkshire Strategic Health Authority (WYSHA): Serious Untoward Incident policies and procedures.

• Infection Control Policies

3.0 Standard Definitions;

Definition of a serious untoward incident (SUI).

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A SUI may be defined as an incident where a patient, member of staff, or member of the public has suffered serious injury, major permanent harm, or unexpected death or where there is cluster/pattern of incidents or actions by NHS staff which have caused or are likely to cause significant public concern.

‘Near misses’ may also constitute SUIs, where the contributory causes are serious and under different circumstances could have led to serious injury, major permanent harm, or unexpected death, but no actual harm resulted on this occasion. A possible example is that of a system failure, the result of which is incorrect/delayed diagnosis. This may not have any serious consequences for some patients, but for others could lead to the wrong treatment/serious delay in treatment and ultimately to death.

Examples of Serious Untoward Incidents are shown as Appendix three

4.0 Information

In the course of the Trust’s business, incidents occur which have serious/potentially serious consequences for patients, the public, staff and the organisation. The PCT has a responsibility to ensure that the risks to all concerned are minimised and that every effort is made to learn from experience and improve clinical practice, organisational practice, systems of working, policies and procedures. One approach to executing these responsibilities is to conduct the review of serious incidents in a manner, which is in keeping with the Trust’s commitment to openness in all of its activities. A sound system for identifying and managing serious incidents allows the PCT to investigate incidents quickly, to review practice and identify trends and patterns. It enables monitoring and evaluation of the quality of patient care, procedures, systems of working and training. The system also identifies liability risks and helps to prepare the Trust’s response to legal claims that may naturally arise out of an incident.

5.0 Roles and Responsibilities

The Chief Executive has overall accountability for Risk Management but will devolve the responsibility for the overall management of Serious Untoward Incidents to the Director of Corporate Services. The management lead for a SUI investigation will usually be the Director with responsibility for the area in which the SUI arises. They may delegate this responsibility to one of their immediate deputies but should seek support from staff with specialist skills, knowledge and experience to assist with the task. The implementation of actions arising from any investigation or inquiry remains the responsibility of the relevant directors and managers, along with the debriefing and support to individuals following a serious incident. The PCT is responsible for ensuring that all commissioned services have robust systems to manage any SUI and that they report them through to the PCT. The Director of Corporate Services is responsible for ensuring that any SUI that occur

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with a commissioned services is investigated and ultimately reported to the relevant authorities e.g. Health Care Commission and the SHA.

6.0 Fair Blame Culture

The PCT recognises that most serious incidents occur as a result of the accumulation of a number of factors and events all conspiring together. Staff should be encouraged to report incidents without fear of disciplinary action in a culture of learning so that quality infuses into all aspects of the Trust’s work. Fear of disciplinary action may deter staff from reporting an incident. The view of the PCT is that disciplinary action will normally not form part of the response to an incident, except in cases where:

• In the view of the Trust, and or any professional registration body, the actions causing the incident/arising from the incident were far removed from acceptable practice.

• Where there is failure to report an incident in which the member of staff was either involved or about which they were aware.

7.0 Links with supporting organisations

There are a number of organisations who are able to support the PCT with the management of a SUI. These include the National Patient Safety Agency (NPSA), The Health Care Commission, The National Clinical Assessment Authority and the Strategic Health Authority (Yorkshire and Humber). The involvement of these organisations must always be considered as part of any investigation. The Risk Management Team for the PCT will ensure that all statutory reporting is completed e.g. the Health and Safety Executive. Appendix one is provides a detailed list of organisations who may be able to assist in any part of an investigation.

8.0 Procedure for Serious/Untoward Incidents

In order for a SUI to be managed effectively a number of actions need to occur at set times. These actions are designed to ensure that the safety of patients and staff occurs as a priority, the relevant staff, managers and organisations are advised on a priority basis and resources are made available.

9.0 Internal reporting

It is important that the Chief Executive should be informed of any serious incidents as soon as possible, according to their level of severity. This will usually be within 1- 2 hours during the working day but must occur within 24 hours of the incident. Out of Hours the Director on Call may be advised in the absence of the Chief Executive. In order to achieve effective internal reporting, the following actions must be undertaken.

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1) The Director on Call must be informed immediately of any of the serious incidents.

2) The Director on call will then inform the Chief Executive (CE), the Director with responsibility for where the SUI occurred and the Head of Communications.

3) The CE will ensure that the PCT Chair is informed as appropriate. 4) The CE, or the Director on Call will decide whether the incident is serious

enough to inform the Strategic Health Authority. 5) If an internal inquiry is required, this should be established as soon as

possible with a Director and investigating officer appointed.

The Strategic Health Authority is responsible for informing and briefing the Department of Health and ministers. Once the decision has been made to brief partner organisations and stakeholders, e.g. NHS Direct, PCT staff, GPs and other contractors, Local Authority, MPs, Strategic Health Authority etc then the Communications Team will ensure that they are briefed and receive regular updates via their relevant Communication Teams.

10. Immediate action

As with any incident the most important action is to ensure that all patients and staff are safe and this must always be completed first. If any action is taken to ensure patient or staff safety then this must be recorded as it may play a vital part in the investigation especially where any items of equipment have been moved to make the area safe. The next action is to ensure that the relevant support and authority is brought in to help manage all aspects of the case. This will involve contacting line managers who should then escalate the case up to include contacting the Director (which will include the Director on call during out of hours). In conjunction with the Director and senior managers decisions will be made to:

1. Inform patient(s) & family/carer/relatives (refer to section eighteen). 2. Inform Police / other agencies. 3. Provide support to staff and patient(s). 4. Provide support to onlookers/public. 5. Quarantine equipment 6. Secure case notes and records. 7. Identify all individuals who may be involved in the case. 8. Advise the Chief Executive. 9. Contact the SHA especially if there is a possibility of adverse media interest

or there is a need to agree a media handling strategy. 10. Contact specialist staff from the PCTe.g. Public Relations, Risk Management.

It is important that as much of the incident is captured early on and therefore it helps if relevant documentation is completed as soon as possible. This includes the completion of a PCTSUI report form (appendix four) which needs to be sent to the Director on call preferably within one hour. It is accepted that in certain circumstances this will not be possible but in these cases it should be reported to the

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line manager and a timescale provided. The first few hours of an incident are often the most important and therefore there are a number of specific actions that need to occur depending on the severity of incident. These actions will include;

1. Ensuring that the relevant support is provided to patients, relatives, carers and staff.

2. Securing all items of equipment, records, case notes, files, data and relevant

information including contact details of all staff, patients and authorities involved. All equipment involved with the case must be quarantined and other than in a police or HSE investigation the equipment must not be released to any other third party (including other NHS or commissioned services) without the express authority of the Director of Corporate Services or deputy with responsibility for SUI.

3. Informing the Strategic Health Authority who then opens an entry in the SHA

electronic data base known as UNIFY (formally known as STEIS). It is always beneficial to provide early information to the SHA in the first instance with more detailed information at a later stage. If there is any doubt on the need to inform the SHA the advice should be sought from the Integrated Governance Team on 0113 2952089 or pager on 07699 760979.

4. Linking with partner organisations to ensure that communication channels are

opened on at least three levels;

1) Clinician to clinician 2) Risk lead to risk lead 3) Communications lead to communications lead.

11. Within 24 hours.

Initial statements must be completed from all staff who may have been involved. Where necessary formal statements may be required at a later stage and these will be obtained in due course. Appendix Eight provides a template for statements and gives information for staff on the process that is followed. A log of all documents related to the incident should be completed with all documents well secured. Where documents are required as part of a police investigation then these must be provided as requested. For criminal investigations consent is not required to release records but any records being released must be copied first and a record made of what documents have been handed over, where there are going, who took them and when.

12. Within 5 working days

A management report/review needs to be prepared by the investigation lead and submitted to the lead director within five working days with the objective of

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establishing if any further action is required. At this stage the report is considered as an interim action that will be used in discussion with the PCTDirectors and the Strategic Health Authority.

13. Within eight weeks.

The SHA will expect to receive a completed report on the investigation and must include the recommendations on actions taken to minimise the risk of reoccurrence and the agreed action plan. The report must be signed off by the Chief Executive or a Board Director with clearly identified leads and timescales and a process for ensuring that all actions are completed. Appendix five sets out the minimum points that the SHA will expect to see contained within the final report. If the eight week timescale cannot be delivered then the SHA Integrated Governance Team must be advised on the causation and the timescales and UNIFY updated as necessary. Appendix six gives the minimum information that the SHA will expect to receive from this report which must be submitted on an exceptions basis

14. Internal reporting and audit of actions

All Serious Untoward Incidents will be reported to the PCT Board via the Governance Committee. The Governance Committee will take an overview of all findings and actions related to the SUI and will ensure that there is an audit trail to ensure that all actions are completed. The operational aspects of the SUI management will be through the PCT Risk Management arrangements

15. Reporting SUI to the Yorkshire and Humber Strategic Health Authority.

All NHS Trusts are required to report all serious untoward incidents to the Strategic Health Authority. These include both clinical and non-clinical incidents as identified in Appendix three The Chief Executive’s office and director (and delegated lead) with responsibility for risk management hold details of “passwords” for accessing UNIFY. Access to UNIFY is controlled and access details will not be provided without the authority of the Director of Corporate Services. The Director on Call or the risk management lead should telephone the SHA to discuss/add to the UNIFY report, particularly where there are concerns about patient safety or potential media interest. Out of hours, the PCT should page the SHA first line on-call manager if the SUI is of an exceptional nature and immediate support is required. In these cases it will be necessary to ring pager number 07699 760979 and leave a message with the operator to contact the SHA on-call manager. The report is made electronically on UNIFY as soon as practically possible (at the latest within 24 hours of the incident during the working week). Reports must be anonomised and contain no identifiable information e.g. patient or staff names.

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The SHA will acknowledge receipt of the UNIFY report by e-mail within two working days. One role of the SHA is to identify any similarities in reports including trends and similar incidents from other organisations and to assist with ensuring that learning takes place across the NHS. Any major updates to UNIFY should be supported by a telephone call or email to the Integrated Governance team using the safe have email address at; [email protected]) In cases where there are serious concerns about the actions of an individual health professional and s/he is considered likely to be seeking work with other employers who would be unaware of the concerns then the Integrated Governance team at the SHA will ensure that the Trust/PCT liaises with the Regional Director of Public Health, who will issue an alert letter on behalf of the SHA if the relevant criteria are met. This action is in line with DH guidance ‘Handling concerns about the performance of healthcare professionals: principles of good practice.’ Where a SUI involves more than one NHS organisation (e.g. a patient affected by system failures both in an acute hospital and in primary care) then the SHA will aid in making the decision to ensure that a lead organisation is identified and reports the joint findings through to the SHA. It is the role of the SHA to performance manage timescales and to ensure that feedback is provided to all Trusts in the Yorkshire and Humber region on any trends and lessons that have been learned.

16. Investigation

Any investigation completed within the PCT requires staff and resources to be allocated to complete the task within the timescales. Directors and senior managers are tasked with ensuring that the investigation and resources are proportionate to the scale and complexity of the SUI in question. Staff conducting an investigation must be suitably trainied and experienced in completing investigations which should use the National Patient Safety Agency Root Cause Analysis as the tool of choice. In more serious cases, particularly where there is likely to be significant public interest, it may be advisable to commission an external review or include an external representative on the investigation team. In these cases it is a requirement to inform the SHA that these representatives are being utilised and to provide the Terms of Reference. Any inquiries must not interfere with other investigations both internal or external e.g. with the Police, HSE or HCC but can be conducted at the same time providing there is no conflict of interest. For precisely these case the Department of Health have in place a Memorandum of Understanding between the DH, HSE and Association of Chief Police Officers (February 2006) on investigating patient safety incidents involving unexpected death or serious untoward harm. This is available from the DH. Appendix eight gives best practice guidance provided by the SHA on investigations

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17. Communication requirements

Clear Communication is a vital action both initially and subsequently both to seek a cause of the incident and to ensure that lessons are learnt and owned by anyone involved or affected by the incident.

18. Communication with patients and their families or carers.

Normally, communication with patients or clients and their relatives will be via the appropriate member of the operational staff e.g. District Nursing Sister. In the first instance the action is to ensure that patients, clients and relatives are supported and advised that an investigation would be conducted and they would be advised of the outcome. It is important that staff do not try to suggest any causation, blame or identify any person involved to a patient without seeking the authority of senior manager. This action is to ensure that only facts are communicated and patients, clients, relatives and other staff are not misinformed. Any requests for information by the media must be referred to the Head of Communications or a Director within the Trust. Staff must not under any circumstances provide statements to the media. This action is again to ensure that the information provided is factual and that no misinformation takes place.

19. Communication with the media.

The Head of Communications is responsible for ensuring that communications channels are opened and maintained with patients, stakeholders and the media and for making sure that the information provided is factual and agreed by the PCT Directors. No information will be provided to the media before it has been given to patients and stakeholders especially the SHA for complex cases involving other organisations. The Head of Communications will ensure that all requests for information are logged and responded to as necessary.

20. Incident Room and help line.

For more serious incidents it may be necessary to set up an incident room with hotline phone lines. Hotline phones will be staffed and managed by PCT staff with a record of all calls being made and provided to the investigation team and where necessary any stakeholders or external investigations e.g. the police. The responsibility for ensuring the hotline numbers are circulated to the general public rests with the communications manager supported by the SHA. The PCT Emergency plan contains specific instructions on how to set up and manage an incident room with equipment provided in all major PCT premises. The PCT Emergency Plan is updated regularly and is therefore not included within this document.

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21. Staff Support

Any Serious Incident has the potential to affect staff both physically and emotionally and this must be supported. The need to provide support may occur directly after the incident or some time afterwards and managers should be alert to those factors which may necessitate support and provide the relevant resources for this to take place. For the purpose of managing Serious Untoward Incidents The term ‘staff ‘ should include directly employed staff and contractors who have been involved in the case e.g. General Practitioners and their staff. The welfare of staff involved in any serious untoward incident must be considered, particularly in relation to psychological trauma or stress. Any support offered must remain confidential to the individual. Managers and Directors should seek advice from the Human Resource Department and Occupational Health on what to look out for with staff who have suffered or may be suffering from stress resulting from an incident. The Occupational Health Department will offer individual counselling either directly or via referral to a commissioned service authorised and financed by the PCT. Staff should be made aware of this service and given the telephone number and encouraged to contact the department to access this service as necessary. It is also important for staff to be kept fully aware of the progress of an inquiry with which they have had clear associations. This will be the responsibility of the investigating team. In particular, staff involved should be kept aware of progress and when the report has been completed, the findings, recommendations and action to be taken should be relayed to them, giving them the opportunity to ask questions.

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Appendix 1

Potential stakeholders/resources for service improvement/risk management

This list is NOT exhaustive, nor in any order of importance.

• Care Standards Improvement Partnership Hyperlink

• Clinical Governance and Complaints Committees

• Risk Management

• Commissioners

• Confidential Enquiry into Maternal and Child Health Hyperlink

• HM Coroner

• Counter Fraud and Security Management Service Hyperlink

• Department of Health Hyperlink

• Environmental Health

• Executive Directors

• General Medical Council Hyperlink

• Nursing Midwifery Council Hyperlink

• Health and Safety Executive Reporting of Injuries, Diseases and Dangerous Occurrences Regulation Hyperlink

• Health Protection Agency Hyperlink

• Health Service Ombudsman Hyperlink

• Healthcare Commission Hyperlink

• Local Authority

• Local Supervising Authority (Midwifery Officer)

• Media

• Medicines and Healthcare products Regulatory Agency Hyperlink

• Memorandum of understanding: Investigating patient safety incidents involving unexpected death or serious

untoward harm Hyperlink

• Mental Health Act Commission Hyperlink

• National Clinical Assessment Service Hyperlink

• NHS Clinical Governance Support Team Hyperlink

• National Confidential Enquiry into Patient Outcome and Death Hyperlink

• National Confidential Inquiry into Suicide and Homicide by People with Mental Illness Hyperlink

• National Institute for Health and Clinical Excellence Hyperlink

• National Institute for Mental Health Executive Hyperlink

• NHS Counter Fraud and Security Management Service Hyperlink

• NHS Information Centre Hyperlink

• NHS Litigation Authority (CNST & RNST) Hyperlink

• National Patient Safety Agency & National Reporting and Learning System Hyperlink

• Other Trusts

• Overview and Scrutiny Committees

• PALS (Patient Advocacy and Liaison Services)

• Patient Experience Committee

• Patient/Carers/Family

• Police Hyperlink

• PPI (Patient and Public Involvement) Forums

• Prison Service Hyperlink

• Protection of Vulnerable Adults Hyperlink

• Safeguarding Boards

• Social Services (notably Child Protection/Mental Health)

• Staff

• Strategic Health Authority Hyperlink

• Trade Unions Hyperlink

• PCT Board

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Appendix 2

National Inquiry Reports 1. Ayling Report Hyperlink 2. David Bennett Inquiry Hyperlink 3. Kerr Haslam Inquiry Hyperlink 4. Richard Neale Report Hyperlink 5. Shipman Inquiry Hyperlink 6. The Victoria Climbie Inquiry Hyperlink

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Appendix 3

EXAMPLES OF SERIOUS UNTOWARD INCIDENTS Only the most serious of incidents require reporting to the SHA. It is difficult to be prescriptive, but the following are examples of events that would warrant reporting.

• Death or serious injury to a patient or member of the public which is alleged to be at the hands of another patient or member of the public while on NHS premises

• Suspected homicide by a person currently in receipt of mental health services (or within the last six months)

• Suicide of a person currently in receipt of NHS mental health services (both out-patients and in-patients) or who have received NHS mental health services in the last six months

• Serious injury of a person currently in receipt of NHS care (or within the last six months) as a result of deliberate self-harm (e.g. attempted suicide) or accidental injury

• Patients detained under the Mental Health Act who abscond from NHS care and who present a serious risk to themselves and/or others. Of particular concern would be those patients who abscond from medium secure or specialist forensic services, those who are likely to pose a risk to the public, attract media attention and/or who commit an offence in the community

• Any death on GP premises (in line with Shipman recommendations)

• Death or serious injury to a child which results in a ‘serious case’ review under the Children's Act 1989, where health has played a major role

• Death or serious injury to a member of staff (including independent contractors e.g. GPs, dentists, opticians, pharmacists) in the course of their NHS duties

• Medication incidents resulting in death/serious injury eg incorrect medication dispensed to patient; drugs given to patients with known allergy

• Failure of medical equipment resulting in death/major injury

• Clinical incidents resulting in death/serious injury e.g. surgery performed on wrong patient, wrong site, etc

• Serious fires or other serious damage, which occurs on NHS/Independent contractor premises. Of particular concern would be any fire which resulted in casualties or major disruption to services

• Serious or unexplained outbreaks of infection or disease in hospital or the wider community (e.g. food poisoning, Legionnaire’s Disease) or the confirmed transmission of serious infectious disease between an NHS staff member and a patient (e.g. HIV/Hepatitis B)

• Major system failure e.g. failure of laboratory services to provide accurate screening results; patient referral system failure for further consultation/treatment

• Major environmental incident (e.g. release of gas/chemicals, inappropriate disposal of clinical waste) which has or could have harmed the public

• Major service disruption e.g. due to power failure, flooding, etc

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• Major breach of patient confidentiality e.g. theft of patient notes or computers/laptops containing patient information; discovery of patient records in public area

• Incidents/concerns regarding the actions of NHS staff (including independent contractors). Examples include fraudulent behaviour, gross misconduct and actions resulting in harm to patients. This could lead to suspension/summary dismissal, media interest and the involvement of the criminal justice system

• A pattern emerging that is causing concern such as a high number of complaints regarding a member of staff (including independent contractors), a particular service and/or hospital that may warrant further investigation and action.

This list is NOT exhaustive nor in any order of importance. Personal judgement will need to be exercised when deciding whether or not to report and manage an incident as a SUI. If in doubt, contact the SHA for advice.

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APPENDIX 4

KIRKLEES PRIMARY CARE TRUST

SERIOUS INCIDENT REPORT FORM

Incident directly involved: Name:…………………………………………………… Male [ ] Female [ ] Staff [ ] Visitor [ ] Contractor [ ]

Home Address: ……………………………………………………………………. Date of Birth: ……………………. ……………………………………………………………………. Post Code: …………………………………………………………………….. Date of Incident:………………………………….

Time of Incident………………………

All Others involved in Incident: 1)

Name: ………………………………………………………….

Date of Birth:..../….../….. Designation: Staff/Patient/Visitor

Home Address:……………………………………… …………………………………………………………………………………………………….

2)

Name: ………………………………………………………….

Date of Birth:..../….../….. Designation: Staff/Patient/Visitor

Home Address:……………………………………… …………………………………………………………………………………………………….

Please tick appropriate box Category of Incident

Sexual assault (alleged or actual)

Alleged abuse of vulnerable adults (alleged or actual)

Actual abuse of vulnerable adults

Serious assault

Loss of clinical records

[ ]

[ ]

[ ]

[ ]

Serious failure/misuse of equipment

Violent incident resulting in hospitalisation

Financial abuse/irregularities

Incident involving child serious case review

Other – Please specify

[ ]

[ ]

[ ]

[ ]

[ ]

Note: Reporting of serious incidents must be in line with procedural timescales.

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Witnesses to the incident but not directly involved:

1) Name:…………………………………………… Date of Birth:..../….../….. Designation: Staff/Patient/Visitor

Home Address:…………………………………………………………………………………………………………………………………


Home Address:…………………………………………………………………………………………………………………………………


Home Address:…………………………………………………………………………………………………………………………………

Who has been informed:

Designation

……………………………………………….

Designation:

…………………………………………….

Name: ………………………………………………………………………

Name: ……………………………………………………………………..

Name: ……………………………………………………………………..

Designation:

……………………………………………….

Brief circumstances of the incident and immediate action (this must be followed up with a statement of facts known/action within 24 hours). FACT ONLY – NOT OPINION MUST BE RECORDED

This initial notification should be followed up by a statement of known facts within one working day and a Management Report/Review within five days. Please fax ( ) the completed form to within 24 hours of the incident. If you have any queries regarding this form please telephone:

Document completed by

Name Designation Date Signature

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APPENDIX 5

The following information should be provided as part of the interim report. This information is the minimum and should be supported by evidence at all stages.

• Author, date of the report, incident reference number (provided by the SHA).

• Factual description of incident, covering the following:

� Who or what was involved? � What happened? � When did it happen? � Where did it happen? � How did it happen?

• Risk rating using the PCT risk rating system.

• Outline of action taken, including any support to relatives, patients and staff, contact with the media and notification to external bodies (e.g. Police/HSE). State who notified these bodies and when.

• Details of follow-up investigation including listing of signed statements, interviews, evidence preserved, etc

• Any other relevant information

• Root cause analysis to identify why the incident occurred.

RCA is a structured investigation that aims to identify the true cause(s) of a problem and the actions necessary to eliminate it, as follows:

The following factors should be considered when undertaking RCA: � Individual factors eg knowledge, experience, competence � Task factors eg consider whether task is routine or exceptional � Equipment factors eg suitability, state of repair � Environmental/working condition factors eg lighting, heating, general stress levels � Communication factors eg written/verbal, between individuals, teams, and organisations � Team factors eg team dynamics, team working � Organisation and management factors eg financial resources and constraints,

organisational policies, leadership and organisational culture.

RCA should not just focus on problems, but also be used to identify and highlight good practice where it has occurred.

• Conclusions

• Recommendations (optional – can go straight to action plan stage)

• Action plan to address root causes and minimise potential for recurrence (see template at Appendix 6). � Clear and specific action points � Name and title of individual(s) responsible for each action � Timescales for each action

• Indication of how learning will be shared.

• Chief Executive/Director sign off.

WHAT happened? HOW it happened? WHY it happened?

Unsafe act Human behaviour Contributory factors

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Appendix 6

ACTION PLAN EXAMPLE

NO.

ISSUE ARISING FROM

RCA/INTERNAL INQUIRY

ACTION

LEAD INDIVIDUAL

TIMESCALE

COMPLETE

1

Operational policy does not include specific

communication standards

a. Revise policy

b. Issue and publicise policy

c. Carry out audit to ensure communication

standards being adhered to in practice

Mr X

Director of Nursing

a. 31.12.06

b. 15.1.07

c. 30.4.07

Appendix 7

Interim SUI report at 8 week point

NB Only to be used by exception – Investigation teams should aim to submit a full investigation report and action plan within eight weeks.

Reason why there is a delay in meeting the eight week timescale.

Description of the incident (as much information as is known at this point):

1. Who, or what was involved? 2. What happened? 3. When did it happen? 4. Where did it happen? 5. How did it happen? 6. What evidence is available? 7. Who is leading the investigation?

Immediate actions taken by the organisation to minimise the risk of recurrence Support offered to:

• Patient

• Relatives/carers

• Staff Contact with media and who the communications lead is. Notification to external bodies (specify who and when) Is an external investigation involved with the investigation? Timescales of interim/final external investigation (anticipated timescales if not known) Timescale for completion of internal investigation, including timeframe for updates to the SHA – default position of eight weekly updates unless circumstances indicate a more appropriate alternative.

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APPENDIX 8

Good Practice Principles for Incident Management

December 2006

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1. Introduction

1.1 This document has been developed from the ‘Serious Untoward Incidents Principles’ document

issued in March 2006 by the former North East Yorkshire and Northern Lincolnshire (NEYNL)

Strategic Health Authority. The original document was developed by NEYNL Trusts and PCTs,

following a workshop jointly co-ordinated by NEYNL Strategic Health Authority and the

National Patient Safety Agency.

1.2 This document, which provides a resource for NHS organisations in developing their own

incident management procedures, should be read in conjunction with the Yorkshire and the

Humber ‘Procedure for the Management of Serious Untoward Incidents’, which outlines

reporting, investigation and action expected in relation to those incidents classified as ‘serious

untoward incidents’ (SUIs).

Issues to consider when developing PCTincident management policy

2. Managing Complexity

2.1 Incidents vary enormously, for example in terms of the numbers of patients affected, the

severity of the outcome, the likelihood of recurrence and the degree of public interest. The

approach taken to investigation and follow-up action should be proportionate to each incident

(including ‘near misses’ which may not have resulted in actual harm, but where there are useful

lessons to be learnt).

2.2 Table 1 sets out some key stages in the investigation/learning process, and can be used

to identify timescales in the management of incidents. Expected timescales for investigation and

reporting can help manage the expectations of staff and patient/family, clarify expectations

between organisations, and maintain confidence in the process.

3

Table 1

Incident type

Examples of key points

Less complex Relates to short period

of treatment in one

department or

specialist area, not a

coroner’s case

Complex Information gathering

covering more than one

department OR

investigation covers

prolonged or multiple

episodes of care OR

involves one other agency

e.g. coroner

Exceptionally

complex Exceptionally complex

investigation involving

multiple agencies OR

possible criminal

charges

Appointing lead investigator

or investigating team

Gathering information from

direct witnesses Staff memory will become

steadily less reliable within two

weeks of the incident.

Providing initial briefing

report on facts established to

date

Completion of investigation

stages i.e. investigation complete root

causes established

Completion of draft report,

recommendations, and

action plan For accuracy checks with those

involved, discussion, refinement,

etc.

Presentation of draft report,

recommendations, and

action plan for formal

approval

Submission of final report to

SHA/PCT etc.

Sharing final report with

patient/family

Supplementary report if any

new findings or

requirements following

coroner’s inquest, court

hearings, etc.

Not applicable

2.3 Individual incident investigations may overlap with complaints, disciplinary procedures, managing

performance, litigation, coroner’s investigations, professional registration, child protection or police

enquiries. PCTincident management policy/procedure should identify how this will be managed, for

example how potential disciplinary issues identified in the course of a SUI investigation will be

referred on to a separate process of investigation.

2.4 There are potentially multiple aims and purposes of incident investigations (see Appendix 14.1).

Incident policy/procedure therefore needs to provide clear guidance on the remit or terms of

reference of investigations, consistent without being restrictive in the event that findings change the

direction of the investigation.

4

“It had looked like a fairly straightforward investigation into an unexpected clinical outcome but as soon

as I started talking to staff there was this whole history of concerns and other incidents related to one

clinician coming out.”

“Staff have generally preferred the same statement to be used internally and for the coroner rather than

write two and that worked well as we had a fair minded coroner who was not looking to make a big issue

out of anything they mentioned that wasn’t relevant to the incident. I’m not sure that will be the same with

the new coroners’ rules though.”

“We couldn’t interview staff until after their police interviews were completed, then we found they were

telling us things they hadn’t told the police.”

“Not all SUIs investigations are the same. The patient might have a new acute illness and was only

admitted for an hour or two – so all the info you need, all the people you need to talk to are right there - or

you might be looking at weeks of admission, different wards, different teams and notes bigger than the

phone directory.”

“We started out with a SUI around a specific incident and ended up becoming much more concerned about

the clinical care provided to a whole cohort of patients.”

3. Distribution

3.1 The process of sharing investigation findings and reports with the patient and/or family needs to

comply with the NPSA’s Being Open principles.

3.2 Unless there are specific exceptions, the patient or family of a patient are likely to have a right to the

full investigation report under Data Protection Act 1998 requirements. Organisations need to support

investigators to ensure this does not inhibit them from identifying areas of concern.

3.3 Staff should as far as possible avoid disclosing in a report health or personal issues of a patient who

died, that the patient may have previously chosen not to disclose to their family.

3.4 Some coroners are fully aware of the incident management process and expect the report to be

shared with them; others require only the information gathered.

3.5 There are many other potential stakeholders (see Appendix 14.2) who may routinely or exceptionally

request or require sight of incident reports.

3.6 PCTpolicies should give clear and consistent guidance on who, how, and in what

circumstances, incident investigation reports are shared.

4. Planning and Administration

4.1 Staff who are expected to lead or participate in SUI investigation teams should be identified so that

they can receive appropriate training and support.

4.2 There should be a mechanism to ensure lead investigator/investigating team roles are allocated fairly

over time between designated staff. This mechanism needs to allow for different types of incident

e.g. clinical, facilities, and public health.

4.3 The personal qualities of the lead investigator/investigating team need to be considered –

assertiveness, objectivity, empathy and tenacity are valuable.

5

4.4 The investigation should reflect the scale and complexity of the incident. Where an investigation

team is to be established, careful consideration should be given to its membership, ensuring that the

team is not too large but that there is adequate representation from different areas. There should be

clearly defined roles and responsibilities for each member of the team.

4.5 Investigations need to be led with a sufficient level of seniority within the organisation1.

4.6 Independence and objectivity are vital; at least one member of the team should be independent of the

service where the incident occurred.

4.7 Where there are high numbers of similar incidents, these may be assigned to a consistent team of

investigators so common trends can be systematically identified e.g. all medication related SUIs

allocated to the same team for a year.

4.8 There should be clarity on how the lead investigator/investigating team are expected to balance the

competing demands of an investigation with their normal roles, whether clinical or managerial, and

how the PCTprovides support to enable them to do both.

4.9 The lead investigator/investigating team must have access to appropriate administrative support.

“I was told to ‘clear my diary’ – but it just meant everything crept back in as urgent or overdue instead of

routine.”

“My admin support did her best but as her normal role was recruitment she struggled with systems for

getting clinical records, etc.”

“I was told I could have admin support from his secretary but the work he had given her always took

priority.”

4.10 An identified person must take responsibility for key pieces of evidence – e.g. notes, x-rays,

equipment – and require written acknowledgement of receipt if handed to others. Hand over in

person, not through internal post.

4.11 Track the location of evidence and the progress of the inquiry e.g. delivery of statements within

deadlines.

4.12 Ensure clinical records are complete e.g. all professionals’ notes and test results, etc. have been

included, and loose items securely filed.

4.13 Photocopy notes so they can be provided to more than one individual for reference whilst they write

statements, to avoid delays.

4.14 Store documentation in a lettered or numbered index file, with each item of evidence

given an individual reference.

5. Patient and family support

5.1 Trusts should review their policies in light of the NPSA Being Open guidance and resources.

5.2 Communication with patients, families and/or carers must be carried out by an appropriate person

with sufficient training and experience. It is not appropriate for the lead investigator/investigating

team to also take lead responsibility for supporting the patient and family.

1 Recommendation 7 of the Chief Medical Officer’s Making Amends document encompasses this point.

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5.3 PCTpolicy should ensure that it is clear who taking lead responsibility for supporting the patient,

family and/or carers e.g. Family Liaison Officer role.

5.4 It can be helpful to have a leaflet or template letter to leave with the patient/family giving the

Family Liaison Officer’s name and number, encouraging them to call at any time, and giving a

fallback name/number for if they are not available.

5.5 Family Liaison responsibilities can potentially last for years e.g. if there are delays in a coroner’s

inquest. Therefore there need to be arrangements for handing over responsibilities and informing

the patient/family, if staff acting as Family Liaison Officers in an ongoing SUI investigation leave

the Trust.

“Some staff are brilliant in this role; some staff, whatever training you give, it’s just not their strength,

involving them just doesn’t work. It’s better to recognise this and work round it than to pretend everyone

is the same.”

“I find there is a lot of difference between specialities. In obstetrics unexpected outcomes like stillbirth,

even when no one is to blame, need talking through, so they have a wealth of experience in talking to

distressed patients. We could do more to tap into that.”

“We find the patient or their family often have questions related to the clinical condition rather than just

the issue we’re investigating, so it helps if the family liaison officer has a clinical background for SUIs

affecting patients, someone like a matron.”

6. Staff support

6.1 Incident management policies/procedures should ensure responsibility for supporting staff is

allocated to an appropriate person. The lead investigator/team cannot combine their role with

supporting staff.

6.2 All staff, to include students and external contractors, should be able to access support.

6.3 Debriefs, if undertaken, must take into account each individuals’ natural coping mechanisms;

timing of debriefs must respect these needs.

6.4 A leaflet outlining how individuals might react to a distressing incident and sources of support

e.g. staff counselling, occupational health is a useful resource in addition to verbal information

(see example at 14.8).

6.5 Informal and mutual support from colleagues or peers is likely to be accessed far more often than

formal support mechanisms; time must be made available to support this.

6.6 Whilst the key purpose of a Root Cause Analysis (RCA) investigation is to understand and act on

the underlying causes, staff need to understand that their statements are potentially disclosable in

the event of legal action, or that they may be shared with the coroner, etc. Staff should also be

advised of their rights e.g. to be accompanied by a friend or union representative. A verbal

explanation should be supported with written material e.g. leaflet, template letter.

6.7 Multidisciplinary meetings including staff who were involved in or witnessed the incident can, in

the right circumstances and with good facilitation, be a very effective part of the investigation

process. But whilst staff may feel benefits from such meetings (e.g. colleagues being supportive,

better understanding of all the factors contributing to the incident, not just their own personal

input) facilitators and delegates should be clear that the meetings are to support the investigation

rather than provide therapy.

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6.8 The aftermath of a SUI is not a good time to explain the process and purpose of SUI

investigations to staff directly involved. Trusts should aim to build this awareness in advance e.g.

through induction, annual training, newsletters, team briefs, etc.

6.9 Staff side representatives/professional organisations also provide support services to their

members. PCTshould ensure staff side representatives are aware of the process and purpose of

SUI investigations so they are equipped to give support to their members.

6.10 Some Trusts share the outcome of all SUI investigations through team brief or newsletters, to

reduce gossip and promote the positive changes that came about from them.

“I have known debriefs work well, but in other instances I’ve been left with the feeling it did more harm

than good. There were delays in identifying our client as her injuries were so severe, and talking about it

seemed to get staff picturing things in their mind they’d have been better off not thinking about.”

“It is extremely difficult to get over that statements and interview notes are really important and could be

used in anything up to litigation and prosecution - whilst still conveying the message we want people to be

open and honest and tell us as much as they can and the whole point is to learn.”

“Everyone knew we’d had [a major environmental incident] and it was the main topic of conversation in

the staff canteen for weeks. It made sense to tell everyone what had actually happened and what we’d done

to ensure we’d cope even better if something similar happened again.”

7. Support for lead investigators/investigating teams

7.1 Root cause analysis (RCA) training should be provided to all lead investigators of SUIs, ideally

two or three days rather than shorter courses.

7.2 Risk assessment is a key skill for the lead investigator/investigating team, particularly in assessing

the impact and possible downside of report recommendations.

7.3 Support should be provided to first time investigators by nominated experienced investigators.

7.4 The lead investigator/investigating team may also experience stress or distress and

therefore should also receive information on available support e.g. staff counselling,

debriefing.

7.5 The lead investigator/investigating team require clear routes to access specialist advice e.g. HR,

clinical governance, specific expert advice, etc. Trusts may wish to identify these prior to

incidents occurring.

7.6 The lead investigator/investigating team need to receive constructive feedback on the

investigation and report to help improve future investigations.

7.7 The lead investigator/investigating team should capture and share any lessons about the process of

investigation to help improve future investigations.

7.8 The lead investigator/investigating team are likely to invest significant time and effort into

carrying out an investigation; it may be appropriate to formally or informally acknowledge this.

“After I had spent several days listening to different members of staff describe [a traumatic death from

haemorrhage] I was seeing the scene myself in my dreams.”

“I was shown one report from a previous SUI but had nothing really to judge myself against. I wasn’t sure

if I was doing a good enough job, although at the end of the day the recommendations were accepted, which

8

was all the feedback I got.”

“The reports I saw all had pages of recommendations so I assumed this was what was wanted, I didn’t

realise the PCTwas trying to move towards a focus on a few really effective actions.”

8. The investigation report

8.1 The purpose of a report is to compile and summarise succinctly the information gathered, and

demonstrate how this has been used to form recommendations. Detail belongs in an appendix or

the investigation file, but care must be taken not to over-simplify a complex situation.

8.2 A one size fits all approach is not appropriate. There should be flexibility to adapt style, format,

and length according to the circumstances.

8.3 Language should be simple and clear and in plain English.

8.4 The tone needs to be clear, factual and objective.

8.5 Only relevant information should be disclosed.

8.6 Reports usually use the third person e.g. refers to the patient, the doctor, the trust, the

investigating team rather than use I/we/you.

8.7 The report should ensure it presents the patient(s) or staff affected as individuals, although

without being overly personal or compromising confidentiality.

8.8 Bullet points are appropriate for sections of the report conveying lists of facts or findings, but text

is more appropriate elsewhere.

8.9 Whilst a report must be factual, the lead investigator/investigating team are required to do more

than simply summarise facts, whilst not moving into speculation. Using the term ‘the

investigating team believes’ or a similar phrase is useful for distinguishing assumptions from fact.

8.10 The report should not assume the reader understands normal processes in the department or the

normal progress of the patient’s condition; these need to be clearly explained in a way lay people

can understand to put the incident in context,

8.11 We become blind to our own jargon and abbreviations; the lead investigator/investigating team

should ensure their drafts are checked for this.

8.12 All paragraphs of a report must be numbered to aid any later referencing.

“We explained at length about what went wrong when the doctor checked the tube and it was some way

into the conversation the family said they were puzzled why we weren’t explaining how come the nurse had

inserted it wrongly in the first place. We hadn’t thought to explain this was common and harmless; the

problem only lay in not detecting it before feeding. We knew that so well that it had never occurred to us to

explain it to them.”

“Two staff members’ accounts of what happened appeared to contradict each other. If that was stated as a

bald fact it implied one or the other was lying. It was important that we added the context that we believed

both were being completely truthful but from very different perspectives.”

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9. Pseudonyms

9.1 The purpose of using pseudonyms in SUI reports, even in incidents made public in other

ways, is to ensure the purpose of the report is used for ‘how and why’ rather than ‘who’

and to ensure the lessons learnt can be shared more widely than patients’ and staff’s

rights to confidentiality would otherwise allow.

9.2 Staff pseudonyms should be terms such as ‘Ms Y’ or ‘Dr X’.

9.3 An acceptable pseudonym for the patient may be best agreed with the patient or family

themselves. Sometimes the family may prefer a real first name to be used.

9.4 Location, exact title or gender e.g. “Charge Nurse Y in ITU” can identify individuals

particularly in specialist departments or roles. General terms such as “the nurse in

charge” are clearer to lay readers as well as not being gender specific.

9.5 Despite all these efforts departments and individuals may be identifiable to those with a

close knowledge of the incident, the patient, the staff or the service in which it occurred.

9.6 It can be easier to use real names initially and replace them at the point where the draft

report is shared outside the immediate investigating team.

9.7 Using pseudonyms is not equivalent to secrecy; a key is retained as part of the investigation file

and to enable Trusts to carry out their responsibility to consider together, rather than in isolation,

incidents/complaints relating to any specific staff member.

“The family told us they were very uncomfortable with the way the report said ‘twin one’. They thought it

made him just a number.”

“When we first moved to anonymous reports committee members sometimes asked things like ‘who is Dr.

A?’ or ‘which medical ward was it?’ but when we asked ‘why do you want to know?’ they were actually a

bit rueful and acknowledged mostly out of curiosity, not need.”

10. Finalising reports and making recommendations

10.1 The root causes of an incident may impact beyond the speciality or department where the incident

occurred and this needs to be recognised in the process of identifying recommendations/action

plans.

10.2 The approving board/committee should consider the effectiveness of the recommendations. Any

consequences of, or competing priorities within the recommendations should be considered. The

lead investigator/investigating team should provide with the information they need to do this e.g.

risk assessment, either/or recommendations with implications.

10.3 Detail of implementation may be more effectively developed by the staff who the

recommendations will affect, rather than by the investigating team.

10.4 Whilst staff directly involved in an incident should have the chance to correct factual inaccuracies

or comment on recommendations before a report is finalised, it should be clear they do not have a

right of veto. Rather than risk situations where the lead investigator/investigating team might be

pressured or influenced, this discussion may be best supported by a third party e.g. Nursing or

Medical Director.

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10.5 A small number of recommendations addressing root causes are much more likely to be

successfully implemented than a multitude of detailed actions.

10.6 Sometimes in the course of an investigation unrelated things can be uncovered which whilst

irrelevant to the actual incident need following up and action taken. This needs to be done

effectively but separately from the SUI action plan.

10.7 Making a recommendation is not equivalent to saying the adverse outcome was avoidable. Please

see the action plan template (section 13) for examples of making these distinctions.

“In the aftermath of a SUI we approved an action plan that said no patient would be transferred for bed

management reasons at night, ever. We didn’t discuss that that might mean we would one day face a SUI

where a new patient couldn’t access specialist care he desperately needed - because we’d made the rule

inviolable.”

“We recommended a policy that meant new staff could only start in clinical areas after they’d been on

induction. We laid out that this presented risks in that wards might be short staffed as their recruits could

only begin at the beginning of each month, but the recommendation was accepted as we’d made the case

that the benefits outweighed that risk.”

“Whilst we were looking at attendance levels at fire training for a SUI we picked up attendance levels at

resuscitation training in the department were equally poor. This had nothing to do with the incident we

were investigating, but we did need to make sure it was picked up, action taken, and monitored separately

from the SUI.”

“We are faced with old action plans with more than 50 action points. Our hopes of ever closing them are

remote.”

11. Action plan

11.1 Action plans are extremely important tools in delivering system improvement following an

incident.

11.2 Action plans should be developed in partnership with the managers and frontline staff who will

be required to deliver them (and who may be a different group of staff from

those involved in the incident itself).

11.3 Action plans should address the root causes of the incident.

11.4 A small number of clear and effective actions are more likely to improve safety than a

long list; quality is more important than quantity.

11.5 Action plans should only address what the PCThas power to address - for example, if

problem is found in another agency’s procedure, the action plan can only state that the other

agency will be informed, it cannot state that the procedure will be changed.

11.6 Many issues identified in action plans need long term monitoring – for example, ensuring certain

standards in nursing documentation are maintained. In these cases, the action plan has to be set

out in a way that is not ‘never-ending’, for example, the action required is to ensure this audit is

added to an existing audit of documentation, then normal PCTprocedures will ensure the

ongoing monitoring.

11.7 Actions plans should be sustainable and congruent with overall clinical governance

plans, as diverting resources to a particular issue at the cost of other areas in the

aftermath of a SUI is unlikely to improve overall future safety.

11

11.8 Action plans should not be so specific they allow no scope for improvement or adaptation when

they are applied in practice.

11.9 Actions should not be confused with outcomes – for example, the action plan may

state that robust procedures and suitable equipment will be introduced for preventing

pressure ulcers; this does not guarantee that no patient will ever develop a pressure

ulcer.

11.10 Actions should be measurable, not solely for ease of performance management but for

practicality – if you can’t measure it, you will never know if you have done it.

11.11 The strengths of barriers to actions should be explored and assessed.

11.12 Actions centred on raising awareness that an incident has happened and encouraging greater

vigilance are unlikely to prevent recurrence, particularly in the longer term.

11.13 Actions should not be vague aspirations such as ‘improve communication’ – if this is an

issue, the action plan should specify what aspect of communication needs to be

improved and exactly how this is going to happen.

11.14 Where training is part of an action plan, it should be appropriate, with identification of

competencies to be achieved. The impact of training should be evaluated. Be aware

that changing knowledge will not necessarily change behaviour. There should be a clear

indication of how training will be continued in future (as the effect of ‘one off’ training will

dissipate over time and with staff turnover).

12. Sample Report

12.1 Producing a model report is impossible, as many different styles and contents may be

appropriate for different incidents. However, the following examples of SUIs and report

formats/contents provide guidelines.

Incident

one

The suicide of a young man with a disfiguring skin condition in the bathroom of an acute

hospital ward.

Incident

two

A woman with asthma who is brain damaged following IV administration of a drug she

was known to be allergic to.

Incident

three

The unexpected and unobserved death of a patient shortly after admission with back pain,

who at post mortem was found to have an undiagnosed ruptured abdominal aortic

aneurysm (AAA).

Incident

four

A fire in a ward area was extinguished without direct harm but created a situation where

the clinical care of patients was compromised

1 Cover page, including

SUI number e.g. 2006/01

Incident number The number used on your main local risk management system

Outline of incident A brief summary of the incident.

2 Contents page

3 Summary One page summary if report over 4

pages

The executive summary should describe the following in the briefest terms

• Nature of the incident and its consequences

• Nature of the investigation

• Findings

• Recommendations

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4 Main body of report

4.1 Terms of reference May be standard to all PCTSUIs or

specific to this incident

Example from incident one

• To establish the facts

• To identify system failures

• To form recommendations and action plans

• To ensure any potential disciplinary or performance issues are flagged

for separate investigation

4.2 Lead investigator: Name, role, qualifications,

department

4.3 Investigation team/SUI panel: Names, roles, qualifications,

department

4.4 Sources of data: Medical records, statements,

interviews, training schedules, staff

rotas, equipment, etc.

A summary or list rather than the actual copies (which belong in the investigation file).


• The patient’s clinical records

• Ward and medical staffing rosters

• Interviews with the four staff on duty

• Statements from three other ward staff who had contact with the

patient on earlier shifts

• Interview with the patient’s mother and stepfather

• Statement from the crash team leader

• Interview with the patient’s admitting consultant

• Telephone interview with the patients’ GP

• Expert advice from independent psychiatrist

• A visit to the location of the incident

• Post-mortem report

4.5 Guidance, legislation, policy

and procedures consulted:

A summary or list rather than the actual copies (which belong in the

investigation file) including the version and date as well as the actual title.

This might include local or national guidance.

This might also include contextual data such as local audits or national

ones (for example, to put issues with nursing documentation in incident two

in the context of national findings on documentation completion).

4.6 Involvement of patient/family in

investigation

e.g. interviews to establish the questions they hope the investigation will

address or to hear their recollection of events.

4.7 Support provided for

patient/family

e.g. family liaison person appointed, information given on sources of

independent support.

4.8 Support provided to other

patients

Some incidents will also cause to distress to other patients, e.g. inpatient

suicide, and if so the support provided should be described.

4.9 Support provided for staff

involved

Refer to informal support e.g. from colleagues, as well as formal support,

written materials or access to support networks. Consider all staff involved

even if not PCT employees e.g. students, contractors.

4.10 Investigation process Refer to tools and techniques used, for example components of RCA such as

fish bones and spider diagrams, processes such as multi-disciplinary review

meetings.

4.11 Any immediate preventative

action taken

Actions taken to prevent recurrence before or during the investigation

should be noted, and their appropriateness or effectiveness and risks

reviewed in the final action plan.

5 Timeline For complex and detailed cases the timeline in the report needs to be a

summary rather than the version with all details compiled during

investigation.


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Date/time Event Supplementary information 2000 - 2003 Patient’ skin condition under management of

GP

April 2003 –

January 2005

Exacerbation of skin condition; attending

dermatology clinic at monthly to quarterly

intervals throughout this period

Patient’s condition only transiently responds to

treatment. Clinic unsure if patient is complying

with treatment

12 February

2005

Attended outpatients; decision made to admit to

initiate intensive treatment regime and assess

response

19 February

2005 14.00

Admitted electively to medical floor Ward has some degree of dermatology

specialism, but limited as dermatology

inpatients low in numbers

The timeline should continue to cover any treatment provided after the incident, whether or not this

was successful, rather than stop at the incident itself

6 Good practice Points in the incident or patient

journey, which deserve positive

acknowledgement.

This section might also be used to

comment on staff co-operation and

openness in the course of the

investigation


The treatment of the patient’s skin condition was consistent with best

practice guidance.

Outpatient dermatology clinic staff clearly had a warm relationship with the

patient, and the patient’s family commented on how much he and they

appreciated this.

Although none of the ward staff had ever faced or been trained for this

situation, once the patient was discovered in the bathroom their actions to

release the ligature and initiate resuscitation were correct and rapidly

performed.

7 Key Care and Service delivery

problems The main problem points (full list

in more complex incidents would be

in investigation file)


Indications over months that the patient was depressed and despairing were

not specifically addressed in primary or secondary care.

The patient was not admitted to a single room.

The patient was given different indications of the likelihood of treatment

succeeding by different staff.

The patient was not noticed to be missing until around ninety minutes after

he entered the bathroom.

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8 Key Contributing factors A summary of most significant

factors in report, with the full list

under headings - e.g. NPSA

fishbone boxes - in investigation

file


Outpatient dermatology was an extremely busy and fast moving department.

Skin conditions, particularly highly visible or disfiguring conditions, are

strongly associated with clinical depression.

Dermatology clinic staff were expert in dermatology, but had little

knowledge and training in detecting depression.

Staff tended to react to the patient’s distress by offering hope that the

treatment plan would be effective, although the likelihood of improvement

was low, and stabilisation was the most realistic outcome.

Hospital policy prioritises single rooms for infection control and terminal

care. Only 10% of hospital beds are in single rooms.

The observation policy was unrealistic in expecting staff to effectively ‘roll

call’ patients every hour, and was therefore routinely ignored.

Whilst the bathroom has a notice asking patients to inform staff before

bathing this is rarely complied with.

Routine medical equipment e.g. bandages and oxygen tubing can be

improvised as a ligature.

9 Root causes/causal factors These should be the most fundamental underlying factors contributing to the

incident that can be addressed. There is often more than one, but if many

root causes are identified they may be missing the underlying cause.

Root causes should be meaningful, not sound bites such as communication

failure or systems failure. Whilst they can usually be summarised to a short

phrase for the investigation summary they are often complex enough to

deserve a sentence or paragraph in the report.

Example from incident two

One of the two root causes of this incident was the complexity and length of

standardised nursing documentation. Over around eight years specific

assessments for pressure ulcers, nutrition, falls risk, delayed discharge, etc.

had been added which had created a situation where short stay wards saw

the documentation as impossible to complete, did not distinguish between

essential and desirable documentation, and therefore routinely failed to

complete key fields such as allergy status.

10 Impact on outcome Clarify whether the issues found in

the investigation directly

contributed to the outcome

Finding problem points, contributing factors and root causes does not in

itself mean the incident’s outcome could have been prevented.

Example from incident three

The delay in diagnosing the patient’s AAA is not believed to have directly

contributed to her death as even if diagnosis had been made earlier her

coexisting illness meant she was too frail for surgery. However, addressing

the underlying problems identified in the course of the investigation could

prevent a future missed diagnosis on a patient who was fit enough to be

offered life saving surgery, and would also improve the likelihood of a

patient with an untreatable AAA receiving appropriate terminal care.

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11 Recommendations Recommendations should be directly linked to root causes and need to be

clear but not detailed (detail belongs in the attached action plan). Most

Trusts agree there should be no more than three to five recommendations.


The observation policy should be revised to provide practical and

achievable standards of observation.

12 Risk assessment Even positive changes have the potential to produce adverse effects in a

system as complex as healthcare. The investigators should describe how

they have considered or explored any potential downside to the

recommendations they have made and how to mitigate these, utilising their

PCTrisk assessment processes and matrixes.

Example from incident two

The recommendation that no staff should be deployed in clinical areas until

they have completed the formal induction provided weekly will involve up to

10 days delay in staff commencement compared with current procedures.

This does have potential to cause temporary staffing difficulties, which

could impact on patients; however, the planned weekly induction sessions

held in a large venue will minimise this.

13 Likelihood of recurrence It is rare in an area like clinical care that depends on human action to be

able to promise an incident has been or will be completely prevented from

recurring. The investigators should indicate the expected impact of their

recommendations. They may wish to refer to Trust’s risk matrix at this

point.

Example from incident three

When the action plan is complete the risk of a similar incident occurring

will be substantially reduced, but cannot be absolutely eliminated because

of the complexity of accurate diagnosis.

14 Sharing lessons Comment on how lessons learnt have been or will be shared with other

organisations e.g. through SHA Clinical Governance network, professional

networks, NPSA, etc.

15 Monitoring arrangements Describe arrangements for local monitoring of action plan, e.g. progress

report to risk committee(s).

16 Acknowledgements It may be appropriate to thank patient and family, staff or experts for their

contribution to the investigation.

17 Dissemination How patient, family and staff involved will be informed of the outcome of

the investigation.

18 Conclusion If the report has a logical flow, from process to findings to analysis to

recommendations, there may not be any need for a specific conclusion – the

root causes and recommendations are in essence the conclusion of the

investigation.

16

Action plan template with examples

13. Sample Action Plan

Incident Number: ABC/001 SUI Number: 2005/999 (Example from Incident four)

Recommendation 1 Recommendation 2

Recommendation(s) to

address root causes

Actions should be taken to improve levels of attendance at fire

training.

Fire training should shift from theory to a focus on individual roles

and responsibilities in a fire emergency for managers of clinical

areas.

Action(s) to achieve

recommendations

• Wider choice of times dates and venues.

• Database with ‘red reminders’ sent to managers once 12

months expired.

• Attendance levels standing agenda item at quarterly directorate

review.

• £100 internal charge for DNA without good reason.

• An expanded training programme should be established for staff

who manage wards, departments, directorates or sites.

• Three tabletop rehearsals will be held annually, covering

normal working hours, weekends and nights.

• Brief ward/department based drills should be carried out

annually.

Level of recommendation(s) PCT wide all areas. PCT wide patient areas.

Implemented by Fire safety team leader. Fire safety team leader.

By when 30/09/05 Programme initiated by 31/12/05.

Resource required (time) • 20 days fire officer (ongoing).

• 2 days IT advice (one off).

• 20 days admin support (ongoing).

• 10 days Matron to integrate clinical issues with fire safety issues

(one off).

• 10 days support from training department.

Resource required (money) Nil Add 0.5 WTE to fire safety team cost £18K p.a.

Resource required (other) Training room use increased x 20 half days. Training room use increased x 10 half days.

Evidence of completion • Planned basic training programme for 2005/06 with

dates/times.

• Printout from database showing ‘red reminders’ sent.

• Copy of Directorate meetings standing agenda.

• Copy of email to team leaders re future £100 DNA charge.

• Planned expanded managers’ training programme for 2005/06

with dates/times.

• Summary of content of expanded programme.

• Summary of materials/programme and planned dates for

tabletop rehearsals.

• Summary of materials/programme and planned dates for

ward/department drills.

Monitoring arrangements Describe arrangements for local

monitoring, e.g. progress report

to risk committee(s).

Review and sign-off by Head of clinical governance. Head of clinical governance.

17

14.5 Report Template

1 Cover page, including

SUI number

Incident number

Outline of incident

2 Contents page

3 Summary

4 Main body of report

4.1 Terms of reference

4.2 Lead investigator

4.3 Investigation team/SUI panel

4.4 Sources of data.

4.5 Guidance, legislation, policy

and procedures consulted:

4.6 Involvement of patient/family in

investigation

4.7 Support provided for

patient/family

4.8 Support provided to other

patients

4.9 Support provided for staff

involved

4.10 Investigation process

4.11 Any immediate preventative

action taken

5 Timeline

Date/time Event Supplementary information

6 Good practice

7 Key Care and Service delivery

problems

8 Key Contributing factors

9 Root causes/causal factors

10 Impact on outcome

11 Recommendations

12 Risk assessment

13 Likelihood of recurrence

14 Sharing lessons

15 Monitoring arrangements

16 Acknowledgements

17 Dissemination

18 Conclusion

18

14.6 Blank Action Plan Template

Incident Number: SUI Number:

Recommendation 1 Recommendation 2

Recommendation(s) to

address root causes

Action(s) to achieve

recommendations

Level of recommendation(s)

Implemented by

By when

Resource required (time)

Resource required (money)

Resource required (other)

Evidence of completion

Monitoring arrangements Describe arrangements for local

monitoring, e.g. progress report

to risk committee(s).

Review and sign-off by

19

Appendix 9

Advice for Staff on Statements/Disclosure:

STAFF GUIDELINES FOR PRODUCING A STATEMENT

1. Purpose

• To tell a third party about events in which the author participated.

• To tell a third party about events which the author witnessed.

2. When writing a statement ensure that:

• Your statement is factual • Your statement is accurate

• You check the facts • It is concise

• It includes all relevant information • It is legible if handwritten

• You give sufficient detail about the incident

• You explain words or phrases of a technical/clinical nature

• You check for errors if it has been typed from hand written

• You retain a copy 3. Do not:

• Exaggerate • Use abbreviations

• Minimise events • Use ambiguous terms

• Include hearsay • Use jargon

• Use cliché

• Sign the statement unless you are100% satisfied with it

However you produce your statement (typed/written) it will be reproduced onto headed paper. You will be given the opportunity to check this prior to signing and dating.

4. Laying out your statement

Centre heading patient’s full name (patient name) I (your full name) my (PIN). My qualifications are (relevant qualifications). I have been asked by the (name of requesting person) to provide a statement detailing my involvement in the care of the late (patient name). I have had access to a copy of the clinical records to assist me. I have been employed at (location) since (date). I have worked on (ward) as a (position and grade) since (date). I first met (patient name) on (date) when I was on the (shift).

(Include all your contact with the patient as well as any observations you remember about their overall condition). Statement ends with – and that was the last contact I had with (patient name). Signed…………………………………. Dated……………………

20

Appendix 10 Serious Untoward Incidents

Information for Staff Involved in the Investigation

Close clinical involvement in an SUI can be traumatic for staff. When events are serious enough for the organisation to instigate an internal investigation, however, it is vital for the safety of all staff and patients that there is full and timely co-operation. The decision to initiate an SUI enquiry rests with the head of service and Director and when this occurs there is a responsibility on the organisation to produce a report with any key recommendations, which may affect immediate practice. A lead investigator will be identified and set a timeframe within which the report must be made. The role of an SUI investigation is NOT to apportion blame, nor to collate evidence for any subsequent legal proceedings. Its aim is to analyse in a systematic way the events leading up to and surrounding an adverse event, and to discover the failings in the organisation that brought it about. These factors may include lack of resource, inadequate training and experience as well as deviation of practice from accepted practice and guidelines. As a member of staff involved in an incident you may be asked to provide a statement and be interviewed by one or more members of the investigation team. This procedure will take place as soon after the incident as can be arranged, whilst the facts remain as clear as possible in your mind. Help in compiling your report can be obtained either from your department manager, the organisation’s Governance Department or from members of Risk and Legal Services. It will almost certainly help you if you make notes surrounding the event as soon as you can after it happened. If you wish you may bring a colleague or staff representative to attend the interview with you. This session is meant purely to establish in the minds of the investigators the accurate sequence of events, and the conditions in the environment at the time of the occurrence. The facts you present will remain confidential to the inquiry team. If as a result of the investigation there are recommendations for a change in practice, those recommendations will be attributed solely to the investigation team. Where serious incidents involve the presence or use of medical equipment, you may be asked about your familiarity and training surrounding it. Any records you may have of training courses or previous experience may be valuable. You should be open and honest in revealing your skills and concerns over issues such as lack of training or familiarity – it is only with such information that changes and improvements may be made. At the completion of an SUI inquiry, the lead investigator will make a report to the Governance Committee. Decisions will be made as to how and when the findings of this report are fed back to involved staff and/or the public. If the incident involves the death of a patient you may be asked to produce a report for the coroner, and subsequently to appear at a Coroner’s inquest. Support for you in both these tasks is available from the organisation’s Governance Department or Risk and Legal Services. The sooner you ask for this the more effective it will be.

Appendix 11

References

1. An Organisation with a Memory, Department of Health, 2000 Hyperlink

2. Being open – Communicating patient safety incident with patients and their carers, NPSA, 2005 Hyperlink

3. Criteria for assessing core standards, Healthcare Commission, 2005

Hyperlink

4. Making amends: a consultation paper setting out proposals for reforming the approach to clinical negligence in the NHS, Department of Health, 2003 Hyperlink

5. Seven Steps to Patient Safety, NPSA, 2004 Hyperlink

6. The NHS Confidentiality Code of Practice, Department of Health, 2003

Hyperlink

Document

Documents

serious incidents

staff app

reporting of incidents

incident management

serious untoward incidents

action plan app

number of incidents

statement provision