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A significant event audit (SEA), also known as significant event analysis, is a method of formally assessing significant events, particularly in primary care in the UK, with a view to improving patient care and services. To be effective, the SEA frequently seeks contributions from all members of the healthcare team and involves a subsequent discussion to answer why the occurrence happened and what lessons can be learned. Events triggering a SEA can be diverse, include both adverse and critical events, as well as good practice. It is most frequently required for appraisal, revalidation and continuing professional development. [1] [2] [3]
The concept of SEA was established with the aid of Mike Pringle's occasional paper on the topic in 1995, where, he defined SEA as;
a process in which individual episodes are analysed, in a systematic and detailed way to ascertain what can be learnt about the overall quality of care, and to indicate changes that might lead to improvements. [4]
It does not necessarily involve an undesirable outcome and can reflect good or bad practice. [2] The Medical Defence Union (MDU) defines SEA as "a way of formally analysing incidents with implications for patient care in order to improve services". [1] For the purposes of appraisal and revalidation a SEA is "any unintended or unexpected event, which could or did lead to harm". [5] This is reflected in the General Medical Council's (GMC) definition which is not the same as that frequently used in primary care. The GMC describe a SEA as;
an untoward or critical incident...which...is any unintended or unexpected event, which could or did lead to harm of one or more patients. This includes incidents which did not cause harm but could have done, or where the event should have been prevented. [6]
SEA may also be referred to as a serious untoward incident, patient safety incident, [5] critical event audit, critical incident analysis, structured case analysis or facilitated case discussion. [1]
SEA is mainly a concept from the UK, [7] [8] where team members come together to constructively review an event that has occurred, broadly equating to doing a case study. [4] It is preferentially used in primary care situations and has some comparisons with root cause analysis. [9] It is most frequently required for appraisal, revalidation and continuing professional development, [10] and unlike clinical audit, SEA is qualitative [2] and considered as a form of quality improvement activity, as events of SEA in primary care frequently do not meet the harm threshold. [11]
It can also be used as part of a GP trainee's learning log. [12] The value of using SEA was highlighted in the publication of the GP contract of 2004, and became part of the GP contract in the UK, with practices requiring to have completed 12 SEAs every three years. [4]
SEA as a risk management technique is endorsed by the National Patient Safety Agency. [4]
Events triggering a SEA can be diverse, include both adverse and critical events, as well as good practice, and are a structured way of reviewing an occurrence that caused harm, a near miss or an identified risk, or a reason for celebration. With the aim of being a positive development, it can cover clinical as well as administrative areas. [3] [13]
Examples could include:
A timeline of the SEA is assembled with the facts gathered via medical records and personal accounts and interviews. This can then be further analysed. [2]
The SEA is frequently set as an agenda item within a wider group meeting, but a separate meeting may also be arranged ad hoc if necessary. [4] Attendees usually comprise a few or a number from the following; [3] [14]
In the meeting, those involved in the event present what happened in the case, followed by questioning and a group discussion about how the situation was dealt with. Actions and a follow-up meeting may be necessary with agreement and the process is recorded as a summary. The SEA is then documented on a form which is frequently bespoke to the practice. [3] [4]
Significant Event Audit Template | |
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Title | |
Date of event | |
Date of SEA meeting | |
SEA lead(s) | |
Team members present | |
What happened? | Detailed description of what actually happened. |
Why did it happen? | Contributing factors as to why the event happened. |
What has been learned? | Demonstrate reflection and learning. |
What has been changed? | Agreed action and show how it is implemented. |
The discussion may lead to a number of outcomes including;
There is no fixed end point, hence outcomes can be re-evaluated at predetermined intervals. [2]
External agencies that may require access to SEA documents include patients and carers, GP appraisers, clinical governance committees, clinical commissioning groups (CCGs) and the (GMC. [2]
GPs are now encouraged to report and share SEAs via their local CCG clinical governance. Other reporting systems include the Medicines and Healthcare products Regulatory Agency's (MHRA) Yellow Card Scheme for adverse medical events. [2]
Restrictions due to the time needed to perform SEA may cause difficulty in going through the process. Other restrictions may include resistance to honesty, the process being emotionally demanding and uncomfortable, and lack of motivation. Leadership and group dynamics may vary and there may be conflicts of interest between staff. [2]
The method of SEA, focusing on the team rather than the individual, is founded on the critical incident technique, developed during the Second World War by aviation psychologist John C. Flanagan, to identify successful and adverse aspects of "combat leadership". Its application now extends to business, organisational psychology, education and healthcare. [2]
Within the NHS, seriously untoward events were analysed via a number of methods including grand rounds, clinico-pathology meetings and confidential enquiries. [2]
In 1995, two general practitioners, Mike Pringle and Colin Bradley, published a "groundbreaking" paper on SEA. [15] They helped instigate and develop SEA into primary care in the UK. [9] Following the publication of A First Class Service , clinical governance was established in April 1999, and subsequently two more documents further promoted SEA as a way of delivering clinical governance. [2]
Pharmacovigilance, also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: pharmakon and vigilare. As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.
Clinical governance is a systematic approach to maintaining and improving the quality of patient care within the National Health Service (NHS). Clinical governance became important in health care after the Bristol heart scandal in 1995, during which an anaesthetist, Dr Stephen Bolsin, exposed the high mortality rate for paediatric cardiac surgery at the Bristol Royal Infirmary. It was originally elaborated within the United Kingdom National Health Service (NHS), and its most widely cited formal definition describes it as:
A framework through which NHS organisations are accountable for continually improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish.
The Association of Anaesthetists, in full the Association of Anaesthetists of Great Britain and Ireland (AAGBI), is a professional association for anaesthetists in the United Kingdom and Ireland.
Clinical audit is a process that has been defined as a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
A serious adverse event (SAE) in human drug trials is defined as any untoward medical occurrence that at any dose
The Royal College of General Practitioners (RCGP) is the professional body for general (medical) practitioners in the United Kingdom. The RCGP represents and supports GPs on key issues including licensing, education, training, research and clinical standards. It is the largest of the medical royal colleges, with over 50,000 members. The RCGP was founded in 1952 in London, England and is a registered charity. Its motto is Cum Scientia Caritas – "Compassion [empowered] with Knowledge."
The General Medical Council (GMC) is a public body that maintains the official register of medical practitioners within the United Kingdom. Its chief responsibility is to "protect, promote and maintain the health and safety of the public" by controlling entry to the register, and suspending or removing members when necessary. It also sets the standards for medical schools in the UK. Membership of the register confers substantial privileges under Part VI of the Medical Act 1983. It is a criminal offence to make a false claim of membership. The GMC is supported by fees paid by its members, and it became a registered charity in 2001.
The Quality and Outcomes Framework (QOF) is a system for the performance management and payment of general practitioners (GPs) in the National Health Service (NHS) in England, Wales, Scotland and Northern Ireland. It was introduced as part of the new general medical services (GMS) contract in April 2004, replacing various other fee arrangements.
Patient safety is a discipline that emphasizes safety in health care through the prevention, reduction, reporting and analysis of error and other types of unnecessary harm that often lead to adverse patient events. The frequency and magnitude of avoidable adverse events, often known as patient safety incidents, experienced by patients was not well known until the 1990s, when multiple countries reported significant numbers of patients harmed and killed by medical errors. Recognizing that healthcare errors impact 1 in every 10 patients around the world, the World Health Organization (WHO) calls patient safety an endemic concern. Indeed, patient safety has emerged as a distinct healthcare discipline supported by an immature yet developing scientific framework. There is a significant transdisciplinary body of theoretical and research literature that informs the science of patient safety.
A patient safety organization (PSO) is a group, institution, or association that improves medical care by reducing medical errors. Common functions of patient safety organizations are data collection and analysis, reporting, education, funding, and advocacy.
The Clinical Practice Research Datalink (CPRD) is an observational and interventional research service that operates as part of the UK Department of Health. It is jointly funded by the National Institute for Health Research (NIHR) and the Medicines and Healthcare products Regulatory Agency (MHRA). CPRD is working closely with the extensive primary care, topic specific and comprehensive NIHR research networks and with NHS Digital.
Revalidation is a mechanism used to "affirm or establish the continuing competence" of health practitioners, whilst strengthening and facilitating ethical and professional "commitment to reducing errors, adhering to best practice and improving quality of care." Medical practitioners, nurses and midwives practicing in the UK are subject to revalidation to prove their skills are up-to-date and they remain fit to practise medicine. It is intended to reassure patients, employers and other professionals, and to contribute to improving patient care and safety. The Medical Board of Australia is currently engaged in a review and trial of revalidation of medical registration in Australia.
Clinical peer review, also known as medical peer review is the process by which health care professionals, including those in nursing and pharmacy, evaluate each other's clinical performance. A discipline-specific process may be referenced accordingly.
Michael Alexander Leary Pringle CBE is a British physician and academic. He is the emeritus professor of general practice (GP) at the University of Nottingham, a past president of the Royal College of General Practitioners (RCGP), best known for his primary care research on clinical audit, significant event audit, revalidation, quality improvement programmes and his contributions to health informatics services and health politics. He is a writer of medicine and fiction, with a number of publications including articles, books, chapters, forewords and guidelines.
Membership of the Royal College of General Practitioners (MRCGP) is a postgraduate medical qualification in the United Kingdom (UK) run by the Royal College of General Practitioners (RCGP). On successful completion of the assessment, general practitioners are eligible to use the post-nominal letters MRCGP that indicate Membership of the RCGP.
Direct care is the care of an identified patient by an identified clinical professional, used throughout the National Health Service in the United Kingdom.
Professor Nick Harding OBE BSc FRCGP FRCP HonMFPH DRCOG DOccMed PGDIP(Cardiology) SFFLM, born 21 December 1969, is a British general practitioner and Chief Medical Officer at Operose Health.
Jack Adcock, a 6-year-old child, was admitted to Leicester Royal Infirmary (LRI) on 18 February 2011. He died later that day, in part because of failings in his treatment. Dr Hadiza Bawa-Garba, the junior doctor who treated him and a nurse, Isabel Amaro, were subsequently found guilty of manslaughter on the grounds of gross negligence. Both were subsequently struck off their respective professional registers, although Bawa-Garba had that decision overturned at appeal. There is an ongoing debate about the judgements against Bawa-Garba, partly around Bawa-Garba's personal culpability versus a context of systemic failures, and partly around the possible use of her reflective notes about her own practice as evidence.
Sir Donald Hamilton Irvine was a British general practitioner (GP) who was president of the General Medical Council (GMC) between 1995 and 2002, during a time when there were a number of high-profile medical failure cases in the UK, including the Alder Hey organs scandal, the Bristol heart scandal and The Shipman Inquiry. He transformed the culture of the GMC by setting out what patients could expect of doctors and is credited with leading significant changes in the regulation of professional medicine and introducing the policy of professional revalidation in the UK.