INCIDENT REPORTING POLICY GENERAL POLICY GP8

Transcription

1 INCIDENT REPORTING POLICY GENERAL POLICY GP8 Applies to: All Wirral Community NHS Trust staff Committee for Approval Quality and Governance Committee Date of Approval January 2015 Date Ratified: January 2015 Review Date: January 2018 Name of Lead Manager Governance Manager Version: V2 UNLESS THIS VERSION HAS BEEN TAKEN DIRECTLY FROM THE TRUST WEBSITE THERE IS NO ASSURANCE THIS IS THE CORRECT VERSION

2 Contents Section 1 Introduction 3 2 Purpose 4 3 Definitions 4 4 Duties within the Organisation 7 5 Responsibilities of Committees and Groups 12 6 Duty of Candour 13 7 Immediate Action following an Incident 14 8 Reporting of Incidents and Near Misses involving Staff, Patients and Others 9 Out of Hours Arrangements Reporting and Communicating to External Agencies Assigning a Risk Score Incident Investigation and Monitoring of Action Plans 16 Page Process for Low (Green) and Moderate (Amber) Incidents Risk Grading Quality Assurance Management of Serious Incidents Process for involving and communicating with external/ Stakeholders and of sharing lessons learnt 17 Analysis and Improvement How information is shared with relevant individuals and groups Staff Training Supporting Staff involved in an Incident complaint or claim Equality Impact Assessment Process for Monitoring Compliance Appendices Appendix 1 Monitoring Tool 26 2/28

3 1. Introduction This policy covers both the reporting and investigation of clinical and non clinical incidents, together with the processes for analysis and improvement. This policy should be read in conjunction with the Trust s Risk Management Strategy, Policy and Guidance document. When investigating a particular incident, the relevant Trust policy should also be consulted, for example Slips Trips and Falls Policy. The Trust s risk management system is based on an open, honest, transparent culture of learning from experience underpinned by a systematic approach to incident management. This cultural approach fully adheres to national guidance from a staff and patient perspective, including the Management of Health and Safety at Work Regulations (1999) and the Sign up to Safety campaign, which underpins the Trust s Patient Safety Strategy. The Trust aims to establish the causes of incidents, complaints and claims, understand these and make sure lessons are learnt and suitable improvements are made to minimise any further recurrence. Serious incidents in healthcare are relatively uncommon but when they do occur the NHS has a responsibility to ensure that there are systemic measures in place for safeguarding people, property, NHS resources and reputation. This includes responsibility to learn from these incidents in order to minimise the risk of them happening again. This organisation takes this reasonability very seriously and the importance of establishing a safety culture within an organisation; a reporting culture, which appreciates the significance of effective incident management. Incident reporting is a fundamental tool of risk management, the aim of which is to collect information about adverse incidents, including near misses, ill health and hazards, which will help to facilitate wider organisational learning. If incidents are not properly managed, they may result in a loss of public confidence in the organisation and a loss of assets. Reporting of incidents are more likely to take place in an organisation where there is a well developed safety culture and where there is strong leadership. The Chief Executive and Directors (including non-executives) have made their support for patient and staff safety transparent by their actions and it is clearly understood throughout the organisation that it is unacceptable to prioritise other objectives at the expense of safety. The policy also includes information on the requirements arising from the Health and Social Care Act 2008 which means that organisations are required to notify the Care Quality Commission (CQC) about events that indicate or may indicate risks to ongoing compliance with the CQC registration requirements or that lead, or may lead to changes in the details about the organisation in the Commission s register. 3/28

4 2. Purpose The purpose of this document is to ensure that all incidents, whether they have caused actual harm, or were a near miss, are reported by staff in a timely manner. This is to ensure all incidents are appropriately managed and investigated, based on their severity, and to ultimately learn and make changes as a result of incidents, complaints and claims in order to improve safety for patients, staff, visitors and contractors. Qualitative and quantitative data analysis will be used in the Quality Report to identify trends, and support on-going monitoring. Trend analysis and monitoring will be further supported by the Trust s Quality Dashboard accessible to all staff via prodacapo on staffzone. The organisation is fully committed to developing a culture of continuous and quality improvement based on the principles of openness, honesty and transparency, fully embedding the learning from national reports including the Mid Staffordshire NHS Foundation Trust Public Inquiry (2013) and A promise to learn a commitment to act (2013). In accordance with a learning culture, the organisation takes a non-punitive approach towards incident reporting based on the science of Human Factors and relevant national guidance, including the NHS serious incident and never events frameworks. 3. Definitions Incident An event or circumstance which could have resulted, or did result, in unnecessary damage, loss or harm to patients, staff, visitors or members of the public. Clinical or Patient Safety Incident is defined as any unintended or unexpected incident which could have or did lead to harm for one or more patients receiving NHS care. (NPSA, 2008). The Trust considers that the terms Patient Safety Incident (PSI) and clinical incident are synonymous. However, this policy and procedure will use the term patient safety incident. Non-Clinical Incident is defined as any event or circumstance that does not involve a patient s treatment or care which leads to, or could potentially lead to, unintended or unexpected harm, loss or damage to staff, financial loss or injure the reputation of the Trust. Near Miss is defined as any unexpected or unintended incident which was prevented either by intervention or by luck (NPSA, 2001). Serious incident requiring investigation 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: The unexpected or avoidable death of one or more patients, staff, visitors or members of the public; 4/28

5 Permanent harm to one or more patients, staff, visitors or members of the public, or where the outcome requires life saving intervention or major surgical/medical intervention, or will shorten life expectancy (this includes incidents graded under the NPSA definition of severe harm (Seven Steps, 2004, p100); a scenario that prevents, or threatens to prevent, a provider organisation s ability to continue to deliver health care services, for example, actual or potential loss or damage to property, reputation or the environment; allegations of abuse; security incidents; adverse media coverage or public concern for the organisation or the wider NHS; one of the core set of Never Events. Never Events Never Events are serious, largely preventable patient safety incidents that should not occur if the available preventative measures have been implemented. These are updated on an annual basis by NHS England. Security incident From April 2010 NHS Security Management Service introduced a Security Incident Reporting System (SIRS). This was developed to provide a clearer picture of security incidents across the health service in England, locally and nationally. The following security incidents must be reported using SIRS: any security incident involving physical assault of NHS staff; non-physical assault of NHS staff (including verbal abuse, attempted assaults and harassment); theft of or criminal damage (including burglary, arson, and vandalism) to NHS property or equipment (including equipment issued to staff); theft of or criminal damage to staff or patient personal property; property damage arising from these types of security incident. Unexpected death Where natural causes are not suspected, local organisations should investigate these to determine if the incident contributed to the unexpected death. Permanent harm Harm directly related to the incident and not to the natural course of the patient s illness or underlying conditions; defined as permanent lessening of bodily functions, including sensory, motor, physiological or intellectual. 5/28

6 Prolonged pain and/or prolonged psychological harm Pain or harm that a patient has experienced, or is likely to experience, for a continuous period of 28 days. Abuse A violation of an individual s human or civil rights by any other person or persons. Abuse may consist of single or repeated acts. It may be physical, verbal or psychological; it may be an act of neglect or an omission to act, or it may occur when a vulnerable person is persuaded to enter into a financial or sexual transaction to which he or she has not consented, or cannot consent. Abuse can occur in any relationship and may result in significant harm, or exploitation, of the person subjected to it. This is defined in No secrets: Guidance on developing and implementing multi-agency policies and procedures to protect vulnerable adults from abuse (DH 2000), and Working Together to Safeguard Children: A guide to interagency working states that abuse and neglect are forms of maltreatment of a child. Somebody may abuse or neglect a child by inflicting harm or by failing to act to prevent harm (Department for Children Schools and Families (2006, p37). External body / agency An organisation that has an official advisory or regulatory role that has been mandated to regulate the corporate and professional activities of NHS Trusts. RIDDOR is the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995 (as amended). RIDDOR Incident is defined as any incident, disease or dangerous occurrence reportable under the RIDDOR regulations by the Health and Safety Executive (HSE). Information Governance incident Any incident involving the actual or potential loss of personal information that could lead to identity fraud or have other significant impact on individuals. The above definition applies irrespective of the media involved and includes both loss of electronic media and paper records. All reported information governance incidents attributable to the actions of staff employed by Wirral Community NHS Trust, are risk rated in accordance with the Checklist guidance for reporting, managing and investigating information governance serious incident requiring investigation (Department of Health, 2013). Information Governance Incidents risk rated against the guidance and reaching a level 2 risk, are reported to the Department of Health and Information Commissioner s Office via the IG Toolkit Incident Reporting Tool. Complaint/Claim A complaint is defined is an expression of dissatisfaction (written or verbal) about a service provided or which is not provided, which requires a response. Examples of complaints include: Concerns about the quality of service provided, the following of standard procedures and good practice, poor communication and the attitude or behaviour of a member of staff. 6/28

7 Root Cause Analysis (RCA) is defined as the process by which the underlying cause(s) of patient safety and non clinical incidents are established. The nature and extent of an RCA will be subject to the nature and level of incident. An action plan will be established for all root causes and issues identified which have contributed to/resulted in an incident. A traumatic or stressful event: one that invokes unusually strong emotions, overcoming normal coping abilities. Examples of such incidents may include the following, although the list is not intended to be exhaustive: Serious Incidents/Complaints/Claims Allegations of negligence Dealing with a major incident Involvement in cases of safeguarding children or adults Cases of harassment and/or bullying Involvement in an incident of violence or aggression, whether as a victim or witness Being called as a witness in a Court of Law 4. Duties within the Organisation Individuals Chief Executive The Chief Executive has the responsibility for patient and staff safety in the organisation and in ensuring there is a culture of non-punitive incident investigation. Nominated Director(s) Including the Non-Executive Directors The nominated directors for patient and staff safety are the Director of Quality and Nursing and the Director of Operations and Performance. They have delegated responsibility from the Chief Executive for this responsibility and for ensuring a culture of non punitive investigation and learning from incidents is developed in the organisation and that all incidents are investigated in a timely manner and escalated appropriately within the organisation. They are responsible for creating a culture of openness in the organisation and ensuring serious incidents are investigated in accordance with the Being Open Policy. The Non-Executive Directors are informed of incidents, the investigation undertaken and the outcomes through the quality report and the quarterly trend reports. It is their responsibility to provide assurance to the board on the process the organisation has in place to investigate serious incidents. 7/28

8 Senior Manager The senior manager with responsibility for patient and staff safety is the Head of Quality and Nursing. It is their responsibility to supervise the incident reporting systems within the organisation and ensure that all incidents are reported to the appropriate committees and those serious incidents are escalated appropriately within the organisation. They are responsible for co-ordinating the development of risk management practices in a non clinical and clinical setting and the communication of the governance framework throughout the organisation and to ensure that learning from incident investigation is shared across the organisation. ensuring that all staff within the organisation are provided with the appropriate learning and development on risk management and incident investigation. reporting incidents to the Care Quality Commission (CQC) that indicate or may indicate risks to ongoing compliance with the registration requirements, or that lead or may lead to changes in the details about the organisation in the CQC's register. giving advice on and for reporting incidents using the Strategic Executive Information System (STEIS)/ national Serious Incident Management System (SIMS). Divisional Managers/Service leads/heads of Service Are responsible and accountable for:. Ensuring that within their areas of responsibility this policy is followed and all incidents and complaints are graded, investigated and actions taken, to the level commensurate with the risk grading outlined in this policy and that the investigation is documented. Escalate incidents as detailed in this policy. Ensuring that incidents with cross Trust impact are brought to the attention of other Divisional and Senior Managers. Ensuring that lessons learnt following the investigation of an incident, complaint or claim, which may apply to areas outside of their remit are brought to the attention of other Divisions and Senior Managers. Ensuring patients and relatives are informed when incidents occur where appropriate and that they are informed of the Trust s policy for investigating incidents complaints and claims. Inviting discussion as appropriate to facilitate a positive outcome. Ensuring that the Complaints policy is followed and facilitate the investigation of complaints Ensuring that identified actions are undertaken following the results of incident, complaints and claims investigation. That these are brought to the attention of their staff and any information, instruction or training required is given. 8/28

9 Ensuring that risk assessments and the divisional risk registers are reviewed regularly. Completing any relevant documentation in relation to the incident e.g. Reporting Injuries, Diseases and Dangerous Occurrences Regulations (RIDDOR), Health and Safety Executive (HSE), the Medicines and Healthcare products Regulatory Agency (MHRA), the Police or the Environmental Health Agency (EHA) and with the support/knowledge of the relevant organisational subject specialist Escalating any risks scoring 15 or above on the Trust s risk matrix to the Director of Quality and Nursing and the Director of Operations and Performance that working day. Line Manager/Team leaders Are responsible for the incident reporting processes within their team and ensuring any immediate actions which need to be taken post incident. Clinical leads/team leaders must review incident forms within 2 working days of receiving them to ensure the appropriate incident documentation is completed within the timescale required by their staff and to ensure any immediate actions required are taken. They are responsible for providing immediate and ongoing support to staff who are involved in a stressful or traumatic event. They will: Arrange for the de-briefing of staff following traumatic or stressful events and deal with any subsequent absence in a compassionate manner. Work through the staff support checklist with any member of staff covered under the scope of this policy, offering support and assistance as required; Take action to refer staff to the Occupational Health and Safety Service or counsellors, as appropriate and facilitate; and Ensure that any recommendations from the Occupational Health and Safety Service are followed through Health & Safety Advisor The Health and Safety Advisor is responsible for ensuring reportable incidents are reported to the Health and Safety Executive within the acceptable time frames. The advisor will: Quality assure the scores on non clinical incident forms support managers to investigate RIDDOR reportable incidents and ensure that the appropriate action plans are put in place Analyse incident data for trends and produce the non clinical risk management reports Provide a range of education and training sessions to support the incident reporting and investigation process Provide support for staff following an incident as required 9/28

10 Risk and Compliance Team The Risk and Compliance Team are responsible for: Facilitating the effective application of the incident reporting policy and associated policies and procedures, supporting staff and managers alike. Reviewing both non-clinical and clinical incident forms received, in order to obtain an overview of the action taken. Ensuring each incident is risk graded and the form contains all relevant information regarding the incident itself and the actions taken to prevent recurrence of the incident where appropriate. Ensuring where necessary that statutory bodies have been notified within the appropriate timescales. Ensuring that the incidents are recorded on the Trust s incident reporting database. The transfer of data to external databases as appropriate e.g. NPSA, MHRA Analysing incidents and producing relevant reports to encourage and monitor appropriate actions are taken to reduce the risk of a recurrent incident. Identification and delivery of corporate training needs, developing training criteria and training programmes and delivery of Risk Management, Health and Safety and incident reporting training programmes to identified staff Liaison with incident reporters regarding appropriate grading of an incident. Supporting the Service Leads/Divisional managers/heads of Service in the development of their divisional/service risk registers and governance groups and advising on the investigation and management of incidents. Ensuring that incidents which score 15 or above on the Trust s risk matrix have been escalated appropriately to the Director of Quality and Nursing and the Director of Operations and Performance by the Head of Service Local Security Management Specialist (LSMS) The Security specialist will Ensure that the relevant external agencies are informed of any incidents relating to security and violence and aggression. Provide support for investigations as required Recommend appropriate controls in response to incidents Caldicott Guardian The Caldicott Guardian is the Medical Director who will: Ensures that the Trust satisfies the highest practicable standards for handling patient identifiable information Protect the confidentiality of patient identifiable information Enable appropriate information sharing Monitor incidents involving patient identifiable information 10/28

11 Senior Information Risk Owner (SIRO) The SIRO is the Director Finance and Resources who will: Take overall ownership of the Trust s information risk policy Act as champion for information risk on the Board Lead the information governance (IG) risk assessment and management processes within the Trust Advise the Board on the effectiveness of information risk management across the Trust All Staff All employees of Wirral Community NHS Trust are responsible for reporting incidents in a timely manner. Incidents involving a high level of patient harm or an SUI should verbally be reported to the line manager and DATIX form completed as soon as practicable and within 24 hours. Other incidents should be reported within 1 working day. Occupational Health Service The Occupational Health and Safety Service provides access to a confidential, independent and impartial counselling service. Any staff involved in traumatic or stressful events may use the service and can either self-refer or be referred by their manager. The Occupational Health practitioners can also provide support and can signpost staff to appropriate external support where this is thought to be more appropriate or is requested. In addition to pre employment screening, and assessment/support following and incident, the Occupational Health Service will assess the fitness to return to work of employees sustaining an injury or absence related to an incident at work. They will provide support for staff following an incident as required. RCA RCA Leads will Lead RCA investigations and ensure the RCA reviews or investigations includes key stakeholders Ensure that all staff involved in the review are supported and understand the process and for documenting the support in the RCA pro forma Prepare action plans with the team involved Ensure all those assigned tasks are aware of their responsibilities and delivery dates Liaise with the patient, staff member or family member and keep them informed of progress and resulting action plans or nominate an appropriate staff member to do so. All communication with patients, carers (and staff if the incident is non-clinical) must be documented. 11/28

12 5. Responsibilities of Committees and Groups Trust Board The Trust Board has ultimate responsibility for the management of serious incidents within the organisation. They are made aware of these incidents and the more high frequency, low risk incidents through escalation from the delegated committee, the Quality and Governance Committee. Quality and Governance Committee The committee with overarching responsibility for risk management is the Quality and Governance Committee. All incidents, non-clinical and clinical, are integrated and reported in the monthly quality report to the Quality and Governance Committee. The Committee considers the organisation s Risk Register and any escalated risks, identifies new risk, allocates risk control and resources, provides guidance around complex risk and makes recommendations for Board assurance and ensures actions are taken as a result of trend analysis; and the cascading of information throughout the organisation. Responsibility for monitoring the completion of action plans as a result of incidents and the subsequent effectiveness of any risk reduction measures is delegated to the Quality Patient Experience and Risk Group. The Quality Patient Experience and Risk Group (QPER) This group plays a key role in the management of incidents. The main duties of the QPER group is to review Divisional risk registers, policies and strategy, analyse trends from patient related incidents, monitor action plans from incidents and investigations and to share learning across the organisation. The Health, Safety and Wellbeing Group The main duties of the Health, Safety & Well Being Group are to provide a forum for discussion designed to improve Wirral Community NHS Trust s overall approach to health and safety management. Infection Prevention and Control Group The Infection Prevention and Control Group will monitor infection control incidents with particular regard to inoculation incidents. Safeguarding Operational Group The Safeguarding Operational Group will monitor safeguarding incidents. Information Governance The Information Governance Group will review and monitor Information Governance incidents. 12/28

13 Divisional Governance Group Divisional Governance Groups will: Review and analyse incident reporting trends within the division identifying areas of improvement Ensure that where division wide learning is identified following an incident that this is communicated to staff. Ensure that risks identified following the investigation process are included in the Divisional risk register together with an action plan and escalated where required Review the risk register and progress against action plans 6. Duty of Candour The Duty of Candour places a contractual requirement on providers of health and adult social care to be open with patients when things go wrong. This approach provides the Trust with a real opportunity to demonstrate its commitment to greater openness and candour, developing a culture dedicated to learning and improvement that continually strives to reduce avoidable harm. The duty of candour applies to patient safety incidents that occur during care provided under the NHS Standard Contract, and result in moderate harm, severe harm or death. When the harm has occurred as a result of care provided by Wirral Community NHS Trust, patients or their family/carer must be provided with an appropriate verbal apology, and be offered feedback following further incident investigation. Patients should at most be informed within 5 days of the incident being identified. This should be captured on the Trust s incident reporting system. The national NPSA definitions of harm adopted by NHS England are as follows: No Harm Impact prevented any patient safety incident that had the potential to cause harm but was prevented, resulting in no harm to people receiving NHS funded care. Impact not prevented any patient safety incident that ran to completion but no harm occurred to people receiving NHS-funded care. Low Any patient safety incident that required extra observation or minor treatment and caused minimal harm, to one or more persons receiving NHS-funded care. Moderate Any patient safety incident that resulted in a moderate increase in treatment and which caused significant but not permanent harm, to one or more persons receiving NHS-funded care. 13/28

14 Severe Any patient safety incident that appears to have resulted in permanent harm to one of more persons receiving NHS-funded care. Death Any patient safety incident that directly resulted in the death of one or more persons receiving NHS-funded care. The responsibilities for verbal/written communication with patients/ relatives/contractors; when communication is to take place; and how this information should be documented as defined in the organisation s Being Open Policy. Where the Being Open Policy indicates, the patient's clinician or the clinician's delegated representative must inform the patient or next of kin and fully document this in the relevant record. The media must not be informed without the patient or next of kin first being informed of any incident. Staff Raising Concerns e.g. Whistleblowing, Open Disclosure The Raising Concerns Policy (Whistleblowing) HRP12 details the procedures to be followed where there are concerns of criminal or unethical activity or misconduct including but not limited to: Breach of a legal obligation (including negligence, breach of contract, breach of administrative law Unsafe or malpractice Miscarriage of justice Danger to health and safety, the environment, staff or patients Unauthorised disclosure of information or breach of security Use of confidential information for personal gain Conflicts of interest with personal or outside business commitments Misuse or theft of financial or other Wirral Community NHS Trust resources Separation of roles during tendering Receipt of gifts or hospitality Suspicions of abuses such as unfair appointments Inappropriate or unprofessional conduct Discrimination, bullying, harassment and victimisation Covering up any of the above in the workplace 7. Immediate Action following an Incident In all instances, the first priority for the organisation is to ensure the needs of individuals affected by the incident are attended to, including any urgent clinical care which may reduce the harmful impact. A safe environment should be re-established, all equipment or medication retained and isolated, and all relevant documentation copied and secured to preserve evidence to facilitate the investigation and learning. If there is a suggestion that a criminal offence has been committed, the organisation should contact the Police. The organisation should give early consideration to the provision of information and support to patients, relatives and carers and staff involved in the incident in accordance with the Being Open Policy. 14/28

15 The needs and involvement of staff in the incident should also be considered. If the incident involves children or vulnerable adult safeguarding concerns, the practitioner reporting the incident must refer the case to the Local Authority Children s or Adults Social Care. WCT s Safeguarding Children and Safeguarding Adults policies must be followed under these circumstances. 8. Reporting of Incidents and Near Misses involving staff, patient and others Reporting an Incident/Near Miss Any staff member involved in or who has witnessed an incident or Near Miss involving patients, staff or others should report the incident via DATIX web using the DIF1 form Incidents involving a high level of patient harm or an SUI should verbally be reported to the line manager immediately and DATIX form completed as soon as practicable. The DIF1 form contains a number of mandatory fields which must be completed prior to submission. Any documentation/evidence relevant to the incident should be attached at this stage or if not in an electronic format forwarded to the DIF2 reviewer for scanning and attachment. Guidance on how to report an incident can be found in the DIF1 user guide located on the intranet. It is essential when reporting to ensure that the information provided in the form contains fact only, not opinion. The form is to be completed within one working day of the incident. If assistance is required in the completion of the online Incident Report Form, the line manager or a member of Quality and Governance should be contacted for advice. In the event of a fatality, major accident, case of disease or dangerous occurrence, or any other health & safety incident arising having potentially major implications, the Director of Quality and Nursing and or Risk Manager should be notified as soon as possible via phone or . In the event that DATIX web is unavailable for more than 24 hours paper based Incident reporting books will be available at reception of the main Wirral Community Trust premises. Staff should report using these forms returning completed forms to Quality and Governance until access to Datix web is resumed. 9. Out of Hours Arrangements Duty Manager On-call Out of hours staff can contact the on call duty manager for advice and support using the dedicated number. The On call Duty Manager will make an assessment as to the appropriate action to be taken. 15/28

16 Out of hours in the event of an unusual, suspicious or unexpected death the decision to contact the police must be made by the Duty Manager on call. 10. Reporting and Communicating to External Agencies A number of legal requirements are placed on the Trust to report incidents, complaints and claims to external agencies irrespective of the severity of the event, e.g. Clinical Commissioning Group (CCG), MHRA, NHS England, and Health & Safety Executive (HSE). 11. Assigning a Risk Score The designated DIF2 reviewer responsible for the team and/or area of responsibility within which the incident occurred will receive the notification of the completed electronic form following submission of the DIF1 form. They are required to complete the on-line management section of the DIF2 form Guidance for completion of the DIF 2 form can be found in the DIF2 user guide located on the staff intranet. The responsible Line Manager shall ensure that, for all incidents, a review takes place, the incident is risk graded and if required an investigation is undertaken and that any necessary remedial action is taken or initiated, recording this on their section of the on-line Incident Report Form. If there is any doubt as to what remedial action should be taken, the Line Manager should consult with the relevant specialist e.g. Health & Safety Advisor, Information Governance Manager or SIRO for information security matters, without delay. Risk scores are assigned using the Trust risk scoring methodology outlined in GP45 The Procedure for Risk Identification and Management. The consequence is multiplied by the likelihood of a similar incident recurring and this identifies a risk score in the risk scoring matrix The grading of the incident should take into account the actual degree of harm (consequence) that occurred as this can affect the way in which the incidents are reported to the NPSA for example grading near misses (where no harm occurred) as severe harm. The grade needs to reflect the actual degree of harm not the potential. Where a patient dies following a patient safety incident the grading must reflect whether the patient s death was directly attributable to the incident. 12. Incident Investigation and Monitoring of Action Plans Adverse incidents and events must be given an appropriate level of investigation in order to identify the true base of the problem. Not all incidents, complaints or claims need to be investigated to the same extent or depth. The Being Open policy defines the level of incident investigation and manager to undertake them dependent on the risk score allocated to the incident. 16/28

17 13. Process for Low ( Green ) and Moderate ( Amber ) Incidents Risk Grading 1-9 Following the review and risk grading of the incident the DIF2 reviewer must determine if further investigation is required. If the review of the incident report identifies that no further action is required then the justification for this must be recorded on the incident form. If an incident is reportable under RIDDOR the Health and Safety Advisor must be informed immediately If the DIF2 reviewer identifies that further action/investigation is required this will be recorded on the incident form together with the outcome and lessons learnt. Any safety measures that are identified and are not within the control of the service must be escalated via the Divisional governance arrangements. The DIF 2 reviewer is responsible for monitoring the completion of any action plans relating to these incidents. Following completion of the DIF2 form the reviewer will submit the incident report to the to the risk team for final approval. Incidents risk graded Incidents graded will require further investigation using techniques such as SBAR or RCA. The level of investigation will be determined by the Risk team in conjunction with the Service lead and or Divisional Manager. Action Plans will be monitored via Divisional Group meetings and in the case of RCAs the Quality Patient Experience and Risk Group Process for Red incidents Risk Grading 15 or above All incidents which are scored 15 or above red using the risk scoring matrix are classified by the Trust as Serious incidents and will follow the process for managing serious incidents detailed below. The Divisional Manager will ensure that any actions immediately required have been undertaken. They will discuss and confirm the score and escalate in hours to the Director of Quality and Nursing and or the Director of Operations and Performance. Out of hours the on call duty manager will escalate in line with the on call pathways. Incidents graded 15 or above will require a RCA and the action plan monitored via QPER 14. Quality Assurance The Risk Team will review the content of all incident forms and quality assure the risk score applied to any incident reports They will ensure that the appropriate level of investigation required is initiated. The Risk Management Team can request that an RCA or SBAR is undertaken in response to an incident, near miss or a result of incident trends associated with low grade incidents 17/28

18 Feedback on the quality of information will be provided to Division where required in order to identify training and compliance requirements. Reports of certain incidents are accessible by pre-determined individuals on the basis on incident coding (specialists) e.g. those incidents involving violence to staff will be accessible to Local Security Management Specialist, medication incidents to the Medicines Governance Pharmacist allowing them the opportunity to request further information and assist in the investigation process. 15. Management of Serious Incidents duty of candour Patient/Relative/Visitor/Contractor Communication and Support The responsibilities for verbal/written communication with patients/ relatives/contractors; when communication is to take place; and how this information should be documented as defined in the organisation s Being Open Policy. Responsibility for Investigation This is defined in the organisation s Being Open policy Where the investigation into a serious incident involves more than one organisation an agreed lead organisation should be agreed at the beginning, anything uncovered by local investigations that may be pertinent, e.g. timelines, care/service delivery problems and causal factors, should be communicated to the agreed lead organisation to ensure a full analysis of the incident and root causes to be determined. Allegations of abuse should always be referred immediately following local multiagency safeguarding arrangements for adults and children and a safeguarding alert raised. Adult safeguarding investigations are co-ordinated by those arrangements and should not begin independently of them. Responsibility for Causal Factor Analysis This analysis is undertaken by the investigation lead; and is submitted to the Head of Quality and Nursing within an agreed timescale dependent on the severity of the incident and reported at the Quality, Patient Experience and Risk Group Group; this information is included in the Quality Report for all non serious investigations. Any investigations into serious incidents would be subject to exception reporting direct to the Board. Responsibility for Causal Factor Analysis Post Investigation The responsibility for this trend analysis sits with the Head of Quality and Nursing and is undertaken quarterly as part of the trend report. This information is reported quarterly to the Quality and Governance Committee. Involving Patients and their Families in Investigations into Serious Incidents The level of patient/family involvement clearly depends on the nature of the incident and the patient or family s wish to be involved, this is defined in the organisational Being Open Policy, which staff are aware of through the staff bulletin and the principles of which are in current use. 18/28

19 Note: Patients and families have the right to request information held by public authorities (Freedom of Information Act 2000). This includes access to medical records and any associated documentation (The Re-use of Public Sector Information Regulations SI 2005/1515). This should be considered when writing incident investigation reports and actions. It may also be necessary, if an incident occurs across a number of organisational boundaries, to work together in a joint investigation, and such investigations would be co-ordinated for the organisation by the Head of Quality and Nursing. Root Cause Analysis (RCA), Situation, and Investigation Report Root cause analysis, investigation reports will be compiled using the organisation s root cause analysis document. An investigation executive summary should be published for each serious incident. It should include a précis of the incident and investigation and be fully anonymised to preserve confidentiality of the people involved and the ward/team/unit/hospital and provider organisation. This will enable the executive summary to be widely shared. Recommendations and Action Planning The Root Cause Analysis makes recommendations post investigation, and a detailed action plan is produced. Action plans should always include persons responsible and the date for completion. Monitoring of Action Plans The action plans produced as a result of RCA investigations are monitored on a monthly basis by the Quality Patient Experience and Risk Group in order to ensure their completion Any risks will be added to the divisional level risk register or escalated in the organisation in accordance with the risk assessment policy. Process of Ensuring Continual Risk Reduction Following the Implementation of Action Plans The organisation will monitor the risk register at the Quality, Patient Experience and Risk Group to ensure that those risk reduction measures taken post investigation, are continuing to be effective, and that risk has not been transferred unwittingly. Media Involvement The process to be followed when managing an incident with media involvement will be managed by the Head of Communications. 19/28

20 16. Process for involving and communicating with external/ Stakeholders and of sharing lessons learnt Sharing of Lessons Learnt The sharing of the lessons learnt post investigation is a critical part of incident management. Learning from patient safety incidents is a collaborative, decentralised and reflective process that draws on experience, knowledge and evidence from a variety of sources. The learning process is a process of change evidenced by demonstrable, measurable and sustainable change in knowledge, skills, behaviour and attitude. Learning can be demonstrated at organisational level by changes and improvements in process, policy, systems and procedures relating to patient safety within healthcare organisations. Individual learning can be demonstrated by changes and improvements in behaviour, beliefs, attitudes and knowledge of staff at the front line of healthcare delivery. Where appropriate, information should also be communicated to external stakeholders in order to ensure appropriate involvement in the investigation and to share lessons learnt from incidents, complaints and claims, including, for example, the Clinical Commissioning Group and partner health organisations and national agencies including NHS England and the Health and Safety Executive (HSE). The responsibility to contact these agencies, and when their involvement may be requested is defined in the Policy for the management of external agencies/visits/inspections/accreditations. It may also be necessary, if an incident occurs across a number of organisational boundaries, to work together in a joint investigation, and such investigations would be co-ordinated for the organisation by the Head of Quality and Nursing. What Constitutes Learning Learning following an incident should be linked to safety related policy, practice and process issues raised by the incident. Examples of learning are given below: solutions to address incident root causes which may be relevant to other teams, services and provider organisations; identification of the components of good practice which reduced the potential impact of the incident, and how they were developed and supported; systems and processes that allowed early detection or intervention which reduced the potential impact of the incident; lessons from conducting the investigation which may improve the management of investigations in future; documentation of identification of the risks, the extent to which the risks have been reduced, identified and how this is measured and monitored. Across organisational boundaries following agreed pathways 20/28

21 Learning from Serious Case Reviews (SCR) Executive representatives from the organisation are part of the local Safeguarding Adults Board (SAB) arrangements in each area and they are responsible for ensuring that communication between the SAB and the NHS Board is maintained. Learning lessons is the prime rationale of SCRs, and SABs are responsible for commissioning each SCR; sharing the learning across all organisations; and monitoring at agreed review periods whether the lessons have been taken on board. The SAB is responsible for ensuring that they receive regular progress reports on a commissioned SCR and to take action if the delay appears unreasonable. The organisations in partnership with the SAB have local policies for implementing the findings from SCR, a process to report to the board, and action plans to implement and monitor changes in practice. Sharing of safety lessons with internal stakeholders Sharing of learning from incidents takes place in a variety of forms including: Review of incidents and RCAs by QPER Group Risk Flyers At team meetings At Divisional governance groups Datix Dashboards Medicines management Bulletin feedback via Datix 17. Analysis and Improvement How incidents complaints and claims are analysed and action plans followed up Incidents, Complaints and claims are reported and managed through modules on DATIX. Within the modules the template forms of incidents, complaints and claims contain fields which allow the incident to be analysed according to incident categories including incident type e.g. staff or Patient or other party and detail which includes a list of incident types e.g. Medication, slip trip or fall. All complaints and claims and incidents are graded using these criteria. How information is combined to provide a risk profile for the organisation The quality and patient experience report contains qualitative and quantitative details of the organisation s performance across a number areas including incidents, complaints and claims and is produced monthly, quarterly and annually by the Quality and Governance unit. This Quality and Patient Experience report demonstrates how the Organisation is performing in relation to the quality objectives that relate to: 21/28

22 Patient Experience Delivering Care Where specific trends are identified the contributors to the report will be responsible for providing an explanation (if possible) for the trend identified The incidence of complaints, claims and incidents are recorded within the quality report, the data is also triangulated by recording the data against category and type so that the common trends can be identified. Where trends are highlighted a narrative on underlying trends is included in the report and where required an action plan initiated for monitoring by QPER and the Quality and Governance committee. 18. How information is shared with relevant individuals and groups The Quality Report is produced on a monthly, quarterly and annual basis and is shared via QPER The Quality and Governance Committee Divisional Managers for discussion at Divisional governance groups The Board How action Plans are followed up Where trend analysis of incidents, complaints and claims identifies area of improvement a risk assessment and action plan will be prepared by a lead nominated by the Head of Quality and Nursing and managed in line with GP45 The procedure for Risk Identification and Management. 19. Staff Training Incident Reporting Training in relation to incident reporting, will be provided on commencement of employment as part of the Induction process. (Refer to HRP25 Induction Policy) Incident Investigation Training on Incident investigation is delivered via Datix Dif 2Training DIF2 reviewers will be required to attend DIF2 training prior to be allocated DIF2 reviewing access on DATIX as identified in the service specific training matrix. RCA/Situation Background Assessment and Recommendations (SBAR) Training Where designated individuals are required to conduct RCAs and SBARs this training this will be recorded on the service specific training matrix. The process for identifying required attendees, booking training, checking that staff complete the relevant training, recording attendance, following up non attendees and monitoring compliance with training is described in the Learning and development Policy GP 46 22/28

23 20. Supporting Staff involved in an Incident complaint or claim Immediate Support Available to Staff Following an Incident It is crucial that individuals are offered support following any incident or near miss. This may be as simple as a Line Manager offering the opportunity to discuss the issue which should be recorded on the incident report form. Line Managers are usually the first senior person that a staff member will come into contact with and should always offer support to staff following a stressful or traumatic incident. Examples of immediate support include: Opportunity for staff member to talk about events and ask questions. This meeting should be used as an opportunity to plan further support meetings. Provision of a named person or service for staff member to contact if further support if anticipated or desired. This may include information about what will happen next regarding the investigation. Referral to internal or external sources of advice. Arrangements for staff member to receive any required medical treatment or assessment. For example if they are in shock or suffer from a pre-existing medical condition that has been exacerbated by the event. The following individuals or groups can provide support and advice: Line Manager or Service Lead Risk/Patient Safety Advisors Health & Safety advisor HR Relevant professional groups (e.g. RCN, RCM, GMC, Unison) Occupational Health Department (access to counselling service). In circumstances where a conflict of interest exists between the Trust and a member of staff, staff will be encouraged to seek external advice from professional groups for example the RCN, GMC or their Union Representative. They may also seek external legal advice from groups such as the Medical Defence Union or Medical Protection Society. Most incidents will not cause a staff member undue distress; however for some incidents and often for Serious Incidents (Sis). Individuals, regardless of grade or position, may feel anxious about their involvement and their future role in the incident investigation process and RCA. For this reason staff members involved in SIs at the Trust must also be offered support as part of the RCA process. All staff who are involved in an RCA will be given an information leaflet by the RCA Lead which explains the RCA process and outlines the type of support available. Ongoing support offered to Staff Managers should remember that, in the initial stages following an event, they or a staff member may be unaware of the impact of that event on their well-being or ability to undertake their full range of duties. For this reason, it is essential that on-going support is provided. This should involve a one to one meeting no later than 2 weeks after the event. At the meeting any follow up arrangements, for members of staff still 23/28