PUTTING THINGS RIGHT dealing with concerns

PUTTING THINGS RIGHT dealing with concerns Llywodraethu da calon iechyd da Good governance at the heart of good health care GUIDANCE ON THE REPORTING AND HANDLING OF SERIOUS INCIDENTS AND OTHER PATIENT RELATED CONCERNS / NO SURPRISES Background The existing NHS Wales serious incident (SI) reporting requirements have been in place since April 2003 (Reporting of Patient-Related Serious Adverse Incidents letter issued by John Hill-Tout). In addition to the SI process, all NHS organisations are required to report all patient safety incidents (irrespective of seriousness and degree of harm) to the National Patient Safety Agency (NPSA s) Reporting and Learning System (RLS). This is to inform the prioritisation and development of safety solutions, including rapid response reports and alerts, in addition to contributing to data which is published on a national and organisational basis. The reporting of SIs to the Welsh Assembly Government and NPSA does not exclude the requirement to report to other bodies, e.g. Healthcare Inspectorate Wales, Health & Safety Executive (RIDDOR), Information Commissioner s Office, Police, Coroner, as appropriate and as required by each individual body. Definitions The definition of a SI in this context extends beyond those which impact directly on patients. The NPSA has suggested the following definition which we would wish to adopt in NHS Wales: A SI requiring investigation is defined as an incident that occurred in relation to NHS funded services and care resulting in: the unexpected or avoidable death of one or more patients, staff, visitors or members of the public; permanent harm to one or more patients, staff, visitors or members of the public or where the outcome requires life-saving intervention or major surgical/medical intervention or will shorten life expectancy (this includes incidents graded under the NPSA definition of severe harm); a scenario that prevents or threatens to prevent an organisation s ability to continue to deliver health care services, for example, actual or potential loss or damage to property, reputation or the environment; a person suffering from abuse; adverse media coverage or public concern for the organisation or the wider NHS; the core set of Never events as updated on an annual basis. http://www.nrls.npsa.nhs.uk/resources/collections/never-events/core-list/ For 2010/11 this includes:- wrong site surgery retained instrument post-operation 1

wrong route administration of chemotherapy misplaced naso-gastric or orogastric tube not detected prior to use inpatient suicide using non-collapsible rails escape from within the secure perimeter of medium or high security mental health services by patients who are transferred prisoners in-hospital maternal death from post-partum haemorrhage after elective caesarean section intravenous administration of mis-selected concentrated potassium chloride Reporting arrangements for reporting serious incidents and other concerns/no surprises to the Welsh Assembly Government Since April 2010, all serious incidents or no surprises (sensitive issues) have been reported, electronically, to the Improving Patient Safety Team Mailbox at the Assembly Government. NHS Organisations are now required to: Complete a revised SI notification form (form 1) for the reporting of all serious incidents (attached at appendix 1) or complete form 2 for the reporting of no surprises (attached at appendix 2). Please note the forms are protected so that the title of the form and the text prompt boxes can not be altered. The field boxes in bold that are completely grey are for Welsh Assembly Government use only ; Ensure that the notification form provides as much information as is available. However, please ensure at all times that there are no patient or staff identifiable details (e.g. patient name, dates of birth, home address, staff names etc); Send the completed notification form to improvingpatientsafety@wales.gsi.gov.uk within 24 hours of the incident; Password protect each notification form; Ensure that each notification form is signed off by the CEO or an Executive Director. An electronic signature should be attached to the form. Please note: Notification forms will be sent back to the organisation if there is no executive sign off or if it is not password protected. Within 24 hours of receipt, the Assembly Government will respond to the notification by returning an electronic copy of the SI form which will confirm: The initial grading of the incident which will indicate the timescale of investigation (as defined below); and, The Assembly Government reference number, which will be the number used in all future correspondence relating to the incident. For incidents that potentially may attract national or significant media attention, please immediately contact a member of the Improving Patient Safety Team (IPST), who will liaise with the Assembly Government Press Office. Appendix 3 indicates the contacts 2

detail of Assembly Government officials within the IPST for your organisations. Direct contact should only be made with the Assembly Government Press Office out of usual working hours. The out-of-hours press office number is 029 2089 8099 and the answer phone will give the contact number of the duty press officer. Grading of Incidents The initial grading of a SI is undertaken on a case by case basis and will clarify the level of investigation required and monitoring approach by the Assembly Government. All incidents submitted to the Assembly Government are reviewed on a weekly basis. If during these review meetings it is decided that the initial grading is inappropriate, it will be revised and you will be informed of this change, plus any further action or information that we may require. Should an organisation wish to discuss the grading assigned to an incident they should contact the relevant Assembly Government official (as shown on appendix 3). A table summarising the grading, expected response and timescales is attached at appendix 4. This has been adapted to suit the Wales context from the NPSA National Framework for Reporting and Learning from Serious Incidents Requiring Investigation. It is expected that the level of investigation is consistent with the triggers and levels of RCA investigation published by NPSA (see appendix 5). Definitions of grading Grade 0 Concerns currently and commonly referred to as a no surprise and/or where it is initially unclear whether a serious incident has occurred will be graded 0. Unless further information is received, Assembly Government will automatically close the incident after 3 days and no further correspondence with the Assembly Government is required. However organisations will wish to assure themselves of a proportionate and appropriate response and ensure arrangements are in place to reduce the risk of re-occurrence. If following initial notification it becomes clear that the issue is an SI then further information should be sent to the Assembly Government and the grading will be reviewed. Grade 1 It is expected that a comprehensive investigation (RCA level 2 investigation) will need to be completed by the organisation within 2 calendar months. In order to close this incident we will require confirmation that an appropriate SI investigation has been undertaken; has been reported to an appropriate committee; an action plan developed and where relevant has identified any actions for wider learning and dissemination. A closure/update report form should be completed for this purpose as attached at appendix 6. This should also be sent to improvingpatientsafety@wales.gsi.gov.uk. The report will be reviewed by the relevant Assembly Government officials. They will confirm that they are content will all actions undertaken and close the incident or seek further information/action before confirming closure. If an incident investigation cannot be completed within the timescale agreed the organisation should complete the closure/update form as far as is possible and seek an extension to the timescale. Grade 2 This will follow a similar process to the above. A comprehensive investigation is required, and in some cases the incident may be referred for independent external review by HIW or 3

other regulatory bodies etc. Grade 2 incidents will be subject to ongoing monitoring by Assembly Government and final agreement through its Patient Safety Committee that the incident has been investigated appropriately and thoroughly before closure. Examples of such incidents could include mental health homicides, maternal deaths, clusters of similar incidents and never events. Monitoring and Closure of Incidents Closure forms and investigation reports (as necessary) for Grade 1 and 2 incidents should be sent to the IPS mailbox. Meetings will only be held with organisations as necessary. These will be dependant on the types of incidents, the grading levels, trend and themes of incidents submitted or if there is concern over the standard or timeliness of the investigation. Public Services Ombudsman for Wales and Independent Review Investigations In relation to reports that detail the investigation conducted by the Public Services Ombudsman for Wales (PSOW) and the Independent Review Panel (IRP), into a concern raised about an NHS Organisation, a copy of the report is also sent to the Welsh Assembly Government. NHS Organisations are required to inform the PSOW and the IRP how they have addressed any recommendations outlined in the report and NHS Organisation are now required to automatically send a copy of any update/action plan to the Improvingpatientsafety@wales.gsi.gov.uk as well as the PSOW and IRP. Learning from Incidents It is key that the outcome of any investigation is used to maximise opportunities for learning and quality improvement. This should be a key element in our overall attempts to reduce adverse events and avoidable harm to patients/service users in line with the aims set out in 1000 Lives Plus programme and individual organisation s local priorities. As well as local learning, organisations are expected to contribute to the wider opportunities for shared learning. This should be identified when completing the incident closure form. Issues and learning arising from incidents and complaints will be considered at the Assembly Government Patient Safety Committee in order to determine any action required, particularly at a national level Regular reports will also be compiled for the Director General/Chief Executive NHS Wales and the executive team to help inform policy development and priorities. 4

Appendix 1 FORM 1 NOTIFICATION OF SERIOUS INCIDENT TO WELSH ASSEMBLY GOVERNMENT WAG Reference Internal Ref or Datix No. Grading Date reported to Risk Management Organisation Reporters Name, Designation and contact details Name: Job title: Contact details: E- mail: Date of making this report When did the incident occur? Where did the incident occur, including site and speciality where relevant? Who did it affect and how many? (personal details should not be included) Brief description of what happened Date: Time (24 hours): Local Authority Area Age of patient(s) if known 5

Brief description of immediate action taken Media interest (actual or potential) Has this SI been reported to the NPSA? What other external agencies have been informed about this incident? Any other relevant information Chief Executive / Executive Sign off Signature: Print Name: Title: Date: For WAG use only: 6

Appendix 2 FORM 2 NOTIFICATION OF NO SURPRISE / SENSITIVE ISSUE TO WELSH ASSEMBLY GOVERNMENT WAG Reference Grading Organisation Reporters Name, Designation and contact details Name: Job title: Contact details: E- mail: Date of making this report Brief description of issue Brief description of any action and media handling Any other relevant information Chief Executive / Executive Sign off Signature: Print Name: Title: Date: 7

Appendix 3 WAG Officials Contact Details The contact details for the following organisations are:- Abertawe Bro Morgannwg University HB Aneurin Bevan HB Cardiff & Vale University HB Cwm Taf HB Public Health Wales NHS Trust Velindre NHS Trust Marion Andrews-Evans 01495 761434 marion.aevans@wales.gsi.gov.uk Jenny Sanger 01495 761414 jenny.sanger@wales.gsi.gov.uk Natalie Harris 01267 225278 natalie.harris@wales.gsi.gov.uk Ann-Marie Carpanini 02920 823218 annm.carpanini@wales.gsi.gov.uk Taryn Ramsay 02920 825113 taryn.ramsay@wales.gsi.gov.uk Sarah Wiltshire 02920 801147 sarah.wiltshire@wales.gsi.gov.uk The contact details for the following organisations are:- Betsi Cadwaladr University HB Hywel Dda HB Powys Teaching HB Welsh Ambulance Services NHS Trust Andrea Hughes 01352 706951 andrea.hughes2@wales.gsi.gov.uk Clare Reece-Archer 01352 706956 clare.reece-archer@wales.gsi.gov.uk Teresa Bridge 02920 826797 teresa.bridge@wales.gsi.gov.uk John Barnes 02920 825857 john.barnes@wales.gsi.gov.uk Carol Clarke 02920 823825 carol.clarke@wales.gsi.gov.uk 8

Appendix 4 Grading of serious incidents Grade 0 Grade 1 Grade 2 Action required: Notification only for no surprises e.g media coverage of an issue, temporary capacity issues, or if it is unclear if a serious incident has occurred at this stage. The organisation must update the Improving Patient Safety Team (IPST) with further information within three working days of a grade 0 incident being notified. If within three working days it is found not to be a serious incident, it will be closed by WAG. Should any further issues arise the HB/Trust should send a further updated report to IPST. A CAMHS admission to an adult ward should always be notified. This will be graded according to the details of each individual case If a serious incident has occurred it will be re graded as a grade 1 or 2. Action required: The HB or Trust will investigate the case and report to the IPST findings, recommendations, associated action plans and learning. HBs and Trusts are responsible for informing IPST of any further issues that may arise during the course of the investigation e.g. media attention Comprehensive Investigation Root Cause Analysis (RCA) required Level 2 Investigation) Action required: Case will be monitored by the WAG. They will review findings, recommendations and associated action plans and learning. Comprehensive Investigation (RCA level 2 investigation) (as above) or Independent Investigation (RCA level 3 Investigation) Monitoring required: IPST will close the incident when it is satisfied that: o the investigation, recommendations and action plan is satisfactory and lessons have been learnt and shared, and o local monitoring arrangements are in place and working efficiently. Timescales: Up to 2 months from the date the incident is notified to the IPST. Extensions will be agreed on an individual case by case basis. Monitoring required: Incidents involving an independent investigation or review or those considered high risk will continue to be monitored by WAG officials until evidence is provided that each action point has been implemented and there is evidence of learning Incidents involving adult or child abuse are referred to local safeguarding arrangements Timescales: For internal investigations timescales as above. For Independent Investigations 6 months for completion of the investigation. Extensions will be agreed on an individual case by case basis. Examples of cases: Unexpected/unexplained death, including primary care Mental health attempted suicides as inpatients Mental Health deaths in the community HCAI outbreaks resulting in the death or harm to patients Patient fall resulting in harm/death Ambulance delays resulting in harm/death to patient Data loss and information security Grade 3 or above hospital acquired pressure ulcer develops IRMER reportable incidents Misidentification/ delay in diagnosis / treatment or misdiagnosis resulting in harm / death Serious medication, blood or device error Example of cases: Maternal deaths Inpatient suicides (including following absconsion) Homicides following contact with mental health services Never Events Safeguarding serious harm or death following allegations of abuse or neglectful behaviours (including sexual abuse) Some incidents listed in grade 1 above may be graded 2 depending on the severity, numbers affected, similar previous incidents etc 9

Appendix 5 Root Cause Analysis Investigation Report National Patient Safety Agency RCA Investigation Report Template - Guidance The following headings are designed to improve the recording of information currently considered good practice for investigation reports. These headings will be evaluated over time to confirm or challenge that understanding. PLEASE READ - Instruction for use of this RCA Report Template 1. Determine the level of investigation to be undertaken Refer to the NPSA s Three Levels of investigation (Level 1 = Concise; Level 2 = Comprehensive; Level 3 = Independent), to the NPSAS s Triggers for Investigation, and to your own organisational policy and terms of reference. 2. Delete all ROWS not required for the level of investigation being undertaken The investigation level numbers in the middle column provide a guide to which rows are needed for which level of investigation. (i.e. for a Level 1 - Concise investigation you only need rows which have the number 1 in the Level column) 3. Write your investigation report in the right hand column Delete examples (in green), and refer to summary guidance in the left hand column as you go. For detailed guidance refer to the NPSA s Guide to RCA investigation report writing. If an investigation produces no information against a heading, add an explanation on why this is the case. If issues arise which require a new heading this can be added as a new row 4. On completion, delete the guidance to produce your final report Delete all guidance both here and in the template below (i.e. all green and red type, all green coloured rows and all green coloured columns) Realign the remaining table containing your own report, so that it fits the whole page. Save the document with the chosen file name for each individual investigation report. Level Quick reference guide Type your investigation report in this column Cover page Organisation name and / or logo Title or Brief outline of incident Incident date Incident number Author(s) Report date Page numbers Document version Computer File Path Contents page CONTENTS Executive summary EXECUTIVE SUMMARY A one page summary of the main report presented succinctly under the following headings:- Brief Incident description Incident date: Incident type: Healthcare specialty: Actual effect on patient and/or service: Actual severity of the incident: Level of investigation conducted Involvement and support of the patient and/or relatives Detection of Incident 10

Care and Service Delivery Problems Contributory Factors Root Causes Lessons Learned Recommendations Arrangements for Sharing Learning Main Report MAIN REPORT Incident description and consequences Concise incident description Incident description and consequences Example only (please delete and add your own findings) A lady with asthma sustained brain damage following IV administration of a drug to which she was known to be allergic. Incident date Incident date: Incident type Incident type: Healthcare speciality involved Specialty: Actual effect on patient and / or service Effect on patient: Actual severity of incident Severity level: Pre-investigation risk assessment Assess the realistic likelihood and severity of recurrence, using your organisation s Risk Matrix Pre-investigation risk assessment A Potential Severity (1-5) B Likelihood of recurrence at that severity (1-5) C Risk Rating (C = A x B) Background and context to the incident A brief description of the service type, service size, clinical team, care type, treatment provided etc. Terms of reference - Outline :- Specific problems to be addressed Who commissioned the report Investigation lead and team Aims, Objectives and Outputs (see examples opposite) Scope, boundaries and collaborations Administration arrangements (accountability, resources, monitoring) Timescales Investigation team Names, Roles, Qualifications, Dept. s Scope and level of investigation State level of investigation (NPSA -1.Concise; 2.Compre.; 3.Independent) Describe the start and end points List services & orgs involved NB: for Level 3 Independent Investigations scope could be included under Terms of Reference Investigation type (i.e. Single / Aggregation / Multi-incident), process, and methods used Gathering information e.g. Interviews Background and context Terms of reference Example only (please amend to build your own aims) To establish the facts i.e.:- what happened (the effect), to whom, when, where, how and why (root causes) To establish whether failings occurred in care or treatment To look for improvements rather than to apportion blame To establish how recurrence may be reduced or eliminated To formulate recommendations and an action plan To provide a report as a record of the investigation process To provide a means of sharing learning from the incident The investigation team Scope and level of investigation Investigation type, process and methods used 11

Incident Mapping e.g. Tabular timeline Identifying Care and service delivery problems e.g. Change analysis Identifying contributory factors & root causes e.g. Fishbones Generating solutions e.g. Barrier analysis Involvement and support of patient and relatives e.g. Meetings to discuss questions the patient anticipates the investigation will address and to hear their recollection of events (anonymised in line with the patient/relative wishes). e.g. Family liaison person appointed, information given on sources of independent support. Involvement and support provided for staff involved Refer (anonymously) to involvement of staff in the investigation, and to formal & informal support provided to those involved and not involved in the incident. Information and evidence gathered A summary list of relevant local and national policy / guidance in place at the time of the incident, and any other data sources used:- (Include:-Title and date of Guidance, Policies, Medical records, interview records, training schedules, staff rotas, equipment, etc) Chronology of events For complex cases any summary timeline included in the report should be a summary Detection of incident Note at which point in the patients treatment the error was identified. e.g. At risk assessment of new/changed service At pre-treatment patient assessment Error recognition pre-care/treatment Error recognition post-care/treatment By Machine/System/Environ. change/alarm By a Count/Audit/Query/Review By Change in patient s condition Notable practice Points in the incident or investigation process where care and/or practice had an important positive impact and may provide valuable learning opportunities. (e.g. Exemplar practice, involvement of the patient, staff openness etc) Involvement and support of patient and relatives Involvement and support provided for staff involved Information and evidence gathered Example only (please delete and add your own findings) Interviews with the four staff on duty - 01.02.08 Interviews with patient relatives - 05.02.08 A visit to the location of the incident -14.02.08 The patient s clinical records Chronology of events See table below Detection of incident Notable practice Example only (please delete and add your own findings) Actions taken to inform the patient and relatives of the error in an open and honest way, and to subsequently involve them in the RCA process was valued by all and greatly enhanced the investigation. Care and service delivery problems A themed list of the key problem points. (Where many problems have been identified the full list should be included in the appendix) Care and service delivery problems Example only (please delete and add your own findings) Nurses on the short stay ward routinely failed to complete the section in the patient notes to highlight the existence of known allergies 12

Contributory factors A list of significant contributory factors (where many contributory factors are identified a full list or fishbone diagrams should be included in the appendix) Root causes (numbered) These are the most fundamental underlying factors contributing to the incident that can be addressed. Root causes should be meaningful, (not sound bites such as communication failure) and there should be a clear link, by analysis, between root CAUSE and EFFECT on the patient. Lessons learned (numbered) Key safety and practice issues identified which may not have contributed to this incident but from which others can learn. Contributory factors Example only (please delete and add your own findings) Over years numerous assessments for nutrition, pressure ulcers, falls risk etc. had been added, causing short stay wards to see the completion of all documentation as impossible. Root causes Example only (please delete and add your own findings) 1. When adding or updating patient assessments and care plans, risk assessment of the wider implications of their use should be conducted and acted upon to reduce the risk of impact on patient safety Lessons learned Example only (please delete and add your own findings) 1. A distinction should be made between essential and desirable documentation in clinical records Recommendations (numbered and referenced) Recommendations should be directly linked to root causes and lessons learned, They should be clear but not detailed (detail belongs in the action plan). It is generally agreed that key recommendations should be kept to a minimum where ever possible. Arrangements for shared learning Describe how learning has been or will be shared with staff and other organisations (e.g. through bulletins, PSAT/Regional offices, professional networks, NPSA, etc.) Recommendations Example only (please delete and add your own findings) 1. Ensure allergy records and other priority assessment sheets are routinely filed prominently for ease of completion 2. Ensure essential assessment criteria are set as mandatory fields in new electronic record development Arrangements for shared learning Example only (please delete and add your own findings) Share findings with other departments caring for short stay patients and include them in piloting solutions Share findings with patient Safety Action Team to identify opportunities for sharing outside the organisation Distribution list Describe who (e.g. patients, relatives and staff involved) will be informed of the outcome of the investigation and how Appendices Include key explanatory documents. e.g. Tabular timeline, Cause + effect chart, Acknowledgements to patients, family, staff or experts etc. Distribution list Appendices Author: Job Title: Date: 13

Chronology (timeline) of events Date & Time Event 14

Root Cause Analysis Investigation Report - Concise Incident description and consequences Incident date: Incident type: Specialty: Effect on patient: Severity level: Scope and level of investigation Involvement and support of patient and relatives Detection of incident Notable practice. Care and service delivery problems Contributory factors Root causes Lessons learned Recommendations Arrangements for shared learning Author: Job Title: Date: 15

Chronology (timeline) of events Date & Time Event 16

Root Cause Analysis Investigation Report - Comprehensive CONTENTS EXECUTIVE SUMMARY Brief Incident description Incident date: Incident type: Healthcare specialty: Actual effect on patient and/or service: Actual severity of the incident: Level of investigation conducted Involvement and support of the patient and/or relatives Detection of Incident Care and Service Delivery Problems Contributory Factors Root Causes Lessons Learned Recommendations Arrangements for Sharing Learning MAIN REPORT Incident description and consequences Incident date: Incident type: Specialty: Effect on patient: Severity level: Pre-investigation risk assessment A Potential Severity (1-5) B Likelihood of recurrence at that severity (1-5) C Risk Rating (C = A x B) Background and context Terms of reference The investigation team Scope and level of investigation 17

Investigation type, process and methods used Involvement and support of patient and relatives Involvement and support provided for staff involved Information and evidence gathered Chronology of events - See table below Detection of incident Notable practice. Care and service delivery problems Contributory factors Root causes Lessons learned Recommendations Arrangements for shared learning Distribution list Appendices Author: Job Title: Date: 18

Chronology (timeline) of events Date & Time Event 19

Appendix 6 FORM 3 CLOSURE / UPDATE FOLLOWING SERIOUS INCIDENT TO WELSH ASSEMBLY GOVERNMENT WAG Reference Organisation Grading Date of incident Summary of incident Summary of investigation findings and recommendations Confirmation of Actions to be implemented Timescale 20

Any outstanding issues Issues identified for shared learning/action Any additional information attached Disclaimer Signature Yes: [ ] No: [ ] I confirm that this incident has been thoroughly investigated and the findings and recommendations have been agreed by the appropriate committee and acted upon Or The information provided on this form summarise the action to date and we request an extension of weeks to complete this investigation. Chief Executive/Executive Director Date FOR WAG USE ONLY: Incident Closed WAG Officials sign off Yes: [ ] No: [ ] Signature: Date: Further action required 21