What are the Underlying Causes of Patient Safety Incidents in Intrapartum Care?
In 16 of the 25 cases of intrapartum-related stillbirth reviewed by the Perinatal Institute, there was poor interpretation of the fetal heart rate [7]. In six cases, there was no appropriate management plan for labour. Other factors implicated in the review include failure to escalate a problem and obtain senior input (18 cases); delay in management/expediting delivery (12 cases); inappropriate use of oxytocics, causing hyper-stimulation (5 cases); and substandard neonatal resuscitation (7 of the 9 neonatal deaths). There was concern about the quality of record keeping in 21 of the 25 cases.
In the study of term or near-term babies born with metabolic acidosis, suboptimal care included failure to respond within the specified time limit in response to a pathological cardiotocograph (CTG) pattern of ≥40 min duration (with the exception of bradycardia), and failure to perform a CTG despite indications [9]. Care was considered suboptimal in relation to administration of oxytocin if this drug was administered without a valid indication, started or increased despite a pathological CTG pattern or uterine hyperactivity or short increment intervals were applied (less than 15 min), or there was uterine hyper-stimulation (six or more uterine contractions per 10 min interval, for more than 20 min), or a CTG tracing was not used continuously.
These deficiencies in clinical care are commonly manifestations of generic deficiencies relating to teamwork. The King’s Fund inquiry into the safety of maternity units in the UK identified inter-professional relationships between doctors and midwives, difficulties with leadership and management, and difficulties with communication between clinicians, ‘particularly at crunch points such as referrals between health professionals, shift changes and in emergencies’, as key problems [11].
These findings from clinical studies and national inquiry indicate that intrapartum risk management could save many mothers and babies from death, neurodevelopmental handicap and other physical or psychological trauma.
Design for Safety
Error in clinical practice cannot be completely eradicated, and risk management should focus more on prevention of harm. In the delivery suite, the vast majority of preventable harm to mothers and babies can be minimized by adopting the following strategies and tactics: (a) standardization of care; (b) good handover practice; (c) maintaining situational awareness; (d) appropriately interpreting and responding to CTGs; (d) judicious use of oxytocin; and (e) early detection of deterioration in maternal condition and responding appropriately to any such deterioration.
Standardization of Care
Variance in clinical care, particularly where such variance is arbitrary, provides fertile ground for unsafe practice. Standardization helps to reduce variance, minimize confusion and promote patient safety. All maternity units should have evidence-supported protocols and guidelines covering various conditions and treatments, including high-risk situations such as vaginal birth after caesarean delivery, medical disorders such as pre-eclampsia, obstetric emergencies such as postpartum haemorrhage and shoulder dystocia, and operative interventions such as instrumental delivery and repair of perineal tears. Although these guidelines are in place in many units, they are often lengthy and unwieldy.
Good Handover Practice
Patient safety requires effective communication and shared mental models with respect to evolving clinical and logistic challenges. The points in the patient’s journey at which there is a transfer of care from one clinician or team to another are ‘hot spots’ of vulnerability: pathogens that threaten patient safety could creep in as a result of communication defects and poor execution of care plans. There is also the risk of the patient’s care falling into the virtual space between professionals. On the delivery suite, the key to avoiding these risks is the inter-shift handover, which affords an opportunity for the team to undertake a baseline assessment of the current clinical situation, assess the resources available (staff, beds, cots, etc.), anticipate developments (‘feed-forward’), plan contingencies and disseminate lessons learned from safety incidents. Each delivery suite should have a structured multidisciplinary inter-shift handover (SMITH) protocol which encompasses pre-handover, handover and post-handover behaviour [12]. This will also help address the inter-professional communication problem identified by the King’s Fund inquiry, as mentioned above. Clarity of purpose and goals is fostered when structured communication (such as the SBAR – Situation, Background, Assessment, Recommendation – framework) is used to report assessments.
Maintaining Situational Awareness
The King’s Fund inquiry recommended that safety awareness training should be introduced into mainstream professional education. Situational awareness is a skill that should be a major part of such training. It is the cognitive state of being aware of what is happening around oneself and understanding how evolving events could affect one’s goals and objectives; it is the ability to maintain the ‘big picture’ and think ahead. It is essential for patient safety on the delivery suite, and without it there can be no effective leadership, appropriate decision making or coherent teamwork [13]. Strategies for maintaining situational awareness include proactively seeking and managing information on unfolding events (e.g. by undertaking periodic ward rounds), implementing a buddy system (periodically the CTG is assessed by a fresh pair of eyes) and use of checklists [14–16]. The World Health Organization (WHO) Surgical Safety checklist has been shown in a random-allocation trial to be effective in reducing perioperative complications, and has been adapted for use in maternity units. In addition to the checks stipulated in the WHO checklist, the maternity checklist requires staff to: check that the resuscitaire is in working order and the neonatal team have been called, if required; ensure that the urinary catheter is draining; check that the baby/babies have been identified with ID bands; and check that cord bloods have been taken, if required.
Checklists have also been used for reporting vaginal examinations, electronic fetal monitoring, fetal scalp blood sampling and operative vaginal deliveries, and for documenting the management of a range of conditions such as shoulder dystocia and postpartum haemorrhage. They help to standardize care and to avoid the deleterious effects of fatigue and cognitive overload, but clinicians using checklists should beware of involuntary automaticity, the phenomenon where an operator drifts into an ‘autopilot’ mode without being aware, devotes minimal attention to the task in hand and becomes at risk of perpetrating an error [17].
Team situational awareness can easily be compromised when staff are working in conditions of high cognitive load and psychological stress due to workforce pressures. A UK national audit showed that there was a shortfall of 2300 in midwives in 2012 (calculated using a benchmark of 29.5 births per midwife per year) and 28 per cent of maternity units reported that they closed to admissions for half a day or more between April and September 2012 [1].
Appropriately Interpreting and Responding to CTGs
Despite the widespread use of electronic fetal monitoring in intrapartum care in resource-rich countries for over three decades, misinterpretation of CTGs in labour and failure to respond appropriately to abnormal traces remain frequent and are major causes of harm to babies. In this author’s opinion, there are two reasons for this. First, the teaching of CTG interpretation has traditionally been based on pattern recognition, with a tendency to bypass the underlying physiology. Such an approach confers the advantage of expediency, but encourages ‘superficial’ rather than deep learning (in educational theory, the ‘superficial’ approach limits learning to isolated facts that are subsequently reproduced, whereas ‘deep learning’ promotes understanding that can be applied in unfamiliar as well as familiar contexts). Second, there is a tacit assumption that failures of interpretation are always due to knowledge deficits, whereas in many cases the problem is not lack of knowledge but perception deficit associated with fatigue, cognitive overload or other factors associated with loss of situational awareness. Risk management interventions aimed at improving CTG interpretation should take account of these two underlying causes of poor interpretation and/or response [18]. The use of a buddy system (‘a fresh pair of eyes’), for example, attempts to pick up perception defects before they result in harm [14].
Judicious Use of Oxytocin
Oxytocin is the most commonly used but also the most dangerous drug in routine obstetric practice. When used judiciously, it is generally safe. Injudicious use is associated with uterine tachysystole, uterine rupture, fetal heart rate abnormalities and concomitant problems, including fetal demise. This risk of serious harm if the drug is administered incorrectly warrants an oxytocin administration protocol based on the best available evidence. In high-risk situations, particularly in the presence of a uterine scar, intrapartum oxytocin should not be administered without the prior approval of a senior obstetrician and without discussing the risk with the woman.
A practical problem is that care providers do not always find the right balance between ‘pushing’ the oxytocin infusion in order to achieve optimal strength and frequency of contractions, and ensuring the safety of mother and baby. Attempts to reduce the incidence of harm and litigation associated with oxytocin have focused on implementation of conservative protocols, with mixed results. In one study, the protocol led to lower oxytocin maximal dosing and lower intensive care nursery admission rates, but greater postpartum blood loss, wound infection and a trend towards higher caesarean delivery rates [19]. In another study, low-dose oxytocin protocols resulted in fewer caesarean deliveries performed for fetal distress (32.52% vs. 38.67%; p = 0.02), but there were significantly higher rates of chorioamnionitis, longer median time from admission to delivery and more caesarean deliveries performed for lack of progress in labour [20].
A meta-analysis did not resolve the question, partly because the definition of high- and low-dose protocols and the outcomes that were measured varied considerably across the nine trials that were included in the analysis [21].
From a practical rather than academic standpoint, perhaps the key issue is not necessarily the oxytocin regime, but the superficial learning of the attending staff (akin to that discussed above in relation to CTGs). The training of staff who are involved in the administration of intrapartum oxytocin should include information about the uterine response rate to oxytocin, the half-life of oxytocin and down-regulation of oxytocin receptors [22]. Knowledge of these facts and concepts should inform clinical practice.
Early Detection of Deterioration in Maternal Condition and Responding Appropriately
With the uptake of scenario training (‘skills drills’), maternity units have progressively become better at managing acute emergencies such as massive haemorrhage and shoulder dystocia. There has, however, been slower progress in the recognition and management of situations where there is a gradual, rather than acute or precipitate, deterioration in the condition of the woman or her baby. Sadly, many women suffer serious morbidity or mortality because their deterioration has not been recognized or has not been managed appropriately [5]. To address the problem of recognition, a Modified Early Obstetric Warning Score (MEOWS) chart was introduced for routine use in the care of all pregnant or postpartum women who become unwell (Figure 29.2) [4,5]. The UK Confidential Enquiry report recommends that care providers should use the charted observations in order to ‘ensure confirmation of normality rather than presumption’ [5]. In other words, use of the chart should change behaviour such that clinicians constantly seek objective confirmation of normality, rather than presume normality and passively await any development that challenges this presumption. The report also states that ‘it is the response to the abnormal score that will affect outcome, not simply its documentation’ – another pointer to the importance of clinician behaviour in the management of risk.
Maternity units in tertiary centres where there is a relatively heavy caseload of high-risk cases should have a dedicated high-dependency room or bay for women who need closer monitoring. Local protocols should specify thresholds for escalation of clinical concerns so that critically ill women are seen by staff with appropriate experience and expertise. With increased consultant presence in the delivery suite, the recurring problem of failure to escalate concerns should be less frequent.
Involve Users
In the last two decades there has been a gradual retreat from the paternalistic approach to clinical practice (‘the doctor knows best’), with concomitantly increasing recognition of the patient’s right to be involved in decisions about her care. ‘Nothing about me without me’ has become the mantra for champions of patient involvement in healthcare delivery. There are, however, two conceptual problems in the current movement.
One is that patient involvement in health services delivery has largely been conceived in terms of patient representation on committees (exemplified by the recruitment of patients into Maternity Services Liaison Committees) – but this is only one dimension of patient involvement. Involvement of pregnant, recently pregnant and non-pregnant women as committee members in policy making and in the design and organization of maternity services is important, but their involvement as front line individuals at the point of healthcare delivery is also important.
The other is that this domain of the RADICAL framework encompasses all users of health services, not just the woman/patient. ‘Users’ of maternity services include not only the woman but also her family and birth partner (who may be a friend or other associate). The engagement of partners is particularly important. Often, partners are witnesses as an error chain develops, and if they are engaged, informed and empowered, they will be in a better position to break the error chain – by asking questions, expressing concerns, alerting midwives and doctors, and supporting the woman in decision making.
The Scottish Health Council has published a document to guide boards and managers in promoting service user involvement in maternity services [23]. The recommendations in this guidance include the use of tools (such as questionnaires, comments cards, graffiti boards, kiosks and handheld patient devices) which encourage women to provide feedback during their hospital treatment, and the use of new technologies (such as Skype, Twitter and social networking sites) to promote user involvement. Community groups, employment networks and education networks could be used to engage maternity service users and to disseminate safety information.
Data collected using the tools and networks listed above also fall under the ‘Collect and Analyse data’ domain of the RADICAL framework, and should be applied in other domains such as raising awareness, design of services and organizational learning. This way, the essence of the framework – that all risk management domains should be integrated – is achieved.
Engagement of users at the front line of intrapartum care should start with antenatal education. A contentious and challenging issue in intrapartum care is how to obtain a valid consent for interventions such as caesarean delivery and operative vaginal delivery when a woman is in the throes of labour. While it is usually an institutional requirement for a consent form to be signed for an emergency caesarean delivery, such ‘consent’ is of questionable (and in many cases, no) legal standing. In the Western world, at least two in every ten deliveries is caesarean, and one in ten deliveries is an operative vaginal delivery. This means that at least three of every ten women will have an operative delivery. All women and their birth partners should be made aware of this chance antenatally, and be provided with appropriate quantity and quality of information. This would help make consent discussions in an emergency intrapartum situation easier and more meaningful.
Involving users also entails finding out how they perceive and respond to safety concerns. Constructive engagement of users during intrapartum care promotes not only clinical safety but also psychological safety. A qualitative study funded by the King’s Fund found that the woman was far more likely to feel unsafe in cases where she and her midwife failed to form this bond; when asked to consider the most important elements of a safe birth, all women talked about having enough experienced staff available [24].
It is also essential to communicate risk in an appropriate and clear manner to women and their families, in order to facilitate safe health behaviour and compliance with medical advice. The UK Confidential Enquiry found that ‘it was not clear that women were made aware of the gravity of the risks they may encounter when refusing to take the advised course of action recommended by their doctor or midwife’ [5].