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* From the Section of Scientific Publications, Mayo Clinic College of Medicine and the Department of Dermatology, Mayo Clinic, Rochester, MN.
Correspondence to: Joseph G. Murphy, MD, Section of Scientific Publications, Mayo Clinic, 200 First St SW, Rochester, MN 55905; e-mail: murphy.joseph{at}mayo.edu)
Abstract
Medical errors may result from lapses in judgment or lack of prudent care by individual physicians, from system errors inherent in the medical-care delivery model or, more frequently, from a combination of the two. Medical error reporting is a sensitive topic for physicians, institutions, and patients. The veil of secrecy that surrounds medical errors deprives health-care practitioners of knowledge that may help prevent similar adverse outcomes for patients in the future. Although reporting individual medical errors to involved patients is obligatory by most professional codes of conduct for physicians, no laws or professional society guidelines mandate widespread reporting of errors to professional colleagues. Furthermore, reports of medical errors in peer-reviewed journals are extremely rare. In 2000, the Joint Commission for Accreditation of Healthcare Organizations described systemic medical errors as "fundamentally an information problem" and called for the development of programs to collect and analyze medical error data. In this review, we define medical errors and detail common motivations and barriers to publication of error reports. We propose a model for confidential error communication and describe US legislation designed to improve patient safety and establish nationwide programs for error disclosure and analysis.
Key Words: ethics • legal liability • medical errors • patient safety
Anything you publish [about a medical error] can and will be used against you at trial. Anonymous
The intellectual argument for reporting medical errors is compelling. Medical errors are common, frequently result in considerable human morbidity and mortality,1234 and often are avoidable with vigilant personnel, fault-tolerant and fail-safe systems, and carefully implemented patient safety policies. Reducing the incidence of serious errors requires education about the circumstances of past medical errors and "near miss" errors.
Errors hidden from peers likely will recur and contribute to future medical errors. This lesson has been learned painfully by the US aviation industry, which had a fatal accident rate of 0.077 accidents per 100,000 departures in 1990.5 After implementation of systems-level error-reduction policies, the fatal accident rate among scheduled US airlines decreased to 0.009 per 100,000 aircraft departures in 2004. This decrease is notable, particularly because the numbers of flight hours, miles flown, and airport departures have increased by approximately 50% in the same time period.
Cogent legal arguments against publicly reporting medical errors include limitation of liability, nonadmission of guilt, and preservation of reputation for individuals and institutions. Medical error reports in peer-reviewed journals are rare and support the contention that threats of legal liability are more compelling than altruistic motives. The ethical dilemma is that suppression of medical error reporting deprives health-care practitioners of knowledge that may prevent future errors. In this review, we define medical errors and detail common motivations and barriers to publication of error reports. We propose a model for confidential error communication and describe US legislation designed to improve patient safety and establish nationwide programs for error disclosure and analysis.
What Is a Medical Error?
Weingart6 reviewed the taxonomy of medical errors and compared it to the tower of Babel. Medical error terminology includes adverse reaction, complication of care, adverse event, preventable adverse event, potential adverse event, sentinel event, and serious reportable event. Other terms that indicate medical errors are unintended consequence, untoward event, and nontherapeutic result. The report To Err is Human: Building a Safer Health System7 by the Institute of Medicine (IOM) defined a medical error as "the failure of a planned action to be completed as intended (eg, error of execution) or the use of a wrong plan to achieve an aim (eg, error of planning)." However, a standard and uniformly applied definition of a medical error does not exist.6 Table 1 lists criteria for different types of medical errors.
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The frequency and gravity of medical errors is perhaps the most pressing health care quality issue of our time... . We believe that the problem of medical errors is endemic to the way health care is carried out... . I would like to stress that medical error reduction is fundamentally an information problem. The solution to reducing the number of medical errors resides in developing mechanisms for collecting, analyzing, and applying existing information. If we are going to make significant strides in enhancing patient safety, we must think in terms of the information we need to obtain, create, and disseminate.
Table 2 summarizes the five information-based tasks (described by Dr. O’Leary) that are required for implementation of an error-reduction strategy.
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Medical errors may result from lapses in technique, communication, or judgment by individuals or from errors inherent in the delivery of medical care. Errors frequently stem from a combination of these causes. Individual errors may be attributable to deficiencies in a physician’s knowledge, skill, or attentiveness, but system-wide errors are attributable to flaws inherent in the method of medical practice. Conversely, fail-safe systems and fault-tolerant systems do not allow any single-point error to result in harm.
Disclosure of system errors generally is more important than disclosure of individual errors because root-cause analysis may yield information that facilitates creation of a resilient and fault-tolerant system. For example, a computer-based medication prescription system that required entry of a patient’s allergies and serum creatinine level could limit medication options when prescriptions were written for patients with known allergies or diminished kidney function.
Ethical Conflict in the Disclosure of Medical Errors
The American College of Physicians Ethics Manual9 states that a physician is obliged to disclose "information [to patients] about procedural or judgment errors made in the course of care if such information is material to the patient’s well-being." The American Medical Association Council on Ethical and Judicial Affairs10 further states, "Situations occasionally occur in which a patient suffers significant medical complications that may have resulted from the physician’s mistake or judgment. In these situations, the physician is ethically required to inform the patient of all facts necessary to ensure understanding of what has occurred." A physician may also be required to report sentinel events and medical device failures to state and federal regulatory agencies. However, no professional organizations mandate reporting of medical errors to medical journals or professional forums.
Reporting medical errors represents a conflict of interest for physicians. Will patient care be improved by widespread publication of a medical error, or is preservation of individual reputation and limitation of legal exposure of paramount importance? How should responsible physicians report errors and educate their colleagues without provoking public indignation, legal opportunism, and grist for the news media?
Motivation To Report Medical Errors
Physicians report personal medical errors almost entirely for altruistic reasons; publicly admitting one’s errors clearly has no financial or academic benefits. The Lancet has taken the lead in this area by publishing the "Uses of Error" column, which allows physicians to illustrate a teaching point by publishing personal accounts of medical errors. Most authors of this column are senior clinicians who should be congratulated for their honesty and altruism.
A physician who uncovers evidence of major errors by colleagues or identifies possible flaws in medical devices faces an ethical dilemma. Such situations may arise when a physician witnesses an error or flaw directly, or when a patient is referred by a colleague or third party for corrective treatment. Physicians are ethically obliged to facilitate disclosure to individual patients; they also should report new and serious medication-related adverse events and possible medical device defects to the relevant regulatory agencies and manufacturers. But when should a physician report previously undocumented problems at professional meetings or in peer-reviewed journals? Currently, no published ethics guidelines mandate a physician to publicly disclose adverse events or device flaws.
An individual physician generally sees only a small percentage of patients treated with a specific medication or medical device. Isolated physicians often have difficulty proving a causal relationship between the adverse event and a medication because individual physicians rarely have sufficient data for meaningful statistical analysis. Publication of poorly supported suspicions or opinions may inappropriately malign valuable procedures, medications, or devices. Even vague and unsupported suspicions may have dramatic commercial repercussions for a device manufacturer or biotechnology company. Physicians may be reluctant to publish unfavorable findings because of the lack of definitive proof, fear that unsupported disclosure will lead to libel suits, and concern about undermining professional relationships with colleagues or medical companies.
Barriers to Publication of Medical Errors
Medical errors are analogous to fratricide in war. Both result in injury from those who strive only to help, and both carry a considerable psychological burden. A survey11 of senior hospital managers indicated that they generally favored disclosure of patient safety incidents to affected patients, but few favored disclosure of moderate or minor injuries to state-run reporting programs. Most thought a mandatory, nonconfidential system would discourage reporting of patient safety incidents to their hospital’s own internal reporting system (69%), would encourage lawsuits (79%), and would have no effect or a negative effect on patient safety (73%).11 Most thought that names of hospitals and health-care professionals should be confidential. In addition, > 90% said that their hospital would report incidents involving serious injury to the state, but far fewer would report moderate or minor injuries, even if they would tell the affected patient or family.11
Disclosure of serious medical errors to patients generally is the best ethical and clinical course. Patients have a fundamental right to know about their health, particularly when a major error has occurred in their medical care. Furthermore, most major errors ultimately are exposed with or without physician disclosure, and patients are more likely to be aggrieved and to sue physicians who are perceived as deceitful.12 Physicians are not under the same bioethical imperative to report errors to colleagues or to publish in peer-reviewed journals.
Some may argue that publication of individual errors does little to improve patient care, but timely reporting of a system-wide medical error may yield corrective action that prevents errors and reduces legal liability over the long term. For example, patients initially confused Lasix, the diuretic (furosemide) [sanofi-aventis US; Bridgewater, NJ], with Losec, the antiulcer proton blocker medication (omeprazole) [AstraZeneca Pharmaceuticals; Wilmington, DE].1314 A relatively minor name change from Losec to Prilosec markedly reduced the likelihood of drug name error.
Hospital lawyers may not be convinced that full disclosure of medical errors beyond ethical requirements constitutes sound legal risk management for physicians and institutions. Describing medical errors in peer-reviewed publications may result in additional litigation and legal liability. These factors could discourage root-cause analysis and delay implementation of comprehensive strategies that identify, prevent, and mitigate similar medical errors.15 Whether apprehension about the legal consequences of admitting errors is accurate or erroneous is debatable, but many physicians undoubtedly hold sincere anxieties about public disclosure of errors. A physician’s legal anxieties may serve as a pretext to avoid directly confronting more difficult issues. By using the legal system as a readily available and unpopular scapegoat, physicians may skirt the more negative implications of their "culture of infallibility."
Under tort law, physicians must provide reasonable care that is appropriate for the circumstances; the level of care is judged by comparing the knowledge and skill of the physician to those of professional counterparts in similar situations. In contrast, most physicians set a much higher standard for themselves and their peers, namely that of perfection. Thus, physicians may regard errors in patient care as manifestations of unacceptable character flaws rather than isolated technical missteps. Furthermore, physicians may confuse blameless misfortune and the natural course of disease with blameworthy deviation from acceptable professional standards; thus, they may become more severe adjudicators of themselves than judges or juries would be when distinguishing between honest misjudgments and negligent errors.
Unsafe medical practices could be promoted by the physicians’ discomfort with medical error discussion and concern over legal liability. Fear of personal blame may prevent physicians from paying close attention to systematic improvements that could decrease medical errors. The health-care system is in many ways a "perfect storm" environment for errors because of disease and therapeutic complexity, variability in physician competence and temperament, and the necessary individualization of patient care.
Ethical ideals and reality may clash. On the pragmatic side, physicians often are most concerned about potentially harmful personal consequences of disclosing an error. In other words, physicians may question whether any benefits to the patient are worth the legal risks to their careers. The American Medical Association Council on Ethical and Judicial Affairs states, "Concern regarding legal liability which might result following truthful disclosure should not affect the physician’s honesty with a patient."9
Most medical errors reported in the Harvard Medical Practice Study1 did not rise to the level of negligence, which was defined as violation of professional standards; furthermore, only a small proportion of medical errors identified resulted in legal action by the patient. Another impediment to disclosure of medical errors is the adversarial legal system that requires proof of negligence before an injured patient can obtain compensation through the tort system; admitting negligence during a particular event may make physicians and institutions vulnerable to subsequent malpractice suits. The major ethical impetus for reporting and reducing the frequency of errors is the restructuring of the medicolegal system to a no-fault, nonadversarial patient compensation system. Such a system would ultimately reduce medical errors by facilitating a move away from the punitive trial-by-ordeal approach to a systems management approach that incorporates research in human factors and root-cause analysis of medical system errors.
The fear of damage to reputation and loss of respect from peers may also inhibit physicians from disclosing errors. Error disclosure to peers must be recognized and accepted as a fundamental part of a comprehensive error-reduction program. Guidelines should be created that describe when physicians should disclose medical errors, particularly system-wide errors. The guidelines should also describe a course of action when one identifies errors made by others (including directly notifying the physician in error) or describes an error he or she has made. In particular, physicians-in-training must be notified in such a way that helps maintain their confidence and professional development.
Government-Based Error-Reporting System
The IOM To Err is Human report,7 published in 1999, indicated that 44,000 to 98,000 Americans died each year from "preventable adverse events" that were attributable to errors in medical management. The report stated that unsafe patient conditions and hindrance of efforts to improve safety were attributable to decentralized and fragmented health-care delivery systems. The IOM recommended that Congress establish mandatory (public) and voluntary (confidential) systems for reporting errors. In the mandatory system, only events that cause death or serious injury must be reported to the state. Such events would be described using a predefined list of core reporting standards, and data would be submitted to a nationwide reporting system for analysis and development of follow-up action. The mandatory system will hold health-care organizations publicly accountable for medical errors, thereby responding to the public’s right to know and providing a strong incentive to improve patient safety. (To date, no federal laws that mandate reporting of medical errors exist.) The voluntary system, maintained and operated separately from the mandatory system, would record a broader set of less serious adverse events. It would complement the mandatory program by identifying systemic patterns of errors before they result in acute harm. Information about medical errors reported to voluntary systems would be protected from legal discovery.
Before the 1999 publication of the IOM report, only 12 states had mandatory error-reporting systems in place.16 As of September 2005, error-reporting systems were established or strengthened in 25 states (24 are mandatory reporting systems, 1 system [in Oregon] is voluntary).17 On the federal level, legislation based on the IOM recommendations was introduced during the 106th Congress; it included the Medical Error Prevention Act of 2000; the Medicare Comprehensive Quality of Care and Safety Act of 2000; the Medical Error Reduction Act of 2000; the Stop All Frequent Errors in Medicare and Medicaid Act of 2000; the Patient Safety and Errors Reduction Act; and the Error Reduction and Improvement in Patient Safety Act.18 Much of the legislation was reintroduced during the 107th and 108th Congresses.
The Patient Safety and Quality Improvement Act (PSQIA) of 200519 was passed by the 109th Congress and signed into law in July 2005. It established a federal system only for voluntary reporting of medical errors. Medical errors and other "patient safety work products" will be reported by physicians, hospitals, and other health-care groups to government-certified patient safety organizations (PSOs). Under direction of the Secretary of Health and Human Services, PSOs will compile and analyze data to develop strategies to improve patient care. Individual physicians or hospitals are unlikely to treat enough patients to identify systemic trends; however, a national PSO database that collects timely information from health-care providers throughout the country could yield actionable items with wide applicability.
The PSQIA includes broad protection for health-care providers who submit information intended to improve patient safety. The protection is analogous to that given to pilots submitting confidential aviation safety information to the Federal Aviation Administration.20 Medical patient safety reports submitted under the PSQIA cannot be used in federal, state, or local civil or administrative proceedings (including disciplinary action against a health-care provider), are protected from disclosure under the Freedom of Information Act,21 and cannot be used to take accrediting action against a provider. Furthermore, civil monetary penalties are established for unlawful disclosures. The establishment of wide protections is intended to protect providers from professional liability or judicial action.
Because PSQIA reports are not mandatory, it is difficult to predict what effect it will have on patient safety. Although the PSQIA has been endorsed by > 100 state and national specialty organizations,22 including the American Medical Association and the Joint Commission on Accreditation of Healthcare Organizations, the practical aspects of such a broad-reaching federal law likely will face implementation obstacles. For example, the true scope of the law is somewhat ill defined. The degree of protection for individuals or organizations who report errors is unclear and may prompt concern over potential lawsuits from medical malpractice attorneys. Furthermore, the Department of Health and Human Services has yet to issue guidelines for certifying PSOs, defining patient safety work products, or developing the structure of the error report (eg, who should report, when reports should be made, etc). The PSQIA effectively is inoperable until these regulations have been defined.
In September 2005, Senators Hillary Rodham Clinton and Barack Obama proposed a bill to establish the National Medical Error Disclosure and Compensation program.23 This program builds on the PSQIA and seeks to reduce malpractice lawsuits by providing liability protection for health-care providers who rapidly disclose medical errors, offer apologies, and offer to enter negotiations for fair compensation. The framework of the bill is based on local hospital and private insurer initiatives that have resulted in greater patient trust and satisfaction. As of December 2006, the bill is still pending review in the Senate Committee on Health, Education, Labor, and Pensions.
Proposed Models of Error Reporting
Until pragmatic details of PSQIA implementation are formulated, hospitals and other health-care providers in the United States lack a large-scale comprehensive method to discover and analyze patterns of medical errors. In the meantime, individual reports of systemic error still have considerable clinical and teaching value and therefore should be disseminated.
Peer-Reviewed Journals
We suggest that medical journals provide an opportunity for physicians to publish medical errors confidentially. Medical journals are in a unique position to provide medical error information to physicians and protect an individual’s reputation. However, legal protection should be provided and should be as broad as possible to encourage truthful and timely reporting of medical errors. Presumably, legal protection similar to that defined by the PSQIA could be provided to those who submit and publish bona fide error reports in good faith; therefore, we recommend that authors, medical institutions, journal editors, affiliated professional societies, and journal publishers be shielded from legal liability. Clearly, anonymous reporting is impossible because journal editors must know the source of the report and must be able to confirm its veracity and likely credibility. Furthermore, an anonymous error-reporting program is susceptible to submission of false reports stemming from malicious intent (eg, discrediting a therapeutic device or medication to affect company stock prices). We propose several principles that should govern medical journal-based error reporting (Table 3
).
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Personal and Institutional Reports
Personal error reporting by individual physicians takes considerable courage and subjects them to maximal legal exposure. Altruistic physicians in legal environments more tolerant than that of the United States may report personal medical errors (eg, the "Uses of Error" column in the British journal The Lancet), but this practice is unlikely to gain widespread acceptance in the United States. Similarly, institutions prize their reputations, and nonstatutory reporting of medical errors is unlikely.
Conclusion
Medical errors cause considerable mortality and morbidity in all health-care systems. Because of the complexity of modern medicine, physicians should strive toward total elimination of medical errors but realistically will never attain this standard. A comprehensive medical error-reduction strategy includes an error-reporting policy that protects practitioners from retribution. If the voluntary medical error-reporting system proposed in the PSQIA does not measurably improve patient safety in the United States, peer-reviewed medical journals and professional physician societies are best suited to disseminate knowledge of medical errors and provide protection against legal opportunism.
Footnotes
Abbreviations: IOM = Institute of Medicine; PSO = patient safety organization; PSQIA = Patient Safety and Quality Improvement Act
The authors have no conflicts of interest to disclose.
Received for publication October 2, 2006. Accepted for publication January 2, 2007.
References
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