Promoting PATIENT SAFETY

A SPECIAL SUPPLEMENT TO THE HASTINGS CENTER REPORT Promoting PATIENT SAFETY AN ETHICAL BASIS FOR POLICY DELIBERATION IRGINIA HARPE . .T . H. .E . V A. S HASTINGS. CENTER AN OVERVIEW OF THE PROJECT his is the final report of a two- equately compensating patients Tyear Hastings Center research and families, contrasted with alter- project that was launched in response native models of dispute resolu- to the landmark 1999 report from the tion, including mediation and no- Institute of Medicine, To Err Is fault liability; Human, and the extraordinary attention that policymakers at the federal, n the needs of patients, families, state, regulatory, and institutional lev- and clinicians affected by harmful els are devoting to patient safety. It errors and how these needs may be seeks to foster clearer and better dis- addressed within systems ap- cussion of the ethical concerns that proaches to patient safety; and are integral to the development and implementation of sound and effec- n the potential conflicts between tive policies to address the problem of the protection of patient privacy medical error. It is intended for poli- required by the Health Insurance cymakers, patient safety advocates, Portability and Accountability Act health care administrators, clinicians, and efforts to use patient data for lawyers, ethicists, educators, and oth- the purposes of safety improve- ers involved in designing and main- ment, and how these conflicts may taining safety policies and practices be resolved. within health care institutions. Although this report is the work of Among the topics discussed in the the project’s principal investigator, report: not a statement of consensus, it draws from the insights of the interdiscipli- n the values, principles, and per- nary group of experts convened by ceived obligations underlying pa- The Hastings Center to make sense of tient safety efforts; the complex phenomenon of patient safety reform. Working group mem- n the historical and continuing bers brought their experience as peo- tensions between “individual” and ple who had suffered from devastat- “system” accountability, between ing medical harms and as institution- error “reporting” to oversight agen- al leaders galvanized to reform by cies and error “disclosure” to pa- tragic events in their own health care tients and families, and between institutions. They brought expertise aggregate safety improvement and as clinicians, chaplains, and risk man- the rights and welfare of individual agers working to deliver health care, patients; confront its problems, and make it safer for patients. They brought fa- n the practical implications for miliarity with the systems thinking patient safety of defining “respon- deployed in air traffic control and in sibility” retrospectively, as praise or the military. And they brought critical blame for past events, or prospec- insight from medical history and soci- tively, as it relates to professional ology, economics, health care pur- obligations and goals for the fu- chasing, health policy, law, philoso- ture; phy, and religious studies. The research project was made On the cover: Hospital, by Frank Moore, n the shortcomings of tort liabili- possible through a major grant from 1992. Oil on wood with frame and attach- ty as a means of building institu- the Patrick and Catherine Weldon ments. 49” x 58” overall. Private Collection, tional cultures of safety, learning Donaghue Medical Research Founda- Italy. Courtesy Sperone Westwater, New from error, supporting truth telling tion. York. as a professional obligation, or ad- S2 July-August 2003 / HASTINGS CENTER REPORT PROMOTING PATIENT SAFETY by Virginia A. Sharpe ver the last three years, patient safety and swift bipartisan action by President Clinton and the the reduction of medical error have come 106th and then the 107th Congress. Shortly after the Oto the fore as significant and pressing mat- report was issued, President Clinton lent his full sup- ters for policy reform in U.S. health care. In 2000, port to efforts aimed at reducing medical error by 50 the Institute of Medicine’s report, To Err Is Human: percent over five years. In Congress, the report Building a Safer Health System presented the most prompted hearings and the introduction of a host of comprehensive set of public policy recommendations bills including the SAFE (Stop All Frequent Errors) on medical error and patient safety ever to have been Act of 2000 (S. 2378), the “Medication Errors Re- proposed in the United States.1 Prompted by three duction Act of 2001” (S. 824 and H.R. 3292), and, large insurance industry-sponsored studies on the recently, the “Patient Safety and Quality Improve- frequency and severity of preventable adverse events, ment Act of 2002” (S. 2590) and the “Patient Safety as well as by a host of media reports on harmful med- Improvement Act of 2002” (H.R. 4889). Although ical errors, the report offered an array of proposals to none of these bills has made it into law, each repre- address at the policy level what is being identified as a sents ongoing debate about the recommendations in new “vital statistic,” namely that as many as 98,000 the IOM report. Americans die each year as a result of medical Since the IOM recommendations have been ei- error—a figure higher than deaths due to motor ve- ther a catalyst or a touchstone for all subsequent pa- hicle accidents, breast cancer, or AIDS. And this fig- tient safety reform proposals—whether by regulation ure does not include those medical harms that are se- or by institutions hoping to escape regulatory man- rious but non-fatal. dates—they must be part of the context of any poli- The IOM recommendations resulted in a surge of cy-relevant discussion of the ethical basis of patient media attention on the issue of medical error and safety. The Institute of Medicine Report he Institute of Medicine report is a public the number of deaths associated with preventable policy document. That is, it proposes the medical error—a key premise in the argument es- Tneed for government intervention to address tablishing the scope and significance of the prob- a problem of serious concern to public health and lem—these challenges have been effectively silenced health care financing. Although there was an imme- by the preponderance of evidence that the rate of diate flurry of resistance to the report’s statistics on harmful medical error, with its enormous human and financial consequences in death, disability, lost Virginia A. Sharpe, “Promoting Patient Safety: An Ethical Basis for income, lost household production, and health care Policy Deliberation,” Hastings Center Report Special Supplement 33, costs, is unacceptable. No. 5 (2003), S1-S20. SPECIAL SUPPLEMENT / Promoting Patient Safety: An Ethical Basis for Policy Deliberation S3 The report observes that health care has lagged behind internal motivations are insufficient to assure quality and other industries in safety and error prevention in part be- patient safety consistently throughout the health care sys- cause, unlike aviation or occupational safety, medicine has tem. Thus, the IOM’s aim is to create external regulatory no designated agency to set and communicate priorities or and economic structures that will create both a level play- to reward performance for safety. As a result, the IOM’s ing field and “sufficient pressure to make errors so cost- keystone recommendation is the establishment of a center ly…that [health care] organizations must take action.”2 for patient safety to be housed at the Agency for Health Given its aims as a comprehensive policy document, it Care Quality and Research under the auspices of the De- is understandable that the IOM places only minimal em- partment of Health and Human Services. The center’s phasis on professional norms or the moral motivation of charge is to set and oversee national goals for patient safe- health care providers as the principal catalyst for change. ty. In order to track national and institutional perfor- The scope of the change proposed requires a uniform set mance, and to hold institutions accountable for harm, the of incentives and accountabilities. Further, if systems IOM also proposes mandatory, public, standardized re- rather than individuals are the most appropriate targets for porting of serious adverse events. In addition to mandato- improvement, then appeals to individual virtue would ry reporting, the IOM advocates efforts to encourage vol- seem to be the wrong focus. We will come back to the re- untary reporting. To motivate participation in a voluntary lationship between individuals and systems, but, for the reporting system, the IOM recommends legislation to ex- moment, it is enough to point out that the role of ethics tend peer review protections, that is, confidentiality, to in public policy goes well beyond the question of moral data collected in health care quality improvement and motivation. Ethics also plays an essential role in the justifi- safety efforts. cation of public policy and the critique of policies already To complement the national initiative, the IOM rec- in place. ommends that patient safety be included as a performance Underlying all public policy deliberations are specific measure for individual and institutional health care social values and assumptions about how these values providers and that institutions and professional societies should be weighed and balanced or prioritized. In order to commit themselves to sustained, formal attention to con- understand and assess the legitimacy of proposed policies tinuous improvement on patient safety. Finally, regarding in a democratic society, therefore, those underlying values medication safety, the IOM recommends that the FDA and assumptions can be made explicit and subject to crit- and health care organizations pay more attention to iden- ical appraisal. tifying and addressing latent errors in the production, dis- This report takes up this large task. It begins by eluci- tribution, and use of drugs and devices. dating the ethical values and concepts underlying the A unifying theme in the report is the role that systems IOM recommendations.

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