Post on 25-May-2018
transcript
Management and Investigation of Serious Incidents, Incidents, Accidents and Near
Misses Policy
Document Reference No. KMPT CorG.017.08
Replacing document KMPT CorG.017.07
Target audience Trust-wide
Author Patient Safety Manager
Group responsible for developing document
Trust-wide Patient Safety and Mortality Review Group
Status Ratified
Authorised/Ratified By Trust-wide Patient Safety and Mortality Review Group
Authorised/Ratified On June 2016
Date of Implementation June 2016
Review Date June 2019
Review This document will be reviewed prior to review date if a legislative change or other event otherwise dictates.
Distribution date November 2016
Number of Pages 57
Contact Point for Queries policies@kmpt.nhs.uk
Copyright Kent and Medway NHS and Social Care Partnership Trust 2016
DOCUMENT TRACKING SHEET
Management of Serious Incidents, Incidents, Accidents and Near Misses Policy
Version Status Date Issued to/approved by Comments
2.1 Draft June 2011 Relevant staff for consultation Review & feedback
2.2 Draft 13/07/11 Policy Group Review & Feedback
2.3 Draft 26/07/11 Clinical Governance Group Review & Feedback
3.0 Approved 27/09/11 Clinical Governance Group Authorised for use
4.0 Approved 28/08/2012 Trust-wide Patient Safety Group
Authorised for use
5.0 Draft April 2014 Trust-wide Patient Safety Group
Review & Feedback
6.0 Approved March 2015 Trust-wide Patient Safety Group
Authorised for use
6.1 Draft October 2015 Patient Safety Manager Review
7.0 Approved November 2015
Quality Committee Ratified
7.1 Draft June 2016 Patient Safety & Mortality Group
Submitted for approval
8.0 Approved June 2016 Patient Safety & Mortality Group
Ratified
REFERENCES
Health and Safety (Consultation with Employees) Regulations 1996 SI 1996/1513
Public Interest Disclosure Act 1998
Department of Health. (1999). Health Service Circular 1999/198. The Public Interest Disclosure Act 1998: Whistle blowing in the NHS. Department of Health. Available at: www.dh.gov.uk
Health and Safety Executive. (2008). Consulting employees on health and safety: A brief guide to the law. HSE. Available at: www.hse.gov.uk
Health and Safety Executive. ‘What is RIDDOR?’ HSE website. HSE. Available at: www.hse.gov.uk
The National Patient Safety Agency (NPSA) website offers further information and resources on incident reporting at www.npsa.org.uk. Incident reporting
� ‘Incident decision tree’ Online tool.
� Seven Steps to Patient Safety in Primary Care Trusts. (2006)
� National Framework for Reporting and Learning from Serious Incidents Requiring Investigation. (2009)
� National Reporting and Learning Service (NRLS) Data Quality Standards: Guidance for Organisations Reporting to the Reporting and Learning System (RLS). (2009)
� Patient Safety Alert: Update. WHO Surgical Safety Checklist. (2009)
� Questions are the answer! Seven questions every Board Member should ask about patient safety. (2009)
� Medical Error: What to do if things go wrong: A guide for junior doctors. (2010)
� Never Events: Framework – Update for 2010/11: Process and action for Primary Care Trusts. (2010)
Department of Health (2005). Independent investigation of adverse events in mental health services. London: Department of Health. Available at: www.dh.gov.uk
Department of Health. (2004). Memorandum of understanding: Investigating patient safety incidents involving unexpected death or serious untoward harm: A protocol for liaison and effective communications between the National Health Service, Association of Chief Police Officers and Health and Safety Executive. London: Department of Health. Available at: www.dh.gov.uk and www.acpo.police.uk
Department of Health. (2006). Safety First. A report for patients, clinicians and healthcare managers. London: Department of Health. Available at: www.dh.gov.uk
Department of Health. (2010). The NHS Constitution: The NHS belongs to us all. London: Department of Health. Available at: www.dh.gov.uk
General Medical Council (GMC) (2008). ‘Raising concerns about patient safety: Guidance for doctors’. GMC website page. London: GMC. Available at: www.gmc-uk.org
Health and Safety Executive (2003). Work Related Death P16. Protocol and Guidance. HSE. Available at: www.hse.gov.uk
Health and Safety Executive (HSE). (2008). Involving your workforce in health and safety: Good practice for all workplaces. HSE. Available at: www.hse.gov.uk
House of Commons. (2009). House of Commons Health Committee: Patient Safety: Sixth Report of Session 2008-09, Volume I. London: The Stationery Office Limited. Available at: www.publications.parliament.uk
National Patient Safety Agency (NPSA) and NHS Confederation. (2008). Briefing Issue 161: Act on reporting. London: NPSA and NHS Confederation. Available at: www.nhsconfed.org
National Screening Committee, NHS Cancer Screening Programmes (2010). Managing Serious Incidents in National Screening Programmes.
NHS Security Management Service. (2010). Security Incident Reporting System. London: NHS Security Management Service. Available at www.nhsbsa.nhs.uk
Patient Safety First. (2009). The ‘How to Guide’ for Implementing Human Factors in Healthcare. London: Patient Safety First. Available at: www.patientsafetyfirst.nhs.uk
Serious Incident Framework – NHS Commissioning Board – March 2013. Available at www.commissioningboard.nhs.uk
Serious Incident Framework (Supporting learning to prevent recurrence) NHS England Patient Safety Domain March 2015
RELATED DOCUMENTS
All Trust and health economy documents which relate in any way to this document
Current Reference code of document
Whistle-blowing / raising concerns KMPT.HR.002
Claims Management Policy and Process KMPT.CorG.014
Investigation of Serious Untoward Incidents, Incidents, Complaints and Claims Policy
KMPT.CorG.020
Health and Safety Policy KMPT.CorG.005
Infection Prevention and Control for Inpatient, Residential and Community Services Policy KMPT.CliG.005
Risk Management Strategy KMPT.CorG.012
Duty of Candour Policy KMPT.CorG.018
Health & Safety Risk Assessment Policy & Guidance KMPT.CorG.004
Learning From Experience Policy KMPT.CorG.011
Staff Support Policy KMPT.HR.044
Safeguarding Vulnerable Adults Policy KMPT.CliG.006
Safeguarding & Protecting Children & Young People Policy KMPT.CliG.030
Information Governance Incident Management Policy KMPT.InfG.028
Information Governance Policy KMPT.InfG.003
SUMMARY OF CHANGES
1. The addition of a weekly Mortality Review Group
CONTENTS
EXECUTIVE SUMMARY ..................................................................................................... 1
1 INTRODUCTION .......................................................................................................... 2
2 INVOLVING PATIENTS AND THEIR FAMILIES IN INVESTIGATIONS INTO SERIOUS INCIDENTS 3
3 PURPOSE OF POLICY AND SCOPE ......................................................................... 4
4 SERIOUS INCIDENT – IDENTIFICATION AND RESPONSE ..................................... 6
5 SERVICE LINES INCIDENT REVIEW PROCESS ....................................................... 7
6 DUTIES, ROLES AND RESPONSIBILITIES - STAFF .............................................. 10
7 THE TRUST BOARD ................................................................................................. 11
8 THE EXECUTIVE MEDICAL DIRECTOR AND DIRECTOR OF NURSING & GOVERNANCE ................................................................................................................. 12
9 EXECUTIVE MEDICAL DIRECTOR (PATIENT SAFETY LEAD).............................. 12
10 NON EXECUTIVE DIRECTORS ................................................................................ 13
11 SERVICE DIRECTORS ............................................................................................. 13
12 SERVICE LINE ASSISTAINT DIRECTORS, LINE MANAGERS AND SERVICE LINE MANAGERS 13
13 THE QUALITY COMMITTEE ..................................................................................... 14
15 INFORMATION GOVERNANCE GROUP ................................................................... 15
16 TRUSTWIDE INFECTION PREVENTION & CONTROL GROUP ............................. 15
17 HEALTH, SAFETY & RISK GROUP ......................................................................... 16
18 LOCAL HEALTH, SAFETY & RISK MEETINGS....................................................... 16
19 SERVICE LINE SERIOUS INCIDENT LEAD ............................................................. 16
20 PATIENT SAFETY MANAGER ................................................................................. 16
21 INFORMATION RIGHTS MANAGER ........................................................................ 16
22 SUB CONTRACTORS, SERVICE PROVIDERS AND VISITORS ............................. 17
23 OUT OF HOURS AND ON CALL RESPONSES ....................................................... 17
24 STAFF/PATIENT/RELATIVE/VISITOR/CONTRACTOR COMMUNICATION AND SUPPORT 17
25 EXTERNAL STAKEHOLDER NOTIFICATION ......................................................... 18
26 PROCESS BY WHICH TO RAISE STAFF CONCERNS ........................................... 19
27 MEDIA INVOLVEMENT .............................................................................................. 19
28 HOTLINE ARRANGEMENTS .................................................................................... 20
29 SAFEGUARDING ...................................................................................................... 20
30 INCIDENT & CAUSAL FACTOR ANALYSIS- THE PRIME REASON(S) WHY AN INCIDENT OCCURRED. ................................................................................................... 20
31 INVOLVEMENT OF RELEVANT STAKEHOLDERS AND MEMORANDUM OF UNDERSTANDING ........................................................................................................... 20
32 MANAGEMENT CLINICAL SI LEARNING REVIEW USING RCA METHODOLOGY AND INVESTIGATION REPORT ............................................................................................... 21
33 SUMMARY POINTS FOR DISSEMINATION OF LEARNING FROM A SERIOUS INCIDENT 22
34 IDENTIFYING ISSUES WHICH MAY BE OF NATIONAL SIGNIFICANCE .............. 22
35 LEARNING FROM SERIOUS CASE REVIEWS (SCR) ............................................. 22
36 RECORD KEEPING AND CONFIDENTIALITY ......................................................... 22
37 EQUALITY IMPACT ASSESSMENT (APPENDIX B) ................................................ 23
38 HUMAN RIGHTS ....................................................................................................... 23
39 MONITORING COMPLIANCE WITH AND EFFECTIVENESS OF THIS DOCUMENT24
40 EXCEPTIONS ............................................................................................................ 25
41 LEARNING FROM EXPERIENCE ............................................................................. 26
42 LINKS WITH OTHER PROCEDURES ....................................................................... 26
APPENDIX A NEVER EVENTS IN MENTAL HEALTH .................................................. 27
APPENDIX B EQUALITY IMPACT ASSESSMENT ....................................................... 28
APPENDIX C ABBREVIATIONS AND DEFINITIONS ................................................... 32
APPENDIX D ROLES AND RESPONSIBILITIES IN THE PROCESS FOR REPORTING ALL SERIOUS INCIDENTS, INCIDENTS, ACCIDENTS & NEAR MISSES INVOLVING STAFF, SERVICE USERS AND OTHERS .......................... 35
APPENDIX F REPORTING TO EXTERNAL STAKEHOLDERS ................................... 43
APPENDIX G SERIOUS INCIDENTS ............................................................................. 45
APPENDIX H SI LEAD REPORTING RESPONSIBILITIES ........................................... 46
APPENDIX I CLASSIFICATION OF INCIDENTS/ACCIDENTS FOR REPORTING INCIDENTS TO NRSL VIA DATIX ........................................................... 47
APPENDIX J SERIOUS INCIDENT QUALITY ASSURANCE CHECKLIST .................. 55
APPENDIX K HOW TO IDENTIFY A REPORTABLE INCIDENT FLOWCHART .......... 56
APPENDIX L HOW TO INVESTIGATE NON SERIOUS INCIDENT .............................. 57
1
EXECUTIVE SUMMARY Serious Incidents requiring investigation in the Trust are rare, but when they do occur, everyone involved must make sure that they follow the Trust’s policies that are in place to respond, investigate and manage such incidents. These measures are in place to protect patients and staff, ensuring that robust investigations are carried out, which will result in the Trust learning from serious incidents to minimise the risk of the incident happening again. This policy sets out the systems, processes and accountability within Kent & Medway NHS & Social Care Partnership Trust for the management and investigating all incidents and near-misses, whether clinical or non-clinical, including Serious Incidents and Notifiable Incidents, to promote high quality, safe, accountable healthcare, minimising risks to patients, clients, staff and the Trust and maximising available resources. When an incident occurs it must be reported to all relevant bodies and therefore, the policy applies to all organisations working within the Trust, including commissioned providers. All of those organisation who are part of the system have a responsibility to share information and learning with their partner organisations.
Accountability Our principal accountability is to patients and their families/carers, whilst supporting our staff. The immediate consideration following a serious incident is that the patient must be safely cared for, and their own, and other patients’ health and welfare, must be secured and further risk mitigated. Patients, families and carers, must be appropriately and fully involved in the response to the serious incident and staff must be assured that the Trust promotes and open, positive and non-punitive approach towards learning from all incidents.
2
1 INTRODUCTION
1.1 It is recognised that things sometimes go wrong and that serious incidents, incidents, accidents and near misses will occur. The aim of this policy is to support a robust safety culture throughout the Trust. This will improve the recognition and reporting of adverse incidents, including near misses, in order to facilitate wider organisational learning to enhance good practice and improve service quality.
1.2 It is important to encourage a reporting culture in which all incidents, however trivial they may appear, are formally reported. This enables the Trust to build a profile of the risks to Service Users, carers and staff and to the business of the Trust. By regularly reviewing patterns and trends in incidents, resources can be more effectively targeted. Services are also better placed to respond to incidents and manage underlying risks. This encourages a safer environment for all.
1.3 This policy describes the Trust’s continuing commitment to a Patient and Staff Safety Culture and ensuring a safe environment for all patients, staff and visitors accessing services and sites.
1.4 This policy applies to all staff within the Trust and wherever the Trust carries responsibility for the staff
it employs, including seconded, agency, bank and contracted staff, including those in commissioned services. All staff have a responsibility to familiarise themselves with this policy and procedure.
1.5 Kent & Medway NHS & Social Care Partnership Trust are committed to ensuring that there are
systemic measures in place for safeguarding people, property, NHS resources and reputation.
1.6 The Trust will:
1.6.1 Ensure that this policy is accessible and well publicised to Service Users, Providers, Carers and Staff:
1.6.2 Be fair to Service Users, Providers, Carers and Staff whilst dealing with concerns or incidents.
1.6.3 Adopt a reasonable and proportionate approach, whilst responding in a timely, conciliatory, open, transparent and sensitive manner that addresses the issues raised.
1.6.4 Ensure effective working relationships with other agencies involved with the same incident.
1.6.5 Maintain a balance between treating staff fairly and maintaining proper accountability for their actions; fostering a learning culture across the Trust and not a culture of blaming staff.
1.6.6 Be supportive to all those involved in the reporting and investigation of an incident.
1.6.7 Ensure that all incidents are fully and fairly investigated in a reasonable and proportionate manner, with an evidence based approach to any decision making as a result of that investigation.
1.6.8 Take all reasonable steps to satisfactorily resolve reported incidents.
1.6.9 Avoid protracted correspondence.
1.6.10 Avoid unnecessary litigation.
1.6.11 Ensure that the Trust’s Serious Incident Investigation procedure emphasises the importance of learning and service improvement as a result of the management and resolution of incidents.
1.6.12 Ensure that Service Users and Carers are able to raise concerns about incidents without fear of being discriminated against.
1.6.13 Outline the Trust’s performance monitoring of its Serious Incidents investigation process.
3
1.7 The Trust Board and Non Executive Directors give their full support to staff who are systematic, effective and efficient in their reporting of, and learning from, all serious incidents, incidents, accidents and near misses.
1.8 Through a regular review of themes and trends it is expected that our organisation will continue to demonstrate a learning culture that actively promotes and improves patient, staff and visitor safety to all our sites. Incident reporting remains a fundamental tool of risk management.
1.9 Having a patient safety culture at the heart of all our decision making will support public confidence in our Trust and promote security.
1.10 Duty of Candour (please see Duty of Candour Policy)
1.10.1 New rules to toughen transparency in NHS organisations to increase patient confidence within the delivery of care has resulted in the Government creating Statutory Regulations relating to Duty of Candour. Candour means being open and honest.
1.10.2 Patients, or someone lawfully acting on their behalf, should as a matter of course be properly informed about all of the elements of their treatment and care and this should involve any incidents that result in harm. This means that as soon as practicable following an incident or as soon as there is awareness that a notifiable incident has occurred the health professional or Trust must:
a) Notify the patient within 10 working days of the incident complaint being known. (or someone lawfully acting on their behalf) that the incident has occurred.
b) Provide the patient with all the information available directly relating to the incident. Some investigations will take longer than 10 days, particularly incidents which occur with community patients. Provide reasonable support following the incident, in cases of a serious incident or complaint the Service Manager or nominated individual will act as a family liaison officer.
2 INVOLVING PATIENTS AND THEIR FAMILIES IN INVESTIGATIONS INTO SERIOUS
INCIDENTS 2.1 The Trust believes that patients and their families/carers are a critical part of learning from serious
incidents. The level of patient/family/carer involvement clearly depends on the nature of the incident, the patient and the patient’s consent for their family to be involved. Access to language and sign interpreters will be provided, as required.
2.2 Initially staff who are providing the patients’ care will meet with the patient/family/carer to talk through
the process of investigation and timescales and will invite the patient/family/carer to be part of the investigation and will identify with them their level of participation.
2.3 Unless there are specific indications to the contrary or the patient/their family requests other arrangements, a series of ongoing open discussions scoping the form of the investigation will take place between the staff providing the patients’ care and the patient and/or their relatives or carers.
2.4 Arrangements should be made for the patient and/or their family and carer to meet with the SI Investigating team to discuss potential areas for investigation and to be an integral part of the investigation process.
2.5 Patients and their families have the right to request information (Freedom of Information Act 2000) and access medical records (The Reuse of Public Sector Information Regulations SI 2005/1515).
For further information on the Duty of Candour and the Trust process for ensuring full compliance please refer to the Duty of Candour – Being Open Policy.
4
3 PURPOSE OF POLICY AND SCOPE 3.1 Purpose of Policy
3.1.1 The purpose of this policy is to ensure a structured consistent, systematic approach to the effective management of serious incidents, incidents, accidents and near misses.
3.1.2 The policy will encompass identification and immediate response to incidents, reporting, investigation and review, the identification of root causes, implementation of actions and dissemination of learning. It will explicitly describe the responsibilities of all Trust staff, seconded and agency staff, and commissioned service providers in relation to the reporting, investigation and management of serious incidents, incidents, accidents and near misses.
3.2 The purpose of this policy is to also establish a clear framework for conducting investigations and to ensure that such investigations are undertaken in a manner that is consistent both with the rights of those who may be involved and the need to establish the facts accurately and expeditiously. We are an organisation who wants to learn from incidents, complaints and claims and develop safer systems and processes. This is an opportunity for staff to review their peers practice and to evaluate and recommend best practice, so that the Trust constantly improves and manages and reduces risk of harm to staff, patients and visitors to our sites.
3.2.1 The policy will ensure that any necessary changes in practice and environment are identified and implemented to continually improve safety. The lessons learnt will be disseminated throughout the Trust and embedded in good practice and safe systems.
3.2.2 The Trust operates a no blame reporting culture but staff through the investigation process will be held accountable for their practice.
3.2.3 Implementation of this policy will continue to improve the opportunities to learn lessons through both quantitative and qualitative data analysis, enable a continuing opportunity to learn from themes and trends that will support a robust safety and learning culture and embed improved practice throughout the Trust.
3.2.4 This document is informed by the latest guidance from the:
a) National Patient Safety Agency1,
b) The Health & Safety Executive2 ,
c) Department of Health3.
d) NHS South of England
e) Care Quality Commission4,
f) Counter Fraud and Security Management Service5
g) Trust Strategic and Operational Objectives
h) NHS Serious Incident Framework
3.2.5 This policy is required under Health & Safety legislation, National Patient Safety Agency: Seven Steps to Patient Safety and the National Framework for Reporting and Learning from Serious Incidents Requiring Investigation (2010, updated 2013) best practice (for definitive list of guidance, best practice, national guidance and legislation go to References section page 2).
1 National Framework for Reporting & Learning from Serious Incidents requiring Investigation, March 2010, National Patient Safety Agency 2 Health & Safety at Work Regulations 1999, Health & Safety Executive
3 Building a Safer NHS for Patients, 2001, Department of Health
4 Essential Standards of Quality and Safety, Care Quality Commission
5 Counter Fraud and Security Management Service
5
3.2.6 The outcome of the policy will be that all staff will report all serious incidents, incidents, accidents and near misses within the described time scales and will take the opportunity to learn. This will enable the Trust to meet its principal objectives.
3.3 Scope of the Policy
Level 1 (near miss) Level 2 (minor
risk) Level 3 (moderate
risk) Level 4 (major risk)
Level 5 (high risk/catastrophe)
Incidents resulting in no injury or damage but potentially could have caused injury/damage/loss. Normally dealt with/investigated by the ward manager/Service Managers/front line staff.
Incidents resulting in very minor injury, Damage or loss. Normally dealt with/investigated by the ward manager or Service Managers/frontline staff
Incidents resulting In moderately serious injury , damage or loss. Requiring formal investigation by the Ward Manager or the Service Manager.
Incidents resulting in grievous harm/potentially life threatening to a person a substantial damage or loss requiring a formal investigation by the Service Manager in consultation with the Assistant Service Director.
Reportable to the Clinical Commissioning Groups, Major incidents resulting in life threatening events extremely serious harm or death, substantial damage or loss requiring a formal investigation by the Assistant Service Director. These incidents may necessitate an inquiry panel.
The following adverse events fall within the scope of this policy:
3.3.1 Adverse Incident/accident – Any unplanned and uncontrolled event which led/could have led to loss or harm for patients, carers, members of staff or members of the public.
3.3.2 Serious Incidents for investigation – Something out of the ordinary or unexpected, with the potential to cause serious harm or loss 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.
3.3.3 Near miss - any unintended or unexpected incident that was prevented by some form of intervention and so resulted in no harm but without the intervention may have resulted in harm to one or more persons
3.3.4 Security incident - thefts, deliberate damage to property etc.
3.3.5 Reportable injuries, Diseases or Dangerous Occurrences (RIDDOR) – these are defined in Schedules1, 2 and 3 of the RIDDOR (1995).
3.3.6 It applies to all incidents that;
a) occur on Trust premises or,
b) occur off Trust premises but involve persons employed by the Trust whilst on Trust business or,
c) involve any patient receiving care from the Trust where the incident is in some way linked to that care – including joint mental health services with local authorities or,
d) are unexpected deaths, apparent suicides, and homicides by former patients within 12 months of discharge.
3.3.7 Safeguarding Children
Where there is harm or potential harm to a child or young person, these policy guidelines must be considered together with Safeguarding Children Policy and procedures.
3.3.8 Safeguarding Adults
The policy guidelines should also be read in conjunction with the Trust’s Adult Safeguarding policy. Staff must always refer to the Kent and Medway Safeguarding procedures and local multi-agency procedures which can be accessed on the Trust intranet and which include details of local leads.
6
3.3.9 Medication errors
Medication errors must be reported via the Trust incident reporting system.
4 SERIOUS INCIDENT – IDENTIFICATION AND RESPONSE 4.1 Immediate Action following a report of a Serious Incident
4.1.1 There are a number of actions which must be taken once the Incident has been reported and graded. It is important that staff adhere to timescales and that the appropriate line management is alerted to incidents. These actions, with timescales are detailed in Appendix D.
4.2 Immediate Response by the Organisation/Provider
4.2.1 The first priority is to ensure the needs of individuals affected by the incident are attended to, which includes any urgent clinical care to ensure the health, safety and well being of those involved.
4.2.2 As soon as practicably possible a safe environment should be re-established, all equipment or medication retained and isolated, and all relevant documentation copied and secured to preserve evidence to facilitate the investigation and learning. If there is a suggestion that a criminal offence has been committed, the Police must be contacted.
4.2.3 Early consideration must be given to the provision of information and support to patients, relatives and carers and staff involved in the incident. See Trust Being Open Policy which contains guidance on support systems available to patients/relatives/visitor/contractors. .
4.2.4 Safeguarding: If the incident raises adult or child safeguarding issues a safeguarding alert must be raised under the Trust’s established local processes. Other agencies which need to be involved in the management of incidents of this nature must be identified and contacted. See Safeguarding Adults and Children’s Policies. For internal/external stakeholders/agencies see Appendix E.
4.2.5 The Named Nurse and Doctor for Safeguarding Children will, on behalf of KMPT review and evaluate the practice of all involved health professionals, and provide an overview report to the Local Safeguarding Children Board. The local Safeguarding Children Board will then produce an overview report and executive summary for the case, including a multi-agency action.
4.3 Reporting Responsibilities and Timescales
4.3.1 Appendices F and G (flowcharts) outline the roles and responsibilities of all staff, together with the timescales for reporting incidents and where they should be reported to. The appendix can be printed off and placed with the Incident Reporting Forms.
4.3.2 All Incident Forms will be graded according to the relevant level, completed and reported by no later than the end of the shift or within the working day. Each incident will be investigated accordingly and this will be recorded on the Incident Form.
4.3.3 All incidents that are a Serious Incident will be reported immediately or as soon as is practicable following the incident. Each incident will be investigated through an Immediate Management investigation. This will then be reviewed by the Service Line incident review panel or via their internal governance structures.
4.3.4 Serious Incidents are to be reported via the STEIS database – see Appendix I for flowchart instructions.
4.3.5 All level 4 and 5 incidents should be immediately escalated through the line management route and notified to the Patient Safety Team prior to submitting the Incident Report.
4.3.6 In the event that a member of staff is unable to complete the form, the responsibility falls to the Line Manager to ensure the form is completed within the timescales.
7
4.3.7 Also important is the immediate grading of the incident in terms of the type of incident and the level of risk rating. This information is attached at Appendix J and is for guidance only. Any incident must be graded according to the severity and this will determine at which level the incident will be reported.
5 SERVICE LINES INCIDENT REVIEW PROCESS
5.1 All service lines must have in place a process to over see the incident investigation process and to quality check any action plans that come out of incidents. They must also have a process in place to ensure that learning is disseminated across their service line and where needed across the trust as a whole. This may be archived via a serious incident review panel as part of the clinical governance process for that service line.
5.2 External Reporting of Serious Incidents
5.2.1 The Patient Safety Manager will be responsible for reporting externally and ensuring that the correct grading and level of investigation is undertaken, this is done in conjunction with the service lines leads for serious incidents see Appendix H. The Patient Safety Manager will ensure that all necessary communication and consultation is maintained with all stakeholders.
5.2.2 As part of the new registration requirements arising from the Health & Social Care Act 2008 the Trust is required to notify the Care Quality Commission (CQC) about incidents that indicate or may indicate risks to ongoing compliance to the registration requirements, or that lead or may lead to changes in the details about the Trust in the Commissions Register.
5.3 Investigation of a Serious Incident
5.3.1 Internal investigations of serious incidents should be completed as soon as possible after the event with a deadline of 60 days. However, within the 60 days time must be allowed for Service Line Scrutiny, Patient Safety Scrutiny and Executive sign off.
5.3.2 For all Serious Incidents the relevant service manager must ensure that an initial management report is completed within 72 hours. This is a short report and will describe the incidents and the manager first impression; recommendations can be made if there are obvious deficits in care that need to be immediately rectified. This report will not have an action plan.
5.3.3 The service manager who completes the initial 72 hour manager’s report will recommend to the service line assistant director of incident review panel the next level of investigation to be carried out this will either be a concise or comprehensive RCA learning review.
5.3.4 The service line assistant director or the service line incident review panel will arrange for a Service Manager from another service to carry out the review. In the case of a comprehensive learning review they will also write the terms of reference
5.3.5 Investigations should follow the NPSA guidance and identify both active (e.g. acts and omissions by staff) and latent (e.g. organisational or environmental issues) failures. Guidance and templates are available from the NPSA and although developed for the investigation of patient safety incidents are applicable to all types of serious incidents. KMPT has draft templates for both concise and comprehensive learning reviews.
5.4 When more than one service line has been providing a service to the service user the investigation will
need to be a joint piece of work and it is expected that a service manager from each service line will take part in the review
5.4.1 The Trust requires that all incidents have appropriate review and investigation relevant to their risk rating. All incidents should be reported via the DATIX system
8
5.4.2 Incident reports received on DATIX will be reviewed by the DATIX team for missing or incomplete information.
5.4.3 Where investigations involve more than one organisation anything uncovered by local investigations that may be pertinent e.g. timelines, care/service delivery problems and causal factors should be communicated to the SI Lead to ensure full analysis of the incident of root causes to be determined.
5.4.4 An integral part of any investigation is to ensure that the views of the service user, carer and or relatives are sought as part of the investigation.
5.4.5 The investigator must ensure that feedback is given to all those that took part in the investigation including the patient, carers and relatives.
5.4.6 See Appendix F and G for Levels 1 – 5 flowcharts
5.5 Serious Incident Action Plan Development and Implementation
5.5.1 The Trust recognises the importance that every opportunity is taken to learn from investigations, developing action plans that are measurable to ensure that change is implemented in order to improve standards and safety.
5.5.2 Once an incident has been investigated, the Trust will ensure that an Action Plan is implemented and monitored that addresses root causes and that progress on the Action Plan is reported to the Board, and to Commissioners as part of contracting arrangements.
5.5.3 Action planning will include the name of the person responsible for ensuring that implementation has taken place with a clearly identified timescale and will include a column that identifies evidence that supports that change has happened. This may include minutes of meetings, audits, good practice reports etc.
5.5.4 The SI Investigator on completion of an investigation will make recommendations which will be presented to the Trust-wide Patient Safety Group. Once agreed, these recommendations will be taken by the Serious Incident Lead involved who will produce an Action Plan for presentation the following month. Each action will have an identified owner, a date of review/completion and a column for evidence that the action has been implemented and tested.
5.6 Monitoring of Incident Action Plans
5.6.1 Once an action has been identified an action plan will be produced and becomes the responsibility of the Service Director to ensure that the actions are implemented and completed. Progress against SI action plans are reported into the Trust-wide Patient Safety group:
a) Service Directors agree and monitor the Action Plans through their local governance meetings and are responsible for overseeing the dissemination of learning within their Service Line.
b) Directors must ensure that an audit trail is available for the Action Plans they are responsible for i.e. minutes of meetings where discussed, evidence of implementation of actions etc.
9
5.6.2 Local Action Plans
This process, below, will ensure the continual reduction of risk:
Action Plans – Category
Who will monitor Reported to Process for ensuring continual risk reduction
Team or local actions plans
Service Manager, Ward Manager, Line Manager
Local Clinical Governance Patient Safety Group. Copy of action plan with evidence submitted for review and sign off
Following completion of actions, review and test that any changes are effective and embedded. Continue to monitor themes and trends and other related incidents. Review risk assessments in light of learning and update risk registers. Provide assurance through the local meetings.
Locality or Service Action plans
Assistant Directors, Service Directors
Reported to Service Line Clinical Governance,
Patient Safety Group
Following completion of actions, review and test that any changes are effective and embedded across the service. Continue to monitor themes and trends and other related incidents. Review risk assessments in light of learning and update risk registers. Provide assurance to Service Directors through appropriate meetings. Share completed actions with Learning From Experience Group. Quantitative data analysis will inform targets for ongoing risk reduction by service lines.
Trust-wide Action plans
SI Lead and Director with a lead for Patient Safety
Reported to Trust-wide Patient Safety Group
Monitor themes and trends and other related incidents. Provide assurance to the Trust Board. Share completed actions with Learning From Experience Group who will continue to monitor learning. Update Risk Register.
5.7 Closure of Serious Incidents (Checklist)
5.7.1 The NPSA guidance advises that a Serious Incident is considered to be CLOSED, only when the closure checkpoints below have been completed and submitted to the relevant body:
a) an appropriate investigation has been undertaken that identifies findings, based on root causes and recommendations;
b) a satisfactory Action Plan has been produced with action points to address each root cause recommendation and with a named lead and clear timescales for implementation;
c) lessons learned have been identified, along with partners or stakeholders with whom the learning has been shared;
d) full completion of the STEIS record covering the above points e.g. date investigation completed, population of RCA/Lessons learned field;
e) evidence demonstrates that each action point has been implemented specifically:
10
f) for non-serious incidents, (local level 1-3,) evidence demonstrating that local monitoring arrangements are in place to ensure action points are going to be implemented is sufficient.
g) for serious incidents, (local level 4-5), evidence demonstrating that each action point has been implemented is required. The closure deadline is 60 working days
5.8 Local Closure
5.8.1 The Trust will close an incident when it is satisfied that:
a) the investigation, recommendations and action plan is satisfactory
b) local monitoring arrangements are in place and working efficiently
c) Lessons Learned have been disseminated and absorbed
d) Serious incidents must be reviewed by The Trust Wide Patient Safety Meeting and have received executive sign off.
e) Serious incidents must be signed off by the CCG prior to closure.
5.8.2 It is the responsibility of the service line to ensure that prior to closure of the incident that they have satisfied themselves that the actions above have been carried out and the actions and the action plans can be show to be completed and signed off either via a serious incident review panel or via the clinical governance meeting.
6 DUTIES, ROLES AND RESPONSIBILITIES - STAFF 6.1 The following outlines an overview of duties, roles and responsibilities for all staff. For details on roles
and timings and reporting requirements please see Appendix D.
6.2 ALL STAFF: Staff at all levels of the Trust has a legal duty to meet their responsibilities set out in this policy. This applies to all staff including seconded staff, agency staff and staff who are not directly employed by this Trust but work within our services,
6.3 It is the responsibility of all staff within the Trust to record, report and grade all serious incidents, accidents and near misses involving patients or Service Users in a timely manner, following the processes and procedures set out in this policy and in accordance with the specific timescales set out in Appendix D.
6.4 It is the responsibility of all staff to ensure that serious incidents, incidents, accidents and near misses
occurring for visitors or other workers, contractors on our sites are recorded, reported and investigated appropriately according to risk grading.
6.5 Where the incident involves a visitor, contractor or other person/people on Trust premises, an Incident Form must be completed by a member of staff, together with the person involved in the incident, if at all possible.
6.6 SERIOUS INCIDENT TIMESCALES: All incidents that are a serious incident will be reported immediately or as soon as is practicable following the incident. Each incident will be investigated through an Immediate Management investigation. This will then be reviewed by the SI Core Team.
6.7 INCIDENT, ACCIDENT AND NEAR MISSES TIMESCALES: All incident forms will be completed and
reported by no later than the end of the shift or within the working day. Each incident will be investigated accordingly and this will be recorded on the Incident Form.
6.8 STAFF SUPPORT – see Section 21.2): Staff will be able to access support following a traumatic
incident – see Staff Support Policy. The Trust operates an open and fair culture in which it is important to learn from adverse and serious adverse incidents and for staff to feel able to be honest and open. All staff however, will be held accountable for their practice.
11
6.9 Investigations and reviews of serious incidents, incidents, accidents, near misses, ill health and
hazards will not be used as part of any disciplinary procedure. The Trust does not seek to blame individuals but will expect all staff to work to their professional Codes of Practice and Trust standards, policies and procedures.
6.10 The Head of Legal Services – will provide advice and support on all incidents with a potential for litigation or where an Inquest is required.
6.11 Communications Department – For advice/action on media handling for all complaints with a potential for media implications.
7 THE TRUST BOARD 7.1 The Trust Board has ultimate responsibility of ensuring that the Trust has a developing safety culture
and receives assurance through bi-monthly summary reports that all documented actions have been taken.
The Trust Board are responsible for ensuring that systems and processes are in place to undertake suitable and sufficient investigations so that learning and implementation can be demonstrated. They will receive assurance from the Integrated Audit & Risk Committee through Summary and Exception reporting. The Board will receive monthly SI Reports. They will demonstrate leadership in underpinning a learning culture by supporting staff in taking forward the Duty of Candour Being Open Policy, and by ensuring that the Trust continues to demonstrate improvements in service delivery and safety.
It is the Trust Board’s responsibility to ensure that staff feel safe to report that the information they share will be treated with respect and acted upon appropriately for the improvement of the safety and quality of health services
7.2 The Trust Board is responsible for monitoring and overseeing all serious incidents and any high
frequency, low risk incidents. The Board will be made aware of these by receiving monthly Serious Incident reports.
7.3 The Trust Board has overall responsibility to ensure that appropriate management of serious incidents,
Incidents, Accidents and Near Miss procedures are effective throughout the Trust. It has delegated responsibility for monitoring and review to the Quality Committee.
7.4 The Trust Board will receive an aggregated monthly report highlighting the significant themes and
trends from all Levels 1 – 5 incidents, and a Serious Incident Report. These reports will be mapped against the NHS South of England grading.
7.5 The SHA requires that the monthly report to the Board also includes the number of SI’s that remain
open at that point in time and reasons why.
7.6 Chief Executive
7.6.1 The Chief Executive has overall responsibility for ensuring that investigations are appropriate and effective and that learning is identified and disseminated across the organisation. The Chief Executive is committed to the Trust demonstrating slow and sustainable effective change based on learning from SI, Incidents, complaints and claims.
7.7 Medical Director (Designated Board Member) Lead for Patient Safety
7.7.1 Takes responsibility for ensuring that all incidents are managed and investigated appropriately according to Trust Policy and all external requirements and takes responsibility for sharing learning. Ensures that the Chief Executive and Trust Board are apprised of incidents that are Serious. As defined by the NHS Serious Incident Framework and reportable to NHS England and other external Stakeholders.
12
7.7.2 Ensures that learning is demonstrable and evidenced and good practice is shared across the organisation.
7.7.3 Takes responsibility for alerting the Chief Executive and initiating the Memorandum of Understanding protocol
8 THE EXECUTIVE MEDICAL DIRECTOR AND DIRECTOR OF NURSING & GOVERNANCE 8.1 Must be notified of all serious incidents and is responsible for informing Board Members of all serious
incidents.
8.2 The Medical Director And Director Of Nursing & Governance will receive the Serious Incident reports
and aggregated reports for incidents, accidents and near misses at the Quality Committee.
8.3 The Executive Medical Director And Director Of Nursing & Governance will receive assurance that the
systems and processes in place are meeting all internal and external standards
8.4 Either the Executive Director of Nursing or the Executive Medical Director will be responsible for
signing off the serious incident as closed.
9 EXECUTIVE MEDICAL DIRECTOR (PATIENT SAFETY LEAD) 9.1 Takes the lead for patient safety and provides assurance to the Chief Executive and the Quality
Committee that the systems and processes relating to safety are meeting all internal and external standards.
9.2 Oversees and Chairs the Trust wide Patient Safety and Mortality Review Group and receives assurance from the Service Lines that safe systems and processes are embedded and effective.
9.3 Will report monthly to the Trust Board and the Quality Committee on serious incidents, incidents,
accidents and near misses.
9.4 Integrated Audit & Risk Committee
9.4.1 The Integrated Audit & Risk Committee on behalf of the Board will review the Incidents, Complaints and Claims report and will ensure that the investigation procedure is suitable and sufficient to identify the learning. They will ensure that lessons learnt have been shared across the organisation and implemented. They will receive assurance that underpins that change has been systematic and embedded throughout the Trust where it is appropriate to the learning. The will provide leadership and support to Service Line Directors in undertaking their programme in continuous learning, review, implementing and sustaining change and then evaluating the outcomes.
9.5 The Trust Wide Patient Safety and Mortality Review Group
9.5.1 The Trust wide Patient Safety Meeting Chaired by the Medical Director, is responsible for reviewing all RCA Reports and for ensuring that evidence is available to demonstrate the learning and to monitor and support local groups with the implementation of the action plans.
9.5.2 They will ensure that learning is disseminated across the Trust and actively support the continuous publication of best practice and examples of learning from SIs, Incidents,
13
10 NON EXECUTIVE DIRECTORS 10.1 Non Executive Directors will be informed by the Chief Executive of serious incidents resulting in death,
permanent harm, and/or serious damage; or those incidents which prevent the Trust from delivering healthcare services and which may result in adverse media coverage or reputational damage.
10.2 Non Executive Directors will ensure representation, as appropriate, on the Trustwide Health, Safety &
Risk Group and meet its annual reporting schedule.
11 SERVICE DIRECTORS 11.1 Directors will ensure that their Service Lines or their areas of responsibility/line management identify
learning from serious incidents, incidents, accidents or near misses. This includes reporting on any themes and trends arising. This will form part of their report to the Trust wide Patient Safety and Mortality Review Group.
11.2 Directors are responsible for ensuring that changes are implemented to continuously improve patient
and staff safety, systems and processes are embedded and that the Trust meets best practice requirements.
11.3 Directors must ensure representation at the appropriate Trust Groups in accordance with the Terms of
Reference of those Groups.
11.4 The Director who is the lead for Risk receives alerts on all serious incidents and will inform the Chief
Executive and Non Executive Directors, as appropriate, as soon as is practically possible.
11.5 For the most serious incidents the service line director will draw up the terms of reference for the investigation and may appoint the investigators
11.6 Service Line Governance/Risk Management Groups
11.6.1 These Service Line Groups will retain responsibility for implementing local action plans and ensuring that there is a system of evaluation. They will provide evidence on service changes and improvements and evidence of the implementation of best practice. They will review and monitor their SI’s, Incidents, Complaints and Claims and will organise any additional investigations.
11.6.2 Service Line Groups will utilise the information gained from the analysis of reports and ensure that risk management and risk reduction strategies are put into place and share this information and evidence as part of their quarterly report or as an ad-hoc report should the situation arise where information needs to be disseminated urgently.
12 SERVICE LINE ASSISTAINT DIRECTORS, LINE MANAGERS AND SERVICE LINE
MANAGERS
12.1 It is the responsibility of all Line Managers to ensure that staff are briefed on their duties and that they have received training on completing the Incident Form, within the required timeframe and are aware of the serious incident reporting process.
12.2 For the serious incidents (Trust level 4 and some 5) the Service Line Assistant Director will draw up the terms of reference for the investigation and may appoint the investigators
12.3 It is the responsibility of the Line Manager to undertake the completion of the Incident Form is within the required timescales, in the event that a member of staff is unable to do so.
14
12.4 Will manage the performance of staff within their Service Lines, to ensure that reporting and response times are met.
12.5 When a manager reviews an incident they will sign the incident report.
12.6 Where a manager undertakes a concise investigation they will complete the report and include their
name and title. If they are directly involved in the incident they will complete an Incident Form following this policy and procedure.
12.7 Will review their staff serious incidents, incidents accidents, near misses, ill health and hazards and
discuss at their Health & Safety groups. Learning will be recorded in the minutes and this will be shared in the Assistant Directors’ and Service Line Directors’ Clinical Governance (Patient Safety) meeting.
12.8 Will produce and review monthly data and annually identify any themes or trends. Learning will be
disseminated to local Health, Safety & Risk groups and highlight reports will be provided to the Trustwide Health, Safety & Risk Group that identifies learning and service changes to continue to improve patient and staff safety and ensure that learning is shared across the Trust.
12.9 Will use qualitative and quantitative data analysis to highlight any trends which may be occurring and
uncover any further need for intervention. Management Clinical SI Learning Review (using RCA methodology) investigations from serious incidents will also contribute to learning and development of safer systems of work and practice.
12.10 Line Managers will ensure that each service line is represented at the Trust wide Patient Safety and
Mortality Review Group Panel meetings.
12.10.1 Will ensure that lessons are learned and appropriate action taken to prevent reoccurrence.
12.10.2 Will ensure support for staff involved in any incident.
12.10.3 Will act as a senior contact for complex cases, ensuring that a ‘wise person’ approach is taken for decision making, ongoing communications and incident case management.
12.11 Will ensure that team members that have been involved in any incident are give feed back on any
investigation and the learning that has taken place.
13 THE QUALITY COMMITTEE
See Terms of Reference – on Trust website at www.kmpt.nhs.uk. 13.1 Has responsibility and the delegated authority to act on behalf of the Trust Board. Ensures all relevant
Board Committees are providing adequate assurance and appraises the Trust Board of quality, risk or performance issues.
13.2 Has overarching responsibility for risk management, including ensuring that all incidents, non clinical
and clinical are reported to external agencies within the relevant time scales.
13.3 The Committee will receive reports from other Trust Governance Groups, e.g. Health, Safety & Risk
Group, Patient Experience Group, Trust-wide Patient Safety Group and Information Governance Group.
13.4 Receives themes and trends from incidents, and serious incident reports and ensures actions are
taken as a result of trend analysis and that information is cascaded through out the Trust. Will receive Health & Safety Exception Reports on serious incidents, incidents, accidents and near misses, the learning identified and the changes that have been implemented.
15
13.5 Ensures that the management of serious incidents, Accidents & near misses policy is in place and that an annual review of the policy is undertaken, based on best practice and Trust events.
13.6 Monitors and addresses non compliance with the Trust policy and procedures.
13.7 Has responsibility for monitoring the completion of action plans and the subsequent effectiveness of
any risk reduction measures introduced.
14 TRUSTWIDE SI & MORTALITY PANEL This will be a once weekly panel that will be chaired by the Patient Safety Manager The Trust reports the deaths of all service users on Datix. A Learning Review will take place for the vast majority, however, there may be cases where the Trust believes the death/reported Level 4/5 incident does not constitute a KMPT Serious Incident. Purpose of the panel:
• To provide oversight of all deaths occurring amongst all service users
• To make Trust decisions regarding which deaths/reported Level 4/5 incidents do not constitute a KMPT SI
• To improve the transparency of reporting levels of unexpected deaths in across all service user groups supported by the Trust
• To review service line allocation for complex cases that cross service lines/other organisation
• To highlight overdue SI Management Investigations (i.e. not completed on Datix)
• To highlight overdue responses overdue to CCG/NHSE queries
• To review ‘near miss’ incidents, ‘themed learning reviews’ & any other incidents in order to consider if they meet the Trust SI criteria
Please see full separate Terms of reference Appendix E
15 INFORMATION GOVERNANCE GROUP See Terms of Reference – on Trust website
15.1 Responsible for monitoring and managing the compliance of all Information Governance initiatives
across the Trust and provides assurance to the Integrated Audit and Risk Committee that all targets and governance requirements are met.
15.2 Monitors and manages the production of Information Management and Technology Business Continuity
Plans across the Trust.
15.3 Acts as the Trust’s IM&T Business Continuity Programme Board.
15.4 Ensures compliance with Governance targets including national standards (CQC Essential Standards
and the Information Governance Toolkit), local best practice (policy requirements and IT project implementations) and audit recommendations (South Coast Audit Data Quality and Audit Commission Fitness for Purpose).
16 TRUSTWIDE INFECTION PREVENTION & CONTROL GROUP
See terms of reference on Trust website. 16.1 Receives all alerts relating to infection, triage alerts and forwards to SI inbox for serious incidents. They
provide reports to the Infection Prevention & Control meeting.
16
16.2 Trustwide Infection Prevention & Control meeting receives all infection related Serious Incidents, reviews and provides learning arising from investigation to the Trust wide Patient Safety and Mortality Review Group.
17 HEALTH, SAFETY & RISK GROUP
See Terms of Reference – on Trust website.
17.1 The Health, Safety & Risk Group will ensure that work is undertaken to support the embedding of changes the new way of working is sufficient to ensure the safety of patients, staff and anyone else accessing Trust premises or services.
17.2 The Service Lines Health and Safety Groups will provide quarterly reports to the Trustwide Health,
Safety & Risk Group through the highlight report process. This will contribute to the Health, Safety & Risk highlight report to the Integrated Audit and Risk Committee.
18 LOCAL HEALTH, SAFETY & RISK MEETINGS See Terms of Reference – on Trust website.
18.1 All DATIX alerts will be reviewed through the reports produced by the Health & Safety team at every meeting within each Service Directorate.
18.2 Data covering a year will be produced month on month to identify themes and trends and this will be
reviewed monthly. Learning from incidents, changes to service delivery, systems and processes will be contained in the highlight reports that Health, Safety & Risk Meetings report to their next level within the organisation up to the Service Directors.
18.3 Each Service Director or representative will be expected to report to the Trustwide Health, Safety &
Risk Group quarterly identifying themes and trends and learning arising from DATIX alerts and serious incidents, to ensure that all parts of the organisation have implemented changes.
19 SERVICE LINE SERIOUS INCIDENT LEAD 19.1 Takes responsibility for ensuring the coordination and reporting of all serious incidents Levels
4 and 5. Chairs the Service Lines Governance Panel and oversees all actions arising and ensures information is shared with all relevant parties, both internally and externally. This is undertaken in conjunction with the Patient Safety Manager
20 PATIENT SAFETY MANAGER 20.1 Has responsibility for reporting on STEIS6 and providing reports and updates to the Commissioners as
appropriate. Will alert the Medical Director or nominated other to any serious incident.
20.2 Maintains all relevant records and provides a report on Serious Incidents to the Quality Committee
monthly and Trust Board every other month.
20.3 Delivers serious incident training and maintains an expertise in Root Cause Analysis methodology and
provides support to those staff undertaking a Management Clinical SI Learning Review (using RCA methodology). Will ensure that investigations are undertaken.
21 INFORMATION RIGHTS MANAGER 21.1 The Information Rights Manager is the Trust Data Protection Officer who manages the Caldicott Office
which is responsible for ensuring the co-ordination and reporting of all incidents pertaining to breaches
6 STEIS: Strategic Executive Information System
17
of information governance and which is covered by the Information Governance Incident Management policy.
21.2 The Information Rights Manager will receive all incidents relating to information governance. All
incidents are considered to be SI’s, this includes “any incident involving the actual or potential loss of personal information that could lead to identity fraud or have other significant impact on individuals” (NHS South East Coast). This is irrespective of any potential media involved and includes both loss of electronic and paper records.
21.3 The Information Rights Manager will ensure that SI information is shared with the Serious Incident
Lead and reports are compiled, aggregated and reported to the Information Governance Group according to the policy.
22 SUB CONTRACTORS, SERVICE PROVIDERS AND VISITORS
22.1 It is the responsibility of Kent & Medway Facilities as part of contractual processes to ensure that contractors are aware and comply with our incident reporting process. If the contractors are unable to complete an Incident Form then it becomes the responsibility of the nearest line manager to the site where the work was being carried out or the contract organiser.
22.2 When a serious incident, incident, accident or near miss occurs involving a visitor to the site, the staff
member or line manager within the site will complete the incident report form and ensure a copy is given to the visitor.
23 OUT OF HOURS AND ON CALL RESPONSES 23.1 When a serious incident, incident, accident or near miss occurs out of hours to either a contractor or
visitor this should be reported by Trust staff to the On Call Manager, if considered appropriate. The On Call Manager will make the decision whether to alert the On Call Director and complete the appropriate forms.
24 STAFF/PATIENT/RELATIVE/VISITOR/CONTRACTOR COMMUNICATION AND SUPPORT
The Trust is committed to the support of staff/patients/relatives/visitor/contractor that are subject to a serious incident, incident, accident or near miss.
24.1 Patients/Relatives/Visitors/Contractors Support
24.1.1 In the first instance support to patients/relatives/visitor/contractor will be offered by the Care Team involved. In the event that a Care Team is not involved then support will be offered by a designated person agreed within the Serious Incident process and the Service Director.
24.1.2 The manager where the incident took place will ensure that all necessary steps are taken to provide any appropriate physical healthcare needs and medical intervention.
24.1.3 As soon as is practicable, the manager after discussion with the SI Lead and Service Director will speak with the patients/relatives/visitor/contractor to determine the appropriate level of support needed. The Service Director or nominated other will then confirm this in writing and include any relevant information leaflets.
24.1.4 The SI Investigator with their permission will meet with patients/relatives/visitor/ contractor pre-investigation and outline the investigation process. See Being Open Policy/Duty of Candour Policy. The SI Investigator will be responsible for ensuring that written and verbal information is available at pre-agreed intervals.
24.1.5 At the conclusion of the investigation the SI Investigator and Service Director or nominated other will arrange to meet with patients/relatives/visitor/contractor and review the investigation, findings and action plan.
18
24.1.6 Further agreed communications or contact will be the responsibility of the Service Director or nominated other.
24.2 Staff Support
24.2.1 It is recognised that many incidents and serious incidents may have a significant impact upon staff affected by the incident. It is important that arrangements are made to ensure the staff involved in incidents receive the necessary support and counselling and also receive appropriate feedback on the outcome of the investigation into the incident. All those involved in the process within the Trust should strive to remain objective at all times and to treat the investigation of each incident as a learning process.
24.2.2 Assistant Directors are responsible for ensuring staff named in incidents have access to support.
24.2.3 The Line Manager or their nominated deputy should offer immediate support and will commence debrief and reassurance to the affected staff. Staff should be offered the opportunity to access counselling services or the support of the Staff and Practice Support Team. Staff support will be offered on an ongoing basis until such time as the member of staff requires it. Records will be kept of any referrals. Senior Managers will meet with staff in other areas which may have been affected by the incident. Please see the Trust Staff Support Policy.
24.2.4 It should be noted that staff may be required to attend court hearings or Coroners Court which may be some considerable time after the event. Staff Support and Counselling Services will continue to be offered whenever staff should need it.
24.2.5 The Trust recognises that informal and mutual support from colleagues and/or peers in these situations are equally as important as the formal clinical supervision and debriefing process.
24.2.6 As well as the support identified within the Trust’s Stress Management Policy, the following support is available to staff:
a) Union Representatives
b) Work Place Colleague
c) Personnel Department
d) Occupational Health
e) Staff Support Service
f) It is essential that all staff involved in an incident are kept informed of progress and the outcome, including the sharing of the formal investigation response in as supportive a way as possible.
24.2.7 After completion of the investigation, all persons involved will be seen individually or as part of a team for feedback and discussions about continuing support will be implemented. Information to the rest of the organisation will be shared in the form of lessons learnt and implementation of action plans.
24.3 Internal sources of advice and support
24.3.1 Head of Legal Services – For advice on all complaints with a potential for litigation or involving inquests.
24.3.2 Communications Department – For advice/action on media handling for all complaints with a potential for media implications.
25 EXTERNAL STAKEHOLDER NOTIFICATION
19
Serious Incidents will be reported to External Stakeholders where necessary and appropriate. See Appendix D.
25.1 All incidents that involve staff will be reported to the Counter Fraud and Security Management service. The Health and Safety team will ensure that incidents involving staff will be uploaded onto the security management service Staff Incident Reporting System (SIRS) database www.cfsms.nhs.uk.
25.2 All incidents relevant to the Health & Safety Executive reportable under the RIDDOR regulations will be reported by line managers. The Health and Safety team on receipt of incident report will check this has been completed. Please see Appendix K.
25.3 The Service Line’s Scrutiny Panel(s)/governance meetings and the Patient Safety Manager will identify when there is a need to involve external agencies following an adverse event or near miss. This will be based on the South East Department of Health guidelines, Health and Safety Executive and the principles of the Memorandum of Understanding:
25.3.1 All suspected homicides
25.3.2 All in suspected patient suicides of patients currently receiving a service
25.3.3 Media involvement
25.3.4 Serious Incidents that cross into other provider services
25.3.5 Death or serious injury through negligence
25.3.6 Death or serious injury of a member of staff
25.3.7 Equipment has significant failure causing serious injury or death
25.3.8 Criminal act
25.3.9 Death in suspicious circumstances (unexplained/unexpected)
25.3.10 Involvement of other agencies requiring other expertise level
26 PROCESS BY WHICH TO RAISE STAFF CONCERNS 26.1 The Trust recognises the importance of clear communication with staff that is documented and
transparent.
26.2 This policy and the Investigation of Serious Incidents, Complaints and Claims Policy will assist in informing staff about the process the Trust will take in reviewing serious incidents, accidents and near misses. The Policy distribution process will ensure that Managers bring any new policies to staff’s attention and there will be additional articles in the Team Brief raising awareness.
26.3 Staff can also raise concerns and report anonymously and directly to the following:
26.3.1 Care Quality Commission
26.3.2 Health & Safety Executive
26.4 24.4 Whistle blowing policy: The Trust always encourages staff to feel confident about reporting
any incident. For all staff there is access to the Whistleblowing Policy and further support can be gained from Staff Support or by using the “Green Button” on the Staff Zone on the intra net.
27 MEDIA INVOLVEMENT 27.1 Communications are a vital element of supporting and delivering effective management of serious
incidents. The Trust ensures that robust communication and media management arrangements are in place for both internal and external communication. In some cases serious incidents may lead to media
20
attention which can be prolonged. The Trust will make every effort to ensure that staff are informed and supported prior to any media involvement (see corporate communication strategy).
28 HOTLINE ARRANGEMENTS 28.1 Initiation during office hours will be by the Chief Executive or Nominated Deputy and out of hours by
the Director on call, using the free phone number based at Trust HQ - 0800 587 6757
28.2 At the earliest opportunity (if during office hours this will be immediately) or if not within thirty minutes of receipt, information will be placed on the web site by Communications to provide information, access to the hotline and for the wider community to be able to record through e mail any concerns or requesting information, all records will be kept and form part of the final record.
28.3 Communications will ensure that the local/national media and the web site (by e-form) have information on contacting the Trust by national post. They will ensure that all post will be collected together and responded to by Communications in conjunction with the Senior Manager on duty supporting the hot line arrangement.
29 SAFEGUARDING
The Trust has specific policies in place for the safeguarding of Adults and Children and this is an integral part of training for all Trust staff. (Please see Safeguarding policies)
30 INCIDENT & CAUSAL FACTOR ANALYSIS- THE PRIME REASON(S) WHY AN INCIDENT
OCCURRED.
30.1 A Root Cause is a fundamental contributory factor. Removal of these will either prevent, or reduce the chances of a similar type of incident from happening in similar circumstances in the future.
30.2 A Causal Factor is something which can lead directly to an incident.
30.3 Responsibility for Causal Factor analysis post investigation
30.4 Where a causal factor is considered to be developing into trends or where a causal factor may result in other actions being deemed necessary a Management Clinical SI Learning Review (using RCA methodology) will be initiated. Terms of reference will be clearly identified for the Investigator/s. The Investigator/s will be sourced from a select number of RCA trained staff. Learning recommendations and actions from the learning review will be reported to the Trust-wide Patient Safety Group
30.5 Governance Task and Finish Group: If a number of SI’s have occurred in a particular geographical
area of a very serious nature or consistent themes are emerging from a particular team or incident type, a specific Governance Task and Finish Group will be set up. This will have formal terms of reference and report to the Quality Committee. The aim will be to embed actions and ensure cultural changes in the service are embedded and a decrease in patient serious incidents.
31 INVOLVEMENT OF RELEVANT STAKEHOLDERS AND MEMORANDUM OF
UNDERSTANDING 31.1 It is recognised that the Trust may have to involve other organisations in the investigation or that other
organisations may take the lead on the investigation process such as a Police Investigation. However, the introduction of the Memorandum of Understanding enables Trusts, Police, NHS organisations and the Health & Safety Executive to meet post incident and identify roles, processes and information sharing.
21
31.2 The Memorandum of Understanding is a protocol for liaison and effective communications between the National Health Service, Association of Chief Officers and Health and Safety Executive. The protocol is used when investigating patient safety incidents involving unexpected death or serious untoward harm.
31.3 A Service Line Director has the responsibility for organising the initial meeting and inviting all relevant parties to attend to scope the investigation process, communication processes, information sharing protocol and to identify and agree the lead role/organisation.
31.4 Other Healthcare providers and Local Authorities will be invited to attend the initial meeting and the same scoping exercise will be undertaken following the principles of the Memorandum of Understanding as appropriate.
31.5 See 4.5 for External Stakeholders. This is not an exhaustive list and during the course of reporting the serious incident it may become apparent that other services or agencies need to be included and invited.
32 MANAGEMENT CLINICAL SI LEARNING REVIEW USING RCA METHODOLOGY AND
INVESTIGATION REPORT 32.1 It should be noted that feedback from the Management SI Clinical learning review, should be given
sensitively, appropriately and should include both positive feedback on areas of good practice as well as any constructive criticism and learning examples that may be available.
32.2 SHARING OF LESSONS LEARNT- See Learning from Experience Policy
32.2.1 The importance of learning from Serious Incidents is fundamental to developing quality services and minimising risk to patients, visitors, contractors, staffs and NHS organisations.
32.3 Summary Points for Dissemination of Learning from a Serious Incident Responsibilities For Sharing Learning
Learning Shared With Example of Communication Methods
Incident occurs Local: Patient and their family/carers directly involved in the incident if appropriate. Staff directly involved in the incident. Similar services/specialities to the service involved in the incident. Trustwide: Other departments with wider organisational applicability. Improvements in process, policy and systems. Learning from Experience Group
Meetings with patients and their families. Presentations at staff meetings. Team Meetings. E-bulletins and newsletters. Intranet. Website. Board papers. Local notice boards. Email. Internal alert systems. Meeting minutes. Incident reporting and investigation outcomes. Risk Management.
National Learning National: Sharing learning nationally, independent sector, other NHS, local authority, Commissioners. Strategic Health Authority: Making the public aware about learning from Serious Incidents.
Performance Management Review Meetings. Assurance mechanisms. Newsletters. Annual Quality Reporting arrangements.
NHS England Nationally: Other organisations across the region and other strategic health authorities. Media. Department of Health. Safeguarding Children Boards.
Regional Network Meetings. Local conferences, seminars, workshops. Periodic serious incident summary reports. Letters to Chief Executives. Press statements.
NPSA All relevant healthcare sectors. Central Alert System (CAS).
22
CQC MHRA HPA HSE CFSMS
Professional networks, bodies and associations. Manufacturers and commercial enterprises. International Safety and Quality Networks.
Chief Executive bulletin. Conferences, seminars and workshops. Alert Guidance information newsletters. E-networks. Link Officers. Professional networks.
Professional networks, bodies and associations
Members Other networks and associations
E-networks. Letters to members. Newsletters and bulletins. Educational meetings.
33 SUMMARY POINTS FOR DISSEMINATION OF LEARNING FROM A SERIOUS INCIDENT 33.1 Learning from incidents is captured on every Manager Investigation report. This information is lifted and
collated for the Learning From Experience Group.
33.2 Each Service Line is expected to report to the Serious Incident Lead when cases can be closed
because they have evidence to support their action plan and that learning has been captured and shared through their Service Line. This information is also lifted and collated for the Learning From Experience Group.
34 IDENTIFYING ISSUES WHICH MAY BE OF NATIONAL SIGNIFICANCE 34.1 During the course of an investigation issues that have a national significance or where it is identified
that learning should be shared across organisations should be reported through the SI Lead who will ensure that this information is shared with the appropriate organisation,
34.2 During the course of the investigation issues that involve equipment, agencies or practice that may have national implications will be reported through the Trust’s External Reporting process.
35 LEARNING FROM SERIOUS CASE REVIEWS (SCR) 35.1 Executive representatives from the NHS are part of our local Safeguarding Children Board (SCB). The
Safeguarding Lead is responsible for ensuring that communication between the SCB and the Trust Board is maintained. A Serious Case Review (SCR) is undertaken to learn lessons and the SCB are responsible for commissioning each SCR and sharing the learning across the Trust. This is monitored at agreed review periods as to whether the lessons have been embedded. The SCB ensures that they receive regular progress reports from an SCR and take action if the delay appears unreasonable. See Safeguarding Children Policy for further information.
36 RECORD KEEPING AND CONFIDENTIALITY 36.1 All NHS Trusts are required to keep full, accurate and secure records (Data Protection Act 1998)
demonstrate public value for money and manage risks (NHS Litigation Authority, Information Governance Toolkit, Essential Standards). Compliance with this Policy and these legal and best practice requirements will be evidenced through information input into the electronic record, RiO.
36.2 Third Party Confidentiality
36.2.1 Only information which is relevant to the incident should be considered for disclosure and then only to those within the NHS who have a demonstrable need to know. It must not be disclosed to the Service User unless the person providing the information has expressly consented to the disclosure. Disclosure of information provided by a third party outside
23
the Trust also requires the express consent of the third party. If the third party objects then it can only be disclosed when there is an overriding public interest in doing so.
36.3 Patient Confidentiality
36.3.1 Care must be taken throughout this Procedure to act in accordance with NHS regulations and guidance, together with the Trust’s Confidentiality Code of Conduct, the Data Protection Act 1998 and the Access to Health Records Act 1990.
36.3.2 The Service User’s express consent is not required to access information about him/her for the purpose of investigating an incident raised by the Service User. However, it is good practice to explain to the Service User that information from his/her health records may need to be disclosed to investigate the incident.
36.3.3 Investigation of an incident does not remove the need to respect a patient’s confidentiality and everyone working within the Trust has a legal duty to keep records confidential.
37 EQUALITY IMPACT ASSESSMENT (APPENDIX B) 37.1 All public bodies are required to have due regard to the aims of the general equality duty when making
decisions and when setting policies. KMPT will continue with the culture of conducting Equality Impact Assessment to ensure a good understanding of the effect of our policies and practices on people within different protected groups. This will facilitate the identification of areas of concerns and may develop practical courses of action to mitigate negative consequences or to promote positive ones
37.2 The Trust is positive in its approach to equality and diversity and the serious incidents policy and process is open to everybody regardless of their age, race, gender, culture, religion, sexual orientation or disability. This policy has been Equality Impact Assessed to ensure that staff and/or service users do not experience a negative impact or disproportionately positive impact as a result of the implementation of the policy.
38 HUMAN RIGHTS
38.1 The Human Rights Act 1998 sets out fundamental provisions with respect to the protection of individual human rights. These include maintaining dignity, ensuring confidentiality and protecting individuals from abuse of various kinds. Employees and volunteers of the Trust must ensure that the trust does not breach the human rights of any individual the trust comes into contact with. If you think your policy/strategy could potentially breach the right of an individual contact the legal team.
24
39 MONITORING COMPLIANCE WITH AND EFFECTIVENESS OF THIS DOCUMENT
What will be monitored How will it be monitored Who will monitor Frequency Evidence to demonstrate monitoring
Action to be taken in the event of non-compliance
Completeness of information on Incident Form as reported via the Datix system
Line Manager will sign to confirm risk rating and management actions Health & Safety Team will check for completeness of the electronic form
Line Manager Health & Safety Team
Each form All forms on receipt
Signature of Line Manager
Trends will be raised with Health & Safety
Manager
Datix forms that are not complete will be contacted by the Health & Safety team
National Reporting & Learning System reports
Through the Risk, Health & Safety Group and Governance & Risk Committee
Patient Safety Manager Six monthly
Reporting to The Quality Committee
Via reporting schedule for key committee/ groups Directorate meetings
Service Directors Medical Director Nurse Director
Monthly Medical and Nurse Director
Reports Minutes of meetings
Medical Director
Demonstration of learning from incidents and evidence of change
Through Clinical Audit and Effectiveness Team RCA Action group Learning from experience group.
Medical Director SI Lead
Learning from experience group
Minutes of meetings Reports re-audit/re-evaluation reports
Follow up with Service line Directors risks highlighted
Reporting within the timescales for Serious Incidents
Trust Wide Patient Safety Meeting
SI lead Monthly Board reports
Minutes of meetings and reports
Service Line Leads on the panel will take action through the Service Lines to ensure compliance
Staff are aware of how to raise concerns
Whistle blowing recorded on the HR data system and reported on a bimonthly basis to the Workforce Committee Concerns recorded in DATIX alerts and reported to Health & Safety Group
Director of HR Bimonthly Bimonthly report to the HR and Remuneration Committee
Workforce Committee will take the required action
25
40 EXCEPTIONS
40.1 There are no exceptions to this policy.
39.1.1 A full Root Cause Analysis investigation may be held in any situation where there is a need to formally establish the facts surrounding any particular incident or occurrence. This may be following a Serious Incident, a complaint, an intimation of a legal claim or a cluster of SI’s, incidents, complaints and claims.
40.1.2 All Formal Complaints will be subject to an investigation using RCA techniques, however where the complaint:
a) crossed one or more teams,
b) has been reported as an SI
c) Safeguarding Vulnerable Adults,
d) Safeguarding Vulnerable Children
e) Was made against a member of staff that was subject to the disciplinary procedure
f) GMC Complaint
g) When a member of staff have received complaints there are one or more incident forms of a similar nature
h) Where a member of staff or staffs is the subject of a complaint/s and/or subject to one or more incidents that could be described as clusters
i) Where there is a complaint about a member of staff and on gaining preliminary information local knowledge gives rise to concern to the Complaints Mangers.
j) Service Line Directors or other members of staff have raised concerns
k) Where there is an opportunity to gather facts and identify learning that will help to reduce or manage risk and develop safer services
l) Clusters of complaints about individuals
Levels of Investigation
40.1.3 All serious Incidents will be subject to an initial 72 hour management report this will look at initial concerns and early learning it will also recommend if a further investigation is required.
A learning review using RCA will automatically be required for all serious incidents such incidents would include the following:
a) Where an un-expected Inpatient death has occurred
b) Homicide
c) All suspected suicides
d) Incidents of violence and serious injury to staff requiring hospital A&E care
e) Incidents where serious property damage has occurred and business continuity plans have been invoked
f) Any other incident that is likely to be highly publicised
g) Service Line Directors or other members of staff have raised concerns
h) Where there is an opportunity to gather facts and identify learning that will help to reduce or manage risk and develop safer services
i) Clusters of incidents that may be linked
This list however is not exhaustive and an investigation may be required in other situations where is deemed necessary to make a formal inquiry into the circumstances and to record the findings thereof.
26
41 LEARNING FROM EXPERIENCE 41.1 Following an investigation, recommendations will be made and from this will be the development of a
‘smart’ action plan. The action plans will be reported into the RCA Action Group who will ensure that the lessons learnt and the action plans are shared in all the Trust Service lines.
41.2 A Trust Wide Action plan of themes and lessons learned is put together and information shared and
disseminated via the Learning from Experience Group. The Group will also ensure that articles go into Team Brief and through the MD Direct Newsletters identifying learning from investigations and how this has changed service delivery or practice. Summary reports, learning and actions will be posted on the web site for access by the wider NHS and the local population.
41.3 Learning will be shared with the wider community through the Trust website.
41.4 Other learning that needs to be shared across the NHS urgently will be reported to the NPSA and
alerted through the Patient Safety Alert system.
42 LINKS WITH OTHER PROCEDURES 42.1 This Procedure does not stand alone. It must, where appropriate be read with the following: -
42.1.1 The Claims Policy and Procedure
42.1.2 The Complaints Procedure
42.1.3 The Complaints Handbook
42.1.4 The Disciplinary Procedure
42.1.5 Being Open Policy
42.1.6 Management of Serious Incidents, Incidents, Accidents and Near Misses Policy
42.1.7 Stakeholder, Carer and User Involvement
42.1.8 Learning from Experience Policy
42.2 This policy will be used by all employees of the Trust
42.3 Employees will be informed on the policy and any changes via the Policy Manager using the Trust web
site.
27
APPENDIX A NEVER EVENTS IN MENTAL HEALTH
Overdose of Insulin due to abbreviations or incorrect device Overdose refers to:
• When a patient receives a tenfold or greater overdose of insulin because a prescriber abbreviates the words ‘unit’ or ‘international units’ , despite the care setting having an electronic prescribing system in place
• When a health care professional fails to use a specific insulin administration device i.e. does not use an insulin syringe or insulin pen to measure insulin
Setting: All patients receiving NHS funded care. Failure to install functional collapsible shower or curtain rails Involves either;
• failure of collapsible curtain or shower rails to collapse when an inpatient suicide is attempted/ successful.
• failure to install collapsible rails and an inpatient suicide is attempted/successful using these non-collapsible rails
Setting: All mental health inpatient premises. Falls from poorly restricted windows A patient falling from poorly restricted window.
• Applies to windows “within reach” of patients. This means windows (including the window sill) that are within reach of someone standing at floor level and that can be exited/fallen from without needing to move furniture or use tools to assist in climbing out of the window.
• Includes windows located in facilities/areas where healthcare is provided and where patients can and do access.
• Includes where patients deliberately or accidentally fall from a window where a restrictor has been fitted but previously damaged or disabled, but does not include events where a patient deliberately disables a restrictor or breaks the window immediately before the fall.
• Includes where patients are able to deliberately overcome a window restrictor by hand or using commonly available flat bladed instruments as well as the ‘key’ provided.
Setting: All patients receiving NHS funded care
Chest or neck entrapment in bedrails Entrapment of a patient’s chest or neck within bedrails, or between bedrails, bed frame or mattress, where the bedrail dimensions or the combined bedrail, bed frame and mattress dimensions do not comply with Medicines and Healthcare products Regulatory Agency (MHRA) guidance Setting: All settings providing NHS funded healthcare, including NHS funded patients in care home settings, and equipment provided by the NHS for use in patients’ own homes. Misplaced naso- or oro-gastric tubes Misplacement and use of a naso- or oro-gastric tube in the pleura or respiratory tract where the misplacement of the tube is not detected prior to commencement of feeding, flush or medication administration. Setting: All patients receiving NHS funded care. Scalding of patients Patient being scalded by water used for washing/bathing
• Excludes scalds from water being used for purposes other than washing/bathing (e.g. from kettles)
Settings: All patients receiving NHS funded care.
28
APPENDIX B EQUALITY IMPACT ASSESSMENT
Full Equality Impact Assessment (EIA) tool If you prefer not to use this tool – you can create a separate document that answers the following questions:
• What is being assessed and what are the intended aims and outcomes?
• Are there any partners/contractors (internal and external) that will be involved in implementation?
• Which groups are currently affected and could be affected in the future (stakeholders)
• Have you got data on staff, Service Users, clients, carers and families by equality strand in relation to the policy?
• Which groups (internal and external) have been consulted?
• Could the policy directly/indirectly discriminate? (refer to definitions in EIA guidance document)
• Is there an opportunity to promote equality and diversity?
• What actions will you take to remove any potential discrimination?
• How will the EIA be monitored?
General Information
1. Name/s of policy, procedure, or practice:
Management of Incidents, Accidents, Near Misses & Serious Incidents Policy
2. Directorate: Medical Directorate
3. Policy Owner: Patient Safety Manager
4. EIA Lead: Patient Safety Manager
5. Lead Manager/Director: Executive Medical Director
6. Date of screening: December 2015
7. Is this a proposed or existing policy, procedure or practice:
Existing policy
8. What are the overall aim/s or purpose of the policy, procedure or practice?
To reaffirm the management of incidents, accidents policy and procedures, to ensure that best practice is implemented and to enable the Trust to underpin its patient and staff safety culture.
9. Which groups of people will be affected by the policy, procedure or practice? E.g. particular Service Users, staff groups
All Trust staff, clients, contractors, visitors
10. Are any other Directorates/teams involved in the delivery of the policy, procedure or practice?
Yes/No: If yes, whom? All staff are responsible for incident reporting and compliance with best practice
11. Are any partner agencies involved in the delivery of the policy, procedure or practice?
Yes/No: If yes, whom?
29
Data and Consultation
12. Do you monitor the policy, procedure or practice in relation to any of the following? NO
Complaints Eligibility criteria KPl’s Service Uptake User Satisfaction Other__________
13. If you answered yes to any of the above, do you collect this data broken down by any of the following? N/A
Age Disability Gender Faith Race Sexual orientation Other___________
14. What consultation with Service Users taken place on the policy, procedure or practice within the last two years? NONE
Who was consulted?
Summarise the findings
Race
Gender
Disablity Age
Sexual orientation
Relgion and Belief
Transgender
Carers
15. What consultation with staff groups has taken place on the policy, procedure or practice? NONE
Which groups? Summarise the findings
Race
Gender
Disability
Age
Sexual orientation
Religion and Belief
Transgender
Carers
16. Is there any other evidence to support this EIA that suggests any group may be affected differentially by this policy, procedure or practice? No evidence identified
Summarise and reference the evidence
Research reports
Consultations and surveys
Demographic data
Equalities monitoring data from local bodies (e.g. KCC or PCTs,
30
charities)
PALS and complaints data
Audits and research reports
EIAs completed by national bodies and partners
Conclusions
17. Will the policy, procedure or practice affect any group differently? NO
If yes – can this be legally justified? (explain)
Race Gender Disability
Sexual Orientation
Religion and Belief
Age
Caring Transgender
18. Does the policy, procedure or practice miss any opportunities to promote equality?
Yes/No (complete Improvement Equality Impact Action Plan)
19. Does the policy, procedure or practice encourage disabled people to participate in public life?
Assessed considered not applicable
20. Does the policy, procedure or practice promote positive attitudes towards disabled people?
Assessed considered not applicable
21. Is there a need to gather more information than is currently available to assess the impact of the policy, procedure or practice
Yes/No (If yes, state what information is needed and how this will be collected)
22. Is it possible to easily modify this policy, procedure or practice to address any issues highlighted above? Please give details of how and when this could implemented
Yes/No: Assessed considered not applicable
23. The EIA has identified: (please tick)
No adverse impact (EIA complete)
Adverse impact that can be mitigated (detail in improvement/equality action plan)
More research/ consultation needed (detail in improvement /equality action plan)
Adverse impact that cannot be mitigated or legally justified (policy must be cancelled)
Race X
Gender X Disability X
Sexual Orientation X Religion and Belief X
Age X Transgender X
Caring X
31
24. Additional comments 25. Improvements/Equality Impact Action Plan
Issue Action Required How will the impact/outcomes be measured in practice
Completion Date
Responsible Officer
SIGNED (or name if electronic): EIA Lead: Steve Norman Head of Department/Directorate: Executive Medical Director Equality & Diversity Team member: Completion Date: July 2015
Send the Full EIA to the Equality and Diversity Team equalities@kmpt.nhs.uk
32
APPENDIX C ABBREVIATIONS AND DEFINITIONS
Patient Safety Incident Any unintended or unexpected incident which could have or did lead to harm for one or more patients receiving NHS funded care.
Root Cause Analysis A structured investigation that aims to identify the true cause of a problem, and the actions necessary to reduce or eliminate it
Human Error
Human error occurs when the actions and decisions of individuals result in failures that can immediately or directly impact patient safety
Harm Harm is defined as injury, suffering, disability or death. Causal Factors A Causal factor is something which can lead directly to an incident. Removal
of these factors will either prevent, or reduce the chances of a similar type of incident from happening in similar circumstances in the future.
External Agency eg Health Care Commission, National Patients Safety Agency Adverse Event An Incident Serious Incident requiring Investigation
is defined as an incident that occurred in relation to NHS funded services and care resulting in one of the following
• The unexpected or avoidable death of one or more patients, staff, visitors or members of the public
• Permanent harm to one or more patients, staff, visitors or members of the public or where the outcome requires life-saving intervention or major surgical/medical intervention, or will shorted life expectancy (this includes incidents, graded under the NPSA
• A scenario that prevents, or threatens to prevent, the Trusts ability to continue to deliver healthcare services, for example, actual or potential loss or damage to property, reputation or the environment
• Allegations of abuse
• Adverse media coverage or public concern for the Trust or the wider NHS
Clusters A number of SI’s, incidents, complaints and claims that are low risk but are an
accumulation in numbers Chronology of Events Time lining – the process by which information is placed in date and time order Retrospective record An account written at a later date and time. Barrier, defences and controls
A control measure that is designed to prevent harm to vulnerable or valuable persons, organisations or objects. These measures may be physical, human action, administrative or natural.
Causal Factors: The prime reason(s) why an incident occurred. A root cause is a fundamental contributory factor. Removal of these will either prevent, or reduce the chances of a similar type of incident from happening in similar circumstances in the future.
Never Event One of the core set of ‘Never Events’ as updated on an annual basis
• Currently including in patient suicide using non-collapsible rails
• Death by scalding
• Death by mal administration of Insulin
• Death by neck entrapment of bed rails Unexpected death where natural causes are not suspected. Trusts should investigate these to
determine if the incident contributed to the unexpected death.
Permanent harm harm directly related to the incident and not to the natural course of the patients illness or underlying conditions, defined as permanent lessening of
33
bodily functions, including sensory, motor, physiological or intellectual. Prolonged pain and/or prolonged psychological harm
pain or harm that a Service User has experienced, or is likely to experience, for a continuous period of 28 days.
Severe harm any patient safety incident that appears to have resulted in permanent harm to one or more persons receiving NHS funded care.
Abuse: a violation of an individuals human and civil rights by any person or persons. Abuse may consist of single or repeated acts. It may be physical, verbal, sexual or psychological; it may be an act of neglect or an omission to act or it may occur when a vulnerable person is persuaded to enter into a financial or sexual transaction to which he or she has not consented or cannot consent. Abuse can occur in any relationship and may result in significant harm, or exploitation, of the person subjected to it. This is defined in No secrets: Guidance on Developing and Implementing Multi Agency Policies and Procedures to Protect Vulnerable Adults from Abuse (DH 2000), and Working Together to Safeguard Children: A Guide to Inter-agency Working states that “abuse and neglect are forms of maltreatment of a child. Somebody may abuse or neglect a child by ‘inflicting harm’ or by failing to act to prevent harm (DCSF 2006, p.37)
Hazard: Situation with a potential to cause harm Risk: The possibility that a specific adverse event will occur.
Likelihood: Probability that an event will occur.
Near Miss: An event with the potential to cause harm but on this occasion did not result in
harmful consequences Harm: An unwanted consequence of an incident that might affect the patients, users,
other people, staff services or the Trust.
Grade: Incidents are graded using a 5 x 5 grading matrix that takes account of severity of consequence in relation to the likelihood of an event occurring as described in the Trust as risk grading.
Investigation: The collection and analysis of the circumstances surrounding an incident to establish a chronology of events and make recommendations about actions to prevent a recurrence, known as Root Cause Analysis methodology.
Risk Reduction The management of risk to reduce the potential for harm Quantitative analysis of data
is a continual process which is supported by investigation made by the Information Analyst and SI Lead. Trust-wide Data is analysed quarterly and annually and reported to the Trust Board. The Trust Board receives a detailed breakdown and report of serious incidents on a monthly basis.
Abbreviation Meaning
NPSA National Patient Safety Agency
NHSLA National Health Service Litigation Authority
CFSMS Counter Fraud and Security Management Service
SI Serious Incident (known previously as Serious Untoward Incident)
SIRS Staff Incident Reporting System
CQC Care Quality Commission
RCA Root Cause Analysis
34
NRLS National Reporting Learning System
RIDDOR Reporting of Injuries, Diseases and Dangerous Occurrences Regulations
STEIS Strategic Executive Information System
MHRA Medicines and Healthcare products Regulatory Agency
HPA Health Protection Agency
HSE Health & Safety Executive
RC Responsible Clinician
Datix Trust incident reporting system
STEIS Strategic electronic Information system
CCG Clinical commissioning Group
SCR Serious Case Review
DHR Domestic homicide Review
35
APPENDIX D ROLES AND RESPONSIBILITIES IN THE PROCESS FOR REPORTING ALL SERIOUS INCIDENTS, INCIDENTS, ACCIDENTS & NEAR MISSES INVOLVING STAFF, SERVICE USERS AND OTHERS
Reporting the Incident; Reporting Timescales and Internal Communication
1. Individual responsibility and actions
2. Role of Line Managers
3. Role of Senior Managers
4. Role of Service Line Directors
5. Role of SI Lead and the purpose of the SI e-mail Inbox
6. Role of Executive Medical Director
7. Role of Service Line Directors including the Non Executive Directors.
1 INDIVIDUAL RESPONSIBILITY AND ACTIONS
Time scale Roles and responsibilities - Incidents
Immediate If you are involved in an incident this is what you need to do:-
Report incidents/accidents via DATIX.
All incidents must be risk rated (see risk matrix pages – section 8). This will determine which Levels (1-5) they are reported at.
Please review the classification of incidents/accidents list at appendix J.
As soon as practically possible following the incident and BEFORE the end of shift
Incidents, accidents, near misses – Levels 1-3 (appendix F)
Members of staff will complete the DIF7 1 form on Datix
The Manager will ensure that the form has been completed.
For all visitors and contractors to the site they will be supported by the member of staff or Manager to complete a DATIX DIF 1 form wherever the incident took place, within the expected timescale.
If out of hours report to the Manager on call and the Manager will contact the Director on Call as appropriate.
Immediate
As soon as is practicable
Internal: ensure any medical devices, medicines or equipment involved in the incident are removed and preserved.
If the following are involved please alert the appropriate Lead;
Medical Devices alert Medical Devices Manager
Medicines alert Chief Pharmacist
Equipment alert Health & Safety Manager/Back Care Advisor (hoists).
Before the completion of the end of shift
Complete the DATIX DIF1 form risk grade the incident using the 5 x 5 matrix, undertake an immediate investigation appropriate to the incident and risk grading to identify learning and any immediate changes to the service or environment and implement and send to Line Manager
Keep a written record of all actions and ensure any statements if required are completed. Ensure a factual clinical patient record is made in the notes. Start written record of all actions taken with timings
Inform Occupational Health of any staff injury. If the Police are contacted then the NHS Security
7 Dif 1: Datix incident form
36
Management Service should be alerted. The Health and Safety team will provide a report via SIRS.
If appropriate and with the patient’s permission the person in charge will contact relatives/carers to inform them of the incident, the subsequent actions and the current circumstances of the patient. (ref: Being Open Policy and the Duty of Candour)
Reporting Serious Incidents using the Serious Incident Alert system – Levels 4 and 5 and complete an DATIX DIF 1 Form and alert line manager (see appendix F)
Immediate Ensure the safety and security of all staff, patients, and visitors to the site and take any remedial action.
Ensure that appropriate physical care if necessary is given or accessed through the Accident & Emergency departments.
Remove or isolate any equipment involved
Start written record of all actions taken with timings
If appropriate contact the Responsible Clinician (RC) and inform of the incident and any injuries. The RC will need to determine the immediate mental state of the patient in the event that the Trust and staff wish to pursue prosecution.
If out of hours to report to the Manager on call and the Director on call
2 ROLE OF LINE MANAGERS
Time scale Roles and responsibilities
Line Manager responsibilities and actions
Incident, accident and near miss Levels 1 – 3 (appendix F)
Within 48 hours
The Line Manager will review the Incident DIF 1 and will confirm the risk grading using the 5 x 5 matrix found in DATIX DIF 2 form.
The risk grading will determine whether a full Manager Investigation Report should be completed. All investigations will follow RCA principles – see Investigation Policy.
If the person completing the form deems the level of the incident to be Levels 4 or 5 the line manager will activate the SI process.
Action
Serious incident (see appendix F)
Immediate Ensure the safety and security of all staff, patients and visitors to the site and ensure any remedial action is taken.
Ensure that appropriate physical care, if necessary, is given or accessed through A & E Department.
Ensure any medical devices, equipment, medicine, involved is isolated, removed and preserved
Ensure written records of all actions with timings are taken.
Review with Line Manager/Service Director
Immediately or as soon as is practicable
Complete the SI Alert form and send to SI@kmpt.nhs.uk e-mail address
Send a copy to the Service Director.
Ensure DATIX DIF 1 Form has been completed.
Members of staff involved will be expected to, and if considered appropriate, give patients involved the opportunity to complete a statement and contribute to the investigation.
Write a detailed statement of the incident including:
• An incident description
• Location of the incident
• The nature of the person reporting the incident
• Name(s) of those involved directly with the incident
• Name(s) and contact details of any witnesses.
Ensure a documented factual account of the incident is placed on the relevant records.
37
Inform Occupational Health of any staff injuries.
With the patient’s permission the person in charge will contact relatives/carers to inform them of the incident, the subsequent actions and the current circumstances of the patient and share any immediate learning and also follow appendix G (supporting family and carers).
Before the end of the working day
Report staff absence or serious patient safety incidents through the Reporting of Injuries, Diseases and Dangerous Occurrences (RIDDOR) reporting regulations 1995 (see appendix J).
Ensure arrangements are in place for staff and patients involved, if appropriate, to debriefed.
Arrange access to patient records.
Ensure that all staff (including those off duty) is notified of any serious patient or staff safety incidents in their area/site/ward. This must be done prior to any Trust press release/media involvement.
Arrange staff debriefing and remind staff how to access staff support and make a record of this.
Seek support from the Security Management Service if considered appropriate for staff.
Service Manager and Service Director, with the Patient Safety Manager, will alert the Lead Director for Patient Safety who will advise the Chief Executive where necessary. The Chief Executive will apprise the Chairman as appropriate.
Within 72 hours
Contact Senior Manager and discuss and identify appropriate roles within the Duty of Candour Policy
Undertake an Immediate Management Investigation and ensure that this is recorded on the DATIX system using the DIFF 2 managers form.
Collect copies of statements and review as part of the Immediate Management investigation and identify any learning or underlying root causes. Complete an Immediate Management investigation DIF 2.
Ensure the incident risk rating has been re-assessed. .
Ensure that changes to services or service delivery or the environment are implemented as soon as is practicable.
Review appropriate risk assessments and risk register and update. Send copies to Line Manager to share with the Service Directors.
Monthly Review all electronic Datix alert forms and Serious Incidents at the Health, Safety & Risk Meetings. Review trends, identify any learning and share with colleagues, ensure risk assessments and risk registers are changed and updated appropriately
Ensure incidents are reviewed in Supervision with the relevant staff member and learning shared.
Out of hours • Receive Serious Incident information and determine response.
• Ensure the immediate safety and well being of the staff and patients
• Gather information and determine whether this can wait until the next morning or the next working day or whether it should be reported to the Director on-call.
• Agree any immediate actions to be taken to ensure the continuing safety of staff and patients and any other party accessing the site.
• Information gathered and recorded must be included in the Immediate Management Investigation.
• Ensure that risk information is shared with all site users.
3 ROLE OF SENIOR MANAGERS
Time scale Roles and responsibilities
Actions – Incidents Levels 1 – 3 (see appendix E)
Immediate If there is any immediate learning that needs to shared with the rest of the service, take to the next Service Management Team meeting.
38
Health, Safety & Risk Meetings
Review all DIF 1 incident alert forms, ensure all appropriate actions and learning have been taken and change where appropriate has occurred and evidence is in place,
review quarterly trends (8 – 15) amber rated risks and identified learning,
review 6 monthly (1 – 6) green rated risks and identified learning including service or environmental changes and include in the Highlight report shared at the Risk, Health, Safety & Risk Meetings.
This is guidance only and will be left to the Senior Managers to determine frequency of review however they must be evidenced by at least the timescales outlined above.
Actions – Serious Incidents, (see appendix E and appendix F)
Immediate Receive appropriate SI Alert
Provide any immediate support to staff, patients and any other visitor to the Trust site.
Arrange additional staff cover and ensure business continuity where appropriate.
Ensure Service Director and SI Lead(s) are apprised of the situation or circumstances.
Ensure debriefing is available for staff and remind staff through that debriefing about access to staff support
As soon as is practicable
Communicate with the local Line Manager and identify roles within the Being Open Policy and support the Local Managers in undertaking the process
4 ROLE OF SERVICE LINE DIRECTORS
As soon as is practicable
Receive alert on Serious Incident and liaise with Service Manager and provide any additional support needed to ensure safety and wellbeing. To consider whether a site visit is appropriate.
Within 4 hours To liaise with the Lead Director for Patient Safety and Chief Executive.
Service Directors, with the Chief Executive and Head of Communications will ensure that all staff associated with the incident or who work on the site are made aware of any media attention prior to the release of information. Consideration should be given to alerting the local community/Commissioners/Department of Health/Local Authority.
Monthly To review all incidents Levels 1 – 5 within Service Line Governance meetings.
Monitor the implementation of Action Plans and share Learning From Trust forums. Apply lessons learnt to improve patient safety. Receive Risk Assessments and Risk Register updates.
5 ROLE OF SI LEAD
Timescale Roles and responsibilities
Actions
As soon as is practicably possible
Receive the SI Alert and review the information and ensure information is recorded on DATIX.
Maintain the database and ensure information is accurate and available
Brief the Medical Director
To provide any immediate risk management support as advised by the Service Director or Assistant Director to ensure the safety and well being of staff, patients and other visitors to the site.
To ensure that information is shared appropriately
Within two working days of the incident occurring
To brief the Commissioners and KCC and Communications as appropriate and ensure that the STEIS system has been updated and the NPSA web site as appropriate. http://www.nrls.npsa.nhs.uk/report-a-patient-safety-incident/
Within 72 hours To receive the Immediate Management Investigation report. To ensure all information is available for review and the decision making process. Update the Commissioners with any additional information.
Monthly To provide monthly reports and updates to the Board
39
Quarterly To review trends and themes and ensure reports outlining the learning from the reviews are reported to the Trust Board
To undertake Management Clinical SI Learning Review investigations using root cause analysis methodology
To oversee and manage the SI Learning Review investigation process and ensure they are fit for purpose
To ensure learning is disseminated across the organisation.
6 ROLE OF EXECUTIVE MEDICAL DIRECTOR Time scale Roles & Responsibilities
As soon as is practicable
Is kept apprised of any serious patient safety related incident and is responsible for informing the Chief Executive and Trust Board.
Bi-monthly Presents Serious Incident Report to the Trust Board and provides assurance to the Chief Executive and the Trust Board that the systems and processes relating to safety are meeting all internal and external standards. Receives alerts on Serious Incidents and informs the Chief Executive and Non Executive Directors as appropriate.
Bi-monthly Receives assurance from the Service Lines that safe systems and processes are embedded and effective.
7 ROLE OF SERVICE LINE DIRECTORS INCLUDING THE NON EXECUTIVE DIRECTORS
Time Scale Roles & Responsibilities
All Directors and Non Executive Directors are expected to complete DATIX DIF 1forms when they are involved in incidents, accidents and near misses.
All Directors should be actively involved in reviewing incident trends for their areas of responsibility and setting objectives.
Support staff during the process of Serious Incidents.
Take responsibility for ensuring that learning from DATIX incident reports, SI reports, are embedded in practice and service delivery. To undertake audit and service reviews that evidence that change has taken place and that it has reduced or managed the risk appropriately.
Service Directors are responsible for ensuring this policy is enacted throughout their teams.
On call Directors who are on call may receive SI alert calls from Managers on call
• The Director will need to confirm with the Manager that the safety and well being of the staff and patients is being managed appropriately.
• The Director will need to ensure that there is an immediate plan to ensure that any immediate learning is shared across the organisation.
• Consideration should be given to informing the Chief Executive, the Strategic Health Authority, Commissioners and the Local Authority and any other Stakeholders.
• Keep a written record of actions
• Share the immediate learning and report with the Service Directors as soon as is practicable.
40
Appendix E
Trust Wide SI & Mortality Panel (Updated 23.05.16)
Terms of Reference The Trust reports the deaths of all service users on Datix. A Learning Review will take place for the vast majority, however, there may be cases where the Trust believe the death/reported Level 4/5 incident does not constitute a KMPT SI. Purpose of the panel:
• To provide oversight of all deaths occurring amongst all service users
• To make Trust decisions regarding which deaths/reported Level 4/5 incidents do not constitute a KMPT SI
• To improve the transparency of reporting levels of unexpected deaths in across all service user groups supported by the Trust
• To review service line allocation for complex cases that cross service lines/other organisation
• To highlight overdue SI Management Investigations (i.e. not completed on Datix)
• To highlight overdue responses overdue to CCG/NHSE queries
• To review ‘near miss’ incidents, ‘themed learning reviews’ & any other incidents in order to consider if they meet the Trust SI criteria
Responsibilities/duties:
1. To review all cases presented by service line leads where the completion of the initial investigation (72 hour SI Managers Report) highlights they do not meet SI criteria.
2. To review all inpatient deaths where the death was to be expected
3. To use the Trust agreed classification to identify the potential need for review or investigation in each case
4. To agree action to be taken for each case with clear rationale:
a. Case closure b. Case downgrading c. Case rejecting (e.g. natural death) d. Completion of Concise Learning Review e. Completion of Comprehensive Learning Review f. Completion of Thematic Learning Review g. Case on hold awaiting cause of death h. Request for another organisation to complete Learning Review i. Request for joint Learning Review (Lead Organisation to be recommended)
5. To develop and update a mortality dashboard which is provided to stakeholders and
reported in the annual report, that provides a full picture of all deaths, themes, CIRs and serious incidents
6. To monitor causes of deaths amongst its service users by using the 2013/14 MHMDS
data release to see if the ICD 10 chapters show any trend
41
7. To provide an evidence base to share with Local Authority commissioners and other providers highlighting themes that are arising relating to social care and other agencies issues
8. To ensure that liaison with acute provider colleagues can take place at a clinical and
managerial level where the Trust has concerns raised with it about care in acute settings Core Membership Trust Wide Patient Safety Manager Complaint/SI Facilitator Service Line SI Lead (rotated) Senior Psychiatrist (rotated) Lead Nurse (rotated) Trust Director (rotated) Ad Hoc Membership SI Lead or their nominated rep to attend the panel when presenting a case to be discussed or when requested by the panel Meeting arrangements The meeting will be held weekly. Video/telephone conference facilities should be made available, as required. Admin support will be provided to the meeting & the chair The meeting chair will be the Patient Safety Manager or their nominated representative
Quorum 4 clinical staff Clinical Governance Structure The panel will be overseen & monitored by the Trust wide Patient Safety & Mortality Group (Part I) A brief overview report will be prepared by the Chair and sent to the Trust EMT (Presented by the Medical Director) Reporting and Monitoring Minutes will be taken at each meeting identifying action points. A brief overview report will be sent to Trust EMT Review of Terms of Reference: Annually by the Trust wide patient Safety & Mortality Group (Part I)
42
Flow Chart for reviewing suspected natural causes deaths.
All patient deaths are reported on the
Datix System as a level 5 incident by
the member of staff who is first aware
of the death
The patient’s death is reviewed by the
patient safety team
The patient’s death is thought to be
unnatural, suspected suicide or an
unexpected sudden death
Service line or across service line
RCA to be conducted
The patients death is suspected to be
from natural causes.
The patients death is reviewed by the
weekly mortality Review and the death
is not suspected of being from natural
causes of there are care concerns
The patients death is confirmed as
natural causes and there are no care
or service delivery problems
Decision is recorded on Datix and the
incident is “allocated for investigation
RCA when completed is reviewed by
the service line’s Governance
Structures and Trust Wide Patient
Safety
Decision is recorded on Datix and the
incident is “rejected” on Datix
The action plan is monitored by the
relevant service line
The completed RCA is sent to the
relevant CCG closure panel within 60
working days
43
APPENDIX F REPORTING TO EXTERNAL STAKEHOLDERS
Reporting Incident Type Timescale Reported By
NHS England
Commissioners
Clinical Commissioning Groups
Local Authorities
Suicide of any person on NHS premises or under the care of a specialist team in the community
Homicide committed by a patient with mental health problems
Serious injury or unexpected death involving a member of staff, visitor, contractor or another person to whom the organisation owes a duty of care
Serious damage to NHS property, particularly resulting in injury or disruption of services e.g. through fire, flood or criminal activity.
Incidents associated with infection that produce, of have the potential to produce, unwanted effects involving the safety of patients, staff or others
Any other Serious incidents that may be identified as a cluster of events that lead to something more significant including those that may attract media attention
Immediately within working hours or within the first hour of the next working day.
Patient Safety Manager
Coroner Death from industrial diseases
Cot death and postnatal deaths
Self harm
Where death may be linked to an accident (whenever it occurred)
Death after operation or before full recovery from anaesthetic
Death due to abortion
Cause of death unknown or within 24 hours of admission
Possibility of complaint about any medical care (negligence)
Neglect or self neglect
Any violent, suspicious or unnatural death
Drug related deaths
Death of anyone currently or recently detained in Police/Prison Custody
Immediate Ward Manager or nominated other
Service Manager
The Trusts Legal Team
Health & Safety Executive(HSE)
Death
Major injury, dangerous occurrences and ”over three day” injuries.
Immediate by telephone to the Health & Safety Executive. For further information go to H&S page on Staffzone
http://staffzone.kmpt.nhs.uk/Health-and-Safety-File.htm
Within 10 days of incident via RIDDOR link on Health & Safety Home page.
Within 10 days from diagnosis via
Ward Manager
Line Manager
Service Manager
Trust Risk Manager
44
Occupational diseases RIDDOR link.
National Health Service Litigation Authority
(NHSLA)
Incidents where the Trust becomes aware that litigation will result
Immediate
Legal Services Team
Professional Regulatory bodies
Incidents where there appears to have been a breech of the professional code of conduct
As soon as the breech becomes apparent
Human Resources and Service Line Directors
Medicines and Healthcare Products Regulatory Agency (MHRA)
Incidents involving injury or risk of serious injury involving healthcare products and equipment
Within 24 hours Ward Managers
Service Managers
Line Managers
Pharmacy Staff
Health & Safety Manager
Medical Devices Manager
Safeguarding Children Board
Any incident involving serious harm to a child
Immediate Safeguarding Lead
Safeguarding Vulnerable Adults Board
Any serious incident involving a vulnerable adult
Immediate Safeguarding Lead
Care Quality Commission
See Care Quality Commission Notification Procedure
As soon as possible Executive Medical Director on behalf of the Chief Executive with the Service Line Director
Environmental Health/Food Standards Agency/Health Protection Agency
Incident involving contaminated food products resulting in illness
Immediate Director of Facilities
Health & Safety Manager
Counter Fraud and Security Management Service (CFSMS)
All physical assaults against NHS staff and professionals
Immediate Via Incident Forms Direct contact from staff
Local Community Any incident that is likely to impact on the local community
As soon as possible Head of Communications
Chief Executive or nominated other
45
APPENDIX G Serious Incident Reporting (Level 4 & 5).
IMMEDIATELY inform manager/ shift lead/service manager/on call manager
� Assesses medical needs of people involved
� BEFORE END OF DAY Qualified staff member completes
SI ALERT FORM (online Datix) • Inform the service user / relatives – Tell them an investigation will be
taking place & investigator will contact them– confirm in writing (As per Duty of Candour)
• Review risk assessment/care plan/observation levels/leave etc
• Consider adult/child protection alert and/or police involvement • Urgent learning shared
�
�
Takes URGENT action as relevant
* Where staff member injured or traumatized, manager considers referral to Occupational Health * Informs Ministry of Justice (Forensic services) * SI Dept communicates with other external agencies/media (e.g. CQC)
�
WITHIN 72 HOURS Manager (with support from Quality Team) completes SI MANAGERS REPORT (on line Datix) & DRAFTS ACTION PLAN
Where disturbed/violent behaviour – Clinical team carry out a Clinical Review meeting using NICE format (within 72 hours)
�
* Considers RIDDOR * Where patient/staff is potentially traumatized, Clinical Team OFFER initial support. Manager/psychology to monitor wellbeing of staff/service user and offer access to further support / counselling if signs of trauma still evident in long term
� WITHIN 10 WORKING DAYS: Clinical Team carry out a Clinical Review to highlight:
• To share and reflect upon current practice (actions before, during and after the incident)
• To highlight ways of improving practice (learning)
• To support staff & service users and encourage the therapeutic relationship between staff, service users & their carers
• To ensure best practice is followed
• To provide an opportunity to highlight issues with trust systems & trust/local policies, procedures and protocols.
�
WITHIN 45 WORKING DAYS Quality Team co-ordinate a LEARNING REVIEW INVESTIGATION to highlight root cause / contributory factors / learning / recommendations. Where appropriate, this includes a Learning Review meeting with the Clinical Team
� Investigators add learning points to the SI action plan for local ownership/implementation
� Learning Review approval at * Local Governance meeting * Service Line Governance meeting * Trust Patient Safety meeting
When action plan completed SI closed by Service Line Governance meeting/Chair.
Serious incidents Serious incidents involving clients, staff or property which result in grievous or substantial damage or loss, requiring further investigation overseen by a director e.g. attempted suicide or homicide with serious injuries, sudden unexpected death to natural causes, absconds of violent or suicidal clients, incidents involving property which result in financial loss or cost to the Trust of £10,000 to £40,000. Incidents involving clients, staff or property which result in death or severe service disruption e.g. suicide or homicide or rape, or incidents involving property which result in financial loss or cost to the Trust
46
APPENDIX H SI LEAD REPORTING RESPONSIBILITIES
Action required: Commissioning CCG will monitor the case and report to NHS England, findings and recommendations and associated action plans. NHS England will monitor progress on a quarterly basis with CCG unless earlier discussion is required or the serious incident is re-graded. Comprehensive Investigation Root Cause Analysis (RCA) required
Monitoring required Local monitoring
• The CCG and/or NHS England will close the incident when it is satisfied the investigation, recommendations and action plan are satisfactory, and local monitoring arrangements are in place and working efficiently.
• Publish incident details within Annual Reports.
Timescales: Up to 45 working days/9 weeks from the date the incident is notified to the CCG/NHS England.
Examples:
• Mental Health – deaths in the community*
• Avoidable/unexplained death
• Mental health – attempted suicides as inpatients*
• Data loss and information security
• Grade 3 pressure ulcer develops
• Poor discharge planning causes harm to patient
Action required: Case will be monitored by the CCG in conjunction with the provider organisation. NHS England will review findings, recommendations and associated action plans. For Never Events’ the commissioning CCG will be obliged to monitor overall numbers and report these in its annual reporting arrangements. Comprehensive Investigation (RCA (as above) or Independent Investigation (RCA Investigation)*
Monitoring required CCG/NHS England. monitoring:
• Incidents leading to an independent investigation or inquiry or those considered high risk will continue to be monitored by the CCG/NHS England. or Local Authority until evidence is provided that each action plan has been implemented. Incidents involving adult or child abuse are referred to local safeguarding arrangements.
• Publish quarterly reports. Timescales: For Independent Investigations allow up to 26 weeks/6 months for completion of investigation. Extensions can be granted on an individual case-by-case basis by the CCG/NHS England..
Examples:
• Maternal Deaths
• Inpatient suicides (including following absconsion)*
• Child protection
• Data loss and information security
• Never Events
• Accusation of physical misconduct or harm is made
• Homicides following recent contact with mental health services*
*Mental health incidents should refer to DH guidance: Independent investigation of adverse events in mental health services.
47
APPENDIX I CLASSIFICATION OF INCIDENTS/ACCIDENTS FOR REPORTING INCIDENTS TO NRSL VIA DATIX Nature or Type of Incident
Level 1 (near miss) NON-SERIOUS INCIDENT
Level 2 (minor risk) NON-SERIOUS INCIDENT
Level 3 (moderate risk) NON-SERIOUS INCIDENT
Level 4 (major risk) SERIOUS INCIDENT
Level 5 (high risk/catastrophe) SERIOUS INCIDENT
Definitions Incidents resulting in no injury or damage but potentially could have caused injury/damage/loss. Normally dealt with/investigated by the ward manager/Service Managers/front line staff.
Incidents resulting in Very minor injury, Damage or loss. Normally dealt with/investigated by the ward manager/Service Managers/frontline staff
Incidents resulting In moderately serious injury , damage or loss requiring formal investigation by the Ward Manager/Service Manager.
Incidents resulting in grievous harm/potentially life threatening to a person a substantial damage or loss requiring a formal investigation by the Service Manager in consultation with the Assistant Service Director.
Reportable to the NHS England, Commissioners and KCC Major incidents resulting in life threatening events extremely serious harm or death, substantial damage or loss requiring a formal investigation by the Assistant Service Director. These incidents may necessitate an inquiry panel.
Absconsion and absent without leave (AWOL) Including Depravation of Liberty Patients
Threats to abscond - with no intent. And attempted absconding Informal client fails to return and not at risk.
Absconds within the grounds/ward/department and returns soon after. Informal client with potential risk leaves the ward. Informal patient fails to return from leave.
Absconds but not deemed violent/suicidal/vulnerable. Detained patient fails to return from leave Informal patient fails to return from leave, but is not deemed vulnerable, violent or suicidal.
Absconds and deemed to be violent/suicidal/vulnerable. Detained client under restriction order fails to return and is deemed violent/suicidal. Detained client fails to return and is deemed violent/suicidal/vulnerable
Absconsion leading to suicide/homicide, serious harm to others or damage to property. AWOL leading to suicide/homicide, serious harm to others or damage property. Restricted patients escape from within the perimeter of a medium secure unit.
Accidents, including needle stick injury Incidents are graded by the level of actual injury / damage sustained rather than by the potential for an
injury / damage to occur.
Any accidents with no injury/minimal loss.
Minor burns/scalding or minor unaccounted for injuries. Accidents resulting in minor injury requiring first aid within the service.
Minor injuries requiring medical attention. “Over 3-day injury” RIDDOR reportable. Needle stick injury with no infection. An event which moderately impacts adversely on a large number of patients or staff
Injuries requiring medical attention in A & E, or hospitalisation. Needle stick injury from infected person Accident resulting in injury that requires medical attention eg. Accident and Emergency referral/an inpatient stay in a an acute hospital and or any fracture. Mismanagement of patient care with long term effects
Causing death/life -threatening Injuries. Causing life threatening disease or death.
48
Nature or Type of Incident
Level 1 (near miss) Level 2 (minor risk) Level 3 (moderate risk) Level 4 (major risk) Level 5 (high risk/catastrophe)
Adult Protection Policy – failure to comply with policy
No action in respect of Adult Protection Policy but this was identified through supervision and a near miss must be recorded. Failure to share information that a vulnerable adult may be at risk from harm or abuse.
No action taken in respect of the Adult Protection policy and a minor incident occurred with no injury. Delay in implementing safeguarding procedures resulting in a failure to provide protection.
No action taken in respect of the Adult Protection Policy and an incident occurred causing Injury or harm requiring A & E assessment. Minor harm to vulnerable adult following a failure to share information or implement safeguarding procedures.
No action in respect of the Adult Protection Policy and an incident occurred causing serious injury and requiring A&E assessment and admission to an acute bed Significant harm to vulnerable adult following a failure to share information or implement safeguarding procedures
No alert in respect of the Adult Protection Policy and an incident occurred and contributed to the death of a Service User or member of the public. Serious adult abuse and or neglect which may or may not cause death of a client.
Aggression: verbal (including racial harassment) Where aggression is staff to patient or staff to staff please consult the Patient Safety Team for grading.
Physical aggression and management
Sexual
(including harassment) Assault by staff on patient; Assault by staff on staff; Allegations of abuse Injuries sustained during restraint
Verbal assault to harm others but no intent – non- directed. Pushing/shoving, pinching, slapping, punching and threats, but no injuries. Chart to now include all types of abuse including sexual, racist or homophobic abuse, financial etc. Control and Restraint undertaken with no injury incurred. Occasional sexual/amorous remarks. Inappropriate behaviour with no intent. Take advice and discuss
With Service Manager/Director prior to deciding the level of severity
Verbal assault including persistent sexist/racist/homophobic remarks – directed at person. Pushing/shoving, pinching, slapping, punching causing minor injury. Biting (skin intact). No implements used. Possession of banned Items. Control and Restraint undertaken with minor injury to staff or patient treated by first aid. Persistent sexual remarks or inappropriate sexual behaviour, innuendoes/homophobic
language. Take advice and discuss with Service
Manager/Director prior to deciding the level of severity.
Verbal assault, racially motivated abuse, threat to kill or maim - directed at person/ property with intent. Threat of assault based on equality characteristics – e.g. race, sexual orientation, transgender, disability etc. Assault by client/staff using implements causing minor injury requiring first aid on ward/department.
Physical aggression resulting in restraint, minor injury requiring medical attention. Possession of a weapon. Control and Restraint with injury requiring medical care or A & E admission. Allegations of sexual assault. Threat of sexual assault. Sexual harassment with physical contact. Sexual exposure. Form of words for stalking to be included… Take advice and discuss with Service
Manager/Director prior to deciding the level of severity.
Verbal assault, racially motivated abuse, threat to kill or maim with real intent – or history of physical aggression. Attacks resulting in
serious injuries
requiring A & E
treatment/hospitalisation, attempted homicide
Attempted homicide. Use of weapon/implement resulting in injury to staff or patient Persistent serious harassment with contact based on equality Characteristics Assault motivated by discriminatory attitudes – e.g. Racist, homophobic Control and Restraint undertaken with significant injury resulting in admission to A & E and/or admission to the Acute Hospitals Trust. Actual minor sexual assault/persistent serious harassment, physical contact with intention to molest. Serious sexual assault. Persistent serious harassment with contact but no intent to molest. Take advice and discuss with Service
Manager/Director prior to deciding the level of severity.
Verbal assault, racially motivated, abuse threat to kill or maim with intent and with outside involvement. Staff and/or patient feel victimised or are placed in serious/immediate danger. Homicide / Manslaughter. Assault of pregnant woman causing physical damage or harm to the child or woman Assault of a person with a disability with serious consequences -e.g. loss of mobility. Assault resulting in serious harm where discriminatory attitudes are clearly identified as the cause. Control and Restraint undertaken resulting in serious injury requiring emergency treatment and/or causes death. Rape/ very serious sexual assault. Take advice and discuss with Service
Manager/Director prior to deciding the level of severity.
49
Nature or Type of Incident
Level 1 (near miss) Level 2 (minor risk) Level 3 (moderate risk) Level 4 (major risk) Level 5 (high risk/catastrophe)
Child Protection Policy - failure to comply with policy (also refer to Safeguarding below)
No action in respect of Child Protection but this was identified through supervision and a near miss must be recorded.
No action taken in respect of the Child Protection policy and a minor incident occurred with no injury to child/children.
No action taken in respect of the Child Protection Policy and an incident occurred causing minor injury or harm to a child/children.
No action in respect of the Child Protection Policy and an incident Occurred causing serious injury to a child/children.
No Alert in respect of the Child Protection Policy and an incident occurred and caused the death of child/children.
Clostridium diff
Patient admitted with C. diff and in consequence Infection control procedures activated.
Patient admitted and later identified as having C diff requiring Infection Control procedure activated.
Patient identified through routine physical health management as having C.diff and Infection Control procedures are activated.
Patient identified with C.diff requires urgent A & E and inpatient care in the Acute Hospitals Trust.
Patient identified as C.diff and dies within the care of the Trust.
Death N/A Expected death from natural causes on an inpatient unit. Unexpected death from natural causes in the community.
Unexpected death from natural causes within an inpatient unit.
Suicide in the community of client known to services within 6 months of the incident. Death related to illicit drug /alcohol misuse of a current Service User.
Suspected Suicide of an in-patient or suicide on Trust Premises. Suspected Suicide of client discharged within 14 days from inpatient services.
Discharge - patient discharge: early or self discharge
Discuss with team and, if necessary take advice prior to deciding the level of severity. As above.
Discuss with team and, if necessary take advice prior to deciding the level of severity. As above.
Discuss with team and, if necessary take advice prior to deciding the level of severity. As above.
Discuss with team and, if necessary take advice prior to deciding the level of severity. As above.
Discuss with team and, if necessary take advice prior to deciding the level of severity. As above.
Discrimination on the basis of protected characteristics under the Equality Act (2010):* Ethnicity / race / gender / Transgender / civil partnership / marriage / Religion / sexual orientation / age / Disability / Pregnancy/maternity Links to Equality Act are clearer, when listed in this way within the policy.
Derogatory comments or behaviour (including the use of unacceptable/ abusive words) based on equality characteristics. Racist or other discriminatory insignia or images. Pornography where this may impact on others (excluding private use).
Persistent inappropriate sexual behaviour Persistent Sexual racist, homophobic or discriminatory comments and/or behaviour. Abuse based on equality characteristics (e.g. racist) directed at person/s. Verbal abuse where discriminatory attitudes are strongly suspected as the cause.
Threat of sexual assault. Threat of assault based on equality characteristics – e.g. race, sexual orientation, transgender, disability etc. Sexual harassment with physical contact. Sexual exposure.
Assault motivated by discriminatory attitudes – e.g. racist, homophobic. Serious sexual assault. Persistent serious harassment with contact based on Equality characteristics.
Assault of pregnant woman causing physical damage or harm to the child or woman. Assault of a person with a disability with serious consequences -e.g. loss of mobility. Assault resulting in serious harm where discriminatory attitudes are clearly identified as the cause.
50
Nature or Type of Incident
Level 1 (near miss) Level 2 (minor risk) Level 3 (moderate risk) Level 4 (major risk) Level 5 (high risk/catastrophe)
Falls Slipping, falling with no injuries.
Slipping, falling with minor injury requiring on site first aid only.
Slipping, falling, sprains requiring medical attention; i.e. accident and emergency referral.
Falls, slipping causing dislocations/fractures requiring medical attention in A & E/ hospitalisation.
Causing death. Please risk assess to confirm whether Level 4 or Level 5 incident.
Fire Setting off fire alarms accidental or deliberate, with little or no disruption.
No injury or damage. Setting off fire alarms accidental or deliberate resulting in evacuation and attendance of fire brigade Threat of arson
Minor injury and/or damage.
Significant damage to property/ person. or significant injury
Substantial damage to property/person e.g. major disruption to service. Fire causing death / life threatening injuries to staff and or patients.
Health and Safety Reported defect to the interior/exterior part or parts of the building not resulting in the disruption to service. Release (spillage/gas discharge) of the substance non hazardous to health.
Accidental release of any substance which may cause ill health. Short term disruption to the service caused by the damage of the exterior/interior part of the building.
Accidental release of any substance which will cause ill health. Any unintentional explosion, misfire, failure of demolition to cause the intended collapse, projection of material beyond a site boundary, injury caused by an explosion;
Explosion or fire causing suspension of normal work for over 24 hours. Health and Safety Incident resulting in patient or staff injury requiring hospitalisation. Accidental release of a biological agent likely to cause severe human illness.
Health and Safety incident resulting in a death of patient or staff.
Human Resources/staffing Short term low staffing level that temporarily reduces service quality < 1day.
Low staffing level that reduces the service quality.
Unsafe staffing level > 1 day. Staff whose professional registration expired continues to practice without prior renewing their license (no lapse at all after 01.11.2015 when it can result in suspension).
Unsafe staffing level > 5 days. No staff attending mandatory training on an ongoing basis. Unregistered staff or staff struck of from the register continues to practise.
Unsafe staffing level for service to operate.
Inappropriate behaviour e.g. consenting to sex
Discuss with team and, if necessary take advice prior to deciding the level of severity.
Discuss with team and, if necessary take advice prior to deciding the level of severity.
Discuss with team and, if necessary take advice prior to deciding the level of severity.
Discuss with team and, if necessary take advice prior to deciding the level of severity.
Discuss with team and, if necessary take advice prior to deciding the level of severity.
Infection Control and Ill Health
Exposure to blood/body fluids/other sources of infection with no risk and no effects.
Exposure to blood/body fluid or other source of infection with minimal risk/no sickness. Infection Control procedures activated and managed internally by the Trust. Patient in an inpatient setting diagnosed with a communicable disease (chicken pox. Measles, TB)
Exposure to blood/body fluid or other source of infection resulting in short-term sickness (minimum 3 days).
Exposure to blood/ body fluid or other source of infection resulting in Serious infection, long term sick leave Infection Control procedures activated with more than one patient affected by the outbreak. The Health Protection Agency contacted Needlestick injury/ human bite that breaks skin Any outbreak of infection (D&V MRSA) Any diagnosis of bacteraemia MRSA, MSSA, E Coli) in a patient. Infection Control Procedures activated with a ward or site closed due to an outbreak of infection. The Health Protection Agency visit and support the Trust Needle stick injury from a patient with a known blood borne virus (HIV, Hep B, Hep C). MRSA, Bacteraemia and C-Diff with infection
Sudden or unexpected death where evidence may be related to exposure to infection. Any Incident involving serious outbreak of infectious diseases in hospital or the community (such as food poisoning) Patient identified as MRSA who dies within the Trust. Infection Control Procedures are activated and patients die as a direct result of the infection. The Health Protection Agency are actively involved in managing the outbreak. Needle stick injury causing recipient to contact a serious illness (HIV, Hep B).
51
Nature or Type of Incident
Level 1 (near miss) Level 2 (minor risk) Level 3 (moderate risk) Level 4 (major risk) Level 5 (high risk/catastrophe)
Information Technology and Communication Management
Use IT HELP Desk for Information Technology to determine the Level. Interruption of the IT system (failure of logging into the system) not affecting individual’s workload to a great extent.
Use IT HELP Desk for Information Technology to determine the Level. Interruption of the IT system (failure of logging into the system) affecting individual ability to perform his tasks efficiently.
Unauthorised use of Information Technology for non NHS Business. Loss of access to PIMS/Web based CPA single site. Loss of Network Services to a single Site. Theft of P.C/Laptop. CATT Team loss of access - one day. Accidental damage to I.T, equipment. Disruption of the IT system (server failure) affecting service provision > 1 day.
Using IT in breach of Trust Policies, i.e. accessing inappropriate web sites. Loss of PIMS/Web CPA to multiple sites. Loss of Network Services to multiple Sites. Theft of P.C/Lap top containing patient information. Deliberate damage to single P.C/Printer/Lap Top.
Using IT resources in breach of legislation. Computer misuse, data protection, human rights etc. Loss of information to PIMS/Web CPA service that prevents access to patient information and causes a negative patient outcome. Loss of Trust Network to multiple sites that prevents clinical staff gaining access to patient information and causes a negative patient outcome. The loss or theft of a lap top where reasonable security has not been undertaken resulting in a breech of confidentiality or data protection and having an adverse outcome on the patient. Theft of multi-PC's containing patient information. Deliberate damage to multiple PC's/printers/lap tops.
Loss/theft of personal/Trust property.
Very low cost or loss to the Trust.
Cost or loss to Trust up to £500. Personal loss/cost to client, staff, public <£100.
Cost or loss to Trust £500 - £10,000. Personal cost/loss to client, staff, public £100 - £5,000.
Cost or loss to Trust £10,000 - £40,000. Personal cost to client, staff, public £5,000 - £10,000.
Cost or loss to Trust of more than £40,000 + Personal loss to client, staff, public or more than £10,000 +.
Medication errors (Wrong dosage)
Incorrect medicine dispensed, but not ingested.
Error in administration of medication with no adverse effects. Delayed and / or omitted (including omissions due to alcohol and / or drug misuse) medication where there are no adverse affects.
Potential effect on client due to incorrect dosage. Delayed and / or omitted (including omissions due to alcohol and / or drug misuse) medication where there are no adverse affects.
Effect on client due to incorrect dosage. Any medication incident causing significant affects Prolonged delayed and omitted medication where there is an adverse affect on the patient.
Leading to serious harm or causing death.
Medication errors (Wrong drug)
The wrong medication, dispensed but not given.
The wrong medication given but with no adverse effects. Prescription is unclear or incorrect but seen and corrected before administration. Delayed and / or omitted (including omissions due to alcohol and / or drug misuse) medication where there are no adverse affects.
The wrong medication given with some minor effects but not serious Prescription is unclear or incorrect and medication is administered with some minor effects. Delayed and / or omitted (including omissions due to alcohol and / or drug misuse) medication where there are no adverse affects.
The wrong medication given requiring A & E intervention. Prescription is unclear or incorrect and medication is administered with adverse effects requiring A & E Intervention. Any medication incident causing significant affects Prolonged delayed and omitted medication where there is an adverse affect on the patient.
The wrong medication contributing to or causing death or serious harm. Prescription is unclear and incorrect medication is given with contributing to or causing death.
MRSA Patient admitted with known MRSA infection with infection control procedures activated.
Patient admitted and later identified as having MRSA requiring Infection Control procedure activated. Patient identified through routine physical health management as having MRSA and requiring Infection Control procedures activated. Patient identified with MRSA requires urgent A&E and Inpatient care in the Acute Hospitals Trust.
Patient identified as MRSA who dies within the Trust.
52
53
Nature or Type of Incident
Level 1 (near miss) Level 2 (minor risk) Level 3 (moderate risk) Level 4 (major risk) Level 5 (high risk/catastrophe)
Physical Health (including seizures, physical illness and pressure ulcer) include refusing appointment Self neglect
Client presents with unexplained minor injury, e.g. bruising
Client presents with physical illness requiring treatment on site. Pressure ulcer graded level 2 or below, suspected initial presentation of pressure ulcer
Client in inpatient setting presents with physical illness requiring referral to A and E and / or ambulance
Patients who have a cardiac arrest Pressure ulcers resulting in a severe wound (where the pressure ulcer develops within our services)
Possession of offensive weapon
Offensive weapon given to client by third party. Client informs staff of possession.
Offensive weapon found on or with client or visitor.
Attempted use of a weapon or actual use of an offensive weapon.
Property damage
Defacing property of walls, minimal cost to the Trust.
Cost or loss to Trust up to 500. Personal loss/cost to client, staff, public up to £100.
Cost to Trust £500 - £5,000.
Cost to Trust £5,000 - £40,000.
Cost to Trust of more than £40,000 + .Service suspended or major disruption.
Records availability
Records not available when required but location known.
Records unavailable, location not known but not "lost".
Can't be tracked in 40 days.
Records lost/unavailable for inquiry.
Records destroyed/lost. Adverse patient reaction.
Records Confidentiality. Data Protection
Records not properly secured but no obvious disclosure. Patient information visible in reception areas (P.C. Screen)
Patient identifiable, information shared Inappropriately. Unauthorised sharing of passwords.
Unauthorised disclosure of patient information with no patient harm. Deliberate use of another staff member’s password.
Information disclosed to unauthorised source - possibility of patient harm.
Information disclosed to unauthorised source and Information Commissioner investigation causing actual patient harm
Records content
Short delay in updating record. Not impacting on case.
Delay in updating record-minimum impact on case or records standards not used (e.g. blue pen, entries not timed).
Record incomplete and other parts of the Record cannot be traced. Paper record conflicts with electronic record.
Alerts details and/or drug missing. Advance Directive is missing.
Deliberate tampering with record content.
Safeguarding Children and young people (includes unborn baby through to 18th birthday)
Failure to share information appropriately that a child may be at risk from harm, or a child being at risk of harm either whilst on Trust premises or from an individual under the direct care of the Trust, without resultant harm being suffered by a child. Visit by a child to Service User terminated Admission of a child aged 17 to a bed not specifically single sex and set aside, or without support from CAHMS staff.
Delay in implementing safeguarding children procedures resulting in failure to provide protection/intervention at an early stage. Child placed at risk during a visit to a Service User. Child in contact with person who is a risk to children whilst under Trust’s care/on Trust premises.
Minor harm to a child. Either following failure to share information to protect the child, or occurring whilst the child or perpetrator was under the direct care of the Trust.
Significant harm to a child. Either following failure to share information to protect the child, or occurring whilst the child or perpetrator was under the direct care of the Trust. Allegations made against staff of behaviour that has harmed, or may have harmed a child. Admission of a child aged 16 or under to an adult ward.
Security incidents Premises or individual areas found unlocked with no public access. Defacing property to walls with minimum cost to the Trust. Trust staff entering secure sites with no visible ID.
Premises or individual areas found unlocked with public access. Defacing property or walls with a cost to the Trust of up to £500. Personal cost /loss to staff of up to £100.
Trespassing on the grounds of secure units. Defacing property or walls with a cost to the Trust of up to £501 - £20,000. Personal cost /loss to staff of over £101.
Break in / robbery of community / inpatient services with staff present.
Cost to Trust of more than £20,000 and security incident resulting in suspension or major disruption of services.
54
Nature or Type of Incident
Level 1 (near miss) Level 2 (minor risk) Level 3 (moderate risk) Level 4 (major risk) Level 5 (high risk/catastrophe)
Self harm
Threats to self harm indicating attention seeking behaviour. Attempted self harm with no injury
Self harm with minor injuries. requiring first aid and or medical attention on site
Minor self-harm requiring medical attention on ward/ in A & E.
Attempted suicide/homicide with serious injuries. Self harm resulting in serious injuries. Attempted suicide or actual suicide injuries
Suicide - in patient or known to service in last 12 months. Self harm resulting in death
Substance Use / Substance Abuse (alcohol & drug)
Suspected possession of alcohol or illicit drugs but no evidence. Failure to provide urine sample on request – Forensic services only Suspicion of illicit drug use in inpatient services
Evidence of alcohol possession or consumption but not intoxicated. Use of alcohol and / or illicit drugs where client not intoxicated Discovery of alcohol and or illicit drugs in inpatient services
Evidence of alcohol and/or illicit drug consumption and intoxicated behaviour posing risk to self/others. Possession of a small quantity of illicit drugs. Client in possession of drugs or alcohol. Suspicion of patient with intent to supply illicit drugs and / or alcohol within in patient services.
Evidence of alcohol and/or illicit drug abuse/consumption and intoxicated behaviour causing risk to self/others. Possession of a large amount of illicit drugs/supplying others with illicit drugs. Overdose of illicit drugs requiring medical intervention.
Death or life threatening situation resulting from use of alcohol or illicit drugs.
Trust Policies and Procedures: failure to comply with
Incident averted because of the vigilance of staff however this must be registered as a near miss.
Incident occurs causing minor harm to a member of staff, Service User or member of the public.
Puts staff/Service Users or members of the public at risk requiring A & E assessment.
Puts staff/Service Users or members of the public at risk requiring A & E assessment and admission to the Acute Services Trust.
Death of a member of staff, Service User or member of the public.
Unaccounted for loss or injury
Anything not covered above involving property or persons either very low loss or no injury.
Anything not covered above involving property or persons either low cost or requiring just verbal support.
Anything not covered above involving property or persons either moderate loss or requiring first aid and counselling only.
Anything not covered above involving property or persons requiring first aid, counselling and medical attention in A & E /hospitalisation.
Sudden or unexpected death not covered above involving property or persons.
Use / Misuse of clinical information
Failure to share information with other agencies or vice versa.
Loss of all or part of a clinical record. Accidental deletion of electronic record. Letters / reports incorrectly addressed.
Unauthorised access to a clinical record. Loss or stolen record outside of Trust premises. Wilful destruction of records. Written or verbal breach of confidentiality.
Breach of information security impacting on service delivery requiring full investigation. Damage to a services reputation. Low key local media coverage. Serious breach of confidentiality e.g. up to 100 people affected.
Major breach of information having Trust wide impact on service delivery and or the reputation of the Trust. Serious breach with either particular sensitivity e.g. sexual health details, 1000 or over people affected.
55
APPENDIX J SERIOUS INCIDENT QUALITY ASSURANCE CHECKLIST
LR Initials
DoB Initials of Reviewers
Date of Meeting
No Element Assured
Comments
Y/N Y/N 1. Was one of the national standard NHS
investigation Learning Review tool used?
2. Was there more than one Learning Review investigator in the core team?
3. Was one of the LR investigators a Clinician? 4. Was there a robust pre and post Learning
Review risk assessment?
5. Were the terms of reference clear and relevant to the incident?
6. Was the methodology used appropriate to the incident? (e.g. patients notes/statements)
7. Did the methodology include face to face interviews of relevant people (individual or group)? (Includes Clinical Team Learning Review Meeting)
8. Is there evidence that those affected (Including service users/staff/relatives /victims/ perpetrators) were involved and supported appropriately?
9. Is there evidence that those with an interest were involved – see above point ?
10. Have notable practices been clearly highlighted?
11. Are good practice guidance/policy/protocols referenced in the Learning Review to determine what should have happened?
12. Are care and service delivery problems clearly identified? (this must include what happened that shouldn’t have /what didn’t happen that should have)
13. Is it clear that contributory factors have been explored/highlighted?
14. Is it clear that root causes/issues have been considered?
15. Have robust points of learning been highlighted?
16. Are there clear recommendations to support the gaps/problems/learning highlighted?
17. Was a timeline/chronology included in the Learning Review?
18. Is there a clear action plan related to the learning/recommendations?
19. Is it clear that individuals have not been unfairly blamed?
20. Comments:
56
APPENDIX K HOW TO IDENTIFY A REPORTABLE INCIDENT FLOWCHART
START HERE Did the incident involve
personal injury to someone?
Was the person injured staff, service user /
visitor or contractor?
Yes
Refer to the ‘RIDDOR Dangerous Occurrences
flowchart 2’, before taking any further action
No
Contractor
Record the incident on Datix form but as a
non reportable incident,
and ensure that the
contractor’s employer is
made aware of
the incident.
Service user / visitor
Were they transferred to hospital or would have been if they were not already admitted to a hospital for treatment
Was it an illness or
injury caused by
Natural Causes?
Was the incident
caused by something The Trust did or did not do i.e. dry a wet
floor, leave something on the floor
etc
Record the incident on Datix form and then
complete and send the
online RIDDOR report at
www.riddor.gov.uk (note
must be completed within 10 days of
incident).
Record the incident on
Datix.
Staff NOTE: Absence as a result of stress, anxiety or depression is currently NOT reportable under RIDDOR. NOTE: If a disease is suspected of being an occupational disease contact the occupational health department for conformation before reporting under RIDDOR
Was the member of
staff working at the time of the incident?
Treat as service user / visitor
accident
Was it an illness or
injury caused by Natural Causes?
Record the incident on Datix form as Natural
Causes
Refer to the ‘RIDDOR Major Injury
Flowchart 3’ before taking any further action. If it was a
Major injury follow the instructions on
Flowchart 3. If it was not a Major injury, continue below.
Is the staff member unable to work for more than 3
consecutive days? (excluding the day of the accident but including any off-duty / non
rostered days)
Record the incident on Datix form and complete the RIDDOR report
on-line at www.riddor.gov.uk (note – must be within 10 days of the
incident) If classified as Levels 4 or 5 implement SUI procedure.
Record the incident on
Datix
No
No
Yes
No
No
Yes
No
Yes
No
No
Yes
Yes
How to identify a Reportable Incident - Flowchart 1
Yes
57
APPENDIX L HOW TO INVESTIGATE NON SERIOUS INCIDENT See Separate Chart for serious incident Level 1: Incidents involving Clients, Staff or property which result in no injury, damage or loss but with the potential to cause injury loss or damage e.g. verbal aggression without intent to harm, accidents with no injury, minimal damage or loss to property Level 2: Incidents involving clients, staff or property which result in minor injury, damage or loss, but no serious consequences e.g. self-harm or assault causing minor injury, or financial loss or cost to the Trust of up to £500 Level 3: Incidents involving clients, staff or property which result in moderately serious injury, damage or loss requiring formal investigation by a senior manager e.g. needlestick injury, allegation of sexual assault – allegation of sexual assault should be an SI, attacks needing medical attention in the ward or department, or financial cost to the Trust of £500 - £10,000
Inform person in charge
Incident or near miss occurs, complete relevant
paper work and follow reporting process
If member of staff involved in incident is injured send copy to Occupational Health within 72 hours.
Each staff member should retain a copy.
Reviews the incident, investigation and re-assesses risk rating in light of the
learning from the investigation. Completes the manager report on Datix
Ensures implementation of any service or environmental changes. Reviews all incidents, identify themes and trends and share learning at the Health & Safety meetings or if urgent share learning with Service Director who will share it across other service
lines
Service Manager � Ensures appropriate action has been
taken to manage risk � If staff incident, follow reporting process � Ensure immediate health & safety
concerns are addressed � Review Risk Assessments & Risk Register
& ensure they are updated as appropriate
IMMEDIATELY OR AS SOON AS PRACTICAL
BEFORE END OF SHIFT
WITHIN 2 WORKING DAYS
Next Health & Safety Meeting
Person in charge � Ensures the Datix alert Dif 1 form is
completed with relevant risk rating of severity
� Completes the investigation � Signs & sends form to service
manager � Ensures a full written account of the
incident is documented in the relevant records
� With client permission Informs clients & relatives
If appropriate inform RC/ Lead Clinician as soon as
is practically possible
Review client’s care plan & assess persons medical care needs. If staff member involved, refer to
Incident Policy & action as required