NHS Fife acknowledges and agrees with the importance of regular and timely review of policy statements and aims to review policies within the timescales set out. New policies will be subject to a review date of no more than 1 year from the date of first issue.
Reviewed policies will have a review date set that is relevant to the content (advised by the author) but will be no longer than 3 years.
If a policy is past its review date then the content will remain extant until either such time as the policy review is complete and the new version published.
If you have any questions regarding the content of this document or suggestions for improvement, please send these to Fife Adverse Events mailbox: firstname.lastname@example.org
1.1 Aim and Purpose
The aim of this policy is to minimise the risk of adverse events occurring by maximising opportunities to learn, ensuring patients are kept safe and staff are supported.
The purpose is to support a consistent and timely approach to the identification, reporting, reviewing and learning from all adverse events and near-misses. These include:
• Clinical events e.g. unexpected deaths, surgical complication, medication incidents
• Non-clinical events e.g. information governance, adverse publicity and finance
• Health and Safety events e.g. RIDDOR reportable incidents, sharps incidents*
• Accidents e.g. Slip, Trip, Falls*
* The organisation will work in accordance with the Health & Safety at Work etc. Act 1974, in particular the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (RIDDOR) 2013 (as amended), the Environmental Protection Act 1990. This policy must be read in conjunction with relevant NHS Fife Health and Safety Policies and Safe use of Medical Sharps Policy (see section 6).
The principles of the policy build on NHS Fife’s key values, which are: to improve health and wellbeing, to improve the quality of health and care services, to improve staff experience and wellbeing and to deliver value and sustainability, and are in line with Learning from adverse events through reporting and review: A national framework for Scotland (July 2018). Access here
1.1.2 Emphasis on learning and promoting good practice
The adverse events management process is focused on learning, locally, organisationally and nationally with a primary purpose to improve systems and care and NOT to apportion blame. Opportunities are identified to learn from good practice as well as ALL level of reviews which includes near misses.
1.1.3 Human Factors/Systems approach
Adverse events act as a ‘window’ on the system allowing a systems analysis. This is important to allow a reflection on the weaknesses of the system, or in the case of near misses, the strengths, and prevention of future events.
1.1.4 Openness about failures
Events are identified, reported and managed in a timely manner. Patients, service users and their families are told what went wrong and why and receive an apology for any harm that has occurred. Reviews of events happen frequently and quickly following their occurrence. Adverse event reporting increases as the organisation moves to a more open culture. Duty of Candour should be a consideration of all adverse event reviews.
The Statutory Duty of Candour (Scottish Government, 2018) is the procedure that organisations providing health services, care services and social work services in Scotland, are required by law to follow when there has been an unintended or unexpected incident arising from the care and/or treatment they have received that results in death or harm (or additional treatment is required to prevent injury that would result in death or harm). It is not intended for circumstances where a patient’s condition deteriorates due to the natural progression of their illness.
1.1.5 Involving patients and families
Patients and their families will remain at the heart of care, this includes when an adverse event has occurred. As a minimum patients/families will be informed that a review is taking place and will be asked what matters to them. The review will be transparent; feedback will be given in a way that best meets the patient/family’s needs with a summary available for them to receive on conclusion of a Significant or Local Adverse Events Review (appendix 5).
1.1.6 Staff support
NHS Fife has a duty of care to all employees following an adverse event which has occurred during the course of their duties. Staff who have been directly involved or witnessed an adverse event will be treated fairly, as individuals and have access to a range of support which will be tailored to their needs, following discussion with line manager or others.
Education and training will be available to assist staff in undertaking adverse events reviews.
1.1.7 Just culture
Individuals are treated fairly. Organisational culture is based upon the values of trust, openness, equality and diversity which encourages and supports staff to recognise, report and learn from adverse events.
1.1.8 Positive safety culture
Avoidance, prevention and mitigation of risks are part of the organisation’s approach and attitude to all its activities and are recognised at all levels of the organisation. Decisions relating to the management of adverse events are risk based, informed and transparent to allow appropriate level of scrutiny.
1.1.9 Personal, professional and organisational accountability
Everyone is responsible for taking action to prevent adverse events, including speaking up when they see practice that endangers safety, in line with the NHS Scotland Whistleblowing Policy. Roles and responsibilities will be explicit and clearly accepted with individual’s understanding when they may be held accountable for their actions.
Management of employee conduct is a separate issue from review of adverse events. In the event of possible negligence, intended harm or professional malpractice, the investigatory process may identify the requirement for a disciplinary procedure under the NHS Scotland Employee Conduct Policy. Any ongoing investigation e.g. Significant Adverse Events Review, may run in parallel to identify any system and process issues.
Appendix 1 contains a glossary of terms used in this policy.
1.2 Summary of Procedure
This policy should be considered alongside the Adverse Event Management Resources available on StaffLink
The following definitions apply to this document:
The term adverse event refers to an unexpected occurrence or event arising that did or could have resulted in harm, loss or damage to persons, property or organisational reputation. It can include any event that may give rise to physical, emotional, psychological harm or death.
A near miss is any situation that could have resulted in an adverse event but did not due to either chance or intervention. This should be considered as an opportunity to review and learn from the circumstances of what happened before those circumstances result in an adverse event at some point in the future.
Harm is defined as an outcome with negative effect. Harm to a person or groups of people may result from unexpected worsening of a medical condition, the inherent risk of an investigation or treatment, violence or aggression, system failure, equipment failure, workplace environment issue, provider performance issues, service disruption, financial loss, or adverse publicity.
People are defined as:
• service users
• members of staff
• family members, and
Groups of people include any functional grouping of individuals such as an organisation. In this way, adverse events that result in, for example, reputational harm or financial harm are included within the scope of the above definitions.
2.1 All employees of NHS Fife working in the Acute Services Division (ASD) the Fife Health & Social Care Partnership (HSCP) and NHS Fife Corporate Directorates have a responsibility to prevent, identify, report and manage adverse events and near misses in line with this Policy.
2.2 The Policy also applies to all permanent and temporary contractors, students, honorary contract holders, bank, agency and volunteer staff working in NHS Fife and Fife H&SCP. It may be used by independent GP, Dental, Pharmacy and Optometry contractors. While the organisation acknowledges that the accountability arrangements of independent contractors differ from those of NHS Fife employees, the Policy is recommended as good practice and contractors should use it in line with the requirements of their own organisation and /or professional body. Please refer to section 3 responsibility.
3.1 The Board is accountable and responsible for the quality of care delivered in the organisation. It seeks assurance that the systems in place support the effective management and learning from adverse events. The Board should be kept informed of serious and ongoing issues and recognise the links between staffing, quality outcomes and safety.
Adverse Events is an integral part of the NHS Fife Clinical Governance Strategic Framework which defines the objectives, expected outcomes, activities and measures required to achieve delivery of safe, effective, person-centred care as an organisation which listens, learns and improves.
3.2 Governance Committees
The Governance Committees seek to provide Fife NHS Board with assurance in respect of adverse event management by seeking assurance that there are systems and processes in place to ensure that adverse event management and reporting is in place and lessons are learned from adverse events.
3.3 The Chief Executive is accountable and responsible to the NHS Board for ensuring that policies and procedures are in place for adverse event management, systems for reporting and learning and any delegation to executive team members. In practice, the Chief Executive delegates this responsibility to the Board Medical Director, Board Director of Nursing and the Director of Property and Asset Management (for Health and Safety).
3.4 The Director of Property and Asset Management is the Executive Lead for Health and Safety and is accountable and responsible to the Chief Executive for ensuring that policies and procedures are in place to enable the effective reporting, recording, management, investigation and monitoring of all adverse events relating to Health and Safety issues. This includes the statutory requirement to report adverse events to the Health & Safety Executive (HSE), etc in accordance with RIDDOR and other statutory instruments.
3.5 Leadership Group 3 (Executive Medical and Nurse Directors)
Overall executive responsibility for Adverse Event Management is delegated to the Executive Medical and Nurse Directors who are charged with providing assurance to the Board that there are effective policies/procedures produced, implemented, managed and monitored for management of adverse events.This includes organisational commissioning of Significant Adverse Event Reviews (SAER), final statutory Duty of Candour decisions and role of executive panel member for review and approval of SAER reports.
3.5.1 Leadership Group 2 (Deputy Medical, Associate Medical, Nurse and Midwifery Directors, Heads of Estates and Facilities/Finance/Workforce/Pharmacy/Allied Health Professions, Associate Director of Digital and Information, Associate Director of Quality and Clinical, Governance, General Mangers)
This leadership group provides assurance that there is a positive culture of reporting and management of adverse events across the organisation. This includes review of SBARs for major and extreme events, commissioning and approval of Local Adverse Event Reviews, making recommendation on SBARs for SAER and scrutiny of the improvement plans developed from SAERs. Where assigned, members of leadership group 2, will take on the role of executive panel member for review and approval of SAER reports.
3.5.2 Leadership Group 1 (Head of Nursing, Head of Midwifery, Heads of Service, AHP Leads, Service Mangers)
This leadership group is responsible for ensuring there is a positive culture of reporting and management of adverse events across services. This includes the second level recommendation on SBARs for major and extreme events. Development, management and monitoring of Improvement plans for SAERs. This group is also responsible for ensuring learning and improvements from adverse events are captured and shared across services.
3.5.3 Line Managers have a responsibility to:
• ensure staff adhere to this policy
• ensure staff fulfil additional reporting requirements
• ensure staff understand the importance of reporting, managing, investigating and learning from adverse event/near misses
• make staff aware of, and enable access to the policy, guidance and appropriate training on the reporting and management of adverse events
• engage and support staff involved in an adverse event
• manage adverse events including review, progress of actions, dissemination and implementation of learning
3.6 Where an adverse event involves more than one Directorate/Service/Division, managers of the areas involved or a representative nominated by NHS Fife/Fife HSCP must agree and identify the most appropriate manager to lead the review of the event.
3.7 All staff must co-operate with their employer to enable the organisation to comply with its statutory duties. This means all staff must adhere to this policy and related procedures, attend related training and participate in adverse event reviews.
3.8 If an adverse event occurs relating to an Independent Contractor, the line manager should report this to the contractor and assist in the review (if appropriate).
3.9 Where an adverse event arises from the activities of a contractor employed by NHS Fife i.e. a member of staff /patient is injured as a result of the contractor’s work activities, in addition to any investigation undertaken by NHS Fife, we expect the contractor to investigate and report their findings to NHS Fife, the HSE and any other relevant enforcing agency if appropriate. Formal notification of the contractor’s investigation shall be forwarded to the relevant Project Manager, Health and Safety Manager and the Associate Director of Quality and Clinical Governance.
4. OPERATIONAL SYSTEM
An overview is provided within this document. This policy should be read alongside the Adverse Events Resource Pack which provides greater clarity on the systems and processes that support the management of adverse events.
4.1 Initial Reporting and Notification of Adverse Events
NHS Fife Board currently uses a web-based (Datix) system for adverse event reporting. This system allows prompt, thorough reporting and requires line manager review/verification and recording of action taken, so learning from the adverse event can be disseminated.
Adverse events reporting must be completed as soon as possible after the event but within one working day for all adverse events unless there are exceptional circumstances for the delay. The adverse event reporting system will automatically send an alert to the Chief Executive and other relevant members of the Executive and Senior Leadership Team for every Major or Extreme adverse event reported.
The system is designed to be confidential but not anonymous thus supporting the ethos of the organisation that our aim in NHS Fife is to minimise the risk of adverse events occurring and maximise our opportunities to learn; to improve systems and practice, care and outcomes and NOT to apportion blame.
These reports are often referred to in legal cases or submitted as evidence in court actions. It is imperative that the person(s) reporting the adverse event, whilst maintaining a person centred approach, reports on fact. Opinion or assumptions must not be included, and details must be accurate for any future review. Acronyms, abbreviations, and inappropriate and inflammatory language must not be used.
The adverse event reporting system will record the following as a Minimum Data Set:
• The location of where the adverse event occurred (Where)
• The date and time of the adverse event (When)
• Brief description of the adverse event (What, Why and How)
• Any immediate action taken
• Personal details relating to the person/people involved in the adverse event (victim/injured party)
• The impact to the person/people or organisation (Injury/result)
• The likelihood of recurrence
• The immediate treatment given to the person/people involved
• Any remedial action taken to minimise risk of recurrence
• Others who were involved in observing or reporting the adverse event
On advice from the Central Legal Office staff must not file a paper copy of the adverse event form or the review report in the patient case record.
4.2 Reporting to external agencies
Specific events must be reported to external organisations.
• Deaths and injuries due to a work related accident to the Health and Safety Executive as set out in the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995 (RIDDOR)
• Events involving health, social care, estates and facilities equipment to the Incident Reporting and Investigation Centre (IRIC) within Health Facilities Scotland as set out in CEL 43 (2009)
• Events relating to blood to the Medicines and Healthcare Products Regulatory Agency (MHRA) as required by the UK Blood Safety and Quality Regulations 2005 and the EU Blood Safety Directive
• Adverse drug reactions, defective medicines and counterfeit medicines via the Yellow Card Scheme to the MHRA
• Suicides of individuals in contact with mental health services to Healthcare Improvement Scotland
• Sudden deaths associated with medical or dental care to the Procurator Fiscal
• Relevant information to UK-wide national audits and enquiries managed by the Healthcare Quality Improvement Partnership (HQIP)
• Information governance events to the eHealth Division within Scottish Government and the Information Commissioner’s Office
• All deaths of patients subject to mental health detention or a community based order under the Mental Health (Care and Treatment) Act 2003 or the Criminal Procedure (Scotland) Act 1995; all homicides committed by people with recent contact with mental health services; and serious crimes (serious assault, serious sexual assault) by an individual who is receiving care from mental health or learning disability services are notified to the Mental Welfare Commission for Scotland
• All maternal (pregnant and up to 1 year post delivery), perinatal (from 22 weeks gestation) and infant deaths (up to 28 days of life) to MBRRACE UK
4.3 Categorisation and Levels of Review
The basic process of adverse event review and analysis should essentially be the same. However, some events due to the complexity or the potential for learning require a more formal, extensive review making full use of all associated techniques to comprehensively examine the chronology, care/service delivery problems and contributory factors.
The category of the event will support the decision-making process for the level of review required. However, it must be stressed that a severe or tragic outcome is not the only determining factor. Near miss events with no adverse outcome and complex lower severity adverse events can also warrant high level review if there is potential for learning.
The level of review will be determined from the category of the event as below and is adapted from the Learning from Adverse Events, National Framework consequence grading (appendix 2) and NHS Fife List of Events that must be graded Major or Extreme (appendix 3).
For Maternity and Neonatal adverse events the level of review will be aligned with the Maternity and neonatal (perinatal) adverse event review process for Scotland - Operational guidance to supplement the Healthcare Improvement Scotland (HIS) national framework (a process summary and links to the document can be found in appendix 4)
4.3.1 Category I – Major or Extreme: Significant Adverse Events: Events which may have contributed or resulted in permanent harm, for example death/life changing injury, intervention required to sustain life, severe financial loss (£>1m), ongoing national adverse publicity, likely to be graded as major or extreme.
Expected level of review:
1. Local Adverse Event Review (LAER) or
2. Significant Adverse Event Review (SAER)
*Full detail of the LAER and SAER process are included within the Adverse Event Management Resource Pack
Leadership teams must complete the SBAR commissioning process within 10 working days of a Major or Extreme (category 1) adverse events being reported. The commissioning process for Corporate, Acute and HSPC can be found at appendix 6. Completion of review is expected within 90 days.
All NHS Scotland Boards are required to report category 1 reviews that have been commissioned on a monthly basis to Healthcare Improvement Scotland; this information is collated and submitted on behalf of the board by Fife Adverse Events.
4.3.2 Category II – Minor to Moderate: Events which 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 or inability to continue work.
• Local management led adverse event review i.e. manager in charge of department with multi disciplinary input as appropriate in consultation with professional lead, inclusive of medical colleagues
• A complex care review (CCR) tool can be used to support reviews that require more in-depth review that are not triggering major or extreme levels of harm
• Reviewer identified and records in Datix, findings, learning and improvement actions.
• Service approves and closes incident no later than 60 days from reporting date. CCR where used should be uploaded to Datix .
4.3.3 Category III – No Harm: Events that had the potential to cause harm but i) 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).
• Line manager/delegate review in discussion with appropriate staff
• Reviewer identified and records in Datix, findings learning and improvement actions
• Service approves and closes incident no later than 10 days from reporting date.
4.4 Multi-Board/Multi-Agency Review
On occasion a review may require multi-board/multi-agency involvement. The lead organisation i.e. where the adverse event was reported, should contact the other organisation(s) and agree the nature of the involvement. A single point of contact for the people affected e.g. patient, member, service user, family or carer should be clearly defined at the outset.
Healthcare Improvement Scotland has issued guidance for use in reviewing adverse events where a Multi-Board or Multi-Agency approach is required. The principles describe a collaborative NHS approach, but the guidance can also be applied to external organisations involved in adverse events, such as social care, local authorities or Police Scotland.
4.5 Investigations by other agencies and departments
The circumstances surrounding an adverse event may require a statutory or other need for a parallel investigation to take place. This may result in:
• a decision being taken to suspend the SAER process
• a requirement to share information with another internal/external group or body (appendix 5)
4.6 Feedback, Closing the Loop and Sharing the Learning
As demonstrated in the Adverse Event Management Flowchart (page 4), feedback to frontline staff is a key element of the adverse event reporting process. The mechanism for this is through Datix following completion of the adverse event record. Consideration must be given to how learning from adverse events is disseminated.
Learning outcomes from adverse events can be disseminated across the organisation in a number of ways including:
• Adverse Events Incident Flashcard - Key organisational learning points can be submitted to the Adverse Event Lead to be included in the monthly flashcard accessible by all staff on StaffLink
• Learning Summaries - a one page learning summary to share key learning points from LAERs and SAERs should be shared with all staff involved in the adverse event, relevant wards and departments and escalated through clinical governance structures for wider learning
• Clinical Groups – All clinical groups have a Clinical Governance and Risk Management structure which should be used as a forum for discussing adverse events, sharing learning and monitoring and following up of actions/changes in practice
5. RISK MANAGEMENT
5.1 As part of our approach to embedding a positive safety culture, NHS Fife and the Fife HSCP recognise the need to avoid, prevent and mitigate risks in all of its activities. In this way, risk assessment and prevention are seen as the first steps in adverse event management.
5.2 Risks identified as a result of adverse events must be assessed and managed in line with the NHS Fife Risk Register/ Risk Assessment Policy GP/R7.
6. RELATED DOCUMENTS
This document should be read in conjunction with the following:
6.1 NHS Fife Adverse Events Management Resource Pack, (due June 2023)
6.3 NHS Fife Health and Safety Policy, 2022
6.4 NHS Fife Safe Use of Medical Sharps Policy, 2018
6.6 NHS Fife Risk Management Framework, 2020
6.7 NHS Scotland Workforce Policy 1, Whistle blowing
6.8 NHS Scotland Workforce Policy 4, Capability
6.9 NHS Scotland Workforce Policy 5, Conduct
6.10 NHS Scotland Workforce Policy 6, Grievance
6.11 NHS Fife Data Protection and Confidentiality Policy GP/D3
6.12 Fife Inter-Agency Adult Support and Protection Guidance (June 2018)
6.13 Scottish Government, National Guidance for Child Protection in Scotland, 2021
6.14 Fife Interagency Child Protection Guidance (2019)
6.22 Duty of Candour eLearning module (TURAS)
6.23 Managing a Significant or Local Adverse Event eLearning module (TURAS)
7.1 NHS Improvement Never Events Policy and Framework (Revised January 2018).
7.2 NHS Healthcare Improvement Scotland (NHS HIS) Learning from Adverse Events through Reporting and Review: A National Framework for NHS Scotland (December 2019, 4th edition)
7.3 Scottish Government, Maternity and neonatal (perinatal) adverse event review process: guidance
7.4 NHS HIS, National Hub for Reviewing and Learning from the Deaths of Children and Young People
7.5 The Health (Tobacco, Nicotine etc. and Care) (Scotland) Act 2016 (asp 14) -part 2 Duty of Candour
7.6 Duty of Candour Factsheets for staff working in health and social care in Scotland. NHS Education for Scotland (NES) 2017
7.7 Health & Safety at Work etc Act 1974
7.8 The Environmental Protection Act 1990 (as amended)
7.9 The Reporting of Injuries Diseases and Dangerous Occurrences Regulations 1995 (as amended 2013)
7.10 UK Blood Safety and Quality Regulations 2005 and the EU Blood Safety Directive 8
7.11 NHS Scotland Code of Practice - Protecting Patient Confidentiality 2012