Risk Management Steering Group April 2014 Audit Committee

Transcription

1 NHS LANARKSHIRE ADVERSE EVENT / INCIDENT MANAGEMENT POLICY Author: Responsible Lead Executive Director: Endorsing Body: Governance or Assurance Committee Corporate Risk Manager Executive Medical Director Risk Management Steering Group April 2014 Audit Committee Implementation Date: July 2014 Version Number: Version 1 Review Date: Interim Review December 2014 Responsible Person September 2015 Corporate Risk Manager Final Version July 2014 Page 1 of 43

2 CONTENTS i) Consultation and Distribution Record ii) Change Record iii) Frequently Asked Questions & Answers 1. INTRODUCTION 2. AIM, PURPOSE AND OUTCOMES 3. SCOPE 3.1 Who is the Policy Intended to Benefit or Affect 3.2 Who are the Stakeholders 4. PRINCIPLE CONTENT 4.1 Adverse Events / Incidents : Recording & Reporting 4.2 Working Definitions 4.3 Reporting Adverse Incidents 4.4 Recording Adverse Incidents 4.5 Confidentiality 4.6 Grading of Adverse Event / Incident 4.7 Notification of Significant Adverse Events / Incidents to Chief Executive and NHSL Board Members 4.8 Commissioning a Significant Adverse Event Review (SAER) 4.9 Guiding Principles for a Significant Adverse Event Review (SAER) 4.10 Significant Adverse Event Review (SAER) Pathway 4.11 Significant Adverse Event Review (SAER) Roles and Responsibilities 4.12 Undertaking a Significant Adverse Event Review (SAER) 4.13 Significant Adverse Event Review : Report Writing 5. ROLES AND RESPONSIBILITIES 6. RESOURCE IMPLICATIONS Final Version July 2014 Page 2 of 43

3 7. COMMUNICATION PLAN 8. QUALITY IMPROVEMENT MONITORING AND REVIEW 9. EQUALITY AND DIVERSITY IMPACT ASSESSMENT 10. REFERENCES Final Version July 2014 Page 3 of 43

4 Contributing Author / Authors CONSULTATION AND DISTRIBUTION RECORD Carol McGhee, Corporate Risk Manager Consultation Process / Stakeholders: Extended Stakeholders Sharon Steven, Datix Systems Administrator Christine Jack, Operational Service Manager (CHPN) Christine Browning, Business Support Manager PSSD Frances Moore, Operational Services Manager (CHPS) Donna Sweeney, Operational Services Manager (Acute) Olwen McNeil, Business Support Manager E-Health Dina Mclellan, WGH Site Clinical Lead for Governance Morag Holmes, Head of Internal Audit Karen McIntyre, Senior Nurse mental Health/Learning Disabilities Margo Cranmer, Partnership Representation Gillian Corbett, Associate Nurse Director (Acute) Susan Friel, Associate Nurse Director (Acute) Philip McMenemy, Associate medical Director (Primary Care) Craig McKay, Communications Manager Maureen Dobbin, Senior Nurse Linda Findlay, Consultant Psychiatrist / Medical Director for Mental Health / Learning Disabilities Kirsty Cole, Organisational Development Manager Maria Docherty, Associate Nurse Director Mental Health / Learning Disabilities Stewart Campbell, Hairmyres Site Clinical Lead for Governance Colin Cunningham, Consultant, Paediatrics Distribution: RMSG Audit Committee Health & Quality Assurance & Improvement Committee Acute Divisional Management Team CHP North and CHP South Divisional Management Teams Final Version July 2014 Page 4 of 43

5 CHANGE RECORD Date Author Change Version No. May 2014 Carol McGhee Previous Risk Management Guidance : Version 1 Incident Management August 2013, superseded by this Policy aligned to the HIS National Framework for Management of Adverse Events. January 2015 Carol McGhee Subsequent to the Vale of Leven Report and Recommendations (2014), specifically, recommendation 72, an addition has been made to Section Version 1 Final Version July 2014 Page 5 of 43

6 Frequently Asked Questions and Answers QUESTIONS What is an adverse event / incident? What is a significant adverse event (SAE)? What does the Grading /Category of Outcome mean? Where would I find the guidance on adverse event/incident management? When do I record an event / incident and how do I record it? ANSWERS An adverse event is defined as an event that could have caused, or did result in, harm to people or groups of people. Harm is defined as an outcome with a negative effect An event that has contributed to or resulted in permanent harm, for example death, intervention required to sustain life, or ongoing national adverse publicity. Category 1 events contributing to or resulting in permanent harm Category 2 events contributing to or resulting in temporary harm Category 3 events that had the potential to cause harm but -an error did not result -an error did not reach the person -an error reached the person but did not result in harm All guidance for managing adverse events can be found within this Policy. All adverse events / incidents are reported to your first line manager and then recorded on to the electronic Datix system. You do not need a password to do this and the Incident Record Form will help you to record the right information needed. What if there is no harm? When would significant adverse events / incidents (SAE s) be reviewed? And, who decides when a significant adverse event review (SAER) would be carried out? If I was involved in the event / incident, how will I know if a SAER is to be undertaken? If I was involved in an adverse event / incident will I be named in the report that is produced? If I was involved in an adverse event / incident, will I be disciplined? If I was involved in the adverse event / incident, or work in the area where it happened, will I get It is important to still record events / incidents that do not result in any harm, to help understand how often and where the same type of incident is happening to allow management action to prevent harm actually happening. A Significant Adverse Event (SAE) is normally referred to as a Category 1 event and will have had a serious outcome, and must be considered for a Significant Adverse Event Review (SAER). As soon as a SAE happens, this will be communicated to your Divisional Nurse Director and your Divisional Medical Director by SBAR, who will then make the decision. A SAER can be commissioned for any category of incident if the situation is not clear. You should be notified by letter, informing you of the SAER and inviting you to interview to give your views and version of events. No. The only persons named are the Review Team. No person(s) involved in the actual event / incident, including patients and families, will be named. The purpose of a SAER is for learning and improvement. If the SAE review identifies evidence that requires further investigation, this will be undertaken through the existing NHSL HR Policies and Procedures. Yes. You will be invited by letter informing you that the report is complete and you can access it through a nominated manager. The contact name and number will be on the letter you receive. Final Version July 2014 Page 6 of 43

7 feedback on the findings? QUESTIONS What if I feel upset by the adverse event, how will I be supported? Who contacts and supports patients and families? How do lessons learned from a SAER get shared across NHS Lanarkshire? Where can I find learning summaries for NHS Lanarkshire? ANSWERS Firstly let your manager know how you feel. You will be advised by your manager what support is available for you and will help to arrange support. You can also self-refer to Occupational Health. When SAER is commissioned, a designated operational manager is identified as the point of contact for staff, patients and families from the beginning of the review process to the sharing of the report with findings and recommendations. The risk management team review SAER s and bring together general lessons identified across NHSL in a quarterly safety brief. This is discussed at all safety briefing meetings in wards and departments. There are also some local lessons learned briefings, ask your managers. All Lessons Identified Safety Briefs are stored on the Risk Management Web Page : If I am asked to be part of a review team, will I have to have training and what am I expected to do? Where are all the statements and information from a SAER held? Will I know about all adverse events /incidents where I work? Do the management teams know about all the adverse events / incidents that happen? Who else knows about adverse events / incidents that happen in NHS Lanarkshire? As a member of a SAER Team, you will be given direction by the SAER Lead and are expected to attend meetings, review policies/procedures, visit the area where the SAE happened (if required), interview staff, review casenotes, understand critical questioning and participate in identifying the causes and making recommendations for improvement. NHS Lanarkshire has a new system for storing all records generated for every SAER and will be kept secure and managed within the information governance standards. It is good practice for your team leader, supervisor, head of service to routinely share information with you regarding what types of adverse events / incident happen, how often they happen and what is being done to prevent them happening. Yes. Management Teams review the events / incidents you record on Datix. There are many Committees and Groups that review the incidents recorded in Datix eg Clinical Governance Groups Health and Safety Groups Falls Groups Site Risk Management Groups Final Version July 2014 Page 7 of 43

8 1. INTRODUCTION NHS Lanarkshire (NHSL) requires to have in place, an accurate and workable incident reporting and recording system that will support good practice and compliance with legal duties from a range of bodies including Health Improvement Scotland (HIS), and the Health & Safety Executive (HSE). NHSL uses the Datix electronic recording system for recording and grading clinical and non-clinical incidents. This policy will be interdependent on other relevant policies and documentation: Being Open Effective management of Employee conduct Policy and Procedures Information Assurance Risk Management Strategy 2. AIM, PURPOSE AND OUTCOMES NHSL aims to provide a consistent framework, including definitions, for the effective management of adverse events / incidents, that is used across all areas to establish an understanding of what could, or what has gone wrong and to further establish matters of fact regarding incidents with the overall aim of improving quality and not attributing blame. This Policy is based on the principles set out in the Health Improvement Scotland (HIS) : National Framework for Adverse Events Management (September 2013). It sets out the requirement for, and the processes supporting, effective adverse event identification, grading, management actions, escalation, review and learning from adverse events. Furthermore, this Policy sets out the standard format for writing of Significant Adverse Event review (SAER), the available toolkit, roles and responsibilities. 3. SCOPE 3.1 This Policy is relevant for: All staff identifying an adverse event / incident Staff recording an adverse event / incident Patients affected by an adverse event /incident Families and Carers affected by an adverse event /incident Staff affected by, or involved in, an adverse event /incident Nominated Commissioners of SAER s Final Version July 2014 Page 8 of 43

9 Operational Managers in ensuring due process is followed, including oversight of action plans Operational Managers in liaising with patients / families / carers / staff Nominated SAER Leads Nominated SAER Team Members Nominated operational support for SAER s Supporting the NHSL Assurance and Improvement Framework Corporate Governance and Assurance The Benefits of developing and maintaining effective adverse event / incident management: Benefits to the Individual Minimising the risk of harm to any patient/staff member/member of the public using or receiving care within NHSL. Evidence of your responsibility as an employee of NHSL to record adverse events / incidents and highlight risks. Ability to record an event / incident that is causing you concern or has resulted in harm. Benefits to the Department Promote safe working environment for employees and patients. To monitor, look at trends, hot spots and common themes. Adverse event / Incident recording will help identify risks specific to individual departments and wards that will then allow prioritisation of activities. Encourage multidisciplinary and multi department working and decisionmaking. Emerging issues empowers actions and change. Benefits to Management and the Organisation Identify and monitor trends Demonstrate compliance with the National Risk Management Standards and Framework Compliance with Corporate Governance Maintain Overview of NHSL Risk Profile Inform/identify training needs 3.2 NHSL has consulted with the stakeholders listed in Section i), a range of professional and managerial staff who have a specific role in ensuring the Policy and supporting procedures is the right approach for NHSL and applied as necessary. Final Version July 2014 Page 9 of 43

10 4. PRINCIPAL CONTENT 4.1 Adverse Events / Incidents : Reporting and Recording Why record and manage incidents? To avoid incidents happening again. To put in place controls to stop the incident recurring. To make sure that incidents are investigated and any lessons learned are shared across NHSL. To identify potential areas of risk by benchmarking, trend analysis and using other statistical analysis. To improve quality. Why record near misses? For early alert of potential incidents 4.2 Working Definitions (as defined by Health Improvement Scotland, September 2013) An adverse event / incident is defined as an event / incident that could have caused, or did result in, harm to people or groups of people Harm is defined as an outcome with a negative effect. Harm to a person or groups of people may result from worsening of a medical condition, the inherent risk of an investigation of treatment, system failure, provider performance issues, service disruption, financial loss or adverse publicity All harm is not avoidable, for example the worsening of a medical condition or the inherent risk of treatment. However, it is often not possible to determine if the harm caused was avoidable until a review is carried out People are defined as: Service users Patients Members of staff Carers Family members, and Visitors Groups of people include any functional grouping of individuals such as an organisation. In this way, adverse events/incidents that result in, for example reputational harm or financial harm are included within the scope of the national approach. Final Version July 2014 Page 10 of 43

11 4.2.6 Never Event: These are very serious, largely preventable patient safety incidents that should not occur if the relevant preventative measures have been put in place. The DoH have set-out a list of never events as adopted by NHS Lanarkshire. 4.3 REPORTING Adverse Events / Incidents and Near Miss Any member of staff observing or discovering an adverse event/incident or near miss must inform their line manager and consider if any other department or service requires an early alert e.g. PSSD, fire advisors, medical physics, pharmacy and ensure that the adverse event / incident is recorded on Datix within 24 hours. Any non NHS employees e.g. contractors or agency staff must inform their designated supervisor of any adverse event / incident as soon as possible, this person will then record an incident on their behalf. If any member of the public or visitor has an adverse event / incident and informs a staff member, the staff member will take the details and if necessary report and record the incident on their behalf. The staff member will take any remedial safety action. Staff will ensure that they speak up when they see practice that endangers patient safety and/or which causes upset and alarm in the workplace, in line with the NHS whistleblowing policy Staff will ensure that they take responsibility for protecting and improving their own health, safety and social wellbeing and for reporting any health and safety issues in line with NHS Board policies (Reference : STAFF GOVERNANCE STANDARD, 2012) Final Version July 2014 Page 11 of 43

12 4.4 RECORDING ADVERSE EVENTS/INCIDENTS AND NEAR MISS Recording of an adverse event / incident should be as close to the time of the incident occurring as possible. If this is not practical then it must be recorded no more than 24 hours after the incident. The outcome of many adverse events / incidents can be identified immediately, e.g. broken bone, damaged equipment, fire etc. In some instances however, the outcome may not be apparent for a few days for example; back sprain resulting from manual handling, or a patient who develops an unexpected pressure sore or complication whilst in our care. There may also be harm to NHSL as a result of, e.g. fraudulent activity, loss of confidential information or other incidents which may impact on NHSL s objectives. All adverse events / incidents are recorded and managed electronically through the Datix Incident Recording System In some areas, recording in paper form may occur but only with the agreement of the Risk Management Team. These are subsequently recorded on Datix 4.5 CONFIDENTIALITY Whilst any member of staff can record an adverse event / incident on Datix only authorised staff members can access the details of the Datix record. In line with Information Assurance information contained within adverse event / incident forms will only be disclosed when necessary to aid review of the incident. When reporting to groups or committees all information must be anonymised Legal Consideration Recording of an adverse event/incident does not constitute any admission of liability on any person. Adverse event / incident records may require to be made available in the event of legal proceedings and it is therefore essential that they are completed accurately and factually. Final Version July 2014 Page 12 of 43

13 4.5.2 Informing Patients and Relatives (Being Open) Staff should follow the NHSL guidance in Being Open Communicating Patient Safety Incidents with Patients and their Carers 4.6 GRADING OF AN ADVERSE EVENT / INCIDENT (as defined by Health Improvement Scotland September 2013) Grading of the adverse event / incident is mandatory in NHSL and facilitated through Datix. The grading outcome will be expressed as either Category 1, Category 2 or Category 3 adverse event / incident. Category 1 Category 2 Category 3 Extreme Major Moderate Minor No Harm Category 1 Events that may have contributed to or resulted in permanent harm, for example death, intervention required to sustain life, severe financial loss ( >1m), ongoing national adverse publicity (likely to have been graded as major or extreme impact on NHS Scotland risk assessment matrix) Category 2 Events that may have contributed to or resulted in temporary harm, for example initial or prolonged treatment, intervention or monitoring required, temporary loss of service, significant financial loss, adverse local publicity (likely to have been graded as minor or moderate impact on NHS Scotland risk assessment matrix. Category 3 Events that had the potential to cause harm but 1) an error did not result, ii) an error did not reach the person iii) an error reached the person but did not result in harm (near misses) (likely to have been graded as negligible impact on NHS Scotland risk assessment matrix). These results can occur either by time intervention or due to good fortune. Final Version July 2014 Page 13 of 43

14 Stage 1 Risk Assessment & Prevention risk assessment should identify the hazards present in the healthcare system by evaluating the likelihood of potential harm from the hazard occurring, and evaluating the potential severity of that harm. Mitigating Actions should be in place, that are proportionate to the risk to prevent it occurring. Stage 2 Identification and Immediate Action Following an Adverse Event Event / Incident /Near Miss Occurs Immediate Management of Event / Incident Incident/Near Miss Make person/area safe and attend to any medical requirements Implement any immediate operational actions to reduce risk of recurrence eg removal of trip hazard or faulty equipment. Stage 3 Initial Reporting and Notification Report to Line Manager Record and Categorise the Severity of the event / incident on Datix Using the grading field Stage 4 Analysis and Categorisation Category 1 Category 2 Category 3 Immediately inform site Senior Nurse/ Service Manager / Head of Function. An SBAR must be forwarded to the Divisional Medical Director / Divisional Nurse Director through the accounts: Acute.SBAR@lanarkshire.scot.nhs.uk for Acute incidents only SignificantIncident.JointCHP@lanarkshire.scot. nhs.uk for CHPN and CHPS incidents only Validation of the categorisation with the decision taken on the commissioning of a SAER. Escalate to Divisional Directors and Board Close the Datix record within 90 days, ensuring all documentation is attached to the Datix Record Level 1 Report Significant Adverse Event Review (SAER) Individual within the ward / department may consider taking advice from the specialist or support services outside the area. Ensure actions to minimise the risk of it happening again are in place. Discuss with senior management if any further actions are required and feedback through team meetings. Close the Datix record within 30 days ensuring all documentation is attached to the Datix record. Level 2 Report Local management review in consultation with Associate Medical Director / Nurse Director or General Manager Any learning points / improvement measures are communicated and monitored at ward / department meetings Close the Datix record at the time of verification or within 10 days ensuring all documentation is attached to the Datix record. Level 3 Report Further enquiries / questions. Trends should be considered for further review. Stage 5 - Review SAER Commissioned Undertake review keeping patient, their family and staff members informed Stage 6 Improvement, Planning & Monitoring Develop Action Plan Submit review report and action plan via the appropriate governance mechanism Governance mechanism quality assurance and closure of review Share learning and implement key learning points Review implementation of actions Implement Action Plan Final Version July 2014 Page 14 of 43

15 Click here for SBAR (Situation Background Assessment/Action Recommendation) definition as seen in Appendix 1 CG&RM Group: Review report & draft action plan Discuss event / lessons learned Direct the sharing of learning Review draft action plan and nominate responsible persons where wider actions are required Send action plan to designated general management lead to oversee Call for assurance report from overseeing manager Category 1 Incident Occurs The completed SBAR on the outcome of the decision making must be attached to the Datix Record. Commissioner returns the SAE Report to the Lead with the proposed amendments. The SAER Lead amends and returns to the Commissioner within 5 working days. Final Version July 2014 Page 15 of 43

16 4.7 NOTIFICATION OF SIGNIFICANT ADVERSE EVENTS / INCIDENT TO CHIEF EXECUTIVE AND NHSL BOARD MEMBERS The purpose of this notification process is to ensure Executive and Non-Executive Board Members are informed of significant adverse events/incidents in a timely manner and can respond appropriately. This builds on existing mechanisms for dealing with adverse events/incidents and concerns currently in place: Handling and Responding to Concerns and Complaints Guidance for Staff Notification to the Chief Executive will normally be by the Operating Divisional Directors, but can be through the Commissioners of Significant Adverse Event Reviews (SAER s) who are: Clinical Adverse Events/Incidents : the Divisional Medical and/or Nursing Directors Non-Clinical Adverse Events/Incidents : General Managers Adverse Events/Incidents that must be notified to the Chief Executive are: Adverse Events / Incidents recorded and graded as Category 1 Never Events Exceptional Adverse Events/Incidents The Chief Executive will assess the adverse event / incident and notify the Chair of the NHSL Board. The Notification Process is outlined in the following algorithm: Final Version July 2014 Page 16 of 43

17 Significant Adverse Events / Incidents to be Notified to the Chief Executive & Board Category 1 Event / Incident Occurs or Never Event Occurs or Exceptional Adverse Event / Incident Occurs Immediately inform site Senior Nurse / Service Manager / Head of Function. An SBAR should be forwarded to Divisional Director / Nurse Director / Site General Manager / Unit General Manager / Head of Department. Validation of the grading with the decision taken on the commissioning of a SAER. Divisional Director notifies the appropriate Executive Director : Medical Director / Nursing Director for clinical adverse events/incidents or Director of Finance for non-clinical adverse events/incidents. On Call Director for out of hours. Notification to the Chief Executive Chief Executive notifies the Chair of the Board and agrees notification to other Board members within 24 hours Medical/Nursing Director informs the Healthcare Quality Assurance & Improvement Committee members for clinical events /incidents within 2-3 working days Director of Finance informs the Audit Committee members for nonclinical events / incidents within 2-3 working days Director of Finance or Medical/Nursing Director provide an update on the Significant Adverse Event or incident under part 2 of the agenda of the next Board Meeting and ensure a SAER executive summary is provided to Board Members. Ensure the completed action plan is provided to the Healthcare Quality Assurance and Improvement Committee / Audit Committee to provide the assurance that any actions or recommendations have been implemented. Final Version July 2014 Page 17 of 43

18 4.8 Commissioning a Significant Adverse Event Review (SAER) The purpose and aim of undertaking a SAER, is to: identify system failures that may have contributed to the incident. determine if there are any learning points for the area where the incident occurred, the staff involved and the service take the opportunity to make improvements minimise the risk of recurrence A SAER will normally be undertaken when unexpected events related to care and treatment result in death, significant harm; or required intervention to save life. The NHSL commissioning criteria for a SAER can also be referred to in appendix 2 SAERs will be commissioned by the designated SAER commissioners as follows: For Clinical adverse events / incidents: Divisional Medical and Nursing Directors For Non Clinical adverse events / incidents: General Managers / Directors of Hospital Sites 4.9 Guiding Principles for a Significant Adverse Event Review (SAER) SAER s are conducted to a high level of detail and must follow the format set out in the NHSL SAER template The SAER Guiding Principles: Includes use of a range of Root Cause Analysis (RCA) Techniques to understand why failures occurred and how they can be managed to minimise recurrence. Undertaken by a multi-disciplinary team not directly involved in the incident. Consideration should be given to appointing an external team. Involve experts / specialists dependent on the nature of the adverse event / incident Led by person(s) experienced and/or trained in RCA Includes discussion with patient / relative / carer May require management of the media via the Communications Department Includes plans for shared learning : locally, organisational and / or nationally as appropriate It is recognised that not all adverse events / incidents reviewed will identify system failures and could identify areas of good practice. Learning points from both system failures and good practice should be noted during the review and shared appropriately. Final Version July 2014 Page 18 of 43

19 4.10 SAER PATHWAY Significant Adverse Event/Incident is categorised as 1. Category 1 2. Never event Within 1 working Day D O C U M E SBAR is completed and sent to designated SAER Commissioner Commission SAER? (refer to commissioning criteria) N T A YES Notify Operational Manager NO T I Within 3 working days O N M A N A SAER Commissioner / Operational Manager agree and select SAER Team Lead and Team Members SAER Commissioner and SAER Team Lead will agree terms of reference / scope SAER Commissioner communicates decision to management and governance committee and ensures the decision is recorded in the Datix Notepad. Local manager considers the need for an alternative understanding of the event/incident e.g. peer review/case note review G Within 80 working days E M E N T Review team undertake SAER and complete report. SAER Team Lead forwards draft report to SAER Commissioner / Operational Manager Operational Manager: Shares the report with the management team Ensures the action plan is completed Communicates with staff and family Within 90 days SAER Commissioner signs off final report and ensures appropriate dissemination. Datix record closed and report retained in the documentation library system. Final Version July 2014 Page 19 of 43

20 4.11 SAER ROLES AND RESPONSIBILITIES Role and Responsibilities of the SAER Commissioner(s) The Commissioner has a vital role to play on behalf of NHS Lanarkshire in ensuring that: A SAER is commissioned for all significant adverse events / incidents meeting the agreed criteria. Consideration is given to all other escalated adverse events / incidents to determine if a SAER is required or not. All decisions should be recorded in the Datix record. Relevant managers are informed of decision to proceed to SAER. A SAER Team and Team Lead are established giving consideration to appropriate membership and liaising with departmental managers. The SAER Team Lead is aware of their responsibilities and timescales. Terms of Reference / scope for the review are agreed. Any concerns found during the SAER process are highlighted and appropriate action taken. The draft report is received within 80 working days with assurance that the appropriate management teams have agreed that the actions are achievable. Returns comments on comments on the draft to the SAER Lead. The final SAER is received by the Commissioner for sign-off within 85 working days. Ensure the original SBAR, final report and action plan are attached to the incident record in Datix and the incident is closed as the final report is attached. Dissemination of SAER Executive Summary and Action Plan through appropriate governance and operational structures. Ensures nominated operational support received intimation when SAER is As recommended in the Vale of Leven Report (2014), internal investigations for commissioned to set up document control and management. significant and exceptional events (including serious outbreaks of infection) should have a degree of impartiality. This can be achieved internally by inviting representation from the Board Internal Audit Department, and / or a Non-Executive Director of the Board and this level of representation must be considered when identifying the investigation team relevant to the incident / event Responsibilities of the SAER Team Lead The nominated SAER Team Lead will be key to ensuring due process is followed during the review, ensuring that there is a nominated site or service contact for patients and families affected and will: Receive the Datix Incident Record, SBAR and any other relevant documents. Lead and guide the Team Members Commence documentation management with the nominated operational support. Ensure the checklist for the patients family / staff involved is complete (see appendix 8) Ensure due process for each stage of the investigation by: Final Version July 2014 Page 20 of 43

21 o Arranging team meetings o Agreeing the Terms Of Reference / scope of review with the commissioner o Assigning work to be undertaken by team members o Overseeing completion of the SAER report Inform the Commissioner of any findings / concerns requiring immediate action at any time during the review Manage relevant documentation (retaining/filing) o Meeting Agendas / Notes o Minutes o Initial Checklist o SBAR o Statements o Interview Records o Completed RCA records o Photographs taken as part of the investigation o Details of any equipment involved, including serial numbers and location o Final SAER report o Policies, Protocols relevant to case Provide the draft report to the Commissioner within 80 days. Ensure that any recommendations and actions contained within the report are achievable within the timescale Responsibilities of the Designated Operational Manager The manager will: Receive notification of the commissioning of a SAER or not. Nominate a senior manager to be the contact for patients and staff from time of incident to completion of the SAER process. Information for Patients and Their Carers Agree the SAER Team Lead and Team Members with the SAER Commissioner (should ideally be outwith the area where the incident occurred) Receive any concerns found during the SAER process and ensure actions are taken. Receive the SAER and receive assurance that the actions are achievable. Dissemination of SAER Executive Summary and Action Plan through appropriate governance and operational structures. Ensure the action plan is completed. Ensure staff undertaking the SAER are offered de-briefing/clinical supervision/occupational Health referral / emotional support. Final Version July 2014 Page 21 of 43

22 4.12 Undertaking a Significant Adverse Event Review (SAER) The Review Process The review process should be undertaken timeously within the following guiding principles: Have an agenda and take notes Organise at least 4 meetings in advance for the team to meet Commit to the meetings, fully participate and complete actions Use the available toolkit Be objective and focused Work within the information assurance principles Generate Questions, Answers and Solutions Write-up the report following each meeting Co-ordinate staff interviews and discuss with Partnership Retain all information in one file Liaise with the nominated patient/family contact and receive questions posed by patients and families to review and ensure you know who this is early on in the process Refer to the risk management guidance Use the standardised report format Final Sign-off will be by the Commissioner of the SAER Information Gathering All material facts relating to the adverse event/incident must be gathered as soon as possible after the event. In determining what information to collect, you must consider the facts leading up to, as well as the incident itself. Consideration should be given to: The people involved or witnessing the adverse event/incident : statements, interviewing staff The place or the environment where the adverse event/incident occurred : visiting area, reviewing plans of the area, sketch of the area or taking photographs The equipment or objects involved : equipment involved should be removed and preserved as evidence The paperwork related to the adverse event/incident : case notes, statements, guidelines, policies, procedures, incident report, maintenance records, manufacturer s instructions, training records, external reports, risk assessments photographs Final Version July 2014 Page 22 of 43

23 Normal working processes, team relationships and adequacy of leadership in the workplace : eliciting custom and practice in the workplace Mapping the Information Mapping out the events will aid the team in understanding the chronology of events and identify issues. When mapping the incident information try to: Avoid moving into analysis Use one of the NHSL tools e.g. tabular timeline, time - person grid Use the notes and statements provided Identify any unconfirmed information requiring verification Exploration of the Contributory Factors linking cause and effect is key to supporting the full process and will generate some critical questions. The Contributory Factors Framework should be applied Analysis of Information The team will reflect on the information collected and will continue to ask Why? for each primary cause identified and the response to each answer until there are no more causes forthcoming. This will inform the findings to be recorded in the report Identifying Problems Throughout the undertaking of the information gathering, the mapping and analysis of information, the problems will be continuously emerging and should be noted throughout and inform the findings of the review. Equally important, areas of good practice will emerge and should be noted Generating Solutions Solutions should be identified when there is agreement about the contributory factors and causes of the adverse event/incident. Solutions will be converted into recommendations within the report and must be considered with a level of reasonableness as what is achievable Learning Lessons Without accurately identifying the cause(s) of adverse events/ incidents, NHSL will be unable to identify systems weaknesses and there will be unable to facilitate change. Learning lessons is vital to minimise recurrence and must be shared across the relevant sectors within NHSL and may be required to be shared nationally. Final Version July 2014 Page 23 of 43

24 Root Cause Analysis For the purpose of this guidance, Root Cause Analysis (RCA) is referred to as the application of a range of critical questioning techniques to understand any harmful factors that may be deep and underlying within the Organisation, resulting in undesirable outcome. In understanding how deep the harmful factors may be, there is the risk of not knowing when to stop asking the questions and this should be at the level where the most basic cause (or causes) that can reasonably be identified, that management has control to fix and, when fixed, will prevent a recurrence. In identifying the root cause(s), there should be the ability to find a solution, and the solution must contribute to prevention of recurrence, embedding knowledge and embracing the principles of being a learning organisation engaged in continuous improvement Application of Root Cause Analysis Tools & Techniques There are a number of different root cause analysis tools and to maintain clarity, these can be grouped according to their purpose for each stage of the SAER. RCA TOOL Narrative Chronology Timeline GATHERING & MAPPING INFORMATION ANALYSIS OF INFORMATION IDENTIFYING PROBLEMS GENERATING SOLUTIONS Time Person Grid Tabular Timeline Site Visits Interviewing Brainwriting Nominal Group Technique Five Why s Fishbone Diagram Contributory Factors Framework Final Version July 2014 Page 24 of 43

25 All RCA templates referred to above can also be accessed on the risk management webpage in the Toolkit Section Report Writing The purpose of this guidance is to: Provide help and support to the nominated SAER Team Lead and Team Members in compiling the SAER report. Provide direction on the critical elements that should be included within the final report. Ensure the report will be easily read for all who require a copy and/or access to the report (patient, family members, staff members, external partners) The Style and the Presentation of the completed report should be consistently applied with the minimum: NHS Lanarkshire Logo L Date of the Adverse Event /Incident Name and Job Title of the Commissioner Datix Incident Reference Number Name and Job Title of the Author(s) of the Report Date of Completed Report Page numbers Numbered paragraphs for ease of referencing Font size 12 in Garamond (as per NHSL guidelines) Guiding Principles for SAER Report Writing should be followed to ensure it presents the patient(s), families or staff involved as individuals without being overly personal or comprising confidentiality: Reports should be written in the third person e.g. refer to the patient, the doctor, the nurse, the organisation, the team rather than I, We or You. The author of the report should not assume that the reader will understand normal care delivery processes and / or hospital, health centre, community team protocols and operational working. Ideally, names of staff should not appear in the report. Reference can be made to Nurse in Charge, Dr Y, Ms X ( a record of the actual names against the coding used should be retained). Final Version July 2014 Page 25 of 43

26 When referring to the patient involved in the adverse event/ incident, the patient should be used at all times and avoid the use of gender specific terms eg her, she, his, he. When referring to family relationships gender specific terms such as mother, father, brother, sister etc should be avoided using alternative terms such as parent, sibling extended family member. The report should be evidence based and the team members are required to analyse the facts, however, speculations should be avoided. The use of terms such as from the evidence it is concluded that.. or from the available information it has been observed that. should be used as the preferred option. Working documents such as statements, timelines, analytical work used in the review should be managed confidentially and files and stored safely. This is overseen by the SAER Team Lead Format of the SAER Report The format of the completed report should be in 3 parts and with copyright permission, is based on work undertaken by the National Patient Safety Agency (NPSA): 1. Executive Summary 2. Main Report 3. Action Plan Executive Summary The executive summary is the short version of the full report and sets out to inform the reader of the key points of the background information, concise analysis and main conclusions and recommendations. It is the interaction between the writer of the report and the target audience and therefore, it should be: Written in the same order as the main report and only include material present in the main report Able to be read separately from the main report Used for sharing at management team meetings Contain short and concise paragraphs The Executive Summary will feature at the front of the report, followed by the Main Section of the Report and should be able to be copied separately for sharing. This will be subject to the same level of redaction as required. Final Version July 2014 Page 26 of 43

27 The SAER Report Format SECTION & REPORT HEADING Executive Summary Main Report 1 Adverse Event/Incident Description and Its Consequence 2 Pre-Review Risk Assessment 3 Background and Context of the Adverse Event/Incident 4 The Review Team 5 The Scope of the Review 6 The Review Type, Process and Methods Used 7 Involvement and Support of the Patient and / or Families 8 Involvement and Support of Staff involved in the Adverse Event / Incident 9 Chronology of Events Leading up to the Adverse Event / Incident 10 Contributory Factors 11 Lessons Learned 12 Recommendations 13 Shared Learning 14 Distribution List 15 Action Plans - SAER Section 1 Adverse Event/Incident Description and Its Consequence This section should provide a clear, concise description of the adverse event/incident and its effects: Adverse Event/Incident date Detection of the adverse event/incident Adverse Event/Incident type Area where the adverse event/incident occurred Actual effect of the adverse event/incident on the patient, staff member, service or others. The severity described should only be those relevant to the adverse event/ incident. Consideration should be given to physical harm, psychological harm, or reputational harm. Avoid, where possible, emotional and judgemental or value laden words to describe events. Final Version July 2014 Page 27 of 43

28 SAER Section 2 Pre-Review Risk Assessment Referring to the grading of the adverse event/incident, the review team should ensure the grading of the adverse event/incident is accurate as Category 1. Immediate, intermediate and long-term recommendations and actions should reflect the assessed level of recurrence. SAER Section 3 Background and Context of the Adverse Event/Incident A brief description should be given of the nature and size of the service and the environment where the adverse event/incident occurred. This should include whether it is a 24 hour service, community service, out-of-hours service, hospital based service, inpatient or out-patient and the constitution of the team providing the service. SAER Section 4 The Review Team SAER s are normally commissioned and undertaken when an adverse event/incident results in serious consequence, and, as such, the review team will require a high degree of leadership, experience, and seniority. Within this section, the core review team members should be identified with their names, job titles and whether they were the chair, team member, specialist advisor or admin support. SAER Section 5 Terms of Reference/Scope of the Review This section should explain how far back the review will cover. Ideally, this should be centred on the most current episode of care/intervention; however, dependent on the adverse event/ incident, more background information may be reviewed. An explanation as to which relevant services or other agencies have or have not been included in the review and why, should be referenced. SAER Section 6 The Review Type, Process and Methods Used Describe the analytical tools used with the process and methods used e.g. : Root Cause Analysis, interviewing of staff involved, interviewing of specialists, collating statements, using other agency reviews e.g. Health & Safety Reports, case note review, review of relevant policies and protocols, visit to area where the adverse event/incident occurred, literature search. SAER Section 7 Involvement and Support of the Patient and/or Families Affected by the Adverse Event/Incident This section should demonstrate the extent to which those affected have: Been given an accurate, open timely and clear explanation of what has happened, regardless of, but with sensitivity to, the distressing nature of the incident Received an apology in the form of a sincere expression of sorrow or regret for the harm that has resulted from the event/incident Final Version July 2014 Page 28 of 43

29 Been informed of the plans regarding what can be done medically to repair or redress the harm done Been given a clear explanation of the SAER process and the expected report The opportunity to outline their own questions to be taken into consideration by the review team SAER Section 8 Involvement and Support of the Staff Involved in the Adverse Event/Incident In the case of a serious patient outcome, outline what support was given or offered to staff after the adverse event/incident and during the review. This may involve advising staff of the Occupational Health Services and the support from Partnership. Within the report, the team should acknowledge the staff participation, co-operation and openness during the review. Names of staff should not feature in the SAER report and staff should be advised that the report will be made anonymous as far as is possible and for particular use, will be subject to redaction. SAER Section 9 Chronology of Events Leading up to the Adverse Event/Incident The chronology of events leading up to the adverse event/ incident will generally be related to the current episode of care / intervention and will be set-out to give the reader a clear understanding of the events leading up to the event/incident. SAER Section 10 Contributory Factors For all adverse events / incidents the contributory factors framework must be considered SAER Section 11 Lessons Learned Lessons learned will be collated from the log commenced by the SAER Team Lead at the beginning of the review and should be addressed by the recommendations. SAER Section 12 Recommendations The recommendations should reflect the findings from the analysis of the contributory factors and any other analytical tools used, along with the lessons learned. Outline how the recommendations were arrived at, who was involved and what solution management tools (if any) were used. SAER Section 13 Shared Learning Record in this section the degree to which sharing is required and the reassurance that where consent to publish information from patients records was necessary to the report, that it has been obtained. Final Version July 2014 Page 29 of 43

30 SAER Section 14 Distribution List Within NHS Lanarkshire Outline where the report will be distributed, ideally this should only be the Executive Summary and Action Plans that will be utilised for learning lessons and will be anonymised through redaction where necessary. Consideration must be given to management teams, local teams and distribution through the clinical governance structure. For sharing with Patient(s), Families, Staff and Statutory External Partners see Section 6 - Sharing a SAER Report. SAER Section 15 Action Plans An action plan must be attached to the report and will be owned by the named responsible Operational Manager on the Action Plan. The Action Plan will set out how each recommendation will be implemented with named leads responsible for each action with reasonable timescales, depending on the action and impact. The Action Plan should be attached to the Executive Summary for internal circulation following approval of recommendations SHARING OUTCOMES FROM SAER s Effective management of SAER s includes the necessary sharing of completed reports with staff involved and across the relevant areas that recommendations will impact on. Essentially, persons affected, and/or families and/or carers, will require feedback and may request a copy of the SAER. Additionally, and when necessary, external partners will require a copy of the SAER. The attached appendices must be used when sharing information as below: Signed Off SAER Report Patient / Person Affected Staff Members involved (directly or indirectly) Family of Deceased Patients External Statutory Partners Letter the patient or person affected by the event/incident using the template in Appendix 3 and attaching an unredacted, watermarked copy of the SAER Report with evaluation request Letter the staff member using the template in Appendix 5 making available an unredacted copy with evaluation request Letter the NOK (and the agreed family contacts no more than 3 contacts) using the template in Appendix 4 and attaching a redacted, watermarked copy of the SAER Report Letter the external partner using the template in Appendix 6 attaching the appropriate level of watermarked report (either unredacted or redacted) Final Version July 2014 Page 30 of 43