Policy for the Reporting and Management of Incidents and Near Misses

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1 IMPORTANT NOTE: This policy is under review. It will be incorporated into a single Incident Management Policy - CORP/RISK 13 v.3 which will also reflect NHS England s Serious Incident Framework published 27 th March The policy extended review date of July 2015 was agreed at PSRG 10 th April Policy for the Reporting and Management of Incidents and Near Misses This procedural document supersedes: CORP/RISK 13 v.1 Policy for the Management of Adverse Incidents and Near Misses including Serious Untoward Incidents. Note: Policy for the Management of a Serious Untoward Incident (SUI) is now a separate procedural document see CORP/RISK 15 v.1 Name and Title of Author Ms M Dalton - Head of Risk and Legal Services Date Revised June 2010 Approved by (Committee/Group) Date of Approval 2 nd July 2010 Date Issued July 2010 Patient Safety Review Group Next Review Date July 2013 extended to July 2015 Target Audience Trust wide WARNING: Always ensure that you are using the most up to date approved procedural document. If you are unsure, you can check that it is the most up to date version by looking on the Trust website: under the headings Freedom of Information Information Classes Policies and Procedures Page 1 of 14

2 Policy for the Reporting and Management of Incidents and Near Misses Amendment Form Please record brief details of the changes made alongside the next version number. If the APD has been reviewed without change, this information will still need to be recorded although the version number will remain the same. Version Date Brief Summary of Changes Author Version 2 June 2010 Title change Substantial changes, please read whole document Mandy Dalton Page 2 of 14

3 Policy for the Reporting and Management of Incidents and Near Misses CONTENTS Number Contents Page 1 Introduction and Background 4 2 Equality Impact Assessment 4 3 NHS Constitution 5 4 Scope/Audience 5 5 Duties 5 6 Committees with Responsibility for Risk Management. 6 7 Definitions 7 8 Procedure for Incident Reporting 7 9 Action Plans 9 10 Involvement of Relevant Stakeholders 9 11 Communication and Organisational Learning 9 12 Process by which to raise Concerns Training Monitoring Compliance and Effectiveness Review, Updating and Archiving of this Document References and Associated Documentation 11 Appendix 1 Appendix 2 Appendix 3 Classification of Severity of Incident Incident Management Flowchart Three Levels of RCA Investigation Page 3 of 14

4 Policy for the Reporting and Management of Incidents and Near Misses 1. Introduction / Background Incident reporting is a fundamental tool of risk management, the aim of which is to collect information about incidents, including near misses, ill health and hazards, which help to facilitate wider organisational learning. If incidents are not properly managed, they may result in a loss of public confidence in the organisation and a loss of assets. The objective of this policy is to ensure effective management and investigation of incidents and near misses in accordance with best practice, learns and shares lessons from them and takes appropriate action to protect patients, staff, contractors, volunteers and members of the public from harm. It has been formulated in response to the Department of Health publications An Organisation with Memory 1, Building a Safer NHS 2, Doing less Harm 3 and the National Patient Safety Agency publications Building a memory: preventing harm, reducing risks and improving patient safety 4, Being Open: Communicating patient safety incidents with patients and their carers 5 and Seven Steps to Patient Safety 6. The policy is also designed to ensure compliance with the requirements of the Care Quality Commission 7 and the National Health Service Litigation Authority 8 & 9. The ultimate aim is to reduce the risk of harm to patients, staff and other users of Trust premises through improving the safety culture and quality of services and the environment. This will be addressed by undertaking qualitative and quantitative data analysis of incidents to highlight any trends Doncaster and Bassetlaw Hospitals NHS Foundation Trust (DBHFT) recognises that in a service as large and complex as the NHS things go wrong. When they do, the Trust supports the view that the response should not be one of blame and retribution but of organisational learning with the aim of encouraging participation in the overall process and supporting staff, rather than exposing them to recrimination. Therefore, the Trust is committed to developing a just or fair blame culture and to encouraging a willingness to admit mistakes without fear of punitive measures. In support of this, the Trust accepts that completion of an Incident Form (AIF) does not constitute an admission of liability and will not result in automatic disciplinary action. There are occasions, however, when it may be necessary to apportion blame: e.g. acts of maliciousness or criminal or gross/repeated professional misconduct. 2. Equality Impact Assessment As part of its development, this Policy and its impact on equality have been reviewed in consultation with trade union and other employee representatives in line with the Trust s Equality Impact Policy CORP/EMP 27. The purpose of the assessment is to minimise and if possible remove any disproportionate impact on employees on the grounds of race, sex, disability, age, sexual orientation or religious or other belief. No detriment was identified. Page 4 of 14

5 3. NHS Constitution CORP/RISK13 v.2 As part of its development, this policy was reviewed in line with the Trust s legal duties as laid down in the NHS Constitution 11. Risk management through incident and nearmiss reporting makes a positive contribution to the development and maintenance of a healthy and safe workplace for employees, other workers and visitors, thereby assisting the Trust in meeting staff rights and NHS pledges. 4. Scope/Audience This policy applies to all staff of DBHFT, whilst acknowledging that for staff other than those directly employed by the Trust the appropriate line management or chain of command will be taken into account. Whilst the policy outlines how the Trust will report, manage, analyse and learn from all clinical and non-clinical events and near misses, implementation does not replace the personal responsibilities of staff with regard to issues of professional accountability for governance. This policy should be read in conjunction with Trust Corporate Policies including: Policy and Guidance for Handling Complaints CORP/COMM 4 Claims Handling Policy CORP/RISK5 Risk Management Strategy CORP/RISK10 Risk assessment policy CORP/HSFS 6 Being Open Policy CORP/RISK14 Policy for the Management of Serious Untoward Incidents CORP/RISK 15 Maternity Services Risk Management Strategy CORP/RISK 16 Information Communication and Technology Strategy CORP/ICT5 Staff Counselling Services CORP/EMP8 Whistleblowing Policy - Voicing your Concerns CORP/EMP14 5. Duties These are the individual and departmental roles and levels of responsibility for incident management within the Trust. 5.1 All Staff All staff have a responsibility for ensuring that incidents and near misses are reported. All staff should be aware of what constitutes an incident or near miss and the process for reporting and management of such incidents. 5.2 The Incident Reporter The reporter must: Ensure the immediate safety of the patient/staff/visitor involved in the incident Complete an incident form (AIF) Inform the appropriate senior member of staff/line manager Send AIF form to the Risk Management Lead/ Head of Department. Page 5 of 14

6 Page 6 of 14 CORP/RISK13 v Risk Management Lead/Head of Department The risk management lead/head of department will: Receive and investigate incidents as forwarded by the reporter and complete all details within the lower section of the form Record details of the long-term actions necessary and forward as appropriate Categorise the severity of the incident in relation to the Actual harm that has occurred (See Appendix 1) Copy the form to any other relevant party Send top copy to the Risk Management Department to ensure entry onto the DATIX system. Must return third copy of form to the Red Risk Management Folder - to ensure a collation and comprehensive history of incidents and actions taken Give appropriate feedback to the reporter Ensure lessons learned are shared across their area of responsibility Undertake a trend analysis of all incidents on a quarterly basis and report this to their local governance groups Complete RIDDOR form when applicable and following advice from Heath & Safety Manager Divisional Nurse/Manager Divisional Managers and Divisional Nurses are responsible for promoting effective risk management and ensuring there are operational systems in place within their teams to fulfil the requirements of this policy. This includes ensuring staff receive feedback on reported incidents together with appropriate risk management training. 5.5 Risk Management Team The risk management team will receive all incident forms and record all incidents on to the Datix system. In addition, they will provide advice, assistance and support to Line Managers and other employees as appropriate and ensure the provision of relevant training associated with this Policy. The Risk Management Team are also responsible for maintaining the database of incidents and monitoring any associated trends occurring, reporting to the relevant committee(s) and feeding back to individuals or teams where requested and appropriate. 5.6 Chief Executive The Chief Executive has ultimate responsibility for safety and risk management across the Trust and will ensure that all incidents are dealt with appropriately and that the culture of fair blame is upheld. 6. Committees with Responsibility for Risk Management 6.1 Patient Safety Review Group (PSRG) The patient safety review group (PSRG) will receive a quarterly, quantitative and qualitative DATIX report incorporating a trend analysis of Incidents and near misses. The PSRG will recommend actions required to ensure the reduction of risk in patient safety and prevent future reoccurrence. The PSRG s role is to ensure actions are taken as a result of trend analysis, and the cascading of information throughout the organisation. 6.2 Clinical Governance Standards Committee

7 The Clinical Governance Standards Committee (CGSC) will receive an executive summary of the quarterly DATIX report and an assurance that systems and processes are in place to address and learn from all incidents and near misses and to ensure effective Risk Management across the Trust. 6.3 Local Clinical Governance Group (LCGG) The Local Clinical Governance Group reviews their incidents to identify significant risks and to facilitate improvement of patient safety, and to influence audit. The Local Clinical Governance Group facilitates appropriate investigations of incidents ensuring a root cause analysis is undertaken as appropriate. The Local Clinical Governance Group will have a clear process to feedback to all staff on lessons learned from incident reporting and investigations. The LCGG has the responsibility to report to the Patient Safety Review Group on request and to the Clinical Governance Standards Committee on an annual basis 6.4 Joint staff side committee (JSCC) The JSCC will receive the quarterly DATIX report and note the Health and Safety section. They will consider the themes and agree further actions and audits. 7. Definitions Throughout this policy, the word incident should be taken to include near-misses unless otherwise specified. Incident any accident, event or circumstance that led to harm, loss or damage to people, property, reputation, or other occurrence that could impact on the organisation s ability to achieve its objectives. Near-miss an incident that did not lead to harm, loss or damage. Near-miss/high risk - an incident that did not lead to harm, loss or damage, however had the potential to cause ACTUAL HARM and SERIOUS CONSEQUENCE. Root cause analysis the process by which the underlying cause(s) of incidents is established 8. Procedure for Incident Reporting 8.1 Reporting the Incident When an incident occurs, the first response must be to make the situation safe. All evidence should be protected and secured, e.g., damaged equipment retained, IT activity logs copied, etc, in case of the need for further investigation. It is essential that an Incident Report Form is completed for all incidents and near misses. Incidents should be managed in accordance with the processes and timescales detailed within the Incident Management Flowchart at Appendix 2 of this Policy. Page 7 of 14

8 All serious C severity incidents should be reported immediately to the Medical Director and Head of Risk & Legal Services. The policy on the management of serious incidents CORP/RISK 15 must then be followed. It is important to record all facts before the memory fades or situation changes. All information required on the form should be provided, stating the facts clearly and legibly, and not giving opinions. Remember that this information may be used in support or defence of legal action. If assistance is required in the completion of the Incident Report Form, a member of the Risk Management Team should be contacted for advice. Reporter must send the form to the Head of Department. N.B **Forms must not be filed in the medical records 8.2 Investigation and grading the incident Investigation is carried out firstly for the purpose of establishing the cause, secondly to initiate such corrective action as may be necessary to remove the possibility of such an event recurring, and thirdly to ensure that, where necessary, formal reports are made to relevant external bodies. The head of department receiving an incident form must complete the portion of the form indicated and categorise the severity of the incident in accordance with actual harm /effect. (See Appendix 1 for guidance) Head of Department will then disseminate the copies as: White top copy (Must be original) to the risk office. Blue Copy to be forwarded to the relevant Clinical Governance team pertinent to the incident. Yellow Copy to remain in the area of completion within the Red - Risk Management folder on the department. The head of department will ensure an investigation is undertaken of the incident, proportionate to the severity and that any necessary remedial action is taken or initiated, recording this within the Action taken to prevent recurrence box. The Head of department should refer to Appendix 3 Three levels of RCA investigation. In the majority of cases, a level 1 Concise Investigation will be undertaken. N.B ** Incidents may need to be re-graded as a consequence of an investigation. It is essential that a risk assessment is undertaken where there is a possibility that a risk remains. If remedial action is not immediate, the risk should be added to the relevant divisional Risk Register and an action plan agreed which will be monitored by the local governance group. Page 8 of 14

9 9. Action Plans CORP/RISK13 v.2 Action plans should be produced post investigation and these will be monitored via the local governance group. Any actions that have wider organisation implications will be reported by the risk management lead to the patient safety review group. Completion of action plans may be the responsibility of a line manager, nominated individual or a group/ committee. 10. Involvement of relevant stakeholders NPSA: All patient safety incidents are reported by the risk department via the National Reporting and Learning System (NRLS) to the National Patient Safety Agency. HSE: Those specific incidents that are reportable to the HSE under the Reporting of Injuries, Diseases and Dangerous Occurrence Regulations 1995 (RIDDOR) are reported by the Head of Department 12 MHRA: Notifiable incidents 10 are reported by the Trust s Medical Devices Manager. Health and Safety incidents are reported to the Health and Safety Executive by the Trust s Health & Safety Manager. The SIRO is responsible for notifying the Department of Health of any category 1-5 information security incident. Where other external bodies such as the Department of Health, the Police or Environmental Health Agency need to be informed, the Chief Executive will determine who should contact the relevant body. 11. Communication & Organisational Learning 11.1 Patient/relative/visitor/contractor communication and support In the event of an incident, effective communication with patients/relatives/visitors/contractors is essential. The Matron or the departmental risk management lead will be responsible for all communication with the patient/relatives/visitors/contractors in accordance with the Being Open Policy CORP/RISK14. It must be remembered that an apology does not constitute an admission of liability. Organisational learning The sharing of lessons learned post investigation is a critical part of risk management. Page 9 of 14

10 All incidents and actions taken are entered onto the Trust database (DATIX). This allows the Trust to analyse incidents and identify trends in a number of ways including: by Division, location, type, and severity. A quarterly aggregated DATIX report and information on organisational learning is reported to the Patient Safety Review Group. Local Clinical Governance Groups receive and share this report at their meetings. It is essential that staff receive appropriate feedback via their line management route, on reported incidents and any actions taken. 12. Process by which to raise concerns Staff must be aware of how to raise concerns regarding all incidents and near misses without a fear of recrimination. Please refer to Whistleblowing Policy - Voicing Your Concerns CORP/EMP Training All members of staff will receive Health and Safety Awareness training as part of the Trust s mandatory and statutory training programme. Managers should ensure that all members of their staff receive sufficient training to enable them to fulfil their individual responsibilities under this policy. That training could be basic, advanced or specialist: for example in root cause analysis. Details of risk management training can be found on the Trust s intranet Learning and Development site, in the Trust s Training and Development Manual. Investigation of incidents, complaints and claims, including root cause analysis will be provided to all matrons, clinical governance leads and risk management leads. 14. Monitoring Compliance and Effectiveness Risk management, which includes the effective implementation of this policy, is monitored through the NHSLA risk management assessments, internal audit and through quarterly Datix reports reviewed by the patient safety review group. 15. Review, Updating and Archiving of this Document The Policy Co-ordinator maintains a database of all Trust approved Policies. The database records dates of approval and issues, version numbers and dates for review. The Risk Management Department will be notified of the review date to ensure a timely update of the policy. Withdrawn and superseded versions of this policy are retained electronically by the Policy Co-ordinator. Page 10 of 14

11 16. References and Associated Documentation CORP/RISK13 v.2 External 1. Department of Health, June An Organisation with a Memory 2. Department of Health, April Building a Safer NHS 3. Department of Health, August Doing Less Harm. 4. National Patient Safety Agency, July Building a Memory: preventing harm, reducing risks and improving patient safety 5. National Patient Safety Agency, Being Open: Communicating patient safety incidents with patients and their carers 6. NPSA : 7 Steps to Patient Safety 7. Care Quality Commission (CQC). (2009) NHS performance ratings 2008/ National Health Service Litigation Authority, April 2005, Clinical Negligence Scheme for Trusts - Clinical Risk Management Standards Maternity 9. National Health Service Litigation Authority, Risk Management Standards.Acute.2010/ Medical Devices Agency, March Safety Notice MDA SN2002(01) 11. Department of Health, January 2009 The Handbook to NHS constitution 12. Reporting of Incidents to the HSE under the Reporting of Injuries, Diseases and Dangerous Occurrence Regulations 1995 (RIDDOR) Internal 1. Claims Handling Policy CORP/RISK5 2. Risk Management Strategy CORP/RISK10 3. Risk assessment policy CORP/HSFS 6 4. Being Open Policy CORP/RISK14 5. Policy for the management of a Serious Incident (SI) CORP/RISK15 6. Maternity Services Risk Management Strategy CORP/RISK Policy and Guidance for Handling Complaints CORP/COMM4 8. Information Communication and Technology Strategy CORP/ICT5 9. Staff Counselling Services CORP/EMP8 10. Whistleblowing Policy - Voicing your Concerns CORP/EMP Equality Impact Assessment Policy CORP/EMP 27 Page 11 of 14

12 Appendix 1 Incident and Near Miss Reporting Classification of Severity of Incident Please use the chart below to define the severity of an Incident or near Miss. What effect or harm did the incident have on this occasion? NEAR MISS (E) No actual harm/low risk MINOR (A) Non Permanent Harm (up to 1 month) MEDIUM (B) Semi Permanent Harm (Up to 1 year) SERIOUS (C) Major & Permanent Harm NEAR MISS/HIGH RISK (D) No Harm Caused e.g.needlestick Injury- Unless known infected Source) Falls = cuts / abrasions Violence & Aggression Medication incidents Fire = slight smoke damage to a room. Equipment = loss or damage to/caused minor injuries. e.g.needlestick Injury - known infected Source. Falls = minor fractures- Arms / legs. Injury to other organs requiring corrective procedure. Hospital acquired grade 2 pressure ulcer. Violence & Aggression RIDDOR reportable accident or illness, i.e. over 3 days Sickness. Fire = moderate fire/ smoke damage to more than one room or causing the loss of one floor. FOLLOW SUI POLICY CORP/ RISK 15 Unexpected or avoidable death. Major Injury i.e. Major Fracture, Amputation, Blindness, Loss of Consciousness. Hospital Acquired Pressure Ulcers grade 3 or 4 Injury to other organ= Major corrective or removal of. Never events Abuse. Patient receiving a radiation dose much greater or less than intended. Serious or critical loss of use of equipment i.e long term power / telephone outage Potential severe harm/ potential death situations when following risk assessment, the risk of recurrence is high. eg Potential wrong site surgery, Transfusion sample taken from the wrong patient (Risk of fatal transfusion reaction), Surgical sample labelled with wrong patient identification." Known or suspected case of health care associated infection, which may result in death or result in major permanent harm e.g. Hepatitis C. Procedures involving the wrong patient or body part Retained Instruments, or other material, after surgery requiring reoperation. ANY SERIOUS INCIDENTS MUST BE REPORTED IMMEDIATLEY, TO HEAD OF RISK & LEGAL SERVICES & CLINICAL DIRECTOR AS SPECIFIED IN THE TRUST POLICIES. Page 12 of 14

13 Appendix 2 INCIDENT MANAGEMENT FLOWCHART CORP/RISK13 v.2 Incident Occurs Make it safe (If incident is serious, follow SUI Policy CORP /RISK 15 Person involved in / witnessing incident Complete AIR form and forward to Head of Department (HOD) Line Manager / Head of Department Review Incident and categorise severity (Appendix 1) consider risk assessment Carry out preliminary investigation (Appendix 3) Take remedial action if possible Copy and forward form to the Risk Management Team within 5 Working Days of receiving. (If incident is serious, follow SI Policy CORP / RISK 15 and forward within 24Hrs) Also copy and forward form to relevant Manager if applicable as follows: Resolve Incident Health &Safety/ Facilities incidents: Copy & forward to Facilities Health & Safety Lead for information and further remedial action Information Security Incidents: Copy & forward to Information Governance Manager for information and further remedial action Other e.g. Finance, Claims, IT, incidents: Copy & forward to relevant Team for information and further remedial action Receiving person/team: Review Incident Report Form Take further remedial action and /or risk assessment as appropriate & notify Sender- Line Manager / Head of Department Resolved Incidents: Agree closure Inform Risk Management team to enable closure of incident on Datix System Risk Management Team Review action taken and input the details of the incident on to the Datix database Prepare quarterly report for Patient Safety Review Group Support Divisional Trend Analysis through logged, reported incidents. Page 13 of 14

14 Appendix 3 Three Levels of RCA investigation guidance Patient safety Root Cause Analysis (RCA) investigations should be conducted at a level appropriate and proportionate to the incident, claim, complaint or concern under review. The following are guidelines for what might be considered appropriate and proportionate: Level 1 Concise Investigation Most commonly used for incidents, claims, complaints or concerns that resulted in no, low or moderate harm to the patient and there is a low risk of recurrence causing harm. Also useful as an executive summary to communicate findings from full, comprehensive or independent investigation reports, following actual or potential severe harm or death outcomes. Commonly involves completion of a summary or one page structured template. Includes the essentials of a thorough and credible investigation, conducted in the briefest terms. Involves a select number of RCA tools (e.g. timeline, 5 why s, contributory factors framework). Conducted by one or more people (with a multidisciplinary approach if more than one investigator). Often conducted by staff local to the incident (ward/department/directorate/gp surgery) Should include person(s) with knowledge of RCA, human error and effective solutions development. If a patient is directly affected, they/relative/carer should be involved. Includes plans for shared learning locally and/or nationally as appropriate. Level 2 Comprehensive investigation Commonly conducted for actual or potential severe harm or death outcomes from incidents, claims, complaints or concerns. Conducted to a high level of detail, including all elements of a thorough and credible investigation. Includes use of appropriate analytical tools (e.g. tabular timeline, contributory factors framework, change analysis, barrier analysis). Normally conducted by a multidisciplinary team, or involves experts/expert opinion/independent advice or specialist investigator(s). Conducted by staff not involved in the incident, locality or directorate in which it occurred. Overseen by a director level chair or facilitator. Led by person(s) experienced and/or trained in RCA, human error and effective solutions development. Includes patient/relative/carer involvement and should include an offer to patient/relative/carer of links to independent representation or advocacy services. May require management of the media via the organisation s communications department. Includes robust recommendations for shared learning, locally and/or nationally as appropriate. Includes a full report with an executive summary and appendices. Level 3 Independent investigation As per Level 2, but in addition: Must be commissioned and conducted by those independent to the provider service organisation involved. Commonly considered for incidents, claims, complaints or concerns of high public interest or attracting media attention. Conducted for mental health homicides which meet Department of Health guidance. Should be conducted where Article 2 of the European Convention on Human Rights is, or is likely to be, engaged. Page 14 of 14

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