Image © Marcela Vieira
Introduction
On a worldwide scale, the UK is a safe place to have a baby and recent data suggest a welcomed reduction in the stillbirth rates¹. But complacency can breed failure and we should not ignore the fact that despite the odd ray of sunshine, maternity services in the UK are in trouble. Scarcely a month goes by without some bad news story and there have been multiple independent enquires - Barrow in Furness (2013), Morecambe Bay (2015), Llantrisant/Merthyr Tydfil (2019), Newham Hospital (2019), Shrewsbury and Telford (2020), East Kent (2021), Nottingham (2021), Worcester (2021), London North West (2021), Wye Valley Maternity Unit (2021). Every corner of the country is affected. Tragically, these enquiries are usually prompted by an excess of maternal/neonatal deaths but this mortality represents the tip of the iceberg. Beneath it lies the mass of morbidity which fuels the litigation process. Obstetric settlements are now reaching eye-watering sums of money, which will have a major impact on the public finances in the future².
It has long been recognised that the problems in delivering a safe maternity service are multifactorial³. Expectant mothers do not always have access to high quality, objective information and are instead subjected to anecdotes and social narratives around childbirth which influence their choices. There are significant problems around training in both midwifery and obstetrics, and recruitment and retention are more challenging than in many other specialities. There is hardly a unit in the country with adequate numbers of frontline staff on every shift. Flawed processes surround collection and interpretation of clinical data, workflows are inefficient and poor infrastructure exists in many units. Each of these are topics in their own right, but in this article I shall concentrate on the Maternity Risk Management (MRM) process because this is usually the first step in identification and analysis of adverse clinical outcomes. The reports generated are used for training purposes, shaping the service, managing complaints, providing information to commissioners and regulators, and disclosed to external reviewers, NHS Resolution or litigation lawyers.
Maternity Risk Management – its purpose and evolution
In 1995 the NHS Litigation Authority introduced clinical risk management and all UK maternity units have been required to have a formal MRM process in place ever since. Its aim then, as it is now, was to analyse adverse outcomes, so we learn from our mistakes and put in place safeguards that mitigate against similar events in the future. Back then the process was simple – cases were reported on an ad hoc basis and a self-appointed panel of no more than three, typically a senior consultant, a senior midwife and an administrator, met up once a month to discuss. They spoke to staff involved and wrote a one paragraph conclusion with bullet points to be read out at the next Perinatal Meeting. The mother met with her consultant, a two-line summary of the discussion was recorded in the case notes and a plan drawn up for any future pregnancy. Since then, MRM has exploded into an increasingly complex spiderweb of formal procedures and processes⁴. It now involves online datix reporting systems, healthcare staff from a range of disciplines, dozens of specially appointed administrators, and individuals with specialist job titles - safety experts, complaints managers, communications champions. Reports require laborious and repetitive transcribing of medical records, staff witness statements are formal signed documents, investigators write lengthy reports outlining recommendations and naming individuals who will be accountable for completion of each task. Cases are presented in front of an MRM panel of 10 or more who will further scrutinise the events and invariably make amendments. Reports are then shared with the mother and her relatives, and they too can challenge the contents prompting further redrafting. It is not unusual for each case to involve 12 versions and be circulated in over 40 e-mails taking several months to complete. Cases are graded according to the severity of harm caused and the likelihood of recurrence. Staff involved are required to reflect upon the findings of the investigation during their next appraisal. To avoid criticisms of bias or blame, serious or complex cases have traditionally been referred for external review, a process made formal by the establishment of the Healthcare Safety Investigation Branch (HSIB) in 2017⁵.
This organisation proports to use a standardised approach to maternity investigations to identify common themes and influence systemic change without apportioning blame or liability. Currently just over 1000 maternity cases per year fulfil the criteria for HSIB investigation.
One might think that after almost three decades of increasingly elaborate MRM processes in place, few maternity service delivery problems would remain undetected and unaddressed. During this time, I have attended countless Perinatal Meetings, listened first-hand to mothers’ accounts of their care, helped staff prepare witness statements, undertaken external review, written expert witness reports and attended trials and I have observed that the stories are all the same. I have also read the reports following local/regional/national enquiries and I note that the problems identified are also depressingly recurrent – “a lethal mix of failings”; a “culture of denial, collusion and incompetence”; “pursuit of normal childbirth at any cost”; dysfunctional relationships between staff; staff lacking in skills and knowledge; failure to escalate concerns; “drive to keep the Caesarean rates low”; “multiple missed opportunities”; poor skill mix; poor leadership. And of course, after each investigation come the recommendations and yes, that’s right – these too are all the same. More CTG training, more simulation training, encouraging better communication between disciplines, restructuring teams - again, continuity of care – again, better supervision and mentoring – again, improving workplace culture - again. Often new names given to the same old concepts. These recommendations inevitably prompt an immediate call to arms from maternity service managers and obtain the automatic and unchallenged support from wider organisations such as the Royal College of Obstetricians & Gynaecologists (RCOG) and the National Institute for Clinical Excellence (NICE). To do otherwise would be unacceptable. So why, after several decades of being the focus of national scrutiny and much reform, are there still persistent and recurring problems?
Maternity Risk Management – why it does not work
In short, the reason MRM does not work is because the people in charge of administering and overseeing the process are not the people directly tasked with delivering the service. MRM panels are largely made up of clinical managers and administrative staff whose main job is to achieve targets set out by healthcare commissioners such as those related to Caesarean section rates, or follow processes as set out by NHS regulatory bodies such as the Care Quality Commission. Thus, MRM has been reduced to a managerial tick box exercise where the emphasis is on demonstration of compliance with targets, systems and procedures rather than improvement in perinatal outcomes. Most maternity managers are from a midwifery background, but their clinical experience is meagre and historical and often obtained elsewhere. To maintain Royal College of Midwifery accreditation they do occasional daytime shifts, typically where they are supernumerary, certainly never out of hours or on Bank Holidays, and definitely not involving sole charge of a complex intrapartum case or acting as a Labour Ward Co-ordinator. Therefore, their operational knowledge of workflows is limited. This problem is not confined to midwifery. I have encountered cases where obstetricians on MRM panels are either retired or do not participate in an on-call rota or have jobs which are predominantly gynaecological in nature. These staff have no active experience of the everyday running of the service but are nonetheless in a position to comment on how well or otherwise frontline staff performed. But why should this disconnect matter?
Understanding this helps explain the oft highlighted problem of NHS workplace culture. Key members of MRM panels are typically Heads of Midwifery, Heads of Speciality or Clinical/ Divisional Directors, all of whom are also in charge of appraisal/revalidation, interview panels, facilitating promotions, writing references, signing off job plans, sanctioning sick/annual/maternity leave, exit interviews and so on. Thus, all frontline staff are acutely aware that if any criticism is made of the care they provided, even if anonymised, their recourse to objection or appeal is limited and may have consequences. Many have seen close colleagues destroyed by this process and resign themselves to silence despite knowing that the investigations are poorly conducted and the conclusions ill-judged. They resolve that it is better to be overlooked than to be identified as a protester. In the event of litigation, the lawyers will take weeks if not months to scrutinise decisions they needed to make in a matter of a few split seconds and although this treatment at the hands of “one of your own” is more hurtful, the fear of future ill-treatment ensures their compliance, and the status quo remains. External reviews are slightly more palatable in that they are conducted by individuals not necessarily known to frontline staff, but the quality of the investigation and thus the conclusions reached are the same and, in any event, it will be the local MRM team that is left to implement the recommendations, so interaction between the shop-floor workers and their immediate line managers cannot be by-passed.
Actions that flow from investigations must, in managerial terms, involve change. Ironically, in the NHS most change takes months if not years to action, but there are examples where major changes can occur overnight. For example, drugs that have been successfully used for decades in countless women can be withdrawn from the hospital formulary at the click of a manager’s e-mail simply because a relatively minor adverse drug interaction occurred in one individual. Managers must be seen to have acted on a poor outcome, the greater good is not considered. In another almost comical example of change for the sake of change following a retained swab event, the pre-counted swabs disappeared from delivery packs within a matter of days. It appears not to have dawned on those who issued this instruction that swabs would still be needed for a delivery only now staff would have to open a separate pack, and still have the problem of counting swabs after the delivery, which is where the problem lay in the first place! But these knee-jerk, reactive changes are easy to effect and serve as evidence of actions taken in response to issues raised by MRM, actions which healthcare regulators reward with improved ratings. Other popular changes include introduction of new proformas or re-writing protocols/guidelines, changes that require evermore retraining and engagement from frontline staff. This process has become so complex in recent years that when I review cases now in addition to NICE/RCOG guidelines, I am often sent regional, local, Trust-specific and, in the case of Trusts which operate over several sites, site-specific guidelines! This makes a mockery of standardised practice and probably explains at least in part the observation reported in the recent Getting in Right the First Time review of maternity services of large variations in practice up and down the country⁶.
Perhaps the greatest disappointment is not that MRM is ineffective or a waste of precious resources. These criticisms could be levelled at most managerially driven processes within the NHS. It is the fact that after hundreds of thousands of maternity investigations this process has failed to put the vast amount of collective information obtained to any use. For example, we know that postdates, problems with fetal monitoring in labour, meconium, intrapartum sepsis, fetal malpresentation, unrecognised macrosomia, unrecognised fetal growth restriction, prolonged use of Syntocinon, difficult instrumental deliveries, Caesarean section performed too late or at full cervical dilation are all disproportionally represented in adverse maternity outcomes. Algorithms using these data could better define the dynamic nature of obstetric risk and promote pro-active rather than reactive care. These data could identify factors that influence emergency response times in real life scenarios or be used to help define avoidable versus unavoidable harm, a concept that both clinicians and litigation lawyers struggle with. Analysis of near miss outcomes is equally valuable in that it highlights interventions that steered the course of events away from disaster. Precursors to poor outcome often lie in the antenatal period, so intelligent application of the root cause analysis model could highlight areas of service deficiencies such as obstetric ultrasound or maternity triage where relatively small investments may yield big returns, not to mention help inform mothers better and assist staff in navigating the choppy waters of informed consent in advance of the fraught intrapartum period. These data could have been used to shape a safe service fit for the future by informing intelligent debate and scrutiny of all aspects of maternity care. Instead, it has failed to address the real problems, failed to include women in the maternity safety debate and left frontline staff fearful, demoralised, disengaged and resigned to the status quo. At a recent HSIB training update course a brave participant asked the panel of mainly ex-clinicians the killer question – “what evidence was there that HSIB had improved outcomes?” This was met with the usual fumbling excuses that this was not something that could be quantified, and that this sort of metric was meaningless, and how much Trusts appreciated their input. It seems evidence-based practice does not apply to managerial processes.
Summary
The Maternity Risk Management System has not helped us learn from our mistakes otherwise we would not keep making the same ones repeatedly. This process has failed to improve outcomes, failed to engage staff, failed to address patient concerns and serves only as a template by which maternity management teams are judged. It is no surprise that the recent report into the Safety of Maternity Services in England⁷ concludes that key areas relating to risk require improvement. We shall only begin to learn from our mistakes and address them meaningfully when we learn to truly value our frontline staff, reward and remunerate them adequately, address the challenges they face, allow them to drive change that is relevant to outcome, limit the reach of managerial power and establish an open dialogue with women using risk data to inform them truthfully and accurately. Only then can we shape a maternity service with safety at the heart of clinical strategy.
References:
¹ www.ons.gov.uk – birth characteristics, 2019
² NHS Resolution Annual Report and accounts 2019/2020, published July 2020
³ Health care professionals’ views about safety in maternity services, King’s Fund 2008
⁴ RCOG- Improving Patient Safety: Risk Management for Maternity and Gynaecology, Sept 2009
⁵ www.hsib.org.uk
⁶ GIRFT National Report – Maternity and Gynaecology, September 2021
⁷ House of Commons Health and Social Care Committee: The Safety of Maternity Services in England, June 2021
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