General Note
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.
Queries
If you have any questions regarding the content of this document or suggestions for improvement, please send these to Fife Adverse Events mailbox: fife.fifeadverseevents@nhs.scot
1. FUNCTION
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 and medical devices
• 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).
1.1.1 Principles
The principles of the policy align to:
• NHS Fife’s organisational values
• NHS Fife’s Clinical Governance Strategic Framework
• Learning from Adverse Events Through Reporting and Review: A National Framework for Scotland (February 2025,:
• Our Leadership Way: A Leadership Framework for NHS Fife
• Whistle Blowing Policy
1.1.2 Emphasis on learning and promoting good practice
The adverse events management process is focused on undertaking quality review to deliver learning, locally, organisationally and nationally with a primary purpose to improve systems and care. The approach emphasises learning and improvement, and is 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.
Human factors play a crucial role in healthcare adverse event reviews by shifting the focus from individual blame to systemic understanding. This approach examines how environmental, organisational, and task-related elements influence human performance, recognizing that errors often stem from system design rather than personal failings. By incorporating human factors, reviews can identify how limitations such as fatigue, stress, and cognitive overload contribute to mistakes, and how system improvements-like better equipment design or clearer communication protocols-can enhance safety. Ultimately, using human factors fosters fairer, more effective reviews that lead to safer healthcare system
1.1.4 Openness about Errors and/or Omissions in Care
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 are at the heart of care, this includes when an adverse event has occurred. Staff should be open and honest with patients and families when an adverse has occurred, regardless of the level of harm experienced. An early apology should be offered in acknowledgment of when something could have gone better/differently. Apologising that an adverse event occurred does not mean the staff member is accepting liability for what has happened.
When a significant adverse event occurs, patients and families should be informed promptly and invited to participate in the review process in a way that suits their preferences. Local guidance (appendix 1) detailing best practice, alongside the patient/family review leaflet supports services in this process. Patient and families can offer unique insights to the event that provide valuable context and help identify learning opportunities. The service where the adverse event happened should identify a single point of contact, known locally as the Key Contact (appendix 2) for the patient/family, this should be recorded as part of the review process. Communication should be compassionate, transparent, and tailored to the patient/families emotional needs, with staff demonstrating sensitivity. Patients and families should be asked about any concerns or questions they have about the event and be supported to adjust their level of
involvement throughout the process. Any concerns or questions require to be considered by the review team, and included within the scope of the review were relevant. Patients/families will be guided to alternative processes to answer any additional points not to be included in the review.
On conclusion of the review, the patient/family should receive a copy of the concluded report and feedback that is transparent and delivered in a way that best meets their needs.
1.1.6 Events Involving Multiple Patients
When an adverse event affects multiple patients, all potentially impacted individuals should be informed simultaneously to minimise speculation and anxiety. While identifying everyone involved may take time, communication-ideally via a standardised letter or email-should be consistent and include relevant details about the event and a named contact for follow-up. Coordinated and timely communication helps ensure transparency and trust. The process and role of the key contact described in single patient events should be similarly applied to multi patient events, recognising that individual meetings may not be feasible due to the scale of the incident.
Where adverse events occur within population-based programmes or have public health implications (e.g. within screening programmes, immunisation programmes or an event which results in a Public Health Incident ), then relevant public health guidance and approaches will apply. See also section 4.3.
1.1.7 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.
NHS Fife Staff Support, following an Adverse Event Pathway and supporting resources is easily accessible to all. The pathway recognises modern healthcare is increasingly challenging and complex and that on occasions adverse events happen which can be traumatic and have a negative effect on the health and wellbeing of staff. To lessen the risk of impact on staff, the pathway provides a process and guidance to enable consistent and streamlined offer of support that is regarded as the norm, rather than by exception in response to adverse events.
1.1.8 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.
1.1.9 Equality and Human Rights
NHS Fife is committed to ensuring that the review and management of adverse events is carried out in a way that upholds the principles of equality, diversity, inclusion, and human rights. This means:
• Fair and equitable treatment: All patients, families, carers, and staff involved in adverse events will be treated with dignity, respect, and compassion, regardless of age, disability, gender reassignment, marriage or civil partnership, pregnancy or maternity, race, religion or belief, sex, or sexual orientation, in line with the Equality Act 2010.
• Human rights–based approach: Investigations and responses will be guided by the principles of fairness, accountability, transparency, and participation, ensuring that people’s rights to safety, respect, and involvement in decisions that affect them are upheld.
• Accessibility and inclusion: Communication and engagement will be tailored to meet individual needs, including the provision of interpreters, accessible formats, and reasonable adjustments for disabled people.
• Staff support and wellbeing: Staff involved in adverse events will be supported in a way that recognises their rights to a safe and respectful workplace, free from discrimination or harassment.
• Learning and improvement: Equality and human rights considerations will be embedded in the analysis of significant adverse events to identify and address any systemic inequalities or barriers to safe, high-quality care.
• Legal duties: This policy supports NHS Scotland’s obligations under the Public Sector Equality Duty, the Fairer Scotland Duty, and the Human Rights Act 1998, ensuring that equality and human rights are mainstreamed into all aspects of adverse event management.
1.2.0 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.
1.2.1 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 3 contains a glossary of terms used in this policy.
1.2.2 Definitions
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 or the intervention that took place that prevented harm from occurring.
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
• 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 that result in, for example, reputational harm or financial harm are included within the scope of the above definitions.
2. LOCATION
2.1 All employees of NHS Fife working in Acute Services, Fife Health & Social Care Partnership (HSCP) and 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. 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. The Chief Executive delegates this responsibility to the Executive Medical Director, Executive 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 The Director of Public Health is accountable and responsible to the Chief Executive for the duty of the health board for protecting public health in accordance with the Public Health etc. (Scotland) Act 2008. Adverse events occurring within population health programmes (e.g. screening or immunisation) are reviewed within the NHS Fife Public Health Assurance Committee, which reports up to the Public Health & Wellbeing Committee.
3.6 Leadership Group 3 (Executive Medical, Nurse and Pharmacy 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 alongside the Director of Pharmacy for review and approval of SAER reports.
3.6.1 Leadership Group 2 (Deputy Medical, Associate Medical, Nurse and Midwifery Directors, Deputy Director of Pharmacy and Medicines, 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 managing adverse events across the organisation. Responsibilities include:
• Reviewing SBARs for major and extreme events
• Commissioning and approving Adverse Event Reviews for major/extreme harm, including sign off of CCR’s where decision is made to downgrade severity to moderate with CCR review.
• Making recommendations on SBARs for SAER
• Overseeing compliance with national target timeframes for SAER completion
• Scrutiny of improvement plans developed from SAERs
The group is supported by a weekly dashboard produced and distributed by the Adverse Events Team. This enables oversight of all open SAERs and associated improvement plans within their areas of responsibility. Through clinical governance structures, the group is expected to escalate any delays in the process.
Where assigned, members of Leadership Group 2 will act as executive panel members for the review and approval of SAER reports.
3.6.2 Leadership Group 1 (Clinical Directors, Clinical Leads, Head of Nursing, Head of Midwifery, Heads of Service, Pharmacy Leads, 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.
3.6.3 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
3.7 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.
3.8 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.
3.9 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).
3.10 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
This policy is supported by the Adverse Events Operational Resource Pack. This resource pack which is dynamic in nature, provides greater clarity on the systems and processes that support the management of adverse events and application of this policy.
4.1 Initial Reporting and Notification of Adverse Events
NHS Fife Board 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 centered 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.
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. This includes:
• 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 and medical devices including software 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
• Children and young people’s death’s to Healthcare Improvement Scotland, through submission of national dataset to the Child Death HUB
• Significant vaccination adverse events to Public Health Scotland
• Incidents relating to all National screening programmes in Scotland to Screening Oversight and Assurance Scotland (SOAS) in line with the Screening Incident Management Policy (2025, V1.3)
4.3 Determining 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 event.
The level of review will be determined from the level of harm as below, and is adapted from the Learning from Adverse Events, National Framework consequence grading (appendix 4), NHS Fife List of Clinical Events that must be graded Major or Extreme (appendix 5a) and NHS Fife List of Events, affecting staff or visitors that must be graded Major or Extreme (appendix 5b).
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.
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 6)
For vaccination adverse event the level of review will be aligned to Public Health Scotland (PHS) Vaccination Adverse Event Management Protocol. Significant vaccination adverse events with impacts for Public Health require to be reported to PHS (an extract from the guidance can be found in appendix 7)
4.3.1 Level 1 – Major or Extreme: Events which may have contributed or resulted in permanent harm, for example patient harm - death/life changing injury, intervention required to sustain life, severe financial loss, significant loss of public trust, ongoing national adverse publicity.
As described in the NHS Fife List of Clinical Events that must be graded Major or Extreme (appendix 5a) there are 5 review options. 4 of the options represent as event specific cluster review processes (cardiac arrest, sudden unexpected death in infancy (SUDI), unexpected drug and alcohol deaths and suicides) creating greater opportunities for thematic learning with governance and escalation options embedded in the process.
All other clinical event outcomes that trigger major/extreme harm should follow the SAER pathway, summarised below in fig. 1 (page 11) and have evidence of robust decision making using the SBAR process for commissioning or not of a SAER.
It may be anticipate that they will be a very small number of non clinical events that could trigger major/extreme harm in respect of the impact on the delivery of clinical service or organisation, as per the consequence rating (appendix 4). In these circumstances it may be appropriate to carry out an alternative review type (i.e Health and Safety, Information Commissioner, estates incidents). Decision making for alternative review type requires agreement with the relevant Executive Lead with evidence of the decision, review and any improvement actions uploaded to the datix record.
All NHS Scotland Boards are required to report category 1 events that have had a SAER commissioned, on a monthly basis to Healthcare Improvement Scotland; this information is collated and submitted on behalf of the board by Fife Adverse Events.
The national standard timeframe for completion of an SAER, as defined by Healthcare Improvement Scotland is 140 days for the complete process. The breakdown of the 4 stages of the process is below:
1. Event occurs and is reported on incident management system to review being commissioned 10 days
2. Commence and close review (report submitted for approval) 90 days
3. Report submitted for review to being approved 30 days
4. Report approved to improvement plan being approved 10 days
Education, training, guidance, and resources for teams conducting a SAER will be delivered in a variety of formats, including e-learning, written guidance documents, and face-to-face workshops. The education and training provided will continue to evolve in response to the needs of NHS Fife and the changing landscape of safety learning reviews, with an increased emphasis on Human Factors and the use of systems thinking tools and techniques.
Fig 1 - Reviewing major/extreme harm adverse events
4.3.2 Level 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.
There are 6 specific moderate harm events types (tissue viability (grade 3), falls with harm, Catheter related E-Coli infection, SABS, extravasation with harm and specific perinatal events that due to continued organisational focus require to have a Complex Care Review (CCR) completed and follow the governance process for the event specific review, approval, sharing and evidence of learning. The governance process is required to reflect thematic learning and improvement with assurance provided annually to CGOG.
For all other minor to moderate harm events the expected review is:
• 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.
• Minor events - Service approves and closes incident no later than 30 days from reporting date.
• Moderate events – Service approves and closes incident no later than 60 days from reporting date. CCR where used should be uploaded to Datix.
4.3.3 Level III – No Harm/near miss: Events that had the potential to cause harm but i) an error did not reach the person (near miss), ii) an error reached the person but did not result in harm.
Expected review
• 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 8)
4.6 Feedback, Closing the Loop and Sharing the Learning
Sharing learning from adverse events is a vital component of delivering high-quality, safe patient care. By reflecting on incidents and openly communicating the lessons learned, we empower staff to make informed changes in practice, reduce the risk of recurrence, and strengthen our collective ability to respond to challenges. This process not only supports professional development but also reinforces a culture of safety, accountability, and continuous improvement across our teams.
Feedback to frontline staff is a key element of the adverse event process. The mechanism for this is through the incident management system, currently Datix, following completion of the adverse event record. Consideration must be given to how learning from adverse events is disseminated in a meaningful manner.
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 SAERs can 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
• SAER’s were significant organisational learning can be referred to the Clinical Organisational Learning Leadership Group for consideration of sharing at a Clinical Organisational Learning Event or on the NHS Fife Clinical Learning Hub.
4.7 Sharing of Adverse Events Reviews
To facilitate this process, review reports must be written in such a manner and format that they are accurate, factual, sensitive, professional, in plain English and anonymised to protect both patient and staff identity and can be shared with patients, families and careers as well as any external agency who requests the report, such as the Mental Welfare Commission or Procurator Fiscal. Further guidance on preparing and sharing of reports can be found in appendix 7.
Factual materials gathered during a SAER – including staff statements and contemporaneous accounts – should be managed with care, as national guidance does not prescribe whether these materials must be retained once the review is complete. Case law indicates that while Boards may be able to resist disclosure of such materials in civil claims, documents may still be recoverable in processes such as Fatal Accident Inquiries, Health & Safety prosecutions, or public inquiries, where courts have wide-ranging powers. As SAERs are no blame and trauma informed, certain elements of the process are intended to remain confidential. To maintain a no-blame culture it is advised that staff statements/factual accounts/interview transcripts are NOT stored either paper or electronic following closure of the SAER. Staff can be advised that they may retain their own contemporaneous account should it be needed for future legal or regulatory proceedings.
Learning summaries, prepared using the HIS national template, should be completed to enable learning to be shared from ward to board. Where appropriate, and following approval by the SAER Panel, these summaries may also be shared with HIS to support and contribute to national learning.
4.8 Closing the Loop
Following an adverse event, it is essential that improvement actions are implemented and clearly evidenced. This is critical for several reasons:
1. Prevention of Recurrence: The primary purpose of reviewing adverse events is to reduce the risk of similar incidents occurring in the future.
2. Public Trust and Transparency: For patients and families, it is our responsibility to demonstrate that learning has taken place and that meaningful change has followed. This is vital for maintaining public trust and confidence.
3. Staff Engagement and Safety Culture: Staff must be actively involved in the improvement process and be able to see the impact of changes. This visibly reinforces our commitment to a culture of safety.
To ensure these outcomes are achieved, for events that result in major or extreme harm and are reviewed under any of the 5 category 1 review processes previously described the following assurance system must be followed:
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 Management Framework, 2020.
6. RELATED DOCUMENTS
This document should be read in conjunction with the following:
6.1 NHS Fife Adverse Events Management Resources on BLINK
6.2 NHS Fife Code of Corporate Governance
6.3 NHS Fife Health and Safety Policy, 2025
6.4 NHS Fife Safe Use of Medical Sharps Policy, 2018
6.5 NHS Fife Risk Register / Risk Assessment Policy (GP/R7)
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)
6.15 Management of public health incidents: guidance on the roles and responsibilities of NHS led incident management teams
6.17 Appendix 2 - Consequence Ratings
6.18 Appendix 3(a) – NHS Fife List of Clinical Events that must be graded major or extreme
6.20 Appendix 4 - Maternity and neonatal (perinatal) adverse event review process summary
6.21 Appendix 5 – Sharing information from adverse events
6.22 Appendix 6 - Engaging Patients/Families in Adverse Events Reviews and the Role of the key contact
6.23 Appendix 7 - PHS Vaccination Adverse Event Management Protocol, level of review guidance
6.24 Appendix 8 - Sharing Information from Adverse Events
6.25 Appendix 9 – Commissioning and approval process for major/extreme incidents Divisional flowcharts
6.26 Duty of Candour eLearning module (TURAS)
7. REFERENCES
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 (February 2025 )
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
7.12 PHS Vaccination Adverse Event Management Protocol, 2024
