Policy/Procedure/Guideline

SERIOUS UNTOWARD INCIDENT POLICY

Version no:1Issue Status: Draft

Date Ratified:Ratified by:Clinical Governance Board

Risk Management Board

Trust Board

Policy Author:Fiona Gow, Acting Head of Clinical Governance

Michelle Nolan, Risk Manager

Andy Dwyer, Clinical Risk Manager

Policy Owner:Kathryn Corder, Acting Director of Nursing

Mark Vaughan, Director of Human Resources Corporate Affairs

Review Frequency: 2 years

Last Review:October 2007Next Review: October 2009

POLICY AWARENESS

People who need to know this policy in detail / Senior Managers and Executive Directors
People who need to have a broad understanding of this policy / All Staff
People who need to know this policy exists / All Staff

CHANGE CONTROL DETAILS

Date / Version / Description / Reason for changes
October 2007 / V01 / New Policy / New Policy

Policy found at: K\Corporate\Policies\Health and Safety\Policies\Section 5. I – Land K\Corporate\Policies\Clinical Governance\Section 5 I-L

CONTENTS

Page
1.0 / Introduction / 3
2.0 / Purpose / 3
3.0 / Duties / 3
3.1 / Duties within the Organisation / 3
3.2 / Duties of Manager/Site Manager Individual Reporting the Incident / 4
3.3 / Duties of the Director of Nursing / Director of Human Resources & Corporate Affairs or the Executive Director on Call / 4
3.4 / Duties of the Chief Executive / 5
3.5 / Consultation and Communication with Stakeholders / 5
4.0 / Definitions / 5
4.1 / Definition of a Serious Untoward Incident / 5
5.0 / Managing a Serious Untoward Incident / 5
5.1 / Reporting a Serious Untoward Incident / 5
5.1.1 / STEIS System / 6
5.1.2 / NHS London / 6
5.2 / Reporting to Other External Agencies / 6
5.3 / Child / Vulnerable Adult Protection Issue / 7
5.4 / Internal Investigation / 7
5.5 / Establishing a Hotline and Helpdesk / 8
5.6 / Communicating with Patients and Relatives / 8
5.7 / Handling Media Interest / 8
5.8 / Commitment to a Fair and Open Culture / 9
5.9 / Support for Staff / 9
5.10 / Monitoring SUI Management / 10
5.10.1 / Updating the SUI Report / 10
5.11 / Following an Internal Investigation / 10
6.0 / External Inquires / 11
7.0 / Follow-up Action / 11
8.0 / Procedure for the Management of Incidents / 12
9.0 / Equality Impact Assessment / 13
10.0 / Training / 13
11.0 / Process for Monitoring Compliance / 13
12.0 / Standard/Key Performance Indicators / 13
13.0 / Associated Documents / 13
14.0 / References / 14
Appendices
A / Types of Incidents to be Reported to SHA Including Guidance as to the Type of Incident Code on STEIS / 15-19
B /

RNOH Risk Classification Matrix

/ 20-21
C / Serious Untoward Incident Report Form / 22-23
D / Action Checklist for Reporting Serious Untoward Incidents / 24

1.0Introduction

The Royal National Orthopaedic Hospital NHS Trust is committed to providing the best possible service to its patients and staff. The Trust recognises that on occasion’sadverse incidents occur and when they do, the underlying causes need to be identified, lessons learnt and changes implemented to minimise or prevent recurrence.

In general terms a Serious Untoward Incident (SUI) is something out of the ordinary or unexpected, with the potential to cause harm, and/or likely to attract public and media interest that occurs on NHS premises or in the provision of an NHS or a commissioned service. This may be because it involves a large number of patients, there is a question of poor clinical management or judgement, a service has failed, a patient has died under unusual circumstances, or there is the perception that any of these has occurred. SUIs are not exclusively clinical issues, an electrical failure for example may have consequences that make it an SUI.

This policy only applies to those adverse incidents which have been categorised as a Serious Untoward Incident (SUI) following a discussion with the Executive Directors responsible for clinical and non clinical risk management (Director of Nursing and Director of Human Resources and Corporate Affairs) or the Executive Director on call and the Chief Executive. All other adverse incidents should be managed as per the Trusts’Incident Reporting Policy.

In the event of the SUI being declared as a Major Incident the Trusts’ Major Incident Procedures will be activated. Refer to the Major Incident Procedure for further guidance.

This policy sets out the reporting arrangements and immediate action to be taken in the event of a Serious Untoward Incident. All SUIs must be reported to the Strategic Health Authority (SHA) – NHS London and the host Primary Care Trust (PCT) Barnet. This enables the SHA and PCT to offer advice and support in managing the incident. It also allows the SHA to ensure ministers and other people are briefed as appropriate. This is an essential part of the accountability of the NHS as a public service.

2.0Purpose

This policy makes clear the actions required to mitigate the consequences of a serious untoward incident in order to:

  • protect the interests of those affected by the incident and ensure their well-being
  • ensure the legal, media and other interest does not damage the Trusts’ reputation or assets.

3.0 Duties

3.1Duties within the Organisation

An adverse incident may be reported internally through the incident reporting system as well as externally e.g. via the Strategic Health Authority or the media. It is the duty of the organisation to have procedures and processes in place as detailed in ‘Building a Safer NHS for Patients’ 2001.

It is the responsibility of all members of staff, if involved in, discovering or observing a Serious Untoward Incident, to immediately report the incident to the line manager or Site Manager (out of hours).

In decided whether or not the incident is a Serious Untoward Incident, consider the possible impact the incident could have, including the media. If it could be damaging to the NHS, the incident needs to be reported. Advice should be sought from the SHA’s Head of Clinical Governance or the relevant Performance Manager or Head of Finance & Performance if the Trust is unsure whether or not an issue needs reporting.

The catchphrase is: “NO SUPRISES”.

3.2Duties of Manager/Site Manager/Individual Reporting the Incident

Manage the incident i.e. take immediate action to ensure the safety of patients/staff/visitors is maintained

Report the incident immediatelyto the Director of Nursing (for a clinical incident) or the Director of Human Resources & Corporate Affairs (for a non-clinical incident) in working hours. Out of hours (17.00 to 08.00 hours Monday – Friday; during weekends and Bank Holidays) the Senior Manager on call must immediately inform the Executive Director on call.

Appendix A lists examples of incidents that must be reported to NHS London. The list is not exhaustive and further discussion with the NHS London Head of Clinical Governance should take place if Trusts require advice or guidance.

3.3Duties of the Director of Nursing / Director of Human Resources & Corporate Affairs or the Executive Director on Call

The Director of Nursing / Director of Human Resources & Corporate Affairs or the Executive Director on Call must ensure that the incident is being managed appropriately. Classifying or grading of the incident needs to be based on the severity of the incident at the time of the incident. See Appendix B for grading of incidents according to the RNOH Risk Classification Matrix.

It should be acknowledged that the risk assessment processes that evaluate whether incidents are SUIs are fundamentally judgement calls and therefore may be open to interpretation. Clear evidence that the assessment process has been applied is necessary to ensure the rationale for decision making is clear and auditable.

It is the responsibility of the Director to whom the incident is reported to confirm the incident meets the criteria of a Serious Untoward Incident. He/she must immediately inform the Chief Executive of the facts of the potential SUI.

The Director shouldinform the Risk Manager immediately of the SUI so that they can assist in the management of the SUI.

The Directorof Nursing / Director of Human Resources & Corporate Affairs or the Executive Director on Call is responsible for completing the Serious Untoward Incident Report Form to ensure that all initial facts are established Appendix C.

3.4Duties of the Chief Executive

It is the responsibility of the Chief Executive (or the nominated deputy) to ascertain the facts and establish in conjunction with the Executive Director if the incident is graded as a SUI. If not graded as a SUI refer to the Trusts’Incident Reporting Policy.

If the incident is classified as a SUI the Chief Executive (or nominated deputy) must ensure that the incident is reported to the relevant external agencies, most notably the SHA and the Trusts’ host PCT.

The Action Checklist for Reporting Serious Untoward Incidents should be reviewed.Appendix D.

3.5Consultation and Communication with Stakeholders

The Royal National Orthopaedic Hospital NHS Trust will ensure that key stakeholders will be fully appraised of the SUI, and that continued communication will be undertaken until the SUI is closed by the SHA and PCT.

4.0Definitions

4.1 Definition of a Serious Untoward Incident

The Royal National Orthopaedic Hospital NHS Trusts’ definition of a Serious Untoward Incident (SUI) is a ‘situation’ in which one or more persons is involved in an event that has serious implications to their well-being and/or is likely to produce significant legal, media or other interest and which, if not properly managed, may result in loss of the Trusts’ reputation and / or assets.

5.0Managing a Serious Untoward Incident

5.1Reporting a Serious Untoward Incident

All Serious Untoward Incidents need to be reported to the SHA- NHS London and to the Trust’s host PCT- Barnet PCT.

The Chief Executive or designated Executive Director should liaise with the SHA and PCT. The SHA needs to be notified immediately if the incident is of particular gravity.

Out of Hours urgent notification should be made to:

08700 555 500 Pager # LON 01

To enhance consistency across the country and enter into line with other Strategic Health Authorities (SHA), NHS London uses UNIFY, the Department of Health electronic Strategic Executive Information System (STEIS) for serious untoward incident reporting. Incidents should be reported by completing the incident reporting electronic form on STEIS as soon as the incident becomes known to the NHS organisation and on the same working day wherever possible.

The SHA will need full anonymised details of the incident, including when and how it happened, and information about how the Trust is managing it, including media handling arrangements if appropriate. Sketchy information early is better than full information late. This should then be followed up with full information at the earliest opportunity.

5.1.1STEIS System

STEIS contains a serious untoward incident module which allows Trusts to add SUI data directly on to STEIS which is then accessible by the SHA.

The Royal National Orthopaedic Hospital NHS Trust has a specific username and password. These are held with the Director of Nursing and Director of Human Resources & Corporate Affairs.

The Director of Nursing or Director of Human Resources &Corporate Affairs will either complete the STEIS form themselves or nominate a designated deputy to undertake this role. It is important to ensure that there are tight controls as to who has access to STEIS.

Once the on-line form has been completed and saved, STEIS will generate a unique log number that should be used in all communication relating to the incident.

An automatic email alert will then be sent to the nominated personnel within NHS London.

The NHS London link personnel who will receive the automatic email alert when a serious untoward incident form is completed will be:

  • Relevant Performance Manager or Head of Finance and Performance
  • Public Health Directorate (Patient Safety), Head of Clinical Governance
  • Director of Communications and all members of the Communications Team

5.1.2NHS London

NHS London has three significant roles in the management of SUIs:

  1. to enable NHS London to monitor the incident and types of SUIs reported and to identify any trends so that learning can take place across the health community;
  2. to enable NHS London to monitor the outcomes and action plan implementation from SUI root cause analysis within the NHS organisation involved in order to share learning locally;
  3. to ensure that SUIs are handled appropriately, specifically regarding ministerial briefings and the briefing of concerned organisations on potential media interest

5.2Reporting to Other External Agencies

The Risk Manager should on behalf of the organisationliaise with other external agencies e.g. Health & Safety Executive (HSE) as directed by the Chief Executive, and keep them fully appraised of the incident and subsequent management.

5.3Child / Vulnerable Adults Protection Issue

Should a child/ vulnerable adults protection issue occur that involves more than one organisation each organisation should complete their own internal investigation and a copy of the final report should be sent to the SHA. When multiple NHS organisations are involved, then one organisation should take the lead role in following the SUI and entering the report onto STEIS noting which other organisations are involved.

5.4Internal Investigation

Following notification and declaration of an SUI, an internal investigation must be promptly established. Where court proceedings in relation to the incident have started, or are likely, legal advice should be sought with a view to ensuring that the investigation does not prejudice those proceedings. The Memorandum of Understanding between the police, the HSE and the NHS should be followed:

The organisations should ensure that the internal investigation team:

  • Has a Chair with sufficient skills and demonstrable independence from the setting in which the incident arose
  • Includes individuals with appropriate investigation skills, such as root cause analysis
  • Is established within 24 hours of notification of the incident
  • Has the active co-operation and participation of internal staff and other relevant agencies (e.g. social services, criminal justice agencies, private providers) in the review process, with representation depending on the weight of the organisation’s involvement in the case
  • Has clear terms of reference, which are reviewed as appropriate
  • Within 3 working days of the incident the Trust must confirm with the SHA their initial findings as to whether the incident remains as a SUI or whether following the initial investigation it is not deemed as a SUI.
  • Has access to such evidence as it needs in order to review the incident
  • Maintains appropriate records
  • Follows NPSA ‘Being Open’ guidance and appropriately communicates with and supports families and other key personnel
  • Reports promptly, with clear recommendations and an action plan if appropriate, within 60 days of the incident to the SHA

5.5Establishing a Hotlineand Helpdesk

For a SUI it may be necessary to provide a hotline and helpdesk to deal with multiple telephone enquires from patients, relatives and other callers. This is to ensure that when things go wrong the Trust manages arrangements and responds quickly and positively to mitigate the consequences and to demonstrate that the main concern is for those potentially affected.

The Hotline and Helpdesk will by co-ordinated by the Director of Nursing. All relevant resources needed, helpdesk and event log forms, dedicated telephones are located in the Director of Nursing’s office.

5.6Communicating with Patients / Relatives

Where an SUI results from a clinical intervention, the lead for the investigating team will:

  • Inform the patient or his/her relative(s), relevant members of the public and staff of the incident as soon as possible and no later than 8 hours after the incident
  • Record the incident and all subsequent treatment given as a result of it, in the patient’s clinical notes
  • Offer appropriate care and counselling
  • Inform the patient’s GP

Where a patient is exposed to clinical risk thorough an indirect SUI, the lead for the investigating team will:

  • Inform the patient or his/her relative(s), relative members of the public and staff of the incident as soon as possible and no later than 8 hours after the incident
  • Offer appropriate care and counselling
  • Record the incident and all subsequent treatment given as a result of it, in the patient’s clinical notes

It is of primary importance that those directly involved in the incident must be kept informed of the progress made in investigating the incident.

5.7Handling Media Interest

Every SUI has potential for media interest and for this reason the SHA must be notified.

The Chief Executive or nominated deputy will contact the Communications Manager who will then liaise with the SHAto ensure appropriate action is taken.

The Communications Department will liaise with the SHA and the relevant Director in ensuring that patients and relatives are informed at the appropriate time that the incident may cause media attention. Patients and relatives will be give an emergency helpline number as advised by the Trust or the SHA.

5.8Commitment to a Fair and Open Culture

A clinical or non clinical error, accident or incident, however serious, is rarely caused wilfully. It is not, in itself evidence of carelessness, neglect or failure to carry out a duty of care. Errors are often caused by a number of factors including process problems, human error, individual behaviour and lack of knowledge or skills. Learning from such incidents can only take place when they are reported and investigated in a positive, open and structured way.

For the Trust, an open and fair culture involves:

  • acknowledging, apologising and explaining when things go wrong
  • conducting a thorough investigation into the incident and reassuring patients and/or their carers that lessons learned will help prevent the incident recurring
  • providing support to cope with the physical and psychological consequences of what happened

For healthcare staff, an fair and open culture has several benefits, including:

  • satisfaction that communication with patients and/or their carers following a patient safety incident has been handled in the most appropriate way
  • improving the understanding of incidents from the perspective of the patient and/or their carers
  • the knowledge that lessons learned from incidents will help prevent them happening again
  • having a good professional reputation for handling a difficult situation well and earning respect among peers and colleagues

To promote a fair and open culture and encourage the reporting of incidents the Trust will take a non-punitive approach to those incidents. Staff remain accountable to their professional bodies for their actions, but disciplinary action will not be taken against a member of staff for reporting an incident unless in the rarest of circumstances there is evidence of: