Consultant Obstetrician and Gynaecologist/Head of Obstetrics and Gynaecology School, Yorkshire and the Humber Deanery, Jessop Hospital Wing, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
A serious incident requiring investigation (SIRI), previously known as a serious untoward incident (SUI), is often an unexpected and a traumatic event for all those involved: the patient, their family and friends and healthcare professionals.
Most NHS hospitals have well-developed pathways and processes for dealing with these incidents.
Revalidation takes SIRIs into account.
This article reviews literature, guidance, best practice recommendations and dealing with the aftermath of a SIRI and discusses how these could be applied to obstetrics and gynaecology training at a trust, deanery and national level.
To understand the meaning of a SIRI.
For trainees and trainers to be aware of what to do in the event of a SIRI and the structure of the support available within the workplace.
The challenge of giving constructive criticism to a colleague, trainee or consultant without discouraging or undermining them.
Understanding when performance at work may be affected by an incident at work and how this may impact on patient safety.
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The NHS is one of the largest organisations in the world. In England between January 2011 and March 2012, over 4.3 million people were seen as new patients in outpatient clinics and 668 195 babies were delivered in NHS hospitals. Most patients are seen and treated by dedicated staff and leave satisfied with their level of care. However, in too many cases errors occur. The high turnover of patients and involvement of multiple members of staff in a patient's journey may mean sometimes mistakes happen. We need to learn from these mistakes and strive to prevent further errors in the future.
The General Medical Council (GMC) lists patient care as the first concern for all doctors. In recent years, improving patient safety, with a strong emphasis on learning from adverse events, has become one of the highest priorities for the Department of Health with the advent of the National Patient Safety Agency (NPSA) and the National Framework for Reporting and Learning from Serious Incidents Requiring Investigation.[2, 4, 5]
In this article we discuss serious incidents requiring investigation (SIRIs), previously known as serious untoward incidents (SUIs), with a particular focus on obstetrics and gynaecology and the training perspective.
Definition of a serious incident requiring investigation (SIRI)
In 2010 SUIs were renamed Serious Incidents Requiring Investigation by the National Reporting and Learning System (NRLS), although many NHS trusts continue to use the term ‘SUI’ in their guidance. Since April 2010 each trust has had a statutory duty to report such incidents to the NPSA so that structured investigations can be undertaken and lessons learnt. The most comprehensive definition of incidents of this kind is given by the NRLS in the National Framework for Reporting and Learning from Serious Incidents Requiring Investigation (Box 1). This document outlines a flow diagram of the reporting process.
Unexpected or avoidable death of one or more patients, staff, visitors or members of the public
Serious harm to one or more patients, staff, visitors or members of the public or where the outcome requires life-saving intervention, major surgical/medical intervention, permanent harm or will shorten life expectancy or result in prolonged pain or psychological harm (this includes incidents graded under the NPSA definition of severe harm)
A scenario that prevents or threatens to prevent a provider organisation's ability to continue to deliver healthcare services, for example, actual or potential loss of personal/organisational information, damage to property, reputation or the environment, or IT failure
Allegations of abuse
Adverse media coverage or public concern about the organisation or the wider NHS
One of the core set of ‘never events’ as updated on an annual basis
There is general agreement among most NHS trusts that the definition includes reference to an incident involving the unexpected death or serious harm to one or more patients, staff, visitor or member of the public, attracting or likely to attract public and/or media interest, involving an NHS service or on an NHS premise. It does not necessarily have to be exclusively a clinical issue, for example a power failure may contribute to a SIRI. Medical directors and chief executives have some discretion over whether a particular incident is declared as a SIRI, but in many organisations some incidents which do not actually involve an extreme outcome are reported, in a spirit of openness. The Being Open framework from the NPSA advocates a culture of ‘no blame’, emphasising learning and supporting of staff involved in patient safety incidents. Box 2 illustrates the list of ‘never events’ from the Department of Health.
Box 2. The Department of Health ‘never events’ list 2012/13
Wrong site surgery
Retained foreign object post-operation
Wrongly prepared high-risk injectable medication
Maladministration of potassium-containing solutions
Wrong route administration of chemotherapy
Wrong route administration of oral/enteral treatment
Intravenous administration of epidural medication
Maladministration of insulin
Overdose of midazolam during conscious sedation
Opioid overdose of an opioid-naïve patient
Inappropriate administration of daily oral methotrexate
Suicide using non-collapsible rails
Escape of a transferred prisoner
Falls from unrestricted windows
Entrapment in bedrails
Transfusion of ABO-incompatible blood components
Transplantation of ABO incompatible organs as a result of error
Misplaced nasogastric or orogastric tubes
Wrong gas administered
Failure to monitor and respond to oxygen saturation
Misidentification of patients
Severe scalding of patients
Maternal death due to postpartum haemorrhage after elective caesarean section
The most serious of all incidents in obstetrics is an unexpected maternal death. The UK has the longest history of formal confidential enquiry into maternal deaths in the world, starting in the 1950s. During the triennium 2006 to 2008, 261 women died in the UK, as a direct or indirect consequence of pregnancy. The healthcare professionals involved in these cases have had to cope with the consequences of the death of a young woman and the impact that it has had on her family, friends and wider community, including the hospital in which the healthcare professionals work.
Training and patient safety
The Temple report in 2010 recognised that training and delivery of patient care are inextricably linked, with ‘training being the most important investment in patient safety for the next 30 years’. In 2010, the Medical Defence Union reported that nearly half of the files it opened involving foundation doctors were requests for help in writing reports or statements including those relating to SIRIs. It is clear, therefore, that even in the early stages of a doctor's career it is important to have an understanding of SIRIs, what to do after the event and what support is available. All doctors, including those in training, have an ethical responsibility to contribute to SIRI investigations. Those involved can be left feeling vulnerable to criticism or blame, as well as having to cope with the aftermath when something has gone wrong, regardless of the depth of their involvement. Documentation of events should be legible, accurate and contemporaneous, explaining the decisions made as fully as possible. The names of other staff members involved, drugs used, timings and interventions need to be included, and it should always be stated if notes were written in retrospect.
In obstetrics, simulation is used to train and update midwives and doctors on various emergencies such as shoulder dystocia and postpartum haemorrhage with courses such as ‘Managing Obstetric Emergencies and Trauma (MOET)’. More recently, it has been recognised that to improve patient safety significantly, training on working effectively in teams and understanding ‘human factors’ involved in serious incidents are as essential as improving clinical knowledge and skills.[13, 14] Creating effective teams and a shared understanding between different healthcare professionals treating a patient, reduces the risk of harm and helps to create a better working environment; with less emphasis on ‘blaming’ individuals for errors and, instead, more emphasis on studying problems that occur in the system that have contributed to the mistake.[15, 16] Improving the environment in hospitals and good team working were highlighted by the Francis report as methods to improve the culture within health care for the benefit of patients and staff.
Revalidation started in December 2012 in the UK. As part of this process, all doctors need to report their involvement in SIRIs; for trainees this should be recorded on Form R prior to their Annual Review of Competence Progression (ARCP). Evidence should be provided of a discussion of the event with their educational supervisor as well as a reflection on the learning that has taken place following the incident.
Learning from a serious incident requiring investigation (SIRI)
Part of the process of investigating a SIRI is to understand how and why things went wrong. A case demonstrating a SIRI is available from the NHS Institute of Innovation and Improvement, and includes a patient story and surgeons’ response as a situational awareness video. The case discusses where and why the SIRI occurred.
What the above-mentioned case from the NHS Institute of Innovation and Improvement illustrates is that many mistakes are due to ‘human factors’, including environmental, organisational and individual characteristics that influence a person's behaviour at work. The Patient Safety First document on implementing human factors in health care explains:
‘Healthcare professionals are human beings, and like all human beings, are fallible. In our personal and working lives we all make mistakes in the things we do, or forget to do, but the impact of these is often non-existent, minor or merely creates inconvenience. However, in healthcare there is always the underlying chance that the consequences could be catastrophic’.
If we recognise human factors as an issue, we can use this knowledge to improve patient safety and reduce errors. The Swiss cheese model of organisational accidents shows us that at each stage of a process layers of defence prevent an error occurring. However, if the ‘holes in the cheese’ (latent conditions) are aligned, a ‘window of opportunity’ opens for the error to take place (Figure 1). During most investigations, what becomes clear is that multiple factors were involved.
Being Open recognises that the effect of harming a patient has consequences for all involved: patients, carers and professionals alike. It argues that ‘being open’ about the events surrounding an incident helps everyone and may reduce complaints and litigation. It focuses on dealing with all involved including staff in a compassionate manner and sets out principles to accomplish this: acknowledgement, truthfulness, clear communication, apology, recognition of patients and their carers, and professional support.
An investigation following a serious incident aims to identify all possible factors that may have contributed to the incident. The hospital's risk management team usually undertakes this. Root cause analysis is performed, using problem-solving tools, such as the Ishikawa fishtail or cause and effect diagram. Figure 2 shows the structure of a fishtail diagram used to investigate a patient safety incident. The final SIRI report is comprised of ‘what, who, when, where, how and why’ the event took place, followed by recommendations for changes and how the report and its findings will be disseminated throughout the department. The final part of the report details action plans on how to implement the changes recommended.
What to do as a trainee following a serious incident requiring investigation (SIRI)
Most deaneries have guidance for trainees involved in serious incidents (Box 3). An early reporting system ensures that trainees get the right support and they are advised to meet with their educational supervisor as soon as possible to discuss the case.
Box 3. Initial steps for a trainee to take following a SIRI
Complete an incident form
Ensure your notes are completed accurately, write in retrospect if necessary but be sure to make it clear when you are writing and when the events took place
Take part in the debrief with the team involved
Discuss the event with your educational supervisor
If requested, write a formal statement. Discuss the event and draft statement with a member of the risk management team
Write a reflection of the event, ensuring it is anonymised and include this in your eportfolio
Follow a medical defence organisation's guide to statement writing such as that of the Medical Defence Union (Box 4)
Box 4. Medical Defence Union advice on preparing a report/statement following a SIRI
Refer closely to the relevant clinical records when preparing a statement
Identify yourself at the beginning of your report with your full name, professional qualifications, experience and status (for example, FY1 doctor). Describe the capacity in which you reviewed the patient and whether this was with another member of the healthcare team. Write in the first person
The report should be capable of standing on its own. Don't assume that the reader of the report has any background knowledge of the case
List the documents you relied on in giving your report and also make clear whether any aspects of your report are based on your memory of events or usual practice
Give a factual description of the chronology of events as you saw them, referring to your clinical notes as a framework
Describe each and every consultation or contact with the patient in turn and make reference to your working diagnosis at each stage and any other action that you took such as discussion with senior colleagues
Avoid the use of medical abbreviations, for example BP should be written as blood pressure and SOB as shortness of breath
Any reference to medication should include the type of medication, such as, antidepressant, antihypertensive and so on, as well as the full dosage and route of administration
Completing an incident form is essential to allow an investigation to commence. The investigation process involves fact finding to obtain an accurate picture of the events with a timeline of the incident and events preceding it drawn up. This is analysed and the processes of care compared with any local protocols or national guidance. The investigation should be conducted in the spirit of openness, involving the patient or their family. Debriefing staff is important as well as providing support to help them engage with the investigation. The results are disseminated to all stakeholders and an action plan is formulated from the investigation's recommendations.
Depending on the nature of the incident, the investigation may lead to a coroner's inquest or GMC fitness to practise case. A coroner's inquest is held in public and therefore attending a hearing to understand what takes place can be helpful if you have been called to give evidence in a future case. It must be remembered that as a public hearing the media may also be present generating uncomfortable press coverage.
In cases involving the coroner be guided by the risk management team and inform your medical defence organisation. Taking time out from clinical practice should be discussed, if felt necessary, with your educational supervisor, college tutor and training programme director. In most cases, supported supervised training is more appropriate to restore confidence and clinical abilities. Exclusion is very unusual and should be viewed as a ‘neutral action’ to protect those involved and allow an investigation to proceed.
Stress is recognised as a contributing factor to staff making mistakes. SIRIs are often very emotionally and physically demanding, and can leave staff with a feeling of reduced control over the situation, so reducing normal coping mechanisms for dealing with stress. For individuals already under stress, experiencing a SIRI can have a serious effect on their abilities to continue functioning at home or work. In surveys involving surgeons and anaesthetists who had experienced an intraoperative death, the majority felt that it was ‘part of the job’ and although some felt that counselling should have been offered, none was available. A high proportion continued to operate after a death on the table. However, of those who did stop, many gave fatigue as a reason, possibly alluding to a common immediate symptom experienced after a stressful event. Expert opinion during the Sheehan inquiry that took place after the deaths of two patients on the same elective list, recommended that after an intraoperative death, surgeons should stop operating that day. The Association of Anaesthetists of Great Britain and Ireland guidance After an unexpected death on the table makes it clear that an assessment should be made on whether the anaesthetist can continue with their list or on call duty. Those involved in a SIRI are likely to go through a range of emotions and physical reactions (Box 5).[22, 23] It is important to recognise that most of these are normal and will diminish over time, but also to understand when and how to ask for help if necessary.
Box 5. Symptoms that may be experienced after involvement in a serious incident
Common feelings after the event*
Reliving the event
‘Doom and gloom’
*These should lessen after a week and fade over time
Feelings that indicate support is required
If any of the common feelings after the event continue for long periods
Feeling overwhelmed by the events
Feeling burnt out
Work performance affected
Feeling isolated/withdrawn behaviour
Difficulty concentrating/poor concentration
The time it takes someone to recover from significant stress depends on their personality, coping mechanisms and available support. If not dealt with, longer-term effects can occur including loss of confidence or emotional detachment. Box 6 lists some personal ‘do's and don'ts’ following a SIRI.
Box 6. Some personal do's and don'ts following a SIRI[22, 23]
Do cooperate with all investigations
Do be open, honest, timely with your documentation/statement of the event, seek help and advice from the risk management team
Do get support from senior colleagues/mentor/educational supervisor and/or college tutor
Do remember to give yourself time to recover
Do get help with other difficult cases or duties
Do seek counselling and support if you are struggling to cope/feeling overwhelmed by the events
Don't become isolated
Don't drink or smoke or self-medicate
The Confidential Enquiry into Maternal and Child Health 2000–2002 advised that staff involved in a maternal death should be offered supportive counselling. This would seem obvious especially in light of some evidence that healthcare professionals may be more at risk of mental health problems than the general population. In Getting a Life, the RCOG recognised that doctors may often struggle with work–life balance, which may lead to stress and burnout.
Not all doctors require formal counselling, but for those who struggle to cope or wish to obtain more support, occupational health can signpost staff towards counselling services provided by the hospital trust. Deaneries and now Local Education and Training Boards (LETBs) also provide independent counselling services for trainees in difficulty.
Counselling and debriefing require appropriate training. The Association of Anaesthetists of Great Britain and Ireland advises that counselling should be provided within the first 72 hours after an incident has taken place if those involved wish to access it. Critical incident stress debriefing has been used for emergency workers in the US and Australia to help reduce long-term effects of stress following a serious incident. It involves a ‘peer-support system’, facilitated by trained counsellors who help individuals involved to recognise symptoms and signs of stress after a critical incident and work together to resolve these. It can help to accelerate recovery and allows those involved to deal with the emotional effects of the critical incident more effectively, however, its critics argue that there is no conclusive evidence that psychological debriefing after a critical event is effective and can do more harm than good. They recognise that each person may have a different response to adverse events and in most cases the effects will follow the normal course of lessening over time.
Employers have a duty of care towards their employees but an individual also has a responsibility to ensure they are fit to work. This is especially true for healthcare professionals for whom patient safety is paramount. The Royal College of General Practitioners has reviewed the evidence of the effects of doctors working under stress may have on their patients and concluded that patient safety can be jeopardised.
Involvement of trainers following a serious incident requiring investigation (SIRI)
All educational supervisors and college tutors should be informed in the event of a SIRI involving a trainee. Ensure that an appointment is made to meet with the trainee as soon as possible to offer support and identify any training needs. Remind them of the importance of writing a reflection on the incident for their logbook and for the purposes of revalidation. Be aware of counselling support services available locally within the trust, deanery or Local Education and Training Board, and national organisations (Box 7) and provide contact information for these services when you meet the trainee. Ensure that the clinical director, director of postgraduate medical education at the trust and the training programme director are aware of the event in case further support for the trainee or yourself is necessary. If it is felt that the trainee may need to take time off, this should be discussed with the college tutor and training programme director, however, continuing to work under direct clinical supervision may be more appropriate. Offer continuing support and attendance at court if the SIRI leads to a coroner's inquest. Finally, be sure to keep written records of all discussions with the trainee and avoid informal discussions with colleagues in open settings. Maintain confidentiality for all concerned.
Box 7. Independent organisations providing support for doctors
SIRIs can have a profound effect on all those involved and by understanding that human factors play a major role in their occurrence, can allow individuals and organisations to put systems in place to mitigate these factors. Reporting and investigation of these incidents allows us to learn from them and make recommendations to improve patient safety by trying to reduce the chances of similar events taking place in the future.[4, 5]
Disclosure of interests
There are no conflicts of interest for any of the authors.
Contribution to authorship
MM took a substantial role in the original concept for the article as well as drafting and revising the article. RG contributed significantly to the concept, drafting and revising of the article. AEC and DJF made significant contributions in critically reviewing and revising the article. All authors were involved in the approval of the final version.