Adverse Events Management Operational Procedure

Transcription

1 Adverse Events Management Operational Procedure Unique ID: Author (s): SG/JB Category/Level/Type: Procedure Version: 1.6 Status: Approved Verified / Approved by: Board Date of Verification: Review Date: April 2015 Date added to Intranet: 30/03/15 Key Words: Adverse Event Management Procedure Comments: Page 1 of 51

2 CONTENTS 1. Introduction Support and Training Managing an Adverse Event Stage 1 Immediate actions following and adverse event Stage 2 - Initial reporting and notification How to report What to report Good Practice Principles: Stage 3 Analysis and rating the severity of harm Stage 4 Adverse Event Review Purpose of an Adverse Event Review Level of review Review Protocol Fair treatment of staff who are involved in Significant Adverse Events Confidentiality Submissions and sign off of adverse events reports Feedback of findings and learning Making improvements Stage 5 Improvement planning and monitoring The use of Quantitative and Qualitative Information Responsibilities Page 2 of 51

3 4. Media Enquiries Key Performance Indicators Review of Procedure Page 3 of 51

4 APPENDICES 1a. Operational Procedure for Communication and Escalation of Significant Adverse Events 1b. Operational Procedure for the Review of Significant Adverse Events 1c. Definition of Significant Adverse Events (use in conjunction with Appendix 1a) 2. RIDDOR Guidance 3. Reporting Bodies 4. Adverse Event Review Templates a. Review Template b. Improvement Plan Summary Document c. Governance Approval Process for SAEs 5. Adverse Event Review Protocol 6. Support for Staff Following a Significant Adverse Event 6a. Support for Staff Following a Significant Adverse Event - Action to be taken by Managers 6b. Support for Staff Following a Significant Adverse Event Page 4 of 51

5 1. Introduction This document is complementary to, and should be read in conjunction with, the NHS Lothian Adverse Events Management Policy. The operational procedure is designed to ensure consistency of approach in the management of adverse events. This will provide the data required to identify weaknesses in systems so that they can be addressed. DATIX is the electronic risk management information system used by NHS Lothian to record information relating to adverse events, complaints, claims and risk registers. DATIX should be used throughout all stages of the management of adverse events to record all information, communications, outcomes and associated actions, so that an audit trail is evident. 2. Support and Training 2.1. NHS Lothian must ensure that managerial staff are provided with appropriate training in the conduct of reviews. The Health and Safety Department provide basic Adverse Event Review training for managers as one of the tools used to help prevent/minimise recurrence and supports the training provided by the Clinical Governance & Risk Management Support Team. Health and Safety advisors will also assist managers in the review of adverse events when requested. All staff are required to undertake training sessions on the content, implementation and management of this policy, procedures and local protocol. This will be covered at induction and through local orientation. Further training will be provided, with any amendments to policy or documentation as necessary and at appropriate times. The Clinical Governance & Risk Management Support Team provides training in adverse event review. This is available to all managers, partnership representatives and any member of staff who may be required to undertake reviews. All staff with management responsibility should attend as part of their training in health and safety and risk management. 3. Managing an Adverse Event Managers, in line with operational management structures, have responsibility for the appropriate management of adverse events and consequences to ensure service improvement. Overall operational management responsibility, including family liaison, therefore rests with the Nurse/Medical Directors for UHS and CH(C)P General Managers for Primary Care. The flowchart and explanatory paragraphs in 3.2 onwards illustrate the generic process and actions to be taken to ensure effect management of an adverse event. There are also a number of additional actions and/or reporting requirements for specific types of adverse events. In some cases, these are statutory reporting requirements to external bodies, including the Health and Safety Executive (HSE), Police, the Mental Welfare Commission, and Scottish Healthcare Supplies. A list of the most relevant bodies and their roles is provided in Appendix 3. Advice on reporting requirements can be sought from the Health and Safety Advisors or the Clinical Governance & Risk Management Support Team. Page 5 of 51

6 Figure 1: Flow chart of actions to be taken to effectively manage adverse events 1. Immediate actions following an adverse event Adverse event occurs Make person/area safe and attend to any medical requirements Implement any immediate operational actions to reduce risk of recurrence e.g. removal of trip hazard or faulty equipment Report on DATIX Continuous improvement through learning and changing practice 2. Initial reporting and notification 3. Analysis and severity rating 4. Review 5. Improvement planning and monitoring Develop improvement plan Rate severity of harm caused by adverse event Establish appropriate level of review Submit review report and improvement plan via the appropriate governance mechanism Share learning and implement key learning points Review severity rating with relevant manager Undertake review keeping patient, their family and staff members informed Governance mechanism, quality assurance and closure of review Implement improvement plan Review of implementation of actions Page 6 of 51

7 3.1. Stage 1 Immediate actions following and adverse event The first priority following any adverse event is to ensure that the needs of individuals affected are attended to. When an individual member of staff becomes aware of an adverse event, they must act immediately to ensure that: they do not put themselves in situations of danger any urgent clinical care that may reduce the harmful impact of the event is given immediate If there are steps that can be taken immediately to reduce the risk of recurrence, then these should be implemented a safe environment is re-established as soon as possible the appropriate line manager/supervisor/person in charge is contacted (for guidance in relation to Management, Communication and Escalation of Significant Adverse Events see Appendices 1a,b & c) the patient, relatives and carers, where appropriate, are informed by the responsible person, their needs met, and support provided (see section 8.1 of the NHS Lothian Adverse Event Management Policy) colleagues are informed and support secured from other professionals any faulty medicine or equipment is removed and labeled so as to prevent future use a timely and objective entry is made in the patient s clinical records. Once aware of the event, the relevant manager is responsible for ensuring that all appropriate actions outlined above have been taken and to ensure that staff/volunteers are supported. See section 8.2 in the NHS Lothian Adverse Event Policy Page 7 of 51

8 3.2. Stage 2 - Initial reporting and notification How to report All adverse events (including near misses) must be reported on DATIX using the electronic Adverse Event Reporting Form as soon as possible and ideally within 24 hours of occurrence. DATIX can be accessed from the home page of the intranet by selecting from the applications menu. Guidance for completing the adverse event form is available on the Intranet. If the electronic Adverse Event Reporting Form is unavailable DUE TO SYSTEMS FAILURE, a paper record of the adverse event should be made and submitted to the Line Manager, who is responsible for it being submitted electronically as soon as possible. If it is not possible for the person(s) involved to complete a form, it should be completed by the Line Manager with assistance from witnesses where required. If the member of staff has been injured, the supervisor/line manager should complete the Adverse Event Reporting Form. Wherever possible, the adverse event or near miss should be reported in the department where the event has occurred. If this occurs in an external area this should be recorded in the adverse event report and the appropriate manager for that area contacted. Staff working in the community should report an adverse event as soon as possible after returning to their base. Staff working in areas provided by other agencies should report the adverse event to the relevant external facilities manager as well as their line manager. When the form is submitted, an is automatically sent to the appropriate manager(s)/senior clinician(s) based on the location of the event. Additional notifications may be sent depending on the type of adverse event and the severity of harm caused. The line manager must ensure that they identify adverse events reported under the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995 (RIDDOR), which must be reported by managers to the Health and Safety Executive within 15 days of the adverse event taking place. (See appendix 2 for reporting requirements under RIDDOR) What to report Any adverse event/near miss, event or circumstance arising during NHS service provision that could have or did lead to unexpected harm, loss or damage should be reported. Harm may be physical, emotional or psychological, (so includes verbal/emotional abuse and child/vulnerable adult protection issues). If an adverse event is not immediately apparent it should be reported retrospectively (e.g. back pain a few days after a manual-handling manoeuvre). Page 8 of 51

9 The following list provides some examples: Patient care e.g. medication error, wrong diagnosis, healthcare associated infection, wrong patient x-ray Personal accidents to patients or staff e.g. slips or falls, needle stick injury Clinical adverse events/near misses regarding patient care or treatment e.g. medication error, misdiagnosis, infection, x-ray Security adverse event e.g. missing patient, intrusion, theft and fraud Information governance e.g. data loss Violence, abuse, harassment including any adverse event which may be experienced as harassment on the grounds of age, disability, ethnicity or race, gender, religion or belief or sexuality 1 Building/ facilities e.g. waste disposal, fire Good Practice Principles: Complete all relevant information to avoid delays in making improvements Avoid selecting the term other when selecting a category for the adverse event Record only facts, avoid speculation and subjective statements reports can become publically available documents Do not use other people s names in the report. These should be recorded in the people involved section Avoid the use of abbreviations and/or jargon Attach or submit any supplementary information to the Line Manager as required, e.g. photograph additional information sheets Stage 3 Analysis and rating the severity of harm All adverse events must be rated for severity of actual harm. This should be identified and included in the initial report of the adverse event and reviewed by the relevant manager. For adverse events which are recorded as near misses, the potential severity of harm should be recorded to ensure that consideration is given to the appropriate level of review and escalation. Table 1 below sets out how severity of harm should be rated. At this point a check should be made of the decisions to escalate (or pass information to others) and/or review (see communication and escalation of significant adverse events (SAEs) Appendix 1b). 1 It is important to consider at the time of any adverse event whether it could have been motivated by racism, sexism etc and this should be included in the report and reviewed appropriately. Page 9 of 51

10 Table 1: Adverse event Grading Table Identification and decision to review Rating of severity of harm of Adverse Event Death or Major Harm - intervention required to sustain life/ long-term incapacity or disability requiring medical treatment and/or counselling Serious harm to organisation e.g. severe financial loss ( > 1 million), ongoing adverse publicity Category I (HIS)* Moderate Significant injury requiring medical treatment and/or counselling, short-term effects. Agency reportable e.g. police (violent & aggressive acts) Moderate harm to organisation/ temporary loss of service, significant financial loss, adverse publicity. Level of Review Review Team Review Template Comprehensive adverse event analysis and review Requires escalation see Adverse Event Operational Procedure (Appendices 1a & 1b) Local management review in consultation with senior management team*. Full review team senior management team* to agree review lead and scope of review *UHS - Medical/Nursing director (may be delegated to Clinical management team) CH(C)P senior management team Single system services lead director Manager in charge of the department/ area to lead review, drawing on information provided by staff. Complete review template (see procedure Appendix 4) Sign off through Governance approval process (See Procedure Appendix 4). All RIDDOR events must be documented on the review template, regardless of actual severity of harm Complete review template in DATIX. All RIDDOR events must be documented on the review template, regardless of actual severity of harm Improvement Plan Complete improvement plan template (See Procedure Appendix 4) Complete improvement plan template in DATIX. Timescale/Key Performance Indicators Commence formal review within 10 working days (KPI 1). Complete within 3 months (maximum 66 working days)/ (KPI 2) Commence formal local review within 10 working days (KPI 3) and complete within 4-6 weeks (maximum 30 working days) /(KPI 4) Category II (HIS)* Minor Minor injury or illness, first aid treatment possibly required Minor harm to organisation example. Local or short term adverse publicity, minor financial loss (< 10K), short term disruption to service. Category II (HIS)* Further inquiries/questions If trends/clusters identified, considered for further review and escalate as appropriate. Local managers, drawing on information provided by staff. If further review required then local management review process. Complete review summary in DATIX. All RIDDOR events must be documented on the review template, regardless of actual severity of harm Complete lessons learned section in DATIX. Commence formal local review within 10 working days (KPI 3) and complete within 4-6 weeks (maximum 30 working days) /(KPI 4) No harm but potential to cause harm i.e. near miss Category III (HIS) * Further inquiries/questions Trends/clusters considered for further review. Local managers in consultation with staff. If further review required then local management review process. Not applicable. If trends identified, undertake local review and escalate as appropriate. Not applicable unless trends require a review then a plan should be developed to address the outcomes Adverse event approved and closed within 10 working days of being reported. (KPI 5) *HIS refer to categories of adverse events I, II and III determined by severity as noted in above table. Page 10 of 51

11 3.4. Stage 4 Adverse Event Review Purpose of an Adverse Event Review The purpose of the review is to determine what happened, how it happened, why it happened, and whether there are learning points for the service or wider organisation. It should follow the principles of a just culture and take a systemsapproach, meaning that it should not focus on individuals. If the review team considers that there are any issues about the performance of an individual member of staff, this should be referred to the appropriate line manager and should not be part of the review. In summary, the review seeks to: allow learning from adverse events and so make improvement by establishing the facts of the adverse event identifying contributory factors rather than causes, especially weaknesses in systems and processes establishing changes/improvements which may be needed enabling support to be provided for the patients, families and staff involved consider whether there are underlying aspects of the adverse event which might be attributable to discrimination or harassment Level of review This will depend primarily on the severity rating of actual harm or potential harm and is summarised in Table 1 above. In certain circumstances, the Medical Director or an Executive Director may decide also to commission an independent review, which may utilise a review team from outwith the service or outwith NHS Lothian. The Director will appoint the members of the review team and be responsible for ensuring the operational team are kept fully up-to-date. Some judgement is required by relevant line management in deciding the level of review for some near misses. For example, there will be occasions where a near miss with no harm has been reported as having potential to case major harm or death and may therefore require the same level of review as a Significant Adverse Event (SAE). A number of services have local protocols approved by the NHS Healthcare Governance Committee to aid decision-making, which have been agreed through the uniqueness of their client group and service provision. These protocols should be used where they exist. The decision-making process and rationale for deciding on the level of review must be clearly recorded in DATIX. Information relating to the adverse event, communications, outcomes and associated actions and/or improvement plans should be recorded and stored in DATIX so that an audit trail is evident. Page 11 of 51

12 Review Protocol The principles of adverse event review are essentially the same, whether an individual reviewing a minor adverse event or a large team reviewing a significant adverse event. The standard process is set out in the NHS Lothian protocol for reviewing adverse events (appendix 6) and summarised in figure 2 below. The protocol outlines a process of adverse event review and has been developed in the light of experience and research (Reason JT1993) 2 into adverse event review both within and outside healthcare. The protocol focuses on harm to people but is suitable for all reviews where there is harm or potential harm to people or the organisation. The purpose of the protocol is to ensure a consistent, systematic and thoughtful approach to the review of adverse events to promote a greater climate of openness and opportunities to identify system failures and to make service improvements. Use of the protocol should be separate from any disciplinary or other procedures used for dealing with persistent poor performance by individuals. Figure 2 Adverse Event Review and Analysis Process Flowchart Establish level of review (See table 1) Select people for Review Team Organisation and Data Gathering Determine Adverse Event Chronology Identify Care & Service Delivery Problems Identify Contributory Factors Make Recommendations and Develop an Improvement Plan 2 Reason, J.T. The human factor in medical accidents. In Vincent C.A. editor. Medical Accidents. Oxford: Oxford Medical Publications; Page 12 of 51

13 The local management team is responsible for ensuring that the review process is followed and that relevant timescales are met Fair treatment of staff The spirit of the review will be characterised by an open and fair culture. In this context, open and fair culture means that the purpose of the review is to identify causes and/or weaknesses in systems. Staff will not be reprimanded for such failures or their consequences; however, individuals retain responsibility for their own actions or inactions. Registered professional staff have additional responsibilities under their professional codes of practice. Adverse event review does not preclude use of the disciplinary process where there has been an alleged act of misconduct or serious breach of professional practice. Although the review is not in itself a disciplinary process, staff are entitled to request support from their trade union or professional regulating body. Further detail is provided in the Protocol (Appendix 6). In the unlikely event that the review uncovers any criminal or potentially criminal act, then the review must stop and the appropriate criminal review process should be used. If the review uncovers misconduct, including malicious or reckless behaviour which may be construed as gross misconduct or a serious breach of the individual s professional code of conduct, then the disciplinary process will be invoked. The two processes may proceed in parallel, provided the rights of the individual are not compromised Confidentiality Confidentiality in the context of the review means: Notes taken during interviews of staff will remain confidential to the review team. Direct quotes or specific information which is attributable will be shared with the interviewee prior to being included in the report Notes of interviews and statements may be made available to the Police if required or when requested under a court order. This will normally be done with the individual s knowledge and consent although a lack of consent cannot override due legal process The review team s report and recommendations will be provided to any disciplinary review but individual interview notes and statements recorded by the review team will only be released with the permission of the individual. This may result in individuals being interviewed/asked for statements more than once The findings of the Review Team will at all times be dealt with in a manner that respects the confidentiality of individual patients, families and staff. Page 13 of 51

14 Submissions and sign off of adverse events reports All completed reports must be approved by the appropriate manager. All Significant Adverse Events (SAEs) reports should be signed-off as follows in accordance with the SAE Governance and Approval Process. Signed off by CH(C)P Director/general manager or UHS director of operations Approved by CH(C)P Clinical Director and Chief Nurse or UHS Medical and Nurse Directors Final approval by NHS Lothian Medical and Nurse directors Closed on DATIX by Clinical Governance & Risk Manager SAEs must not be closed by the service. This will be done by the Clinical Governance & Risk Manager at the end of the formal governance approval process Feedback of findings and learning Managers at the relevant level must ensure that feedback is given to patients and families where appropriate, and staff, including NHS Lothian volunteers, either individually or collectively Making improvements Managers at the relevant level must ensure that improvements identified as part of the review are completed. This includes escalating outstanding issues to an appropriate channel for further action Stage 5 Improvement planning and monitoring The use of Quantitative and Qualitative Information The use of quantitative and qualitative information on adverse events as well as effective communication of trends and outcomes of adverse events, including near misses, is crucial in order to drive the improvement of current processes, practices and systems, including identification of contributory factors. The review of adverse events is a formal part of the review process to be undertaken by every team and levels of management throughout the organisation. When reports are being produced for wide dissemination, staff should make every attempt to remove patient and staff identification. This would include names, sex, and references to the patient s profession, for example. (See Appendix 4a) The outcomes of adverse event reviews are to: provide information, trends etc to inform action planning identify the need for further attention by multi-disciplinary teams lead to local learning groups, when appropriate lead to the sharing of information which could be useful to others. Page 14 of 51

15 Responsibilities Responsibility for the effective management of adverse events and providing assurance to the NHS Lothian Board that learning is translated into service improvement rests with operational management at all levels and with the Healthcare Governance and Health and Safety Committees. Specific responsibilities are detailed in table 3 below. Page 15 of 51

16 Table 3 Responsibility Services/ Departments Action Review adverse event when reported Escalate lessons learned to UHS/CH(C)P senior management teams where there are implications beyond the local service Implement and monitor improvement plan until completed Encourage regular discussion of adverse events at relevant forums/team meetings to share learning locally. Rationale: Share learning, enhance safety and make service improvements. Quality Improvement Teams UHS /CH(C)P Senior Management teams Review learning from Adverse Events reviews and use to inform improvement programmes. Rationale: Ensure quality improvement plans reflect quality concerns and enhance safety of the service. Have in place systematic processes to: assure effectiveness of implementation of the policy and operational procedure within all relevant services review all adverse events statistics quality assure severity of harm ratings of adverse events to ensure appropriate levels of review review individual SAEs and escalate SAEs to NHS Lothian Executive Directors (see appendix 1b) monitor implementation of associated improvement plans including the effectiveness of any changes implemented following a review and that these are embedded across all relevant areas identify and monitor trends ensure that regular thematic reviews are undertaken to extract learning and support the development of organisational memory and continuous improvement with regard to safety support the need for effective learning and improvement to drive quality, including proactively sharing emerging risks and learning with peers in an open, transparent and timely way have robust processes in place to ensure that learning from adverse events is shared locally and at national level as appropriate and local improvements embedded. Rationale: Share learning, enhance safety and ensure that service improvements are implemented. Page 16 of 51

17 Lead executive and senior operational managers NHS Lothian Medical and Nurse Directors Corporate Management Team NHS Lothian Healthcare Governance Committee Review weekly report of all SAEs resulting in death/major harm. Rationale: Gain assurance that appropriate action is being taken to safeguard patients and staff in a timely manner. Understand the impact on individual patients and staff. Review and sign-off all SAE review reports Rationale: Assurance quality of SAE reviews. Review all adverse events statistics Identifying and monitor trends Ensure that action has been taken. Review quarterly Adverse event statistics Review individual SAEs by exception Monitor trends Seek assurance that action has been taken Review an annual report of compliance with key performance indicators (KPIs). Rationale: Gain assurance that appropriate action has been taken and safety issues are addressed in improvement programmes and implemented. Provide assurance to the Board. NHS Lothian Health and Safety Committee Review quarterly Health and safety related Adverse Event statistics Monitor trends Identify themes and support the development and implementation of associated improvement programmes Seek assurance that action has been Produce an annual report for staff governance committee. Rationale: Gain assurance that appropriate action has been taken and safety issues are addressed in improvement programmes and implemented. Provide assurance to the Board. Clinical Governance & Risk Management Team Produce statistical information for deliberation and improvement planning by the Healthcare Governance Committee Develop and implement improvement plans in response to identified trends, in association with relevant executive leads/operational managers Facilitate adverse event management through development and maintenance of infrastructure, including the DATIX system Provide training and advice on adverse event management, including review. Promote an adverse event reporting culture that is open, honest and focussed on service improvement Undertake independent review of the quality of adverse event reporting and review, including evaluation of staff and patients experience of the process. Rationale: Provide support to operational management and Healthcare Governance Committee for effective management of adverse events and associated service improvement. Page 17 of 51

18 Assure quality of data and adverse event reviews. Health & Safety Advisors Produce statistical information on RIDDOR and staff related adverse events for deliberation and improvement planning by the Health and Safety Committees and local safety groups Develop and implement improvement plans in response to identified trends, in association with relevant executive leads/operational managers Provide training and advice on health and safety related adverse event management, including review Promote an adverse event reporting culture that is open, honest and focussed on service improvement. Rationale: Provide support to operational management and Health and Safety Committee for effective management of adverse events and associated service improvement. Internal Audit Carry out periodic independent audits as part of the internal audit programme Monitor compliance against recommendations. Rationale: Provide assurance of compliance with policy and procedure. Page 18 of 51

19 4. Media Enquiries In all instances, external enquiries regarding any adverse event must be referred to the Director of Communications who, along with the appropriate Executive Director, will agree a response. Communications with the media will only be via the Nurse/Medical Director/CH(C)P General Manager, Director of Communications or another designated senior manager. Managers should expect and prepare for media interest in any serious adverse event within NHS Lothian. Such interest is most likely where a child or a vulnerable adult is involved, wrong treatment is given, or where groups of people are put at risk as a result of service failures, e.g. in a diagnostic reporting process or where there has been an outbreak of food poisoning. Therefore, inform Communications Team when escalation of an adverse event takes place so they are prepared. Media contact can be achieved through a variety of means, including a press conference, the releasing of a press statement or being available for ad hoc press enquiries. 5. Key Performance Indicators Managers are responsible for ensuring compliance with the procedures and achievement of the following Key Performance Indicators (See table 1, section 3.3). 6. Review of Procedure The procedure will be reviewed annually by the Clinical Governance & Risk Management Support Team and Health and Safety Department. Changes may also be made by exception and through an annual review by any of the groups with oversight responsibility. Page 19 of 51

20 APPENDIX 1a OPERATIONAL PROCEDURE FOR MANAGEMENT AND REVIEW OF SIGNIFICANT ADVERSE EVENTS (SAEs) Adverse event occurs, including near miss STAGE 1 Deal with immediate situation and make safe. Inform one or more of UHS Clinical Management (CH(C)P) senior management team members as appropriate to event. STAGE 2/3 Assess immediate impact: harm to people, disruption to services etc. Identify further immediate actions required/taken & complete DATIX report. Any significant event that has an adverse impact on the service delivery or has caused a major injury to an individual must be immediately reported (see operational procedure for communication and escalation). Note: It is the responsibility of the UHS Nurse/Medical Director/CH(C)P General Manager to appoint a named Lead to liaise with patient/relatives throughout to close of adverse event. Major Harm or Death plus No Immediate Harm but: - Media-sensitive issues - Major Service disruption - HAI outbreak - Unexpected serious clinical events - Serious near miss STAGE 4 Review Pathway SAEs and all events and near misses that are, or have the potential to be, classified as major harm or death or serious harm to the organisation must have a full review. Allegations of acts of gross misconduct will be reviewed as per the conduct policy UHS Medical/Nurse Director/Director of Ops/CH(C)P General Manager/Clinical Director/Chief Nurse are made aware of the adverse event and appoint review team and Lead. Guidance must be sought from UHS Medical/Nurse Director/CH(C)P Chief Nurse/Clinical Director to establish the scope of the review and confirm team involvement. The review team will include senior management and more than one reviewer, including partnership representatives where appropriate. STAGE 5 Use NHS Lothian review protocol (see adverse event management procedure) Review Lead completes a comprehensive report using the standard template and delivers to: Director of Ops/CH(C)P Manager to enter formal governance approval process. This includes sign off by: UHS Medical and Nurse Director/CH(C)P Clinical Director/ Chief Nurse NHS Lothian Medical and Nurse Directors Closure by Clinical Governance & Risk Manager Service Manager and Employee Relations Manager if progressing under Conduct Policy progressing under Capability Policy. Team appointed to take forward Improvement Plan - Feed back results to staff - Monitor & Review - Share learning Page 20 of 51

21 APPENDIX 1b OPERATIONAL PROCEDURE FOR COMMUNICATION & ESCALATION OF SIGNIFICANT ADVERSE EVENTS (SAEs) Adverse Event Occurs Stage 1 Deal with immediate situation and make safe Stage 2 Inform Line Management as appropriate to the event. Record on Datix (Automatic notifications will be sent by determined by severity of event) Major Harm or Death plus No Immediate Harm but: -Media Sensitive Issues -HAI outbreak -Serious near miss -Major Service disruption -Unexpected serious clinical events Communication Pathway UHS Medical/Nurse Directors/CH(C)P General Managers/ Clinical Directors/Chief Nurses UHS Medical Director/Nurse Director CH(C)P General Manager Informs relevant Executive Directors For controlled drugs also contact Accountable Officer NHS Lothian Executive Directors: Nurse Director Medical Director Director of Communications Director of Public Health Director of Scheduled Care Director of Unscheduled Care Director of Pharmacy Director of Strategic Planning Director of Finance Director of Human Resources and Organisational Development Out of Hours/Public Holiday Contact Executive on call When the Executive on call/ CH(C)P General manger is informed, they will make a judgment about the severity of the adverse event and level and timing of escalation Joint Director of HSCP NHS Lothian Chief Executive Informs relevant non -Executive Directors Chairman/Vice Chairman Employee Director Non Executive Directors Director of Operations/CH(C)P General Manager to consider informing / escalating to: - University Deanery if involves Junior Doctor - Police - Central Legal Office - Procurator Fiscal - Environmental Health - Scottish Centre for Infection & Environmental Health (SCIEH) - Food Standards Agency - Scottish Healthcare Supplies (SHS) - Health & Safety Executive Reporting of Injuries, Diseases and Dangerous Occurrences - Serious Hazards of Transfusion (SHOT) - Healthcare Improvement Scotland - Scottish Environmental Protection Agency (SEPA) = See appendix 3 for further guidance DEFINITION OF SIGNIFICANT ADVERSE EVENTS (SAE) APPENDIX 1c Page 21 of 51

22 (Follow operational procedure flowcharts for SAE adverse event reviews and communication) Definition of a Significant Adverse Event A significant adverse event is defined as an extraordinary event that could have, or did, have serious consequences, including immediate or delayed emotional reactions, physical or psychological harm for patients, public, staff or organisation. The severity of the actual outcome of such adverse events in terms of harm will either be Extreme or Major. Occasionally a Significant Adverse Event will have no actual harm, but is deemed significant because there is either a potential for serious harm or it is a media-sensitive issue. For example: Death or major injury connected with employment, care, treatment, or related to participation in research activity Death or injury of patient, member of staff / visitor / other where foul play is suspected Death of a patient where suicide may have been the cause Patient / staff member / other person s death resulting from violent, suspicious or unexplained cause Any adverse event which may be experienced as harassment on the grounds of age, disability, ethnicity or race, gender, religion or belief, or sexuality Near miss events such as a patient absconding, an accident, violent, suspicious or unexplained adverse events which may not result in injury or disability but which could be an indicator of potential suicide or danger to others Major outbreaks of infection Serious medication adverse events Major clinical errors Systematic screening / diagnostic errors Failure in infrastructure putting people at risk e.g. electricity, medical gases Fire involving injury and or financial loss Unauthorised interference with or malfunctioning of medical equipment or supplies Loss of patient confidential data Suspected theft. Page 22 of 51

23 APPENDIX 2 REPORTING REQUIREMENTS UNDER RIDDOR NHSL has a legal duty to report certain accidents/adverse events within a set timescale. To assist you in awareness of the adverse events that require to be reported, here are listings as set out in RIDDOR Reporting of Injuries, Diseases and Dangerous Occurrence Regulations 1995 (add link to HSE website). Reporting on Datix does not automatically report adverse events to the HSE (Health and Safety Executive) or your manager. Managers must therefore contact HSE with the Datix number to inform them of the adverse event. Various adverse events/accidents need to be reported, including:- any fatal injuries to employees or other people in an accident connected with your business any major injuries to employees or other people in an accident connected with your business any of the dangerous occurrences listed in the regulations. Managers are required to report directly to the HSE. Occupational Health and Safety Advisers (OH&S) will continue to provide advice and monitor. The adverse event needs to be submitted electronically via the HSE website within a 15-day time period. (add link) Information required includes: person s full name, home address, home phone number, date of birth, actual injury sustained, first aid if given, estimated time off work, and other information, e.g. if related to assault, or moving and handling - were they up to date on specific training? Types of reportable injury Deaths All deaths to workers and non-workers must be reported if they arise from a workrelated accident, including an act of physical violence to a worker. Suicides are not reportable, as the death does not result from a work-related accident. Specific injuries to workers (including volunteers) The list of specific injuries in RIDDOR 2013 (regulation 4) includes: a fracture, other than to finger, thumb, foot or toe amputation of an arm, hand, finger, thumb, leg, foot or toe permanent loss of sight or reduction of sight crush injuries leading to internal organ damage serious burns (covering more than 10% of the body, or damaging the eyes, respiratory system or other vital organs) scalpings (separation of skin from the head ) which require hospital treatment unconsciousness caused by head injury or asphyxia Page 23 of 51

24 any other injury arising from working in an enclosed space, which leads to hypothermia, heat-induced illness or requires resuscitation or admittance to hospital for more than 24 hours. Over-seven-day injuries to workers This is where an employee, or self-employed person, is away from work or unable to perform their normal work duties for more than seven consecutive days (not counting the day of the accident). Injuries to non-workers Work-related accidents* involving members of the public or people who are not at work (e.g. visitors) must be reported if a person is injured, and is taken from the scene of the accident to hospital for treatment to that injury. There is no requirement to establish what hospital treatment was actually provided, and no need to report adverse events where people are taken to hospital purely as a precaution when no injury is apparent. If the accident occurred at a hospital, the report only needs to be made if the injury is a specific injury (see previous section). Reportable occupational diseases Employers and self-employed people must report diagnoses of certain occupational diseases, where these are likely to have been caused or made worse by their work. These diseases include (regulations 8 & 9): carpal tunnel syndrome severe cramp of the hand or forearm occupational dermatitis hand-arm vibration syndrome occupational asthma tendonitis or tenosynovitis of the hand or forearm any occupational cancer any disease attributed to an occupational exposure to a biological agent. Please ask your local H&S advisor, if more advice/direction is required. *this means accidents arising out of, or in connection with, NHS Lothian work activity Page 24 of 51

25 Specific Types of Adverse Events (AEs) APPENDIX 3 Type of AE Action required Inform relevant Internal contact: Consider External contact: Equipment / Product / Consumable For full guidance and to determine if an internal safety alert is required refer to the NHS Lothian Guide for Assessing and Reporting Suspected Faulty Medical Devices, Clinical Consumables or Equipment. Immediately remove from use and retain all items involved, including packaging and any disposables/consumables attached to equipment concerned at the time of the adverse event, such as fluid administration set, syringes Do not change any settings on equipment Quarantine equipment/product on the premises and clearly identify and label as not for use with the contact details of the person who quarantined the equipment attached Ensure that it is stored in a secure place for inspection and ensure that it cannot cause harm to any person or be tampered with Equipment should not be removed from the premises or interfered with until it has been inspected by the relevant internal technical department Exceptions to this are the Police and the Health and Safety Executive who are empowered to remove anything Medical Physics Estates & Facilities Procurement (Supply Chain) NHS Lothian Safety Alerts Adverse Events Reporting and Investigation Centre (IRIC) Scotland National Procurement (National Distribution Centre) mpany/new-national-distribution-centre/ Page 25 of 51

26 Type of AE Action required Inform relevant Internal contact: Consider External contact: Criminal, suspicious and potentially fatal e.g. weapons involving suicide, self harm Defective medicine i.e. there are concerns about their safety or efficacy e.g. particulate matter in infusion bags, crumbling tablets, items incorrectly labelled by manufacturer relevant to their reviews. Record the make, model, serial/lot number/batch number/unique identifier, date of manufacture, supplier, and expiry date if applicable Contact the dept responsible for the equipment / product immediately e.g. Medical Physics / Estates & Facilities / Procurement as reviews are often helped by seeing the equipment in situ. Treat area as a potential crime scene and call the Police immediately Leave the scene intact, including any articles involved and cordoned off until the Police or HSE advise otherwise and initial internal review is complete. Try to establish whether the adverse event is due to a defect and not due to an accident, error in the administration of the medicine, or an adverse patient reaction to a nondefective medicine. If defective: Remove the medicine from use and retain all items involved, including packaging, and quarantine safely Record the nature of the defect and reasons for doubts as to the medicine's efficacy or safety Report immediately to relevant staff internally If an adverse reaction is suspected: Follow the yellow card scheme ( Patient s Medical Team Senior Pharmacist On-call Pharmacist if out-ofhours Police Scotland Yellow card scheme Page 26 of 51

27 Type of AE Action required Inform relevant Internal contact: Consider External contact: Controlled drugs Deal with the immediate needs of the patient Notify Accountable Officer immediately. If criminal activity is suspected, relevant manager should call the Police Ensure Accountable Officer is kept informed throughout review. Loss of confidential data e.g. Breaches of confidentiality, information security or access to further clinical information Adverse events covered by RIDDOR or COSHH Must be referred to the Caldicott Guardian for NHS Lothian (Director for Public Health & Health Policy) The Caldicott Guardian will assess the level of risk and if necessary escalate to the Information Commissioner s Office. Line managers must report relevant adverse events directly to HSE, using the electronic form on the HSE Website. Accountable Officer angela.timoney@nhs.net judie.gajree@nhslothian.scot.nhs.uk Caldicott Guardian (Director for Public Health and Public Policy) Information Governance Manager IT security Health and Safety department Estates & Facilities department Police Scotland Information Commissioner s Office ion/scotland Health and Safety Executive (HSE) RIDDOR (Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (1995) COSHH (Control of substances hazardous to health) Mental health/learning disabilities service users Consultant must notify Mental Welfare Commission of relevant adverse events Suicides or suspected suicides must be reported to Healthcare Improvement Scotland (HIS). Executive Director with responsibility for Mental Health services alex.mcmahon@nhslothian.scot.nhs.uk Mental Welfare Commission Healthcare Improvement Scotland ur_work/mental_health/suicide_reviews.asp x Page 27 of 51

28 Type of AE Action required Inform relevant Internal contact: Consider External contact: Blood products / components The SNBTS (Scottish National Blood Transfusion Service) would raise these alerts and send them directly to the relevant transfusion laboratory (RIE, WGH or SJH). Transfusion Laboratory RIE, WGH or SJH. SNBTS (Scottish National Blood Transfusion Service) Serious Hazards of Transfusion (SHOT) Adult Support and Protection In the first instance refer to NHSL policies and procedures for Adult Support and Protection. Child Protection In the first instance refer to NHSL policies and procedures for Child Protection If a child protection concern requires a child protection referral, this should be reported IMMEDIATELY to the Paediatrician On-Call for Child Protection, relevant senior social work practitioner, or Police Public Protection Unit. /NHSLothian/Corporate/A- Z/PublicProtection/ASAP/Pages/ Introduction.aspx /NHSLothian/Corporate/A- Z/PublicProtection/ChildProtecti on/pages/default.aspx Other external agencies who you/specialist staff may consider contacting depending on type of adverse event Health Protection Scotland (HPS) The Scottish Government website which provides further information: upport-social-care/adult-support- Protection The Scottish Government website which provides further information: oung-people/protecting/child-protection HPS is responsible for: Coordinating the management of adverse events and outbreaks which affect the whole country, multiple NHS boards or which have a significant impact in one NHS board area (inc. infectious hazards and bio-terrorism) Taking forward specific health protection programmes which look at (e.g. HAI, vaccine preventable diseases, STIs) Is the national surveillance centre for communicable diseases and the health problems associated with environmental hazards Commissioning the NHS specialist microbiology and laboratory services. Page 28 of 51

29 Type of AE Action required Inform relevant Internal contact: Consider External contact: Procurator Fiscal National Services Scotland (NSS) Central Legal Office Counter Fraud Services (part of NSS) Scottish Environmental Protection Agency (SEPA) Food Standards Agency EHRC (Equality and Human Rights Commission) In relation to sudden, unexplained or suspicious deaths. Working with NHS and the wider public sector covering Litigation, Employment, Commercial Contracts and Commercial Property. NHSScotland Counter Fraud Services (CFS) provide a full service to NHSScotland (NHSS) through a centrally-based, professionally-qualified team of specialists dedicated only to counter fraud work. SEPA responsibilities include regulating: activities that may pollute water activities that may pollute air waste storage, transport, treatment and disposal the keeping and disposal of radioactive materials activities that may contaminate land. To report an issue with food products and food handling, such as poor hygiene in a food outlet or a trading standards issue, such as mislabelling. The EHRC have a statutory remit to promote and monitor human rights, and to protect, enforce and promote equality across the nine "protected" grounds - age, disability, gender, race, religion and belief, pregnancy and maternity, marriage and civil partnership, sexual orientation and gender reassignment. The EHRC have a legal right to request information on adverse events of harassment and discrimination. Page 29 of 51

30 APPENDIX 4a ADVERSE EVENT REVIEW TEMPLATE Please read the Adverse Event Review Protocol before initiating this review This can be found on the NHS Lothian intranet under: Healthcare > A-Z > Adverse Event Review > Adverse Event Management > Adverse Event Review Protocol This template should be used for review of all Significant Adverse Events (SAE) resulting in major harm or death and for RIDDOR-reportable adverse events. Please save the template securely on your NHS shared drive as you work through the review. Once completed, update the document control details (within the footer) and attach the latest version into the relevant Datix adverse event as Draft. Please note also that there must be no person-identifiable information in the main body of the report instead please say patient A, ward B, doctor C etc throughout. This does not include the Description of Review Team and Reported to boxes where names and designations must be provided. Summary adverse event description and outcome: Datix ID No: Identification number ID Summarise the report highlights, stating as briefly as possible: purpose, findings and end result of the adverse event. Description of Review Team Names and Designation Time period of review: Start Finish Record start Record date of date of report review Reported to Whoever commissioned the review, name them in this section Adverse event date: Enter the reported date as per DATIX entry Adverse event type: Refer to DATIX adverse event form Adverse event coding Location of Adverse Enter location exact as recorded in DATIX event: Actual effect on Enter experience, for example fracture, medication error, slip, trip patient/staff/ please or fall specify: Scope and level of review For example, internal review within service, led by CNM with the involvement of a multidisciplinary team using information from consultant, staff and case notes; external review led by consultant from another board using information from clinical team, police and social work. Involvement and support of patient and relatives in response to Adverse event Document what was done to ensure that the patient is informed of the situation and reassured throughout the whole episode of care. With the patient s consent, and where appropriate, involve relatives, next of kin and carers in Page 30 of 51

31 the review. Detection of Adverse event (who, when & how) Who identified the adverse event, what was the date and time, how was the adverse event noticed, and what immediate action was taken Chronology of Adverse event (dates & times of key events/ actions, use separate sheet if required) Use the tabular timeline in the adverse event review protocol (Section D) Care & Service Delivery problems that led to the Adverse event Care & Service Delivery problems arise in the delivery in the process of care, usually actions or omissions by members of staff. (see adverse event review protocol section E) For example, staff did not attend training on new equipment introduced to ward, staff did not receive training in escalation process for deteriorating patients. Contributory factors, e.g. patient/ staff, task/ technology, individual/ team, environment Contributory Factors Guidance Contributory factors are those associated with each Care/Service Delivery problem that has been identified. (see adverse event review protocol section F) For example, if communication was identified as a contributory factor, you would need to explore further aspects of communication what failed the what, where, why, who and how. FACTOR TYPE CONTRIBUTORY INFLUENCING FACTOR Patient Focus Task and Technology factors Individual (staff) factors Team factors Work Environmental factors Organisational and Management factors Institutional Context factors Key issues Key issues identified by the review, for example, ward staff failed to recognise deterioration in patient and escalate appropriately. Lessons learned Refer to key Issues, for example, there is no clear local protocol in place for identifying deteriorating patients in this ward and appropriately escalating. Recommendations Should: follow naturally from contributory factors, key issues and lesson learned be strong and advocate actions be listed in priority order For example, develop, test and implement protocol for identifying deteriorating patients and escalating appropriately; ensure all staff trained in use. Improvement plan Sets out how NHS Lothian will improve systems by addressing recommendations. This should be documented using the improvement plan summary template at the end of this document. Page 31 of 51

32 Arrangements for shared learning where, when & by whom Document arrangements e.g. Team meetings, feedback to individuals, operational management group meetings. Ensure staff who are outwith the service are informed of any actions required and completion timescales. Consider sharing outwith NHS Lothian. Copy of the report - learning / recommendations / improvement plan to QIT members. Author: Date: For SAE, the adverse event must not be closed on Datix until this report has completed the formal governance approval process. This will be done at the end of the process by Clinical Governance & Risk Management Support Team staff. This sign-off process can be found on the NHS Lothian intranet under: Healthcare > A-Z > Risk Management > SAE Sign-off process SIGNED OFF BY (IF SIGNIFICANT ADVERSE EVENT) CH(C)P Director / General Manager / UHS Director of Operations UHS Nurse / Medical Director / CH(C)P Clinical Director / Chief Nurse Signed: Date: Signed: Date: FINAL APPROVAL NHS Board Medical Director Signed: Date: NHS Board Nurse Director Signed: Date: Please ensure that the Improvement Plan Summary on the following page is completed. Page 32 of 51

33 Improvement Plan Summary Document Datix No:. APPENDIX 4b Contributory Factors As identified on your fishbone, including notes. Issues linked to contributing factors Care & Service delivery problems. Something happened that should not have happened or something that should have happened did not. Actions to Address Factors Think about how we can improve the identified system weakness. Consider: improvements to protocol guidelines etc innovative ideas for improvements. Level of Recommendation (Individual, Team, Service Directorate, Organisation) Select from above the list. By Whom Give titles / designation. By When Timescale need to be achievable Discuss with staff in the by whom column. should be clear date not nonspecific such as 3 months or ongoing Resource Requirements Discuss with people named in by whom staff column. Evidence of Completion Refer to Actions to Address Factors agree key milestones in the planning phase of action plan. Proof of completion is vital. Completion Sign-off Improvement Plan actions signed off by relevant Service Senior Manager Note: It is the responsibility of the author of the improvement plan summary document to ensure that individuals named in the plan are aware of and have accepted responsibility to deliver relevant actions. Page 33 of 51