Toward Safer Care: Reporting Systems, Checklists and Process Standardization

September 27, 2011

Health care is a decade or more behind other high-risk industries in its attention to basic safety. By comparison, the aviation industry has focused extensively on building safe systems since World War II, and its ongoing efforts have produced the intended results. For instance, between 1990 and 1994, the airline fatality rate in the United States was less than one-third the rate experienced in mid-century. This culminated in an exemplary year in 1998—the first year with zero passenger deaths on any commercial airlines in that country.

In health care, preventable injuries resulting from care have been estimated to affect between 3% and 4% of hospital patients.1 The increased complexity of health care has led to a corresponding increase in the number of medical errors. A significant proportion of hospitalized patients (up to 10%) suffer a medical error, nearly half of which are preventable.2 Broadly speaking, our patients are victims of 5 categories of harm: being subjected to a sudden (sometimes catastrophic) event, encountering a poorly performing practitioner, being treated by a service that performs suboptimally over a period of time, being unable to gain access to best practice, or experiencing a recognized complication or side effect of treatment.

Significant advances in patient safety have been made internationally through the World Health Organization (WHO) Patient Safety Program (formerly the World Alliance for Patient Safety) and through legislation that paves the way for patient safety to become a key component of clinical care.3 Yet patient safety is not readily embraced as a public health problem. Unless this is rectified, we will never understand the true burden of harm associated with patient safety, nor will we be able to provide robust, evidence-based solutions.

What About Reporting Systems?

A notable patient safety reporting system in the United Kingdom is the National Reporting and Learning System (NRLS), which is housed at the National Patient Safety Agency (NPSA) in England and Wales. To date, it is one of the largest systems in the world and contains over 5.5 million records of incidents related to patient safety. The database has 75 data fields, including patient demographics, specialty, location and category of incident, along with space to write a brief description of the health care incident. Each incident reported as leading to death or serious harm is reviewed by trained clinical staff. A range of outputs are produced to provide solutions to patient safety problems, including one-page reports called Rapid  Response Reports, quarterly data summaries and topic-specific information, such as how to prevent in-patient falls in hospitals. These outputs are underpinned by extensive consultations with subject-matter experts and professional organizations. National Health Service (NHS) organizations are also given strict deadlines to implement any specific findings dictated in the reports.4

However, like all large patient safety incident reporting systems worldwide, under-reporting is a limitation of the NRLS. Therefore, these systems should not be used to determine the prevalence of a particular kind of error or type of harm. But they can be valuable in assessing trends, provided that we acknowledge that any increases may simply represent more comprehensive reporting of the actual incident.

Are Checklists More than Just a Piece of Paper?

It is clear that substantial aspects of clinical practice are now too complex for groups of health care professionals to carry out reliably from memory alone. Surgery is one such example where clinicians are faced with high levels of uncertainty in their daily work which may affect the quality and safety of care patients receive.5 This understanding means that it is important for professionals (and their respective bodies) to identify and implement strategies that reduce the risk of iatrogenic harm while at the same time increasing the likelihood of optimal outcomes.

In January 2007, the WHO launched a program aimed at improving the safety of surgical care globally. This initiative, known as Safe Surgery Saves Lives, identified minimum standards of surgical care that can be universally applied across countries and settings. A core set of safety checks was developed (WHO Surgical Safety Checklist) that can be used in any surgical setting and operating theatre. Each step in the checklist is simple, widely applicable and measurable. This checklist has been shown to be associated with a reduced risk of death and major complications in a range of clinical settings.6

Can Process Standardization Reduce Harm?

Health care-associated infections affect at least 300 000 in-patients annually in the United Kingdom and represent a significant, yet largely preventable, burden to health care systems.7 Hand hygiene by health care workers is the leading prevention measure, yet compliance with good practice is generally low.8Baseline levels of compliance range drastically from 5% to 81%.9,10 Although much work remains to be done, inspiration and invaluable lessons can be drawn from multimodal strategies that have been successful in improving hand hygiene in health care settings and in subsequently reducing health care-associated infections.11 The NPSA cleanyourhands campaign12 relied on process standardization and lessons learned from this initiative have been extended to other areas, such as reducing central line infections, and are also applicable to other disciplines like dental care.

Three key hurdles need to be cleared to significantly advance patient safety, from both a theoretical and practical perspective. A carefully orchestrated interplay is required to maximize patient safety reporting systems as tools for reporting and learning, capacity needs to be increased in the science of patient safety, and greater efforts are required to disseminate patient safety tools to minimize iatrogenic harm.


Sir Liam Donaldson is chair of the National Patient Safety Agency and envoy for patient safety for the World Health Organization. He served as England's chief medical officer from 1998 to 2010.

Sir Liam Donaldson served as the 2011 Dr. John S. Zapp Memorial Lecturer at the Organization for Safety, Asepsis and Prevention (OSAP) Infection Prevention and Safety Symposium.

Correspondence to: Sir Liam Donaldson, National Patient Safety Agency, 4-8 Maple Street, London, UK, W1T 5HD. Email:

The views expressed are those of the author and do not necessarily reflect the opinions or official policies of the Canadian Dental Association.

This article has been peer reviewed.


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