7 Ensuring safety and quality
Introduction
We will focus on the actual application of risk assessment strategies and clinical governance related to midwifery continuity of care as developed by health services in several different countries. These perspectives and approaches reflect the ‘techno-rational approach’ (Davis-Floyd 2002) and dominant view in current discourses about risk in health care, and which are applied to the organisation of maternity services. In doing so we are mindful of another significant body of work that provides valuable social and cultural interpretations of risk assessment and of woman-centred approaches to ‘working with risk’ (Skinner 2006) and ‘being safe in practice’ (Smythe 2003), which are important concepts to incorporate into best practice maternity care. We recommend that you consider this material to aid a broader understanding of how we manage risk and work with women in the promotion of safe and effective care.
The chapter begins with some definitions and descriptions of how concepts of ‘safety’ and ‘quality’ are referred to both in the literature and in practice. Midwives, obstetricians and users of maternity services for example, see the concept of ‘risk’ differently. The challenges inherent in dealing with clinical uncertainty are explored in some detail. Frameworks for the effective management of risk are described using both service-wide and model-specific international examples. Strategically, the international quality and safety frameworks emphasise and mandate integration of services and the development of networks within maternity services. In doing so, they buttress midwifery continuity of care projects into existing mainstream services, promoting their sustainability. Strategies for ensuring consistency in practice, and the maintenance of high standards of professional care in midwifery continuity of care in Australia, New Zealand and the United Kingdom are explored at the end of the chapter.
Starting with terminology
Clinical governance: Clinical governance is defined as ‘the framework through which [health] organisations are accountable for continuously improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish’. The main components are clear lines of responsibility and accountability for clinical practice, clinical practice improvement programs, risk management systems, incident monitoring and professional practice performance monitoring and development systems (Department of Health 1998).
Incident: An incident is an unplanned event resulting in or having the potential for injury, ill health, damage or other loss. Any event that could have had adverse consequences but did not, and is indistinguishable from fully-fledged adverse events in all but outcome, should also be considered to be an incident. These are known as ‘near misses’ (NSW Health 2003).
Quality: Quality in relation to health care is often best described by a framework including attributes or performance characteristics. Generally quality frameworks include safety, effectiveness, patient centredness, timeliness, efficiency and equitability of care (Committee on Quality Health Care in America 2001).
Risk: Risk is defined as the chance of something happening that will have an impact upon objectives. It is usually measured in terms of consequences and likelihood (Standards Australia & Standards New Zealand 2004).
Risk management: Risk management includes the culture, processes and structures that are directed towards the effective management of potential opportunities and adverse effects (Standards Australia & Standards New Zealand 2004). Clinical risk management is risk management within the clinical context, and obstetric risk management is risk management within the obstetric context. Risk management strategies, tools or controls are initiatives aimed at eliminating or minimising identified risk.
Safety: Most definitions of safety within health care define it in terms of absence of harm. The World Health Organization (2007) describes ‘patient safety solutions’ as ‘any system, design or intervention that has demonstrated the ability to prevent or mitigate patient harm stemming from the processes of health care’.
Perception of risk
Perhaps the biggest challenge to safety and quality in maternity service provision is the individual or, in some cases, collective perception of risk. The word risk generally has a negative connotation. When we think of risk, we usually think of some danger, jeopardy, peril, hazard, menace or threat. When discussing the risks associated with pregnancy with women we invariably focus on the negative or unwanted outcomes. Compounding this, individuals can modify their own perception of risk.
We rarely, if ever, think of risk in its broadest sense, which is best described as ‘the chance of something happening that will have an impact on objectives’ (Standards Australia & Standards New Zealand 2004). Clearly, from such a definition impacts can be both positive and negative. This is perhaps best evidenced in the financial world where the perception of risk that drives activity is generally a positive one. Risk is often specified in terms of an event or circumstance and the consequences that flow from it, and it is usually measured in terms of a combination of the consequences of an event and their likelihood (Standards Australia & Standards New Zealand 2004).
Challenges to safety and quality
Clinical risk management and uncertainty
Clinical risk management is a subset of the broad notion of risk management. Every action or inaction in clinical decision making may be associated with positive and negative effects. The complexity of some clinical situations means that not all risks can be anticipated or known. However even in straightforward clinical scenarios, for example whether to have a particular test or not, risk may not be adequately discussed because of gaps in knowledge or simply that there is uncertainty as to how much and what information should be communicated. Midwives, particularly in midwifery continuity of care models, confront this regularly in antenatal care provision. Box 1 outlines some of the fundamental challenges in discussing clinical risk in health generally. These need to be adapted to the context of midwifery continuity of care.
Box 1 Fundamental challenges in promoting safety and quality in health care
Let’s take a look at a practical example of what we are talking about. Read the following story from practice and reflect on how you might discuss the risks associated with this woman’s pregnancy in the context of midwifery continuity of care.
When we talk about risk and maternity service provision, including midwifery continuity of care, the issue is complicated by the socio-political events of the last 20 years where risk management and risk avoidance have become synonymous. In obstetrics, in the past decade caesarean section has been seen as the preferred clinical risk ‘treatment’. In Australia there was a professional indemnity insurance crisis in the 1990s, when obstetricians and the federal and state governments wrestled with the issue of who should fund indemnity for specialist obstetricians. This environment and these events saw the clinical practice of obstetrics, and maternity care more generally, change considerably. Then in 2000, the much criticised Term Breech Trial (Hannah et al. 2000) further added to changes in obstetric practice. All of these influences have resulted in significant changes in clinical practice (declining obstetric skills, increasing rates of placenta praevia–accreta and so on), which in turn now need to be ‘risk managed’ by the clinicians and health service. While these issues are specific to Australia, similar changes, reforms and re-organisations have occurred in other countries including New Zealand and across the United Kingdom. These changes have had similar flow-on effects on maternity care provision.
The quality and safety agenda has been slow to be embraced by some clinicians, and the concept of risk management is not well understood. Threats to personal autonomy and perceived personal risk seem to dominate any discussion on clinical risk management. Examination of clinical decision making reveals that intuition plays an important role. Such intuition involves personal ‘decision rules’ which are often built up over many years: ‘once a caesarean always a caesarean’, ‘never trust a multipara’, ‘breech plus one other risk factor equals caesarean section’ are examples of such ‘decision rules’. What appears to also operate is that intuitive decision making is more likely to occur particularly under conditions of uncertainty (Hall 2002).
With respect to clinical decision making, there are three main sources of uncertainty: technical, personal and conceptual (Hall 2002). The main technical source of uncertainty is that there is usually insufficient information to predict outcomes. The clinician–patient relationship itself can contribute to a degree of personal uncertainty. Conceptual uncertainty results from an inability to assess differing patient needs for the same resources; the application of general criteria to individual patients; or the applicability of past experiences to present patients. The net result is the tendency to uphold medical orthodoxy, that is the safest and most comfortable position is to do what others are doing. Such uncertainty can be a considerable source of stress, which can be evidenced by responses such as withdrawal from active professional involvement, black humour, bullying and harassment. Another concerning outcome from such uncertainty is that it can stimulate activity, in other words the propensity to resolve uncertainty and ambiguity by action rather than inaction. This may, in part, explain the rising intervention rates seen in maternity care in most western countries over the last 15 years.
Midwifery and obstetric education will go some way to overcoming the difficulties in decision making and dealing with uncertainty. However in order to overcome individual or group perception of risk, a generic framework for risk management is required. In Australia and New Zealand we were fortunate to have such a framework with the Australian and New Zealand Standard (2004) AS/NZS 4360: Risk Management (Box 3). This standard, while not specifically tailored for maternity services, is widely used for risk management in many contexts such as finance or insurance, and similar standards exist in other parts of the developed world. While this framework is specific to Australia and New Zealand, the essential elements will be present in almost all risk management frameworks. We have had experience of using the framework to implement and sustain midwifery continuity of care, which makes it useful for discussion.
Applying such a generic framework to changes in maternity service provision is possible (Tracy et al. 2005). The results of such an exercise include the establishment of a comprehensive risk register, an action plan for the proposed additional controls, the development of an evaluation tool for existing and additional controls, and the ability for additional controls to be incorporated into the plan for the service. The process of applying the framework in midwifery continuity of care models can be a positive change management strategy.
Risk management in action
A risk assessment framework for MGP: Australia
The Ryde Midwifery Group Practice (RMGP) is a primary maternity service utilising caseload midwifery that enables pregnant women from Ryde, Sydney, to give birth at their local hospital and receive continuity of care from a known midwife throughout their pregnancy, birth and postnatal period. The service was developed in collaboration with consumers and doctors from the Ryde area and commenced in March 2004 (Tracy & Hartz 2005).
While appropriate and innovative by Australian standards, this midwifery-led model of care presented unknown and untested safety, organisational and operational risks in the local context. To facilitate the integration of the new service into the existing service, the Australian and New Zealand Standard AS/NZS 4360: Risk Management (Standards Australia & Standards New Zealand 2004) was utilised to develop the risk management framework.
In 2003, local integration of maternity services as well as a number of other catalysts prompted a review of maternity services at Ryde Hospital. These catalysts included diminishing obstetric analgesia–anaesthesia capabilities, falling birth numbers, concerns over the quality and safety of the existing service model; all of which were emerging in the presence of strong consumer demand for a continuing local service. They provided the impetus for a change in the way maternity services were delivered at Ryde. A local solution for this problem was sought. Establishment of the RMGP represented a reorganisation of existing midwifery services to meet the needs of women attending Ryde Hospital.