Incident & Serious Incidents Reporting and Management Policy

Transcription

1 Incident & Serious Incidents Reporting and Management Policy ID Number Authors Name Authors job title Division Department Version Number Ratifying Committee Ratified date March 2014 Review date March 2016 Date added to intranet Name of manager responsible for review Job title of manager responsible for review address for this manager Referenced (yes/no) Key words (to aid searching) User Group Equality Impact Assessment Date Document added to the intranet G004 Caroline White Interim Associate Director for Quality Governance Trust wide All in patient areas V10 Board Assoc Director Quality Governance Yes Incident, Accident, Safety, Injury, Investigation, NPSA, Reporting All Staff. Completed. The Trust is committed to promoting an environment that values diversity. All staff are responsible for ensuring that all patients and their carers are treated equally and fairly and not discriminated against on the grounds of race, sex, disability, religion, age, sexual orientation or any other unjustifiable reason in the application of this policy, and recognising the need to work in partnership with and seek guidance from other agencies and services to ensure that special needs are met.

2 Change History Version Date Author Reason Ratification Required 8 June 08 Nicola Havutcu Yes 8.1 Nov 08 Nick Egginton Updated based on new SUI No reporting process 8.2 May 09 Nick Egginton MHRA reporting process added No 8.3 July 09 Sirajul Islam Updated based on organisational No changes in governance structure 8.4 Sept 09 Nick Egginton Changes to Training section and No SUI reporting process. 8.5 Jan 10 Nick Egginton Small changes to supporting staff No 9 July 10 Nick Egginton Policy up for renewal Yes 10 March 14 Caroline white Policy reviewed and revised to align with new organisational structures and in light of various national reports, including the Berwick report. Amalgamation of Yes reporting and investigations policies

3 Contents 1. Introduction Purpose Scope Roles and Responsibilities Trust Board Audit Committee Patient Safety, Quality and Risk Committee Divisional Governance and Quality Groups The SI Decision Meeting Serious Incident Review Group (SIRG) Panels of the Quality and Safety Group Chief Executive Chief Nurse Executive Directors and Divisional Management Triumvirate Medical Director Associate Director of Quality Governance The Serious Incident Coordinator Health and Safety Manager Information Governance Manager Specialist Advisors Departmental Ward Managers / Matrons / Sisters/ corporate department heads Divisional risk leads Trust Local Security Management Specialist All staff, contractors, volunteers, students, work experience placements Definitions Actions to be Taken Immediately Following an Incident Incident Reporting Process for Reporting to External Agencies Managing incidents Negligible Incidents Minor Incidents Moderate Incidents Management of Serious Incidents (SI) Defining a Serious Incident Reporting requirements for SIs Reporting and Investigation of SIs Staff Support for those involved in the incident Conduct of investigation Personal Debrief Leave Arrangements Occupational Health Support Communication with staff involved Support for the Investigating Officer Support for patients/ relatives/ carers Communication with the affected individual (including patients)... 18

4 13. Communication with many affected individuals Liaison with other interested parties Official bodies Communications with Media Root Cause Analysis Risk Reduction Measures Development and Monitoring of Action Plans for SIRI Safekeeping of the Records of the Investigation Disciplinary Action Training Monitoring & Review of Incident Reporting & Investigation Policy Key Related Documents (not an exhaustive list) References Equality Impact Assessment Appendices Appendix One: Steps to be taken when a serious DRAFT 1 - Jan 2014 incident occurs simplified flowchart Appendix Two: Serious Incident Categories Guidance Appendix Three: Types of RIDDOR Incidents Appendix Four: Never Events List Appendix Five: A guide to serious incident grading for investigation purposes Appendix Six: Assessing the Severity of the Information Governance Incidents Appendix Seven: Device Incident Management Appendix Eight: Serious Incident Process

5 1. Introduction The West Hertfordshire Hospitals Trust (WHHT) is committed to making safety a priority and to doing its reasonable best to prevent injury, ill-health and harm to patients, staff and visitors, and to prevent loss and damage to NHS assets, the Trust s reputation and to prevent breaches of patient confidentiality. WHHT recognises that although serious incidents in health and social care are relatively uncommon, from time to time things can and do go wrong. When adverse incidents do occur the Trust has a responsibility to ensure that there are systematic measures in place for safeguarding people, property, Trust resources and reputation. This includes responsibility to learn from these incidents in order to minimise the risk of them happening again. To achieve this the Board will have in place a robust system of identifying, investigating and learning from all types of incidents. Learning from the identification of root causes of incidents will provide a key lever for change and improvement in relation to safety. The reporting and management of incidents is a critical tool in assisting the organisation to effectively manage risk. The reporting of incidents and near misses provides valuable data which can help improve safety, prevent the recurrence of incidents and facilitate wider organisational and cross-organisational learning. This policy covers the reporting and investigation processes for all clinical and non-clinical incidents including Serious Incidents (SIs), near misses and hazards and applies to incidents involving service users, visitors or carers, the public, employees or business of the Trust. This policy for all staff includes the principles of being open and duty of candour. Where incidents occur we need to evidence openness, honesty and transparency so that early warning systems can work. Expectations of the duty of candour following the Francis report and the contractual duty as described in the NHS Standard Contract 2013/14 & 14/15 (SC35) include ensuring that any patient harmed by the provision of a healthcare service is informed of the fact and an appropriate remedy offered, regardless of whether a complaint has been made or a question asked about it. 2. Purpose The Trust recognises that incidents may occur because of problems with systems, processes or by individuals. It is the Policy of the Trust to promote a positive approach to incident reporting throughout the organisation. Staff are encouraged and will be supported to be open and honest about events and issues that have or could cause damage to people, property or the organisation. The Trust operates an open and fair blame culture and will accept vicarious liability for the actions of staff as long as they were carrying out their duties in accordance with Trust policy, their professional standards, information, instruction, training and supervision they had received. Disciplinary action will only be considered in accordance with the Disciplinary Policy. The Trust wishes to learn lessons and improve through the investigation of incidents. It is imperative that the Datix incident reporting system is used as a proactive mechanism for risk management.

6 The objectives of the policy are consistent with the National Patient Safety Agency guidance on the Seven Steps to Patient Safety (2009) which are: Promoting a culture of learning through review and reflection of incidents and near misses, Ensuring a consistent approach across the organisation in the reporting and management of incidents, Enabling the effective reporting and provision of information on incident trends to ensure that lessons can be learnt and improvements made reducing re-occurrence of similar incidents, Improving the safety of service users, staff and visitors, Minimising the human, organisational and financial impacts of incidents through effective management, Enabling the identification and correction/ improvement of weaknesses in practices, systems or equipment, Ensuring the onward reporting of serious hazards and incidents to relevant stakeholders. 3. Scope This Policy applies to all Trust staff and contractors working on Trust premises, including staff on interim or honorary contract and volunteers. It covers all types of incidents. 4. Roles and Responsibilities 4.1Trust Board The Board is accountable for ensuring there is a sound system of effective risk management within the Trust including ensuring that all incidents are reported and investigated and all Serious Incidents (SI) have been fully investigated via Root Cause Analysis and appropriate actions to prevent reoccurrence have been taken and that learning and improvement from Serious Incidents is being shared and improvements made as a result. The Board is responsible for having systems to provide assurance that this is working effectively. This assurance is further reinforced through the presentation of an Annual Report to the Board on Incidents, Serious Incidents and Learning from Experience. 4.2 Audit Committee The Audit Committee is responsible for ensuring that the Board has a sound assessment of risk and incidents and that the Trust has adequate plans, processes and systems for minimising risk and incidents. It will receive copies of the internal audit of the incident reporting processes. 4.3 Patient Safety, Quality and Risk Committee The committee will review reports concerning specific incident trends (i.e. pressure sores, patient falls) or Serious Incidents (SI), it will also be responsible for reviewing external high level incidents for learning purposes (e.g. Mid Staffs). The committee will receive a Complaints, Litigation, Incident and PALS (CLIPS) summary report for review on a quarterly basis, this will include incident trend analysis, SIs reported and a summary of the actions taken and lessons learnt.

7 4.4 Divisional Governance and Quality Groups The role of the Divisional Group is to review and monitor matters related to their own services and to have as agenda items: analysis of all incidents reported to demonstrate: o o receipt of summary of new SIs* monitoring report of progress against performance indicators, trends in incidents (Patient and Health and Safety) receipt of investigation reports for SIs, agreement of action plans for SIs and any trends identified In addition the Group will have a work plan to include regular analysis of specific groups of incidents e.g. RIDDOR reported incidents Medication Incident Report Medical Devices Incident Report *In respect of the review of any new SIs the Group will monitor progress which will include a brief summary of events. To identify immediate action was taken and when the incident was reported; to ask of the investigator: What is the current situation with any reports that are due and what lessons have been identified from reports that are complete. The Group will then determine how and when lessons learned for that Division will be shared. 4.5 The SI Decision Meeting The SI Decision Meeting will be convened daily, as required, to determine whether any reported potential serious incident should be considered a SIRI and therefore warrant a full Root Cause Analysis Investigation. The Meeting will comprise of an executive director or their nominated deputy, usually the Medical Director and/ or Chief Nurse, the Associate Director of Quality Governance and/or a representative from the governance team, and a Divisional representative from the area where the incident occurred to present information on from the divisions. In the meeting a Lead Investigator who will be responsible for investigating and reporting on the incident will be identified. The Lead Investigator will be someone who has not been directly involved in the incident itself and will be preferably from outside the Division involved in the SIRI. The Lead investigator will be identified from the Trust register of trained investigators who have received training in Root Cause Analysis. In addition to the Lead Investigator, a further RCA-trained investigator will be allocated to the Investigation Team. Experts for particular specialisms or subject areas will also be identified, when required, to work as part of the Investigation Team to ensure the necessary expertise is available to inform the investigation, conduct investigatory meetings and support the analysis of findings.

8 4.6 Serious Incident Review Group (SIRG) The SIRG will meet to obtain assurance of the implementation of the action plans associated with all SIs. It will receive assurance that the actions carried out as a result of the RCA recommendations have been implemented and their effectiveness is monitored on an ongoing basis. 4.7 Panels of the Quality and Safety Group Each of the reporting panels of the Quality and Safety Group listed below (but not limited to) has a responsibility for reviewing incident trends or serious incidents that relate to the panel s scope and remit. These reports will be provided by the Governance team on a reporting schedule agreed with the chair of the committee: - Medical Devices Panel - Drugs and Therapeutics Panel - Infection Control Panel - Thrombosis & Anticoagulation Group - Safeguarding Panel - Hospital Transfusion Panel - Resuscitation Panel In addition the following Groups should review SIs and incidents trends - Informatics Group - Workforce Group - Patient Experience Group 4.8 Chief Executive The Chief Executive has overall responsibility for risk management and shall ensure systems are in place to maintain effective systems for incident management. The Chief Executive is responsible for: Ensuring that this policy is implemented by all directly employed staff, contractors and volunteers Ensuring that systems are in place to minimise risk, identity issues early and manage promptly. Leading the development of a culture where openness is encouraged and employees feel able to report incidents and near misses. Ensuring that wherever care is commissioned, the provider has robust arrangements in place for the recording, reporting, investigating and learning from incidents. 4.9 Chief Nurse The Chief Nurse has Executive responsibility for Quality Governance and as such reports directly to the Board and the Chief Executive on all matters relating to incidents and SIs.

9 4.10 Executive Directors and Divisional Management Triumvirate Executive Directors and Divisional Management Triumvirate (Divisional Director, Head of Nursing and Divisional Manager) are responsible to the Board for: Implementing this policy, on behalf of the Chief Executive; Encouraging a responsible culture which encourages individuals to report all types of incidents; ensuring staff at all levels understand the need to report all incidents and near misses as per this policy. They will be responsible for ensuring any serious incidents and or incident trends are reviewed and investigated at a local level and escalated as required. Delegating responsibility to local managers for the policy s implementation at local level; Ensuring sufficient resources are available, as far as reasonably practicable, to deal with identified hazards and risks that might lead to an adverse incident. Team leaders, Service Managers and Matrons are responsible for ensuring the Governance Department and Divisional Management triumvirate (Divisional Director, Head of Nursing, Divisional Manager) are informed of any incidents that need to be escalated as potential SIs Medical Director The Medical Director is also the Caldicott Guardian and has responsibility for ensuring personal identifiable data is safe and secure. Any incident which involves breaches of confidentiality will be investigated with appropriate reference to the Trust Caldicott Guardian, Senior Information Risk Officer (SIRO) and Information Governance Manager Associate Director of Quality Governance The Associate Director of Quality Governance is responsible for ensuring that all of the quality governance systems and processes, including incident reporting, are fit for purpose and are implemented in practice. Where they are not, to make recommendations as appropriate to the Patient Safety, Quality and Risk Committee and the Board The Serious Incident Coordinator The Serious Incident Coordinator oversees the incident reporting processes Trust wide, they are responsible to ensure: Mandatory training courses including incident reporting take place Manage the SI log and action tracker Manage the SI reporting process, ensuring divisions are aware of these processes (including timelines) and reporting all SIs (including action plans and evidence) to the CCG on request. Escalate any issues relating to the non-implementation of SI actions and meeting of set SI timelines to the Associate Director of Quality Governance and Patient Safety, Quality and Risk Committee or other relevant governance committee or group. Ensuring that the appropriate incident reports are provided for the appropriate committees

10 Provide support on the incident reporting process Raising awareness to the SI decision making panel of any trends in incident reports where the organisation may wish to review the group as if the incidents were a single serious incident 4.14 Health and Safety Manager RIDDOR - The Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995 (RIDDOR) as amended 2013 require a range of incidents to be reported to the Health & Safety Executive (HSE) where an employee is absent from the workplace or unable to carry out their normal duties for more than 7 consecutive days after a workplace injury and any Trust activity or work that adversely impacts on the health and well-being of a patient or visitor to the Trust. Reportable incidents may include the following: fractures; amputations; an injury likely to cause loss of sight; any crush injury to the head or torso causing damage to the brain or internal organ; any burn injury (including scalding) which covers more than 10% of the whole body s total surface area; any loss of consciousness caused by head injury or asphyxia Staff, of patient affected by dermatitis or develops an allergy to latex Visitor slipping on water on the floor in corridor and breaking an arm or leg The Health and Safety Manager or Occupational Health Manager will, when required, complete RIDDOR forms and send them to the Health and Safety Executive (HSE) within 15 days. The Health and Safety Manager will offer assistance and training regarding the Trust s RIDDOR responsibilities. The Health and Safety Manager will also monitor the reporting of all Health and Safety related incidents, including circulation of Health and Safety incident statistics. In addition they will liaise with the HSE in respect of any requested site inspections in line with the External Assessment Visits Policy 4.15 Information Governance Manager The Information Governance Manager will oversee the reporting of information governance incidents, be involved with agreeing the terms of reference for investigations and provide the expertise to the management, investigation and closure of all Information Governance SIRI (Serious Incident Requiring Investigation). They will also be responsible for involving the Caldicott Guardian and Senior Information Risk Officer (SIRO) where appropriate Specialist Advisors The Trust employs a number of specialists who will advise all services on their speciality this includes: Medical Devices; Infection Prevention and Control; Tissue Viability; Safeguarding. In all cases the Datix system will send information to specialists as incidents are reported. The specialist advisor will liaise with the service where the incident has occurred to deal with immediate actions, as well as developing the action plan and ensuring that actions are complete to the appropriate standard. In addition they will liaise external bodies in respect of any requested site inspections in line with the External Assessment Visits Policy and provide advice to the investigator,

11 4.17 Departmental Ward Managers / Matrons / Sisters/ corporate department heads All Departmental Ward Managers / Matrons / Sisters are responsible for: Ensuring that the Incident reporting form is properly processed as per the Trust s requirements outlined in this policy. Immediate post incident support for staff involved in the incident and record any actions taken to support staff in the incident report. Reviewing all incident reports in a timely manner, ensuring they are properly and fully completed. Carrying out investigations relevant to the severity of the incident, which occur within their area of responsibility. Referring member/s of staff to Occupational Health if deemed appropriate Ensuring that all members of their staff receive sufficient training so that they fulfil their individual responsibility in meeting the policy requirements Divisional risk leads Divisional risk leads are responsible for: Undertaking daily checks of incidents reported on DatixWeb system awaiting approval. Ensuring incidents are appropriately investigated within the divisions Set up an appropriate system for the management of DatixWeb incidents for the division. Ensuring appropriate feedback mechanisms are in place for teams to learn and improve. Ensuring statistical incident data is presented at the local meeting responsible for incidents. Providing incident information in the report to the Divisional Governance and Quality Group meeting and to the Quality and Safety Group; specifically on the actions taken and lesson learnt following incidents. Ensuring investigations are carried out Providing training to staff on the incident reporting process. Ensure the Being Open process if followed as outlined in the Being Open Policy Trust Local Security Management Specialist Any incident that has implications for the security e.g. violence and aggression against a member of staff or loss of identity must be reported to the Trust Security Manager Datix Administrator The Datix Administrator is responsible for: Reviewing all reported incidents (on Datix) daily, excluding weekends.

12 Weekly uploading of incidents to the National Reporting and Learning System (NRLS) established by the former NPSA. Providing support, training and advice on the use of Datix and, as required, the principles of incident and SI reporting, investigation and management to staff Investigator Any member of staff (not exclusive to clinical staff) may be appointed to a Serious Incident investigation team. Investigators will usually be band 7 and above. Anyone appointed as an investigator must have completed appropriate Root Cause Analysis (RCA) Training. An investigator is responsible for carrying out an investigation into an incident adhering to this policy and ensuring that recommendations are provided to the appropriate individuals and forums All staff, contractors, volunteers, students, work experience placements Employees Responsibilities: each employee has a duty to report an accident, incident or near miss to their manager as soon as is reasonably practicable after the incident. Employees will also be responsible for the reporting of incidents involving patients, visitors etc. The report will be made using the Datix system: Only where it is not available, due to power failure etc., will a paper report be acceptable. Contractors, Volunteers, students, work experience placements etc: shall report any incident to a member of staff who will then have the responsibility for reporting. The person identifying the incident will be responsible for taking any required immediate action, giving a witness statement and taking part in any investigation as required by the investigating officer. Where a person identifying the incident is unable to report the incident, i.e. as a result of injuries sustained, unconsciousness etc., the responsibility for reporting will rest with their manager. All employees (including temporary staff, placement students, sub-contractors, and people on honorary contracts or volunteers) are responsible for reading and adhering to this policy. Staff must report incidents, including near-misses in accordance with this policy and fully co-operate with any investigations. They must ensure the patient/service user involved is aware of the incident consequences and actions taken, in line with the Being Open Policy. Staff reporting the incidents should include their name as reporter and the area in which they work. However, there is scope to report incidents and concerns anonymously although this may make it more challenging to investigate. Staff should consult the Raising Concerns Policy or contact HR for advice if they feel it is necessary to retain their anonymity. 5. Definitions 5.1Incident An incident is described as any event which has given rise to potential or actual harm or injury, to patient dissatisfaction or to damage/ loss of property (Ref: NHS Executive). This definition includes patient/ service user injury, fire, theft, vandalism, assault and employee accident and near misses. It includes incidents resulting from negligent acts, deliberate or unforeseen.

13 5.2 Near Miss An incident that had the potential to cause harm but was prevented. 5.3 Non-Clinical incidents An unplanned or unexpected event in which a member of staff/contractor or the public has been, or could have been injured, killed, or suffer mental trauma, or led to loss or damage to equipment or property, or other financial loss. For example: A member of staff hurts his/her back A member of staff subject to verbal abuse A member of the public falls in the car park Fire on work premises Theft loss or damage to organisation or personal property 5.4 Patient Safety Incident Any unintended or unexpected event that could have or did lead to harm on organisation premises where NHS funded care is provided, including a patient s own home or anywhere in the community. For example: Delayed treatment that has or could have caused harm Diagnostic results not communicated or lost Record Keeping poor recording, incomplete, failure to document Procedures carried out incorrectly or incorrect procedure applied to an individual Patients notes lost, unavailable, incomplete The wrong medication is prescribed, administered, missed or lost Patient falls Absconsion from (non) secure settings Inappropriate/unsafe patient discharge Confidentiality breach Staff shortages Faulty Equipment medical such as feeding pump, syringe driver, catheter. 5.5 Serious Incident (SI) A Serious Incident is defined when a patient, member of staff, or member of the public suffers serious harm or unexpected death on organisation premises, premises where health care is provided, including in a patient s own home or anywhere in the community; Where staff actions are likely to cause significant public concern; Any event that might seriously impact upon the delivery of service plans and/or may attract media attention and/or result in a settlement following litigation and/or may reflect a serious breach of standards of service. For further guidance on what constitutes a SI please see below under SI Management. 5.6 Hazard A hazard can be defined as: anything that can cause harm. Hazards are situations with the potential to cause harm or damage and could include faulty equipment, worn or loose

14 floor coverings, irritant chemicals etc. Incident reporting forms must be completed for all hazards. Individual responsibilities are not however discharged by the mere completion of an incident reporting form and all reasonable steps should be taken at the time to minimise the risk of injury arising from any identified hazard. 5.7 Harm Harm can be defined as: injury (physical or psychological), disease, suffering, disability or death In most instances, harm can be considered to be unexpected if it is not the result of the natural course of the patient s illness or underlying condition. 5.8 Never Event Never events are a sub-set of Serious Incidents and are defined as serious, largely preventable patient safety incidents that should not occur if the available preventative measures have been implemented by healthcare providers. For full list see Appendix 4 6. Actions to be Taken Immediately Following an Incident Some incidents will require prompt and specific action to deal with the problem. This may include the following: Emergency medical care Summoning assistance Ensuring all at risk; patients, staff, visitors and others, are moved to a safe environment Treating/caring for others affected If equipment / machinery is involved, removing it from service (marking it clearly out of order ) and contacting the Clinical Engineering Department. Notifying senior members of staff on duty Recording the action taken in the patient s medical records. Records might not be at hand, but they should be found and either tracked or made secure. Member of staff to report the incident via DatixWeb (or paper version) Request that all those who observed what happened prepare a witness statement as soon after the event as possible. 7. Incident Reporting Guidance is available to staff and managers on using the DatixWeb Incident Reporting systems and is available on the intranet All incidents must be reported using DatixWeb, if the system is unavailable or the individual reporter is unsure how to report using the system then a paper incident form must be completed. The Divisional risk lead must be informed if the above circumstances arise. If the person involved in an incident is unable to complete the incident report form for any reason, then a witness or colleague should do so on their behalf. All information given, including written statements must accurately state the facts, without expressing personal opinion or allocating blame.

15 The initial incident report must be completed on Datix as soon as possible following the incident. All sections of the DatixWeb / Paper incident report form should be completed as fully as possible for all types of incidents. Once the form has been completed it should be submitted / given to the appropriate manager. The line manager will first ensure all steps, to make safe the person and the environment, have already been taken. If they have not then the manager will take such steps as are required. The manager will then ensure the form has been correctly and fully completed. The manager will undertake an immediate assessment of the seriousness of the incident and include this in the initial report. ALL incidents need to be investigated so that the Trust can learn lessons and if necessary modify practice to prevent re-occurrence. There are sections within the Datix Incident Report to record actions taken and lessons learned and these must be completed before the incident is closed. All staff have a responsibility, set out in this policy, to escalate incidents as potential SIs if the incident meets the national SI criteria. If staff are unsure they should discuss with their line manager or the SI Coordinator. Where it is determined that the incident is Moderate or Serious alert the SI Coordinator as well as informing their line manager or in their absence the Divisional Head of Nursing. The SI Coordinator will then initiate the SI Decision Meeting. All relevant papers will be gathered together and will be presented at the following morning s SI meeting for confirmation of status as a Serious Incident. 8. Process for Reporting to External Agencies Following reports on Datix, the system will alert relevant internal specialists to support the external reporting of specific types of incidents for instance medicines, radiation, Health and Safety, medical device, information governance. The Trust specialist for that work area will contact the division and ascertain if appropriate action is being taken and to be involved in the root cause analysis if that is deemed appropriate. The Trust Serious Incident Coordinator will report all Serious Incidents to commissioners using the STEIS system and also informally to agree grading of the SI. 9. Managing incidents The way in which an incident is managed will be determined by the grading of the incident. This will determine the level of investigation and the reporting required. 9.1 Negligible Incidents All negligible incidents should provide a summary of the immediate action taken following the incident by the initial reporter. All negligible incidents should have the investigation section (which includes lessons learnt and actions taken) of the DIF2 DatixWeb form completed by either the ward manager or matron reviewing the incident.

16 Incident trends (which include minor incidents), the lessons learnt and actions taken will be reviewed through the Divisional Governance and Quality Group. 9.2 Minor Incidents All minor incidents will provide a summary of the immediate action taken following the incident by the initial reporter. All minor incidents will have the investigation section (which includes lessons learnt and actions taken) of the DIF2 DatixWeb form completed by either the ward manager or matron reviewing the incident. Incident trends (which includes minor incidents), the lessons learnt and actions taken will be reviewed through the Divisional Governance and Quality Group. 9.3 Moderate Incidents All moderate incidents will provide a summary of the immediate action taken following the incident by the initial reporter. They will have the investigation section (which includes lessons learnt and actions taken) of the DIF2 DatixWeb form completed by either the ward manager or matron reviewing the incident. Incident trends (which include moderate incidents), the lessons learnt and actions taken will be reviewed through the Divisional Governance and Quality Group and escalated through the Divisional report to the Quality and Safety Group and up to Patient Safety and Quality Committee as required. The Being Open Policy will be applied to all patient safety incidents identified as having caused moderate or greater harm. 10. Management of Serious Incidents (SI) 10.1 Defining a Serious Incident A 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: Unexpected or avoidable death of one or more patients, staff, visitors or members of the public; Serious harm to one or more patients, staff, visitors or members of the public or where the outcome requires life-saving intervention, major surgical/medical intervention, permanent harm or will shorten life expectancy or result in prolonged pain or psychological harm (this includes incidents graded under the NPSA definition of severe harm); A scenario that prevents or threatens to prevent a provider organisation s ability to continue to deliver healthcare services, for example, actual or potential loss of personal/organisational information, damage to property, reputation or the environment, or IT failure; Allegations of abuse/ neglect (safeguarding) Adverse media coverage or public concern about the organisation or the wider NHS; One of the core set of Never Events as updated on an annual basis see Appendix 4

17 The above is applicable where an incident is classified as an event of circumstance that could have resulted, or did result, in unnecessary damage, loss or harm such as physical or mental injury to a patient, staff, visitors or members of the public Reporting requirements for SIs SIs will be reported as with all other incidents on the Datix system. Additional people will be contacted as soon as possible as outlined in the process chart at Appendix Reporting and Investigation of SIs The National Framework for Reporting and Learning from Serious Incident Requiring Investigation (NPSA 2010) and the supplementary guidance issued by NHS Commissioning Board Serious Incident Framework (2013) requires that all Serious Incidents (SIs) are reported on the STEIS system within 48 hours of knowledge of the incident. If there is uncertainty about the status of an incident, provider organisations are advised to err on the side of caution and if in doubt to seek advice from the CCG. All Serious Incidents will be fully investigated using Root Cause Analysis techniques by a lead investigator from a different Division to the one where the incident occurred. A team including people from the division will support that investigation. It is the responsibility of the relevant service / senior manager where the incident occurred to ensure that as recognised by the investigation, all learning points and safety improvements are appropriately identified and action plans drawn up, implemented, monitored and reviewed. The National Framework requires that such incidents are subject to robust investigation to establish the root cause/s of the incident and to make recommendations as to what actions are required to prevent or minimise the likelihood of the incident happening again. Depending on the type of incident, in line with the national framework, the Trust is required to provide a Board-level approved final investigation report to commissioners detailing the investigation, findings, recommendations and outlining an action plan within 45, or 60 days if a grade 2 serious incident, of the incident being reported. The Trust will be monitored to ensure the actions required are implemented. 11. Staff Support for those involved in the incident 11.1 Conduct of investigation It is essential that all investigations are conducted in a manner that is demonstrably supportive to those involved. The process must be seen as being about listening, learning and improving. This will include providing those who are being investigated with a full account of the reasons for the investigation, giving them a proper opportunity to talk to the Lead Investigating Officer and ensuring that they are kept informed of progress. Also any findings of the investigation and response to third parties must be shared with those whose actions are being investigated. It will be the role of the Divisional Managers and Heads of Nursing, including on-call managers, to be alert to those factors, which may necessitate and provide the necessary resources for this to take place. The welfare of any staff involved in an incident must be considered particularly in relation to psychological trauma or stress.

18 Such support may take different forms depending on the type of incident and the level of involvement of the staff member or the personal injury (physical or mental) suffered by the individual. Support may include: 11.2 Personal Debrief The personal debrief is where the manager and the staff member involved sit in private and discuss the incident in an uncritical atmosphere Leave Arrangements Leave may be taken as sick leave, annual leave or compassionate leave dependent on circumstances of the incident. When leave is taken following an incident due to personal injury or to a member of staff not being fit to work for any other reason, including stress related reasons; a return to work de-brief will occur before duties are assumed 11.4 Occupational Health Support The line manager can refer the individual for counselling (via Occupational Health) if it is appropriate 11.5 Communication with staff involved It is also important for staff to be kept fully informed of the progress of an investigation with which they have had clear associations. This will be the responsibility of the manager undertaking the review or chair of any investigation team. In particular staff must be kept aware of progress and when the report has been completed, the findings, recommendations and action to be taken will be relayed to them, giving them the opportunity to ask questions Support for the Investigating Officer Where an investigation is likely to be time consuming the Divisional Management triumvirate (Divisional Director, Head of Nursing, Divisional Manager) will assist the Investigating Officer in reprioritising his/her existing workload while the investigation is taking place. Where the Investigating Officer feels that the investigation might result in a recommendation for disciplinary action he/she will contact the relevant HR Manager as soon as possible for advice and support. Investigating Officers will seek the support of the Divisional Director for the locality if medical/staffing issues have been identified. If there are any reasonable concerns about the objectivity of the Divisional Director, such support will be sought from the Medical Director or nominated clinical representative. 12. Support for patients/ relatives/ carers 12.1 Communication with the affected individual (including patients) Every effort must be made to inform the individual involved as soon as possible before any media contact is made and in line with the Being Open Policy. The individual will receive treatment, care and support, and be given full information on the incident, including the outcome of the investigation. If the individual is incapacitated then next of kin and or significant other, must be informed in lieu of the patient. Where the incident has led to death or serious injury, the individual s next of kin must be informed before any media contact is made. The Divisional Management triumvirate will be responsible for delegating these tasks where appropriate, usually to the most senior clinician involved in the patient s care. See the Being Open Policy.

19 13. Communication with many affected individuals It is acknowledged that on occasion, particularly where many patients have been involved or the incident has come to light some months later, it may not be possible to inform the individuals affected prior to the media becoming aware, although it will be the responsibility of the Divisional Management Triumvirate to ensure every effort to do has been demonstrated. There may be circumstances where there are multiple enquiries needing to be responded to, or a complex, high profile incident needing well coordinated action planning and implementation. In these events hotline arrangements will be implemented. 14. Liaison with other interested parties 14.1 Official bodies It is the responsibility of the Chief Nurse / Medical Director to determine whether external bodies are to be involved in the investigation, based on the detail of the incident itself. It will be the responsibility of the Lead Director to inform and involve any organisation as appropriate; this may include one or more of the following: Professional body, e.g. NMC, GMC, HCPC Health and Safety Executive GPs (particularly if the incident involves many patients), NHS England, CCG, other NHS Trusts and DH where applicable. NHS Litigation Authority/ Trust legal Advisors Police/ Coroner/ Social Services Medicines and Healthcare products Regulatory Agency Public Health Bodies (e.g. SHOT, MHRA) Local Supervising Authorities for a maternal death Child Protection Agency N.B: This list is not exhaustive Communications with Media In circumstances where there is actual or anticipated media interest in an incident, then the Director of Communications will be responsible for dealing with the Trust s response to the media, in conjunction with the Chief Executive and the Communications team. It will be the responsibility of the Director of Communications to make every effort to ensure staff are briefed on how to deal with the media should they be approached. 15. Root Cause Analysis All serious incidents requiring investigation will undergo Root Cause Analysis (RCA). In addition adverse trends that are identified as part of the trends analysis of incidents may also trigger a more in-depth RCA investigation. The Root Cause investigating team will be responsible for: Determining the conduct of the investigation and agreeing terms of reference for the investigation with the appropriate Divisional Management Triumvirate;

20 Applying Root Cause Analysis methodology to identify all the care management problems including as appropriate: Requesting written accounts from relevant persons for the purpose of the investigation, Interviewing relevant persons, the staff member must be given a copy of the interview notes for them to read, sign, date and time; Setting up a round table RCA meeting to review the incident; Providing a chronology of events; Providing a draft report within 4 weeks of notification of the incident occurring; Providing a final report within 6 weeks, in the accepted Trust format, that identifies the specific and general contributory factors and indicates any issues to be addressed (or recommendations) for action by the appropriate Divisional Management Team to prevent recurrence; Providing update reports on progress with the investigation to the relevant Divisional Management Team and Divisional Management Triumvirates; and The Divisional Management Team are responsible for ensuring feedback is given to the staff and the patient/family involved in the incident highlighting the care and service delivery problems identified. Where an incident involves another organisation the Risk Management Team will be responsible for liaising with the other organisation to ensure that they are aware of any matters which they may need to investigate. 16. Risk Reduction Measures Development and Monitoring of Action Plans for SIRI Following completion of an investigation where a patient has suffered serious injury or death or the incident is a never event (excluding deaths associated with hospital acquired infections e.g. MRSA and Clostridium Diff and injuries related to falls and pressure ulcers), the Lead Investigator will prepare and circulate a template action plan populated with the issues to be addressed, for completion by the relevant Divisional Management Team. The Divisional Management Team will be responsible for identifying actions in response to the identified issues to be addressed. This action plan will be developed and presented at the Serious Incident Panel by the Divisional Management Team at the scheduled meeting to ensure a timely response to the issues identified, in line with the National Framework (NPSA 2010). The Divisional Management Team will take ownership of the action plan(s) and ensure the implementation is closely monitored. For cross Divisional issues, the action plans will be disseminated to the Divisional Management Teams with specific reference to the actions to be taken within each Division and what action is being taken at a Corporate level. Where a patient has suffered serious injury or death or the incident is a never event the Divisional Management Team, where the incident occurred, will be responsible for presenting the action plan at Serious Incident Review Group. The Divisional Management Teams are responsible for ensuring the actions are developed to address the issues identified in collaboration with the staff members responsible for the implementation of the actions. The plans must indicate the actions to be taken, the timescale for the actions to be completed, the relevant leads for the actions and any update on progress.

21 The Divisional Management Teams must identify a named individual in the Division with overall responsibility for monitoring the action plan and ensuring that the actions are completed within the agreed timescales. Effective and timely implementation of actions is required to ensure that lessons are learned following a serious incident requiring 17. Safekeeping of the Records of the Investigation The Risk Management Team will be responsible for ensuring the safekeeping of collated information and reports, including the original notes or photocopies if notes are still needed for patient care, and imaging if necessary. 18. Disciplinary Action The Trust recognises that the most incidents occur as a result of an accumulation of a number of factors and events all conspiring together. Staff should be encouraged to report incidents without fear of disciplinary action in a culture of learning and fair blame. Fear of disciplinary action may defer staff from reporting a serious incident. The view of the Trust is that disciplinary action should not form part of a response to an incident except in cases where one or more of the following apply: Where in the view of the Trust, and / or any professional registration body, the actions causing the incident / arising from the incident were far removed from acceptable practice Where there was intent to harm and / or criminal offence has taken place Where there is failure to report an incident in which the member of staff was either involved or about which they were aware To ensure a robust and consistent approach to incident investigation, the Trust must use the NPSA s Incident Decision Tree (IDT) which can be found at Training Risk management, Patient Safety and Health and Safety training needs are identified in the Trust Training Needs Analysis. Managers and Staff must ensure they undertake the required training as required by their position in the Trust. This applies to both those employed under contract or on the premises in any other circumstance e.g. as a volunteer. 20. Monitoring & Review of Incident Reporting & Investigation Policy The Incident and Serious Incident Reporting and Management Policy will be monitored for effectiveness by the following processes: Incident reviews at monthly Divisional Governance and Quality Group Meetings Review of NRLS Feedback Reports Quarterly incident trend analysis reports to the Quality and Safety Group and the Patient Safety, Quality and Risk Committee, Trist Leadership Executive Committee and the Trust Board Internal Audits of the Incident Reporting Process

22 21. Key Related Documents (not an exhaustive list) Being Open Policy Child Protection Procedures Claims Handling Policy Complaints Policy Datix Policy Freedom of Speech Policy Health & Safety Policies Human Resources Policies Infection Control Manual Medicines Policies Policy for Safeguarding Adults Raising Concerns at Work Risk Management Strategy Trust Record Management Policy Also: Risk Management Intranet Site 22. References Serious Incident Framework, NHS Commissioning Board 2013 Health and Safety Executive: RIDDOR - Reporting of Injuries, Diseases and Dangerous Occurrences Regulations The Local Supervising Authority Midwifery Officer s, Annual Report, (April 2011 March 2012) NPSA Information Resource to support the reporting of Serious Incidents (2010) Environmental Permitting (England & Wales) Regulations (2010) National Framework for Serious Incidents Requiring Investigation (2010) World Health Organisation: The Conceptual Framework for the international Classification for Patient Safety. (2009) Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations (2009) National Patient Safety Agency: Being Open: Communicating patient safety incidents with patients and their carers (2005) Root Cause Analysis Toolkit National Patient Safety Agency (2004) Seven Steps to Patient Safety National Patient Safety Agency (2004) Ionising Radiation (Medical Exposures) Regulations 2000 Ionising Radiations Regulations 1999 Health & Social care act 2008 (regulated activities) regulation 2009 Corporate Manslaughter Act 2007 Criminal Justice Act 2003 Health and Safety at Work Act 1974

23 Equality Impact Assessment Title of the policy/guidance: Incident & Serious Incidents Reporting & management Policy 1 Does the policy/guidance affect one group less or more favourably than another on the basis of: Race Ethnic origins (including gypsies and travellers) Nationality Gender Culture Religion or belief Sexual orientation Age Disability - learning disabilities, physical disability, sensory impairment and mental health problems 2 Is there any evidence that some groups are affected differently? 3 If you have identified potential discrimination, are any exceptions valid, legal and/or justifiable? 4 Is the impact of the policy/guidance likely to be negative? (If no, please go to question 5) If so can the impact be avoided? What alternatives are there to achieving the policy/guidance without the impact? Yes/No No No No No No No No No No No No NO N/A N/A Comments Can we reduce the impact by taking N/A different action? 5 Please consider the following questions relating to Human Rights Act: Will it affect a person s right No to life? Will someone be deprived of their liberty or have their No security threatened? Could this result in a person being treated in a degrading or inhuman manner? Is there a possibility that a person will be prevented from exercising their beliefs? Will anyone s private and family life be interfered with? No No No

24 Appendix: 1 Steps to be taken when a serious incident occurs simplified flowchart Incident occurs, immediate actions taken and to ensure safety Inform manager and report on Datix Inform Patient If SI, report to CCG via STEIS and to other relevant organisations if necessary (e.g. TDA for grade 2 SIs) within two working days of incident being identified. Initiate Trust SI Process to decide whether incident meets SI criteria Update STEIS after 72 hours if any significant changes occur Investigation team clarified and scope of investigation determined. Dates for submission of Final Report to CCG set; within 45 days for Grade 1 and 60 days for Grade 2 Undertake investigation keeping the patient and/or family updated. SI Panel convened to ensure investigation is robust and actions plan is SMART Risk and Governance team to provide support throughout investigation Obtain Executive approval for RCA investigation final report Submit incident report and action plan to CCG Commissioner signs of incident as closed Implement action plan Share learning if appropriate Review implementation of actions

25 Appendix :2 Serious Incident Categories Guidance Serious Incident category Abuse of Adult Description The abuse of an adult described in No secrets. This includes: Death of a vulnerable adult where abuse or neglect is suspected to be a factor in the death; When a vulnerable adult has suffered significant injuries suspected to be as a result of abuse; Where a vulnerable adult has suffered further harm as a result of a health care worker failing to follow procedures Blood Transfusion Children Emergency Plan invoked Health Protection (Note: outbreaks, serious incidents of Serious adverse reaction: Any unintended response in a donor or in a patient that is associated with the collection, or transfusion of blood or blood components that is fatal, life-threatening, disabling or incapacitating, or results in or prolongs hospitalisation or morbidity. Serious adverse events Any untoward occurrence associated with the collection, testing, processing, storage and distribution, of blood or blood components that might lead to death or life-threatening, disabling or incapacitating conditions for patients or which results in or prolongs hospitalisation or morbidity. Microbiological contamination of transfusion leading to major morbidity or death. Incorrect blood component transfused leading to serious incident or death DRAFT 1 - Jan 2014 factor in the death Significant harm to a child where reported under the local child protection procedures. This could be defined as:- a child death where abuse or neglect is suspected to be a when a child has suffered significant injuries suspected to be as a result of child abuse where a child has suffered further harm as a result of a health care worker failing to follow procedures unexplained child death in a health care setting unexplained death of more than one sibling when a serious case review is to be undertaken children and adults with complex health needs failing to obtain their assessed and agreed packages of health care, thus putting their health at serious risk Multiple attendances at A&E for a single child or more than one sibling; Death of a child on a protective register Adverse incident that would invoke an emergency plan (affecting business continuity including multiple ward closure due to infection, serious damage to occupied NHS property through fire, flood or criminal damage, IT failure (for terrorist activity see separate section). Wilful damage to property, destruction and vandalism. Major outbreaks, serious incidents of communicable disease or exposure to environmental hazards caused by healthcare failures or other NHS system failures that have put patients/staff at harm/risk of harm or restrict service delivery e.g.: outbreaks of infection that involve presumed transmission within healthcare settings (acute, community) e.g. norovirus, Clostridium

26 Appendix :2 Serious Incident Categories Guidance communicable disease and other health protection incidents that are not related to failures of healthcare remain reportable to the Health Protection Agency (HPA) in line with statutory responsibilities and other HPA guidance and agreements). Information technology Medical Devices Medicines and serious adverse drug reactions Medico-legal incidents/litigation difficile, Panton-valentine leukociden (PVL) positive, Methicillin Resistant Staphylococcus Aureus (MRSA) etc cases/outbreaks of infection with an NHS-attributable food, water or environmental source e.g. nosocomial legionnaires' disease, salmonella outbreak etc case of blood borne virus (hepatitis B, C, HIV), TB etc. infection in a healthcare worker that necessitates consideration of a look-back exercise case of infection in a patient to whom others have been exposed that necessitates consideration of a look-back exercise failed vaccination cold chain failed sterilisation of instruments an outbreak e.g. of viral gastroenteritis, necessitating ward closures to new patients and resulting in significant restrictions of hospital activity a confirmed death of a patient due to hospital acquired infection including MRSA and C. difficile exposure to chemical agents or radiation caused by failures in healthcare settings an outbreak/health protection incident that is poorly managed, resulting in harm From February 2007, the Department of Health has required mandatory reporting by Acute Trusts of each case of Methicillin- Resistant Staphylococcus Aureus (MRSA) bacteraemia as a serious incident. The mechanism for this is separate from STEIS and requires the completion of an reporting pro forma to the Strategic Health Authority. DRAFT 1 - Jan 2014 Systems failure leading to serious outcomes. Data loss resulting in severe breach of confidentiality. those which could attract media attention. Cancellation of surgery by the Trust for a patient on more than three occasions. Serious fraud or security-related media matters (to be reported to NHS SMS). Any serious harm to staff or patients involving medical equipment whether due to human error or due to equipment found to be or suspected of being faulty or to have failed e.g. hoist collapsing, defibrillator failing. Any medical device-related incident that causes, or has the potential to cause, unexpected or unwanted effects involving the safety of device users (including patients) or other persons. Suspected or actual serious side effects or adverse drug reactions (ADRs) from a medicine, be it:- prescription medicines herbal remedies over-the-counter (OTC) medicines counterfeit medicines causing harm or potential harm Suspicion of large scale theft or any incident that might give rise to serious criminal charges. Potential legal claims against the hospital regarding a serious incident. Potential legal claims against the hospital or Department of Health that may affect national policy. Impending court hearing or out of court settlement in cases of large

27 Appendix :2 Serious Incident Categories Guidance scale litigation, including negligence claims (as defined by the NHS Litigation Authority [NHSLA], large scale claims are considered to be those over 250,000). Mental health, substance misuse and incidents involving learning disabilities Mental health, substance misuse and learning disabilities (staff related) Mortality/ Morbidity/ Care incidents A serious offence including homicide committed by an individual in receipt of mental health and/or learning disability services. Patients detained under the Mental Health Act 1983 who are absent without leave from health services and who present a serious risk to themselves and/or others. Specific national guidance governs incidents such as homicides and other serious incidents involving mentally ill people (Health Service Guidance 94, 27) Arrangements for dealing with major incidents (Health Service Circular 98, 197). The criteria set out below will at times duplicate the criteria already stated but they are included to remind those delivering mental health services of the need to report them:- the absence without leave of a patient detained under the Mental Health Act 1983 where there is serious cause for concern patient/s receiving inpatient care in secure accommodation who go missing (but not detained under the Mental Health Act 1983) homicide or suspected DRAFT 1 - Jan 2014 homicide by a patient who has received mental health services. NB if it occurs within six months of receiving treatment, this triggers the setting up of an independent inquiry as described in Chapter 3.4: Investigation all deaths within secure settings (to be dealt with as a death in custody) all deaths of persons who are subject to the Mental Health Act 1983 or equivalent legal restriction who has or is receiving care and treatment from the mental health services:- - any serious criminal acts involving patients - an incident that causes serious harm or injury or places life in jeopardy whether by a patient, staff or visitor in mental health and learning disability services - admission of a child under 18 to an adult mental health ward - an inpatient who is missing from the ward who is considered a risk to themselves or others - an episode of restraint that does not comply with national or local trust policy A serious offence involves an assault of staff by patients, causing: - serious harm or injury to staff or - places life of staff members in jeopardy - death or serious injury to staff occurs - a member of staff is a victim of abuse - a security issue Clusters of unexpected or unexplained deaths. Where the death results in adverse comments from a coroner. Maternity: maternal deaths, neonatal deaths and unexpected stillbirths. The suicide of any person currently in receipt of NHS services on or off NHS premises, or who has been discharged within the last twelve months. Suicide is defined as death:- where there is obvious evidence or strong suspicion of self harm where the above does not apply initially but emerges later from a clinical review of the case, or discussion at the incident monitoring group

28 Appendix :2 Serious Incident Categories Guidance where the Coroner s verdict is suicide (or open verdict) Death or injury where foul play is suspected. Situations when a patient requires additional intervention(s) as a result of failures in the assessment or diagnosis process. The accidental death of, or serious harm to, a patient, a member of staff, or visitor on NHS or primary care premises, or involving NHS or primary care staff or equipment. Out of county critical care transfers or any other transfer that could have resulted in a serious untoward incident. Abuse that has been perpetrated within the remit of the organisation; this may be abuse by a member of staff, visitor or member of the public. Grade 3 and above pressure sores Premises/ Equipment incidents Professional misconduct Screening programmes Serious damage that occurs on the premises of NHS, primary care, or independent sector premises providing NHS work, serious damage to property belonging to NHS or primary care, or any incident that results in serious injury to any individual or serious disruption to services (such as evacuation of patients due to fire). Failure of equipment so serious as to endanger life, whether or not injury results. Suspicion of malicious activity, such as tampering with equipment. Circumstances that lead to the provider organisation no longer being able to provide an element of service and not reportable through situation reports (SITREP) (such as closure of caseloads to new referrals). DRAFT 1 - Jan 2014 Allegations of serious professional misconduct. An actual or possible failure of the screening service that has consequences for the clinical management of patients e.g. loss of test results, failure to detect cancers, incorrect notification of results to a patient or groups of patients. The screening programmes which are covered are:- breast cancer cervical screening bowel cancer diabetic retinopathy abdominal aortic aneurysm - fetal anomaly infectious diseases in pregnancy sickle cell and thalassaemia newborn blood spot newborn hearing newborn and Infant Physical Examination Staff-related incidents Serious complaints about a member of staff or primary care contractor or any incident relating to a staff member where adverse media interest could occur. Any serious criminal acts involving patients or staff. Suspicion of a serious error or errors by a member of staff, primary care contractor or other healthcare contractor. Where a member of staff is suspected of harming patients. A serious drug error, such as mal-administered spinal injections. Where professional competence is in question (see NPSA Incident Decision Tree). A serious breach of confidentiality.

29 Appendix :2 Serious Incident Categories Guidance Where a member of staff is suspected of committing serious fraud. The exclusion of employed doctors or dentists under the NHS Trust disciplinary procedures that refer to High Professional Standards in the Modern NHS: a framework for the initial handling of concerns about doctors and dentists in the NHS (HSC 2003/12). Significant disciplinary matters of other staff. Serious verbal and/or physical aggression. Where a member of staff shows gross disrespect for the dignity of a patient/deceased patient Terrorism and chemical, biological, radiological or nuclear (CBRN) incidents Unexpected death, serious harm or injury Included in this criteria: Clusters of lesser harm incidents in a single organisation Violence towards health care staff Any act of terrorism is normally covered under the Major Incident Policy and will therefore have a comprehensive list of definitions. Generally, the following incidents must be reported:- terrorist threats/incidents which include incendiary devices or the use of other weapons including chemical, biological, radiological or nuclear agents (CBRN) potential or confirmed chemical, biological, radiological or nuclear agents (CBRN) incident DRAFT 1 - Jan 2014 incident framework should be followed in conjunction with the national Patients, individuals or groups of individuals suffering serious or catastrophic harm or unexpected death whilst in receipt of health services, including screening and immunisation/radiation errors and equipment failures. Serious injury or unexpected death of any individual to whom the organisation owes a duty of care including staff, visitor, contractor or any other person. Counter Fraud and Security Management Service (CFSMS) in the case of fraud and violence to staff. In such circumstances this serious guidance. Serious violence/death of healthcare worker.

30 Appendix-3 Types of RIDDOR Incidents Death or Major Injury Over Seven Day Injury Disease Dangerous Occurrence If there is an accident at work and: Employee, or self employed person working on Trust premises is killed or suffers a major injury A member of the public is killed or taken to hospital as a result of a major injury If there is an accident connected with work (including an act of physical violence) and the employee, or a self employed person working on Trust premises, suffers an over-seven-day injury If a doctor notifies an employee that they are suffering from a work-related disease then this needs to be reported. If something happens which does not result in a reportable injury but could have. It may be a dangerous occurrence, which must be immediately reported to the enforcing authority Example definitions of a Major Injury Fracture other than to fingers, thumbs or toes Amputation Dislocation of the shoulder, hip, knee, or spine Injury resulting from an electric shock or electric burn leading to unconsciousness or requiring resuscitation or admittance to hospital for more than 24 hours Loss of sight (whether temporary or permanent). A chemical or hot metal burn to the eye or any penetrating injury to the eye. Definition of an over-seven -day injury An injury which is not major, but results in the injured person being away from work or unable to do the full range of their normal duties for more than seven days (including any days they wouldn t normally be expected to work such as weekend, rest days, or holidays) not counting the day of the injury itself. There may be cases when reportable injuries or conditions resulting from an accident will either be: A) Unrecognisable without medical examination, which is conducted after some time B) Delayed for some time after the accident For example if a member of staff has an incident and comes back to work for a day, but then goes sick or cannot carry out their full range of duties as a direct result of the incident for 7 or more days. Example definitions of a Disease Inflammation, ulceration or malignant disease of the skin due to ionising radiation. Physically demanding work causing severe or prolonged friction or pressure on the hand.( Bursitis or subcutaneous cellulites) Physically demanding work, frequent or repeated movements, constrained postures or extremes of extension or flexion of the hand or wrist. (Traumatic inflammation of the tendons) Carpal tunnel syndrome. Hand-arm vibration syndrome. Infections due to biological agents Hepatitis. Legionellosis Infections due to biological agents Example definitions of a Dangerous Occurrence The collapse of, the overturning of, or the failure of any load-bearing part of any crane, lift, hoist, access platform etc Failure of any closed vessel / pressure system Electrical Short circuit overload Malfunction of radiation generators (fixed or mobile radiology equipment) Collapse of Scaffolding Incidents in respect of a pipeline or pipeline works Any accident or incident which resulted or could have resulted in the release or escape of a biological agent likely to cause severe human infection or illness. Collapse of building or structure (unintended collapse or partial collapse) Escape of flammable substances Under RIDDOR it is an offence to fail to report a reportable event or to fail to report within the specified periods. Immediately Reportable Events All incidents resulting in Death or Major injury or acute illness are to be notified by the Health and Safety Advisor to the Health and Safety Executive (HSE) by the fastest practicable means, i.e. by telephone or via DatixWeb. The above list of incidents is not exhaustive see HSE website for more information.

31 Appendix Never Events List Never events are a sub-set of Serious Incidents and are defined as serious, largely preventable patient safety incidents that should not occur if the available preventative measures have been implemented by healthcare providers 1. Wrong site surgery 2. Wrong implant/prosthesis 3. Retained foreign object post-procedure 4. Wrongly prepared high-risk injectable medication 5. Maladministration of a potassium-containing solution 6. Wrong route administration of chemotherapy 7. Wrong route administration of oral/enteral treatment 8. Intravenous administration of epidural medication 9. Maladministration of Insulin 10. Overdose of midazolam during conscious sedation 11. Opioid overdose of an opioid-naïve patient 12. Inappropriate administration of daily oral methotrexate 13. Suicide using non collapsible rails 14. Escape of a transferred prisoner 15. Falls from unrestricted windows 16. Entrapment in bedrails 17. Transfusion of ABO-incompatible blood components 18. Transplantation of ABO incompatible organs as a result of error 19. Misplaced naso- or oro-gastric tubes 20. Wrong gas administered 21. Failure to monitor and respond to oxygen saturation 22. Air embolism 23. Misidentification of patients 24. Severe scalding of patients 25. Maternal death due to post partum haemorrhage after elective caesarean section Full details of the specific exclusions and detailed guidance may be found at:

32 Appendix 5 A guide to serious incident grading for investigation purposes This table provides a guide as to the grading of serious incidents for investigation purposes. Action required Notification only it is unclear if a serious incident has occurred. GRADE 0 GRADE 1 The organisation must update the CCG/NHS ENGLAND with further information within three working days of a grade 0 incident being notified. If within three working days it is found not to be a serious incident, it can be downgraded with the agreement of the accountable NHS ENGLAND/CCG. If a serious incident has occurred it will be re-graded as a grade 1 or 2. Action required Commissioning CCGs will monitor the case and report findings, recommendations and associated action plans to the NHS ENGLAND. NHS ENGLAND will monitor progress on a quarterly basis with CCG unless earlier discussion is required or the serious incident regarded. 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 reports within Annual Reports. Timescales: Up to 45 working days/9 weeks from the date the incident is notified to the CCG Examples of cases HCAI outbreaks Avoidable/unexplained death Data loss and information security (DH Criteria level 1) Grade 3 pressure ulcer develops Poor discharge planning causes harm to patient

33 Appendix 5 A guide to serious incident grading for investigation purposes This table provides a guide as to the grading of serious incidents for investigation purposes. Action Required Case will be monitored by the NHS ENGLAND/CCG/LA in conjunction with the provider organisation. GRADE 2 The Local Area Team/CCG/LA will review findings, recommendations and associated action plans. For Never Events, the commissioning CCG will be obliged to monitor. Comprehensive Investigation (as above) or Independent Investigation Monitoring required NHS ENGLAND/CCG monitoring Incidents leading to an independent investigation or inquiry or those considered high risk will continue to be monitored by the Local Area Team/CCG/LA or Local Authority until evidence is provided that each action point has been implemented. Incidents involving adult or child abuse are referred to local safeguarding. 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 NHS ENGLAND/CCG Examples of cases Data loss and information security (DH Criteria level 2 or higher: see IG SIRI categorisation below) Never Events Accusation of physical misconduct or harm is made

34 Appendix 5 A guide to serious incident grading for investigation purposes This table provides a guide as to the grading of serious incidents for investigation purposes. Incident grade 1 2 Example incidents Investigation grade and action Timeframe Commissioner responsible Apparent suicide of people currently under the care of community mental health services. Mental health inpatient attempted suicides. Avoidable or unexplained death. Failure to meet standards for ambulance service response times, resulting in patient death/severe harm HCAI outbreaks. Grade 3 and 4 pressure ulcers. Data loss & information security (DH Criteria level 1). Adult safeguarding incident. Inpatient suicides (including following absconsion) Maternal deaths Child protection incidents Never Events Accusation of physical misconduct or harm Data loss and information security (DH Criteria level 2 or higher) Selected Grade 2 incidents: The need for independent investigations is identified and arranged by the commissioner or Investigation Level 1 Concise root cause analysis (RCA) for incidents involving No Harm and Low Harm and/or where the circumstances are very similar to other previous incidents. In these cases it is more proportionate to use a concise RCA to ensure there are no unique factors and then focus resources on implementing improvement than conducting comprehensive investigations that will not produce new learning. These will be a small minority of cases. Investigation Level 2 Comprehensive RCA for incidents involving moderate and severe harm or death. This should be the default level for most incidents Investigation Level 2 Comprehensive RCA (note NHS trusts should directly notify the NTDA of Grade 2 serious incidents) Investigation Level 3 Independent RCA (note NHS trusts should directly notify the NTDA of Grade 2 serious incidents) Following initial reporting within 2 working days, the provider organisation must submit a completed investigation within 45 working days Following initial reporting within 2 working days, the provider organisation must submit a completed investigation within 60 working days Following initial reporting within 2 working days independent Seek assurance and evidence from the provider that relevant policies and procedures are in place and implemented, for example by reviewing a sample of incident investigations and action plans as well as monitoring serious incident data trends. Close incidents after receipt of evidence demonstrating that local monitoring arrangements are in place to ensure action points are going to be implemented. Likely to involve specific assistance with and contribution to the incident response and investigation. Close incident after receipt of evidence demonstrating that each action point has been implemented is required. As for Grade 2 above but in addition, commissioning the independent investigation.

35 Appendix 5 A guide to serious incident grading for investigation purposes This table provides a guide as to the grading of serious incidents for investigation purposes. NHS CB, for example a major system failure with multiple stakeholders. Homicides following recent contact with mental health services require an independent investigation. These will be commissioned by the relevant NHS CB area team. investigators should be commissioned to complete an investigation within 6 months

36 Appendix: 6Assessing the Severity of the Information Governance Incidents The following process should be followed to categorise an IG SIRI (from the IG SIRI guidance, June 2013) Step 1: Establish the scale of the incident. If this is not known it will be necessary to estimate the maximum potential scale point. Baseline Scale 0 Information about less than 10 individuals 1 Information about individuals 1 Information about individuals 2 Information about individuals 2 Information about individuals 2 Information about 501 1,000 individuals 3 Information about 1,001 5,000 individuals 3 Information about 5,001 10,000 individuals 3 Information about 10, ,000 individuals 3 Information about 100,001 + individuals Step 2: Identify which sensitivity characteristics may apply and the baseline scale point will adjust accordingly. Sensitivity Factors (SF) modify baseline scale Low: For each of the following factors reduce the baseline score by 1-1 for each No clinical data at risk Limited demographic data at risk e.g. address not included, name not included Security controls/difficulty to access data partially mitigates risk Medium: The following factors have no effect on baseline score 0 Basic demographic data at risk e.g. equivalent to telephone directory Limited clinical information at risk e.g. clinic attendance, ward handover sheet High: For each of the following factors increase the baseline score by 1 Detailed clinical information at risk e.g. case notes Particularly sensitive information at risk e.g. HIV, STD, Mental Health, Children One or more previous incidents of a similar type in past 12 months Failure to securely encrypt mobile technology or other obvious security failing Celebrity involved or other newsworthy aspects or media interest +1 for each A complaint has been made to the Information Commissioner Individuals affected are likely to suffer significant distress or embarrassment Individuals affected have been placed at risk of physical harm Individuals affected may suffer significant detriment e.g. financial loss Incident has incurred or risked incurring a clinical untoward incident

37 Appendix: 6Assessing the Severity of the Information Governance Incidents Step 3: Where adjusted scale indicates that the incident is level 2, the incident will be reported to the ICO and DH automatically via the IG Incident Reporting Tool. Final Score Level of SIRI 1 or less Level 1 IG SIRI (Not Reportable) 2 or more Level 2 IG SIRI (Reportable) Example Incident Classification A B C D Health Visitor data inappropriately disclosed in response to an FOI request. Data relating to 292 children, detailing their client and referral references, their ages, an indicator of their level of need, and details of each disability or impairment that led to their being in contact with the health visiting service e.g. autism, chromosomal abnormalities etc. Baseline scale factor 2 Sensitivity Factors -1 Limited demographic data 0 Limited clinical information +1 Particularly sensitive information +1 Parents likely to be distressed Final scale point 3 so this is a level 2 reportable SIRI Imaging system supplier has been extracting PID in addition to non-identifying performance data. A range of data items including names and some clinical data and images have been transferred to the USA but are being held securely and no data has been disclosed to a third party. Baseline scale factor 3 (estimated) Sensitivity Factors -1 Limited demographic data 0 Limited clinical information -1 Data held securely +1 Sensitive images +1 Data sent to USA deemed newsworthy Final scale point 2 so this is level 2 and is reportable SIRI Information about a child and the circumstances of an associated child protection plan has been faxed to the wrong address. Baseline scale factor Sensitivity Factors -1 No clinical data at risk 0 Basic demographic data +1 Sensitive information +1 Information may cause distress Final scale point 1 so this is a level 1 SIRI and not reportable Subsequent to incident c the same error is made again and the recipient this time informs the Trust she has complained to the ICO. Baseline scale factor 0 Sensitivity Factors -1 No clinical data at risk 0 Basic demographic data +1 Sensitive information +1 Information may cause distress +1 Repeat incident +1 Complaint to ICO 1 Final scale point 3 so this is a level 2 reportable SIRI

38 Appendix: 6Assessing the Severity of the Information Governance Incidents E F G H Two diaries containing information relating to the care of 240 midwifery patients were stolen from a nurse s car. Baseline scale factor 2 Sensitivity Factors 0 Basic demographic data 0 Limited clinical information Final scale point 2 so this is a level 2 reportable SIRI A member of staff took a ward handover sheet home by mistake and disposed of it is a public waste bin where it was found by a member of the public. 19 individual s details were included. Baseline scale factor 1 Sensitivity Factors -1 Limited demographic data 0 Limited clinical information +1 Security failure re disposal of data Final scale point 1 so this is a level 1 SIRI and not reportable A filing cabinet containing CDs with personal data relating to several thousand members of staff sent to landfill in error during an office move. Baseline scale factor 3 Sensitivity Factors -1 No clinical data at risk -1 Landfill unlikely to be accessed 0 Basic demographic data +1 Security failure (no encryption & poor disposal) 2 Final scale point 2 so this is a level 2 reportable SIRI Loss of an individual s medical records. The records were found to be missing when the patient concerned made a subject access request. Baseline scale factor 0 Sensitivity Factors 0 Basic demographic data +1 Detailed clinical information +1 Patient distressed +1 Complaint to ICO Final scale point 3 so this is a level 2 reportable SIRI

39 Appendix: 7Device Incident Management Reporting a defect or incident Incidents involving equipment will be reported in the same way as any other incident. The equipment will be withdrawn from service immediately, quarantined, labelled Defective Do Not Use and handed over to Clinical Engineering Department for further investigation. Whenever practicable the device controls and settings should remain in the same position as when the incident occurred and all relevant information must be documented. Until the MHRA has been given the opportunity to carry out an investigation, they will not be: Discarded Repaired Returned to the manufacturer They will be: Clearly identified and labelled Stored securely MHRA The Medicines and Healthcare products Regulatory Agency (MHRA) is the executive agency of the Department of Health charged with protecting and promoting public health and patient safety by ensuring that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and effectiveness, and that they are used safely. One way they aim to achieve this is by investigating reports of adverse incidents involving medical devices and, where appropriate, instigating corrective actions to reduce the risk of recurrence. Dealing with the manufacturer The manufacturer or supplier should be informed promptly of incidents and, if accompanied by an appropriate person, may be allowed to inspect the items this will be coordinated by the Lead investigator. To facilitate an investigation, it may be possible to provide the manufacturer with a sample of unused stock from a large batch. However, until advised to the contrary by the MHRA, the manufacturer must not be allowed to exchange, interfere with, or remove any part of the product implicated in the incident as this might prejudice our investigations, or those of other official bodies.

40 Appendix:8 Serious Incident Process Radiation accidents and incidents may be reportable to a variety of external organisations. Advice should always be sought from the Regional Radiation Protection Service. Health & Safety Executive (HSE) The following circumstances may be reportable to the HSE: If any member of staff or public receives a dose above a dose limit (IRR Reg. 25). If a patient receives a dose "much larger than intended" due to an equipment failure/malfunction (IRR Reg. 32(6)). See Appendix 4 If an unauthorised amount of a radioactive substance is released into the environment (IRR Reg. 30 (1)). If a radioactive substance is lost or stolen (IRR Reg. 30 (3)). If a gamma irradiation source (e.g. in radiotherapy) fails to return to the safe position at the end of an intended exposure (RIDDOR Reg. 3(c) Schedule 8 (1b)). Notification to HSE can be via at:[email protected] Or in writing: HSE East Grinstead Office, Phoenix House, Cantelupe Road, East Grinstead, West Sussex, RH19 3BE. Tel: Fax: Care Quality Commission (CQC) The following circumstances may be reportable to the Care Quality Commission (CQC): A patient receives a dose much larger than intended due to a unacceptable practice, e.g. a procedural error. (IRMER Reg. 4(5)). The wrong patient is irradiated. Notifications for IRMER incidents should be via the online form at and ofionisingradiation/reportingincidents.cfm Environmental Agency (EA) The following circumstances must be reported to the EA: If an unauthorised amount of a radioactive substance is released into the environment. If a radioactive substance is lost or stolen. (The police must also be informed) Department for Transport (DfT) The following circumstances must be reported to the DfT: As required by the Carriage of Dangerous Goods, the following circumstances may be reportable to the DfT (Radioactive Materials Transport Division) and Police: Suspected loss, escape or theft of radioactive material or damage to the package in transit A vehicle transporting radioactive material is overturned, seriously damaged or involved in a fire If any package of radioactive material can not be delivered.

41 Appendix:8 Serious Incident Process Potential SI identified Inform manager and report on Datix as with all other incidents Contact SI Coordinator ASAP via phone call AND Mon-Fri 9am-5pm contact SI Coordinator on ext: 8210 For Out of Hours contact the On-Call Manager via the Switchboard SI Decision Meeting coordinated by SI Coordinator SI Decision Meeting held at 9.00am every weekday morning chaired by Chief Nurse or Medical Director. All SIs from the previous day before 3pm or over the weekend will be discussed at this meeting. SIs identified overnight will be discussed the following day. Attendees at SI Decision Meeting, minimum 3 people: -Chief Nurse/Medical Director - Divisional/ Directorate Representative from Division/Directorate incident declared. If query over which Division responsible, representatives from each expected. -Member of Quality and Safety Team -SI Coordinator to complete SI Decision Template -Divisional Risk Lead if possible SI Decision Meeting SI Decision Template to be completed showing reasoning for SI being declared or not and clarifying further information needed to complete an investigation e.g. Scope, Terms of Reference and Being Open Lead. Investigations for Externally and Internally Declared SIs will use the Trust s Root Cause Analysis Template and the NPSA s toolkit SI Decision Meeting will set a date for the SI Panel that will review the SI RCA Investigation Report to and approve it can be submitted to CCG. The SI Panel will meet as soon as possible after the Final RCA report completed therefore giving another possible 3/4 weeks depending on grade, for further investigation and re-writing. RCA Lead Investigator and co-investigator chosen from Trust list of trained investigators. The Lead Investigator should be someone from outside of the speciality where the incident occurred. A subject matter expert should be co-opted to the investigation as required. The Lead Investigator to provide 72 hour report to SI Coordinator to update STEIS. Further Process and Closure SI Coordinator to report SI on STEIS within 48 hours of knowledge of Incident. SI Coordinator to report on STEIS the 72 hour update if necessary. Risk and Governance Team to provide support to investigators. SI Panel will provide scrutiny and challenge to RCA Investigation Report and recommend changes made before submission to CCG. SI Coordinator will clarify timescale for changes to be made and to request extension from CCG if necessary. If SI Panel require changes, executive sign off may be given virtually or another panel reconvened if necessary. Once the Final RCA Investigation Report has been signed off by either the SI Panel or Chief Nurse or Medical Director post changes, the SI Coordinator will submit Report to CCG. If CCG require changes, SI Coordinator will facilitate timescales and sign off will be given by another panel if necessary of virtually by Chief Nurse or Medical Director. Once the RCA Final Report is accepted by the CCG and is closed on STEIS the SI Coordinator will inform the Division.

42 Appendix:8 Serious Incident Process SI Panel Process SI Panel: o Chair Medical Director or Chief Nurse o Investigation Lead o Senior Representation from Divisional/Departmental/Directorate affected i.e. Divisional Director, Divisional Manager or Head of Nursing. o Divisional Risk Lead o Member of Corporate Governance team o Minutes/Notes to be taken by SI Coordinator Remit of the SI Panel: To review the RCA final report to gain assurance that the root cause(s) have been found, there are clear lessons learnt, the recommendations are robust and the Action Plan is SMART. Checklist - an appropriate investigation that identifies findings, based on root causes and recommendations; - a satisfactory, SMART action plan with action points to address each root cause with a named lead (by job title) and timescale for implementation - evidence demonstrating that monitoring arrangements are in place to ensure action points have been or are going to be implemented; - lessons learned, including partners or stakeholders with whom the learning has been shared; - full completion of the STEIS record covering the above points e.g. date investigation completed, population of RCA/Lessons learned field; - Ensure that all staff throughout the report should be referred to by job title and an appendix should be available for internal use to identify staff - Ensure Final Report is shared in line with the Being Open Policy and Duty of Candour Note: Where necessary, for example, where actions are essentially continuous or long-term, an action plan can be considered to be implemented and grade 2 incidents can be closed when the relevant actions to address these long-term issues have been initiated. This must be subject to evidence of appropriate monitoring. Submit RCA Final Report to CCG If the RCA Final Report is approved, it will be submitted to CCG. If the SI Panel decide further work is necessary, clear recommendations will be given and a timeframe for completion. Depending on the volume of changes necessary either a secondary panel will meet or sign off can be given via . If necessary an extension will be requested from the CCG. Action Tracker The Action Plan from the Final RCA report will be tracked by the SI Coordinator and reviewed in appropriate forums