Adverse event reporting.pdf

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nursing practice standards to label and trace all tubing, to a requirement for medical device manufacturers to develop incompatible connectors for all medical tubing. Appendix 1 contains an excerpt from the landmark Institute of Medicine report To Err is Human, which provides an overview of the systems approach to human error within health-care and other industries. Core concepts The four core principles underlying the guidelines are: • The fundamental role of patient safety reporting systems is to enhance patient safety by learning from failures of the health-care system. • Reporting must be safe. Individuals who report incidents must not be punished or suffer other ill-effects from reporting. • Reporting is only of value if it leads to a constructive response. At a minimum, this entails feedback of findings from data analysis. Ideally, it also includes recommendations for changes in processes and systems of health care. • Meaningful analysis, learning, and dissemination of lessons learned requires expertise and other human and financial resources. The agency that receives reports must be capable of disseminating information, making recommendations for changes, and informing the development of solutions. Organization of the Guidelines Section 2 describes the role of reporting in enhancing patient safety, its purposes and the ways in which reporting can enhance safety. Section 3 discusses the essential components of a patient safety reporting system, considering the types of systems, the process of reporting (what is reported, by whom, and how), analysis of reports, response and dissemination, and application of results. Section 4 examines alternative sources of information for safety. Reporting is but one method of obtaining such information, not necessarily the best. Other sources of useful data are briefly described. Section 5 provides information about several existing national reporting systems, both governmentally sponsored and those implemented by non-governmental agencies or groups. This illustrates the broad variation in how Member States have dealt with these issues.
Section 6 describes the characteristics of successful reporting systems. While experience is limited in health care, successful existing systems have common features in purpose, design and operation, that have general applicability. Section 7 outlines the requirements for a national adverse event reporting system, including the mechanism for collecting reports, the capacity to perform investigations, the expertise required, the technical infrastructure, and the capacity to disseminate findings. Section 8 concludes with recommendations to WHO Member States. References 1. 2. 3. 4. 5. 6. World Alliance for Patient Safety Forward Programme 2005. Geneva, World Health Organization, 2004. Kohn LT, Corrigan JM, Donaldson MS, eds. To err is human: Building a safer health system. Washington, DC, National Academy Press, 1999. Reason J. Human Error Cambridge, Cambridge University Press, 1990. Hiatt H et al. A study of medical injury and medical malpractice. An overview. New England Journal of Medicine 1989, 321(7):480-484. Leape LL et al. Preventing medical injury. Quality Review Bulletin. 1993,19:144-149. Bates DW, Leape LL, Petrycki S. Incidence and preventability of adverse drug events in hospitalized adults. Journal of General Internal Medicine. 1993, 8:289-294.
Page 2 and 3: WHO/EIP/SPO/QPS/05.3 © World Healt
Page 4 and 5: ACKNOWLEDGEMENTS WHO wishes to ackn
Page 7: TABLE OF CONTENTS 1. INTRODUCTION .
Page 10 and 11: The guidelines draw on a review of
Page 14 and 15: 2. THE ROLE OF REPORTING IN ENHANCI
Page 16 and 17: ous contributing factors that lead
Page 18 and 19: 3. COMPONENTS OF A REPORTING SYSTEM
Page 20 and 21: The Netherlands has a two-tiered pr
Page 22 and 23: dosage (7). Adverse drug reactions
Page 24 and 25: A higher level of structured report
Page 26 and 27: scales and definitions; these are o
Page 28 and 29: Analysis Hazard identification At a
Page 30 and 31: the outcome. For example, regressio
Page 32 and 33: 4. ALTERNATIVE SOURCES OF INFORMATI
Page 34 and 35: Medical record review Medical recor
Page 36 and 37: and solutions. Observation can also
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Page 40 and 41: A major issue for all reporting sys
Page 42 and 43: What is reported: Patient safety in
Page 44 and 45: Ireland Type of reporting system: T
Page 46 and 47: Private and non-government initiate
Page 48 and 49: Who reports: Reports are received f
Page 50 and 51: during accreditation survey. The JC
Page 52 and 53: Non-punitive. The most important ch
Page 54 and 55: References 1. 2. 3. 4. 5. 6. 7. Coh
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will be referenced to illustrate se
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highlighting a single element as th
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Latent errors pose the greatest thr
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• a set of processes that identif
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Another aspect of making systems mo
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Where processes may have been monit
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and the use of simulators for train
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32. Cook and Woods, 1994. 33. Reaso
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7. What is the data infrastructure?
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