‘While in the later parts of this volume I have described the, at times, complex methods by which obstetric difficulties may be surmounted, I must from the outset make plain to the reader that the foundation of successful and safe obstetrics rests foremost upon prevention rather than upon operative skill. Many of the serious complications of pregnancy and most of the hazards of labour can be prevented, or their dangerous consequences obviated, if they were anticipated’.
PR Myerscough
Munro Kerr’s Operative Obstetrics, 10th edition, 1982
Introduction
The practice of operative obstetrics is underpinned by the Hippocratic exhortation, primum non nocere (first, do no harm). Unfortunately, errors do happen and sometimes these result in harm to the patient. Harm may result not only from errors of commission but also from errors of omission (particularly, failure to take preventative action). Intrapartum care is particularly susceptible to patient safety incidents, for a variety of reasons including: there are effectively two patients in one (mother and baby); swift transitions occur from low to high-risk situations; the margins between safety and harm in intrapartum care are thin; high levels of both surgical and medical expertise are often required; and speedy action is frequently essential.
Maternity care providers are obliged to adopt a systematic approach towards reducing the risk of incidents and of harm to patients. Risk management provides this approach. It is the totality of attitudes, structures and processes that are employed in a formal and integrated manner to protect the safety of patients and other service users. It addresses the following basic questions: What could go wrong? What are the chances of it happening and what would be the impact? What can we do to minimize the chance of this happening or to mitigate damage when it has gone wrong? What can we learn from things that have gone wrong, and how can lessons be shared?
The risk of patient safety incidents is likely to be contained more effectively if these questions are addressed proactively and prospectively, rather than by fire-fighting after the event. Often, however, efforts to manage risk during labour and delivery are haphazard rather than tailored, reactive rather than proactive, and diffuse rather than integrated.
One way of facilitating an integrated and proactive approach to risk management is the use of the RADICAL framework, which comprises the following domains in an integrated grid: Raise Awareness, Design for safety, Involve users, Collect and Analyse patient safety data, and Learn from patient safety incidents. RADICAL is both a procedural and cognitive framework; it is a way of conceptualizing risk management, emphasizing the integration of various domains and finding a balance between the individual practitioner’s accountability and the responsibilities of the organization.
Raising Awareness
To effectively reduce the occurrence of patient safety incidents on the labour ward, staff need to be aware of the prevalence and underlying causes of these incidents. In this regard, awareness can be raised through local newsletters, clinical and academic meetings, maternity dashboards (a tool to benchmark quality and safety against agreed standards) and multiprofessional education. Local and national statistics concerning legal claims and complaints are also useful and should be widely disseminated.
Are Delivery Units as Safe as They Should Be?
Legal claims for problems occurring in labour are sometimes in excess of £6m per claim. An analysis of maternity claims in the period 2000–2010 published by the UK National Health Service Litigation Authority showed that there were 5087 injury claims out of a total of 5.5m births. Although this amounts to less than one claim for every 1000 births, not every injury results in a claim and claims are the tip of the iceberg; also, not every episode of error in healthcare results in harm. The three most frequent categories of claim were those relating to management of labour (14.05%), caesarean section (13.24%) and cerebral palsy (10.65%). Two of these categories, namely cerebral palsy and management of labour, along with cardiotocograph (CTG) interpretation, were also the most expensive and together accounted for 70% of the total value of all the maternity claims. Other harms which commonly result in claims include perineal trauma and uterine rupture. The key risk management themes that emerged from the project were the need for formal processes to manage risk at all levels; learning and training; supervision and support; protocols and guidance; and learning lessons from patient safety incidents.
Many patient safety incidents are potentially preventable. Previous studies, for example, implicated suboptimal care in half of maternal deaths and three-quarters of intrapartum-related fetal/neonatal deaths. High profile investigations and reports indicate that basic safety concerns are not always addressed, and case studies show that a proactive, formal programme to improve safety in childbirth yields measurable improvements.
Underlying Causes
Factors that have been implicated in failures of maternity services include systemic deficiencies in the management of high-risk cases; lack of input from consultants (including absence of consultant ward rounds on the labour ward); ineffective teamwork between obstetricians and midwives; workforce deficiencies; failure to recognize severity of a woman’s condition; and poor documentation.
Some of these factors (such as workforce issues and the organization of services) are intrinsic characteristics of the department that predispose to the occurrence of incidents (‘latent pathogens’), and their control requires an organizational approach. Others relate to individual practitioner knowledge, skills and competencies, and behaviour, which are amenable to correction by individual effort. It is particularly important for doctors and midwives to be aware of the value of non-technical skills in reducing the occurrence of patient safety incidents. These skills include teamwork, leadership and situational awareness.
Situational awareness is being aware of unfolding events and understanding how these affect individual and team goals and objectives; it is the ability to maintain the ‘big picture’ and think ahead. This is an important attribute on the labour ward. A consistent finding of enquiries into intrapartum-related perinatal deaths was that they were due mainly to clinicians’ failure to recognize a problem and take appropriate action. In the National Health Service Litigation Authority (NHSLA) report, only 21% of the claims involved high-risk pregnancies, indicating the need to keep the eye on the ball at all times; the transition from low risk to high risk could be swift. Practices and interventions that help maintain situational awareness include having cardiotocograph readings ‘buddied’ periodically (a second clinician independently interprets the trace), and the use of checklists. In some obstetric units in the UK, a checklist/sticker is used each time a CTG is interpreted to ensure none of the key elements (baseline rate, accelerations, decelerations, variability, overall classification and plan) is omitted.
Another way of maintaining situational awareness is to continually assess and reassess priorities, ensuring that staff are deployed appropriately and that each woman gets the attention she needs when she needs it. For this purpose, the labour ward whiteboard should be seen and treated as a dynamic rather than static dashboard.
Design for Safety
Human error cannot be totally eliminated, but the risk of patient safety incidents can be reduced if, at individual and unit levels, we aim to provide care in a way that reflects safety awareness and a commitment to reducing the likelihood of error. Interventions such as clinical practice guidelines, care bundles, communication tools, handover protocols, promotion of hand hygiene, use of a surgical safety checklist and team training fall under this domain.
Clinical Practice Guidance
One safety lesson from ‘high-reliability organizations’ (such as the aviation industry) is that errors are less likely to happen if processes are standardized and if there is less reliance on memory. Staff should have access to referenced, evidence-based multidisciplinary guidelines for the management of various conditions and scenarios in labour and delivery. Ideally these should be available electronically. Policies and guidelines should be reviewed and updated, following a pre-specified schedule (e.g. every 3 years) and when there are major new research findings that warrant immediate change of practice. The Royal College of Obstetricians and Gynaecologists, Society of Obstetricians and Gynaecologists of Canada, Royal Australia and New Zealand College of Obstetricians and Gynaecologists and the American College of Obstetricians and Gynecologists have produced rich repositories of evidence-based guidelines and clinical standards which are accessible on their websites. The UK National Institute for Health and Clinical Excellence has also produced evidence-based guidelines for intrapartum care. The delivery unit should be proactive in addressing high-risk conditions such as oxytocin induction and augmentation of labour, interpretation of CTG, vaginal birth after caesarean section, operative vaginal delivery, massive obstetric haemorrhage, obesity and management of perineal trauma.
Tools Facilitating Delivery of Safer Care
Teamwork, effective communication, training and avoidance of fatigue are essential for protecting patient safety on the labour ward and in the operating theatre. A variety of tools have been devised to address this.
A care bundle is a group of evidence-based interventions related to a disease or care process that, when executed together, result in better outcomes than when implemented individually. Care bundles have been developed for induction and augmentation of labour and for electronic fetal monitoring, and the care bundle for placenta praevia has been found to be particularly useful and easy to implement.
The use of a surgical safety checklist has been shown to reduce the occurrence of patient safety incidents, and one has been devised specifically for maternity services. Implementation of the checklist is straightforward and facilitates team work.
There should be a personal, recorded handover of care between staff when there is a change of shift and when a patient is transferred from one professional to another. Each delivery unit should have its own structured multidisciplinary intershift handover (SMITH) protocol specifying what should be done before a handover ward round begins, how the handover should be conducted and how action points from the ward round should be documented and followed up.
Interpretation of Cardiotocographs: Beware of Cognitive and Systemic Pitfalls
While it is widely recognized that failure of CTG interpretation is a common antecedent of patient safety incidents, interventions to address the problem are almost always based on the premise that these failures reflect a knowledge deficit. Education on the correct interpretation of CTGs will increase knowledge and promote better interpretation, but it must be complemented by interventions that address other sources of failure to recognize or act on an abnormal CTG. These other sources include team and communication failures, fatigue and loss of situational awareness (discussed above).
Oxytocin: Boon or Bane?
The use of oxytocin is one of the most beneficial pharmacological interventions in obstetrics, but its injudicious use is also one of the most common causes of adverse outcomes and litigation. Projects that encourage clinicians to treat oxytocin with respect have been shown to decrease not only the incidence of uterine tachysystole but also the rate of primary caesarean section.
To ensure that this time-honoured drug remains a boon rather than bane, guidelines for its use should be adhered to. The indication for induction or augmentation of labour should be clear, the infusion regime should be followed to the letter, the fetus should be continuously monitored, and uterine contractions and the progress of labour should be carefully assessed. Malpresentation and obstructed labour should be excluded before labour is induced or augmented. Particular care should be taken in multiparous women and those with a uterine scar. In such cases, oxytocin should be used only with the approval of a senior obstetrician. In the event of uterine tachysystole, there should be timely recognition, and the infusion should be reduced or discontinued, depending on the fetal cardiograph. Oxytocin should not be used in labour where there are no facilities for an immediate caesarean section.
The same degree of respect accorded to oxytocin should be extended to other oxytocic drugs such as prostaglandin and misoprostol. In contemporary obstetric practice in the developed world, spontaneous rupture of the multigravid uterus is rare, and the vast majority of ruptures follow the administration of oxytocic drugs (prostaglandin or oxytocin) to induce or augment labour in a scarred uterus. Local guidelines should be categorical about how oxytocics may or may not be used in women scheduled for vaginal birth after caesarean section.
Instrumental Delivery: To Fail to Prepare Is to Prepare to Fail
Approximately 1 in 10 deliveries in the Western world is an instrumental delivery, and morbidity from this operation could be considerable. Obstetricians and midwives should therefore be attuned to patient safety issues in operative vaginal delivery, adequate preparation and pre-application assessment being the key to harm-free care. The path to safety traverses the following:
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The use of non-operative interventions (such as delayed pushing) to reduce the rate of instrumental deliveries
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Making the right decisions as to when instrumental delivery is indicated or contraindicated
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Appropriate management of ‘trial of instrumental delivery’
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Ensuring competence and supervision
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Keeping good records of instrumental deliveries
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Maintaining mindfulness and awareness of error-inducing factors
Table 2-1 gives a taxonomy of error in instrumental delivery that could be used to contain risk.
Type of Error | Description | Possible Consequence | Safe Practice |
---|---|---|---|
A: Action | |||
Operation omitted | Abdominal palpation not done | Level of presenting part misjudged | Use of proforma/checklist |
Operation mistimed | Rotation done during a contraction | Cervical spine injury to the fetus | Rotate only when uterus is relaxed |
Operation too long or too short | Prolonged traction | Intracranial injury | Stick to time limits and number of pulls |
Operation in wrong | Traction directed forwards and upwards too soon; this causes premature extension of the head, as a result of which a larger diameter of the head emerges at the introitus | Third degree perineal tear | Mind axis of traction |
Operation too much | Continuous traction applied | Compression of fetal head | Only apply traction during contraction |
B: Information Retrieval | |||
Information not retrieved | No assessment regarding thromboprophylaxis | Prophylaxis not prescribed | Incorporate this assessment into documentation proforma |
History of diabetes disregarded | Shoulder dystocia not anticipated | Identify background risk factors before offering instrumental delivery | |
Wrong information retrieved | Mistaken head level or position | Misapplication of instrument; trauma | Double check |
Thinking the cervix is fully dilated when it is not | Cervical tear | ||
Incomplete information retrieved | Failure to assess moulding | Traumatic delivery; brain injury | Adopt systematic approach to assessment |
Omission of equipment check | Delay in delivery; stress and impairment of cognition | ||
C: Procedural Checks | |||
Check omitted or not properly done | Failure to ensure cup does not catch tissue | Vaginal laceration | Training |
Check for proper application of forceps not done | Trauma to baby’s face and eye | Understand reason for check | |
No check for descent with pull | Undue traction applied | Beware of confirmation bias | |
PR not done at end of procedure | Third degree tear missed | Include VE, PR, swab check in documentation | |
VE not done at end of procedure. Swabs not counted | Retained swab in vagina | ||
D: Communication | |||
Failure to communicate | With woman | Valid consent not obtained | Verbal and eye contact; empathy |
With midwife | Patient given conflicting information | Preoperative briefing | |
With senior colleague | Required supervision not provided | ||
With anaesthetist | Inadequate analgesia | Team work | |
With paediatrician | Neonatal resuscitation delayed | ||
E: Selection (Choosing from a Number of Options) | |||
Wrong ventouse cup type | Avoidable failure of ventouse | ||
Ill-advised sequential instrumentation | Neonatal handicap | ||
F: Cognition | |||
Failure to anticipate | Failure to anticipate PPH in prolonged labour | Massive haemorrhage | Have Syntocinon infusion ready at delivery |
Failure to ask the right questions | No descent despite traction: is position correctly determined? Is pull in the right direction? | Trauma | Situational awareness |
Forceps have less than secure grip of head: is there undiagnosed OP? Is forceps applied over baby’s face? | Trauma | Situational awareness |