Incident/Serious Incident Reporting Policy

Transcription

1 Incident/Serious Incident Reporting Policy This policy describes the process for reporting, investigating and managing incidents and serious incidents. Key Words: Incident, Serious Incident, accident, RIDDOR Investigation Version: 9 Adopted by: Quality Assurance Committee Date Adopted 25 July 2016 Name of Author: Name of responsible Committee: Date issued for publication: Victoria McDonnell-Trust Lead for Risk and Patient Safety/Jo Nicholls-Patient Safety Manager Patient Safety Group October 2016 Review date: January 2019 Expiry date: 1 June 2019 Target audience: All Staff Type of Policy Clinical Non Clinical e.g. HR or Education related Which Relevant CQC Regulation 12 & 13 Fundamental Standards?

2 Contents Contents Page Version Control...4 Equality Statement...5 Due Regard...5 Definitions that apply to this policy...6 THE POLICY 1.0 Purpose of the Policy Summary and Key Points Introduction Scope of the Policy Confidentiality Definition of an Incident Flowchart/Process chart Roles and responsibilities within the Organisation Process by which to raise concerns Media Involvement Serious Incidents Serious Incidents Investigation Sharing of Lessons Learnt Training Requirements Monitoring Compliance and Effectiveness Standards/Performance Indicators References and Bibliography...39

3 REFERENCES AND ASSOCIATED DOCUMENTATION Appendix 1 Information Governance Checklist Appendix 2 72-Hour Report Form Appendix 3 Heads of service checklist following an SI...55 Appendix 4 Minimum Standards for Serious Investigation Reports...56 Appendix 5 Minimum Standards for Action Plans...57 Appendix 6 Witness/Victim Statement...58 Appendix 7 Due Regard Screening Template...59 Appendix 8 Training Needs Analysis...60 Appendix 9 NHS Constitution Checklist...61 Appendix 10 Safeguarding Review/SI process...62 Appendix 11 Stakeholder and Consultation

4 Version Control and Summary of Changes Version number Date Comments (description change and amendments) 09/03/ Pg 8 amended section /04/2012 Pg11 added bullet point to section 7.2 to ensure that RIDDOR incidents are notified to the Trust health and safety team Pg 15 section added regarding the role of the Health and Safety Committee Pg 17 section 11.0 health and safety team added Pg 19 section 15.0 investigation methodologies added Pg 21 section added to 15.5 as to how the health and safety committee will monitor non clinical action plans Pg 22- section 17 monitoring compliance with the policy will include reports being sent to the health and safety committee for the monitoring of non clinical incidents 4 17/09/2012 Addition of Witness/Victim Statement and contents list/formatting 5 07/03/2013 NHSLA Criteria update 6 21/01/2014 Review of policy in light of internal review Review of Policy in relation to national and local 7 12/04/2016 policy changes 26/10/16 Addition of the Safeguarding/ SI process flow chart 8 (appendix 10) 19/12/2017 Revised following audit of Medical Device 9 Processes by 360 assurance page 17 sentence removed For further information contact: Trust Lead Risk and Patient Safety or Trust Patient Safety Manager Leicestershire Partnership NHS Trust Room 170, Pen Lloyd Building County Hall Glenfield, Leicester LE3 8TH 4

5 Equality Statement Leicestershire Partnership NHS Trust (LPT) aims to design and implement policy documents that meet the diverse needs of our service, population and workforce, ensuring that none are placed at a disadvantage over others. It takes into account the provisions of the Equality Act 2010 and promotes equal opportunities for all. This document has been assessed to ensure that no one receives less favourable treatment on the protected characteristics of their age, disability, sex (gender), gender reassignment, sexual orientation, marriage and civil partnership, race, religion or belief, pregnancy and maternity. In carrying out its functions, LPT must have due regard to the different needs of different protected equality groups in their area. This applies to all the activities for which LPT is responsible, including policy development and review and implementation. Due Regard Trusts commitment to equality means that this policy has been screened in relation to paying due regard to the general duty of the Equality Act 2010 to eliminate unlawful discrimination, harassment, victimisation; advance equality of opportunity and foster good relations. This is evidenced by incident forms being completed either electronically or on paper dependent on whether staff can access or use a computer. This policy is also available in other formats such as braille Due regard will also be given through the use of HR best practice and adherence to all relevant employment legislation. In addition to the examples highlighted above, equality monitoring of all relevant protected characteristics to whom the policy applies will be undertaken. Robust actions to reduce, mitigate and where possible remove any adverse impact will be agreed and effectively monitored. This policy will be continually reviewed to ensure any inequality of opportunity for service users, patients, carers and staff is eliminated. The Due regard assessment template is Appendix 8 of this document. 5

6 Definitions/Abbreviations that apply to this Policy NPSA HSE CQC STEIS RCA RIDDOR E-IRF SI CCG SHA NRLS MHRA LSAB LSCB QAC DOLs LIO DH IQPR EHA OLM AT NTDA National Patient Safety Agency Health and Safety Executive Care Quality Commission Strategic Executive Information System Root Cause analysis The Reporting of Injuries, Disease, and Dangerous Occurrences Regulations Electronic Incident Reporting Form Serious Incident Clinical Commissioning Group Strategic Health Authority National Reporting and Learning System Medicines and Healthcare Products Regulatory Agency Leicestershire Safeguarding Adults Board Leicestershire Safeguarding Childrens Board Quality Assurance Committee Deprivation of Liberty Lead Investigation Officer Department of Health Integrated Quality and Performance Report Environmental Health Agency Organisational Learning Management database Area Team (NHS England Area Team) NHS Trust Development Authority 6

7 1.0 Purpose of the Policy 1.1 This policy aims to establish a clear and consistent approach to the reporting, investigation and management of all incidents so that LPT provides a safe environment for patients, staff and visitors. It provides a framework within which all accidents, incidents, near misses and serious incidents can be managed, escalated and reported on appropriately, whether they have caused actual harm, or were reported as a near miss, and are reported by staff in a timely manner. All incidents, accidents and near misses will be appropriately managed and investigated, based on their severity, to ultimately learn and make changes as a result of any incidents, complaints and claims in order to improve safety, for patients, staff, visitors and contractors. 1.2 This policy ensures that arrangements are in place to adhere to both the legislative and reporting requirements for NHS England s National Reporting and Learning System (NRLS), Health and Safety Executive (HSE), Care Quality Commission (CQC) registration process, the NHS Trust Development Authority (NTDA), the Trusts commissioners and both internal and external stakeholders. 1.3 The Trust Board accepts that fear of disciplinary action may deter staff from reporting incidents and has therefore chosen to adopt a positive, open and fair approach, where all staff will feel safe to report incidents and safety issues. The incident investigation process will be fair and equitable and focussed on learning and change. 2.0 Summary and Key Points 2.1 Leicestershire Partnership Trust (LPT) recognises that patient and staff safety is every employee s concern. It is acknowledged that in a complex health care arena there will be occurrences that may or will result in harm to a patient, member of staff, volunteer, visitor or contractor. LPT is committed to ensuring that lessons are learned from such occurrences so that the organisation can identify measures to reduce risk to other patients, staff, visitors, volunteers or contractors rather than apportioning blame. LPT acknowledges that when things go wrong, open and honest and candid communication has an important role to play in helping to put things right. 2.2 Seven Key Principles Making services safe for patients is fundamental to the provision of high quality care and it is essential that providers of healthcare have sound and reliable systems in place for staff to report when patients have, or could have, been harmed. Open and honest reporting is a vital and integral component of commitment to the safety and welfare of patients As Serious Incidents are important for learning to avoid their future recurrence, the mainstay of reporting is an unimpeachable analysis of the root cause or causes of any given incident. Only through scrutiny and learning of, with service improvement in response to, Serious Incidents can patient experience, safety and quality be assured. 7

8 LPT has a responsibility to expect SIs to be reported in a timely manner, to be effectively and appropriately investigated, with robust action plans developed and implemented with learning shared as appropriate. LPT require its staff to comply with the 7 key principles in the management of all SIs (NHSE SI Framework 2015, part 2). I. Open and transparent NHS Being Open guidance and the Duty of Candour must be followed in relation to a notifiable incident (i.e. an incident involving moderate or severe harm or death). II. III. IV. Preventative There must be a focus on learning and developing safe systems and processes, emphasizing accountability and avoidance of apportioning inappropriate blame. The Incident Decision Tree (IDT) must be used (a relaunch of the IDT will be issued by NHSE during 2015/16 and any updates included in the revision of this local policy). Objective Those involved in the direct care of affected patients must not be investigators, and neither should investigators work directly with those involved in the delivery of that care. Timely and responsive SIs on StEIS and Internal Investigations must be reported within 48 hours of the incident being identified and investigations completed within 60 working days. V. Systems based Root Cause Analysis (RCA) methodology of investigation must be utilised by staff with the appropriate skills, training and capacity. VI. Proportionate Serious Incidents require a comprehensive investigation but LPT recognise that some incidents can be investigated by an individual (with support from others as required). Investigation reports should detail the selection of the panel or individual investigating and provide assurance of their objectivity (re 3 above). VII. Collaborative 1 Where more than one organisation is involved in the provision of care the lead provider must report the SI on StEIS and produce a 72-hour report detailing all other care providers, indicating how they will engage with those providers and co-ordinate any multi-agency investigation report that will be agreed by all parties involved. 1 For multiple commissioners, LLR CCGs will adhere to the RASCI (Responsible, Accountable, Supporting, Consulted, Informed) model in line with the NHSE SI Framework,

9 3.0 Introduction This policy is an organisation-wide document for the Management of Incidents, including the Management of Serious Incidents and applies to all staff employed by LPT. Incident reporting is a fundamental tool of risk management, where we aim to collect information about adverse incidents, including near misses, ill health and hazards, to facilitate wider organisational learning and improve practice. The Trust Board supports a Just culture, which acknowledges that sometimes things go wrong, but as an organisation we learn from our mistakes and take action to put things right. 4.0 Scope The policy applies to all patients, staff, visitors and contractors where injury, damage, loss, harm or near miss occurs within LPT. This may be at premises operated by LPT, or at other locations where work is carried out by or on behalf of LPT. The policy also applies where employees are required to travel between locations as part of their job. This policy outlines the arrangements for identifying, managing, investigating and reporting all incidents, serious incidents and near misses within LPT. The appropriate commissioner will be informed of serious incidents that have occurred within LPT via the LPT Patient Safety Team. 5.0 Confidentiality Reports relating to an incident should contain anonymised information for example the content of any reports relating to Serious Incidents should not contain the names of practitioners or patients. Staff should be referred to by their job title where practical. Other individuals should be referred to by initials only. 9

10 6.0 Definition of an incident An incident is an adverse event that gives rise to, or has the potential to produce, unexpected or unwanted effects which could be detrimental to the safety or health of: Patients; Staff; Contractors; Members of the public; Organisation; Property; Equipment ; The Trust encourages the reporting of all patient safety incidents. This includes: Incidents that you have been involved in; Incidents that you may have witnessed; Incidents that caused no harm or minimal harm; Incidents with a more serious outcome; Prevented patient safety incidents (known as near misses ). (NPSA, 2011). 6.1 Serious incidents are: events in health care where the potential for learning is so great, or the consequences to patients, families and carers, staff or organisations are so significant, that they warrant using additional resources to mount a comprehensive response. Serious incidents can extend beyond incidents which affect patients directly and include incidents which may indirectly impact patient safety or an organisation s ability to deliver ongoing healthcare. (NHSE SI Framework, 2015) There is no definitive list of events/incidents that constitute a SI therefore providers should not produce a local list as this could lead to inconsistent or inappropriate management of incidents. This policy also covers the Managing Safety Incidents in National Screening Programmes Policy October The screening programmes included are: NHS diabetic eye screening programme programme NHS abdominal aortic aneurysm screening programme NHS foetal anomaly screening programme NHS infectious diseases in pregnancy programme NHS sickle cell and thalassaemia programme NHS New-born blood spot programme NHS Newborn hearing screening programme NHS Newborn and infant physical examination programme Definition of a screening safety incident include: any unintended or unexpected incident(s), acts of commission or acts of omission that occur in the delivery of an NHS screening programme that could 10

11 have or did lead to harm to one or more persons participating in the screening programme, or to staff working in the screening programme. harm or a risk of harm because one or more persons eligible for screening are not offered screening. Characteristics are: they occur at a particular point of the screening pathway, at the interfaces between parts of the pathway or between screening and the next stage of care. they can affect populations as well as individuals. Although the level of risk to an individual may be low, because of the large numbers of people offered screening, this may equate to a high population risk. the root cause can be an individual error or a failure of a system(s), or equipment or IT. 6.2 Internal Root Cause Analysis (RCA) Investigation (see Appendix 4) An Internal RCA investigation will be completed on incidents that cause serious concern but do not meet the criteria to be input on to STEIS. The Patient Safety Team will discuss the incident with the relevant directorate leads and confirm which incidents will have an RCA completed. The decision to escalate an incident to an internal investigation will be determined by a number of factors including: The potential risk that the incident will recur Multiple similar incidents with the potential to harm patients The identification of potential care or service delivery issues following initial fact finding An incident linked to a complaint or concern Where it is identified that specialist support is required for the RCA, the specialist leads will be informed e.g. infection prevention control, health and safety, estates and facilities. 6.3 The Reporting of Injuries, Diseases, and Dangerous Occurrences Regulations 2013 (RIDDOR) Reportable Incidents The following must be reported under RIDDOR by the line manager to the Health and Safety Executive (HSE) and to the Trust Health and Safety team without delay; A death or major injury of any person as a result of an accident arising out of or in conjunction with work, for example where serious systematic failures in arrangements for delivery of care indicate significant failure to manage health and safety, and service users are exposed to a high level of risk including death or major injury; Any person at work and not employed by another company/organisation sustaining reportable major injuries as a result of an accident arising out of or in connection with work, including: a) Fracture diagnosed by a registered medical practitioner of any bone except fingers, thumbs or toes; b) Amputation of: arm, hand, finger, thumb, leg, foot or toe; c) Injury diagnosed by a registered medical practitioner as being likely to cause permanent blinding or reduction in sight in one eye or both eyes; 11

12 d) Crush injury to the head or torso causing damage to the brain or internal organs in the chest or abdomen; e) Burn injury (including scalping) which covers >10% of the whole body surface OR causes significant damage to the eyes, respiratory system or other vital organs; f) Loss of consciousness resulting from head injury or asphyxia; g) Any degree of scalping requiring hospital treatment; h) Injury arising from working in an enclosed space which leads to hypothermia or heat-induced illness OR requires resuscitation or admittance to hospital for > 24 hours. People not at work (patients, visitors, etc.) Work related accidents resulting in the person being taken directly to hospital from the scene of the accident for treatment* in respect of the injury; (*examinations and diagnostic tests do not constitute treatment in such circumstances) OR a specified injury a-h listed above if the injured person is already at a hospital; There is no requirement to report incidents where people are taken to hospital purely as a precaution when no injury is apparent; Any dangerous occurrence, i.e: a) Collapse, overturning or failure of load bearing parts of lifts and lifting equipment; b) Electrical incidents causing explosion of fire resulting in stoppage of plant for >24 hours OR cause significant risk of death; c) Exposure to biological agents likely to cause severe human infection or illness i.e. sharps injury from a source patient known to have a positive blood borne infection. An employee or other person at work is away from work or unable to perform their normal duties for more than 7 consecutive days as a result of a physical injury caused by an accident at work. If a doctor (or occupational health service doctor) notifies the line manager that their employee has a diagnosis of a reportable disease and the employee undertakes work that links with that condition, it must be reported under reportable disease e.g. some skin diseases, cancers, occupational asthma, hepatitis and certain musculoskeletal disorders seek advice from the Health & Safety Compliance Team. The death of an employee if this occurs sometime after the reportable injury that led to the employee s death, but not for more than one year afterwards. Retain RIDDOR reports for minimum of 10 years. Please contact the Health, Safety and Compliance Team for further information. 12

13 6.4 Never Events Never Events are defined as seriously, largely preventable patient safety incidents that should not occur if the available preventative measures have been implemented by healthcare providers. Whilst recognising that every incident must be considered on a case-by-case basis, the definitions provided in the NHSE SI Framework, 2015 in part 1, section 1 describe circumstances where a SI must be declared. This includes Never Events from the Never Events List 2015/16 accessible at: To be never event an incident must fulfil the following criteria: The incident has clear potential for, or has caused severe harm/death; There is evidence of occurrence in the past (i.e. it is a known source of risk) There is existing national guidance and/or national safety recommendations on how the event can be prevented and support for implementation; The event is largely preventable if the guidance is implemented; Occurrence can be easily defined, identified and continually measured. (The Never Events list 2015/16) 6.5 Serious Incident Types SIs linked with criminal proceedings LPT should continue with SI investigations where there are criminal proceedings linked to the event/incident. However LPT acknowledges that there will be exceptional cases where SI investigations may be put on hold (i.e. following a formal request by police, HM Coroner or Judge) In such cases LPT will submit written evidence of this to Head of Patient Safety at the CCG as part of the Extension Request process and make reference to this when the SI report is produced. This will also apply to internally investigated SIs Deaths in custody where health provision is a commissioned service LPT will report as an SI, any severe harm or death of people in custody who are actively receiving ongoing healthcare within the custody setting, or where the incident occurs during the provision of healthcare, including those detained under the Mental Health Act (1983). A short form template will be completed for these incidents. LPT will cross reference their short form report against the PPO or IPCC final report and additionally share this with LLR CCGs for identification of potential additional learning opportunities. For mental health patients who die whilst detained under the Mental Health Act (1983) or where the Mental Capacity Act (2005) applies, LPT must report the incident to the CQC as soon as the incident is identified. All such incidents must be subject to an investigation. For those deaths where the cause of death is unknown and/or where there is reason to believe the death may have been avoidable or unexpected (i.e. not caused by the natural course of the patient s illness or underlying medical condition when managed in accordance with best practice including suicide and self-inflicted death) then the death must be reported as a SI and investigated through this route. 13

14 6.5.3 Safeguarding Local Authorities have a particular role to play in safeguarding adults and children and young people in vulnerable circumstances. Providers and commissioners must ensure that information about abuse or potential abuse is shared with Local Authority safeguarding teams. Providers and commissioners must liaise regularly with the local authority safeguarding lead(s) to ensure that there is a coherent multi-agency approach to investigating safeguarding concerns, which is agreed by relevant partners. (See appendix 10) The interface between the serious incident process and local safeguarding procedures are articulated in the local multi-agency safeguarding protocol and policies Safeguarding Children Child deaths, significant harm and serious sexual abuse may or may not trigger an SI review; however all are reported to the LSCB (Local Safeguarding Children s Board). An SI will be reported in accordance to the criteria below: Unexpected death Where the death of the child was not anticipated within a 24 hour period following the incident, the following criteria apply to determine the reporting route: There are suspicious concerns and/or healthcare management issues identified. There are no suspicious concerns, but healthcare management issues have been identified. The case needs to be reported as an SI and reported to the LSCB CDOP Child Death Overview Panel (CDOP). Once the SI investigation report is complete, it must be submitted to the LSCB CDOP and LLR CCGs patient safety team for review and closure; There are possible suspicious circumstances or child protection concerns, but no care management issues identified. The case needs to be reported to the LSCB for consideration as to whether or not a serious case review (SCR) should take place and to the CDOP. If no care management issues are confirmed, the case does not require reporting as an SI There are possible suspicious circumstances or child protection concerns and healthcare management issues. The case needs to be reported to the LSCB for consideration as to whether or not a SCR is required, however, this should not hamper the Trust s internal investigation. The final SI report must be submitted to the LSCB and LLR CCGs patient safety team in accordance to agreed timescales. Where the death of a child is caused by a mental health service user and the LSCB investigation would not cover the full requirements of HSG 94/27. Expected (anticipated) death Where the expected death of a child was anticipated within a 24 hour period following the incident, no SI investigation is required but the case needs to be reported to the LSCB (CDOP) for review; (unless the death was anticipated but was following a patient safety incident) Processes have been developed regarding the interface between SI reporting in health services serious case reviews and child death reviews. 14

15 Child harm (significant) Where a child has been significantly harmed but not died as a result of, the following considerations need to be explored as to whether the incident is an SI or not: Has the harm occurred on NHS premises, as a result of NHS funded care, or caused by the direct actions of healthcare staff? If not to all the above, it is useful to consider whether or not the child has been in receipt of healthcare within the last 12 months. If so, the case will need to be reported as an SI as well as to the LSCB; Any child under the age of 18 admitted to an adult mental health ward qualifies as an SI; Allegations of serious abuse (physical/mental/sexual) against healthcare staff who work with children must be reported as an SI and to the designated safeguarding professional. For further guidance, please refer to LLR Safeguarding children and adults policy Serious Case Reviews (SCR) and Safeguarding Adult Reviews This section is to be read in conjunction with the NHSE SI Framework 2015/16 and: LLR Adult Safeguarding Procedures - Care and Support Statutory Guidance Issued under the Care Act 2014 Department of Health /Care-Act-Guidance.pdf The interface (Memorandum of Understanding) between the SI process and local safeguarding procedures is articulated in the LLR Adult Safeguarding Procedures. Providers should contribute towards the statutory requirement on safeguarding reviews (and enquiries) as required to do so by the Local Safeguarding Board and where it is indicated that a SI within healthcare has occurred, this must be reported to LLR CCGs under the SI procedures in addition to the joint working arrangements Reporting safeguarding alerts to Adult Social Care In Leicester, Leicestershire and Rutland all alerts will usually be made to the lead agency, which is Leicester City Council, Leicestershire County Council or Rutland County Council, depending on the individual s place of residence Adult Serious Reviews (ASRs) and Domestic Homicide Reviews (DHRs) Domestic homicide incidents should be declared and managed as SIs in line with the NHSE SI Framework The NHSE SI Framework 2015 provides definitions and indicates that the initiation of a DHR does not automatically constitute a SI in the healthcare service. Providers should contribute towards the statutory requirement on all ASRS and DHRs (and enquiries) as required to do so by the Local Safeguarding Board. Where it is indicated that a SI within healthcare has occurred, this must be reported to LLR CCGs under the SI procedures in addition to the joint working arrangements. 15

16 6.5.7 Loss of Confidential Information The Trust will follow the latest Department of Health Guidance Checklist for Reporting, Managing and investigating Information Governance SI (Jan 2009), which states that any incident involving the actual or potential loss of personal information that could lead to identity fraud or have other significant impact on individuals should be considered as serious Never Events Never events are serious, largely preventable patient safety incidents that should not occur after the preventable measures have been implemented. The reporting and management of Never Events is therefore built upon existing safety processes and mechanisms already established within the NHS. Never Events must be reported as an SI in accordance with this policy. From 07 February 2012 at the time of reporting a Never Event, the AT will be asking organisations to be clear about the following information for each member of staff involved without breaching the confidentiality of individuals; When was their last appraisal Did it include ( relevant to the issue ) adherence to the WHO Surgical Checklist Whether this is the first issue with which the individual has been involved What remedial or disciplinary action has/ is being considered or has been taken to that point Referral to a professional body - GMC, NMC, HPC. Status of that referral to date SIs Linked to IT Incidents NHS Clinical Safety Management System aims to ensure that IT systems implemented in hospitals, GP practices, pharmacies, prisons and other healthcare environments are delivered, deployed and operate in an acceptably safe manner for patients (NHS Connecting for Health (CfH) Clinical Safety Incident Management Process ) and comply with DSCN 14/2009 (System Suppliers) and 18/2009 (Organisations) SI (including near misses that have put patients at risk) of IT system failures, must be reported as a SI. Examples are: Loss of clinical data due to adverse event with no back up available; Data corruption, such as incorrect merging of clinical records; Inappropriate access to clinical records, such as incorrect procedure followed to ensure correct patient identified; Misuse of access rights, such as using smartcard to view persons clinical records where no legitimate relationship (not under individual or services care) for clinical care exists. IT related Clinical incidents involving software within the CfH product set should also be reported to the IT Local Help desk initiating CfH processes to be undertaken in parallel with this policy. 16

17 6.6 Examples of incidents Please note that this is not an exhaustive list but merely an indication of the types of incidents that should be routinely reported: Accidents: Slips, trips & falls, cuts, burns, bumps, muscular strains, manual handling injuries, car accidents. Clinical Incidents: Error or mishap in clinical procedure, incorrect prescription or administration of drugs, absconding patients, self-inflicted injuries, incidents leading to increased length of stay, or unplanned readmission, sharps injury. Violent/Unsociable Behaviour: Assault (physical, verbal or sexual), violent, aggressive or severely disruptive behaviour by patients, staff or a member of the public, theft and damage to property. Hate incidents: an incident which may or may not be a crime of abuse in any form including but not exclusively physical violence, verbal abuse, damage to property, where the victim or other persons perceive the act to have been motivated by prejudice of hostility towards any aspects of a person s identity e.g. Disability, gender identity, race, ethnicity, nationality, religion, faith, belief, sexual orientation or alternative sub cultures. Dangerous Occurrences: Electrical or mechanical faults, fire (including false alarms), equipment malfunction or failure which may result in risks to employees, patients, visitors or contractors, spillage of hazardous substances or explosions. Medical Devices (e.g. Catheters, Dressings, Endoscopes, Examination gloves, Hospital beds, Implants powered and non-powered, Incontinence products, IV administration sets and pumps, Ophthalmic equipment, Patient monitoring equipment (e.g. cardiac monitors), Physiotherapy equipment,, Sphygmomanometers, Surgical instruments and equipment, Syringes and needles, Thermometers, Urine drainage systems, Vaginal specula,): Any adverse incident involving a device or its instructions for use, especially if the incident has led to or, were it to occur again, could lead to: Death, life-threatening illness or injury; Deterioration in health or permanent impairment of body structure or function; The necessity for medical or surgical intervention (including implant revision) Hospitalisation or prolongation of existing hospitalisation; Unreliable test results and associated risk of misdiagnosis or inappropriate treatment. Ongoing faults that successive service/maintenance visits have failed to rectify this must be reported as an incident within LPT. When a report form is submitted to the MHRA, a unique reference number will be generated; this should be reported to the incident team. A comprehensive list of what constitutes a medical device can be found in the LPT Medical Devices Policy. 7.0 Flowchart/process chart 17

18 I. SI FLOW CHART 60 days Incident reported identified as SI Heads up SI to all leads If not clearly identifiable from incident details PST to request 72 hour report If clearly identified as STEIS reportable from incident details report onto STEIS (24 hours) If not STEIS reportable internal SI process begins If 72 hour report identifies STEIS reportable. PST to report onto STEIS 72 hour report forwarded onto commissioners Head of Service to complete ToR and embed in 72 hour report and identify lead investigator and inform PST PST for forward ToR to Commissioners SI investigation and interim meetings with Commissioning Manager Draft report to Head of Service and PST for comments Draft report returned to investigator with changes/amendments/additional information/clarification Amended report back to Heads of Service for completion of action plan - Final report and AP complete and sign off agreed within the Division. Forward to PST for submission to Commissioners 18

19 II. Clinical Governance and Adult Safeguarding Process 19

20 III. IT Clinical Incident Management Procedure IT Clinical Incident Management Procedure User /Service identify actual / potential clinical incident involving IT Trust Incident Form e.g. IR1 completed Trust service lead and (Clinical) IMT Lead informed YES Is the clinical system part of the National Programme for IT? E.g. SystmOne, icm, Lorenzo NO Local Service Desk (LSD) informed LSD escalate as clinical risk to National Service Desk and record National Incident Number IT and Service Lead initiate combined investigation in accordance with RAG grading Local incident reporting mechanisms initiated as per local procedures e.g. SUI reporting procedure Graded Green/Amber? Investigation undertaking in line with Trust policy Graded RED? SUI process employed Inform Local Service Desk Mark as Potential / Actual clinical risk Inform SHA? Needs Escalating? Trust investigation officer liaise with CfH Clinical Safety Team Trust investigating officer liaise with: SHA Clinical Safety Officer SHA Patient Safety / SUI lead Connecting for Health (CfH) Safety team Document Actions / Outcomes of investigation Communicate to SHA Clinical Safety Officer to facilitate learning Document of actions / outcomes shared with SHA Clinical Safety Officer and National Service Desk 20

21 8.0 Duties and Responsibilities within the Organisation Organisations providing NHS funded care in England are required to demonstrate accountability for effective governance and learning from a serious incident. The leadership at a provider organisation is ultimately responsible for the quality of care that is provided by that organisation. Serious incident management is a critical component of corporate and clinical governance, and providers are responsible for arranging and resourcing investigations and must ensure robust systems are in place for recognising, reporting, investigating and responding to serious incidents. The principles and processes associated with robust serious incident management must be endorsed within an organisation s Incident Reporting and Management Policy. The NHS has a responsibility to ensure that when a serious incident does happen, there are systemic measures in place for safeguarding people, property, the service s resources and its reputation, and for understanding why the event occurred. There is also a responsibility to ensure that steps are taken to reduce the chance of a similar incident happening again. Taken from: National framework for reporting and learning from serious incidents requiring investigation (NPSA) (Aug 2009). All organisations should ensure their staff understands what constitutes a serious incident and the procedures in place to ensure incidents are investigated and managed in an appropriate way. LPT has a legal obligation to ensure that all incidents, accidents and near misses are managed and reported appropriately. We are accountable to our commissioners, through contracting and commissioning arrangements, and also to NHS England in relation to specific categories of serious incidents. The Senior Information Risk Owner (SIRO) (Chief Nurse and Executive Director of Quality) is responsible for ensuring that information risk and any information incidents are managed in accordance with the Department of Health Guidance Checklist for Reporting, Managing and Investigating Information Governance Serious Incidents (Jan 2009). 8.1 All staff (who are involved in/witness or become aware of any incident): It is mandatory for staff to report all incidents in accordance with this policy; An electronic incident form (eirf) must be completed immediately after the incident or by the end of the working day; When a member of staff becomes aware of the incident it is his/her responsibility to inform the manager of the service and to do what he or she can to make the situation as safe as possible. All staff have a responsibility to cooperate and assist fully with the investigation of incidents and provide factually accurate and comprehensive statements if asked to do so. All staff with responsibility for or who are involved in record keeping must ensure that there are contemporaneous notes in place which cover the events that have occurred. This must include all facts related to the incident, when it was known that an incident occurred, the actions taken in response to the incident, the care and treatment provided to the patient. 21

22 For Serious Incidents, all staff within the reporting lines must keep an updated chronology of the events which occurred and draft witness statements as soon as possible after the incident. (refer to Appendix 7). All staff may be required to provide additional information on incidents during investigations; this may include provision of further statements or attendance at interviews. 8.2 Line Managers Line managers are responsible for ensuring: that all staff have had access to this policy, and have read and understood it and that all relevant staff attend incident reporting training; that the incident is reported on the eirf system; that all necessary remedial action has been taken to make the service/area safe and to prevent a recurrence of the event; that the manager s form on Safeguard is completed within 5 working days and includes details of all actions taken to date. This will be monitored by the Incidents Team; that Serious Incidents are escalated to Patient Safety Team using the eirf system, and as appropriate to the Head of Service; that a verbal apology is given to the patient and their family/carer in accordance with the Duty of Candour Policy for all patient safety incidents. A written record should be kept of this apology in the patient s records and also recorded on the Duty of Candour tab on Safeguard; Immediate collection of basic background information after the incident, to inform any investigation; if the incident involves/ or there is concern over child protection issues/vulnerable adult issues, they must contact the Head of Safeguarding for Children and Adults; that any RIDDOR incidents are notified to the Trust Health, Safety and Compliance Team in addition to reporting to the HSE without delay; that 72hr reports are completed within the timescale given by the patient safety team this will be monitored and tracked by the Patient Safety Team; that if a member of staff is involved they are provided with appropriate support including a referral to Occupational Health Department or Accident and Emergency where this is deemed necessary; that any actions resulting from an investigation are implemented; that any learning as a result of the incident is disseminated and shared amongst their team and elsewhere as appropriate. 8.3 Heads of Service and Clinical Governance Leads Ensure that all incidents are investigated and analysed, so that learning and improvements are identified to ensure these are embedded in practice; Ensure that the principles of the Duty of Candour are implemented when dealing with incidents; Responsible for ensuring the appropriate escalation of potential Serious Incidents to the Patient Safety Team and Divisional Director; 22

23 Responsible for ensuring that the Health and Safety team have been contacted if the incident is reportable under Health and Safety Legislation or would attract the attention of the HSE; Ensure the review of investigation reports through divisional sign-off processes before submission to commissioners; Ensure that a comprehensive 72hr report has been submitted to the patient safety team within the timescale with terms of reference for the investigation embedded and the Duty of Candour section complete; Ensure that any feedback from the commissioners on SI reports is responded to within the given timescale. The On Call Manager has responsibility for notifying the On Call Director if a serious incident is reported to them during the out of hours period. The On Call Director has responsibility for the management of serious incidents during the out of hours period. 8.4 Divisional Directors will act as sponsor for each SI investigation, ensuring sufficient time and resource is made available to investigator(s); will establish an agreed group of professionals to review and critique SI reports before submission to commissioners to ensure high quality reports are submitted in a timely manner; Sign off the final investigation report when satisfied that it is robust and of a good standard before it is submitted to the Commissioners. 8.5 Trust Lead Risk and Patient Safety and Patient Safety Manager In the event of an incident the Trust Lead Risk and Patient Safety or Patient Safety Manager will: Decide which incidents meet the criteria for reporting to the Co-ordinating Commissioner (outlined in this policy) and ensure that those that do are reported; Request a 72hr report on the incident and give a timeframe for completion; Review responses to commissioner feedback before reports are re-submitted; Identify any SI investigations which will not be completed within timescale due to circumstances which cannot be changed e.g. sickness of key witnesses and request extensions under circumstances agreed with the commissioners; Attend where possible the Divisional SI sign off meetings; Produce monthly and quarterly reports identifying SIs reported, progress with SI investigations and quantitative and qualitative analysis of the more common incident reports. These will be shared through the LPT Governance structure and to the Quality Assurance committee; Provide training for staff regarding the Serious Incident (SI) investigation process as required; Ensure all incidents are processed according to severity and potential impact Ensure all incidents are triaged within 1 working day of initial report as a fail-safe to formal SI notification processes (see 6.2). 23

24 8.6 Incidents Team Leader On receipt of the electronic Incident Reporting Form (E-IRF), the Incidents Team Leader will: Ensure that systems are in place to report all Patient Safety Incidents (PSIs) within the requirements of the NRLS (National Reporting and Learning System); in line with the NRLS Data Quality Standards; Maintain the data system for recording physical assaults on staff in line with NHS Protect definitions and provide reports from the data to the Local Security Management Specialists and / or other persons as required by their role; Provide, on request, analysis of accident and incident trends and report to the relevant groups as detailed above. The analysis will highlight where possible deviations from the norm, areas of good practice, and potential areas of poor performance requiring further investigative work by the appropriate service or group; Ensure information and training is provided for staff regarding grading of incidents and completion of eirfs; Ensure that all incidents of staff assault are uploaded within the requirements of the Security Information Reporting System (SIRS). 8.7 Risk Manager Report incidents involving medical devices to the Medicines and Healthcare Products Regulatory Agency (MHRA). 8.8 Head of Information Governance In the event of an incident involving security of information the Information Governance Team will be responsible for assessing the incident category and notifying relevant external bodies and appropriate key staff and organisations in line with Department of Health Guidance. An incident should be categorised at the highest level that applies when considering the characteristics and risks of the incident. The Guidance for assessment of the severity of the incident could be found in the Appendix 1. The immediate response to the incident and the escalation process for reporting and investigating will vary according to the severity of the incident. 8.9 Trust Lead for Safeguarding Children and Adults On receipt of a safeguarding incident, the Trust lead for safeguarding will: Ensure that staff follows the multi-agency safeguarding procedures agreed by the Local Safeguarding Adult Board and Local Safeguarding Children Board. Provide guidance and support to named professionals and managers with investigation processes. Review the investigation report to ensure that safeguarding risks are managed. Communicate with Designated Professionals and LSAB & LSCB board areas where there are parallel investigation processes in place, i.e Child Death Overview Processes, Serious Case Reviews, Significant Incident Learning Processes. 24

25 8.10 Head of Trust Health & Safety Compliance In the event of an incident that: is reportable under RIDDOR or has resulted in harm, injury or near miss to a member of staff, visitor or contractor; results physical or criminal damage to the buildings or environment; is in breach or contravenes any health and safety legislation. The Head of Trust Health & Safety Compliance will be responsible: assessing the level of investigation required; undertake as appropriate RIDDOR and incident investigation and maintain records; to liaise with the Health & Safety Executive; for investigations undertaken resulting from incidents which identify further risk to the organisation, undertake appropriate risk assessments, develop action plans to address and ; transfer as appropriate to the organisational risk register based on the risk assessment; escalate and provide reports as appropriate in line with the policy to the Health and Safety Committee and the Quality Assurance Committee Chief Nurse Ensuring that this policy is implemented and effective within the Organisation. Is the Executive Lead for the management of incidents. Will chair an executive oversight group responsible for reviewing and agreeing Serious Incident Reports and ensuring action plans are implemented and provide assurance that lessons are learnt Role of the Chief Executive The Chief Executive holds ultimate accountability for patient safety and will scrutinise SI and incident reports and trend analysis as part of the integrated performance report. The Chief Executive will champion the non-punitive stance of the Trust board and lead an open culture of learning and continual improvement 8.13 Role of the Quality Assurance Committee (QAC) The QAC will receive highlight reports from the corporate Patient Safety and Experience Group and the Health and Safety Committee on issues regarding Serious Incident Investigations. The Q.A.C will receive exception reports i.e. areas of concern Corporate Patient Safety Group The Patient Safety Group will receive and monitor the patient safety report and report by exception to Quality Assurance Committee. The Group shall make whatever recommendations to the Quality Assurance Committee it deems appropriate on any area within its remit where action or improvement is needed. 25

26 8.15 The Health and Safety Committee The Health and Safety Committee will receive and monitor non clinical incidents quarterly reports which include RIDDOR incidents, Security Management Services quarterly report and report by exception to the Quality Assurance Committee Role of the Trust Board As part of the Integrated Quality and Performance Report (IQPR) the Trust board will review performance of SI investigations, and identified trends, track action plans and recommendations. They will seek assurance that lessons have been learned and appropriate action has taken place to reduce risk. The Trust Board has a legal responsibility for Trust policies and for ensuring that they are carried out effectively. Trust Board Sub-committees have the responsibility for ratifying policies and protocols Role of NHS England Area Team (AT) Commissioners will report to the NHS England Area Team as appropriate. Communications and media relations are an integral part of the SI process. The AT will work with commissioners and provider organisations to ensure that where a serious incident could attract media attention, appropriate media handling strategies are put in place. Where political interest is likely the AT will liaise with the NHS Business Unit at the Department of Health on behalf of the region Role of Commissioners The Commissioner of the reporting provider will provide clarity to all organisations when more than one provider within its locality is involved in a serious incident. The Commissioner will advise on whom the co-ordinating organisation should be and identify the key stakeholders. If however any of the providers involved are outside of the commissioner s boundary then the NHS England Area Team must be informed who will then assist in the decision as to the co-ordinating organisation. The co-ordinating organisation will, in discussion with the aforementioned organisations, arrange a meeting that includes all key stakeholders to establish the scope of the investigation and terms of reference. At this meeting a lead professional of an appropriate level and seniority will be nominated to lead the investigation. All key stakeholders will contribute and work together with the nominated lead to ensure a comprehensive report is produced. 26