Regulatory and Political Determinants of Approaches to Safety

We have illustrated our five strategies within hospitals from the perspectives of both managers and frontline clinicians. To some degree they can determine the strategies they use to enhance safety. However they are also constrained by the wider regulatory and political environment. Regulators and politicians also have to decide on safety strategies for the wider system and their actions also determine the nature and feasibility of safety strategies within the organisations they influence. The two examples below show that the wider regulatory and political environment has a powerful influence not only on the form of healthcare that is delivered but on the safety strategies that can be adopted.

In France, the regulations governing radiotherapy, which are the province of the Nuclear Safety Agency (ASN), are much stricter than those governing the use of chemotherapy which is overseen by Haute Autorite de Sante (HAS). As a result, radiotherapists work to an ultra-safe model with many stipulations about the conditions of operation and an absolute requirement to minimise all errors and adverse events. ASN never hesitates to audit and suspend approval in cases of overdose or other serious problems. In contrast, oncologists have much greater freedom of action and are able to begin with a high dose (to bring maximum benefit) and reduce the dose as necessary depending on the patient's tolerance of unacceptable side effects. There are strict controls on the pharmaceutical production and on the preparation of chemotherapy, but comparatively few restraints on decisions about dose which are determined by the expert judgement of oncologists. These differences are in large part due to the different highlevel requirements coming from the relevant authorities. Risk controls are

Fig. 7.3 Safety strategies in peri-operative care in Europe and the United States

imposed on radiotherapy, while much autonomy and adaptation is allowed for chemotherapy.

Different political contexts and levels of funding obviously influence the healthcare that can be delivered but also affect the safety strategies that can be employed. In this respect there are marked differences between approaches

adopted in Europe and the United States in the surgical treatment of older patients with complex problems (Fig. 7.3). In Europe approximately 8.5 % of patients having major surgery are admitted to intensive care at some point in their hospital stay; mortality can be 4 % for all patients overall and as high as 20 % for older patients who are a poor anaesthetic risk. In contrast in the United States, 61 % of similar patients are admitted to intensive care; mortality is 2.1 % for all patients and 10–15 % for older patients with anaesthetic risk. These improvements in outcome in the United States are impressive but come at a considerable cost. In 2013, critical care services alone accounted for 4 % of all US health care expenditures, or nearly 1 % GDP (Neuman and Fleisher 2013). Europe has not made that choice which in turn means that different strategies must be employed which have a much stronger emphasis on the detection of problems and rapid response to mitigate the expected poorer outcomes (Fig. 7.3). In fact differences in mortality between high and low-volume hospitals are not associated with large differences in complication rates. Instead, these differences seem to be associated with the ability of a hospital to effectively rescue patients from complications. Strategies focusing on the timely recognition and management of complications once they occur may be essential to improving outcomes at low-volume hospitals (Ghaferi et al. 2009, 2011).

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