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Leaflet reference: MIS12-300-CC Review date: January 2014 Management of Significant Adverse Events and Reviews Supporting guidance and resources Version 2, June 2013 All our publications are available in other formats Visit our website www.nhsaaa.net Leaflet reference: MIS12-300-CC Review date: January 2014 Foreword In June 2012 Healthcare Improvement Scotland published their report into NHS Ayrshire & Arran’s management of Significant Adverse Event Reviews (SAERs). In response, we developed an improvement plan to address the issues raised by HIS’ review. The improvement plan set out the actions we would take to ensure that, by 1 October 2012, NHS Ayrshire & Arran would have in place an improved process for responding to and reviewing significant adverse events. This process would enable: • greater involvement of staff, patients and families; • learning and improvement; and • robust governance and reporting; all supported by a business control system which would track every stage of a review. This single publication introduced that new process. It contains all the guidance and resources you might need if you are involved in any aspect of a significant adverse event review. It includes a step-bystep guide for conducting SAERs; sets out clearly the roles and responsibilities of those leading a review; and spells out our commitments to staff, patients and families about what they can expect during a review. This publication is also available on our public website, www.nhsaaa.net, and is published on our staff intranet, AthenA, as a suite of separate documents for the use of staff. The content of this publication has been reviewed by staff involved in the reviews commissioned since October 2012. The content has been revised as a result of feedback and learning. I am very grateful to all staff who played a part in developing and further improving how we manage Significant Adverse Event Reviews. I am delighted to endorse this second version of this guidance. John G Burns Chief Executive June 2013 2. Leaflet reference: MIS12-300-CC Review date: January 2014 Contents Page Significant Adverse Events to be reported4-5 SAER review process6-10 Commitments to patients and families involved in a Significant Adverse Event11 Our commitments to staff12-13 SAER process - roles and responsibilities14-18 Adverse event / near miss reporting and escalation process: immediate action guidance19-20 Checklist for immediate management actions following a Significant Adverse Event21-22 Checklist for decision making in commissioning a Significant Adverse Event Review23-25 Checklist for process of managing a Significant Adverse Event Review26-27 Checklist for implementing system analysis 28-29 Yorkshire Contributory Factors Framework (YCFF) 30-33 Guidance on disclosure of confidential information from Significant Adverse Event Reviews33-38 Evaluation of the Significant Adverse Event Review process 39 SAER staff evaluation questionnaire 40-41 SAER family evaluation questionnaire 42-43 SAER team evaluation questionnaire 44-45 Action Plan Guidance Document 46-56 SAER recommended reading and resources 57-59 3. Leaflet reference: MIS12-300-CC Review date: January 2014 Significant Adverse Events to be reported This list of Significant Adverse Events describes distinct events categorised by the organisation as ones that must always be reported when they may have resulted in: • unexpected death1; • significant harm (harm includes negative physical and emotional impact) to a patient and family; and • may have required intervention to save life. These events must always be reported to the appropriate Associate Medical and Nurse Director who will carry out initial review of the event, inform the relevant Director and refer the event to the Executive Medical and Nurse Director for a decision whether to progress to Significant Adverse Event Review (SAER). This must be actioned as soon as possible based on a brief review of the event. This initial review is not an in-depth systems analysis. The AMD and AND may recommend a Directorate led system analysis following this initial review . These events have been grouped into the following categories – events that should never happen, unexpected events related to care and treatment and environmental events. There may be other significant adverse events that, although not on this list, will still have ‘Major’ or ‘Extreme’ consequences and should to be reported through the Datix system. Events that should never happen Surgery performed on the wrong body part Surgery performed on the wrong patient Wrong procedure performed on a patient Unintended retention of a foreign object after surgery or a procedure 4. 1 Staff may be uncertain as to what constitutes unexpected death in relation to some conditions or clinical scenarios. If there is any doubt or concern that not reporting may mean care system improvement opportunities would be missed, the death should be reported. Leaflet reference: MIS12-300-CC Review date: January 2014 Unexpected events related to care and treatment that have caused death, significant harm or required intervention to save life Unexpected anaesthetic, intra-operative or immediate post operative death Medication error – wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation or wrong route of administration Haemolytic reaction due to the administration of incompatible blood Unexpected significant hypo or hyperglycaemia occurring in the secondary healthcare environment Grade 3 and 4 pressure ulcers acquired in hospital with no previous skin problems Unexpected death from sepsis Venous thrombo–embolus acquired in hospital where prophylaxis was indicated but not given Death of patient after an inpatient fall Maternal death Intra-partum stillbirth or unexpected early neonatal death (0-7 days) Patient suicide whilst under the care of the mental health services Death or serious injury to others whilst under the care of mental health services Missed diagnosis of cancer or a life limiting condition. Death or significant harm of a child or vulnerable adult due to physical neglect or intentional harm Environmental events that have caused death, significant harm or required intervention to save life Electrocution whilst receiving healthcare Other events These are events that would be reported via the Datix system, are a significant near miss or recurring theme that the senior clinical team in conjunction with the Associate Nurse or Medical Director agree warrant review using the SAER process. The rationale for review will be due to the potential to cause significant harm or death. In these cases the event will be escalated to the Executive Nurse and Medical Director for decision making. Inhalation of toxic substances – including legionella Burns and scalds whilst receiving healthcare Criminal events such as wilful administration of care process, treatment or medications to cause harm, physical assault or sexual assault may require review using the SAER process. These events will initially be subject to review by police. 5. Leaflet reference: MIS12-300-CC Review date: January 2014 SAER Process Lead responsibility Directorates Lead responsibility Executive Medical and Nurse Directorates Timeline (Days) Process Descriptor Refer to supporting guidance 0 Significant Adverse Event or a DATIX event with a consequence rating of Major or Extreme occurs Make patient and situation safe, prevent further harm Inform Line Manager and or Duty Manager (if out of hours) Consultant and Senior Nurse responsible for care Line Manager or Duty Manager to inform Director (in hours) or on call Director (out of hours) Line Manager or duty manager to assess and address staff support needs Inform family An event that has resulted in unexpected death or significant harm to a patient and family and may have required intervention to save life. Mandatory Distinct Significant Adverse Events to be reported 0 0 0 0 0 6. All to document what has happened Lead responsibility Shared Director and EMNDs Datix Adverse Event/ Immediate Action Guidance Checklist for Immediate Management Actions following a Significant Adverse Event Checklist for Immediate Management Actions following a Significant Adverse Event Checklist for Immediate Management Actions following a Significant Adverse Event Are staff psychologically safe to continue to work or do they require to be relieved of duties and supported to get home? Following discussion with the line manager inform the family that an event has occurred and extend invitation to visit. Checklist for Immediate Management Actions following a Significant Adverse Event Checklist for Immediate Management Actions following a Significant Adverse Event SAER Commitments to Patients and Families To capture what, how, who and when Checklist for Decision of the event Making in Commissioning a Significant Adverse Event Review Leaflet reference: MIS12-300-CC Review date: January 2014 Timeline within 3 working days Descriptor Escalation will be followed by initial Directorate review of event and determine if reportable to END/ EMD. If this is the case an initial SBAR (which need not be informed by a comprehensive review process) should be submitted on day 3. 1 working Line Manager / Duty CNM or CD responsible for days Manager will Inform submission of the SBAR to the (WD) the Associate Nurse appropriate AND AMD 1 working day Director, Associate Medical Director and Executive Nurse / Medical Director of the occurrence of the event and report the event through the Datix incident reporting system. 2 WD Process Escalation to Associate Medical and Nurse Director The Head of Occupational Health and Safety should be advised. AND/AMD to conduct initial review and will provide the Executive Medical and Nurse Directors with the original Datix and SBAR information, of their assessment of the event and recommendations regarding progression or not to full SAER review. Where medication is involved the advice of the Director of Pharmacy should be sought and included. AND/AMD to review SBAR and use professional judgement to make a recommendation to the EMD and END. Refer to supporting guidance Checklist for Immediate Management Actions following a Significant Adverse Event Checklist for Immediate Management Actions following a Significant Adverse Event Checklist for Decision Making in Commissioning a Significant Adverse Event Review 7. Leaflet reference: MIS12-300-CC Review date: January 2014 Timeline (Days) 1 WD Process Descriptor Supporting Resources END/EMD to make decision regarding initiation of SAER process or reasons why not. The decision must be recorded and Directorate management team concerned informed. Checklist for Decision Making in Commissioning a Significant Adverse Event Review 1-3 WD Decision whether to progress to SAER made and communicated to the Director and AND, AMD. Inform SAER Support Co-ordinator (SSC) SAER Initiated Convene Leadership Oversight Group (LOG) to initiate the SAER Corporate AD responsible for convening LOG. The LOG will focus on family, staff and organisation requirements and will agree the Lead Reviewer, Technical Lead and the family and staff contact person. The LOG will not meet again until end of process unless required due to the need to undertake remedial action. Arrange to meet Corporate AD responsible for with Family to agree conducting meeting with family in expectations and conjunction with the Lead Reviewer contact and family contact person. Within 5 WD Within 5 WD Up to 45 WD 8. Arrange to meet with Staff to agree expectations and contact Corporate AD responsible for conducting meeting with Staff in conjunction with the Lead Reviewer and staff contact person. Conduct SAER using Lead Reviewer will work with SAER Systems Analysis Technical Lead and identified subject matter experts to conduct SAER process. The whole process will be overseen by the allocated Corporate AD’s SAER Roles and Responsibilities SAER Commitments to Patients and Families Checklist for Process of Managing a Significant Adverse Event Review SAER Commitments to Staff Checklist for Process of Managing a Significant Adverse Event Review Guidance on Disclosure of SAER Confidential Information (including FAQs) Checklist for Implementing Systems Analysis. Please refer to SAER Recommended reading and resources document. Leaflet reference: MIS12-300-CC Review date: January 2014 Timeline (Days) Within 5 WD Agreed date Process Descriptor Supporting Resources All those involved with SAER process will be given access to the SAER electronic systems to review and monitor progress on implementation. If at any time during the review process there are concerns that any issues about conduct are being identified, the Lead Reviewer will consult the Corporate Assistant Director who will formally initiate a pause to allow the relevant operational management and HR colleagues to discuss actions necessary. This pause will be no longer than 48 hours. Formal meeting of LOG to receive completed report and consider recommendations. Corporate AD will be responsible for monitoring progress. SAER monitoring system The LOG will receive details of the SAER review process. It should also receive confirmation that requests for factual accuracy checks have been actioned and that the SAER process has been followed. Formal approval by Formal approval will be generated Executive Sponsor following the LOG meeting Findings and Issue of report in line with recommendations information sharing guidance and presented to families face to face meeting. and staff Checklist for Process of Managing a Significant Adverse Event Review Report 9. Leaflet reference: MIS12-300-CC Review date: January 2014 Within 10 Directorate is WD formally notified of approval and requirement for development of action plan in response to recommendations. Through Review and process evaluation of process implementation from all perspectives Action plan developed in line with organisational guidance. Guidance document for action plans Formal evaluation of process, family and staff experience. SAER Staff Evaluation Questionnaire * Next Directorate will present the report and action plan to the next Healthcare Governance Committee. Directorate presents to Healthcare Healthcare Governance Governance Committee Committee where assurance requirements will be agreed. Ongoing Ongoing scrutiny and assurance to Board and/ or Healthcare Governance Committee Quarterly Healthcare Governance Committee to receive report on evaluation of the process and changes that are required. Quarterly Directors to receive briefing on links between Significant Adverse Events and other issues to inform crossorganisational learning and Board Learning and Improvement Reports 10. SAER Patient &/or Families Questionnaire SAER Review Team Members Evaluation Questionnaire SBAR Template Healthcare Governance Committee SBAR Template will approve the report and action plan and identify ongoing monitoring requirements SBAR Template Healthcare Governance Unit will identify themes and commission system wide improvement initiatives and ensure system wide learning. Leaflet reference: MIS12-300-CC Review date: January 2014 Commitments to patients and families involved in a Significant Adverse Event NHS Ayrshire & Arran has agreed what patients and/or carers/families can expect to happen every time a Significant Adverse Event occurs. NHS Ayrshire & Arran is committed to ensuring that when a Significant Adverse Event occurs the immediate crisis will be managed effectively to: • ensure the patient and their family are safe and supported; • staff members are safe and supported; and • the organisation learns from the event and ensures any required improvements are made. A significant adverse clinical event is any event that resulted in the unexpected death or significant harm (harm includes negative physical and emotional impact) to a patient. All Significant Adverse Events will be reviewed in accordance with NHS Ayrshire & Arran’s agreed process. NHS Ayrshire & Arran recognises the significant impact that such an adverse event will have on patients and/or their carers/family. The organisational response to such an event will be: • compassionate; • transparent; • honest; • timely; and • consistent with a focus on the needs of the patient and/or carers/family. When an event occurs patients and/or their carers/families can expect the following: • we will keep you informed of our actions from the time that the adverse event happens through to the point when we have identified the learning and improvements to be made; • we will communicate with you respectfully and honestly, in a way that compassionately acknowledges and recognises the emotional impact of the adverse event on you and your family; • we will support you by providing a consistent named contact person; • we will work with you to involve you in the review process, taking account of your preferences and providing you with the opportunity to share details of your experiences with staff to support their learning; and • we will provide you with a sincere and honest apology for identified failings. 11. Leaflet reference: MIS12-300-CC Review date: January 2014 Our commitments to staff Introduction NHS Ayrshire & Arran has agreed what staff can expect to happen every time a Significant Adverse Event occurs and what the organisation expects from staff. NHS Ayrshire & Arran is committed to developing and shaping our organisational culture with values, beliefs and behaviours that: • recognise the importance of our staff in delivering quality services; • support our managers and leaders to value staff, their health, safety and wellbeing; and • support an honest, fair and just culture underpinned by respect and dignity. This requires every member of staff to play their part; and to understand their roles, responsibilities and commitments. For the NHS Board, the revised Staff Governance Standard sets out what it must achieve in order to continuously improve the fair and effective management of staff. NHS Ayrshire & Arran recognises the importance of staff governance as a feature of high performance which ensures that all staff have a positive employment experience in which they are fully engaged with both their job, their team, and their organisation. Achieving such an outcome will not only have a positive impact on organisational performance (and therefore on the quality of the services we provide), it is also an important component in providing all employees with dignity at work. For staff, the Staff Governance Standard, together with existing staff Codes of Conduct, sets out the responsibilities, standards of performance and behaviours expected. Our approach to supporting staff through significant adverse events will reflect these aims and has been agreed in partnership with staff through the Area Partnership Forum. Significant Adverse Event Review NHS Ayrshire & Arran is committed to ensuring that when a Significant Adverse Event occurs the event will be managed effectively to ensure that: • the patient and their family are safe and supported; • staff members are safe and supported; • the organisation appropriately reviews what happened in an open, fair and thorough way, within defined timelines; and • learns from the event and implements any required improvements. Significant Adverse Events are those categorised by the Board as events that may have resulted in the unexpected death or significant harm (harm includes negative physical and emotional impact) to a patient or member of staff; and may have required intervention to save life. All Significant Adverse Events will be reviewed in accordance with NHS Ayrshire & Arran’s agreed process, which uses validated investigation tools to guide decision making, identify root causes, and determine associated learning. 12. Leaflet reference: MIS12-300-CC Review date: January 2014 Supporting staff The Board recognises the impact that a significant adverse event may have on staff and has listened to feedback from staff. Our commitment to staff is that the Board’s revised approach will be: • fair and thorough; • compassionate; • transparent; • honest; • timely and consistent; while all the time being focussed on the needs of the patient, their family and staff. The Board’s commitments to staff when a significant adverse event occurs are: • we will ensure that you are safe and fully supported throughout the process; • we will communicate with you respectfully and honestly, in a way that compassionately acknowledges and recognises the emotional impact the event may have had on you. This communication will be provided by a named contact person; • we will work with you to involve you in the review process, listening to your experience and ensuring this informs the process and the resultant learning; • we will ensure that the review is completed thoroughly, fairly and as quickly as possible; • we will keep you informed of progress of the significant adverse event review, through your named contact, from the time that the event happens through to the point when we have identified the learning and improvements to be made; and • we will ensure you receive feedback on the findings, recommendations and wider learning. In return, the Board’s expectations from staff are: • ensure that you seek to fully understand the revised process and support its implementation within your area of work; • if you are required to participate in a review process; • you fully and actively engage throughout the process from initial review to developing and delivering improvement plans and identifying learning; • you communicate openly, respectfully and honestly with everyone involved; • you operate within all relevant professional code of conducts as well as the Board’s code of confidentiality; • you fully implement any learning and education relevant to your role or sphere of practice; and • you identify if you need help and support and accept this when it is offered. 13. Leaflet reference: MIS12-300-CC Review date: January 2014 SAER process - roles and responsibilities Line or Duty Manager When a significant adverse event happens, the line or duty manager will follow an agreed checklist to support the consistent approach to the management of these events: • in conjunction with the clinician involved, make sure that the patient and situation are safe and prevent further harm • ensure the immediate needs of all staff involved have been assessed (including requirement to finish shift early) and that safe staffing levels have been secured • ensure on-call Staff Care support has been called and appropriate psychological first aid delivered e.g. defusing, one-to-one support. Follow up debrief/ support arranged • ensure all staff involved are offered staff resource pack • inform the Associate Nurse Director, Associate Medical Director and Executive Nurse / Medical Director of the occurrence of the event and report the event through the Datix incident reporting system • the Head of Occupational Health and Safety should be contacted for advice Associate Nurse and Medical Directors When a significant adverse event happens, the line or duty manager will make the Associate Nurse and Medical Director aware of this and report the event through Datix. The Associate Nurse or Medical Director will oversee Directorate review, escalation to EMD/END and submission of SBAR. The Associate Nurse or Medical Director (AND/AMD) will: • review the information • take cognisance of any situational factors • ensure that advice has been sought from the Head of Employment Relations and Head of Occupational Health & Safety • will provide the Executive Medical and Nurse Directors with the original Datix and SBAR information, of their assessment of the event and recommendations regarding progression or not to full SAER. review. The Executive Sponsor - Executive Medical / Nurse Director The Executive Sponsor is responsible for deciding if a full review SAER requires to be commissioned. To make this decision the Executive Sponsor will: • review the information received from the Associate Nurse or Medical Director regarding the event. • take cognisance of the organisations agreed approach to dealing with such events and use expert professional judgement to decide if the event constituted - unexpected death, significant harm or had the potential to cause significant harm – this may be seen in situations where a near miss has occurred. • ensure that the checklist outlining the rationale for commissioning an SAER is completed and stored within the integrated organisational system for tracking and monitoring review process and actions. 14. Leaflet reference: MIS12-300-CC Review date: January 2014 The Corporate Assistant Director (Executive Medical/Nurse Directorates) When an SAER has been commissioned the Corporate Assistant Director will: • convene a Leadership Oversight Group (LOG) (see below). • provide a corporate oversight and guidance role for the SAER team, supporting consistency in approach. • ensure timelines are met and monitor progress against agreed organisational procedures • act as a source of specialist advice in respect of scrutiny and improvement dimensions of SAER processes • escalate to Executive Sponsor and Director where issues arise that need resolution to implement SAER procedures. • ensure that corporate support resources are allocated to Directorates to implement all elements of SAER process consistently and reliably Role and responsibilities of the Leadership Oversight Group (LOG) The LOG will be chaired by the Executive Sponsor and will be convened to support the Executive Sponsor to oversee the progress and outcome of the review process. Emphasis will be on consistently implementing a review model that provides independent scrutiny and effectively involves members of staff who work in the area where the adverse event took place. In particular there will be a focus on enabling a consistent approach to delivery of expected timescales, communication, staff and family involvement and support. Members of the LOG will be the Executive Sponsor, Director, Corporate Assistant Director, Directorate AND or AMD, Lead Reviewer, Technical Lead with administrative support in attendance. Where medicines are involved the Director of Pharmacy should be a member of the LOG The LOG will: • meet at the beginning of the review process and again at the end to receive the report. It will meet on an interim basis if necessary • develop the Terms of Reference of the review. The Terms of Reference will cover key questions arising from initial review of the event, taking account of available information • confirm the Lead Reviewer (from outside the service involved) who has been identified by the organisation as appropriately skilled and competent in systems analysis. • identify Subject Matter Expert(s) (this includes clinical and corporate support departments) to participate in the review process. The Subject Matter Expert(s) will be from the service/clinical specialty involved, but not from the team directly involved in the episode of care Receive the investigation report on completion for review and approval The Lead reviewer, AND/AMD from the area in which the event occurred, the Corporate Assistant Director and the family/ staff contact person will meet with the family and staff to discuss the findings and recommendations of the report. 15. Leaflet reference: MIS12-300-CC Review date: January 2014 The Director 2 The Director will: • make sure that staff involved are aware that SAER has been called. • ensure that the SAER team has full authorisation to conduct the review and that service managers likely to be involved are aware of this • nominate a staff and family contact person. The nominated contact person will update the progress / status of the review to the family and staff involved. • facilitate the requirements of the review team that will include, staff statements, records, policies and releasing staff for interviews if necessary. • where the investigation raises the possibility of external scrutiny, e.g. Fatal Accident Inquiry or Inquiry by The Mental Welfare Commission/ HIS, senior staff should be made aware of this immediately. On receipt of the final SAER report the Director will ensure an action plan is developed. The plan must be developed in accordance with the agreed format for SAER action plans. • submit the report to the Executive Medical Director for onward submission to the Healthcare Governance Committee. • present the final report and action plan to the Clinical Governance Committee. • ensure there are structures in place to share learning throughout the Directorate. The SAER team The Lead Reviewer will be responsible for conducting the review into the root causes of an adverse event. The lead reviewer will work closely with the Technical Lead and seek support and guidance where required from the Corporate Assistant Director. The review team will: • carry out a full and thorough systems review using established guidance such as the ‘Systems Analysis of Clinical Incidents’ (The London Protocol) and the Six Steps of Root Cause Analysis. • involve subject matter experts as appropriate • ensure the clinical team involved in the incident have opportunity to provide information • ensure the checklist is completed in relation to the activity of the SAER team • ensure the progress / status of the review is kept up to date for the use by the members of the LOG and the nominated staff and family liaison person. • provide a clear, comprehensive and structured review report that meets the Terms of Reference and details findings, conclusions and recommendations. • they will have recognised knowledge and skills in systems analysis and/or root cause analysis and have a proven track record in conducting SAER. • Ensure that recommendations are realistic, stretching but achievable; and that these focus on factors that were contributory to the harm. Incidental issues should be noted for consideration as part of organisational learning themes • request factual accuracy checks from Directorate staff (including management) and patient/family. 16. 2 This may also be other Directors with operational responsibilities, depending upon the nature of the significant adverse event – eg. Director of Pharmacy, Public Health or Information and Clinical Support Services. Leaflet reference: MIS12-300-CC Review date: January 2014 The Lead Reviewer The Lead reviewer will be a senior clinician identified by the organisation as having the necessary skills, knowledge and attitudes to lead the review of a significant adverse event. They will have recognised knowledge and skills in systems analysis and/or root cause analysis and have a proven track record in conducting SAER. They will participate in a rota to ensure planned availability and responsiveness. The organisation expects that this will be regarded as an integral part of the job demands of senior clinical posts. Technical Lead The Technical Lead is someone with advanced knowledge and skill in relation to systems analysis, RCA, review strategies and scrutiny. The Technical Lead will: • work with the Lead Reviewer to ensure that the timeline is created. • guide and coordinate the team in adopting approaches that meet with defined process (reflecting their specialist knowledge and familiarity with the process). • work with the Lead Reviewer to ensure timescales are met • ensure the report is written in an appropriate format. SAER Support Coordinator The SAER Support Coordinator will be responsible for overseeing the flow and recording of the process on a daily basis. This will include: • transferring detail of decision making to create SAER site • assist Corporate Assistant Director to convene LOG • ensure the progress and status of the review is kept up to date for the use by the members of the LOG and the nominated staff and family contact person • record the activity of the team within the SAER monitoring and tracking system Family Contact Person The family contact person will provide regular contact with the family to share information and updates on the progress of the review. The contact person will have the required skills to respectfully disclose sensitive information. This person may be the Lead Reviewer, this decision will be made by the LOG. At the family meeting the family will be asked what their wishes are in relation to ongoing contact. The family contact person will be responsible for documenting this information in the system and for updating the system with: • the date and time of contact • information discussed at those contacts • actions agreed at those contacts • recording when actions are delivered and what the action was. 17. Leaflet reference: MIS12-300-CC Review date: January 2014 Staff Contact Person The staff contact person will provide regular contact with the staff to share information and update staff on the progress of the review. The contact person will have the required skills to respectfully disclose sensitive information. At the Staff meeting, the staff will be advised who the contact person is and how to contact them. The contact person will be responsible for documenting this information in relation to contact with staff and for updating the system with; • the date and time of contacts • information discussed at those contacts • any actions agreed at those contacts recording when actions are delivered and what the action was 18. Leaflet reference: MIS12-300-CC Review date: January 2014 Datix adverse event / near miss reporting and escalation process: Immediate action guidance This guidance includes out of hours contact Adverse event or Immediate action near miss occurs • Keep yourself safe. • Raise the alarm for help from others (if applicable) • Make person(s) / area safe • Label and remove equipment involved • Report Initial assessment of consequence impact If you have answered ‘yes’ to the question about death or significant harm then the consequence score must be either MAJOR or EXTREME. For all other adverse events determine the consequence impact by choosing a colour below. 1 - Insignificant or 2 - minor Injury requiring no or some first aid Clinical outcome or reduced quality of patient experience not related / directly related to care delivery – readily resolvable Short term low staff levels results in minor impact to service / patient care Short term disruption in service with minor impact to patient care / project / objective Organisational financial loss < £10 k Local media short term adverse publicity 3 - Moderate 4 - Major 5 - Extreme Injury requiring clinical Significant harm treatment / intervention requiring intervention to save life Clinical outcome Adverse event leading to actual death or potential for death affecting service / safe delivery of patient care Adverse clinical outcome resulting in continued ongoing long term effects resulting in short term Major injury or injury adverse effects - expect likely to result in long recovery < 1week term incapacity / Ongoing low staff levels disability Adverse clinical outcome resulting in long term effects - expect recovery > 1week Disruption in service with significant impact to delivery of patient care / project / objective Sustained loss of service Organisational financial which has serious impact on delivery of loss £10-100 k patient care / objective / Local media long term project adverse publicity Organisational financial loss £100 k-1m Adverse event leading to major or permanent incapacity / disability Permanent loss of core service / facility Organisational financial loss >£1m National media adverse publicity >3 days and or MP/MSP concern / question National media adverse publicity <3 days 19. Leaflet reference: MIS12-300-CC Review date: January 2014 Action and escalation Reporter Action: Action and escalation Reporter Action: Action and escalation Reporter Action: Action and escalation Reporter Action: Complete on-line Datix Form Immediately inform your shift / line manager or supervisor Immediately inform your shift / line manager or supervisor Immediately inform your shift / line manager or supervisor Complete on-line Datix Form Ensure the scene is left undisturbed until informed otherwise Ensure the scene is left undisturbed until informed otherwise Complete on-line Datix Form Complete on-line Datix Form Shift / line manager or supervisor must: Shift / line manager or supervisor must: Notify Manager - Who will refer to Immediate Notify Manager - Who will refer to Immediate Escalation to relevant Directors; Inform and seek advice from Head of Communications and Head of Occupational Health and Safety. Escalation to relevant Directors; Inform and seek advice from Head of Communications and Head of Occupational Health and Safety. Ensure the scene is left undisturbed until informed otherwise Ensure the scene is left undisturbed until informed otherwise Contact police if required Contact police if required Request written information from staff to be provided Request written information from staff to be provided Check on-line Datix Form completed Check on-line Datix Form completed Inform your line manager or supervisor next available opportunity Shift / line manager or supervisor must: Consider escalating further Consider taking staff statements Management Actions Checklist 20. Management Actions Checklist Leaflet reference: MIS12-300-CC Review date: January 2014 Checklist for immediate management actions following a Significant Adverse Event The following checklist is an aide memoire to support managers with the Significant Adverse Event Review process. A significant adverse event relates to NHS Ayrshire and Arran’s list of mandatory distinct reportable events and all adverse events attracting a consequence score Major or Extreme. This checklist is based on best practice and focuses on the three priority elements of the patient and family, the staff and the organisation. Date: Time: Manager completing checklist: Patient Name: CHI Number: Incident Date: Datix Ref Number: Consequence Score: Directorate Service: Speciality: Location: Immediate action Assess the situation Tick √ Comments if - No or N/A • Ensure appropriate actions taken to establish a safe environment • Ensure the safety of individual/s (patient’s / staff / visitors) • Ensure clinical needs of patient have been assessed and met • Ensure the patient’s named medical consultant has been notified • Ensure patient clinical record is complete (nursing & medical) Communication • Escalate to Executive Medical / Executive Nurse Director • Escalate to Director • Escalate to Associate Medical or Associate Nurse Director • Escalate to any other relevant Director (if non-clinical incident) • Inform and seek advice of Head of Communications, Head of Occupational Health and Safety • Any other relevant external Agency e.g. Procurator Fiscal, Strathclyde Police • Where a medicine is involved escalate to the Director of Pharmacy Preserve the scene until it has been: • Physically assessed and/or photographed • Isolate / remove / label any equipment involved • Released for use by an appropriately authorised person (eg. police officer, HSE Inspector, Senior Manager) Yes Yes Yes 21. Leaflet reference: MIS12-300-CC Review date: January 2014 Patient and family support Yes • Ensure the patient/family have been notified of the event and of action taken • Offer to meet with the patient/family to discuss the event • Contact religious/spiritual advisor if requested by relative e.g. chaplaincy / CISM Staff support • Ensure staff needs have been assessed and met - Are they able to continue with their duties? • Issue staff with the Staff Support Resource Pack /details of support available • Ensure that all staff involved have immediate access to CISM if requested for appropriate psychological / emotional support Organisation • Ensure adequate staffing levels if staff involved are unable to continue their duties. Redeploy/Call in staff as necessary Yes Yes • Notify the Critical Incident Stress Management (CISM) Coordinator of event • Ensure the adverse event is recorded in the Datix incident system within 6 hours • Ensure patient clinical record is complete with any omissions added as a retrospective record • Ensure that the patient clinical record is photocopied if the original is no longer clinically required for the patient’s care at this time 22. • Ensure the process for collection of written information is initiated (eg staff written statements) • Write an SBAR, Using the Checklist for Decision Making in Commissioning a Significant Adverse Event Review Leaflet reference: MIS12-300-CC Review date: January 2014 Checklist for decision making in commissioning a Significant Adverse Event Review SAER reporting and decision form Date of incident: Date escalated to AMD/AND: Patient name: CHI number: Incident date: Datix ref number: Consequence score: Directorate Service: Speciality: Location: SBAR communication Situation Background Assessment Yes The event is on the organisation’s list of distinct adverse events that must always be submitted for review. The adverse event has attracted a consequence score of ‘Major’ or ‘Extreme’. There has been an unexpected death. No 23. Leaflet reference: MIS12-300-CC Review date: January 2014 Assessment Yes No Advice has been sought from the Head of Employment Relations and Head of Occupational Health and Safety There has been significant harm either physical or emotional. The event required intervention was required to save life. There is a potential wider impact which may result in harm to a significant number of patients. The event requires that an external agency be notified, such as the health and safety executive. The Event Potentially raises child protection issues. The event potentially raises adult protection issues, specifically: • Abuse or neglect is known or suspected to be a factor in the death of the adult at risk which may include chronic health conditions going untreated. • The death is by suicide or accidental death or failure to obtain appropriate care or medical treatment which may include significant undiagnosed mental health problems or dangerous assumptions that a person had capacity for decision making that in retrospect may be unlikely. • The death is an alleged murder, culpable homicide, reckless conduct or act of violence Recommendation Completed by Date A significant adverse event relates to NHS Ayrshire & Arran’s list of distinct reportable events and/or all adverse events attracting a consequence score of ‘Major’ or ‘Extreme’. 24. The rationale to initiate an SAER is based on best practice and focuses on the three priority elements of unexpected death, significant harm (harm includes negative physical and emotional impact to a patient and family) or which may have required intervention to save life. Leaflet reference: MIS12-300-CC Review date: January 2014 Executive Director completing: Date: Rationale for decision Does the Executive Sponsor agree with the AMD and AND recommendations? Yes No Yes No Rationale for progressing to SAER Rationale for not progressing to SAER For further action • by Directorate • Other • Corporate Assistant Director: • Lead Reviewer: 25. Leaflet reference: MIS12-300-CC Review date: January 2014 Checklist for process of managing a Significant Adverse Event Review The following checklist is an aide memoire to support Corporate Assistant Director with the Significant Adverse Event Review process. This checklist is based on best practice and focuses on the three priority elements of the patient and family, the staff and the organisation. Datix ref number: SAER ref number: Person completing checklist: Corporate Assistant Director: Executive Nurse/Medical Director Sponsor: Technical Lead: Responsible Director: Lead Reviewer / Family contact: Staff contact: Dimensions Internal Notification (pre 1st LOG meeting) • Leadership Oversight Group (LOG) meeting arranged within 3 working days (in accordance with rota) • Appoint Lead Reviewer (in accordance with rota) • Appoint technical lead (in accordance with rota) • Director to nominate directorate staff contact person • Lead Reviewer appointed as family contact person Leadership Oversight Group (LOG) 1st meeting • LOG confirms the following roles • Technical Lead • Family Contact Person (if not Lead Reviewer) • Staff Contact Person • Subject Expert(s) • LOG confirms HR and Occupational Health and Safety issues considered at SAER declaration • Develop draft Terms of Reference (TOR) Patient / Family meetings: • Ensure family contact initiated • Family involvement and communication preferences documented • Next family contact agreed 26. Date Comments if - No or N/A Leaflet reference: MIS12-300-CC Review date: January 2014 Staff meetings: • Ensure staff contact initiated • Staff involvement and communication preferences documented • Next staff contact agreed Leadership Oversight Group (LOG) 2nd meeting • Meet within 5 working days of the submission of the report. • Review report to ensure TOR and patient / family / staff comments are considered • Confirm SAER process followed and consider recommendations • Confirm factual accuracy feedback received to inform report. Systems analysis • Review is conducted in accordance with the checklist for implementing systems analysis. • Technical Lead to ensure that all implementation resources are available to those who require them. Executive Sponsorship approval process • Ensure patient / family / staff comments are included in final report • Final draft report signed off by Executive Sponsor Formal feedback to patient / family • Report sent to family and meeting arranged with 10 working days • Corporate Lead; Lead Reviewer and subject expert (if applicable) to provide formal feedback to family Formal feedback to staff • Redacted report sent to staff involved and invitation to attend feedback session within 10 working days • Director to arrange formal feedback session within 10 working days Dissemination of final report and development of action plan • Final report to responsible Director(s) • Director arranges development of the action plan • Director monitors progress • Director arranges to present report and action plan at Healthcare Governance Committee 27. Leaflet reference: MIS12-300-CC Review date: January 2014 Checklist for implementing system analysis Patient Name: Directorate: CHI Number: Service: Incident Date: Speciality: Datix Ref: Location: SAE on list (Yes/No): Consequence score: Date Action Yes Started Step 1 – Organisation and Data Gathering • Collect all healthcare records q • Collect relevant protocols and procedures q • Request information from staff regarding sequence of event q • Identify and collect other relevant information (e.g. staff notes) q • Ensure all information is stored in SAER System q • Arrange staff interviews (insert London extract) q Step 2 – Determine the Chronology of the Incident Use all sources of information to develop chronology of events • narrative element • timeline • time person grid • flow charts q q q q Step 3 – Identify Clinical Delivery Problems (CDPs) • Facilitate discussion on possible care delivery problems ❏ • Include all those involved 28. ❏ Comments if – No or N/A Leaflet reference: MIS12-300-CC Review date: January 2014 Step 4 – Identify the Contributory Factors For each CDP, identify contributory factors ❏ Consider use of • Fishbone diagram ❏ • chronological mapping ❏ • Five whys ❏ • Use Yorkshire Contributory Factor Framework (YCFF) to ❏ identify possible contributions ❏ • Analysis complete Step 5 – Making recommendations • Consider involving the service when developing the recommendations • Do they map against each contributory factor? • Is there at least one recommendation for each contributory factor? ❏ ❏ ❏ 29. Leaflet reference: MIS12-300-CC Review date: January 2014 Incident Investigation in Hospitals Yorkshire Contributory Factors Framework (YCFF) Version 1.6 Based on : BMJ Quality & Safety – March 2012 – doi:10.1136/bmjqs-2011-000443 CONTRIBUTORY FACTOR DOMAIN Situational Factors Team Factors For example: • Conflicting team goals • Lack of respect for colleagues • Poor delegation • Absence of feedback Relevant to Incident? □ Yes Individual Staff Factors For example: • Fatigue • Stress • Rushed • Distraction • Inexperience □ Yes Task Characteristics For example: • Unfamiliar task • Difficult task • Monotonous task □ Yes Patient Factors For example: • Language barrier • Uncooperative • Complex medical history • Unusual physiology • Intoxicated □ Yes CONTRIBUTORY FACTOR DOMAIN Local Working Conditions Workload & Staffing issues For example: • High unit workload • Insufficient staff • Unable to contact staff • Staff sickness Relevant to Incident? □ Yes Prompting question Did the staff involved function as a team? □ Maybe □ No On the day of the incident, how did you feel? □ Maybe □ No Did the task features make to incident more likely? □ Maybe □ No □ Maybe Were there any reasons this incident was more likely to occur to this particular patient? □ No □ Maybe Prompting question Did staff provision match the expected workload around the time of the incident? □ No 30. R Lawton, R McEachan, J Anderson & PA Laloë – Yorkshire Quality & Safety Research Group Leaflet reference: MIS12-300-CC Review date: January 2014 CONTRIBUTORY FACTOR DOMAIN Local Working Conditions Leadership, Supervision & Roles For example: • Inappropriate delegation • Unclear responsibilities • Remote supervision Relevant to Incident? □ Yes Drugs, Equipment & Supplies For example: • Unavailable drugs • Equipment not working • Inadequate maintenance • No supplies delivery □ Yes CONTRIBUTORY FACTOR DOMAIN Latent/Organisational Factors Physical Environment For example: • Poor layout • Lack of space • Excessive noise / heat / cold • Poor visibility (e.g. position of nurses’ station) • Poor lighting • Poor access to patient Relevant to Incident? □ Yes Support from other departments This includes support from IT, HR, porters, estates or clinical services such as radiology, phlebotomy, pharmacy, biochemistry, blood bank, microbiology, physiotherapy, medical or surgical subspecialities, theatres, GP, ambulance… □ Yes Scheduling & Bed Management For example: • Delay in the provision of care • Transfer to inappropriate ward • Difficulties finding a bed • Lack of out-of-hours support □ Yes Staff Training & Education For example • Inadequate training • No protected time for teaching • Training not standardised • No regular/yearly updates □ Yes Prompting question Did everyone understand their role? □ Maybe □ No □ Maybe Were the correct drugs, equipment & supplies available and working properly? □ No □ Maybe Prompting question Did the ward environment hinder your work in any way? □ No Were there any problems from other departments? □ Maybe □ No □ Maybe Did any time or bed pressures play a role in the incident? □ No Were there any issues with staff skill or knowledge? □ Maybe □ No 31. Leaflet reference: MIS12-300-CC Review date: January 2014 32. CONTRIBUTORY FACTOR DOMAIN Latent/Organisational Factors Local Policies, Protocols & Procedures For example: • No protocol exists • Protocol too complicated • Lack of standardisation • Contradictory policies exist Relevant to Incident? □ Yes CONTRIBUTORY FACTOR DOMAIN Latent/External Factors Design of Equipment, Supplies & Drugs For example: • Confusing equipment design • Equipment not fit for purpose • Similar drug names • Ambiguous labelling & packaging Relevant to Incident? □ Yes National Policies For example: • Commissioned resources • National screening policy • Interference by government organisations • National medical / nursing standards • 4 hour Emergency Department target □ Yes CONTRIBUTORY FACTOR DOMAIN General Factors Safety Culture For example: • Patient safety awareness • Fear of documenting errors • Attitude to risk management Relevant to Incident? □ Yes Communication Written and Verbal Communication For example: • Poor communication between staff • Handover problems • Lack of communication/notes • Unable to read notes • Inappropriate abbreviations used • Unable to contact correct staff • Notes availability □ Yes Prompting question Did local policies & protocols help or hinder? □ Maybe □ No □ Maybe Prompting question Is there any characteristic about the equipment, disposables or drugs used that was unhelpful? □ No Have any national policies influenced this incident? □ Maybe □ No □ Maybe Prompting question How would you describe the culture of your clinical area in relation to patient safety? □ No Were the notes available, accurate & readable? □ Maybe □ No Did poor or absent verbal communication worsen the situation? Leaflet reference: MIS12-300-CC Review date: January 2014 Guidance on disclosure of confidential information from Significant Adverse Event Reviews This document provides guidance on the disclosure of confidential information gathered during Significant Adverse Event Reviews. First, frequently asked questions are outlined; second, some general principles to consider in relation to information from SAERs; and finally some background details on the laws governing the disclosure and sharing of confidential information obtained during a review will be outlined. Details of additional resources and sources of advice are outlined at the end of this document. Frequently asked questions about disclosure of confidential information arising from SAERs Can I give unredacted copies of an SAER report to all members of a family ? No. Unredacted copies of an SAER report can be given to a patient’s nominated family member, and other family members if the relevant consent is in place. The only content of a report provided to a family that would be redacted would be personal information relating to staff that a family was not entitled to. Can I give copies of a full unredacted SAER report to all of the people directly involved with the event ? Not if the report contains personal information about individuals who have not consented for this information to be disclosed. Redacted copies can be provided to all staff involved. Unredacted copies can only be provided when all consents are in place or when the people being given the confidential information already know it by virtue of their existing need to know (e.g. having been a doctor or nurse involved with the case that the SAER refers to). Can I send the full SAER report round my team to support the need for learning from the SAER ? Redacted copies of the SAER (with all personal information removed) can be sent round teams to support learning and improvement actions. 33. Leaflet reference: MIS12-300-CC Review date: January 2014 Will a statement that I have provided be shared with the family ? Statements will not be routinely disclosed to family members unless staff who have provided the statement consent to this. Family representatives may be provided with a summary of the information contained within statements. The following questions will help with thinking and decision-making about sharing information. It may help to think about these before contacting colleagues for guidance and/or approval for the release of confidential information for an SAER Is it OK to disclose adverse event information to the person’s next of kin ? The term ‘next of kin’ has no legal standing in relation to the issue or the provision of healthcare services. The right of access to information contained within a health record of someone who has died is granted on the basis of being the personal representative (which has a legal definition) of the patient, rather than being a family member or surviving family member. Disclosure of information of a living person can take place with their consent, or in some circumstances this can be regarded as implied. Who does the information that you are considering relate to ? If the information relates to someone who is alive, the Data Protection Act 1998 will govern the sharing of the information. Personal data shall not be shared unless at least one of the conditions in Schedule 2 is met. If it is deemed to be sensitive personal data then sharing it must be in accordance of Schedules 2 and 3 of the Act. Advice will be provided by the Information Governance Manager and Caldicott Guardian. If the information relates to a staff member (who is living) then the sharing of the information will be governed by the Data Protection Act 1998. 34. Leaflet reference: MIS12-300-CC Review date: January 2014 Does the information relate to a patient who is not alive? Some of the information gathered during a Significant Adverse Event Review will be regarded as personal health information and as such sharing will be governed by the Access to Health Records Act 1990. That is, that sharing of the personal health information can only be with the consent of the person’s representative. The remaining information will be governed by common law, where confidentiality is required after death. Is it possible to remove all details that could lead to people being identified? If the information is shared or disclosed in a way that means that the person is not identifiable, then sharing information more widely (such as by means of publication), is possible. Copies of redacted significant adverse event reports can be shared widely and published if there are no data included that identify the person(s) involved (directly or by deduction). If the information is not closely linked with health records information or, in the case of staff, relates to information generated by or about staff, how do I decide if it constitutes personal data? In these circumstances, consider whether the information is of biographical significance. This is when the information relates specifically to the life of a person and this can then identify them when linked with other details in the document e.g. Mr X worked as a senior policeman. ‘Senior policeman’ is of biographical significance and could, if linked with other information, lead to deductive identification. If it is then you will require the consent of the person (or their representative before it can be shared in anything other than an anonymised form). Whose personal data do I wish to share? This could be a patient, relative, staff member involved in care or staff member involved in the review process. The decisions about disclosure of information will vary depending upon who the information relates to and who the person(s) are that are requesting the information or to whom it is to be disclosed. 35. Leaflet reference: MIS12-300-CC Review date: January 2014 To whom am I considering the disclosure or sharing of this information ? Another colleague involved in the review ? A relative ? A member of the public ? The person to whom the information is to be disclosed will also determine whether it is legal to do so. For example, disclosure of personal details of a staff member to a relative who has said they want to know more about the staff member’s opinions would not be required by law. Disclosure of personal clinical details to a relative without a patient’s consent (or in the case of someone who has died their legal representative) would not be legally sanctioned, even if that person claimed that right as a family member. How do I get consent from someone to disclose information ? Consent can be given verbally and then documented that this has happened. The Executive Medical Directorate liaise with the personal representatives of all deceased patients whose care is subject to an SAER, to request written consent for sharing of reports with other family members. Although every scenario generally needs to be considered in accordance with the information in question and all of the issues outlined here, there are some general principles that the Board will adopt in relation to disclosure and sharing of information obtained during the course of adverse event reviews. These are: • The patient or (in the case of people who have died, the patient’s representative) will determine who should receive full copies of the review report (including information that identifies the person who is the subject of the review process). • The Executive Medical Directorate will prepare redacted copies of all SAER reports for dissemination across the Board and publication on the Board website. These will have all personal data (as defined by the Data Protection Act, Access to Health Records Act and common law of confidentiality) removed. In all other cases, full reports and documentation can be shared with all of those directly involved with the incident if all of the people whose personal information contained therein have consented. 36. Leaflet reference: MIS12-300-CC Review date: January 2014 • The names of staff who were involved with the care of the person(s) whose care is subject to review will not be publically disclosed in general, though these can be provided to the patient and/or their personal representatives upon request. • The names of staff involved in the review of an adverse event can be publically disclosed (unless there is evidence to suggest that doing so would put staff at risk of harm), as can the names of those with responsibility for implementing actions arising from the learning and changes required through the review of adverse events. • Personal data relating to staff obtained during an adverse event review will not be disclosed to other people without consent (or in the presence of another legal requirement for disclosure). • Personal data relating to staff (for example, details that states that a Doctor on duty had previously experienced stress and depression; or that a nurse had stated that she had been worried about personal issues on the night of the event) will not be shared publically when referenced in relation to a significant adverse event review. Staff members usually provide written accounts of events, these often contain a combination of personal data about patients, third party individuals and staff themselves. Patients and their legal representatives can be provided with copies of these if the people consent to the elements that constitute personal data being disclosed. If they do not consent to this, patients and their legal representatives have a right to receive summaries of the information contained within the written accounts/statements and will be provided with this. In view of the wide range of factors that can influence decision-making and the application of the laws referred to here, advice should be sought on a case by case basis and/or if there are any uncertainties. 37. Leaflet reference: MIS12-300-CC Review date: January 2013 Laws governing confidential information from Significant Adverse Event Reviews Information obtained during adverse event review is confidential 31 and, as such, sharing or disclosing adverse event related information to others is subject to legal requirements. These are outlined in the Data Protection Act 1998, Access to Health Records Act 1990, Human Rights Act 1998, in common law and in relation to the Freedom of Information (Scotland) 2002 Act. Staff members are often uncertain about what information obtained during the course of an investigation can be disclosed to others. This is an area that is subject to high level of variation in understanding of the law and there are often very different perceptions of what can be shared. The Data Protection Act only applies to the personal data of people who are still alive. The DPA distinguishes between two types of data – personal data and sensitive personal data. More stringent conditions apply to processing sensitive personal data. Significant amounts of information obtained during adverse event reviews are classified as personal data – sensitive personal data health information in relation to health and personal information in relation to staff involved with the incident under review. The personal information within health records of people who have died is regulated by the Access to Health Records Act 1990 and also common law obligations because of the nature of the information and the circumstances in which it has been provided. Article 8 of the European Convention on Human Rights provides that ‘Everyone has the right to respect for his private and family life, his home and his correspondence.’ 3 This has a specific legal definition in relation to whether information has the necessary quality of confidence about it and is imparted in circumstances that require an obligation of confidence. For further information or advice Information Governance Team, Executive Medical Directorate, NHS Ayrshire & Arran Tel: 01292 513693 Email: [email protected] Assistant Director, Executive Nurse Directorate, NHS Ayrshire & Arran Tel: 01292 617084 Email: [email protected] Freedom of Information Officer, Communications Department, NHS Ayrshire & Arran Tel: 01563 826112 Email: [email protected] 38. Leaflet reference: MIS12-300-CC Review date: January 2013 Evaluation of the Significant Adverse Events Review process The evaluation process is focused on the following ‘key’ elements: • Adherence to the process • Compliance with the statement of commitment to staff • Compliance with the statement of commitment to the patient and their family Methodology Evaluation will be an ongoing process to assess consistency of application of the process and supporting documents. It is proposed to take a triangulated approach to facilitate validation of data through cross verification from more than two sources. The proposed methodology is outlined below: Audit of SAER Documentation Patient & Family/Staff Evaluation Questionnaire Patient & Family/Staff Interview/ Focus Group Application • The Healthcare Governance Unit will audit adherence to the process and completion of all associated documentation following the completion of each SAER • The Healthcare Governance Unit will invite every member of staff directly involved in the SAER to complete and return an anonymous questionnaire • The Healthcare Governance Unit will invite the patient and/or the family involved in the SAER to complete and return a questionnaire • The Patients and Community Relations Team will undertake one-to-one interviews and/ or focus groups with a sample of staff and patient/family involved in the SAER to explore their experience of the process (using an agreed interview template) Review An evaluation report will be developed by the Healthcare Governance Unit and tabled at the Continuous Clinical Improvement Board in order to review and refine of the SAER process. All stakeholders will receive feedback. 39. Leaflet reference: MIS12-300-CC Review date: January 2014 SAER staff evaluation questionnaire Please complete and return in the envelope provided. All responses will be treated in the strictest confidence. SAER number: 1. Immediately following the adverse event I was adequately supported by the organisation. Totally agree Agree Neutral Disagree Totally disagree 2. I was provided with a named contact from the Staff Care Team within 24 hours of the adverse event happening. Yes No 3. I was provided with the opportunity to attend a full debrief following the adverse event. Totally agree 4. Neutral Disagree Totally disagree I had ample opportunity to discuss my personal involvement in the significant adverse event with members of the review team. Totally agree 5. Agree Agree Neutral Disagree Totally disagree I was satisfied with my level of involvement in the root cause analysis process. Totally agree Agree Neutral Disagree Totally disagree 6. I received accurate, consistent and timely information about the progress of the significant adverse review. Totally agree Agree Neutral Disagree Totally disagree 7. I was satisfied with the process of receiving and discussing the findings and recommendations arising from the significant adverse event. Totally agree 8. Neutral Disagree Totally disagree I was treated fairly and consistently throughout the process of reviewing the significant adverse event. Totally agree 9. Agree Agree Neutral Disagree Totally disagree Overall I was satisfied with my experience and involvement in the significant adverse event process. Totally agree Agree Neutral Disagree Totally disagree 10. Please provide any additional comments you wish to make regarding any aspect of the Significant Adverse Event Process 40. Leaflet reference: MIS12-300-CC Review date: January 2014 If you wish to discuss any aspect of your involvement in the Significant Adverse Event Process further please contact your line manager or phone the Healthcare Governance Unit on 01292 513664 Thank you for taking the time to complete this questionnaire. Your feedback will inform the continuous improvement of the process. This questionnaire focuses on your experience of the Significant Adverse Event Review Process. Please complete and return in the envelope provided. All responses will be treated in the strictest confidence. 41. Leaflet Leaflet reference: reference: MIS12-300-CC MIS12-300-CC Review Review date: date: January January 2014 2013 SAER family evaluation questionnaire Are you responding as an individual or on behalf of your family (please circle) Individual On behalf of your family SAER number: 1. I was informed promptly that the adverse event had occurred. Totally agree Agree Neutral Disagree Totally disagree 2. I was promptly provided with information on what had happened and offered the opportunity to ask questions. Yes No 3. I was satisfied with the information I received regarding the Significant Adverse Event review process. Totally agree Agree Neutral Disagree Totally disagree 4. I was kept informed of the progress of the review through to the point when we have identified the learning and improvements to be made. Totally agree Agree Neutral Disagree Totally disagree 5. I was communicated with in a respectful and honest manner, in a way that compassionately acknowledged and recognised the emotional impact of the adverse event on my family and me. Totally agree Agree Neutral Disagree Totally disagree 6. I received consistent support from a named contact person. Totally agree 7. Disagree Totally disagree Agree Neutral Disagree Totally disagree I was provided with a sincere and honest apology for identified failings. Totally agree 9. Neutral I felt involved in the review process and my preferences were taken into account including the opportunity to share details of your experiences with staff to support their learning. Totally agree 8. Agree Agree Neutral Disagree Totally disagree Overall I was satisfied with my experience and involvement in the significant adverse event process. Totally agree Agree Neutral Disagree Totally disagree 10. Please provide any additional comments you wish to make regarding any aspect of the Significant Adverse Event Process 42. Leaflet reference: MIS12-300-CC Review date: January 2013 If you wish to discuss any aspect of your involvement in the Significant Adverse Event Process further please get in touch with your named contact. Thank you for taking the time to complete this questionnaire. Your feedback will inform the continuous improvement of the process. 43. Leaflet Leaflet reference: reference: MIS12-300-CC MIS12-300-CC Review Review date: date: January January 2014 2013 SAER Review Team Members evaluation questionnaire SAER number: Please complete and return in the envelope provided. All responses will be treated in the strictest confidence. Lead Reviewer Technical Lead Subject matter expert 1. The SAER SharePoint system was demonstrated to me Yes 2. I was able to navigate and obtain all necessary information from the SAER SharePoint system. Totally agree 3. Totally disagree Agree Neutral Disagree Totally disagree Agree Neutral Disagree Totally disagree Agree Neutral Totally disagree N/A I felt supported as the subject matter expert by my manager. Totally agree 7. Disagree I was satisfied with the level of opportunity to contribute to the review process. Totally agree 6. Neutral The Review Team meetings ran to the planned schedule. Totally agree 5. Agree I received timely information about dates of meetings. Totally agree 4. No Agree Neutral Disagree Totally disagree Disagree Totally disagree I felt supported by others in the SAER Review Team Totally agree Agree Neutral 8. I was adequately supported by my manager in relation to releasing time to participate in the review process. Totally agree Agree Neutral Disagree Totally disagree 9. I felt that the review process was achievable within the timescale. Totally agree Agree Neutral Disagree Totally disagree 10. I was satisfied that the Leadership Oversight Group respected the Review Team’s opinion (report). Totally agree 11. Neutral Disagree Totally disagree I received feedback following the final Leadership Oversight Group meeting. Totally agree 44. Agree Agree Neutral Disagree Totally disagree Leaflet reference: MIS12-300-CC Review date: January 2013 12. I was advised timeously that the report had been accepted / approved by the Leadership Oversight Group. Totally agree Agree Neutral Disagree Totally disagree 13. I had the opportunity to attend a debrief of the review process. Totally agree Agree Neutral Disagree Totally disagree 14. Overall, I was satisfied with my experience with the SAER process Totally agree Agree Neutral Disagree Totally disagree 15. Overall I was satisfied with my involvement with the SAER Process. Totally agree Agree Neutral Disagree Totally disagree 16. Please provide any additional comments you wish to make regarding any aspect of the SAER process including any suggestions for improvement. Thank you for taking the time to complete this questionnaire. Your feedback will inform the continuous improvement of the process. This questionnaire focuses on your experience of the Significant Adverse Event Review Process. Please complete and return in the envelope provided. All responses will be treated in the strictest confidence. 45. Leaflet reference: MIS12-300-CC Review date: January 2014 Guidance Document for NHS Ayrshire and Arran Action Plans Please Note – If you are using a paper copy of this document you must check AthenA to ensure that you have the most up to date version 46. File Name: ActionPlanGuidance300113 Produced by: Healthcare Quality Version: 8 Page 1 of Date: 14/05/2013 Review Date: 03/05/2014 Leaflet reference: MIS12-300-CC Review date: January 2014 INTRODUCTION This document provides guidance in completing all Action Plans within NHS Ayrshire and Arran. It introduces the template designed to document the status of an action plan and detail specific evidence of progress towards implementation. The importance of completing each column is outlined below. • Appendix 1 provides an example of an Action Plan. • Appendix 2 provides an Action Plan Template ready for use. THE ACTION PLAN TEMPLATE Recommendation(s) In this section the recommendation(s) from a report such as Significant Adverse Event Reviews (SAER), complaints, Scottish Public Service Ombudsman (SPSO), inspection or local review should be entered. Each recommendation should be numbered accordingly. Action(s) Action(s) should be linked to each recommendation. For example if Recommendation 1.0 has 3 actions then number as Action 1.1, Action 1.2 and Action 1.3. Target Date for Completion Enter a specific date when the action will have been completed. For example record as 31st March 2013 and not March 2013. Responsible Officer Include the job title/role of the person responsible for implementation. Evidence of Effective Implementation At the point of creating the action plan this is the description of the evidence that will be sought to confirm that the action has been effectively implemented. Evidence should be aligned to each action. When the action has been closed the details of the evidence in support of effective implementation needs to be included. Documents supporting evidence of effective implementation should be embedded within the action plan. To embed a Word Document please follow attached instructions: 1. 2. 3. 4. 5. 6. 7. Go to Insert on the menu bar Select Object Select Tab “Create from File” Tick box “Display as icon” Browse and then find where the relevant is saved on the PC Highlight the document and then click on “Insert” and “OK” The document will then be inserted into the action plan. N.B. On occasions, the message “Word cannot start the converter mswrd632” will appear with two options – “Show Help” or “OK”. Continue to click on “OK” until the document is inserted. f the embedded document then proves difficult to open, right click the document and select “Document Object” and select “Open”. File Name: ActionPlanGuidance300113 Produced by: Healthcare Quality Version: 8 Page 2 of Date: 14/05/2013 Review Date: 03/05/2014 47. Leaflet reference: MIS12-300-CC Review date: January 2014 Action Status The status of each action should be recorded as either Open or Closed. If the action is ongoing i.e. monthly results to be produced ... the status of this action should be recorded as open. If an action is completed prior to the Target Date for completion, the status should still be recorded as closed. Longer action plans If an action plan contains an extended amount of text and extends over two or more pages, correct formatting should be included for reasons of clarity and ease of reading. To do this: 1. 2. 3. 4. Highlight the row in the table which contains the appropriate column headings. Right click this row, and from the pop-up menu select “Table Properties…” From the pop-up window select the “Row” tab. Ensure the checkbox next to “Repeat as header row at the top of each page” has a tick. An example of this can be seen in Appendix 2, where the action plan extends over two pages. 48. Leaflet reference: MIS12-300-CC Review date: January 2014 Guidance on the development of actions When actions are developed from recommendations it is important to keep in mind some general guidance to afford them optimal chance of success. Actions that are SMART (Specific, Measurable, Achievable, Relevant, and Timely) are likely to be achieved. SMART actions provide a way of ensuring everyone understands them, they are trackable, relevant, there are enough resources to achieve them and a firm deadline is set. Specific Actions should specify what they need to achieve. This means that the action should be clear and unambiguous. A specific action has a much greater chance of being accomplished than a general one. To make actions specific, they must tell a team exactly what is expected, why is it important, who is involved, where is it going to happen and which attributes are important. Specific in the context of developing actions means that a behaviour, achievement or observable action is described which is also linked to a rate, number, percentage or frequency. To increase specificity use verbs which are action-orientated to describe what should be undertaken to fulfil objectives. Action verbs include: • • • • • • • • Analyse apply change create determine differentiate identify perform Avoid jargon, words and phrases which are (or can be construed as) misleading or ambiguous such as: • • • be aware of have an awareness of be prepared for a variety of Measurable You should be able to measure whether you are meeting the action or not. To do that, a system, method or procedure has to exist which allows the tracking and recording of the behaviour or action. Setting an action/goal that requires phone calls to be answered within one minute is acceptable, provided a system exists which measures whether this is actually being achieved. If none exists, the manager should be prepared to set time aside time to monitor the response rates to incoming phone calls. 49. Leaflet reference: MIS12-300-CC Review date: January 2014 A measurable action will usually answer questions such as: • • • How much? How many? How will I know when it is accomplished? Measurable is the most important consideration. You will know that you've achieved your action/goal, because here is the evidence. Achievable The actions/goals that are set with people need to be capable of being reached, put most basically; there is a likelihood of success but that does not mean that they are easy or simple. They still need to be stretching and agreed by the parties involved. Achievable is linked to measurable. Usually, there's no point in starting a job you know you can't finish, or one where you can't tell if or when you've finished it. How can I decide if it's achievable? • • • • • You know it is measurable Others have done it successfully (before you, or somewhere else) It's theoretically possible (i.e. clearly not 'not achievable') You have the necessary resources, or at least a realistic chance of getting them You've assessed the limitations. Relevant This is focused on choosing actions/goals that matter. A Bank Manager's goal to "Make 40 egg sandwiches by 1.00pm" may be specific, measurable, achievable, and timely, but lacks relevance. In many instances, the accomplishment of an action/goal requires the support of others: resources, a champion voice, someone to knock down obstacles. Goals that are relevant to your team and your organisation will receive that necessary support. Relevant goals (when met) drive the team, department, and organisation forward. A goal that supports or is in alignment with other goals would be considered a relevant goal. They should add useful value within the context in which they are being set, being aligned with strategies and higher goals. A relevant action/goal can answer yes to these questions: • • • Does this seem worthwhile? Is this the right time? Does this match our other efforts/needs? 50. File Name: ActionPlanGuidance300113 Version: 8 Date: 14/05/2013 Leaflet reference: MIS12-300-CC Review date: January 2014 Timely Commitment to a deadline helps a team focus their efforts on completion of the action/goal on or before the due date. An action/goal with a deadline is intended to establish a sense of urgency. This part of the S.M.A.R.T. criteria is intended to prevent goals from being overtaken by the day-to-day crises that invariably arise in an organisation. A time-bound goal will usually answer the question: • • • • When? What can I do 6 months from now? What can I do 6 weeks from now? What can I do today? 51. 52. Version: 8 Page 7 of 11 2.1 A report on the findings and recommendations from the SPSO report will be circulated to all department nursing staff. [evidence: copy of extract from case notes] Discussion should be clearly documented in the patient’s case notes (With the name, Nursing Grade / GMC number of the communicator). [evidence required: Revised Discharge letter] A standardised discharge letter clearly stating follow up and discharge medication is in use across NHS Ayrshire and Arran Evidence of Effective Implementation [evidence: minutes of ward managers’ meeting December 2012] Clinical Nurse The SPSO report circulated at the Manager Ward Managers Meeting December 2012. Date: 14/05/2013 Review Date: 03/05/2014 25th November 2012 Ward Managers 25th November 2012 1.2 Effective communication between staff and the patient to ensure they are comfortable with follow up arrangements File Name: ActionPlanGuidance300113 Produced by: Healthcare Quality 2.0 Findings and recommendations from Scottish Public Services Ombudsman (SPSO) report should be shared with staff for action and/or information Executive Medical Director 31st May 2013 1.1 A standardised discharge letter will be used across the organisation with follow up arrangements and treatment on discharge 1.0 Discharge letters should clearly state any follow up required and by whom, and detail any medication required on discharge Responsible Officer Target Date For Completion Action Recommendation Action Plan Example A Closed Closed Open Action Status Appendix 1 Leaflet reference: MIS12-300-CC Review date: January 2014 Version: 8 Page 8 of 11 3.1 An audit of nursing documentation will be undertaken based on the NMC guidelines, 5 cases per week until 95% compliance with criteria is met. File Name: ActionPlanGuidance300113 Produced by: Healthcare Quality 3.0 The Board emphasise to all nursing and midwifery staff, the importance of adhering to the Nursing and Midwifery Council (NMC) 2009 guidelines/record keeping: guidance for nursing and midwives 2.2 Ward Managers will discuss the complaint and the findings of SPSO with their nursing team. Ward Managers 30th November 2013 Date: 14/05/2013 Review Date: 03/05/2014 Ward Managers 15th February 2013 [Evidence: run charts produced and presented to the ward managers / SMT on a monthly basis] Audit results will be recorded on a run chart to monitor improvement. [Evidence: copy of safety brief / ward] Complaint and findings of SPSO discussed at ward’s daily meeting and noted on the safety briefing. Open Closed Leaflet reference: MIS12-300-CC Review date: January 2014 53. 54. 1.1 Charge Nurse will lead all ward rounds taking up-todate information from named nurse and reporting back on consultants findings and decisions 2.1 Supplement monitoring charts must be completed by staff allocated and any refusal/dislikes must be documented on chart and reported to Charge Nurse/ Dietitian 1.0 Ward rounds must be supported by Charge Nurse/ Nurse in Charge in leadership/ coordinating role. This encourages continuity of care, identifying and highlighting any problems/ potential problems with individual patients 2.0 Where nutritional supplements are prescribed, supplement monitoring charts must be used 3.0 Weight must be 3.1 All patients weight, height recorded and BMI and BMI should be accurately calculated for accurately recorded on all patients. Patients admission to ward and MUST should be reviewed as per assessment completed as MUST assessment tool directed with File Name: ActionPlanGuidance250313v6 Version: 6 Produced by: Healthcare Quality Page 9 of 11 Action Recommendation Action Plan Example B Ward Managers Ward Managers 30th April 2013 30th June 2013 Date: 25/03/2013 Review Date: 25/03/2014 Ward Managers Responsible Officer Target Date For Completion 31st January 2013 An audit of completion of 5 nursing documentation entries monthly will demonstrate recording of height, weight, BMI and MUST assessment on admission to ward for every [Evidence required: audit results on use of supplement monitoring charts] An audit of completion of 5 supplement monitoring charts demonstrating 100% compliance must be undertaken monthly [Evidence: extract from health record demonstrating coordinated approach by Charge Nurse; safety briefing] Ward rounds supported by Charge Nurse, coordinated information at ward round, safety briefing/handover and within patients health record Evidence of Effective Implementation Open Open Closed Action Status Appendix 2 Leaflet reference: MIS12-300-CC Review date: January 2014 Version: 6 Page 10 of 11 recommendations followed Action File Name: ActionPlanGuidance250313v6 Produced by: Healthcare Quality Recommendation Responsible Officer Date: 25/03/2013 Review Date: 25/03/2014 Target Date For Completion [Evidence required: audit results] patient Evidence of Effective Implementation Action Status Leaflet reference: MIS12-300-CC Review date: January 2014 55. 56. File Name: [Document Name] Produced by: [Author, Service] 4.0 3.0 2.0 1.0 Recommendation Action Plan Template Action Version: [Version No] Page 11 of 11 Target Date For Completion Responsible Officer Date: [Date produced] Review [Date due for review] Evidence of Effective Implementation Action Status Appendix 3 Leaflet reference: MIS12-300-CC Review date: January 2014 Leaflet reference: MIS12-300-CC Review date: January 2014 57. Significant Adverse Event Reviews Recommended reading and resources The following documents are recommended reading for staff wishing more details in respect of the management of Significant Adverse Events: Conway J, Federico F, Stewart K, Campbell MJ. Respectful Management of Serious Clinical Adverse Events (Second Edition). IHI Innovation Series white paper. Cambridge, Massachusetts: Institute for Healthcare Improvement; 2011. (Available at http://www.ihi.org/knowledge/Pages/IHIWhitePapers/RespectfulManagementSeriousClinicalAEsWhitePaper.aspx). 4 Disclosure of Adverse Events to Patients. Annotated Bibliography. Available at http://www.ihi.org/knowledge/Pages/Tools/DisclosureofAdverseEventstoPatientsAnnotatedBibliography.aspx 5 Communicating After an Adverse Event. Available at: http://www.ihi.org/knowledge/Pages/Tools/CommunicatingAfteranAdverseEventBiblio.aspx 6 Conway, J; Sadler, B & Stewart K. (2010). Planning for a Clinical Crisis, Healthcare Executive, Nov/Dec 2010, 78-81. Available at: http://www.primaris.org/sites/default/files/article_on_clinical_crisis.pdf Federico, F & Conway, J (2011). Planning for a Clinical Crisis: Next Steps, Healthcare Executive, Nov/Dec 2011, 74-76 Available at: http://www.fadelibrary.org.uk/wp/wp-content/uploads/downloads/2011/10/Planning-for-a-clinical-crisis-Next-steps.pdf Taylor-Adams, S & Vincent, C. ‘Systems Analysis of Clinical Incidents. The London Protocol’ Available at http://www1.imperial.ac.uk/resources/C85B6574-7E28-4BE6-BE61-E94C3F6243CE/london%20protocol_e.pdf Mahajan, R. P. (2010). Critical Incident Reporting and Learning, British Journal of Anaesthesia, 105(1), 69-75. Available at http://bja.oxfordjournals.org/content/105/1/69.full.pdf+html 4 5 6 Note 58. that registration with IHI required to access this. Significant Adverse Event Reviews Recommended reading and resources Reason, J (2000). Human error: models and management. British Medical Journal, 320, 768-770. (18 March). Login to Knowledge Network (http://www.knowledge.scot.nhs.uk/home.aspx) and then paper accessible via http://www.bmj.com/content/320/7237/768.pdf%2Bhtml Seys, D, Scott, S, Wu, A, Van Gerven, E et al. (2012). Supporting involved healthcare professionals (second victims) following an adverse health event: A literature review. International Journal of Nursing Studies. Pre-print available from Professor White, Assistant Director, Executive Medical Directorate by kind permission of the authors. Seys, D, Wu, A, Van Gerven, E, Vleugels, A et al (2012). Health Care Professionals as Second Victims after Adverse Events: A Systematic Review, Evaluation & The Health Professions. Pre-print available from Professor White, Assistant Director, Executive Medical Directorate by kind permission of the authors. Wojcieszak, D, Saxton, JW & Finkelstein, MM. (2010). Sorry Works. Disclosure, Apology and Relationships Prevent Medical Malpractice Claims, Bloomington Indiana: AuthorHouse Publications. The Institute for Healthcare Improvement Knowledge Center has a wide range of further written, audio and visual materials available at: http://www.ihi.org/knowledge/Pages/Tools/LeadershipResponseSentinelEventEffectiveCrisisMgmt.aspx 7 For general reading materials in relation to Quality Improvement, see http://www.amazon.co.uk/registry/wishlist/1NWNOL8WGJF21/ref=cm_wl_rlist_go_o_C-2 If you have resources or materials that you think other colleagues would find useful or helpful then please email [email protected] with details in order that these can be included in a future version of this list of resources. Executive Nurse Directorate, 01 April 2013. 7 Note that registration with IHI required to access this. 59.