NHS Northamptonshire Policy for the Reporting and Handling of Serious Incidents (SI)

NHS Northamptonshire Policy for the Reporting and Handling of Serious Incidents (SI) Version: 2011 Ratified by: Executive Management Team on behalf of the NHS Northamptonshire Board Date Ratified: 6 April 2011 Name of Originator/ Author: David Knight Associate Director Patient Safety Name of Responsible Individual: Jan Norman Director of Safeguarding Date Issued: 7 April 2011 Review Date: April 2012 Target Audience Provider Organisations NHS Northamptonshire commissioning arm Page 1 of 41

Contents Policy for the Reporting and Handling of Serious Incidents (SI)... 1 1.0 Introduction... 4 2.0 Purpose... 5 3.0 Duties... 6 4.0 Definitions... 10 4.1 Serious Incident:... 10 4.2. Homicides by Mental Health Patients... 11 4.3. Suicides... 12 4.4. Safeguarding children and adults... 12 4.5. Deaths and Serious Injuries in Custody... 15 4.6. Healthcare Associated Infections... 15 4.7 Norovirus out-breaks... 17 4.8 Maternity Services... 18 4.9 Loss of Confidential Information... 18 4.10 Screening Incidents... 19 4.11 Never Events... 20 5.0 Reporting Requirements... 21 6.0 Reporting and investigation outcomes... 23 7.0 Monitoring Compliance... 25 8.0 Related Protocols... 26 Appendix 1 Reporting Framework Flowchart... 27 Appendix 2 Grading Process for SIs in Northamptonshire... 28 Appendix 3 Quality Assurance Critique Tool... 29 Appendix 4 (NHSN) Serious Incident (SI) Sign off structure... 33 Appendix 5 Information Governance Checklist... 35 Appendix 6 Minimum Standards for Investigation Reports... 36 Appendix 7 Minimum Standards for Action Plans... 38 Equality Impact Assessment... 40 Page 2 of 41

Contact details For provider organisations when contacting NHS Northamptonshire In hours NHS Northamptonshire Patient Safety Team Tel: 01604 651185 Northants.SUI@nhs.net Associate Director for Patient Safety Tel: 01604 651748 Mobile: 07769 683230 Out of Hours NHS Northamptonshire Director on Call Tel: 07796 548664 (Only to be used for very serious incidents as per paragraph 5.5 of this policy) For NHS Northamptonshire when contacting NHS East Midlands In hours NHS EM Directorate of Patient Care Tel: 0115 968 4439 Out of Hours NHS East Midlands Senior Manager on call Tel: 08700 555500 Give call group code NHSEM1 Page 3 of 41

1.0 Introduction 1.1 Making services safe for patients is fundamental to the provision of high-quality care and it is essential that providers of healthcare have good systems in place for staff to report when patients have, or could have been harmed. Open and honest reporting demonstrates a commitment to patients and their safety and is a mark of high reliability. The focus on reporting should be on analysing the root cause of the incident because serious incidents yield important lessons about changing processes to reduce risk. 1.2 In December 2010 David Nicholson issued Equity and excellence: Liberating the NHS managing the transition and the 20011/12 operating framework which states that commissioners will carry out their functions with a view to securing continuous quality improvement.the duty will cover the three domains of quality. safety, effectiveness and patient experience and will support a system focused on improving outcomes for patients. Learning from the investigation of serious incidents is key to improving patient outcomes. Page 4 of 41

2.0 Purpose 2.1 The purpose of this Policy is to make explicit the requirements for managing Serious Incidents (SIs) for the Northamptonshire health care community. Definitions of SIs are provided in section 4 of this policy. 2.2 NHS Northamptonshire expects all organisations commissioned to provide healthcare within the county to incorporate the requirements of this policy into their contracting arrangements and own local policies. This document details the PCT s approach in supporting learning and performance managing services commissioned by NHS Northamptonshire. 2.3 NHS Northamptonshire, in consultation with provider organisations, will update this policy in keeping with any national changes to the definition of SIs. 2.4 This policy should compliment, not replace, the incident reporting systems already in place within NHS organisations. It does not replace the duty to inform the Police and other authorities, such as Social Care, where appropriate. National guidance governs certain types of incidents e.g. homicides and other serious incidents involving mentally ill people (HSG/94/27) and arrangements for dealing with major incidents (HSC/98/197). In certain specific instances organisations will need to inform other agencies in accordance with national guidance, such as the Medicines and Healthcare products Regulatory Agency (MHRA) in the case of equipment failure, the Care Quality Commission (CQC), the Counter Fraud Operational Service in the case of fraud and the Health Protection Agency in cases of infection control. In such circumstances this SI policy should be followed in conjunction with the relevant national guidance. Page 5 of 41

3.0 Duties NHS Northamptonshire 3.1. NHS Northamptonshire performance monitors the contract in place with each of its provider organisations as required by the SHA and has developed systems and processes to enable lessons to be learned from SIs. 3.2. NHS Northamptonshire is required by the Department of Health to receive information on all SIs from all organisations from whom they commission NHS services. 3.3. NHS Northamptonshire receives timely information from our providers (Northampton General Hospital NHS Trust, Kettering General Hospital NHS Foundation Trust, Northamptonshire Healthcare NHS Foundation Trust, NHS Northamptonshire Provider Services and all independent providers/contractors, prison healthcare and any others providing care to NHS patients regarding all SIs and related investigation reports. This is required to: Ensure any relevant remedial action is made as soon as possible Ensure appropriate engagement in a joint investigation Support good governance Ensure that questions from the public and or media can be managed appropriately Share lessons learned across all providers Inform future commissioning discussions 3.4. In order to facilitate dissemination of lessons learned from the investigation of Sis, the NHS Northamptonshire patient safety team has regular meetings with individual provider organisations. At the end of the financial year NHS Northamptonshire publicly reports on Never Events (see section 4.9) and incidents of data loss (see section 4.7). 3.5. NHS Northamptonshire supports provider organisational learning and benchmarking through quarterly SI Assurance Meetings and quarterly Clinical Quality Review Meetings with individual organisations. At the individual organisation SI Assurance Meetings providers must supply updates on the implementation of, and outcomes from, Page 6 of 41

SI investigation report action plans. This may also include, where appropriate, assurance from providers on actions plans following Coroner s Rule 43 reports. 1 3.6. The NHS Northamptonshire Patient Safety team monitors the NHS Strategic Executive Information System (STEIS) for new incident reports on a daily basis. Incidents are graded using the grading matrix (appendix 2) within five working days. The grading result is communicated on the STEIS report. 3.7. On receipt of a completed investigation report and action plan the NHSN Patient Safety team use the quality assurance document (appendix 3) to assess the report and action plan within 10 working days. The NHSN Patients Safety Team then either recommends that the NHSN SI Assurance and Review Group (terms of reference for the group are provided as appendix 4) close the investigation on STEIS; or liaises directly with the reporting organisation within 20 working days to agree further action required and timeframe for completion of those actions. 3.8. NHS Northamptonshire will close an investigation when the investigation report clearly identifies learning including findings, contributory factors and conclusions and recommendations. 3.9. The Trust Board receives assurance through the reporting processes in place in NHS Northamptonshire for compliance with agreed timeframes to grade the seriousness of SIs; submission of investigation reports from provider organisations and, review of submitted reports. Provider Organisations 3.10. Providers of healthcare to NHS patients must report incidents that fulfil the SI criteria outlined in section 4 of this policy to NHS Northamptonshire on the NHS Strategic Executive Information System (STEIS). This includes NHS Foundation Trusts, Prison Health Care, the Independent Sector, Primary Care Independent Contractors and Care Homes where the NHS is paying for the care provided. Those providers without access to STEIS should contact the NHS Northamptonshire Patient Safety Team directly. Contact details for the NHS Northamptonshire patient safety team are provided on page 3 of this policy. 1 Guidance for Coroners on Rule 43 pub: MoJ 2008 Page 7 of 41

3.11. Chief Executives of the provider organisations are required to identify an Executive Lead for the management of incidents. The Executive Lead is required to develop and implement an effective risk management system, providing staff with a clear framework for prompt incident reporting. This must include training and support to ensure that appropriate action takes place, risk is mitigated and there is a strong culture of learning and improvement. 3.12. When more than one organisation is involved in an SI, it is the responsibility of the organisation identifying the SI to liaise with the other organisations involved to agree which organisation will report on STEIS. The organisation with the most significant involvement in the SI will take the lead in investigating the incident. This involves collaboration with other organisations involved in the incident and/or managing the outcome. 3.13. All organisations are required to contribute to the root cause analysis (RCA) investigation in a timely, responsive and cooperative manner. The NHS Northamptonshire Patient Safety Team may be contacted to provide support, advice or assistance in brokering an agreement to identify the lead organisation if this is either unclear or is disputed. 3.14. All provider organisations must ensure they have a mechanism in place for reporting incidents to the National Patient Safety Agency (NPSA) through the Reporting and Learning System (RLS) and directly to the CQC if this is required. 3.15. Provider organisations must inform NHS Northamptonshire if they are considering commissioning services (or parts of) through other organisations and must assure NHS Northamptonshire that any commissioned services are compliant with this policy. Strategic Health Authority (SHA) 3.16. NHS East Midlands (NHS EM) is required by the Department of Health to receive information on all SIs via all Commissioning PCTs and the contractual arrangements with the providers from whom they commission services for NHS patients. This encompasses all East Midlands providers of health care to NHS patients, including foundation trusts, primary care independent contractors, independent sector treatment Page 8 of 41

centres, prison healthcare and any others providing care to NHS patients. NHS EM supports the Commissioning PCTs as a critical friend and supplies benchmarked information and offers solutions for improvement. 3.17. NHS EM works in partnership with Commissioning PCTs and provider organisations to provide leadership and vision for patient safety throughout the East Midlands, encouraging openness and the development of a learning culture, providing support and expert advice to shape and train the workforce enabling commissioning PCTs to have the capacity and capability to effectively undertake their role, and support providers in carrying out local investigations. 3.18. Where a Commissioning PCT has an SI within its own working practices, the SHA will monitor the progress of the investigation and assure itself that a robust, systematic investigation has been conducted. 3.19. NHS EM is also the local supervising authority for midwifery services. All SIs, as defined in the LSA Guideline Reporting and Monitoring of Serious Incidents and Events July 2006, must be reported to the Local Supervising Authority Midwifery Officers (LSAMO) and reported as an SI on the Strategic Executive Information System (STEIS). Other midwifery incidents which are not deemed an SI but are reportable under this guideline do not require reporting on STEIS. 3.20. NHS EM remains responsible for reviewing all homicides committed by mental health service users and other very serious incidents as determined by the Policy for Managing and Investigating the Most Serious Events in Mental Health Services, June 2008. In the event of such an incident, NHSEM will review internal investigation reports for assurance that criteria for commissioning an independent investigation are met. If appropriate, NHSEM will commission the investigation; liaise with relevant stakeholders; publish findings; performance monitor action plans and share learning across the NHS. 3.21. Communications and media relations are an integral part of the SI process. NHS EM will work with Commissioning PCTs 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 NHS East Midlands will liaise with the NHS Business Unit at the Department of Health on behalf of the region. Page 9 of 41

4.0 Definitions 4.1 Serious Incident: An incident (including healthcare associated Infections) where care management failures are suspected, which resulted in serious neglect, serious injury, major permanent harm or death (or the risk of) to a patient as a result of NHS funded health care An accident occurring on NHS premises that resulted in serious injury, major permanent harm or death (or the risk of) to a patient, member of staff, contractor or member of the public or any other person. The actions of staff providing NHS funded care that are likely to cause significant public concern i.e. serious instances of abuse (physical/sexual/mental). An event that might adversely impact on the delivery of services causing invocation of the Trusts business continuity plan, initiation of the major incident policy or may reflect a serious breach of standards. (NB: Any media issue that is not related to a serious incident must not be reported through STEIS but through relevant communication teams.) Any incident which meets the definition of an SI must be reported on STEIS. Where it is uncertain whether an incident is an SI, discussions with the NHS Northamptonshire patient safety team should take place. Contact details for the NHS Northamptonshire patient safety team are provided on page 3 of this policy. Commissioned services without access to STEIS should report to NHS Northamptonshire through their locally agreed process. Supplementary terms An Incident is an event or circumstance which could have resulted, or did result in unnecessary damage, loss or harm Permanent harm permanent lessening of bodily functions, including sensory, motor, physiological or intellectual Major harm hazard to life or function of an organ, requiring life saving intervention (surgical / medical) or will shorten life expectancy Page 10 of 41

Abuse violation of an individual s human rights. This could be physical, mental, or sexual 4.2. Homicides by Mental Health Patients NHS EM is responsible for commissioning independent investigations. While the reports generated are the property of the SHA, a full copy of the final report will be shared with NHS Northamptonshire to ensure learning is disseminated. Commissioning in this context refers to determining when an independent investigation is necessary, appointing an independent investigation team, agreeing terms of reference, publishing and distributing the resultant report and ensuring a process for subsequent action to address issues raised. NHS Northamptonshire will review and where appropriate comment on the independent investigation terms of reference. NHS EM will update NHS Northamptonshire on the progress of the investigation on a quarterly basis as a minimum. A decision on whether the final independent investigation report will be anonymised will be taken at the time terms of reference are being agreed. A final draft of the independent investigation report will be shared with NHS Northamptonshire before a final definitive version of the report is agreed with NHS East Midlands. A copy of the full investigation report and any summary documents will be provided to NHS Northamptonshire in electronic and hardcopy format. NHS Northamptonshire will be consulted on the media and press briefing process in advance of the report being made public. Liability for the payment for these investigations rests with the PCT where the perpetrator resided at the time of the incident. Criteria for independent investigations An independent investigation should be undertaken in the following circumstances: A homicide has been committed by a person who is or, has been under the care, i.e. subject to a regular or enhanced care programme approach, of specialist mental health services in the six months prior to the event. Page 11 of 41

It is necessary to comply with the State s obligations under Article 2 of the European Convention on Human Rights. Whenever a State agent is, or may be, responsible for a death, there is an obligation on the State to carry out an effective investigation. This means that the investigation should be independent, prompt, provide a sufficient element of public scrutiny and involve the next of kin to an appropriate extent. The SHA determines that an adverse event warrants independent investigation, for example if there is concern that an event may represent significant systemic service failure, such as a cluster of suicides. 4.3. Suicides Suspected suicide, actual suicide and attempted suicide of any person currently in receipt of NHS services on or off NHS premises should be reported as a SI. This includes: Patients currently in receipt of mental health services, or who have been discharged within the last 12 months. Patients of primary care practitioners. Patients receiving treatment in an acute setting Suicide is defined as death where: There is obvious evidence or strong suspicion of self harm, or The above does not apply initially but emerges later from a clinical review or investigation of the case, or Where the Coroner s verdict is suicide, or where the narrative indicates that the individual took their own life 4.4. Safeguarding children and adults Child deaths, significant harm and serious sexual abuse may or may not trigger an SI review; however all are reported to the Northamptonshire Safeguarding Children s Board (LSCB). SIs will be reported in accordance to the criteria below: Expected Death (anticipated) Where the death of a child was anticipated within 24 hour period No SI investigation is required but the case needs to be reported to the LSCB child death panel for review. Unexpected Death Page 12 of 41

Where the death of the child wasn t anticipated within a 24 hour period And there are no suspicious concerns and no healthcare management issues identified. The case needs to be reported to the LSCB child death review panel only. However this does not require reporting as an SI. And there are no suspicious concerns, but healthcare management issues have been identified. The case needs to be reported as a SI and to the LSCB child death review panel. Once the SI investigation report is complete it must be submitted to the LSCB child death overview panel and Commissioning PCT for review and closure. And 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. If no care management issues are confirmed the case does not require reporting as an SI at this point. And 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 serious case review should take place. The case also needs to be reported as an SI. However should the case then meet the criteria for an SCR the NHS Northamptonshire representative on the LSCBN SCR committee will report the case on STEIS. If, during the SCR process, specific healthcare management problems which meet the SI criteria become apparent within any organisation this must be reported on STEIS and contact must be made with the NHS Northamptonshire patient safety team. A separate investigation will not be required providing the individual management review (IMR) process complies with the rigour of an SI investigation. Child harm (significant) Where a child has been significantly harmed but not died, the following considerations need to be explored to determine whether the incident is an SI. Has the harm occurred on NHS premises, as a result of NHS funded care, or caused by the direct actions of healthcare staff? If no to all the above, organisations should consider whether the child has been in receipt of healthcare within the last 12 months. If so, the case should be reported to the LSCB and also as an SI. Page 13 of 41

The admission of any child under the age of 16 to an adult mental health ward must be reported as an SI and via the Board safeguarding person. For cases where the child is aged between 16-18 years this should be reported through the safeguarding route only. 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 process identified in the LSCBN inter-agency child protection procedures. Vulnerable Adults A vulnerable adult is someone over the age of 18 years in need of services by reason of mental or other disability who is unable to take care of or protect themselves against harm or exploitation. All incidents of abuse including neglect to a vulnerable adult are notified through Safeguarding Adults procedures. In the following circumstances, the case needs to be reported as an SI as well as through Safeguarding Adults procedures. An SI is required, in addition to notification through Safeguarding Adults, where: a vulnerable adult dies (including death by suicide) and abuse or neglect is known or suspected to be a factor in the vulnerable adult s death a vulnerable adult has sustained a potentially life threatening injury through abuse or neglect; serious sexual abuse; or sustained serious and permanent impairment of health or development through abuse or neglect And/or where: the harm occurred on NHS premises as a result of NHS funded care caused by the direct actions of healthcare staff the case gives rise to concern about the way in which healthcare staff and services have worked together to safeguard vulnerable adults consideration where healthcare delivered within the last 12 months is implicated in the concern Page 14 of 41

In these cases of death or significant harm, the case may also be investigated as a Serious Case Review under Safeguarding Adults procedures. The interagency decision to investigate as a SCR should not delay the investigation as an SI. The SI report will form the basis of any SCR individual management report, and must be submitted in accordance with the Northamptonshire Adult Safeguarding Board agreed timescales. 4.5. Deaths and Serious Injuries in Custody All deaths in custody 2 (including those that appear to be natural causes) and near misses, such as serious self harm, attempted suicide, failures within healthcare services must be reported to NHS Northamptonshire as an SI. NHS Northamptonshire will record on STEIS. In addition deaths after release of up to 3 months must also be reported and investigated as an SI. NHS Northamptonshire is responsible for ensuring that a death in custody incident is subject to a clinical review by an independent investigator. This must be a clinician, with an understanding of prison healthcare, and skills in RCA techniques. This clinical review will contribute to the Prison and Probation Ombudsman Investigation and should be completed in accordance with their timescale of 10 weeks. NHS Northamptonshire will need to obtain assurances from the Prison healthcare staff that recommendations outlined in the final report have been actioned and implemented. Detailed guidance developed by the prisons and probation ombudsman, DH and NPSA is available at: http://www.ppo.gov.uk/download/otherreports/clinical_guidance_pcts_undertaking_clinical_review_july_09.pdf All other incidents reported as serious must be thoroughly investigated internally and in accordance with this policy. 4.6. Healthcare Associated Infections All identified cases of MRSA bacteraemia Clostridium difficile cases as follows: 2 This policy relates to people in receipt of NHS care and as such deaths in police custody fall outside its remit. Page 15 of 41

Classified as 1a and 1b on the death certificate where it is clear clostridium difficile has made a significant contribution to cause of death. (The Consultant responsible for managing patient care at time of patient s death is accountable/required to decide whether clostridium difficile was a contributory factor of death). - Cases where a serious complication including colectomy arise due to clostridium difficile All Hospital and Community based outbreaks that: result in high mortality for staff, patients or the community involve highly virulent and transmissible organisms (ref 4.7) require control measures that have an impact on the care of other patients, including limitation of access to healthcare services or where business continuity will be affected are sufficiently serious to require the convening of an incident team and/or are transmissible with an impact on staff, patients or the community Infected healthcare worker or patient incidents necessitating consideration of look back investigations (e.g. TB, vcjd, blood borne infections) Significant breakdown of infection control procedures with an actual, or potential for, cross-infection (e.g. release of products from a failed sterilisation cycle, contaminated blood transfusion). There are occasions when a HCAI incident is identified by one organisation but it is relevant for another to lead the RCA or systematic incident investigation. This predominately relates to incidents that happen within 48 hours of admission to a healthcare environment. The organisation identifying an MRSA bacteraemia must record it on the Health Protection Agency Healthcare Associated Infection Data Capture System. Unless otherwise agreed with NHS Northamptonshire a report on all incidents must be completed onto STEIS defining the key findings, root causes linked with targeted and Page 16 of 41

specific recommendations and actions required within 20 working days for MRSA bacteraemia and clostridium difficile cases. 4.7 Norovirus out-breaks In December 2010 NHS EM issued instructions for the reporting of norovirus out-breaks as SIs: Inpatient Providers (Including Acute Trusts, Mental health and Learning Disabilities, Prison Health, Community Providers) Either of the following two triggers will result in the organisation reporting an SI 1. One or more wards closed due to norovirus 2. An outbreak meeting has been called A report of the full outbreak of all areas affected needs to be submitted within 20 days of the end of the outbreak. For all other providers (Nursing Homes, Residential Home, Care Homes) The current system will remain in place where all outbreaks will be reported to the HPA. The HPA will share the information they have with all Directors of Infection Control in Primary and Secondary care, NHS East Midlands, Public Health, Microbiologist and Ambulance Trust The HPA are currently reviewing the reporting guidelines and the region will review the process when this work has been completed. In order to manage closure dates on STEIS organisations must inform the Patient Safety Team at NHS Northamptonshire when the outbreak has ended (and the ward/clinical area has reopened). Providers may submit a report directly on to STEIS in circumstances where outbreak incidents have been graded as low. This must provide a synopsis/executive summary of the investigation including findings, conclusions (clearly outlining any contributory factors) and actions to be taken; or submit a full report as per the existing arrangements. As with any SI, trusts must complete a full investigation using RCA. If Page 17 of 41

the investigation raises concerns that indicate that the incident should be re-graded, a full version of the report must be submitted as per existing arrangements. 4.8 Maternity Services Trusts will need to follow the guidance on reporting and investigating SI on the LSA. - http://www.eastmidlands.nhs.uk/the-local-supervising-authority-midwifery Any serious untoward occurrence in maternity care, inclusive of those in the LSA guidance that meet the definition of an SI should be reported on STEIS. 4.9 Loss of Confidential Information Providers of healthcare and NHS Northamptonshire commissioning arm 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. http://www.connectingforhealth.nhs.uk/systemsandservices/infogov/security/risk/ The immediate response to the incident and the escalation process for reporting and investigating will vary according to the severity of the incident. An incident should be categorised at the highest level that applies when considering the characteristics and risks of the incident. All report all incidents rated as 1 5 should be reported Page 18 of 41

0 1 2 3 4 5 No significant reflection on any individual or body Media interest very unlikely Damage to an individual s reputation. Possible media interest, e.g. celebrity Damage to a team s reputation. Some local media interest that may not go public Damage to a services reputation/ Low key local media coverage. Damage to an organisation s reputation/ Local media coverage. Damage to NHS reputation/ National media coverage. Minor breach of confidentiality. Only a single individual affected involved Potentially serious breach. Less than 5 people affected or risk assessed as low, e.g. files were encrypted Serious potential breach & risk assessed high e.g. unencrypted clinical records lost. Up to 20 people affected Serious breach of confidentiality e.g. up to 100 people affected Serious breach with either particular sensitivity e.g. sexual health details, or up to 1000 people affected Serious breach with potential for ID theft or over 1000 people affected The SHA Communication Team will be responsible for notifying the DH of any category 3-5 incident reported by forwarding details to the appropriate dedicated mailbox established within the DH. Incidents must be notified to DH Communications only if only the lighter shaded risk areas in the top two rows in the table apply and to both DH Communications and the NHS Business Unit if the significant risks in the darker shaded area at the bottom right of the table apply. A checklist is attached as appendix 5 - this information will be required when reporting a data loss SI. 4.10 Screening Incidents National screening programmes are public health interventions, which aim to identify disease or conditions in defined populations in order to either reduce morbidity or mortality. Screening programmes are sometimes made complicated because the activity of screening often takes place within pathways across several organisations. Often there are a wider range of organisations involved, including those at a national level and organisations who externally quality assure the screening programmes. The management of an SI may be complex with the potential to cause delay or confusion. A separate policy for managing serious incidents in screening has been developed by the regional Directors of Public Health. Page 19 of 41

The policy states that a screening SI is: An actual or possible failure at any stage in the pathway of the screening service, which exposes the programme to unknown levels of risk that screening, and assessment or treatment of screen-positive people have been inadequate, and hence there are possible serious consequences for the clinical management of patients. The level of risk to an individual may be low, but because of the large numbers involved the corporate risk may be very high. 4.11 Never Events Never events are serious, largely preventable patient safety incidents that should not occur after the preventable measures have been implemented. The Never events framework 2011/12 provides the list of never events (new or modified events in italics): Wrong site surgery Wrong implant/prosthesis Retained foreign object post-operation Wrongly prepared high-risk injectable medication Maladministration of potassium-containing solutions Wrong route administration of chemotherapy Wrong route administration of oral/enteral treatment Intravenous administration of epidural medication Maladministration of Insulin Overdose of midazolam during conscious sedation Opioid overdose of an opioid-naïve patient Inappropriate administration of daily oral methotrexate Suicide using non-collapsible rails Escape of a transferred prisoner Falls from unrestricted windows Entrapment in bedrails Transfusion of ABO-incompatible blood components Transplantation of ABO or HLA-incompatible Organs Misplaced naso- or oro-gastric tubes Wrong gas administered Failure to monitor and respond to oxygen saturation Page 20 of 41

The reporting and management of Never Events is therefore built upon existing safety processes and mechanisms already established within the NHS. NHS Northamptonshire ensures that the complete core list of never events is included in contractual arrangements with healthcare providers. The list of Never Events may be extended subject to either national or local (within Northamptonshire) approval. Providers must ensure that the national standards and guidance to reduce the risk of a Never Event have been implemented. Never Events must be reported as an SI in accordance with this policy. Providers must conduct a systematic investigation into why the SI occurred and discuss learning and preventative action with NHS Northamptonshire. http://www.dh.gov.uk/en/publicationsandstatistics/publications/publicationspolicyandg uidance/dh_124552 5.0 Reporting Requirements 5.1 The Director of Quality and Safeguarding, NHS Northamptonshire, is the executive lead for the SI process. The Associate Director of Patient Safety acts as the main contact with the SHA and provider organisations. In their absence, including out of hours, a suitable deputy will be available (Director on call) to liaise with provider organisations and SHA. In Office Hours 09:00 to 17:00 Provider organisations should ensure that serious incidents are reported within one working day of becoming aware of the incident. If an incident fulfils the criteria of a high profile incident (as per paragraph 5.5 below) the provider should contact the NHS Northamptonshire Associate Director for Patient Safety (or the NHS Northamptonshire Patient Safety Team in their absence) as soon as possible. Page 21 of 41

If NHS Northamptonshire becomes aware of an incident that is high profile and likely to attract media attention / other external interest NHS Northamptonshire will contact the NHS EM Directorate of Patient Care on 0115 968 4520 immediately. NHS Northamptonshire monitors that all other serious incidents are reported using the Untoward Incident Module of STEIS within one working day of the organisations identifying an SI. 5.2. NHS Northamptonshire Patient Safety team will ensure that in the interests of confidentiality and the Data Protection Act, all entries to STEIS and subsequent investigation reports are anonymised. Reports must not contain the names of practitioners or patients. Reporting from any service will be anonymous, with the proviso that there is an audit trail on a need to know basis. If the SI merits the necessity of identifying the individual(s) concerned, a senior member of NHS Northamptonshire will contact the organisation to discuss the incident and ascertain more detailed information. The Data Protection Act (1998) will be adhered to at all times 5.3. Provider organisations experiencing difficulties completing STEIS should contact the NHS Northamptonshire patient safety team. Out of Hours 17:01 to 08:59 5.4. NHS Northamptonshire has internal Out of Hours systems to support the reporting of high profile SIs (as described in 5.5 below) by their provider organisations to themselves and to the SHA. Those serious incidents which fulfil the criteria should be reported to NHS Northamptonshire s Director on Call via the provider organisation s senior manager on call arrangements. 5.5. The following incidents will be reported by the NHS Northamptonshire to the NHS EM Director on Call. Where there is any doubt over the matter, the NHS Northamptonshire will contact the NHS EM Director on call for advice. incidents which necessitate activation of the NHS Trust or PCT Major Incident Plan and where the East Midlands SHA need to take action e.g. attendance of NHS EM Director required at multi-agency gold command. Page 22 of 41

incidents that will give rise to significant media interest or will be of interest to other agencies such as the Police or other external agencies. incidents that will be of significant public concern. When contacting the NHS EM Director on Call (by telephoning 08700 555500 and requesting that a message be sent for call sign code NHSEM1) the NHS Northamptonshire Director on call will provide the following information: 1. Name 2. Organisation 3. Message and contact telephone number 5.6. The NHS EM Director receiving the call out of hours will in discussion with the NHS organisation make the decision to notify other NHS EM senior managers out of hours and the DH Media Centre. NHS EM will contact the NHS organisation on the next working day to receive a verbal progress report and discuss ongoing management of the SI, briefing other senior managers and the DH media centre as appropriate. 5.7. The Serious Incident module of STEIS should be completed as soon as possible on the first working day following the incident. See appendix 1 for flow chart. 6.0 Reporting and investigation outcomes 6.1 NHS Northamptonshire requires provider organisations to report all incidents that fulfil the NHS EM SI definition within one working day of becoming aware that an SI has occurred. Organisations must provide a rationale for any delay on the further information section of STEIS. 6.2 NHS Northamptonshire will review all reported SIs and grade them against the risk / management tool outlined in this policy (Appendix 2) and record on STEIS. Where an SI is graded high or involves more than one organisation which falls into a different locality, discussions with NHS Northamptonshire Patient Safety team will take place to ensure appropriate management. Page 23 of 41

6.3 A systematic investigation will be conducted to a level proportionate with the seriousness of the incident, compliant with the Minimum Standards for Investigation Reports and Action Plans (Appendices 6 and 7). 6.4 Unless otherwise agreed with NHS Northamptonshire Patient Safety team, the final report must be completed within 60 working days of the incident being reported; 20 working days for incidents of MRSA bacteraemia and C diff related deaths (part 1a and 1b of the death certificate) and within 20 working days of the end of an outbreak. 6.5 If, due to ongoing proceedings (for example litigation, criminal investigations or impending inquest), the provider organisation has not closed the incident internally at this stage, NHS Northamptonshire will record the SI as out-with and ensure that STEIS is updated. NHS Northamptonshire will review the investigation within 10 working days and feed back the findings to the provider organisations within 20 working days of the review. NHS Northamptonshire will not close an incident until it is satisfied that an appropriate investigation has been undertaken, clear contributory (or causal) factors have been identified, any relevant patient safety alerts (such as Central Alert System [CAS] or NPSA Rapid Response Reports [RRR]) have been referenced and considered, lessons to be learned have been identified and a robust action plan developed. The NHS Northamptonshire quality assurance criteria for signing off investigation reports is available at appendix 3 6.6 A core incident review and closure group comprising senior staff from the Safeguarding and Quality Directorate meet monthly to review all submitted reports. Representatives from Commissioning and Public Health are invited to attend. In addition the NHS Northamptonshire Patient Safety Team may draw on professional advice from within NHS Northamptonshire when closing incidents on STEIS. The Patient Safety Team will ensure that the relevant NHS Northamptonshire contracting lead is advised regarding SI reporting and actions on lessons learned. 6.7 For very serious incidents NHS Northamptonshire will ultimately make the decision to close this may not be until there is assurance that the defined actions have been implemented. 6.8 If the police or Health and Safety Executive (HSE) are involved in any SI then the principles outlined in the Memorandum of Understanding between the Police, HSE and DH should be followed. If any restrictions are placed on investigations by either the Page 24 of 41

police or Health and Safety Executive this needs to be clearly documented in the organisation s records and in reports to the NHS Northamptonshire or NHS EM. 6.9 Investigation reports must not contain patient or staff identifiable information. Electronic reports should be saved by STEIS number rather than any person identifiable information. It is the responsibility of the organisation that generated the investigative report to retain the document for a period of 30 years. Copies shared with other organisations may be destroyed in accordance with the local confidentiality procedure once the report is no longer of use. 7 Monitoring Compliance 7.1 NHS EM performance manages NHS Northamptonshire through the PCT review process against the criteria outlined below. NHS Northamptonshire will monitor provider organisation s compliance with this policy through the development of performance metrics and quarterly review meetings which will measure the points below: Appropriateness of reporting, what has been reported and does not fulfil the investigation criteria and triangulation of the RLS data to establish whether incidents are not being reported that should be Timeliness of reporting in accordance with the standards laid out in this policy Quality of investigation and report provided (fulfils at least the minimum requirement as laid out in the policy) Closure meets agreed timescale Closure information is adequate Learning is disseminated Action plans are implemented within agreed timescale 7.2 This information will be measured through a variety of methodologies such as performance data, audit and review of documentary evidence which demonstrates compliance (linked to the Care Quality Commission requirements and NHSLA) Page 25 of 41

8.0 Related Protocols 8.1 A number of protocols relate to the management of SIs which should be followed as appropriate in individual cases. Child protection procedures in respect of children who have been or are suspected of being abused Vulnerable Adults policies DH guidance on Serious Adverse Events relating to the discharge of mentally disordered people and their continuing care in the community relating to: violent incidents, victims under 18 years of age, or homicides and suicides (HSG (94) 27 and amendments). Retained Organs Good Practice guidance NHS Complaints Procedure Major Incident Plan/Event policies Memorandum of Understanding NPSA Being Open Policy framework for the reporting and briefing of incidents and issues in high security hospitals Deaths in Custody Guidelines NHS East Midlands Protocol on Managing Adverse Events in Mental Health Services Information Governance and Code of Conduct guidelines Page 26 of 41

Appendix 1 Reporting Framework Flowchart Serious Incident (SI) occurs Trust requiring advice regarding SIs should contact their commissioning PCT Patient Safety team (PS) on the agreed phone number In hours (9:00 17:00) the PCT will inform NHS East Midlands of any SIs High profile and likely to attract local/ national media attention, wider impact or other external interest. Contact NHS EM on 0115 968 4520 Trust Comms works with SHA Comms to develop media handling strategy and develop a MBU alert *For out of hours (17:01-8.59) contact NHS Northamptonshire Director on call on 07796 548664 for SIs that fulfil any of the following criteria: Activation of NHS Trust /PCT Major Incident Plan (multiagency gold command) High profile and likely to attract local/national media interest. Involvement of police and other agencies. Significant public concern. NHS Provider logs incident onto STEIS within 24 hours or next working day for OOHrs Investigation carried out by provider organisation including Root Cause Analysis and Lessons learned If further information required PCT PS Team to request from Trust If PCT PS team confirm incident does not meet SI criteria then Trust proceed with own internal policy. Where already logged on STEIS, PCT PS team will close incident. PCT PS team to notify NHS EM administrator to delete from STEIS system Provider organisation updates STEIS and forwards any reports/action plans requested by PCT PS Team. Trusts request closure of incidents to PCT PS Team within 60 working days and 20 working days for infection control incidents. PCT PS team provides feedback on the report within 10 working days. Closes incident on STEIS, once satisfied with provider response. The SHA will monitor the High Level incidents. The PCT will contact the SHA for Closure in such cases. PCT PS team is not satisfied with Trust response more information will be requested. A timeframe for resubmission will be agreed. Trust implement Action Plans, PCT may request regular updates on progress and lessons learned disseminated Page 27 of 41

Appendix 2 Grading Process for SIs in Northamptonshire Grade Criteria Suggested Management/ Closure Information Low Moderate Most Serious Appears to be Isolated or self contained incident Low level of organisational system failures Potential low level of learning relevant only to organisation / specialty Incident / look back exercise where 3 9 people involved Incident that has potential to generate local media interest Potential for Coroners inquest Actual / Potential serious breach of personal identifiable information where less then 5 people have been affected or the risk has been assessed as low e.g. encrypted electronic information. Strong evidence of organisational system failures Potential for moderate level of learning relevant for other local organisations / care sectors Possible regional multi-agency involvement (within SHA boundary) Incident / look back exercise where 10-29 people involved. Incident that has potential to generate sustained local media interest Potential high profile Coroners inquest Actual / Potential serious breach of personal identifiable information where 6-20 people have been affected or the risk has been assessed as high e.g. unencrypted electronic information. Evidence of severe failing within an organisation Potential for high likelihood of learning Regional / national learning Possible multi agency involvement cross SHA boundary Incident / look back exercise where > 30 people involved Incident that has potential to generate national/international media interest Incident that has potential for criminal prosecution, HCC visit or NHS investigation Actual / Potential serious breach of personal identifiable information with, either loss of sensitive information e.g. sexual health data or 21+ people have been affected or potential for ID theft. NHS Northamptonshire to review and close based on information provided in the internal investigation report. If recommendations address key issues identified in the report then close. 60 working day deadline If recommendations appear too broad or weak an action plan will be requested. A further 20 working days will be allowed for its development. NHS Northamptonshire to monitor investigation progression, review report after receipt of closure request and monitor implementation of action plan. Request regular updates from organisations on progression of investigation Full copy of internal investigation and action plan required to enable closure. 60 working days deadline. A further 20 working days for action plan to be developed. Regular review of action plans to ensure implementation NHS Northamptonshire to monitor investigation progression (monthly updates to SHA) PCT to request interim management report within 72 hrs of incident being reported and share with SHA If death has occurred keep case open until after inquest SHA and PCT to review investigation upon closure request and to close incident after discussion. SHA to appoint a lead for monitoring the implementation of the action plan Page 28 of 41

Appendix 3 Quality Assurance Critique Tool PART 1 - CLINICIAN TO CRITIQUE THE REPORT REPORTING ORGANISATION: SI INCIDENT TYPE: DATE SUBMITTED FOR CLOSURE: CRITIQUED BY: LEVEL OF INVESTIGATION REQUIRED STEIS NUMBER: JOINT SHA CLOSURE DATE CRITIQUED: MEDIUM NO REPORT SECTIONS SECTION REQUIREMENTS YES / NO COMMENTS / RECOMMENDATIONS 1. Cover page Organisation Logo Yes STEIS Number Yes Authors Report date Document version Section Outcome 5 2. Executive Brief Incident description Yes Summary Level of investigation conducted Yes Care/Service delivery problems Contributory factors/root Causes Conclusion Recommendations Actions taken Section Outcome 7 3. Summary Incident description Yes Incident type Specialty / Service Actual effect on patient + or service Severity of incident Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Page 29 of 41

Section Outcome 5 4. Background Brief description of the patient, history of previous care/relevant patient information and diagnosis/reason for admission/treatment provided. Yes Service description, relevant information and size of clinical team Outline of relevant local and national policy / guidance in place at time (including evidence that CAS/RRR alerts have been considered) Section Outcome 4 QUALITY 5. Investigation Procedure & Methodology Terms of Reference - outline of investigation plan, scope & Investigation team membership Good Good How/what information is to be gathered e.g. interviews, case note reviews etc. List of Data Sources. 6. Being open Description of support provided for patient, relatives and staff 7.Analysis & Findings Chronology of Events (including dates, events and notable practice) Clearly identifies Care & Service delivery problems (E.g. Tabular timeline, barrier analysis) Clearly Identifies any contributory factors including, where applicable, the Root Cause (E.g. 5 whys, fishbone, NPSA taxonomy) Findings are evidence based, factual (not opinion) Yes No Good Good Good Good Good 8.Conclusion Should answer the critical questions in the ToR and links back to analysis and findings Good 9.Recommendations Directly linked to the contributory factors and the investigative opinion. Needs to be clear with minutiae detail in the action plan. Good 10. Lessons learned Positive features Good Page 30 of 41

11. Action plan & Monitoring Arrangements Mitigating factors Changes already made Adopts 'SMART' principles (Specific, Measurable, Achievable, Responsible and Timed) Action plan addresses contributory factors and recommendations Good Good Good Good Description of arrangements for monitoring action Good plan. 12. Overall report Anonymous Good Additional Comments Jargon free / plain English Clinical content is appropriate Critically evaluating care provided in a nondefensive/open manner Good Good Good PART 2 - APPROVAL FOR CLOSURE AGREED APPROVAL: YES / NO DATE TRUST INFORMED OF DECISION UPDATED FINAL REPORT DUE DATE DATE UPDATED FINAL REPORT RECEIVED PART 3a - CAPTURING THE LEARNING KEY ISSUES IDENTIFIED IN THE REPORT Page 31 of 41

PART 3b - CONTRIBUTORY FACTORS PATIENT FACTORS Social Factors INDIVIDUAL FACTORS TASK FACTORS COMMUNICATION FACTORS TEAM FACTORS EDUCATION AND TRAINING EQUIPMENT FACTORS WORK ENVIRONMENT FACTORS ORGANISATIONAL FACTORS Psychological Issues Guidelines Procedures and Policies Written Communication Leadership Supervision Usability Environment Organisational Structure Page 32 of 41

1 Appendix 4 (NHSN) Serious Incident (SI) Sign off structure NHS Northamptonshire (NHSN) Serious Incident (SI) Sign off structure. Terms of reference March 2011 Overall objectives: 1. To confirm and challenge the investigation reports received from all providers to ensure that the necessary actions have been completed and lessons learned. 2. To enable closure of SI reports on the Strategic Executive Information System (STEIS). 3. To indentify trends and themes arising from SIs. 4. To provide assurance to the NHSN Board via the Quality and Risk Committee. The structure has two tiers: SI subgroup Membership: Associate Director of Patient Safety (Chair) Patient Safety and Quality Manager (deputy Chair) Team Administrator - Safeguarding Directorate Frequency: weekly The group will: For new incidents reported on STEIS 1. Review and grade all new SIs reported and gain assurance that all the necessary parties have been informed of the incident including out of county. 2. Identify key concerns / triggers from the SI reports 3. Alert NHS Northamptonshire communications of any incidents that may be of interest to the media. For all SI investigation reports submitted to NHSN 1. Review final investigation reports to ensure that all appropriate actions have been taken by applying the NHSN quality assurance critique tool (appendix 3 of the Policy for reporting and handling serious incidents). 2. Ensure all SIs have been investigated formally and fully in accordance with the NHS Northamptonshire SI policy. 3. Where necessary gain expert advice regarding incidents from within NHSN. 4. Make recommendations for action (including closures) to the SI Assurance and Review Group. Page 33 of 41

SI Assurance and Review Group Membership (quorate at three core team members) Deputy Director of Quality standards (Chair) (core) Associate Director of Patient Safety (Deputy Chair) (core) Clinical Quality Manager (core) Associate Director of Infection Control (core) Team Administrator - Safeguarding Directorate Mental Health commissioning representative Associate Medical Director (core) Public Health Consultant Associate Director, Mental Capacity Act and Safeguarding Adults (as required) Designated Nurse for Safeguarding children (as required) SHA representative Ad-hoc attendees to be invited where specialist knowledge is required for example LSAMO (contact may be virtual by telephone or email). Medicines management representative (as required). Frequency: monthly The group will: 1. Receive incident report quality assurance critique tool developed by the SI subgroup. 2. Confirm and challenge whether all SIs have been investigated formally and fully in accordance with the NHS Northamptonshire SI policy to enable closure. 3. Make consider and agree further action (closures, clarifications and resubmissions). 4. Identify lessons learned to be shared with other providers via meetings with individual organisations and across the whole health economy as necessary. 5. Triangulate information arising from SIs with intelligence from members own specialist areas. 6. Identify any themes and trends arising from SI investigations. 7. Identify and agree key lines of enquiry for wider follow up with providers through contract and/or quality meetings. 8. Consider the commissioning of independent or external reviews or investigations if required. Accountability The NHS Northamptonshire SI sub and SI Assurance and Review Groups are accountable to the NHS Northamptonshire Trust Board via the Governance and Risk committee. Reporting arrangements The SI Assurance and Review Group will report monthly to the Trust Board. This report will focus on: Compliance with the NHS Northamptonshire SI policy including information on SIs reported/closed etc. Evidence of scrutiny and analysis of themes from SIs (including analysis of contributory factors identified within reports) The escalation of trends Sharing learning from serious incident investigations March 2011 Page 34 of 41

Appendix 5 Information Governance Checklist Information required by the Department of Health for category 3+ SI Unique SI Reference: Initial assessment of level of SI (1-5): NHS East Midlands: Local Organisation(s) involved: Required Information Check 01 Date, time and location of the incident 02 Confirmation that DH guidelines for incident management are being followed and that disciplinary action will be invoked if appropriate 03 Description of what happened: Theft, accidental loss, inappropriate disclosure, procedural failure etc. 04 The number of patients/ staff (individual data subjects) data involved and/or the number of records 05 The type of record or data involved and sensitivity 06 The media (paper, electronic, tape) of the records 07 If electronic media, whether encrypted or not 08 Whether the SI is in the public domain and whether the media (press etc.) are involved or there is a potential for media interest 09 Whether the reputation of an individual, team, an organisation or the NHS as a whole is at risk and whether there are legal implications 10 Whether the Information Commissioner has been or will be notified and if not why not 11 Whether the data subjects have been or will be notified and if not why not 12 Whether the police have been involved 13 Immediate action taken, including whether any staff have been suspended pending the results of the investigation 14 Whether there are any consequent risks of the incident (e.g. patient safety, continuity of treatment etc.) and how these will be managed 15 What steps have been or will be taken to recover records/data (if applicable) 16 What lessons have been learned from the incident and how will recurrence be prevented 17 Whether, and to what degree, any member of staff has been disciplined if not appropriate why? 18 Closure of SI only when all aspects, including any disciplinary action taken against staff, are settled. Notes: Page 35 of 41

Appendix 6 Minimum Standards for Investigation Reports Body of report should contain: Cover Page Contents Page Executive Summary (Graded Medium / High) Terms of reference Summary of the incident Background Organisation Logo Author(s) Incident Number (STEIS) Report date Document Version Page & Paragraph should be numbered List of sections and page numbers Max 2 sides of A4 to include: Incident description and consequences Level of investigation conduced Care + service delivery problems Contributory factors (root cause) Recommendations Sharing arrangements Action plan (part of full report) At what point does the investigation start and stop e.g. episode of care. Outline the terms of reference agreed by the key stakeholders (including family where appropriate) Outline briefly the incident and what makes this incident an SI. Incident type, specialty involved, effect on patient and severity of incident should be included. Include a brief description of the patient, their medical needs, the care and treatment provided. The service type, size of clinical team, the experience and skills of the staff involved in the incident and their training records. Also explain the relevance of local and national policy / guidance at the time of the incident. Investigation methodology Brief description of the type of investigation narrow / broad, single / aggregate. How the information was gathered e.g. interviews, clinical records, statements, management reports. Type of RCA tool used Being open Chronology of events Discussion Analysis and findings Description of support provided to the patients involved, their relatives and staff. Description of the event taken from the tabular timeline (this should be attached as an appendix) This section should demonstrate critical analysis of the event and provide findings and conclusions based on evidence. This section needs to clearly identify the care and Page 36 of 41

service delivery problems and analysis of each using a recognised RCA methodology to identify the causal factors The contributory factors will fall into one of the NPSA taxonomies, it may be useful to identify these Individual Factors Team and Social Factors Communication Factors Task Factors Education and Training Factors Equipment and Resource Factors Working Conditions Organisational and Strategic Factors Patient Factors Lessons Learned Recommendations Conclusion Implementation, monitoring & evaluation Arrangements for sharing and learning Things that went well and things that went badly. This could relate to the incident or the investigation process. These need to directly link to the key learning points (care +service delivery problems) and address the problem not the symptoms. Be clear and concise and kept to a minimum and designed to reduce the likelihood of recurrence or severity. They need to be specific, measureable, realistic and timed (SMART) Summary of the key findings and should answer the questions posed in the terms of reference. Describe the arrangements for the local monitoring of the action plan, arrangements for evaluating long term solutions i.e. risk register Describe how the lessons learned will be disseminated with staff, other organisations such as the commissioning PCT for local learning, the SHA for regional learning, and the NPSA for national learning. Appendices List of documents reviewed Root Cause Analysis tools; timeline, fishbone diagrams, 5 whys etc Any associated policies / guidelines (such as relevant CAS or RRR alerts) that are too complicated to explain fully in the report Page 37 of 41

Appendix 7 Minimum Standards for Action Plans The action plan must define: Who has agreed the action plan Who will monitor the implementation of the action plan How often the action plan will be reviewed Who will sign off the action plan when all actions have been completed The action plan must contain: 1. Recommendations based on the contributing factors These should be the analysis and findings of the investigation the recommendations from the report 2. Action agreed This should be the actions the organisation needs to take to resolve the contributory factor. 3. Level of recommendation Does this action need to be taken at: Unique specific to the area Common organisation specific Universal have regional / national significance 4. By who Who in the Trust will ensure the action is completed 5. Planned Action Start Date Date at which the organisation intends to start the particular action. 6. Planned Action End Date Target date for completion of the action. 7. Resource requirements To be able to complete the action, what resources are required? 8. Evidence of completion What evidence will be available to demonstrate that the action has been completed? This should include any intended post action plan reviews or audits. 9. Sign-off Date when the action has been completed. Page 38 of 41

ACTION PLAN EXAMPLE ACTION PLAN DEVELOPED BY DATE ACTION PLAN SIGNED OFF BY DATE Recommendations Level of Recommen dation Unique Common Universal Agreed Action By Whom Planned Action Start Date Planned Action End Date Resources Required (risk vs. benefit vs. cost) Expected Outcome Evidence of Completion Sign Off Page 39 of 41

Equality Impact Assessment Equality Impact Assessment Questions and Definitions Yes/No Comments Name of document being assessed: Policy for the Reporting and Handling of Serious Incidents (SI) Does the document/guidance content affect one group less or more favourably than another on the basis of: Refers to the protected characteristic of race. It refers to a group of people defined by their race, Race colour, nationality (e.g. citizenship), ethnic or national origins (e.g. gypsies and travellers) Religion has the meaning usually given to it but belief includes religious and philosophical Religion or beliefs including lack of belief (e.g. atheism). belief Generally, a belief should affect your life choices or the way you live for it to be included in the definition. Refers to eliminating sex discrimination and Gender harassment and to promote equality for women and Sexual Orientation Gender Identity Age Disability Socio- Economic Carers men. Whether a person's sexual attraction is towards their own sex, the opposite sex or to both sexes. Whether a person's gender identity is with their own gender or the opposite gender. This refers to a person belonging to a particular age group, which can mean people of the same age (e.g. 32-year-olds) or range of ages (e.g. 18 30-year-olds, or people over 50) A person has a disability if he or she has a physical or mental impairment which has a substantial and long-term adverse effect on that person's ability to carry out normal day-to-day activities. A group of people who face disadvantage based on their location, background and other protected characteristics e.g. Post Code Lottery - where they live means there life expectancy is lower. A person cares for a child under 16 or a disabled child under 18, or if they re a carer for an adult, where it has an effect on that person's ability to carry out normal day-to-day activities. No No No No No No No No No Page 40 of 41