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1 Proceduree for performance management of serious untoward incidents reportable on the Strategic Executive Information System (StEIS) REFERENCE NUMBER APPROVING COMMITTEE(S) AND DATE REVIEW DUE DATE Version 1 September 2012 Clinical Executive September 2013 ) 1 of 34

2 CONTENTS 1. INTRODUCTION Purpose Scope... 5 This procedure applies to those members of staff that are directly employed by the CCG or working on behalf of the CCG in a commission support unit PROCEDURE Reporting StEIS Incidents Reporting Flowchart Contact Out of Hours Initial Assessment Criteria for SUI Management and Accountability... 6 Criteria for Assessing the 45 Working Day Internal Investigation Reports Criteria for Incident Closure Learning from Experience and Post Incident Review (PIR) Supporting Staff and Advice Supporting Patients and Relatives (Being Open) Never Events ROLES AND RESPONSIBILITIES Chief Officer CCG Quality Improvement Committee Senior Information Risk Owner (SIRO) Committee Responsibility MONITORING COMPLIANCE KEY PERFORMANCE INDICATORS (KPIs) APPENDIX FLOW CHART FOR REPORTING SERIOUS UNTOWARD INCIDENTS APPENDIX NHS NORTH WEST SHA TYPES AND THRESHOLDS FOR REPORTING StEIS APPENDIX 2a: StEIS/ UNIFY INCIDENT AREAS AND EXAMPLES APPENDIX PROCEDURE FOR MATERNITY, INFANT AND CHILD INCIDENTS REPORTED ON STEIS Introduction Page 2 of 34

3 Timescales for Reporting an Incident on StEIS Multiple Reports on StEIS for the Same Incident Incident Types on StEIS and Types of Investigations Safeguarding Children Incidents Reported on StEIS for which the SHA will Performance Manage Deadlines on Investigation Completion for Incidents where the SHA is the Performance Manager Updates required by the SHA where the SHA is the Performance Manager Maternity, Infant and Child Incidents for PCT Commissioners to Performance Manage Closing Safeguarding Incidents Where the SHA is the Performance Manager Appendix 1: Definitions APPENDIX 4: EXAMPLE REPORT CONTENT Page 3 of 34

4 West Lancashire CCG is committed to ensuring that, as far as it is reasonably practicable, the way we provide services to the public and the way we treat our staff reflects their individual needs and does not discriminate against individuals or groups on the basis of their age, disability, gender, race, religion/belief or sexual orientation. Should a member of staff or any other person require access to this policy in another language or format (such as Braille or large print) they can do so by contacting the West Lancashire CCG who will do its utmost to support and develop equitable access to all policies. Senior managers within the CCG have a responsibility for ensuring that a system is in place for their area of responsibility that keeps staff up to date with new policy changes. It is the responsibility of all staff employed directly or indirectly by the CCG to make themselves aware of the policies and procedures of that CCG. Page 4 of 34

5 1. INTRODUCTION This procedure outlines the responsibilities of the Clinical Commissioning Group (CCG) in relation to performance management of Serious Untowards Incidents (SUI) which are reportable on the Strategic Executive Information System (StEIS) in its commissioned and contracted NHS Services. Alongside performance management the procedure includes the CCG s reporting and communication mechanism. (appendix 1). Staff should also make reference to schedule 12 reporting arrangements and contacts. The role of the commissioning organisation (CCG) is to ensure incidents are properly investigated, lessons learned are embedded, quality is raised and to ensure patient safety. Incidents that reach the criterion identified within NHS North of England StEIS/Unify types and thresholds for reporting document (appendix 2 and 2a) shall be recorded on the Strategic Executive Information System (StEIS) 1.1 Purpose The purpose of this procedure is to define the CCG s governance arrangements, for the performance management of Serious Untoward Incidents reportable on StEIS and to ensure that all reported incidents are appropriately managed within CCG s commissioned services in order to address the concerns of patients and promote public confidence. 1.2 Scope This procedure applies to those members of staff that are directly employed by the CCG or working on behalf of the CCG in a commission support unit. This procedure will guide CCG staff responsible for the performance management of SUIs for its commissioned and contracted NHS services, through the StEIS / UNIFY reporting system. This procedure may also serve to inform the providers of services under contract with the CCG of their responsibilities. 2. PROCEDURE 2.1 Reporting StEIS Incidents NHS organisations should report any StEIS incident to the CCG within a maximum of 48 hours or as soon as known following notification using the StEIS/UNIFY database. Care should be taken to ensure that all sections are completed and as much detail as possible is included in the initial StEIS/UNIFY report. Information should be provided in a manner, which maintains the anonymity of patients and staff involved, in line with Caldicott principles. In the event of the StEIS/UNIFY reporting system failure, contact with the CCG could be made by Page 5 of 34

6 the agreed schedule 12 arrangements and the incident entered onto StEIS/UNIFY once the system is back on line. If relevant, the following information should be provided in the Further Information field. Number of patients affected; Impact of patient(s) Designation of staff involved; Confirmation of which, if any, medical devices or equipment were involved; Confirmation of which, if any, medicines were involved; The impact of the incident on staff Whether the patient s family has been informed and if not are there any plans to do so; if a decision not to inform the family has been taken has this been properly recorded was the patient involved in this decision; If the family has been contacted how is contact with the family being maintained; is there a named person for this purpose; Any other information deemed relevant by the reporting organisation 2.2 Reporting Flowchart Having completed the initial StEIS/UNIFY report form, the reporting organisation must then take appropriate measures to investigate the incident. Please refer to the flowchart (appendix 1) for details of the recommended process for incidents which meet the CCG s escalation criteria and will therefore remain the responsibility of the CCG to performance manage. 2.3 Contact Out of Hours Where the authorised named individual in the NHS organisation believes that the incident has significant implications for the NHS in terms of clinical care, management of media issues, and warrants the immediate involvement of the CCG out of hours, the CCG on-call Executive Director can be contacted when the situation requires escalation. If so, they will agree any action that needs to be taken with the relevant NHS organisation. Please refer to the Schedule 12 arrangements for details of the recommended process. 2.4 Initial Assessment Once the CCG have received notification of a StEIS reportable incident, an assessment will be carried out. The following options will be considered: 2.5 Criteria for SUI Management and Accountability Where the incident is graded O or I the CCG will performance manage the incident. Grade 2 incidents will be performance managed by NHS North of England (NHS North West National Framework for Reporting and Learning 2010). Page 6 of 34

7 Grade O Low level incident it may be unclear if a serious incident has occurred. If within three working days it is found not to be a serious incident, it can be downgraded with the agreement of the CCG or regraded to 1 or 2. Grade 1 The CCG will monitor the incident, report, action plan and lessons learned. The CCG will close the incident when it is satisfied that the action plan has been implemented and lessons learned. (NPSA National Framework for Reporting and Learning from Serious Incidents requiring investigation requirement of a comprehensive investigation Root Cause Analysis Level 2 ). Grade 2 NHS North of England will be performance managing the incident reports, action plan and lessons learned. Examples of Grade 2 incidents are:- Safeguarding, Serious Case Reviews, Homicide, Inpatient Homicide. (NPSA Requirement of an independent investigation Root Cause Analysis Level 3) The incident does not meet the StEIS/UNIFY reporting criteria and no further action is needed. Removal from StEIS/UNIFY would be requested following discussion with the reporting organisation. No further action is needed and The CCG will confirm that the incident is closed. The CCG may declare a particular incident to be a major incident and involve the oncall Director of Public Health and/or Regional Director of Public Health in the incident management (for further information please see the NHS North of England On-call Standard Operating Procedure for Public Health at the Regional Level guidance). The CCG undertake performance management of the incident and advises NHS North of England as appropriate. If NHS North of England retains performance management of the incident the reporting organisation will be requested to proceed with its internal investigation processes and provide NHS North of England with an internal investigation report within 45 working days from the date the incident was reported onto the StEIS/UNIFY system. The incident meets The CCG s escalation criteria (appendix 1) and is managed by The CCG in collaboration with the associate organisation When The CCG requires escalation of a StEIS incident, the CCG will brief NHS North of England as appropriate and agree the level of involvement with the organisation. Depending on the severity of the incident this could include Submission of internal investigation report in 45 working days Agree terms of reference and investigation/review panel NHS North of England commissions an independent investigation (HSG (94) 27 guidance replacing paragraph 33-36) The CCG will liaise with the reporting organisation to confirm the appropriate level of investigation and reports required and internal investigation reports will be required within 45 Page 7 of 34

8 working days from the date the incident was reported onto the StEIS/UNIFY system. If the organisation faces unavoidable delays in its investigation of an incident e.g. police investigation, the CCG should be notified of the reason for the delay and the anticipated delay period and a new reporting timescale will be negotiated on a case by case basis as required. Criteria for Assessing the 45 Working Day Internal Investigation Reports The following criteria are used by The CCG when appraising the 45 working day Internal Investigation reports: Has the report examined the workings of risk management systems (including incident reporting and the related incident management systems) and clinical governance arrangements in the organisation; has the report assessed whether these systems are fit for purpose; Have the authors of the report interviewed/sought information from the key workers/managers involved in the case; Has the report adequately addressed all of the investigation terms of reference; Is the report internally consistent, i.e. do the main conclusions follow from the body of the report; Are the main recommendations directed at the appropriate sector of the health community i.e. primary care, secondary care, local authority Is there a robust action plan in place to meet the report s recommendations Any further action will be agreed with the organisation on a case by case basis as required. Once completed the incident may be recommended for closure. 2.6 Criteria for Incident Closure Closure of incidents reported on StEIS/UNIFY may be considered after submission of the internal investigation report and action plan (If appropriate). However if there are significant recommendations closure may be delayed until these recommendations or the associated action plan has been implemented. Main criteria for the closure of an incident are: The report is robust and has fulfilled the terms of reference An action plan has been agreed between the relevant organisations, which addresses the recommendations and has been ratified by the NHS organisation board Evidence has been submitted that significant recommendations have been implemented. Page 8 of 34

9 2.7 StEIS Reporting involving Data Extract from Department of Health Gateway Ref N Information Governance Assurance Programme Annex A; Reporting of Personal data Related Incidents Incidents are graded on a severity scale of 0-5; those rated at 3-5 should be reported as SUIs and reported to The CCG and the Information Commissioner. Those incidents rated at 1-2 should be aggregated and reported in the Annual Report No significant reflection on any individual body. Media interest very unlikely Damage to a services reputation/low key local media coverage Damage to an organisations reputation/local media coverage 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 teams reputation. Some local media interest that may not go public Serious potential breach and risk assessed high e.g. uncrypted clinical records lost. Up to 20 people affected Serious breach of confidentiality e.g. up to 100 people affected Serious breach with either particular sensitivity e.g. sexual health details or up to 1000 people affected Damage to NHS reputation/national media coverage Serious breach with potential for ID theft or over 1000 people affected. 2.8 Learning from Experience and Post Incident Review (PIR) The CCG is committed to quality and safety in commissioning services. The CCG will make explicit reference within contracts regarding its expectation regarding incident reporting and management. The CCG may request a Post Incident Review (PIR) for those incidents where it is appropriate. This review does not replace any internal mechanisms for review a provider organisation may have. The PIR will take place after the performance management process has concluded and following receipt of the internal investigation report from the provider organisation. The reviews will provide opportunities to facilitate the sharing of good practice and lessons learned. Page 9 of 34

10 2.9 Supporting Staff and Advice Staff will be supported by their line manager in the first instance and support from the assurance team during and following an investigation, particularly when staff are required to provide or give evidence during legal and non-legal proceedings Supporting Patients and Relatives (Being Open) Central to CCG s strategy to improve patient safety is the commitment to provide good communications between healthcare organisations and patients and/or carers when a patient is harmed as a result of a patient safety incident. The CCG shall follow the guidance in the Being Open policy and the Department of Health initiative Building a Safer NHS for Patients 2.11 Never Events Never Events are defined as serious, largely preventable patient safety incidents that should not occur if the preventative measures have been implemented by health providers (NPSA Never Events Framework 2010/11) To be a Never Event an incident must fulfil the following criteria: The incident has clear potential for or has caused severe harm or death There is evidence of occurrence in the past There is existing national guidance and/or national safety recommendations on how the event can be prevented and support for implementation The event is largely preventable if the guidance is implemented Occurrence can be easily defined, identified and continually measured. The Department of Health The Never Events List 2011/12 identifies 25 Never Events which when identified as occurring in a provider service are reportable on the StEIS database. 3. ROLES AND RESPONSIBILITIES 3.1 Chief Officer The CCG Chief Officer has overarching responsibility for the management of the StEIS system and is in discussions with commissioning support services to delegate responsibility for the performance management of SUIs. 3.2 CCG Quality Improvement Committee The service provider will coordinate a review team of appropriately experience personnel to objectively assess the adequacy and appropriateness of the reporting organisations investigation report, action plan, assurances and lessons learned before Page 10 of 34

11 consideration to facilitate closure of the incident. The Quality Improvement Committee will receive details of this investigation report. The Committee shall receive performance reports regarding SUI incidents, trends and lessons learned to ensure organisational learning to prevent recurrence. If the Committee have any concerns the Chair of the Committee will draw then to the attention of the Governing Body. 3.3 Senior Information Risk Owner (SIRO) The SIRO has a corporate responsibility for overseeing incidents relating to information governance breaches. 3.4 Committee Responsibility The CCG s Executive Committee shall receive performance reports regarding SUI incidents, trends and lessons learned to ensure organisational learning to prevent recurrence. 4. MONITORING COMPLIANCE An annual review of the policy and processes shall be carried out to review the effectiveness of the performance management of SUIs, the process of reporting, recording and lessons learned in order to prevent similar incidents occurring. This review and monitoring process shall be carried out by the CCG s Quality Improvement Committee. 5. KEY PERFORMANCE INDICATORS (KPIs) All Incidents will be reported within 48 hours All Reports will be received within 45 days (or less) unless mitigating circumstances are agreed with commissioner The CCG will evidence feedback on lessons learned. The CCG can demonstrate contact with associate PCTs within timeframes identified in StEIS criteria. The CCG can demonstrate monitoring / reviewing action plans produced from StEIS incidents. Page 11 of 34

12 APPENDIX 1 FLOW CHART FOR REPORTING SERIOUS UNTOWARD INCIDENTS Page 12 of 34

13 APPENDIX 2 NHS NORTH WEST SHA TYPES AND THRESHOLDS FOR REPORTING StEIS Type Threshold Key words Current incident In addition to free text description type on StEIS Abscond Escape from within the secure perimeter of medium or high security mental health services by patients who are transferred prisoners Secure Unit Never Event (NE) Mental Health Act status Informal patient 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 restrictions (NE) Patients detained under the Mental Health Act, and current risk assessment confirms current risk of; ~violence/risk to others ~self harm ~neglect exploitation (vulnerable adult) Informal patient and current risk assessment confirms current risk of; ~violence/risk to others ~self harm ~neglect ~exploitation (vulnerable adult) Accident Whilst in Hospital Accident on NHS premises or whilst receiving NHS funded care which results in; ~permanent harm to one or more patients where the outcome requires life-saving intervention or major surgical/medical intervention or will shorten life expectancy This includes Entrapment of an adult in bedrails (NE) Patient scalded by water during bathing (NE) Permanent harm Unexpected death Entrapment of an adult in bedrails Never Event (NE) Page 13 of 34

14 Type Threshold Key words Current incident type on StEIS Admission of under 18s to adult mental health ward Include all admissions of an under 18 yr old to an adult MH inpatient unit. Include the actual age of service user and the reason for admission describing if the admission was required because of clinical need or lack of a bed in an age appropriate setting. In addition to free text description Actual age in years eg 15 years and 364 days Admission of under 16s to adult mental health ward Adverse media coverage or public concern about the organisation or the wider NHS Allegation against HC non- Professional To include under 18 admissions CAMHS clients Incidents where there may not be permanent harm or death but result in a repeated pattern of negative media attention for the organisation for example; - An incident is reported in more than one local paper and television or national media and the organisation is being criticised for the quality and safety of patient care. This does not include workforce, financial issues, etc. Where a member of staff shows gross disrespect for the dignity of a patient/deceased patient. Serious; -verbal and/or physical aggression. - criminal acts involving patients or staff - complaints about a member of staff or primary care contractor or any incident relating to a staff member where significant adverse media interest could occur - breach of confidentiality - fraud CAMHS client Actual age in years e.g. 15 years and 364 days Serious Fraud Assault Safeguarding (adult) Safeguarding (child) Criminal acts involving patients or staff Conduct Allegation Against HC Professional Where a member of staff shows gross disrespect for the dignity of a patient/deceased patient. Serious; -verbal and/or physical aggression. - criminal acts involving patients or staff - complaints about a member of staff or primary care contractor or any incident relating to a staff member where significant adverse media interest could occur - breach of confidentiality - fraud Serious Fraud Assault Safeguarding (adult) Safeguarding (child) Criminal acts involving patients or staff Professional performance Page 14 of 34

15 Type Threshold Key words Current incident type on StEIS Ambulance Accident - Road Traffic Collision Where; - patients/staff or the public have been harmed and ambulance personnel had contributed to the RTA -where there had been a significant impact on business continuity in terms of delays to the assessment and transfer of patients In addition to free text description Ambulance Delay Where; -where there had been a significant impact on the assessment and treatment of patients with the potential for permanent harm and ambulance services had contributed to the delay Ambulance (general) Assault (unknown assailant) Bogus Health Workers Child Abuse (family) Child abuse (institutional) -where there had been a significant impact on business continuity in terms of delays to the assessment and transfer of other patients and other organisations had contributed to the delay Permanent harm to one or more patients or staff Local media long term moderate effect impact on public perception of Trust & staff morale National media >3 days public confidence in organisation Permanent harm to one or more patients or staff Local media long term moderate effect impact on public perception of Trust & staff morale National media >3 days public confidence in organisation Permanent harm to one or more patients Local media long term moderate effect impact on public perception of Trust & staff morale National media >3 days public confidence in organisation Abuse with one or more children within the family context (this would include adopted and looked after children in a foster care setting) Abuse of one or more children by one or more perpetrators in an institutional setting where there is a health professional linked to the institution (this would include a school, nursery, child minder etc) and children who are looked after in a residential setting or an inpatient in a health care setting. Permanent harm Employee Patient Collision Media interest Permanent harm Media interest Employee Patient Permanent harm Media interest Physical Emotional Sexual Neglect Actual age in days, weeks, months or years e.g. 6 day old Safeguarding, child protection Page 15 of 34

16 Type Threshold Key words Current incident type on StEIS Child Abuse (multiple) Networked abuse with one or more children by one or more perpetrators, e.g. paedophile ring, child trafficking etc In addition to free text description Child Death Unexpected child death up to 17 years and 364 days. Safeguarding; Abuse, Neglect, SUDI, SUDC Actual age in days, weeks, months or years e.g. 6 day old Child Serious Injury Where there is permanent harm that doesn't involve safeguarding or abuse and where there is a link to health services, for example on health service premises, whilst undergoing health treatment, etc. This link would not include where the child was accessing health care for an unrelated episode for example an accident that occurred to a child and there was Health Visitor or School Nurse involvement with the family. Communicable Disease and Infection Issue Employee Patient PVL Legionnaires Salmonella Hepatitis B, C, HIV TB Confidential Information Leak C.Diff & Health Care Acquired Infections Delayed diagnosis Major breaches of confidentiality such as the loss or theft of personal identifiable records or information, hard copy or electronic. An incident involving the actual loss of personal information that could lead to identity fraud or have other significant impact on individuals should be considered as serious, i.e. incidents rated 3-5. Incidents rated as 1 and 2 should also be reported as grade 0 for notification only. Which results in; death or permanent harm to one or more patients, where the outcome requires life-saving intervention or major surgical/medical intervention which will shorten life expectancy This includes missed and mis-diagnosis, which results in; permanent harm to one or more patients, where the outcome requires life-saving intervention or major surgical/medical intervention will shorten life expectancy Indicate the grade (1-5). No. of individuals (numeric) Whether the individual(s) have been informed. How the information was held; paper, memory stick, laptop etc and whether it was encrypted. If the Information Commissioner has been informed. Whether there is any media interest. Cdiff deaths cert part 1 or part 2 MRSA deaths cert part 1 or part 2 Permanent harm Unexpected death Vulnerable adult Page 16 of 34

17 Type Threshold Key words Current incident type on StEIS Drug Incident (general) To include Medication Never Events which results in; permanent harm or death to one or more patients, where the outcome requires life-saving intervention or major surgical/medical intervention or will shorten life expectancy And Wrong gas administered or failure to administer any gas (NE) Intravascular air embolism introduced during IV infusion/bolus dose or through haemodialysis circuit.(ne) In addition to free text description Never Event Permanent harm Wrong patient Wrong dose Infusion pump Vulnerable adult Failure to act upon test results Failure to obtain consent Health & Safety Where the failure results in; permanent harm to one or more patients, where the outcome requires life-saving intervention or major surgical/medical intervention or will shorten life expectancy Where the procedure or treatment results in; permanent harm to one or more patients, where the outcome requires life-saving intervention or major surgical/medical intervention or will shorten life expectancy Which resulted in closure of a facility which had consequences for business continuity; Chemical incident Fire Accident on NHS premises which results in; permanent harm to one or more staff, visitors or members of the public where the outcome requires lifesaving intervention or major surgical/medical intervention or will shorten life expectancy Cancer Asbestos Permanent harm Unexpected death Homicide by Inpatient (in receipt) Homicide by Inpatient (not in receipt) Homicide by Outpatient (in receipt) Homicide by Outpatient (not in receipt) For use where HSG Guidance applies For use where HSG Guidance applies For use where HSG Guidance applies For use where HSG Guidance applies Date last seen dd/mm/yyyy (numeric) Date last seen dd/mm/yyyy (numeric) Date last seen dd/mm/yyyy (numeric) Date last seen dd/mm/yyyy (numeric) Page 17 of 34

18 Type Threshold Key words Current incident type on StEIS Hospital Equipment Failure Hospital estate infrastructure which leads to; Sustained loss of service which has serious impact on delivery of patient care resulting in major contingency plans being invoked In addition to free text description IT Infected Health Care Worker Maternity services - intrapartum death Maternity services - intrauterine death Maternity services - maternal death Sustained loss of service which has serious impact on delivery of patient care resulting in major contingency plans being invoked Infected healthcare worker where the infection was not known and no controls were in place with a reportable communicable disease eg TB, measles etc For an intrapartum death (24+ weeks gestation) that is : Unexpected and Suspicious Where there are clear failings by health (See definitions in Appendix 1 of the Maternity, Infant and Child Incidents Reported on StEIS Procedure) For an intrauterine death (24+ weeks gestation) that is : Unexpected and Suspicious Where there are clear failings by health (See definitions in Appendix 1 of the Maternity, Infant and Child Incidents Reported on StEIS Procedure) For a maternal death that is : Unexpected and Suspicious Unexpected and Unexplained Where there are clear failings by health (See definitions in Appendix 1 of the Maternity, Infant and Child Incidents Reported on StEIS Procedure) State which disease Specify exact location or service provider Specify exact location or service provider Specify exact location or service provider Maternity services - unexpected neonatal death. For a neonatal death (a child that dies between 0 to 28 days) that is: Unexpected and Suspicious Unexpected and Unexplained Where there are clear failings by health (See definitions in Appendix 1 of the Maternity, Infant and Child Incidents Reported on StEIS Procedure) Medical equipment failure This means medical devices (not hospital infrastructure) which leads to; Permanent harm to one or more patients where the outcome requires life-saving intervention or major surgical/medical intervention or will shorten life expectancy Sustained loss of service which has serious impact on delivery of patient care resulting in major contingency plans being invoked Permanent harm Unexpected death Page 18 of 34

19 Type Threshold Key words Current incident type on StEIS Mental Health Act - Class B incident Other Mental Health Act incidents except deaths e.g. illegal detention Misidentification of patients which result in severe harm or death due to failure to use standard wristband identification processes ie those that comply with NPSA guidance. (NE) In addition to free text description Never Event (NE) Pressure Sore - (Grade 3 or 4) Avoidable Pressure Ulcer; Avoidable means that the person receiving care developed a pressure ulcer and the provider of care did not do one of the following; evaluate the person s clinical condition and pressure ulcer risk factors; plan and implement interventions that are consistent with the persons need and goals, and recognised standards of practice; monitor and evaluate the impact of the interventions; or revise the interventions as appropriate. Hospital and community acquired grade 3 and 4 pressure ulcers should be reported on STEIS by the NHS provider. Please indicate whether it is a community or acute sector acquired by using the Care Sector drop down on StEIS. Primary care acquired pressure ulcers in commissioned independent providers should be reported on STEIS by the commissioning organisation, this includes care commissioned in nursing or residential care homes. Incident found in patients own homes where there is no input from any health services should be reported to the commissioner and internal analysis undertaken of any significant trends. These do not need to be reported on STEIS. All Grade 3&4 Pressure Ulcer Incidents should be assessed for evidence of neglect or abuse and if this is substantiated the Trust must report this to the Local Safeguarding Board and the Care Quality Commission (CQC) as well as on StEIS. Vulnerable adult Unexpected death Specify grade State grade Safeguarding Safeguarding vulnerable adult Where an individual suffers permanent harm or death as a result of a safeguarding vulnerable adults issue where they are in receipt of health care services (except GPs). Grade 3&4 Pressure Ulcer Incidents may be an indicator of neglect or abuse, if this is substantiated then please report using the Safeguarding vulnerable adult incident type on StEIS. Physical, sexual, emotional or financial abuse or neglect Page 19 of 34

20 Type Threshold Key words Current incident type on StEIS Screening Issues To be used for national screening programmes only. An actual or possible failure at any stage in the screening pathway that exposes the programme to unknown levels of risk that screening, assessment or treatment has been inadequate, and that as a result 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. The screening programmes covered are: -breast cancer -cervical screening -bowel cancer -diabetic retinopathy -abdominal aortic aneurysm -fetal anomaly (including Downs) -infectious diseases in pregnancy -sickle cell and thalassaemia -newborn blood spot -newborn hearing -newborn and infant physical examination In addition to free text description Please select; -breast cancer cervical -screening bowel cancer -diabetic retinopathy -abdominal aortic aneurysm -fetal anomaly (including Downs) -infectious diseases in pregnancy -sickle cell and thalassaemia -newborn blood spot -newborn hearing -newborn and Infant Physical Examination Security Threat Serious Incident by Inpatient (in receipt) Serious Incident by Inpatient (not in receipt) Sustained loss of service resulting in major contingency plans being invoked Local media long term moderate effect impact on public perception of Trust & staff morale National media >3 days public confidence in organisation MP concerned (questions in the House) Which leads to; Permanent harm to one or more patients where the outcome requires life-saving intervention or major surgical/medical intervention or will shorten life expectancy For acute trust this would mean patients who are on special observations provided by a mental health trust. Which leads to; Permanent harm to one or more patients where the outcome requires life-saving intervention or major surgical/medical intervention or will shorten life expectancy For mental health trusts this would be for those who are absent, on leave, during transfer etc Terrorism Violence Self harm Patient on patient Patient on staff Violence Self harm Patient on patient Patient on staff Page 20 of 34

21 Type Threshold Key words Current incident type on StEIS Serious Incident by Outpatient (in receipt) Serious Incident by Outpatient (not in receipt) Slips/Trips/Falls Which leads to; Permanent harm to one or more patients where the outcome requires life-saving intervention or major surgical/medical intervention or will shorten life expectancy. Severe harm to a mental health inpatient as a result of a suicide attempt using non-collapsible curtain or shower rails. (NE) Which leads to; Permanent harm to one or more patients where the outcome requires life-saving intervention or major surgical/medical intervention or will shorten life expectancy A slip, trip or fall which occurred on NHS premises or whilst receiving NHS funded care which results in; ~permanent harm to one or more patients where the outcome requires life-saving intervention or major surgical/medical intervention or will shorten life expectancy This includes falls from unrestricted windows (NE) Although fracture neck of femur would not normally be reportable on StEIS. However if a provider noted a trend it would be reportable under this category. In addition to free text description Violence Self harm Patient on patient/public Patient on staff Violence Self harm Patient on patient/public Patient on staff Fall from unrestricted windows Never Event (NE) Sub-optimal care of the deteriorating patient Surgical Error Where the deterioration was not recognised or not acted upon and this has lead to permanent harm or death. This includes failure to monitor or respond to oxygen saturation levels in a patient undergoing general or regional anaesthesia or conscious sedation for a healthcare procedure (NE) Which leads to; Permanent harm to one or more patients where the outcome requires life-saving intervention or major surgical/medical intervention or will shorten life expectancy Retained foreign object post-operation, excluding objects that are found to be missing prior to completion of surgery where further action to remove would be more damaging (NE) Transplantation of ABO or HLA-incompatible organs, if the antibodies are clinically significant. (NE) Never Event (NE) Retained foreign object post-operation Never event Page 21 of 34

22 Type Threshold Key words Current incident type on StEIS Transfusion Incident Which leads to; Permanent harm to one or more patients where the outcome requires life-saving intervention or major surgical/medical intervention or will shorten life expectancy In addition to free text description Permanent harm Death Serious adverse reaction Microbiological contamination Incorrect blood component Unexpected Death (general) Ward / Unit Closure Wrong site surgery This includes transfusion of ABO-incompatible blood components, unless it is planned as part of the treatment (NE) Patients, individuals or groups of individuals suffering serious or catastrophic harm or unexpected death whilst in receipt of health services. This includes maternal death as a result of post partum haemorrhage after elective caesarian section (NE) Domestic abuse homicides where there are children resident or where the domestic abuse was known by health care professionals Death of a mental health inpatient as a result of a suicide attempt using non-collapsible curtain or shower rails. (NE) Which leads to; Sustained loss of service which has serious impact on delivery of patient care resulting in major contingency plans being invoked Disruption to facility leading to significant knock-on effect across local health economy A surgical intervention performed; On the wrong site or organ (NE) Where the wrong implant/prosthesis is inserted (NE) and the incident is detected at any time after the start of the operation and the patient requires further surgery on the correct site and may have complications after surgery. Excludes; wrong site anaesthetic block where the wrong site is selected because of unknown/unexpected abnormalities in the patient's anatomy where the implant/prosthesis placement is intentionally different and based on clinical judgement at the time of the operation Never event (define which one) Community, in- or out-patient Death in custody Maternal death Cdiff Vulnerable adult Critical care transfer (out of county) Employee/ Patient/ Visitor/ Contractor Domestic homicide For MH include details of: client of; CMHT, Crisis, AOT, EIA, Substance Misuse. If an unexpected death may be the result of homicide discuss with SHA. Norovirus Cdiff MRSA Other infections Never Event (NE) Wrong site surgery Wrong implant/prosthesis Page 22 of 34

23 APPENDIX 2a: StEIS/ UNIFY INCIDENT AREAS AND EXAMPLES. INCIDENT AREA Untoward death of patients, staff, contractors working for NHS Or Serious risk or Injury INCIDENT EXAMPLES Acute and Primary Care Trust Death or serious injury to a child, which results in a part 8 serious case review under the Children Act 1989 and 2004 in which health has a major role. Death leading to public concern and/or external inquiry involving NHS service provision (including children, vulnerable and other adults e.g. deaths in custody) Homicide or serious injury to a member of staff (including independent contractors) or patient in the course of their duties or whilst on NHS premises Staff actions that may lead to the involvement of the criminal justice system Serious Injury of a person currently in receipt of NHS care such as deliberate self-harm, accidental injury or injury inflicted by another person Serious injury or harm, as a result of the actions of a health care professional to a person currently in receipt of NHS care Serious injury to a vulnerable adult resulting in an investigation under local adult protection arrangements Any instance of staff or patients being poisoned / infected in the course of receiving treatment or as a direct result of NHS employment Inpatient admissions of Under 18 year old CAMHS clients to adult clinical units. N.B. for patients aged years pleased indicate if the admission location was based on clinical/risk assessment and patient identified need (i.e. was the admission to an adult placement a deliberate clinical decision/choice) or due to lack of CAMHS beds/facilities availability Page 23 of 34

24 INCIDENT EXAMPLES Mental Health/Learning Disabilities Trusts Untoward death of patients, staff, contractors working for NHS Or Serious risk or Injury The unexpected death of a person currently in receipt of NHS care where the death is as a result of suspected suicide, as a result of a homicide or is likely to be of public concern, e.g. of particular concern is any such death occurring on NHS premises or potentially high profile patient suicides involving bridges and railway lines Death resulting from violence/aggression Homicide or serious injury to a member of staff (including independent contractors) or patient in the course of their duties or whilst on NHS premises Staff actions that may lead to the involvement of the criminal justice system Serious injury of a person currently in receipt of NHS care such as deliberate self-harm, accidental injury or injury inflicted by another person Serious injury of harm of a person currently in receipt of NHS care as a result of the action so f a health care professional Serious injury to a vulnerable adult resulting in an inquiry under local adult protection arrangements Patients detained under the Mental Health Act 1983/2007 who abscond from mental health/learning disability services and who present a serious risk to themselves and/or to others. Of particular concern are those patients who abscond from medium/high secure or specialist forensic services, those who are likely to pose a risk to the public, attract media attention and/or who commit an offence whilst at large, were police are informed of the absconsion and missing persons alerts are issued. Informal admission patients who abscond but are considered to be vulnerable/high risk should also be reported. Any instance of staff or patients being poisoned/infected in the course of receiving treatment or as a direct result of NHS employment Inpatient admissions of Under 18 year old CAMHS clients to adult clinical units. N.B. for patients aged years please indicate if the admission location was based on clinical/risk assessment and patient identified need (i.e. was the admission to an adult placement a deliberate clinical decision/choice) or due to lack of CAMHS beds/facilities. Page 24 of 34

25 APPENDIX 3 PROCEDURE FOR MATERNITY, INFANT AND CHILD INCIDENTS REPORTED ON STEIS Introduction This document clarifies the roles and responsibilities of the SHA, PCT Commissioners and Providers. The sections include: Timescales for Reporting an Incident on StEIS Multiple Reports on StEIS for the Same Incident Incident Types on StEIS and Types of Investigations Safeguarding Children Incidents Reported on StEIS for which the SHA will Performance Manage Deadlines on Investigation Completion for Incidents where the SHA is the Performance Manager Updates Required by the SHA where the SHA is the Performance Manager Maternity, Infant and Child Incidents for PCT Commissioners to Performance Manage Closing Safeguarding Incidents Where the SHA is the Performance Manager This work has been developed in consultation with the North West Designated Nurses for Safeguarding and has since been consulted on widely across the North West. This work originated as it became apparent that different PCTs were all using different thresholds with which to report these types of incidents to StEIS and it was unclear who the Performance Manager would be. Some definitions, which are used throughout this document, can be found in Appendix 1 for Age of an Infant and Child, Unexpected Death, Expected Death and Suspicious Circumstances. Timescales for Reporting an Incident on StEIS The NPSA National Framework states that a StEIS reportable incident should be reported within 48 hours from the time the incident is known and this is an element that PCTs/Trusts are monitored on by the SHA. However, the Safeguarding Incidents are an exception to this and the full extent of the incident is sometimes not clear until after the initial strategy meeting. Therefore, unless there is media attention, the safeguarding incidents should be reported within 48 hours of the strategy meeting taking place. The SHA will work to monitor the timeliness of Child Safeguarding incidents separately to take this into account. However, if it is an unexpected child death where there are clear suspicious circumstances/safeguarding concerns (see definitions in appendix 1), these should be Page 25 of 34

26 reported within the 48 hour timeframe from when the death is known. This is usually done initially by the Acute Provider who receives the child s body. However, once more information is known, this StEIS report may be shut down and the Community Provider asked to report the incident where the bulk of the information exists. For older children, sometimes this is a Mental Health Provider. This will be discussed between the SHA and the Lead Professionals for each incident as appropriate and a joint decision made. When an acute or mental health provider reports a StEIS incident, they should include in the description the PCT where the child is resident. This helps the SHA to identify which Designated Nurse to approach. There can also be a delay in reporting to StEIS when a death which originally believed not to be suspicious, follows the Child Death Overview Panel (CDOP) process but then the CDOP Panel with a fuller picture of the evidence decides that it needs referring to the LSCB Serious Case/Critical Incident Review Panel, which subsequently determines that it meets the criteria for a Serious Case Review. At the time of reporting, the SHA will ask for a lead person to be identified who will provide the SHA with updates as required. Multiple Reports on StEIS for the Same Incident Sometimes an incident is reported by more than one organisation. This is fine as it is acknowledged that organisations may have different involvement with the people associated with the incident. The SHA will work with all the organisations that have reported and agree which organisation will co-ordinate the incident. It is usually the organisation with the most involvement or most recent relevant involvement/information. For example an acute organisation may report an incident where they have treated a child or received a child s body. A mental health provider learns that an adult patient of theirs has inflicted the injuries on the child and they report, as well as the community provider. Once a decision has been made based on the information available, the other organisation s StEIS incidents will be closed down and the organisation that is lead for the incident will leave theirs open and updates on this StEIS report. However, the lead organisation will still need the help of the other organisations in producing a full investigation report/root Cause Analysis or information to contribute to a Serious Case Review, Domestic Homicide Review, etc. Incident Types on StEIS and Types of Investigations Below are the StEIS Incident Types that are available on StEIS that most apply to infants and children. These are the main fields but the reporter will need to review the NHS North West Serious Untoward Incident (SUI) Reporting Criteria and Threshold sheet for further information or if the incident does not fit into one of these fields. Child Abuse (family) Abuse with one or more children within the family context (this would include adopted and looked after children in a foster care setting). See section 5 & 8 to see which child abuse incidents meet the criteria for reporting to StEIS. Page 26 of 34

27 Child abuse (institutional) Child Abuse (multiple) Abuse with one or more children by one or more perpetrators in an institutional setting where there is a health professional linked to the institution (this would include a school, nursery, child minder etc) and children who are looked after in a residential setting or an inpatient in a health care setting. See section 5 & 8 to see which child abuse incidents meet the criteria for reporting to StEIS. Networked abuse with one or more children by one or more perpetrators, e.g. paedophile ring, child trafficking etc Child Death Child Serious Injury Maternity services - intrapartum death Maternity services - intrauterine death Maternity services - maternal death Maternity services - unexpected neonatal death. ( A neonatal death is a child that dies between 0 to 28 days) Admission of under 16s to adult mental health ward Unexpected child death up to 17 years and 364 days. See section 5 & 8 to see which child deaths meet the criteria for reporting to StEIS. Where there is permanent harm that doesn't involve safeguarding or abuse. See section 8 to see which incidents meet the criteria for reporting to StEIS. For an intrapartum death (24+ weeks gestation) that is: Unexpected and Suspicious Where there are clear failings by health (See definitions in Appendix 1) For an intrauterine death (24+ weeks gestation) that is: Unexpected and Suspicious Where there are clear failings by health (See definitions in Appendix 1) For a maternal death that is: Unexpected and Suspicious Unexpected and Unexplained Where there are clear failings by health (See definitions in Appendix 1): For a neonatal death that is: Unexpected and Suspicious Unexpected and Unexplained Where there are clear failings by health (See definitions in Appendix 1) To include under 18 admissions CAMHS clients. These are performance managed by the SHA Patient Safety Mental Health Lead. The NPSA National Framework states: Grade 1 incidents requiring Level 2 (comprehensive) investigations should be completed in up to 45 working days Grade 2 incidents requiring Level 2 (comprehensive) investigations should be completed in up to 60 working days Grade 2 incidents requiring Level 3 (Independent) investigations should be completed in up to 26 weeks Serious Case Reviews would fall into the Grade 2/Level 3 category. However, NHS Northwest has extended this time period for serious case reviews to report on status at 9 months with a view to finishing those by this timescale where appropriate. Page 27 of 34