NHS Milton Keynes and Northamptonshire Policy for the Reporting and Management of Serious Incidents

Transcription

1 NHS Milton Keynes and Northamptonshire Policy for the Reporting and Management of Serious Incidents 2012 Version: Ratified by: Date Ratified: Name of Originator/ Author: Name of Responsible Individual: Final Cluster Management Team 6 th June 2012 Amended at Northants CCGs quality committee 8 th January 2013 MK&N Quality and Patient Safety Team Jan Norman Director of Nursing Date Issued: 18 th June 2012 Expiry Date: End of March 2013 Target Audience Provider Organisations and NHS Milton Keynes & NHS Northamptonshire staff

2 Contents Page Essential Contact Numbers Introduction Purpose Definitions Homicides by Mental Health Patients Suicides Safeguarding Children Child Harm Safeguarding Adults Deaths and Serious Incidents in Custody Healthcare Associated Infections Maternity Services Loss of Confidential Information Additional Guidance for SIs Linked to IT Incidents Screening Incidents Never Events Pressure Ulcers Duties Strategic Health Authority NHS Milton Keynes & Northamptonshire Provider Organisations Reporting Requirements In Office Hours 09:00 to 17: Out of Hours 17:01 to 08: Reporting and investigation outcomes Reporting of Serious incidents Involvement of External Agencies Compliance with the Data Protection Act Joint Investigations Grading of Serious Incidents Requesting 72 hour reports Senior Briefing Investigation Timescales Extensions Level of Investigation/Root Cause Analysis (RCA) Risk assessments Action Plans Updating STEIS with investigation outcomes Being Open & Patient Involvement Assurance and Review Review of Submitted RCAs Requests for Further Information Serious Incident Assurance and Review Groups (SIARG) Serious Incident Assurance Meetings (SIAM) Monitoring Compliance Related Protocols 29 Appendix 1 Reporting Framework Flowchart 30 Appendix 2 IT Clinical Incident Management Procedure 31 Appendix 3 NPSA Grading Guidance 32 2

3 Contents Page Appendix 4 RCA Audit Tool 33 Appendix 5 IG Checklist 35 Appendix 6 Minimum Standards for Investigation Reports 36 Appendix 7 Minimum Standards for Action Plans 38 Appendix 8 Milton Keynes Interface between serious incidents reporting in health services, serious case reviews and child death review 40 Appendix 9 Northamptonshire Interface between serious incidents reporting in health services, serious case reviews and child death review 45 Appendix 10 Supplementary Terms 50 Appendix 11 Criteria for Independent Investigations 51 Appendix 12 Never Events 52 Appendix 13 NHS Milton Keynes & Northamptonshire SI extension request guidance 57 3

4 Strategic Health Authority NHS Milton Keynes & NHS Northamptonshire Essential Contact Numbers In hours NHS MK&N Patient Safety Coordinator Tel: Quality & Safety Manager Tel: Mobile: Out of Hours NHS Northamptonshire Director on Call Tel: NHS Milton Keynes Director on Call Tel: (Only to be used for very serious incidents as per paragraph 5.3 of this policy) NHS EM Directorate of Patient Care Tel: NHS Midlands & East Senior Manager on call Tel: Ask to leave a message for call sign EastMids1 Please leave a very concise message, including name and contact telephone number 4

5 1.0 Introduction 1.1 Reporting and Learning from Serious Incidents Requiring Investigation. The NPSA (National Patient Safety Agency) has provided NHS Providers with a clear framework and their intention is that the framework can be locally embedded. This policy is designed to help NHS providers take appropriate steps in the best interest of their patients/clients/service user s, staff and the NHS as a whole. It contains the minimum reporting requirements expected in the East Midlands region. Individual Commissioners may set additional requirements through their commissioning and quality monitoring processes. 1.2 Making services safe for patients is fundamental to the provision of highquality 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 of reporting should be on analysing the root cause of the incident because serious incidents yield important lessons about changing process to reduce risk. It is only through active learning and service improvement from serious incidents that the benefits of experience are actually realised. 1.3 It is an expectation that healthcare providers within their incident investigation processes adhere to the Being Open (ref: NPSA 2009 Being Open Saying Sorry When Things Go Wrong) principles and have their own internal Being Open policy. 1.4 NHS Midlands and East provide a central point for the health community where information about Serious Incidents (SI) can be recorded monitored, analysed and learning disseminated. NHS Midlands and East are also able to provide its constituent organisations with specialist knowledge and objective advice on a range of issues. The Strategic Health Authority is also required to manage the media appropriately and brief the Department of Health therefore requiring timely and accurate details. 1.5 The SHA (Strategic Health Authority) will seek assurance from NHS Milton Keynes and Northamptonshire that there are robust systems for reporting and monitoring performance of commissioned services. There is an expectation that all serious incidents will be thoroughly investigated and associated action plans implemented. 2.0 Purpose 2.1 The purpose of this Policy is to make explicit the requirements for managing Serious Incidents (SIs). 2.2 NHS Milton Keynes and Northamptonshire expects all organisations commissioned to provide NHS funded healthcare within the region to incorporate the requirements of this policy into their contracting arrangements and own local policies. The provisions of this policy are a requirement within the NHS Standard Contract (Section C 7.3). This document outlines the approach for supporting learning and performance managing commissioned services. 5

6 2.3 NHS Milton Keynes and Northamptonshire, in consultation with NHS Midlands and East will update this policy in keeping with any national or regional changes to the definition of SIs. 2.4 This policy should complement, 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) [Health Service Guidance] and arrangements for dealing with major incidents (HSC/98/197) [Health Service Circular]. 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. 3.0 Definitions This policy follows the NPSA framework National Framework for Reporting and Learning from Serious Incidents Requiring Investigation (National Patient Safety Agency, 2010) in which a Serious Incident is defined as: A Serious Incident is defined by the NPSA in the National Framework for Reporting and Learning from Serious Incidents Requiring Investigation (March 2010) as an incident that occurred in relation to NHS-funded services and care resulting in: unexpected or unavoidable death, serious harm, a provider organisation s inability to continue to deliver healthcare services, allegations of abuse, adverse media coverage and/or one of the core set of Never Events NB: Any media issue that is not related to a serious incident must not be reported through STEIS (Strategic Executive Information System) but through relevant communication teams All identified serious incidents must be notified to the relevant bodies without delay and within two working days of becoming aware of the incident occurring. If there is a delay in reporting the incident a rationale must be recorded on STEIS by the reporting organisation. 3.1 Homicides by Mental Health Patients Department of Health has agreed that incidents of homicides committed by mental health patients will continue to be managed by 6

7 the SHA, even if the mental health trust involved is a foundation trust. This is because SHAs are independent from both the provision and commissioning of services. Homicides will be managed in accordance with the NHS Midlands and East Homicide Protocol which meets the requirements of HSG (94) 27 and subsequent amendments ( Not all homicides will meet the criteria for HSG (94) 27. All homicide investigation reports should be submitted to NHS Milton Keynes and Northamptonshire as per usual SI processes. 3.2 Suicides Suspected suicide, actual suicide and attempted suicide of any person currently in receipt of NHS services on or off NHS premises must 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 where on review of chronology have identified care/service delivery problems 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 3.3 Safeguarding Children Child deaths, significant harm and serious sexual abuse may or may not trigger a SI review; however all are reported to the LSCB (Local Safeguarding Children s Board). SI will be reported in accordance to the criteria below: Expected Death (anticipated) Where the death of a child was anticipated within a 24 hour period No SI investigation is required but the case needs to be reported to the LSCB Child Death Overview Panel (CDOP) for review. Unexpected Death Where the death of the child was not anticipated within a 24 hour period, consider which of the following criteria applies: o There are no suspicious concerns and no healthcare management issues identified. The case needs to be reported to the LSCB CDOP only. However this does not require reporting as a SI. 7

8 o There are no suspicious concerns, but healthcare management issues have been identified. The case needs to be reported as a SI and reported to the LSCB CDOP. Once the SI investigation report is complete it must be submitted to the LSCB CDOP and Commissioner for review and closure. o 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 a SI. o 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 should take place and to the CDOP. The case also needs to be reported as a SI. It may take a little time to confirm whether or not a SCR is required, however this should not hamper the trusts internal investigation. The final SI report must be submitted to the LSCB in accordance to agreed timescales and the commissioner. Where the death of a child is caused by a mental health user and the LSCB investigation would not cover the full requirements of HSG 94/ Processes have been developed regarding the interface between SI reporting in health services serious case reviews and child death review. Details of these processes can be found in appendixes 8 and 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 a 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 no to all the above, it s 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 (ref page 16 of the NPSA Framework information resource) Allegations of serious abuse (physical / mental / sexual) against healthcare staff who work with children must be reported as a SI and to the designated safeguarding professional. 8

9 3.5 Safeguarding 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 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 and 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 Local interagency procedures may agree a single process for investigation e.g. agreement that one investigation is carried out for the dual purpose of the serious incident process and safeguarding adults interagency process. In these circumstances, terms of reference for the SI should be agreed with the interagency safeguarding adults service. This should include agreed timeframes and reporting mechanisms to meet the requirements of both processes, recognising the need for openness and transparency for patients and their representatives 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 (IMR). 3.6 Deaths and Serious Injuries in Custody All deaths in custody (including those that appear to be natural causes) and near misses, such as serious self harm, attempted suicide, and serious failures within healthcare services must be reported as a Serious Incident and recorded on STEIS. In addition, deaths of offenders who were known to healthcare services and died after release of up to 3 months must also be reported and 9

10 investigated. It is not suggested that these are subject to a commissioned clinical review but should be systematically investigated as part of the Providers SI policy to identify if any learning can be identified to prevent similar incidents NHS Milton Keynes and Northamptonshire will ensure that a death in custody incident is subjected to a clinical review by an independent investigator. This must be a clinician, with skills in Root Cause Analysis (RCA) techniques. This clinical review will contribute to the Prison and Probation Ombudsman (PPO) Investigation and should be completed in accordance to the PPO timescale of 10 weeks. The NHS Milton Keynes and Northamptonshire will review the clinical review to ensure it has been conducted in a robust manner and obtain assurances from the Prison healthcare staff that any recommendations outlined have been actioned and implemented. All other incidents reported as serious must be thoroughly investigated internally and in accordance with this policy. 3.7 Healthcare Associated Infections (HCAI) MRSA (Meticillin Resistant Staphylococcus Aureus) All identified cases of MRSA bacteraemia need to be reported as an SI Clostridium difficile Clostridium difficile cases need reporting as an SI as follows: - 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 Other Hospital and Community based outbreaks All the following Hospital and Community based outbreaks should be reported as SIs: - Result in high mortality for staff, patients or the community - Involve highly virulent and transmissible organisms - 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 outbreak meeting/ incident team and/or are transmissible with an impact on staff, patients or the community 10

11 - Infected healthcare worker or patient incidents necessitating consideration of look back investigation (e.g. tuberculosis, variant Creutzfeldt Jakob disease, 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) Norovirus Out-Breaks In December 2010 NHS East Midlands issued instructions for the reporting of norovirus out-breaks as SIs and these still apply: 3.8 Maternity Services a. 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. b. For all other providers (Nursing Homes, Residential Home, Care Homes) All outbreaks will be reported to the Health Protection Agency (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. If a HCAI is relevant to more than one organisation it is expected that organisations work together to ensure an appropriate investigation is undertaken and lessons learned and disseminated. The commissioning organisation will act as arbitrator where there is any doubt as to ownership Maternal death Death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of the provider of the termination or the duration of pregnancy, from any cause related to or aggravated by the pregnancy or its management but not from accidental or incidental causes (World Health Organisation [WHO] 2011). This will include: Direct Deaths resulting from obstetric complications of the pregnant state (pregnancy, labour and puerperium), from interventions, omissions, incorrect treatment or from a chain of events resulting from any of the above (Centre for Maternal and Child Enquiries [CMACE], 2011). Indirect Deaths resulting from previous existing disease, or disease that developed during pregnancy and which is not the 11

12 result of direct obstetric causes, but which was aggravated by the physiological effects of pregnancy (CMACE 2011). Pregnancy-related death Death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of the cause of death where cause of death attribution is inadequate (WHO 2011) Late Maternal death Deaths occurring between 42 days and 6 months after delivery or end of pregnancy that are the direct result of Direct maternal causes Unexpected death Deaths occurring after 42 days following delivery or end of pregnancy that are a result of Indirect maternal causes Trusts will need to follow the guidance on reporting and investigating SIs from the LSA The following national maternity and new born categories have been added to STEIS. In some cases this investigation will be in addition to the Local Supervising Authority of Midwives investigation. Where possible they should be aligned: Maternal death- specifically those that occur whilst under booked care Intra uterine deaths- those over 37 weeks gestation Intra partum death- specifically those that die during labour or during an inpatient admission Unexpected neonatal death- specifically from 37 weeks gestation to 28 days post delivery Maternal unplanned admission to Intensive Care Unit (Level III admissions only): Patients requiring advanced respiratory support alone or basic respiratory support together with support of at least two other organs Includes complex patients requiring support for multi-organ failure Unexpected admission to NICU (neonatal intensive care unit)- specifically those with Apgar Score below 4 at five minutes Serious Drug Administration Errors will be reported as per SI Policy Surgical Operative Obstetric Errors as per SI Policy Lost Cytology/Histopathology Tissues or Errors as per SI policy 3.9 Loss of Confidential Information 12

13 3.9.1 Trusts will need to follow the latest Department of Health Guidance Checklist for Reporting, Managing and investigating Information Governance (IG) SI (Jan 2009); curity/risk/ 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 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. Trusts should report all incidents rated as 1 5. This scale is usually referred to as the Matthew Swindells scale or checklist. SI Level 1 SI Level No significant reflection on any individual or body. Media interest very unlikely. Minor breach of confidentiality. Only a single individual affected. Damage to an individual s reputation. Possible media interest e.g. celebrity involved Potentially serious breach. Less than 5 people affected or risk assessed as low e.g. files were encrypted. Damage to a team s reputation. Some local media interest that may not go public Serious potential breach and risk assessed high e.g. unencrypted clinical records lost. Up to 20 people affected. Damage to a service s reputation. Low key local media coverage. Serious breach of confidentiality e.g. up to 100 people affected. Damage to an organisation s reputation. Local media coverage. Serious breach with either particular sensitivity e.g. sexual health details or up to 1000 people affected. Damage to NHS reputation. National media coverage. Serious breach with potential for ID theft or over 1000 people affected The SHA Communication Team will be responsible for notifying the Department of Health (DH) of any category 3-5 incident reported by forwarding details to the appropriate dedicated mailbox established within the DH. Incidents falling within the top row definitions must be notified to DH Comms. Incidents falling within the definitions in the darkest shaded area must be reported to both DH Comms and the NHS Business Unit A checklist and guidance for IG incidents are attached as appendix 2 and Additional Guidance for 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 Dataset Change Notice DSCN) 14/2009 (System Suppliers) and 18/2009 (Organisations) SI (including near misses that 13

14 have put patients at risk) of information technology (IT) system failures, must be reported as a SI. Examples are: 3.11 Screening Incidents 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 Connecting for Health (CfH) product set should also be reported to the IT Local Help desk initiating CfH processes to be undertaken in parallel 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 Therefore the management of a SI becomes complicated with the potential to cause delay or confusion. For this reason a policy for managing serious incidents in screening has been developed by the regional Directors of Public Health 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 Never Events Never events are serious, largely preventable patient safety incidents that should not occur after the preventable measures have been implemented NHS Midlands and East have stipulated that additional information is required from providers: When a Never Event is reported provider organisations are required to provide the following specific (anonymised) information for each member of staff involved: 14

15 - When was their last appraisal - Did the appraisal 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 General Medical Council, Nursing and Midwifery Council, Health Professional Councils. Status of that referral to date This information should form part of the 72 hour (early management) report and submitted to the commissioner. The final investigation report must also include a full update on this issue. NHS Milton Keynes and Northamptonshire will forward the 72 hour report to the SHA patient safety team. Organisations may wish to use a recognised tool such as the incident decision tree when assessing whether management action may be appropriate Pressure Ulcers Pressure ulcers of grade 3 and 4 are to be reported as a serious incident on STEIS and to clarify the process; the following reporting guidance has been developed: Tissue Viabilitiy Guidance for Reportin 4.0 Duties 4.1 Strategic Health Authority NHS Midlands and East as part of its assurance and performance role is required by the Department of Health to receive information on all serious incidents via the healthcare commissioners and the contractual arrangements with the providers from whom they commission services for NHS patients. This will encompass all East Midlands providers of health care to NHS patients, including foundation trusts, primary care independent contractors, independent sector treatment centres, prison healthcare and any others providing care to NHS patients. NHS Midlands and East will support the commissioners as a critical friend supplying them with benchmarked information and offering solutions for improvement NHS Midlands and East will work in partnership with Commissioners 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 commissioner 15

16 clusters to have the capacity and capability to effectively undertake their role, and support providers in carrying out local investigations Where a commissioner has a 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 NHS Midlands and East 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 Officer (LSAMO) and reported as a SI on the Strategic Executive Information System (STEIS). Other midwifery incidents which are not deemed a SI but are reportable under the Local Supervising Authority (LSA) guideline do not require reporting on STEIS (please see page 15 for the link) NHS Midlands and East 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 The SHA will inform the Commissioner where this is the case. The SHA will therefore subsequently review the internal investigation reports to establish whether the criteria for commissioning an independent investigation has been met. Where this is the case NHS Midlands and East will commission the investigation and liaise with relevant stakeholders where appropriate, publish the findings, ensure an action plan is developed locally and share learning across the NHS. It will also performance monitor action plans to ensure safety is paramount Communications and media relations is an integral part of the SI process. NHS Midlands and East 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 NHS Midlands and East will liaise with the NHS Business Unit at the Department of Health on behalf of the region. 4.2 NHS Milton Keynes and Northamptonshire NHS Milton Keynes and Northamptonshire performance monitor the contract in place with all its provider organisations as required by the SHA NHS Milton Keynes and Northamptonshire is required by the Department of Health to receive information on all SIs from all organisations from whom they commission NHS services NHS Milton Keynes and Northamptonshire receives timely information from providers including independent providers/contractors, prison healthcare and any others providing care to NHS patients regarding all SIs and related investigation reports. 16

17 4.2.4 This is required to: Inform future commissioning discussions Ensure that questions from the public and or media can be managed appropriately Support good governance Ensure any relevant remedial action is made as soon as possible Ensure appropriate engagement in a joint investigation NHS Milton Keynes and Northamptonshire supports provider organisational learning and benchmarking through quarterly SI Assurance Meetings and Clinical Quality Review Meetings with individual organisations. At the individual organisation SI Assurance Meetings (SIAM) providers must supply updates on the implementation of, and outcomes from, SI investigation report action plans. This may also include, where appropriate, assurance from providers on actions plans following Coroner s Rule 43 reports. 1 Please see paragraph 7.4 for further information about SIAM The NHS Milton Keynes and Northamptonshire Patient Safety team monitors the NHS Strategic Executive Information System (STEIS) for new incident reports on a daily basis. Please see section 6.1 for further detail The Trust Board receives assurance through the reporting processes in place in NHS Milton Keynes and Northamptonshire for compliance with agreed timeframes for reporting incidents, submission of investigation reports from provider organisations and review of submitted reports. Throughout the year, NHS Milton Keynes and Northamptonshire produce and review quarterly reports on provider SIs to the Board. At the end of the financial year NHS Milton Keynes and Northamptonshire report never events and incidents of data loss to the public part of the Board. 4.3 Provider Organisations Providers of healthcare to NHS patients are required to report to the Co-ordinating Commissioner those incidents that fulfil the SI criteria outlined within this policy. This would include 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 Providers who have access to STEIS must report incidents directly onto the STEIS system. The CCG patient safety team will report incidents onto STEIS for those services who do not have access e.g. independent contractors, Primary Care, Care Homes etc. 1 Guidance for Coroners on Rule 43 pub: Ministry of Justice (MOJ)

18 Independent providers should also ensure that they have systems in place to report incidents, including serious incidents, to the national reporting and learning service. Guidance on reporting is available at the Nene CCG and Corby CCG websites and on the NPSA website at Chief Executives of the provider organisations are required to identify an Executive Lead for the management of incidents. The Executive Lead will be required to implement an effective risk management system, providing staff with a clear framework for prompt incident reporting, including training and support ensuring that appropriate actions are taking place, that risk is mitigated and there is a strong culture of learning and improvement If more than one provider within the locality is involved in a SI, the organisation that has identified the incident will inform its co-ordinating commissioner. The commissioner will advise on who the co-ordinating organisation will be and assist in the identification of the key stakeholders. If however any of the providers involved are outside of the commissioners locality or region then the SHA will be informed and advise. 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 All provider organisations need to ensure they have a mechanism in place for regularly reporting all incidents, including SIs to the NPSA through the Reporting and Learning System Provider organisations must inform NHS Milton Keynes and Northamptonshire if they are considering commissioning services (or parts of) through other organisations. The Commissioners will assist the provider in developing a robust contract / Service level agreement to ensure patients safety is incorporated in line with this policy. 5.0 Reporting Requirements In addition to an executive lead identified to manage the SI process, NHS Milton Keynes and Northamptonshire has nominated an appropriate senior member of staff to be the main contact with the SHA and its provider organisations. In their absence, including out of hours, a suitable deputy via the NHS Milton Keynes and Northamptonshire on call arrangements. 5.1 In Office Hours 09:00 to 17: If NHS Milton Keynes and Northamptonshire becomes aware of an incident that is high profile and likely to attract media attention / other external interest NHS Milton Keynes and Northamptonshire has a 18

19 robust process in place so that NHS Midlands and East Clinical Directorate on is contacted immediately NHS Milton Keynes and Northamptonshire ensures that all other serious incidents will be reported using the Untoward Incident Module of STEIS within 2 working days of identifying a SI. Provider organisations are required to provide a rationale on STEIS for any delays in reporting on STEIS after the SI has been identified NHS Milton Keynes and Northamptonshire ensure that providers, in the interests of confidentiality and the Data Protection Act, complete entries to STEIS and subsequent investigation reports are anonymised. It must not contain the names of practitioners or patients. To this end 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 the Health Authority will contact the Trust to discuss the incident and ascertain more detailed information. The Data Protection Act (1998) will be adhered to at all times Trusts experiencing difficulties completing STEIS may contact NHS Milton Keynes and Northamptonshire for guidance. The regional administrator can, with the agreement of the provider and commissioning organisation, transfer or remove duplicate or inaccurate STEIS entries. 5.2 Out of Hours 17:01 to 08: NHS Milton Keynes and Northamptonshire has internal Out of Hours systems in place to support the reporting of high profile SIs by their provider organisations to themselves and to the SHA The following incidents must be reported by NHS Milton Keynes and Northamptonshire in a timely manner to the NHS Midlands and East Director On Call. Where there is any doubt, NHS Milton Keynes and Northamptonshire will contact the NHS Midlands and East Director on call for advice. - Incidents which necessitate activation of the NHS Trust or commissioner Major Incident Plan and where NHS Midlands & East needs to take action e.g. attendance of NHS Midlands and East Director required at multi-agency gold command. - 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. 19

20 5.2.4 When contacting the Director on Call (tel: and ask for a message to be sent for call sign code NHSEM1) please provide the following information in your message: 1. Name 2. Organisation 3. Message 4. Contact telephone number The Director receiving the call out of hours will in discussion with the NHS organisation make the decision to notify other NHS Midlands and East senior managers out of hours and the DH Media Centre. NHS Midlands and East 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. The SI module of STEIS should be completed as Appendix 1 flow chart. 6.0 Reporting and investigation outcomes 6.1 Reporting of Serious incidents NHS Milton Keynes and Northamptonshire will ensure that all SIs that fulfil the NHS Midlands and East SI definition are reported by their provider organisations within 2 working days of becoming aware that an SI had occurred. If the provider organisation is unclear that an incident fulfils the SI reporting criteria they must discuss with the commissioner first. The provider will update them on the status of the incident within 3 working days and report on STEIS accordingly NHS Milton Keynes and Northamptonshire will review all SIs reported within 2 working days NHS Milton Keynes and Northamptonshire will ensure that all SIs reported by their provider organisations are subject to a systematic investigation at a level appropriate to the seriousness of the incident and should meet the Minimum Standards for Investigation Reports and Action Plans (appendix 7). These standards are based on the Root Cause Analysis (RCA) training provided by the NPSA. 6.2 Involvement of External Agencies 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 (DH Guidance 22/11/2006). The purpose of the protocol is to promote effective working relationships setting out general principles when liaising with each other. A decision to report an incident to the Police or HSE needs to be made at a sufficiently senior level. 6.3 Compliance with the Data Protection Act 20

21 6.3.1 All NHS organisations must comply with the Data Protection Act, therefore when reporting a SI the investigation reports must not contain names or identifiable information; any reports submitted with identifiable information will be returned to the provider organisation. 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 must be transported safely (physically or electronically) between organisations and in accordance to local policies and procedures. Those copies shared may be destroyed in accordance with the local confidentiality procedure once the report is no longer of use NB - Any investigation reports submitted with personally identifiable details (including patient or staff information) will be returned to providers for resubmission. Should providers then breach the deadline for submission consideration will be given as to whether contract penalties may apply. 6.4 Joint Investigations Where a SI is reported by a provider organisation which is graded Level 2 and involves another organisation out of NHS Midlands and East boundary, discussions with the SHA will take place to ensure appropriate management. Providers must ensure that a clearly identified contact/team within their organisation who will act as the key point of contact for communication with NHS Milton Keynes and Northamptonshire When a SI involves two or more services/organisations it should be agreed between those services/organisations who should lead on an investigation. Organisations should make initial contact with each other via their respective risk management teams, only when organisations/services cannot decide who should lead an investigation should the commissioner be contacted to arbitrate. If any of the providers involved are outside of the commissioner s boundary then the SHA must be informed. The SHA will then assist in the decision as to the co-ordinating organisation. 6.5 Grading of Serious Incidents Once an incident has been reported the provider organisation will assess the severity of the incident and will be allocated a grading; 0, 1 or 2 (Appendix 4). NHS Milton Keynes and Northamptonshire will liaise with providers should any dispute in relation to grading occur. Grade 0 A grade 0 incident is reported for notification only. This type of incident is reported as it is initially unclear whether or not the incident qualifies as a serious incident at this early stage. The unexpected death of a patient may be initially classified as a grade 0 incident as the cause of death has not yet been determined by a post mortem and therefore it is unclear what 21

22 level of investigation is required. The provider organisation must update NHS MK&N with further information within three working days of a grade 0 incident being notified by way of a 72 hour or early management report (EMR). If within three working days it is found not to be a serious incident, it can be downgraded with NHS Milton Keynes and Northamptonshire s agreement and/or the SHA, therefore no longer being classified as a serious incident. If within that time the incident is found to be a serious incident it will be re-graded as a grade 1 or 2 incident. If the commissioner is not informed within that timeframe the incident will be automatically re-graded on the fourth working day. Grade 1 NHS Milton Keynes and Northamptonshire monitor the investigation and report findings, recommendations and associate action plans to the SHA. The SHA will monitor progress on a quarterly basis with the commissioner unless earlier discussion is required because of the nature of the serious incident eg. a trend of incidents. A review of these incidents should be included in annual reports. This level of investigation will require a Comprehensive (Root Cause Analysis (RCA) level 2) Investigation, as defined by the NPSA National Framework for Reporting and Learning from Serious Incidents Requiring Investigation. Incidents would include; mental health deaths in the community or attempted suicides as inpatients, Healthcare Acquired Infections (HCAI) outbreaks, avoidable/unexplained deaths, ambulance service missing target for arrival resulting in death or severe harm to a patient, grade 3 pressure ulcer, poor discharge planning causing harm to patient. For further guidance please see the NPSA Information Resource to Support the Reporting of Serious Incidents. Grade 2 Incidents leading to an independent investigation or inquiry or those considered high risk will continue to be monitored by the commissioner and SHA until evidence is provided that each action point has been implemented. Incidents involving adult or child abuse are referred to local safeguarding arrangements. A review of these incidents should be included in quarterly reports. This level of investigation will require a Comprehensive (RCA level 2) Investigation or an Independent Investigation (RCA level 3), as defined by the NPSA National Framework for Reporting and Learning from Serious Incidents Requiring Investigation. Incidents would include; maternal deaths, inpatient suicides (including those following absconsions), child protection 22

23 6.6 Requesting 72 hour reports (paragraph 3.5.2), data loss and information security (DH Criteria Level 3-5), Never Events, accusation of physical misconduct or harm, homicide following recent contact with mental health services. For further guidance please see the NPSA Information Resource to Support the Reporting of Serious Incidents There may be occasions when NHS Milton Keynes and Northamptonshire require additional information following any STEIS notification dependent on the detail provided within the initial STEIS notification. This is most likely (but not restricted) to apply to grade 2 and above incidents. NHS Milton Keynes and Northamptonshire may request additional information (72 hour reports) from providers as required. This report should, as a minimum, contain an overview of events (as understood at the time of reporting), any key critical questions which the investigation will be seeking to examine and actions taken to mitigate any identified risks and to minimise the risk of recurrence. Providers should ensure that reports are submitted promptly and within three working days of the request Paragraph 3.20 defines the additional reporting requirements for 72 hour reports in place for never events. 6.7 Senior Briefing To ensure that directors and their deputies and the relevant CCG Chair and their accountable officer are informed of potentially volatile SIs, the Clinical Quality and Patient Safety Managers occasionally provide senior briefing to the executive at NHS Midlands and East. Whilst each case is individually reviewed, it is difficult to predict what might constitute a senior brief. However, below is a list of subjects that require briefings: Unexpected deaths related to out of hours or urgent care SIs involving high profile prisoners All unexpected child deaths and cases that may lead to serious case review or domestic homicide review Adult protection Never events Significant data losses 6.8 Investigation Timescales The amount of time allowed for an investigation differs depending on the grade of incident. Grade 0 Grade 0 incidents do not require a RCA however a 72 hour report may be requested to justify the incident no longer being classified as an SI. 23

24 6.9 Extensions Grade 1 Grade 1 incidents require a RCA level 2 (comprehensive) investigation, as defined by the NPSA National Framework for Reporting and Learning from Serious Incidents Requiring Investigation. Grade 1 RCA level 2 investigations must be completed and provided to their lead commissioner within 45 working days (nine weeks) of the incident being reported. Grade 2 Grade 2 incidents require, depending on the circumstances of the incident, a RCA level 2 (comprehensive) investigations or an independent investigation (RCA level 3 investigation), as defined by the NPSA National Framework for Reporting and Learning from Serious Incidents Requiring Investigation. For Grade 2 incidents, 60 working days (12 weeks) will be allowed for level 2 investigations and 26 weeks (six months) allowed for independent investigations (RCA level 3 investigation) If required, extensions should be requested in a timely manner and in accordance with local agreements; they must be agreed on a case-bycase basis. Extension requests must be completed in a timely manner prior to deadline and using the extension requests form. Requests must be made by the provider organisation s risk management team The extension request form is available at appendix Level of Investigation/Root Cause Analysis (RCA) Organisations will ensure that they have staff trained in best practice root cause analysis methodologies and techniques. It is good practice to assemble an investigation team for an incident allowing a wider range of areas to be considered. Members of the investigation team must have no conflict of interest in the incident concerned. Once a team is assembled, Terms of Reference should be drawn up to ensure each member of the investigation team is aware of their responsibilities. Comprehensive Root Cause Analysis (RCA Level 2) Investigation A comprehensive (RCA level 2) investigation, as defined by the NPSA National Framework for Reporting and Learning from Serious Incidents Requiring Investigation, will be: 1. Conducted with a high level of detail, including all elements of a thorough and credible investigation. 2. Conducted by a multidisciplinary team, or involves experts/expert opinion/independent advice or specialist investigator(s). 24

25 6.11 Risk assessments 3. Conducted by staff not involved in the incident, locality or directorate in which it occurred. 4. Overseen by a director level chair or facilitator. 5. Led by person(s) experienced and/or trained in RCA, human error and effective solutions development. 6. Includes patient/relative/carer involvement and should include an offer to patient/relative/carer of links to independent representation or advocacy services in line with Being Open. 7. May require management of the media via the organisation s communications department. 8. Includes robust recommendations for shared learning, locally and/or nationally as appropriate. 9. Results in full report with an executive summary and appendices. Independent (RCA level 3) Investigation An independent (RCA level 3) investigation, as defined by the NPSA National Framework for Reporting and Learning from Serious Incidents Requiring Investigation, will be: 1. Commissioned and co-ordinated by the Strategic Health Authority and independent to the provider organisation service/s and organisation/s involved in the incident, for independent investigations only. 2. Commonly considered for incidents of high public interest or attracting media attention. 3. An independent investigation must be conducted for mental health homicides (where there has been recent contact with mental health services) that meet Department of Health guidance. 4. Should be conducted where Article 2 of the European Convention on Human Rights is, or is likely to be, engaged Following all untoward incidents and near misses, all related risk assessments must be reviewed and the risk register updated Action Plans Each investigation will provide an action plan to ensure, where possible, to reduce the risk of recurrence, addressing both latent and 25

26 active failures. Each recommendation determined by an investigation should have a corresponding action with a clear deadline and responsible person allocated. Implementation and completion of action plans will be monitored through the SI Review Groups. NHS Milton Keynes and Northamptonshire will review all submitted investigations within 20 working days and feed back their findings to the provider organisations, requesting further development were necessary within agreed timescales. Organisations should ensure that any relevant patient safety alerts (such as Central Alert System [CAS] or NPSA Rapid Response Reports [RRR]) have been referenced and considered Updating STEIS with investigation outcomes When the investigation has been completed provider organisations will update the root causes and lessons learnt section of STEIS. The information provided should include key details of the investigation including an overview of the incident, findings, contributory factors, root causes, recommendations and actions Being Open & Patient Involvement Patients, families and carers involved in adverse incidents should expect openness and honesty from providers and the services commissioned by them, with timely communication essential to this principle. Effective communication with patients begins at the start of and throughout their care and this should be no different when a patient safety incident occurs. Openness about what happened and discussing patient safety incidents promptly, fully and compassionately can help patients cope better with the physical and psychological consequences of what happened. This principle is called Being Open It is equally important that they continue to receive support to cope with the physical and psychological advice and the appropriate required care. Patients, families and carers should also be kept informed of any changes implemented or ongoing actions as a result of an adverse event, and receive assurances that similar events will not occur again. Adopting an open and honest approach when things go wrong is fundamental to the partnership between patients and those who provide their care If patients, carers or families decide not to be involved in the investigation process or informed of an investigation outcome they will be informed that they may change their mind and request the information at any time. 7.0 Assurance and Review 7.1 Review of Submitted RCAs 26

27 7.1.1 On receipt of a completed investigation report and action plan the NHS Milton Keynes and Northamptonshire Patient Safety team use the quality assurance document (appendix 5) to assess the report and action plan NHS Milton Keynes and Northamptonshire will consider the closure of an investigation when the investigation report clearly identifies learning including findings, contributory factors, analysis of any root causes, conclusions, recommendations and an action plan When the review of an RCA requires the reviewer to have experience or specialised knowledge regarding the reporting area or incident type e.g. safeguarding, that is not possessed by a member of the Patient Safety Team, support will be sought from other NHS MK&N departments e.g. commissioners specialising in specific service types, information governance leads, etc to provide their opinion Feedback will be provided to reporting organisations regarding each RCA within 20 working days of the report s submission When NHS MK&N Patient Safety Team are satisfied that the report is sufficient they will recommend to the relevant Serious Incident Review Group (SIARG) that the incident can be closed. 7.2 Requests for Further Information If NHS MK&N decide that a submitted report requires further information before a recommendation to close can be made, a request will be sent to the reporting organisation detailing specific questions or highlighting where further information is required NHS MK&N may request that a revised report be submitted including the required information A deadline will be given to the reporting organisation by which the further information must be provided. 7.3 Serious Incident Assurance and Review Groups (SIARG) The purpose of the Serious Incident and Review Groups is to: To confirm and challenge the investigation reports received from all providers to ensure that the necessary actions have been completed, a thorough investigation has taken place and lessons were learned. To enable closure of SI reports on the Strategic Executive Information System (STEIS). To indentify trends and themes arising from SIs. To provide assurance to the NHS Milton Keynes & Northamptonshire Board and the Milton Keynes Clinical Commissioning Group (CCG). 27

28 7.3.2 Two SIARGs have been developed, one for the review of Milton Keynes reported incident and one for Northamptonshire reported incidents SIARGs are virtual groups taking place monthly via The membership of each SIARG will consist of NHS MK&N staff who have experience, commissioning responsibility or specialised knowledge of commissioned services or incident type. When an incident falls outside the expertise of the SIARG membership the opinion/closure recommendation of the report reviewer will be provided to the group to aid their decision The SIARG will review the findings of incident investigations and decide whether the incident can be closed. If SIARG require further information before agreeing closure, this will be taken forward by the Patient Safety Team. If SIARG agree the closure of a serious incident, STEIS will be updated, the incident closed and the service informed by the Patient Safety Team. 7.4 Serious Incident Assurance Meetings (SIAM) The purpose of the SI Assurance Meetings is to: Ensure implementation of all actions agreed as a result of SI investigations Ensure that evidence of demonstrable outcomes from SI action plans available Agree dissemination of learning from SIs Review any identified trends SIAMs will be held with each of the five main providers: Kettering General Hospital, Milton Keynes Community Health Services, Milton Keynes Hospital Foundation Trust, Northampton General Hospital and Northampton Hospital Foundation Trust SIAMs will take place quarterly or as case load demands The meeting will operate in addition to regular update meetings with providers. 8.0 Monitoring Compliance 8.1 NHS Midlands and East performance manages NHS Milton Keynes and Northamptonshire against the criteria outlined below through the quarterly commissioner performance review process. 8.2 NHS Milton Keynes and Northamptonshire monitor provider organisations adherence to the policy through regional performance metrics outlined in this policy: 28

29 Appropriateness of reporting - The number of incidents reported in total, the number of incidents reported that do not fulfil the criteria. Review of the NPSA Reporting and Learning System (RLS) data to establish which incidents categorised as serious are not being reported as SIs. Timeliness of reporting in accordance with the standards laid out in this policy The time lapse between the date the incident occurred and the date reported (verbally as well as on STEIS). The majority of SIs should be reported within 48 hours or 2 working days. Quality of investigation and report provided (fulfils at least the minimum requirement as laid out in the policy as appendix 6) Reported incidents are reviewed by the Commissioners within 3 working days. If the organisation has not graded within 3 working days the Commissioner will grade Investigation conducted within agreed timescale Commissioner reviews investigation report within 20 working days Learning is disseminated 8.3 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 CQC Standards and NHS litigation Authority). 9.0 Related Protocols 9.1 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 Safeguarding 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 Midlands and East Protocol on Managing Adverse Events in Mental Health Services Information Governance and Code of Conduct guidelines 29

30 Appendix 1 Reporting Framework Flowchart 30

31 Appendix 2 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 31

32 Appendix 3 NPSA grading guidance 32

33 Appendix 4 RCA Audit Tool Reporting Organisation: SI Incident Type: Date Submitted For Closure: Critiqued By: Level Of Investigation Required STEIS Number: Joint SHA Closure Date Critiqued: Report Sections 1. Cover page Section Requirements Organisation Logo Authors Yes / No Comments / Recommendations 2. Footer Incident number Incident Type Document version Investigation Lead Service Page numbers 3. Executive Summary Incident number Incident Date Incident Type Description of incident Incident Grade Level of investigation Service/s involved Effect to patient/service Severity of incident (consequences) Involvement and support of patient/s and relatives (Being Open) Detection of incident Care and service delivery problems Contributory factors Root causes Lessons learned Recommendations Arrangements for shared learning Report date 4. Contents Page Contents page 5. Incident description and consequences Incident Date Incident Type Description of incident Incident Grade Level of investigation Service/s involved Effect to patient/service Severity of incident (consequences) Pre-investigation risk assessment Background and context 6. Terms of Reference Purpose Objectives 33

34 Key questions/ issues to be addressed Key Deliverables Scope Investigation type, process and methods used Investigation Commissioner Investigation team Resources Involvement of other organisations/services Stakeholders/ audience Investigation timescales/schedule 7. Investigation 8. Findings 9. Sharing and review Involvement and support of patient/s and relatives Involvement and support provided for staff involved Information and evidence gathered Chronology of events Detection of incident Notable practice Care and service delivery problems Contributory factors Root causes Lessons learned Post-investigation risk assessment Recommendations Action Plan Appendices Arrangements for shared learning Reviewed by Distribution list 10. Anonymity Anonymous report Additional Comments 34

35 Appendix 5 IG 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: 35

36 Appendix 6 Minimum Standards for Investigation Reports Body of report must contain: Cover Page Organisation Logo Author(s) Incident Number (STEIS) Report date Document Version Page & Paragraph should be numbered Contents Page Executive Summary (Graded Level 1 or 2) Terms of reference Summary of the incident Background 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 a 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 was the information 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 36

37 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 Learnt 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 and 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 commissioner 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 that are too complicated to explain fully in the report Terms of Reference 37

38 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? 9. Sign-off Date when the action has been completed. 38

39 ACTION PLAN EXAMPLE ACTION PLAN DEVELOPED BY DATE ACTION PLAN SIGNED OFF BY DATE Recommendations Level of Recommendation 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

40 Appendix 8 Milton Keynes Interagency procedures Interface between serious incidents reporting in health services, serious case reviews and child death review. 1. Aims and objectives This procedure seeks to ensure effective interface between child protection procedures and procedures carried out through the serious incident investigation process for health services. An effective interface ensures comprehensive investigation, transparency and learning across the multi-agency safeguarding children partnership. 2. Context Health organisations providing NHS care are required to report serious incidents to their commissioning body. Serious incidents include incidents such as serious harm, unexpected or avoidable death and abuse (inflicting or failing to act to prevent harm). In relation to children and young people, it is important to consider whether the nature of the serious incident has implications for safeguarding children and whether any lessons learned will be beneficial to share across the multi agency safeguarding partnership. Where a child dies, the death is notified through the child death review process in order for themes and individual lessons to be identified. In some circumstances, the child s death may also be notifiable to health commissioners as a serious incident. 3. Process for serious case review Where a serious incident is reported to the health commissioner, the patient safety team will identify whether there are potential implications for safeguarding children in the broadest sense. The team will seek specialist advice via the Designated Professionals for Safeguarding Children. The Designated Professionals will identify whether the case meets the threshold for referral through to the SCR sub-group in line with inter-agency procedures Referral of the serious incident to SCR Sub-group Where a referral is made to the SCR sub-group, it will determine whether the criteria for a serious case review are met or whether there may be learning from an individual management review (IMR). Where the committee decision is to manage the case as a SCR or IMR, the serious incident investigation process will be integrated with this process so that the serious incident investigation forms the basis of the IMR carried out under the remit of the SCR sub-group. Terms of reference for the SCR/IMR should be shared with the investigating health organisation and the health commissioner s designated professionals & patient safety team so that they are aware of any additional requirements not currently covered under

41 the serious incident terms of reference. The patient safety team must also be made aware of timeframes for the SCR/IMR as this may have implications for timeframes required for the serious incident investigation Decision that serious incident should not be referred to SCR Sub-group Where a serious incident is assessed by the Designated Professionals as not reaching the threshold for referral to SCR sub-group, the serious incident will continue to be investigated as defined by patient safety procedures. The investigation may identify new information and trigger referral to the SCR subgroup as described in 3.1 above. 41

42 FLOWCHART INTERFACE BETWEEN SERIOUS INCIDENTS AND SERIOUS CASE REVIEW Health organisation identifies that an incident involving a child has occurred Commissioners Patient Safety Team (PST) advised PST consult designated professionals Designated professionals determine potential for safeguarding children issues & need for referral to SCR sub-group Reporting organisation commences investigation MK SCR sub-group reviews information against the SCR criteria Reporting organisation amends original ToR if required MK SCR sub-group establish terms of reference (ToR) and advise commissioners and investigating organisation/s Reporting organisation submits investigation report Commissioner reviews investigation report with input from designated professionals. Considers whether information within the report raises any additional concerns re safeguarding children If additional concerns are identified the reporting organisation and MK SCR sub-group informed If no additional concerns closes incident and works with trust to monitor outcomes. Report to MK SCR sub-group. Learning shared via SCR subgroup 42

43 4. Process for child deaths When a child dies, deaths are notified by the professional confirming the child death to the MKSCB child death coordinator (designated person). The lead paediatrician ensures a review is held with the relevant agencies and professionals involved and presents findings to the Child Death Overview Panel. Health organisations that have provided NHS care must also consider whether the circumstances of the death constitute a serious incident. Where investigation as a serious incident is required, this will be reported to their commissioning body. Where a child s death is being investigated as a serious incident, the investigation may also identify learning that the patient safety team and Designated Professionals identify as beneficial to share across the multi agency safeguarding partnership. This will be shared through the CDOP The child death coordinator will share information with the patient safety team about all child deaths in order to triangulate information and provide robust assurance that deaths are being appropriately reported as serious incidents. 43

44 FLOWCHART INTERFACE BETWEEN SERIOUS INCIDENTS AND CHILD DEATH REVIEW SEE AMENDED VERSION DEATH OF A CHILD OR YOUNG PERSON Death is sudden/unexpected Death is not sudden/unexpected LSCB CDOP Co-ordinator informed Early professionals discussion. Strategy meeting if indicated. May a SCR be needed? (Decision for LSCB SCR SG) Is this a serious incident? (Decision for Health Organisation) Liaison between CDOP Co-ordinator and Patient Safety Team Health organisation decides if this death represents a Serious Incident no yes Autopsy Commissioners PST advised of SI and confirms notification Decision re SCR/SI reviewed after autopsy results become available (or at any time subsequently) Inquest Decision for SCR/SI reviewed after Inquest SI ToR agreed Commissioner and LSCB CDOP Co-ordinator notified Reporting organisation commences investigation Reporting organisation submits investigation report Commissioner reviews report with Designated professionals CDOP meeting SI report provided to inform CDOP discussion If no additional concerns identified actions agreed and Serious Incident closed Implementation of actions and monitoring outcomes agreed from SI and CDOP processes 44

45 Appendix 9 Northamptonshire Interagency procedures Interface between serious incidents reporting in health services, serious case reviews and child death review. 1. Aims and objectives This procedure seeks to ensure effective interface between child protection procedures and procedures carried out through the serious incident investigation process for health services. An effective interface ensures comprehensive investigation, transparency and learning across the multi-agency safeguarding children partnership. 2. Context Health organisations providing NHS care are required to report serious incidents to their commissioning body. Serious incidents include incidents such as serious harm, unexpected or avoidable death and abuse (inflicting or failing to act to prevent harm). In relation to children and young people, it is important to consider whether the nature of the serious incident has implications for safeguarding children and whether any lessons learned will be beneficial to share across the multi agency safeguarding partnership. Where a child dies, the death is notified through the child death review process in order for themes and individual lessons to be identified. In some circumstances, the child s death may also be notifiable to health commissioners as a serious incident. 3. Process for serious case review Where a serious incident is reported to the health commissioner, the patient safety team will identify whether there are potential implications for safeguarding children in the broadest sense. The team will seek specialist advice via the Designated Professionals for Safeguarding Children. The Designated Professionals will identify whether the case meets the threshold for referral through to the SCR committee in line with inter-agency procedures Referral of the serious incident to SCR committee Where a referral is made to the SCR committee, the committee will determine whether the criteria for a serious case review are met or whether there may be learning from an individual management review (IMR). Where the committee decision is to manage the case as a SCR or IMR, the serious incident investigation process will be integrated with this process so that the serious incident investigation forms the basis of the IMR carried out under the remit of the SCR committee. Terms of reference for the SCR/IMR should be shared with the investigating health organisation and the health commissioner s designated professionals & patient safety team so that they are aware of any additional requirements not currently covered under the serious incident terms of reference. The patient safety team must also be made 45

46 aware of timeframes for the SCR/IMR as this may have implications for timeframes required for the serious incident investigation Decision that serious incident should not be referred to SCR committee Where a serious incident is assessed by the Designated Professionals as not reaching the threshold for referral to SCR committee, the serious incident will continue to be investigated as defined by patient safety procedures. The investigation may identify new information and trigger referral to the SCR committee as described in 3.1 above. 46

47 FLOWCHART INTERFACE BETWEEN SERIOUS INCIDENTS AND SERIOUS CASE REVIEW Health organisation identifies that an incident involving a child has occurred Commissioners Patient Safety Team (PST) advised PST consult designated professionals Designated professionals determine potential for safeguarding children issues & need for referral to SCR committee Reporting organisation commences investigation LSCB reviews information against the SCR criteria Reporting organisation amends original ToR if required LSCB establish terms of reference (ToR) and advice commissioners and investigating organisation/s Reporting organisation submits investigation report Commissioner reviews investigation report with input from designated professionals. Considers whether information within the report raises any additional concerns re safeguarding children If additional concerns are identified the reporting organisation and LSCB informed If no additional concerns closes incident and works with trust to monitor outcomes. Report to LSCB. Learning shared via SCR committee 47

48 4. Process for child deaths When a child dies, deaths are notified by the professional confirming the child death to the LSCB child death coordinator (designated person). The lead paediatrician carries out a review with the relevant agencies and professionals involved and presents findings to the Child Death Overview Panel. Health organisations that have provided NHS care must also consider whether the circumstances of the death constitute a serious incident. Where investigation as a serious incident is required, this will be reported to their commissioning body. Where a child s death is being investigated as a serious incident, the investigation may also identify learning that the patient safety team and Designated Professionals identify as beneficial to share across the multi agency safeguarding partnership. This will be shared through the CDOP The child death coordinator will share information with the patient safety team about all child deaths in order to triangulate information and provide robust assurance that deaths are being appropriately reported as serious incidents. 48

49 FLOWCHART INTERFACE BETWEEN SERIOUS INCIDENTS AND CHILD DEATH REVIEW Professional confirming child s death notifies LSCB child death coordinator Strategy discussions and early professionals meeting (if sudden and unexpected death) i) May an SCR be indicated? recommendation via LSCBN Health organization considers if serious incident Liaison between child death coordinator and PST for all child deaths Commissioners Patient Safety Team (PST) advised of serious incident confirm notification has been made SI TOR agreed in line with procedures for child deaths (including unexpected deaths) & advice commissioner and CDOP ii) May an SI be indicated? lead paediatrician makes recommendation to health organisation Reporting organisation commences investigation Professionals review meeting reconsiders whether SCR or SI may be indicated (as above) and makes recommendation Reporting organisation submits investigation report SI report informs CDR discussions. Commissioner reviews investigation report with input from designated professionals CDOP informed of outcome If no additional concerns, actions agreed and serious incident closed Implementation of actions and monitoring outcomes agreed from SI and CDOP process 49

50 Appendix 10 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. Abuse Violation of an individual s human rights. This could be physical, mental, or sexual. 50

51 Appendix 11 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. - 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. The only time a homicide inquiry is not commissioned by the SHA is when the victim is a child and it is considered that the report by the Local Safeguarding Children Board (LSCB) fully covers the remit of an independent inquiry to fulfil the requirements above. Once the commissioned report is completed, it is sent to the Trust/ commissioner and the report and joint action plan is shared at the Trust/commissioner and SHA Boards. 51

52 Appendix 12 Never Events The Never events Framework -2012/13 (updated January 2012) provides the list of never events SURGICAL 1. Wrong site surgery A surgical intervention performed on the wrong site (for example wrong knee, wrong eye, wrong patient, wrong limb, or wrong organ); the incident is detected at any time after the start of the operation and the patient requires further surgery, on the correct site, and/or may have complications following the wrong surgery. Includes biopsy, radiological procedures and drain insertion, where the intervention is considered surgical. Excludes wrong site anaesthetic block. Excludes interventions where the wrong site is selected because of unknown/unexpected abnormalities in the patient s anatomy. This should be documented in the patient s notes. Setting: All healthcare premises. 2. Wrong implant/prosthesis Surgical placement of the wrong implant or prosthesis where the implant/prosthesis placed in the patient is other than that specified in the operating plan either prior to or during the procedure. The incident is detected at any time after the implant/prosthesis is placed in the patient and the patient requires further surgery to replace the incorrect implant/prosthesis and/or suffers complications following the surgery. Excludes where the implant/prosthesis placed in the patient is intentionally different from the operating plan, where this is based on clinical judgement at the time of the operation. Excludes where the implant/prosthesis placed in the patient is intentionally planned and placed but later found to be suboptimal. Setting: All healthcare premises. 3. Retained foreign object post-operation Unintended retention of a foreign object in a patient after surgical intervention, including interventional radiology, cardiology and vaginal birth. Includes swabs, needles, implants, fragments of screws, instruments and guidewires. Excludes where any relevant objects are found to be missing prior to the completion of the surgical intervention and may be within the patient, but where further action to locate and/or retrieve would be more damaging than retention, or impossible. This must be documented in the patient s notes and the patient informed. Settings: All healthcare premises. MEDICATION EVENTS 4. Wrongly prepared high-risk injectable medication Death or severe harm as a result of a wrongly prepared high-risk injectable medication. High-risk injectable medicines are identified using the NPSA s risk assessment tool1. A list of highrisk medicines has been prepared by the NHS Aseptic Pharmacy Services Group using this tool2. Organisations should have their own list of high-risk medications for the purposes of the never event policy, which may vary from the NHS Aseptic Pharmacy Services Group list, depending on local circumstances. A high risk injectable medicine is considered wrongly prepared if it was not prepared in accordance with the manufacturer's Specification of Product Characteristics; 1 NPSA High Risk Medication Risk Assessment Tool, 2007, available at ype=attachment 52

53 2 Pharmaceutical Aseptic Services Group. Example risk assessment of injectable medicines Available at The never events list 2012/13 prepared in accordance with a protocol formally agreed by the local organisation (for example for off-label or unlicensed product use) prepared in accordance with patient specific directions of a prescriber in an urgent or emergency situation and supported by evidence or expert advice. This event excludes any incidents that are covered by other never events. Where death or severe harm cannot be attributed to incorrect preparation, treat as a Serious Untoward Incident. Setting: All healthcare settings. 5. Maladministration of potassium-containing solutions Death or severe harm as a result of maladministration of a potassium-containing solution. Maladministration refers to; selection of strong potassium solution instead of intended other medication, wrong route administration, for example a solution intended for central venous catheter administration given peripherally, infusion at a rate greater than intended. Setting: All healthcare settings. 6. Wrong route administration of chemotherapy Intravenous or other chemotherapy (for example, vincristine) that is correctly prescribed but administered via the wrong route (usually into the intrathecal space). Setting: All healthcare premises. 7. Wrong route administration of oral/enteral treatment Death or severe harm as a result of oral/enteral medication, feed or flush administered by any parenteral route. Setting: All healthcare settings. 8. Intravenous administration of epidural medication Death or severe harm as a result of intravenous administration of epidural medication. A broader never event covering intravenous administration of intrathecal medication or intrathecal administration of intravenous medication is intended once the deadlines for Patient Safety Alert 004A and B actions have passed. Setting: All healthcare premises. 9. Maladministration of Insulin Death or severe harm as a result of maladministration of insulin by a health professional. Maladministration in this instance refers to when a health professional uses any abbreviation for the words unit or units when prescribing insulin in writing, issues an unclear or misinterpreted verbal instruction to a colleague, fails to use a specific insulin administration device e.g. an insulin syringe or insulin pen to draw up or administer insulin, or fails to give insulin when correctly prescribed. Setting: All healthcare settings. 10. Overdose of midazolam during conscious sedation Death or severe harm as a result of overdose of midazolam injection following use of high strength midazolam (5mg/ml or 2mg/ml) for conscious sedation. Excludes areas where use of high strength midazolam is appropriate. These are specifically only in general anaesthesia, intensive care, palliative care, or where its use has been formally risk assessed. Excludes paediatric care. Setting: All healthcare premises. 11. Opioid overdose of an opioid-naïve patient 53

54 Death or severe harm as a result of an overdose of an opioid given to a patient who was opioid naïve. Specifically this means: Where a dose is used that is not consistent with the dosing protocol agreed by the healthcare organisation, or the manufacturer s recommended dosage for opioid-naïve patients*. Where the prescriber fails to ensure they were familiar with the therapeutic characteristics of the opioid prescribed. Excluded are cases where the patient was already receiving opioid medication. Setting: All healthcare settings. 12. Inappropriate administration of daily oral methotrexate Prescription, supply or administration of daily oral methotrexate to a patient for non-cancer treatment including supply to the patient with the instruction to take daily. Excludes cancer treatment with daily oral methotrexate Excludes where the error is intercepted before the patient is supplied with the medication. Setting: All healthcare settings. MENTAL HEALTH 13. Suicide using non-collapsible rails Death or severe harm to a mental health inpatient as a result of a suicide attempt using noncollapsible curtain or shower rails. Setting: All mental health inpatient premises. 14. Escape of a transferred prisoner A patient who is a transferred prisoner escaping from medium or high secure mental health services where they have been placed for treatment subject to Ministry of Justice restriction directions. Setting: All medium and high secure mental health inpatient premises. GENERAL HEALTHCARE 15. Falls from unrestricted windows Death or severe harm as a result of a patient falling from an unrestricted window. Applies to windows within reach of patients. This means windows (including the window sill) that are within reach of someone standing at floor level and that can be exited/fallen from without needing to move furniture or use tools to assist in climbing out of the window. Includes windows located in facilities/areas where healthcare is provided and where patients can and do access. Includes where patients deliberately or accidentally fall from a window where a restrictor has been fitted but previously damaged or disabled, but does not include events where a patient deliberately disables a restrictor or breaks the window immediately before the fall. Setting: All healthcare premises. 16. Entrapment in bedrails Death or severe harm as a result of entrapment of an adult in bedrails that do not comply with Medicines and Healthcare products Regulatory Agency (MHRA) dimensional guidance. Setting: All adult inpatient care premises. 17. Transfusion of ABO-incompatible blood components Death or severe harm as a result of the inadvertent transfusion of ABO-incompatible blood components. Excludes where ABO-incompatible blood components are deliberately transfused with appropriate management. Setting: All healthcare premises. 18. Transplantation of ABO incompatible organs as a result of error Death or severe harm arising from inadvertent ABO mismatched solid organ transplantation 54

55 Excluded are scenarios in which clinically appropriate ABO incompatible solid organs are transplanted deliberately. In this context, incompatible antibodies must be clinically significant. If the recipient has donorspecific anti-abo antibodies and is therefore likely to have an immune reaction to a specific ABO incompatible organ, then it would be a never event to transplant that organ inadvertently and without appropriate management. Setting: All healthcare premises. 19. Misplaced naso- or oro-gastric tubes Death or severe harm as a result of a naso- or oro-gastric tube being misplaced in the respiratory tract. Setting: All healthcare premises. 20. Wrong gas administered Death or severe harm as a result of the administration of the wrong gas, or failure to administer any gas, through a line designated for Medical Gas Pipeline Systems (MGPS) or through a line connected directly to a portable gas cylinder. Setting: All healthcare premises. 21. Failure to monitor and respond to oxygen saturation Death or severe harm as a result of failure to monitor or respond to oxygen saturation levels in a patient undergoing general or regional anaesthesia, or conscious sedation for a healthcare procedure (e.g. endoscopy). Includes failure to physically have monitoring in place, and failure to act on relevant information from monitoring oxygen saturation. Excludes where action is taken in response to recorded adverse oxygen saturation levels, but this fails to prevent death or severe harm for other reasons (e.g. pre-existing problems with oxygenation that cannot be resolved). Excludes incidents where the accepted limitations of monitoring equipment mean that adverse readings may be artefactual (e.g. shock/vasoconstriction). Setting: All healthcare premises. 22. Air embolism Death or severe harm as a result of intravascular air embolism introduced during intravascular infusion/bolus administration or through a haemodialysis circuit. Excludes the introduction of air emboli through other routes. This therefore excludes introduction via surgical intervention (particularly Ear, Nose and Throat surgery and neurosurgery), during foam scleropathy and during the insertion of a central venous catheter. Introduction of an air embolism after the insertion of a central venous catheter, through the line, and during its removal, is included. Excludes where the introduction of the air embolism was caused by the actions of the patient. Settings: All healthcare premises. 23. Misidentification of patients Death or severe harm as a result of administration of the wrong treatment following inpatient misidentification due to a failure to use standard wristband (or identity band) identification processes. Failure to use standard wristband identification processes means; Failure to use patient wristbands that meet the NPSA s design requirements. Failure to include the four core patient identifiers on wristbands last name, first name, date of birth and NHS number. Failure to follow clear and consistent processes for producing, applying and checking patient wristbands. Printing several labels with patient details at one time. This definition excludes those units where wristbands are deliberately not used, primarily some mental health inpatient units (this requires local agreement). It also excludes instances where the patient refuses to wear a wristband despite a clear explanation of the risks of not doing so, or where it has been documented that the patient cannot wear a wristband due to their clinical condition or treatment, or in emergency care environments where high patient turnover, insufficient patient identity information, or the need for rapid treatment can delay wristband use. 55

56 Setting: All healthcare premises. 24. Severe scalding of patients Death or severe harm as a result of a patient being scalded by water used for washing/bathing Excludes scalds from water being used for purposes other than washing/bathing (eg from kettles). Settings: All healthcare premises. MATERNITY 25. Maternal death due to post partum haemorrhage after elective caesarean section In-hospital death of a mother as a result of haemorrhage following elective caesarean section. Excludes cases where placenta accreta is found, or where there is a pre-existing bleeding disorder, or the mother refuses blood components for any reason. Excludes emergency caesarean section and where a scheduled elective caesarean section is brought forward. Setting: All healthcare premises. 56

57 Appendix 13 NHS Milton Keynes and Northamptonshire Serious incident extension request guidance Providers are given timeframes in accordance with the NPSA Framework to complete a full RCA and produce a final report and action plan following a Serious Incident. If a provider organisation is unable to meet deadlines an extension can be requested. Such requests will be granted under the following circumstances: - Sickness/availability/absence of a Key individual. If short-term sickness/absence PCT to consider length of absence and extend accordingly. o Negotiation of extension to a maximum of 20 working days. If long-term sickness/absence (exceeds 20 working days) - a contingency plan must be in place to ensure that the report is investigated within the agreed timeframe. Multi-agency involvement if a serious incident investigation involves multiagencies and a delay is encountered. o Negotiation of extension to a maximum of 20 working days. Ad hoc requests outside the categories above will be considered on a case-by-case basis. o Extension may be granted to a maximum of 20 working days. Failure by the provider to co-ordinate internal discussions is not a sufficient reason and no extension will be granted. Please ensure that extension requests are forwarded as soon as you are aware that a deadline will not be met. Please the request to: Northants.SUI@nhs.net 57