One of the greatest achievements of the past 10 years is the acknowledgement that medical, nursing and midwifery error can lead to patient harm and instigate more open discussion by health professionals, politicians and the general public (Vincent, 2010). Previously, many adverse health care events were witnessed that could have been avoided had the lessons of past experience been learned properly. Vincent (2010) noted that although many adverse events took place, health professionals and the public showed no appetite for investigating them.
In 2000, a report commissioned by health ministers from an expert group under the chairmanship of the chief medical officer set out to review the nature and scale of serious failures in health care. The report, An organisation with a memory, examined the factors involved in organisational failure. It took a range of practical experience from other sectors, looked at the state of learning from adverse events within the NHS and made recommendations that are still in effect today.
At the time this report was written, the cost to the NHS of adverse incidents was an estimated £2 billion a year in additional hospital stays alone, without taking account of human or wider economic costs (Department of Health (DH), 2000). The report identified that human error was sometimes the factor that immediately precipitated a serious failure, but frequently there were deeper systemic factors. If addressed, these could have prevented the error or acted as a safety net to mitigate the consequences.
Vincent et al (2001) retrospectively studied hospital case records to make preliminary estimates of the incidence and costs of medical errors. He concluded that approximately 11% of patients admitted to hospital experienced an adverse event. Some events were serious and traumatic for both patients and staff. Others were frequent and so minor that they went unnoticed in routine clinical care. Together, these event types have economic consequences.
It was estimated that the costs of settling lawsuits for midwifery mistakes in 2010 was £86.5 million (Campbell, 2011). Most of this cost was to address the burden of caring for an injured child. Such large economic and personal costs create regular newspaper headlines and form the basis of much discussion around the need for a rigorous risk management process in midwifery. The midwife carries a tremendous responsibility and when something goes wrong is immediately made aware she will be facing considerable pressure from impending investigative procedures. In most cases this will be carried out by both her employing organisation and her Local Supervisory Authority (LSA). This may have an impact on her health, financial security and her personal and professional life.
Supervision and midwifery risk management
Tools to assist midwifery incident investigation have been developed and used by supervisors of midwives (SoMs) and risk managers for several years. One example is the National Patient Safety Agency (NPSA) ‘incident decision tree’ that supports a root cause analysis (Meadows et al, 2005). The incident decision tree is also frequently used in health care domains. Such tools were created to assist NHS managers, senior clinicians and SoMs to provide a process for investigating actions by staff involved in serious adverse incidents. However, although some of these tools are useful, they have tended to be reporting systems that were management driven and not tailored specifically to midwifery. Porteous (2011) noted that while collaboration between midwifery management and midwifery supervision is vital to the success of any investigation into practice, it should be stressed that SoMs are required to conduct their own investigations on behalf of the LSA, independent of any management inquiry.
The Nurses, Midwives and Health Visitors’ Act 1992 introduced the role of SoM as a means of regulating the profession by ensuring midwives were appropriately educated. The Act was repealed and replaced in 1997, but the role of the SoM has remained the same. Essentially, SoMs aim to protect mothers and babies by actively promoting safe practice, identifying poor practice and taking remedial action when required. This statutory supervision of midwives is independent of employment to ensure midwives registered and working within the UK are entitled to practise as midwives and remain on that part of the Nursing and Midwifery Council's (NMC's) register (Porteous, 2011).
Since 2007 midwifery supervisory investigations have been based on the NMC's standards for supervised practice (NMC, 2007). This aims to provide a consistent approach for SoMs to investigate adverse incidents involving midwives during the course of their practice (Capito, 2009). The SoM is also encouraged to seek advice at any time during the investigation from her local supervising authority midwifery officer (LSAMO). The LSAMO has the authority to suspend a midwife from practice at any time or to refer them to the NMC.
When examining this statutory function it is essential to note that it is looking primarily at midwifery practice issues and attempting to identify deviations from the midwifery rules and standards (NMC, 2012). These standards describe what would reasonably be expected from a practising midwife. Following conclusion of the investigation, the SoM recommends a course of action for the midwife involved. This can be either no action, a local action plan, a local supervising authority practice programme or referral to the NMC.
Supervisory investigation process
Following an adverse event the SoM uses a decision toolkit to decide whether there is adequate information to judge whether to proceed to a formal investigation. If there is any uncertainty prompts can be followed as indicated on the decision-making proforma. If the SoM, after consulting with the LSAMO, decides that the incident merits a full supervisory investigation the formal investigation process begins. The report includes a chronological event timeline detailing the incident as it unfolded. The event log notes the time, actions, staff involved, evidence source and the SoM's commentary.
Reasons for deciding to investigate are documented. After consulting the LSAMO the midwife is informed verbally and by letter of the decision to conduct a local investigation, including the reasons why. The midwife is informed that the investigatory process should take no longer than 45 days. She is also asked to produce a statement of her involvement in the incident. The midwife's own SoM and the health care Trust's head of midwifery are informed and given the time and place of the supervisory interview. The investigating SoM must not be the named SoM for the midwife concerned. The named SoM will support the midwife during the investigatory process.
During the interview details of the midwife's actions during the adverse event are recorded by a scribe and a copy of the transcript is sent to both the midwife, her named SoM and the LSAMO within a week for all to verify. The midwife being investigated and the investigating SoM should have had access to all relevant medical and midwifery records before the interview. The investigation can include patients and their families and other professional colleagues.
Importantly, the supervisory investigation can be performed concurrently with a management investigation, although these must not be carried out by the same individual.
A summary of concerns is drawn up and a detailed analysis of each concern is identified with reference to relevant NMC documents, national policies and guidelines relating to evidence-based practice, as well as local the health care Trust's policies. The investigatory process then identifies mitigation issues in three areas: human factors, system delivery factors and local governance problems that are, and could be, relevant to the event.
The summary of the investigation's findings is produced from the facts and evidence, and a recommendation to the LSA chosen from one of four options. In order of severity these are:
The report along with the recommended outcome is shared with the head of midwifery and can, on behalf of the LSA, when applicable, be shared with the woman and her family. The midwife has a period of 10 working days to appeal to her LSA once she has been informed of the recommendation.
Accountability
Gould (2009) notes that professional recognition in midwifery comes at no insignificant cost, as midwifery supervision was written into statute at that time. She goes on to say that midwifery supervision, although presented as supportive, was borne out of necessity in an era disproportionally influenced by men and medicalisation. Midwifery supervision is ultimately there to protect the public through professional accountability and responsibility linked to statutory professional regulation.
The DH (2010) view is that midwives are supported in providing safe, family-focused maternity services through a supervisory framework. Statutory supervision of midwives protects the public by promoting best practice, preventing poor practice and intervening in unacceptable practice. SoMs are instrumental in promoting the core role of the midwife and in ensuring that service delivery models are safe, family-centred and evidence-based (DH, 2010). It has become apparent that accountability has become a concern for many professional groups not least midwives and has become a matter for specific attention over the past two decades.
Nursing and midwifery have been in the vanguard of accepting the concept of accountability. Bergman (1981) believed that the reasons for this came from society and the profession. As health care resources are limited, the public is unhappy to see scarce resources spent without a reasonable explanation of how they are being used. The public is now better educated and demanding a part in the decision making and evaluation of their health care.
In many areas throughout Britain there are local action groups such as ‘maternity services liaison committees’. These are frequently attended and supported by local SoMs who receive feedback and incorporate the opinions into local service delivery. As far back as 1993 the government accepted an expert report called Changing childbirth, which recommended giving women more choice in their care (DH, 1993). The changes carried out were not a response to the increasing litigation, which was an issue at that time, but as a result of pressure from consumer groups and midwives (Drife, 1995).
Professionally, midwives are no longer blindly directed by other professionals and the problem-solving nature of the job requires analysis and accounting to oneself and others. Midwives are autonomous at the point of registration and take on responsibilities on a scale not observed in other professions until advanced practice level. The professional role and responsibility is expanding and midwives, like other professionals, feel the need to share, report, be judged and approved.
There has been much written dissecting the issue of accountability. Walker (2002), in his paper on theoretical models and their implications for social service organisations, argued that accountability was a theoretically embedded concept, with each theory producing various conflicting models. He distinguished objective accountability from subjective responsibility: objective accountability being the formal obligation to give an account of one's actions to those in super-ordinate positions of authority. Subjective responsibility is understood not as a formal externally imposed duty but as a ‘felt sense of obligation’.
Responsibility and regulation
Within the process of the supervisory investigation, the midwife is called upon to account for her actions. The midwife submits a statement of her involvement in the incident, which is discussed in detail during the subsequent investigatory interview. Her actions are then mapped against various NMC rules and standards and The Code, which clearly defines responsibilities. This investigatory process predominately uses a person-centred risk management model. However, there is recognition of a systems approach in the section for mitigation. This allows the investigating SoM to identify system delivery and local governance problems. Reason (2000) noted that the person-centred approach remained the dominant tradition in medicine. He argued that blaming individuals is always more emotionally satisfying than targeting institutions.
Reason (2000) suggested that by focusing on the individual origins of error, unsafe acts are isolated from their system context—a serious weakness of the person-centred approach. Far from being random, mistakes tend to fall into recurrent patterns and the same set of circumstances can provoke similar errors regardless of the people involved. However in the first few years of the patient safety movement, errors were deemed to stem largely from system flaws (Wachter, 2012). He argued that this was swinging back towards individual and collective accountability, the latter being the accountability at a collective level of the clinician, health care team and organisation.
Until as recently as the past decade there was little concerted effort to address issues of harm and safety at an organisational level. Safety was largely subsumed within the clinical governance agenda and deemed the responsibility of individual clinicians. The focus was on retrospective reporting of adverse incidents rather than proactive approaches to improving patient safety. The National Patient Safety Agency (NPSA) (2004) published Seven steps to patient safety—an overview guide for NHS staff. This argued that studies have shown that the best way of reducing error rates is to target the underlying systems failures, rather than take action against individuals. It gave the first step to patient safety as the creation of a culture that is open and fair (NPSA, 2004).
Separating supervision from regulation
The Scottish Patient Safety Programme (2002) is a government sponsored approach to improve the safety of patients across the Scottish health care system. The maternity workstream (MQIC) is currently focusing on safety issues that have been identified from adverse event reporting. Some of the information that has led to the identification of issues has been derived from midwifery supervisory investigations. The staff work culture and the promotion of multidisciplinary teamwork forms a large part of this agenda.
The supervision investigatory process sits alongside the local risk management system of the health care trust. Without adequate consultation it can lead to confusion for the midwife involved in the supervision investigation. Despite every LSA reporting on all their investigations and themes in their annual report to the NMC, individual reports are confidential to the midwife, her Trust and the individual involved. However, the details and teachings from these reported themes are not often discussed by midwives in a wider forum. This differs from the local health care Trust risk management policy, in which the number and type of adverse events are regularly circulated to all staff in a newsletter.
Step 6 of the NPSA's report (2004), encourages organisations to use root cause analysis to learn how and why incidents happen. Emslie et al (2002) describes this at its simplest level as getting the right people together to constructively and openly look at the sequence of events leading up to an incident to determine the underlying systematic causes.
Conversely, the supervision investigation is carried out by one SoM with the assistance and guidance of her LSAMO. Although the process involves undertaking a detailed analysis of all the identified concerns taking account of mitigating ‘systems factors’, the report focuses almost entirely on the individual midwife's ‘fitness-to-practise’
The Parliamentary and Health Service Ombudsman (2013), suggested that the midwifery supervision and regulatory arrangements at local level failed to identify poor midwifery practice at Morecambe Bay NHS Foundation Trust. Cases investigated were said to have illuminated a potential confusion of the supervisory and regulatory roles of SoMs. Some cases also highlighted that the current arrangements did not always allow information about poor care to be escalated effectively to the hospital's clinical governance regulatory system. The NMC undertook extraordinary reviews of the Morecambe Bay NHS Foundation Trust, including an examination of whether supervision was achieving the required standard (NMC, 2011). In response to this learning, the midwives’ rules and standards were revised in 2012 (NMC, 2012). These changes were designed to mitigate any risks inherent in the SoM's dual role of support and regulation.
There are few similarities to the supervisory arrangements for midwifery in the regulation of other professions. The closest example is the role of the Responsible Officer within medical regulation. However, there are important differences between the Responsible Officer's role, which was established to help deliver revalidation, and the SoMs, as the Responsible Officer does not have a role in investigating adverse events on behalf of the General Medical Council (GMC). The GMC believed this introduced a conflict of interest. As medical directors, Responsible Officers might have a vested interest in having their doctors deemed fit for revalidation, consequently it was felt this allowed for inconsistency.
This important document concluded that the NMC is not a system regulator and therefore while it sets requirements, and receives information, relating to systems it does not have powers of enforcement. As a mechanism for regulation midwifery supervision has been accused of weaknesses in its regulatory purposes. Its cost-effectiveness and suitability for recommending to other groups of health professionals has been questioned. The report recommended that midwifery supervision and regulation should be separated, and that the NMC should directly control regulatory activity.
Regulation
The Law Commission's remit was to review the UK law relating to the regulation of health care professionals and, in England only, the regulation of social workers (Law Commission, 2013). There are nine regulatory bodies, one of which is the NMC, which are responsible for regulating 32 professions in the UK—consisting of approximately 1.44 million professionals. The draft Bill creates a single legal framework for all the regulators of health and social care professionals. The regulators’ existing governing legislation would be repealed, and replaced with a single Act of Parliament to provide the legal framework. The NMC would retain its obligations to make rules regulating midwifery practice. The current schemes of protected titles and functions would be maintained, subject to amendment only by government.
The regulators would be given flexibility around how to investigate allegations. There is no requirement in the draft Bill to establish statutory investigation committees. The regulators would all have the same powers to establish systems of case examiners or formal panel hearings. This draft Bill gives all the regulators a general power to require the disclosure of all information where the fitness-to-practise of a registrant is in question. It would appear that under this proposed system fitness to practice would be wholly the decision of the regulatory body and not the LSA.
Case for supervisory investigations
The supervisory investigation has been criticised for being associated with the ‘blame culture’ and for creating a duplication of the investigation process, exposing the midwife in question to two stressful investigatory processes. Midwives may make some mistakes because of human error and some will be caused by inadequate organisational structures and system failures (Porteous, 2011). However, these mistakes are not the same as a misconduct or a lack of competence, which the supervisory investigations are best placed to identify and manage.
Reason's work on human error is frequently cited as the main force behind the ‘no blame’ approach to medical error. However, he argued that justice works two ways, and severe sanctions for the few can protect the innocence of many. He stressed that if staff are a danger to patients they should not be caring for them (Reason, 2000). Therefore, if midwifery is proud of its autonomy it should also be accountable for any lack of competence.
Paeglis (2012) added an interesting concept to the debate on supervisory investigations when she suggested that they be carried out by a SoM outside the health care Trust within which the concern arose. An evaluation of this initiative was outlined in the Yorkshire and Humberside LSA Annual report (Paeglis et al, 2010). The overall qualitative finding was that the human skills of the investigating supervisor were of most significance whether internally or externally led. Additional benefits included more objectivity and clarity between the LSA and the management process.
Critics have also purported that this supervision process places the midwife in the dock while medical colleagues involved with an incident are not under a similar investigation. Travaglia et al (2011) examined the perspectives of five groups of health care workers to compare and contrast their descriptions of quality and safety activities. They concluded that clear differences in the perspectives of professional groups were evident. Their research suggested that for nurses and midwives safety was associated with ‘practice and policy’ and ‘ward and care’. Safety for the medical staff was about improvement in their professional skills. Unlike nurses who directly linked mechanisms of quality and safety to their work, medical staff conceptually distanced these activities from their ‘medical work’.
As the safety and quality movement passes into a third decade it is thought that much of what Wachter called the ‘low hanging fruit’ has now been picked (Travaglia, 2011). Most well developed organisations now have a selection of risk management strategies in place. Different models are required for assessing human factors and system issues, and for assessing all other influencing variables.
Conclusion
Evidence suggests that the supervisory investigation process needs to be retained. It is uniquely placed for midwifery fitness-to-practise issues to be examined by an SoM who is an experienced clinical midwife, not a manager who may be neither a midwife or a clinician. The LSA can protect the public by taking immediate action to suspend a midwife pending referral to the NMC. It is a statutory responsibility of the SoM to investigate critical incidents and identify any action required, while seeking to achieve a positive learning experience for the midwife involved. Gould (2009) noted that the tenure of midwifery supervised practice is never broken and spent, unlike the management system where any disciplinary action is always time limited and removed from file after a certain length of time. This is an area that could be explored for review and comparison.
The supervisory investigative process is required to communicate to midwives the gravity of what is at stake. Supervisors of midwives above all else must be able to convey to midwives the real cost of their professionalism in their daily interactions and talk about accountability and professional responsibility to midwives at all stages in their career. Capito 2009 noted that the aim of this investigatory process is to reduce the number of midwives being referred to the NMC, as well as ensuring competency and improved quality in midwifery care. It is not yet evident what system will be put in place following the Law Commission's recommendations and the possibility of action following investigative procedures being placed largely in the hands of the NMC regulatory body.
The statutory supervision of midwives, being independent of employment, has identified and highlighted the need for the role of the SoM, as an experienced clinical midwife providing clinical leadership throughout the investigation.
Until any change is imposed, the supervisory investigation process should be retained to provide midwives with this comprehensive statutory function to ensure the security of the profession.