Introduction

The purpose of health care is to heal, but sometimes it results in unintended harm. For an unbelievably long time in the history of health care, the magnitude of this outcome was not appreciated by the health professions and the public. We were all asleep, so to speak. It is now known that such harm is rife in health care, but that this is largely preventable. Health professionals have woken up to the reality that many patients die or suffer physical and psychological morbidity as a result of professionals’ efforts to care and to cure. Consequently, ‘patient safety’ has become a major preoccupation among contemporary healthcare providers, commissioners, regulators, policy makers, and researchers. The transition from slumber to wide-awakeness was most welcome, but there was one problem: because we were woken with a bang rather than a gentle arousal, we stormed into a frenzy of inchoate patient-safety activities. It was like a family in a troubled environment making a dash for safety without first taking time out to fully assess their situation, get their bearings, and plan their exit strategy and route. Ten years after the rude awakening, various assessments arrived at the conclusion that only limited progress had been made in patient safety despite the frenzy.

The high expectations were not met for many possible reasons. Patient safety can be conceptualised narrowly or broadly; its taxonomy is relatively underdeveloped; it cuts across disciplines as disparate as medicine, cognitive psychology, organisational psychology, engineering, sociology and law; and there are few established metrics — we do not know enough about what elements to measure and how to measure them.

In the first few years of the patient-safety movement, huge emphasis was placed on the reporting of patient-safety incidents. In the UK, risk management became more or less defined by incident reporting. This encouraged a reactive rather than proactive and prospective approach. With the embedding of clinical governance, more attention was paid to the standardisation of healthcare processes through clinical guidelines and clinical audit. Patient safety was already in full gear before the ‘patient’ in ‘patient safety’ was given its due place (‘nothing about me without me)’. Although the scope of patient-safety interventions has broadened over the years, the domains remain rather ill-defined and uncoordinated, and no framework brings all domains together. A ‘patient safety footprint’, which captures all domains, needs to be defined.

What is the patient safety footprint?

The term ‘patient safety footprint’ is used in this paper to encapsulate the totality of attributes and domains that define or describe the degree of protection accorded to patient safety by a healthcare provider. Although the development of strategies and tools for measuring and monitoring patient safety is still in its infancy, this should not stop individual practitioners and organisations from asking ‘how safe is the service that I/we provide?’, in other words, ‘what is my/our patient safety footprint?’. The term is derived from similar (but not identical) usage elsewhere. The term ecological footprint refers to the measure of human demand on the ecosystem. The carbon footprint is the totality of greenhouse gas emissions caused by an individual, organisation, event or product. The water footprint is the cumulative volume of fresh water used by a consumer, producer or process, and the term can be applied to individual consumers, communities, nations, business enterprises or manufactured products.

The patient safety footprint captures the multiple dimensions or domains of safer health care. It is a mark of quality and of progress in quality improvement. In contemporary healthcare delivery, each provider should regard the mapping of patient safety footprint as a corporate and professional responsibility. This responsibility was recently underscored by the much-publicised report of an in-depth inquiry into failings at a UK healthcare provider organisation.

What is the patient safety footprint?

The term ‘patient safety footprint’ is used in this paper to encapsulate the totality of attributes and domains that define or describe the degree of protection accorded to patient safety by a healthcare provider. Although the development of strategies and tools for measuring and monitoring patient safety is still in its infancy, this should not stop individual practitioners and organisations from asking ‘how safe is the service that I/we provide?’, in other words, ‘what is my/our patient safety footprint?’. The term is derived from similar (but not identical) usage elsewhere. The term ecological footprint refers to the measure of human demand on the ecosystem. The carbon footprint is the totality of greenhouse gas emissions caused by an individual, organisation, event or product. The water footprint is the cumulative volume of fresh water used by a consumer, producer or process, and the term can be applied to individual consumers, communities, nations, business enterprises or manufactured products.

The patient safety footprint captures the multiple dimensions or domains of safer health care. It is a mark of quality and of progress in quality improvement. In contemporary healthcare delivery, each provider should regard the mapping of patient safety footprint as a corporate and professional responsibility. This responsibility was recently underscored by the much-publicised report of an in-depth inquiry into failings at a UK healthcare provider organisation.

Patient-safety indicators

Despite the burgeoning of policy, research, management and training activities in patient safety, no framework fully captures the patient-safety footprint. Various indicators of patient safety have been devised, but these are almost always narrowly constructed, covering specific clinical specialties, disease conditions or single domains. Often, these indicators are derived from an approach to patient safety that focuses on prevention of specific medical accidents rather than enhancement of quality (including safety). For example, almost all of the 24 patient safety indicators recommended for use in Europe were clinical measures relating to surgical complications, medication errors, obstetrics, falls, and specific diagnostic areas.

Where domains of safety have been described, one or more domains have been left out. For example, a UK regulatory agency described six key elements of patient safety that boards need to address: leadership, staff engagement, guidelines and training, safety metrics, learning cycle, and resourcing. Missing from this list was patient involvement, a key element to which boards should pay attention.

Pronovost et al. devised a score card for patient safety based on the following four questions: how often do we harm patients? How often do we provide the interventions that patients should receive? How do we know we have learned from defects? How well have we created a culture of safety? The first three of these domains are respectively equivalent to the well-known Donabedian triad of structure, process and outcome, and to these the authors have added a fourth dimension, context. This score card provides a broader framework but does not specify domains of intervention.

A framework with the acronym RADICAL specifies and captures all domains required for mapping the patient safety footprint. The framework was first described as a tool for managing risk in gynaecology. The framework and its underlying principles were subsequently elaborated. In this paper, I describe how RADICAL may be used to map the patient safety footprint, using examples in obstetrics and gynaecology.

The framework

RADICAL comprises the following domains in an integrated grid: (R)aise (A)wareness, (D)esign for safety, (I)nvolve users, (C)ollect and (A)nalyse patient safety data, and (L)earn from patient safety incidents ( Fig. 1 ).

The RADICAL framework.

In addition to comprehensive coverage of the domains of patient safety, RADICAL emphasises the links between domains; these links are as important as the domains themselves. The framework challenges service providers to address each domain and also to show how each domain has informed, and been informed by, other domains.

The framework has foundations in schema theory and in the bionomic approach to patient safety (see chapter on the bionomic approach to patient safety and its application in gynaecological surgery in this issue of Best Practice and Research Clinical Obstetrics and Gynaecology ). The schema theory of learning states that all knowledge is organised into units (schemata). It hypothesises that the schema a person uses during learning will determine how the learner interprets the task to be learned, how the learner understands the information, and what knowledge the learner acquires. A schema is a cognitive framework or concept that helps organise and interpret information, including information about relationships between objects, situations, events and actions. Schemas facilitate comprehension and interpretation of vast data. The RADICAL framework provides schema for organising current knowledge about patient safety, and allows for new knowledge to be readily assimilated. People are more likely to notice things that fit into their schema.

The bionomic approach to patient safety draws on the principles of human ecology, particularly the principles of inter-dependence and integration, and applies them to the understanding, protection, and promotion of patient safety (See chapter on the bionomic approach to patient safety and its application in gynaecological surgery in this issue of Best Practice and Research Clinical Obstetrics and Gynaecology ). The individual healthcare provider is in a dynamic relationship with other components of the healthcare system, including other individual practitioners. The inter-dependence and integration of the domains of patient safety is a quintessential attribute of this approach.

Raise awareness

Generally, healthcare providers are aware of ‘patient safety’, but knowledge of fundamental concepts relating to error reduction, trapping and mitigation tends to be thin. Patient safety is now being incorporated into training at all levels: undergraduate, postgraduate, vocational, and continuing professional education. Individuals should be acutely aware of their role as guardians of patient safety, and be equipped with safety skills required for this role. To give an example of the value of safety skills in obstetrics, regardless of a clinicians’ knowledge of the underlying physiology of electronic fetal monitoring, they could fail to interpret a cardiotocograph appropriately if they lose situational awareness.

Apart from general knowledge about principles of accident causation, healthcare providers need to know about hazards and risks in their areas of practice, and how these can be contained. This awareness is informed by patient-safety data and by lessons learned from safety incidents. It, in turn, informs the design of interventions that contain hazards and prevent accidents.

Awareness is promoted through vehicles such as multi-professional training, newsletters, team meetings, safety alerts, educational supervision, mentoring, preceptorship, and roadshows. For decades, awareness of major risks in maternity care in the UK was generated and maintained by the triennial Confidential Enquiries into Maternal Deaths (CEMD). It was, for example, the CEMD that brought to national attention the contribution of psychiatric conditions to maternal death. Awareness generated by the CEMD was largely responsible for establishing safer practice in thromboembolism prophylaxis, management of hypertensive disorders, and treatment of sepsis in pregnancy.