Review
Clinical risk management in obstetric practice

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Abstract

This review aims to describe why risk management is of particular importance in obstetrics and to describe the practical functioning of the maternity risk management process in a tertiary care teaching hospital maternity service. In addition recent developments such as Duty of Candour, the NHS England Serious Incident Framework, and the Early Notification Scheme for severe new-born brain injury are also covered. This topic is especially relevant given the number of maternity unit scandals over recent years.

Introduction

Risk management as a concept is a process that is not confined to healthcare but can be applied in any situation where there is the possibility of harm occurring. In a generic sense it can be defined as the identification, assessment, and prioritization of risks followed by coordinated and economical application of resources to minimize, monitor, and control the probability and/or impact of unfortunate events.

Informal risk management is something good clinicians have been doing for many years. At its most basic this has entailed recognizing when something “has gone wrong”, investigating events in a reflective manner, and trying to learn from the incident. This is the basis to the morbidity and mortality meetings that most departments have run. However, over the past decade or more the NHS has adopted a more formal approach to risk management. This has been in response to: well publicised failures in care such as the “Bristol heart babies scandal”; a recognition that the application of good practice in regard to risk was patchy; research findings that errors in care were much more prevalent than generally recognized with as many as 1 in 10 hospital in-patients suffering avoidable harm; and a desire to reduce the harm and financial cost associated with medical error. Although the landscape of risk management in the NHS today can appear complex, it is important to recognize that the principles are straight forward: the primary aim of risk management is to improve the quality of care and to achieve better outcomes for our patients, and in order to do that we must look with openness and objectivity at what is happening within the services that we deliver.

Risk management is of particular relevance to maternity care because the consequences of error, such as maternal death or a handicapped baby are so catastrophic. Indeed it is for this reason that many would argue that the labour ward is the area of highest risk within the entire health service. According to the NHS Litigation Authority (NHSLA) in 2015/16, although obstetrics took 3rd place in the ranking of the number of medico-legal claims received by speciality, it took 1st place when specialities are ranked according to the financial value of such claims, accounting for 42% of the total value of all claims received (Figure 1, Figure 2). Not all claims are successful, but nonetheless an increasing amount of money is being paid out by the NHS via the NHSLA in legal costs and claims settlement (Figure 3). In 2015/16 such expenditure amounted to £1488.5 million, approximately 1.28% of the total NHS budget for England, and the figure is progressively rising. At a time of unprecedented financial pressure on clinical services this is a very considerable sum to be spent outside of the clinical environment.

Unfortunately the human cost of maternity claims can be devastating. One of the most tragic outcomes is catastrophic brain damage occurring in a baby who entered the labour or delivery process healthy and undamaged. Such children may require intensive lifelong supportive care, and the impact upon the individual and their family is huge. Not surprisingly the courts tend to award significant damages to fund such care, and awards in such cases now often exceed £10 million. Box 1 summarizes an article from the Daily Mail in 2015 reporting such a case, and captures both the human and financial consequences of such a case. Over the past decade the number of such cases has remained constant at approximately 200 per year, whilst their financial value has increased progressively (Figure 4).

Although there is much national guidance, in practice the management of incidents which do not result in severe harm, will be determined by local trust policy, however the management of incidents graded as severe is subject to reporting to commissioners and NHS England, and specific national guidance. The aim of this review is to describe the functioning of the risk management process from the perspective of the front-line maternity department itself.

Section snippets

Types of risk

Clinical risk management predominantly deals with risk to our patients. The other risks listed in Box 2 all flow from the occurrence of harm to patients. Other risks may be considerable, for example the reputational harm to the Mid Staffordshire NHS Trust arising from the recognition that there had been preventable harm to patients resulted in the dissolution of the organization on 1st November 2014. Specifically what we are interested in is potentially preventable harm to, or death of,

Identification of risk

There are many sources through which information on risk may be identified (Box 3). A well functioning risk management system will receive and analyse information on risk from any source, and will be pro-active in monitoring data and searching out evidence of risk. If the internal sources of data are being used openly and effectively then the department should become aware of risk issues before they come to the attention of external bodies. Also staff members at all levels and all professional

Triage: what happens when an incident is reported?

All incidents submitted through the IRS are triaged by the risk management team. In most maternity units this will be undertaken by the risk/patient safety manager, who will usually be an individual with a clinical background in maternity, with the advice of the obstetric consultant lead for maternity risk where required. In our unit we triage incidents in to one of four categories based on the degree of potentially preventable harm caused by the incident:

  • Green – no harm

  • Yellow – minor harm

  • Amber

Duty of Candour and communication with the patient and family

Communication with the patient and family affected by a significant risk incident is vital. Such communication has always been a hallmark of good medical practice, but it has now become a statutory responsibility since the introduction of Duty of Candour (DOC) in November 2014. DOC applies to all instances where moderate or severe harm may have occurred – therefore it applies to all Amber and Red incidents. In practice complying with DOC largely falls within usual medical practice. An

Information gathering

RCA is central to the investigation of the more serious Amber and Red incidents. Although the functions of the National Patient Safety Agency have now been absorbed in to NHS England, useful guidance regarding how to conduct a root cause analysis may be still be found on their website. The purpose of an RCA investigation is to establish what happened and why, and the depth of investigation will vary according to the nature of the incident – the more serious the incident the greater the depth of

Risk management culture

An effective risk management process is one which “completes the circle”: that is it translates recognition and understanding of risk/error in to effective action which can be seen to improve safety. To achieve this a high level of staff engagement is necessary, which requires a risk management culture which is perceived as learning, educational and supportive – what is termed a “no blame culture”. It is also vital that the learning from the risk management process can be shared as widely as

Medico-legal perspective

One of the issues with medico-legal claims in maternity is that there is usually a considerable time lag between the birth of a handicapped child and the full resolution of a claim; this is because it is not possible to make a complete assessment of a child's needs until they reach the age of 5 or 6. After such an interval it is unlikely that the clinical staff involved will have any realistic prospect of remembering the case. The advantage of a well conducted robust risk investigation is that

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