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Adverse Event Reporting Policy 

Post Holder Responsible for Policy:
Head of Risk Management
Directorate Responsible for Policy:
Quality Directorate
Contact Details:

Salisbury District Hospital

01722 336262

Date Written:
October 2006
Date Revised:
August 2015
Approved By:
Clinical Risk Group
Date Approved:
30th July 2015
Next Due for Revision:
August 2018
Date Policy Becomes Live:
October 2006

Version Information

Version No. Author Review Date Description of Changes
2
.
0
Head of Risk Management
August 2015
Updates: Insertion of quick reference guide for reporting and managing incidents Addition of guidance in relation to incidents that trigger Duty of Candour (DoC). Detailed actions required following reportable incident. Appendix A – How to guide for incident reporting Appendix B – Assessing the level of risk matrix updated to include DoC, guidance on grading security incidents etc.

Table Of Contents

Introduction
Purpose
Scope
Exceptions/ contraindications
Definitions
Responsibilities
Reporting Requirements
Actions Required Following a Reportable Adverse Event
Investigating and Analysing Adverse Events and Near Misses
Recording Incidents and Organisational Learning
The Trust Risk Register
Support for Staff
Patient Information and Support
Monitoring the Effectiveness of this Policy
Evidence Base & Appendices
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Introduction

Quick Reference Guide (click the link)

LINK

In a service as large and complex as the NHS, things will sometimes go wrong.  When they do, the response should not be one of blame and retribution, but of learning that leads to improvement that reduces the risk to patients, visitors and staff.  Salisbury NHS Foundation Trust is committed to developing an open and fair organisational culture that promotes a willingness to report mistakes without fear of punitive measures. There are occasions, of course, when it may be necessary to take action against individuals in situations where it is determined there are acts of maliciousness or criminal or gross or repeated professional misconduct.

The policy has been developed in line with Department of Health and National Patient Safety Agency guidance.

The policy is also designed to assist the organisation to comply with  requirements of external agencies such as the Care Quality Commission (CQC), Clinical Commissioning Groups (CCG), The Health and Safety Executive (HSE). The primary aim is to reduce the risk of harm to patients, staff and by improving the safety and quality of services and the environment.

 

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Purpose

 

The purpose of this policy is to ensure the appropriate identification and investigation of adverse events and near misses within Salisbury NHS Foundation Trust. 

The policy should be read in conjunction with the following policies available on the Trust Intranet:

Ø  Duty of Candour and Being Open Policy

Ø  Risk Management Strategy

Ø  Risk Management Policy and Procedure 

Ø  Raising Concerns Policy ‘Whistleblowing’

Ø  Serious  Incidents Requiring Investigation (SIRI) Policy 

Ø  Handling Comments, Concerns Complaints and Compliments Policy

Ø  Management of Claims Policy

Ø  Information Risk and security policy

This policy reflects an integrated system covering the management, reporting, analysis and learning from all adverse events involving patients, visitors and staff, as well as other types of events not directly involving people.

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Scope

 

This policy applies to all permanent, locum, agency, bank and voluntary staff of Salisbury NHS Foundation Trust, acknowledging that for staff other than those directly employed by the Trust the appropriate line management or escalation processes will apply.

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Exceptions/ contraindications

 

There are no exceptions to Salisbury NHS Foundation Trust's commitment to learning from adverse events, it is therefore expected that all staff will comply with this policy by reporting adverse events.   Learning and service improvement requires open, honest and timely reporting of both near misses (where potential harm has been prevented) and actual events. 

No disciplinary action will result from reporting adverse events/patient safety incidents and near misses, other than where one or more of the following applies:

Ø  The incident results in a police investigation and prosecution

Ø  There are repeated occurrences involving the same individual

Ø  In the view of the Trust and/or any professional body the action causing the incident was far removed from acceptable practice, constituting gross misconduct.

The disciplinary process may however be invoked where this policy has not been complied with and an adverse event has not been reported.

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Definitions

 

Individuals - the definition of individuals directly or indirectly involved in patient care includes all Trust employees, bank, locum or agency staff, contractors and volunteers. All health care professionals are covered by this definition; including doctors, nurses, allied health care professionals, and managers.

Adverse Event – any event or circumstance arising that could have or did lead to unintended or unexpected harm, loss or damage to any individual or the Trust. Adverse events may or may not be clinical and may involve actual or potential injury, misdiagnosis or treatment, equipment failure, damage, loss, fire, theft, violence, abuse accidents, near misses or hazards.

Examples of adverse events are:

Ø  Any aspect of clinical care or service which is contrary to the specified or expected standards so putting the patient at risk

Ø  Any situation which has placed patient(s), staff member(s), visitor(s), contractor(s) at unnecessary risk including accidents of any kind, illness which is work related (including stress), or any form of violence/aggression.

Ø  Any situation placing the Trust in an adverse legal and/or media position

Ø  Any situation which puts the Trust’s property or assets in an adverse position or at risk of loss/damage

Patient Safety Incident – any unintended or unexpected incident which could have, or did, lead to harm for one or more patients receiving NHS funded healthcare.

Harm - unexpected 'injury (physical or psychological), disease, suffering, disability or death'. In most instances, harm can be considered to be unexpected if it is not related to the natural cause of the patient’s illness or underlying condition.

Near Miss – an unplanned event that did not result in injury, illness, or damage – but had the potential to do so. Only a fortunate break in the chain of events prevented an injury, fatality or damage occurring.

Serious Incident (SI) – an incident that occurred during NHS funded healthcare (including in the community) which resulted in one or more of the following:

·         unexpected or avoidable death or severe harm of one or more patients, staff or members of the public

·         a ‘never event’ – all never events are defined as a SI although not all necessarily result in severe harm or death.

·         a scenario that prevents, or threatens to prevent, an organisation’s ability to continue to deliver healthcare   services, including data loss, property damage or incidents in population programmes like screening and immunisation where harm potentially may extend to a large population

·         allegations or incidents of physical abuse and sexual assault or abuse

·         loss of confidence in the service, adverse media coverage or public concern about healthcare or an organisation.

If in doubt, it is better to report an incident as a potential SI, as this can then be confirmed by the Risk Management Team. However, most grade 3 and 4 pressure ulcers, deaths attributable to either C Difficile or MRSA (where stated on part 1 of death certificate), deaths or major harm attributable to acts/omissions in the management of patient care, and ‘Never Events’ – as defined by the Department of Health must be reported as SI’s.

All serious incidents within the Trust will be managed in line with the NHS England framework (see Serious Incidents Requiring Investigation Policy).

Never Event - serious incidents that are wholly preventable as guidance or safety recommendations that provide strong systemic protective barriers are available at a national level and should have been implemented by all healthcare providers

There are 14 never events listed.

A serious Incident or never event requires immediate action; please refer to the Serious Incident Requiring Investigation Policy for further instruction.

Serious Incidents in Screening Programmes - an actual or possible failure at any stage in the pathway of the screening service, which exposes the programme to unknown levels of risk that screening, assessment or treatment have been inadequate, and hence there are possible serious consequences for the clinical management of patients. Specific guidance is available to clarify the accountabilities for reporting, investigating and managing screening incidents: Public Health England, NHS Screening Programmes, Managing Safety Incidents in NHS Screening Programmes – updated interim guidance, 2015.

Root Cause Analysis – a recognised way of investigating incidents, claims and complaints, which offers a framework identifying what, how and why the event happened. Analysis can then be used to identify areas of change, develop recommendations and look for new solutions.

DatixWeb - Patient safety software that enables the Trust to provide a comprehensive oversight of risk and governance activities.

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Responsibilities

 

The Director of Nursing is the Executive Director with lead responsibility for risk management.

Responsibilities are outlined throughout this policy which sets out the reporting, investigating and management of adverse events.

It is a requirement that all staff are aware of what constitutes an adverse event, have a working knowledge of this policy, know how to access it and are aware of their individual responsibilities.

Salisbury NHS Foundation Trust actively promotes awareness and understanding of adverse events, based on definitions outlined above, to all individuals directly or indirectly involved in patient care. This is disseminated through induction, ongoing training programmes, poster and awareness campaigns, and as part of ongoing appraisal processes.

All staff have a duty to follow this policy by reporting any adverse event or ‘near miss’ immediately but at least within 12 hours, according to the procedures outlined in this document. Normally this will be through completion of an on-line electronic incident form ’Datix’. Guidance on completion of the form, which is accessible to all staff via the Trust’s intranet homepage, is contained within the form. There is no ‘login’ or password required to report an incident, thus ensuring that reporting adverse events is open to all staff. Guidance may also be sought from any line or senior manager or from the Risk Management Department (ext. 2035/2496/4829). Training in this process is mandatory and is provided as part of the induction process for all staff at departmental level.

The person discovering an incident must:

·         Ensure the immediate safety of those directly affected by the adverse event or near miss

·         Immediately inform the appropriate senior member of staff/line manager

·         Complete an on-line electronic adverse incident form(Datix)

·         Instigate Duty of Candour requirement for all incidents graded moderate or above (see Duty of Candour and Being Open Policy).

The immediate line manager (e.g. ward manager, department manager, Consultant, Lead Clinician) has a responsibility to receive and investigate any report and to escalate more serious reports to a Directorate Management Team member as well as forwarding to the Head of Risk  (see section 8 major and catastrophic events and Serious Incident Requiring Investigation Policy). The person responsible for taking action must also feedback details of the action taken to the event reporter.  The line manager must, and has authority to, take reasonable immediate actions to prevent recurrence of an adverse event.  These actions might include ensuring that injured staff are seen by the Occupational Health Department, referral to other policies that contain references to external agencies, undertaking a risk assessment as soon as practicable, and changing working practice.

For all incidents graded moderate or above the Duty of Candour process must be followed.

Reference should be made to relevant Trust policies or procedures that detail immediate action to be taken, which can all be found on the Intranet.  For example:

Ø  Duty of Candour and Being Open Policy

Ø  Serious Incident Requiring Investigation Policy 

Ø  Capability Policy and Procedure

Ø  Control of Substances Hazardous to Health (COSHH)

Ø  Fire Precautions Policy

Ø  Infection Control Policies

Ø  Manual Handling of Loads Policy

Ø  Staff Counseling Policy

Ø  Prevention and Management of Stress at Work 

Ø  Needlestick Action Pack (NAP) guidelines, available in every clinical area.

Ø  Slips, Trips and Falls Policy

Ø  Inpatient Falls Policy

Ø  Security Policy

Ø  Safeguarding Vulnerable Adults/Adults at Risk Policy

Ø  Information Risk and Security policy

The Directorate Management Teams must have a sound working knowledge of this policy including the Serious Incident Requiring Investigation Policy. The Directorate Management teams have a responsibility to investigate and take action when requested or required on all events referred to them, and to feedback to staff and the Risk Management department. The Directorate Management Team is responsible for ensuring that agreed actions arising out of incident investigations are completed by appropriate teams/departments, and for ensuring that the Directorate fosters an ethos of learning from error in order to minimise future risk. This will require close working with the Risk Management team. The Directorate Management team must have clear processes of feedback to Directorate staff on lessons learned from adverse event reporting and subsequent investigations.

The Head of Risk has a responsibility to ensure that all reported events are logged on the Datix Risk Management Database and for ensuring that appropriate action has been taken by the Trust. The Head of Risk will provide a report on themes and trends in adverse event reports to managers in their area, the Directorate Management teams via performance and quality meetings and across the Trust to the Clinical Risk Group, Clinical Management Board and Clinical Governance Committee.  The Head of Risk will work in collaboration with the Directorate Management Teams in ensuring that learning from error can be evidenced across the Trust. The Head of Risk is responsible for the coordination of any Clinical Reviews/Serious Incident Inquiries.

The Trust Board and Sub Committees, through the Risk Management and Clinical Governance arrangements, have a responsibility to ensure that organisational learning arises through incident reporting and analysis, and lessons are shared throughout the organisation which can demonstrate improvements in practice as a result.

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Reporting Requirements

Patients Detained Under the Mental Health Act
The death of any patient in receipt of care whilst detained or liable to be detained under the Mental Health Act must be reported through the adverse events process. This incident data is a requirement of the Care Quality Commission compliance with regulations

Trigger Lists
There are no governed Trust-wide trigger lists however clinical teams in each department may find it helpful to develop trigger lists which identify reportable adverse events and near misses specific to their areas governance needs.  The lists must be made available in each department to ensure clear guidance on requirements for reporting.

Raising Concerns
For staff who have any concerns around what is happening in their work place, maybe regarding the delivery of care or services, conduct, poor practice, dangers to the public/staff/environment the Raising Concerns route should be pursued. Please refer to the Raising Concerns ‘Whistleblowing’ Policy on the intranet.

External Reporting of Adverse Events
Some adverse events must also be reported to external bodies. Appendix C outlines these agencies and the responsibilities of members of staff in this respect. Where an incident occurs which relates to a patient who is under police escort, arrest, or has been reported to the police a joint investigation must be carried out as per the Memorandum of Understanding (2006), this is detailed in Appendix D.

The National Reporting and Learning System (NRLS) receive anonymised data from all Patient Safety Incidents reported in the Trust. This information is used to identify national patient safety issues. The Head of Risk is responsible for responding and reporting on any NHS England Patient Safety Alerts or reports received including any actions taken. This work is overseen by the Clinical Risk Group.

The Director of Nursing is responsible for ensuring that appropriate action has been taken to report externally any incidents as required including where necessary, to the host commissioning CCG.

It is the responsibility of the patient’s Consultant to ensure that the patient’s GP has been informed of any major or catastrophic incident.

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Actions Required Following a Reportable Adverse Event

 

All reported events are immediately graded by the reporter on submission of an electronic incident report via the Trust’s intranet home page (no login is required to report an incident).

The person responsible for completing the adverse event report should make an initial judgement about the actual impact, and grade the event accordingly – for guidance refer to Assessing the Level of Risk, Measures of Consequence (Appendix B).

The immediate assessment of grade should be undertaken quickly and it is not necessary for the assessor to be in possession of all the facts at the time of grading the event.  There is always scope for re-grading as the facts and issues emerge.

All incidents or alerts raised regarding Adult Safeguarding should be reported within 12 hours and the appropriate actions undertaken as identified in the Safeguarding Vulnerable Adults/Adults at Risk Policy.

Near Misses (No harm to patient, impact prevented)

The reporter must:

  • Ensure the immediate safety of those directly affected by the incident
  • Complete an on-line electronic adverse incident form
  • Inform the appropriate senior member of staff / line manager

 The senior member of staff must:

  • Review the incident within 5 days, and confirm the grading.
  • Complete details of investigation and any long-term actions necessary, on the electronic form  and submit the incident for closure on DatixWeb within a further 5 days
  • Ensure feedback is provided to the reporter

Note: consideration should be given to the potential severity of the near miss had it actually impacted upon a patient, staff member or visitor and the appropriate level of investigation pursued. Whilst the actual grading of the incident should appropriately reflect that no harm was caused on this occasion, the potential severity of the event can be recognised as part of the final grading on conclusion of the investigation.

No Harm (Event occurred but did not cause harm to patient) or Minor (Low harm) 

The reporter must:

  • Ensure the immediate safety of those directly affected by the incident
  • Complete an on-line electronic adverse incident form
  • Inform the appropriate senior member of staff / line manager

 The senior member of staff must:

  • Review the incident within 5 days and confirm the grading
  • Complete details of investigation and any long-term actions necessary, on the electronic form  and submit the incident for closure on DatixWeb within a further 5 days
  • Ensure feedback is provided to the reporter

Moderate (Moderate harm)

The reporter must:

  • Ensure the immediate safety of those directly affected by the incident
  • Complete an on-line electronic adverse incident form
  • Inform the appropriate senior member of staff/line manager

The senior member of staff must:

  • Review the incident within 5 days and confirm the grading;
  • Ensure an investigation is instigated, ensuring the Directorate Senior Nurse is kept updated
  • As part of the investigation process make certain a member of staff is identified to communicate with the patient or relatives and ensure compliance with Duty of Candour requirements.  Further guidance is available in the Trust’s Duty of Candour and Being Open Policy
  • Ensure feedback on decision to investigate is given to reporter;
  • Inform Risk Management of the outcome of the investigation and submit the incident for closure on DatixWeb

Major and Catastrophic (Severe/permanent harm or death)

Incidents graded major or catastrophic should be managed in accordance with the Trust’s Serious Incidents Requiring Investigation Policy. In summary:

Within office hours (08:30 – 17:00)

The reporter of the major or catastrophic incident will:

  • Ensure the immediate safety of those directly affected by the incident;
  • Preserve the key components of the incident, if necessary e.g. retention of equipment; make note of who was present and the role they played, consider environmental factors such as wet floors
  • Complete an on-line electronic adverse incident form; and
  • Immediately inform the appropriate senior member of staff/line manager

The Risk Management Team, Line Managers and relevant specialist members of staff will be automatically notified of the incident via email.

The senior member of staff will:

  • Inform the Directorate Management Team;
    • The Directorate Lead must take advice from the Head of Risk and Director of Nursing (Executive Lead for Risk) immediately in order to establish whether the event should be reported as a Serious Incident
  • Inform the patient’s consultant;
  • Determine who will speak to the patient or relatives and ensure compliance with Duty of Candour requirements (see Duty of Candour and Being Open Policy)
  • Confirm preservation of  the key components of the incident, if necessary e.g. retention of equipment; make note of who was present and the role they played, consider environmental factors such as wet floors
  • Request statements; and
  • Ensure the appropriate support is provided to staff
  • Inform the on-call Supervisor of Midwives if applicable

Out of hours (With the exception of pressure ulcers)

The senior member of staff, via the Clinical Site Team, will inform:

  • Hospital Duty Manager (assumes role of investigating manager and escalates to Executive Director on call if required)
  • On-call consultant if applicable
  • Inform the on-call Supervisor of Midwives if applicable
  • Determine who will speak to the patient or relatives and ensure compliance with Duty of Candour requirements see Being Open Policy
  • The Director of Nursing and Head of Risk must be informed by 09:00 the following working day.

If required:

  • Executive Director on call assumes role of Press Officer OOH if required
  • Executive  Director on call to inform CCG/Comms Team (if necessary; depending on type/severity/scale of incident) e.g. an incident potentially causing high media interest or disruption to service provision

All confirmed major or catastrophic incidents must be subject to a panel inquiry, investigated using full RCA and be signed off through the Clinical Risk Group.

The Director of Nursing will inform the Chief Executive Officer, Medical Director, Public Relations Manager and Litigation Manager as appropriate (please refer to Serious Incidents Requiring Investigation Policy).

It is the responsibility of the patient’s consultant to inform the GP of any major or catastrophic event leading to patient harm.

The Director of Nursing will also advise on external reporting requirements (Appendix C) and whether there is the need to set up a Clinical Review or Serious Incident Investigation.

All persons involved in the incident must on request provide a statement documenting the sequence of events and their involvement. Statements should be written as soon as possible and be a factual account only (see Appendix E for guidance notes).

In the event of a Serious Incident where one or more patients are involved in an event which is likely to produce significant legal, media or other interest the Serious  Incident Immediate Response Policy, which includes the Procedure for Activating a Hotline and Helpdesk must be referred to and followed.

Safeguarding

If staff identify or suspect abuse to a vulnerable adult/adult at risk and a safeguarding alert is required an on-line electronic adverse incident form should be completed. Staff should refer to the ‘Vulnerable adults/Adults at Risk Policy’.

If a concern  regarding the welfare of a child, and/or a suspected safeguarding incident, staff should refer to the Child Safeguarding policy, complete the reporting form and contact the named nurse or midwife for safeguarding children.

Screening Incidents

Incidents relating to national screening programmes must be discussed with the Regional   Quality Assurance Director in line with local and national guidelines and escalated to Commissioners as appropriate.

SFT currently participates in the following national screening programmes:

        Bowel Cancer

·                     Abdominal Aortic Aneurysm

        Cervical Cancer

        Diabetic retinopathy

        Newborn screening

Informing the Police

It is the responsibility of the person in charge of a department at the time of an adverse event to ensure that the police are informed if death or injury of any patient, employee, visitor, volunteer, contractor, where the person in charge considers there to be unusual or suspicious circumstances. Any equipment involved should be retained until the police have visited.  

Record Keeping

Where an event is graded as major or catastrophic it is essential to maintain a contemporaneous record of events.  This should record when, where, why and who made any decisions relating to the event and exactly what action is taken (see Serious Incident Immediate Response Policy for proforma). The Investigating Officer has responsibility for ensuring that an incident report form is completed and all related records are kept secure until such time that they are handed over to the Head of Risk Management. Once handed over, the Head of Risk has responsibility for ensuring that notes and records of events are kept within the relevant incident file.

Patient records that are requested for an incident investigation, Clinical Review/Serious Incident Inquiry will be copied, filed in the appropriate Clinical Review/Serious Incident Inquiry file and the original Patient Records returned, thus enabling them to be available for ongoing treatment.

As well as collecting statements from all those involved in the event it may also be necessary to interview the witnesses; notes of any interviews/meetings must be taken and kept in the incident file. All statements and interview records must be legible, signed, dated and timed.

The Head of Risk will ensure regular update reports are delivered to the Director of Nursing and Chief Executive through Part 2 of the Trust Board and to the Litigation Manager and Customer Care Manager through the CLIP (Complaints, Litigation and Incidents) meeting.

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Investigating and Analysing Adverse Events and Near Misses

 

Statement of Requirement

Adverse events and near misses are subject to an appropriate level of investigation and root cause analysis and, where relevant, an improvement strategy prepared. Not all events need to be investigated to the same extent or depth and the following offers guidance based on the grading of the severity/impact of the event. Further detail can be found in the procedural document Adverse Events, An Organisation Wide Approach to Investigation, analysis, and Learning.

Major/Catastrophic Events:

All major or catastrophic events are subject to a full and thorough investigation utilising root cause analysis techniques as part of the Serious Incident Requiring Investigation Policy. All incidents meeting the threshold of a serious incident must be investigated and reviewed according to principles set out in the Serious Incident Framework.

  • A Serious Incident Inquiry should be initiated in response to any SI. These incidents are reportable externally to the Trust and the final report shared with the local CCG. Guidance is available to support establishing whether an incident is externally reportable: ‘Serious Incident Framework(NHS England, 2015). The final report is signed off by the CEO.
  • A Clinical/Non Clinical Review may be commissioned by the Director of Nursing to formally investigate adverse events not categorised as an SI but serious in nature, crossing departmental boundaries, complex, and/or carrying a high likelihood of reoccurrence. The final report is signed off by the CEO.
  • Departmental/Local Reviews may be used to investigate an adverse event which has occurred within that speciality. A panel is not convened but an RCA exercise is facilitated with the department involved directly contributing. This form of review can only work with the full co-operation of the team/department involved. The outcome of the review and recommendations shall be reported via the Clinical Risk Group and Risk Management Report Cards. 

For these incidents it must be determined who will speak to the patient or relatives and ensure compliance with Duty of Candour requirements see Being Open Policy.

Moderate Events:

Moderate events warrant an investigation that is proportionate to the event, attempt should be made to establish root cause(s).  Investigation and analysis will be carried out perhaps by only one or two key staff e.g. local manager and/or clinician. A Departmental/Local Review may be carried out for some incidents in this category.

For these incidents it must be determined who will speak to the patient or relatives and ensure compliance with Duty of Candour requirements see Duty of Candour and Being Open Policy.

Minor Events:

These are unlikely to warrant in-depth investigation, but root cause analysis of any trends identified should be undertaken, perhaps as part of a working group, and a preventative risk management strategy established to prevent/reduce recurrence.

Systems of simple data collection of frequently occurring minor events or near misses are being established to facilitate easy and quick reporting and subsequent trend analysis. Please contact the Risk Department on ext. 2496/4829 for further details.

Root Cause Analysis

Root Cause Analysis (RCA) is a problem solving methodology for discovering the cause(s) and contributory factors of the problems, or difficulties identified. It fosters a systems based approach to the analysis rather than person centered approach, and has been shown to provide a means for identifying effective solution strategies to a broad range of problems.

The adoption of the RCA approach is essential to finding effective solutions to identified problems, and will assist in the development of an open and fair culture where the emphasis is on learning and not apportioning blame.

All line managers should attend training in RCA techniques and should use these techniques to investigate adverse events and to enable them to complete the investigation stage of the Adverse Event Report form.  Once root causes have been established corrective action must be agreed with a completion date and persons responsible for implementation identified.

Guidance notes on conducting an RCA are enclosed in Appendix F. A template for Departmental/Local Reviews are enclosed in Appendix G. Tools for use as an adjunct to training and the guidance notes are available on ICID under Clinical Effectiveness, sub-heading Risk Management.

Please contact the Risk Department on extension 4829 for further details on RCA training.

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Recording Incidents and Organisational Learning

Central recording of adverse incidents and near misses

All adverse incidents and near misses and the outcome of any investigations are automatically inputted onto the electronic database (DatixWeb) which is maintained within the Risk Management Department, to support analysis and feedback, identification of key themes and organisational learning.

Organisational Learning

No adverse event policy will be effective unless there is organisational learning and feedback on the lessons learned and any required changes in practice implemented. The Trust has introduced a number of processes to enable learning and feedback, which include:

 Internal

  • A systematic approach to the recording and trending of incidents through the use of an electronic reporting system and database;
  • Monitoring of incidents at the monthly Clinical Risk Group;
  • Presentation of quarterly information to the Clinical Governance Committee;
  • Production of reports specifically tailored to the needs of various groups e.g. Health and Safety Committee, Needlestick Action Group, pressure ulcer review group, falls group;

External

  • Reporting of all patient safety incidents to the National Reporting and Learning System (NRLS).  The reports produced by the NRLS, are then used for both benchmarking and learning across the Trust;
  • Reporting of all patients safety incidents to the Care Quality Commission, via the NRLS;
  • Reporting onto STEIS (Strategic Executive Information System)
  • Receipt by the Commissioners of targeted reports;
  • A monthly meeting with the Commissioners at which various aspects of incidents are discussed, to provide assurance on organisational learning;
  • Reporting of any relevant incident to external agencies, as required.

 Governance and reporting arrangements in place in the Trust ensure that learning arising from adverse incidents are

 

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The Trust Risk Register

 

Where there is a theme or trend identified from incidents reported and measures cannot be taken within the ward or department to prevent/reduce recurrence, then a risk assessment must be undertaken and recorded via Datixweb.

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Support for Staff

 

When things do go wrong it is not to be underestimated how difficult the situation can be for those involved. The Trust recognises that in most cases, the cause of an incident will be a combination of events and factors that cannot be linked solely to the actions of individual staff, but those staff involved will still require support through the investigation process and sometimes beyond. This process is detailed in the Duty of Candour and Being Open Policy.

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Patient Information and Support

 

The Trust actively supports open relationships between healthcare organisations, healthcare teams, staff and patients and / or their carers / family. When things go wrong, it is vital that all parties (or their carers / family if appropriate) are kept fully informed, to ensure that trust and respect for the team providing the care to the patient is not lost. 

This has been further regulated through the introduction of the statutory Duty of Candour. This places a duty on the organisation to be open with patients, informing them of any moderate or serious patient safety incidents in which they have been involved. When ‘being open’ the Trust should acknowledge the incident occurred, apologise to the patient or next of kin and explain why the incident occurred and what actions will be put in place to try and prevent a recurrence (See Duty of Candour, Being Open Policy).

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Monitoring the Effectiveness of this Policy

 
  • Responsibilities in their entirety shall be monitored through the Risk Management Report cards and feedback at the Directorate Performance and Quality meetings. This monitoring mechanism shall also take into account whether the process for reporting adverse events is being followed within departments and professional groups.
  • Monitoring of duties and the process for reporting of incidents shall be reported by the Head of Risk to the Clinical Risk Group who shall monitor that this is occurring as specified.
  • The process for reporting to external agencies shall be reported by the Head of Risk to the Clinical Risk Group who shall monitor that this is occurring as specified.
  • The Raising Concerns ‘Whistleblowing’ process shall be monitored by the Head of Clinical Effectiveness as author of that policy and reported to the Clinical Governance Committee.

 

Staff are also able to raise concerns in line with the Trust’s Whistleblowing Policy. This policy enables staff to raise concerns about wrongdoing at work in a way which protects their interests, and which ensures at the same time, that instances of wrongdoing, alleged wrongdoing or apparent wrongdoing are properly investigated and dealt with.  The policy is designed to:

  • Provide a way for members of staff concerned about the care or safety of patients to speak out in the event of other procedures failing or being exhausted.
  • Provide an effective and confidential process to enable staff to challenge practices or behaviours if they believe others are acting in an unlawful and/or unethical way
  • Ensure victimisation or retribution against staff will not be tolerated
  • Protect staff if they speak out appropriately.
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Evidence Base & Appendices

 

Sources of information

1.   Department of Health, June 2000. An Organisation With A Memory. 

      LINK

2.    Department of Health, National Patient Safety Agency, Doing Less Harm, August 2001.

3.    National Patient Safety Agency (2005) Building a memory: preventing harm, reducing risks and improving patient safety. Online www.npsa.nhs.uk

4.     National Patient Safety Agency (2009) Being Open. Online www.npsa.nhs.uk/beingopen

5.    NHS England (2015) Serious Incident Framework: Supporting learning to prevent recurrence. Patient Safety Domain. London. http://www.england.nhs.uk/ourwork/patientsafety/serious-incident/

6.    National Patient Safety Agency, Seven Steps to Patient Safety. 2004. (www.npsa.nhs.uk/sevensteps)

7.    NHS England, Revised Never Events Policy and Framework, 2015.

http://www.england.nhs.uk/wp-content/uploads/2015/04/never-evnts-pol-framwrk-apr.pdf

8.    National Patient Safety Agency, 2010. Information Resource to Support the Reporting of Serious Incidents

(www.nrls.npsa.nhs.uk/patientsafetydirect)

9.    Department of Health, 2013. Statement of Government Policy on adult Safeguarding. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/197402/Statement_of_Gov_Policy.pdf

10. Public Health England, NHS Screening Programmes, Managing Safety Incidents in NHS Screening Programmes – updated interim guidance, 2015. 

       LINK

11. NMC/GMC, Openness and honesty when things go wrong: the professional duty of candour. 2015

http://www.gmc-uk.org/static/documents/content/DoC_guidance_englsih.pdf

12. Care Quality Commission, Regulation 20: Duty of Candour, 2015.

http://www.cqc.org.uk/content/regulation-20-duty-candour#full-regulation

Appendices

 Appendix  Description  Attachment
 A ‘How to’ Guide – Incident Reporting  
 B Assessing the Level of Risk – (Guidance, Risk Assessment Matrix and Definitions of Harm)  
 C Reporting to external agencies  
 D Joint Investigations between Salisbury NHS Foundation Trust and the Police  
 E Guidance notes for witnesses & Guidance on providing a written statement  
 F

Principles of a Root Cause Analysis Investigation

 
 G Template for Departmental/Local Review  
 H  Equality Analysis  
     

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