Patient Safety Culture and Health Care Ethics

A SPECIAL S U P P L E H E N T TO THE H/HTIHGS CENTEH REPOUT

ETY

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POLICY DELIBERATIOI

VIRGINIA A. SHARPE

On the cover: Hospital, by Frank Moore, 1992. Oil on wood with frame and attach- ments. 49" X 58" overall. Private Collection, Italy. Courtesy Sperone Westwater, New York.

This is the final report of a two-year Hastings Center research project that was launched in response to the landmark 1999 report from the Institute of Medicine, To Err Is Human, and the extraordinary atten- tion that policymakers at the federal, state, regulatory, and institutional lev- els are devoting to patient safety. It seeks to foster clearer and better dis- cussion of the ethical concerns that are integral to the development and implementation of sound and effec- tive policies to address the problem of medical error. It is intended for poli- cymakers, patient safety advocates, health care administrators, clinicians, lawyers, ethicists, educators, and oth- ers involved in designing and main- taining safety policies and practices within health care institutions.

Among the topics discussed in the report:

H the values, principles, and per- ceived obligations underlying pa- tient safety efforts;

• the historical and continuing tensions between "individual" and "system" accountability, between error "reporting" to oversight agen- cies and error "disclosure" to pa- tients and families, and between aggregate safety improvement and the rights and welfare of individual patients;

• the practical implications for patient safety of defming "respon- sibility" retrospectively, as praise or blame for past events, or prospec- tively, as it relates to professional obligations and goals for the fu- ture;

S the shortcomings of tort liabili- ty as a means of building institu- tional cultures of safety, learning from error, supporting truth telling as a professional obligation, or ad-

equately compensating patients and families, contrasted with alter- native models of dispute resolu- tion, including mediation and no- fault liability;

SB the needs of patients, families, and clinicians affected by harmful errors and how these needs may be addressed within systems ap- proaches to patient safety; and

SI the potential conflicts berween the protection of patient privacy required by the Health Insurance Portability and Accountability Act and efforts to use patient data for the purposes of safety improve- ment, and how these conflicts may be resolved.

Although this report is the work of the project's principal investigator, not a statement of consensus, it draws from the insights of the interdiscipli- nary group of experts convened by The Hastings Center to make sense of the complex phenomenon of patient safety reform. Working group mem- bers brought their experience as peo- ple who had suffered from devastat- ing medical harms and as institution- al leaders galvanized to reform by tragic events in their own health care institutions. They brought expertise as clinicians, chaplains, and risk man- agers working to deliver health care, confront its problems, and make it safer for patients. They brought fa- miliariry with the systems thinking deployed in air traffic control and in the military. And they brought critical insight from medical history and soci- ology, economics, health care pur- chasing, health policy, law, philoso- phy, and religious studies.

The research project was made possible through a major grant from the Patrick and Catherine Weldon Donaghue Medical Research Founda- tion.

S 2 July-August 2003 / HASTINGS CENTER REPORT

AW ETHICAL BASIS FOR POLICY DELIBERAIION by Virginia A. Sharpe

ver the last three years, patient safety and

) the reduction of medical error have come

to the fore as significant and pressing mat-

ters for policy reform in U.S. health care. In 2000,

the Institute of Medicine's report. To Err Is Human:

Building a Safer Health System presented the most

comprehensive set of public policy recommendations

on medical error and patient safety ever to have been

proposed in the United States.' Prompted by three

large insurance industry-sponsored studies on the

frequency and severity of preventable adverse events,

as well as by a host of media reports on harmful med-

ical errors, the report offered an array of proposals to

address at the policy level whzt is being identified as a

new "vital statistic," namely that as many as 98,000

Americans die each year as a result of medical

error—a figure higher than deaths due to motor ve-

hicle accidents, breast cancer, or AIDS. And this fig-

ure does not include those medical harms that are se-

rious but non-fatal.

The IOM recommendations resulted in a surge of

media attention on the issue of medical error and

swift: bipartisan action by President Clinton and the

106th and then the 107th Congress. Shortly after the

report was issued. President Clinton lent his full sup-

port to efforts aimed at reducing medical error by 50

percent over five years. In Congress, the report

prompted hearings and the introduction of a host of

bills including the SAFE (Stop All Frequent Errors)

Act of 2000 (S. 2378), the "Medication Errors Re-

duction Act of 2001" (S. 824 and H.R. 3292), and,

recently, the "Patient Safety and Quality Improve-

ment Act of 2002" (S. 2590) and the "Patient Safety

Improvement Act of 2002" (H.R. 4889). Although

none of these bills has made it into law, each repre-

sents ongoing debate about the recommendations in

the IOM report.

Since the IOM recommendations have been ei-

ther a catalyst or a touchstone for all subsequent pa-

tient safety reform proposals—whether by regulation

or by institutions hoping to escape regulatory man-

dates—they must be part of the context of any poli-

cy-relevant discussion of the ethical basis of patient

safety.

The Institute of Medicine report is a publicpolicy document. That is, it proposes theneed for government intervention to address a problem of serious concern to public health and health care financing. Although there was an imme- diate flurry of resistance to the report's statistics on

Virginia A. Sharpe, "Promoting Patient Safety: An Ethical Basis for Policy Deliheration," Hastings Center Report Special Supplement 33, No. 5(2003), SI-S20.

the number of deaths associated with preventable medical error—a key premise in the argument es- tablishing the scope and significance of the prob- lem—these challenges have been effectively silenced by the preponderance of evidence that the rate of harmful medical error, with its enormous human and financial consequences in death, disability, lost income, lost household production, and health care costs, is unacceptable.

SPECIAL SUPPLEMENT / Promoting Patient Safety: An Ethical Basis for Policy Deliberation

The report observes that health care has lagged behind other industries in safety and error prevention in part be- cause, unlike aviation or occupational safety, medicine has no designated agency to set and communicate priorities or to reward performance for safety. As a result, the IOM's keystone recommendation is the establishment of a center for patient safety to be housed at the Agency for Health Care Quality and Research under the auspices of the De- partment of Health and Human Services. The center's charge is to set and oversee national goals for patient safe- ty. In order to track national and institutional perfor- mance, and to hold institutions accountable for harm, the IOM also proposes mandatory, public, standardized re- porting of serious adverse events. In addition to mandato- ry reporting, the IOM advocates efforts to encourage vol- untary reporting. To motivate participation in a voluntary reporting system, the IOM recommends legislation to ex- tend peer review protections, that is, confidentiality, to data collected in health care quality improvement and safety efiforts.

To complement the national initiative, the IOM rec- ommends that patient safety be included as a performance measure for individual and institutional health care providers and that institutions and professional societies commit themselves to sustained, formal attention to con- tinuous improvement on patient safety. Finally, regarding medication safety, the IOM recommends that the FDA and health care organizations pay more attention to iden- tifying and addressing latent errors in the production, dis- tribution, and use of drugs and devices.

A unifying theme in the report is the role that systems play in the occurrence of medical mistakes. Over the last few decades, research conducted on error in medicine and other high-risk, high-variability industries has revealed that most quality failures in these industries result not from poor, incompetent, or purposefully harmflil individ- ual performance but from the very complexity of systems. In the hospital setting, systems of drug dissemination or infection control, for example, can be designed either to prevent or to facilitate error by individual providers. Rec- ognizing the system dimensions of the problem, the IOM recommendations promote human factors research— which examines the interface between humans and ma- chines in complex work environments—to get at the root causes of error and adverse events. The report encourages non-punitive, voluntary reporting as an essential ingredi- ent in understanding lesser injuries and "near misses"— that is, those errors that have the potential to cause harm, but have not yet caused harm.

Although the IOM acknowledges the role that profes- sional ethics and norms play in motivating health care quality, it bases its recommendations on the premise that

internal motivations are insufficient to assure quality and patient safety consistently throughout the health care sys- tem. Thus, the IOM's aim is to create external regulatory and economic structures that will create both a level play- ing field and "sufficient pressure to make errors so cost- ly. ..that [health care] organizations must take action."^

Given its aims as a comprehensive policy document, it is understandable that the IOM places only minimal em- phasis on professional norms or the moral motivation of health care providers as the principal catalyst for change. The scope of the change proposed requires a uniform set of incentives and accountabilities. Further, if systems rather than individuals are the most appropriate targets for improvement, then appeals to individual virtue would seem to be the wrong focus. We will come back to the re- lationship between individuals and systems, but, for the moment, it is enough to point out that the role of ethics in public policy goes well beyond the question of moral motivation. Ethics also plays an essential role in i\\e. justifi- cation of public policy and the critique of policies already in place.

Underlying all public policy deliberations are specific social values and assumptions about how these values should be weighed and balanced or prioritized. In order to understand and assess the legitimacy of proposed policies in a democratic society, therefore, those underlying values and assumptions can be made explicit and subject to crit- ical appraisal.

This report takes up this large task. It begins by eluci- dating the ethical values and concepts underlying the IOM recommendations. The central sections of the report are devoted to a careful unpackaging of the notion of ac- countability. The report argues that accountability re- quires a sophisticated understanding of the causal expla- nation for errors—an account of errors not merely as causes of harm but as themselves caused by complex sys- tems. The notion of accountability itself can also be expli- cated in different ways; this report argues that account- ability should be understood not merely in a retrospective and fundamentally retributive way, but also in a foreword- looking or prospective sense oriented to the deliberative and practical processes involved in setting and meeting goals—such as improved patient safety. Both senses of ac- countability must be borne in mind in assessing the pros and cons of the different possible ways of compensating patients for adverse events. The demands of justice and safety improvement, which sometimes conflict and must be balanced against each other, argue for compensation schemes based on no-fault liability or mediation. Tradi- tional tort liability is the worst way of achieving these two goals.

September-October 2003 / HASTINGS CENTER REPORT

' No Harm." The guiding value of patient safety an be understood to derive from two longstanding

principles of health care ethics: beneficence, the positive obligation to prevent and remove harm, and nonmalefi- cence, the negative obligation to refrain from inflicting harm. As far as medical error is concerned, the principle of beneficence establishes a moral argument against errors of omission such as a misdiagnosis or failure to provide re- quired treatments. The principle of nonmaleficence estab- lishes an argument against errors of commission, such as surgical slips, drug administration to the wrong patient, or the transmission of nosocomial infection. Together, these two principles constitute the obligation to "do no harm."^

Traditionally, the relationship between the clinician and the patient has been regarded as a fiduciary relation- ship. That is, the power disparity between doctor and pa- tient, the patient's vulnerability, and the doctor's offer to help are understood to place special obligations on health care providers, as professionals, to promote a patient's health interests, to respect the patient's autonomy, and to hold his or her good "in trust."^

Medical error and injury happens to an identifiable in- dividual. From the point of view of fiduciary ethics, that is, professionalism, the individual patient is the focus of the obligation to do no harm.' This patient-centered focus is acknowledged by the IOM in its definition of safety as "freedom from accidental injury." This definition, says the report, "recognizes that this is the primary safety goal from the patient's perspective."''

The principle of utility. The goal of patient safety can also be justified by the principle of utility, understood in the simplest terms as the achievement of the greatest good for the greatest number or the net aggregate benefit across a population. For example, policy recommendations are aimed at patient safety as a public health problem—a problem requiring strategies to improve overall safety in the health care system. As such, they are based on the principle of utility. From the point of view of public health ethics, the patient population in the aggregate is the normative focus, and safety improvements are measured in terms of population-based or epidemiologic statistics such as the IOM's target goal of a "fifty percent reduction in errors over five years."^

The value of patient safety is also understood to derive from its economic utility. As the IOM report states on the second page of its executive summary, the total national cost of preventable medical error is between seventeen and twenty-nine billion dollars a year. The assumption behind the report's recommendations is that efforts to reduce

error by the target of 50 percent over five years will be jus- tified by the reduction of associated costs.

Utilitarian and fiduciary justifications for patient safety can come into tension. For example, although it is possi- ble that the incentive to reduce the extra costs associated with preventable error will coincide with the imperative to protect patients from harmftil outcomes, such a coinci- dence is by no means assured. One can easily imagine a cost-conscious hospital deciding against certain strategies to improve safety because the up-front costs are prohibi- tive. Likewise, without a clear prioritization ofthe fiducia- ry justification for safety—which gives priority to patient welfare as a policy objective—it is easy to imagine safety proposals being reduced to their economic value. Under such circumstances, policy makers might suppose that economic considerations alone will justify certain safety trade-offs.*

One of the biggest ethical challenges for patient safety reform will be in confronting the fact that strategies to im- prove overall patient safety have the potential to compro- mise obligations to individual patients. For example, the IOM recommends mandatory reporting of serious adverse events and voluntary reporting of lesser harms and near misses. To the extent that institutions direct their resources to meeting the standards for mandatory reporting, they may de-emphasize voluntary reporting and the follow-up necessitated by it. This could have the paradoxical effect of making safety improvement activities contingent on a pa- tient having been seriously harmed.

p appreciate fully what is at stake here, we need to iL grapple with the complex issue of accountability. Ac-

countability for harmful medical error is expressed in the IOM's call for a nationwide mandatory system for report- ing serious adverse events and in its call for performance standards on patient safety and quality improvement for health care organizations.' Accountability is grounded, in the report, in the public's right to know about and be pro- tected from hazards. It also derives from the principle of fairness.

From a regulatory perspective, hazards in the health care setting are matters of public safety. The IOM's rec- ommendations regarding mandatory reporting are de- signed to generate standardized information that can be used to understand and track known hazards and to take preventive action. As the report states: "The public has the right to expect health care organizations to respond to ev- idence of safety hazards by taking whatever steps are nec- essary to make it difficult or impossible for a similar event

SPECIAL SUPPLEMENT / Promoting Patient Safety: An Ethical Basis for Policy Deliberation

to occur in the future. The public also has a right to be in- formed about unsafe conditions."'"

The principle of fairness operates on two levels in the mandatory reporting proposal. First, mandatory reporting is intended to level the playing field for health care insti- tutions so that none is exempt from data collection on safety, or from penalties or civil liability in the case of se- rious patient harms. Second, mandatory reporting to oversight bodies is intended to provide an avenue for harmed patients to gain access to information regarding the circumstances surrounding an injury and use it to seek justice for negligent harm associated with care."

Although a number of states currently mandate exter- nal reporting of serious adverse events—usually to the state health department—in most cases the information collected is intended to be protected by law from poten- tial claimants.'2 Many state programs fail to provide pub- lic access to the information and most require subpoena or court order for release of information. By contrast, the IOM proposes meaningful public access to information about serious harms; it states that "requests by providers for confidentiality and protection from liability seem in- appropriate in this context.""

A conceptual distinction between reporting and disclo- sure is important. Reporting refers to the provision of in- formation to oversight bodies such as state agencies, or the proposed Center for Patient Safety. Disclosure, by con- trast, refers to the provision of information to patients and their families. It is important to point out that the IOM's emphasis on accountability and the public's right to know in the context of mandatory reporting have nothing to do with active disclosure of information by health care insti- tutions to harmed parties. Although the mandatory re- porting of serious or fatal adverse events would, in princi- ple, trigger meaningful investigation and administrative action, it does not automatically direct that information to the patients who have been harmed. The "right to know" invoked by the IOM, is thus not an endorsement of the individual's right to know or of the obligation of re- spect for the autonomy of individuals. In this way, the IOM's understanding of accountability is extremely nar- row and points up one of the ways in which a public health or safety approach overlooks obligations to specific individuals.

Although it is not a feature of the IOM's recommen- dations, the need for disclosure, understood as a prima facie obligation of professionalism,'^ is being addressed on other fronts in the patient safety movement. For example, in 2001, the JCAHO put into effect a disclosure standard that requires hospitals and physicians to inform patients (and families) about "unanticipated outcomes" associated with their care." This requirement is included in the JCAHO's Patient Right's and Organizational Ethics stan- dards. Likewise, a number of forward-looking health care institutions, such as the Veterans Affairs (VA) Medical Center in Lexington, Kentucky,"' have embraced disclo-

sure as an institutional obligation that has the added ad- vantage, from a consequentialist point of view, of not re- sulting in a negative financial impact on the hospital. As Steve Kraman of the Lexington VA hospital says, "We didn't start doing this to try to limit payments; we did it because we decided we weren't going to sit on or hide ev- idence that we had harmed a patient just because the pa- tient didn't know it. . . .We started doing it because it was the right thing to do, and afier a decade of doing it decid- ed to look back to see what the experience had been. The indication that it's costing us less money was really unex- pected."'^ Implicit in Kraman's remark is an endorsement of disclosure as an obligation of professionalism, as "the right thing to do."

The IOM also calls for accountability of health care in- stitutions to performance standards regarding continuous improvement in safety and quality. The emphasis here is on pressure that will be applied by regulators, accreditors, and purchasers to evaluate and compare hospitals accord- ing to their demonstrated commitment to safety. Given its public policy focus, the IOM report focuses on ac- countability oi organizations, not oi individuals. If we look at the history of medicine, however, we see that it is indi- viduals—specifically physicians—who have historically been regarded as the locus of health care quality and who have been held responsible for it.'*

These assumptions have shaped medical culture to the extent that a rethinking of accountability must be central to the "culture change" that is the rallying cry of reform. If, as safety experts both within and outside medicine maintain," it is flaws in a system, rather than in individ- ual character or performance, that produce the vast ma- jority of preventable errors—a premise this essay ac- cepts—then the dominant strategy of blaming individuals will continue to be ineffectual and counterproductive in improving safety. This point was made early by leaders of the patient safety movement: "A new understanding of ac- countability that moves beyond blaming individuals when they make mistakes must be established if progress is to be made."^" The dynamic between institutional and individual accountability is one of the most important and complex issues at the heart of patient safety reform. We analyze this concept and its practical implications later in this essay.

In addition to its recommendations regarding a nation-wide mandatory reporting system, the IOM also rec- ommends that voluntary, confidential reporting systems be implemented within health care institutions and en- couraged through accrediting bodies. In this context, con- fidentiality refers specifically to the restriction of public access to information on the quality and safety of health care delivery—also known as "peer review protection." Ordinarily, when we speak of "confidentiality" in health

September-October 2003 / HASTINGS CENTER REPORT

care we are referring to the confidentiality of patient in- formation and restricted access to that information except by patient consent.^' Such systems, many of which are al- ready in place in health care and other high-risk indus- tries, are essential to safety improvement efforts, insofar as they can encourage providers to supply information need- ed to identify and take action to address hazardous condi- tions. As many observers of high-risk industries have noted, it is the information about near misses that pro- vides the richest resource for safety improvement efforts.̂ ^ In its distinction between thresholds for mandatory and voluntary reporting, the IOM combines, under the vol- untary reporting system, near misses and errors that have caused minor or moderate injuries.

In order fot voluntary reporting to be workable, the IOM states, providers need to be assured that the infor- mation they report will not be used against them in the context of malpractice litigation. As such, the IOM rec- ommends that "Congress pass legislation to extend peet review protections to data related to patient safety and quality improvement that are. . . collected or shared with others solely fot purposes of improving safety and quali- ty." Although the guarantee of sectecy has a political put- pose (to gain participation ftom clinicians who would otherwise feat exposure to liability), from an ethical point of view, the guarantee of peet ptotection is justified by the principle of utility. A reduction in harmful errors across the patient population can be achieved only if front-line health cate professionals are willing to supply information regarding specific health cate delivery problems. The free How of this information to cteate an epidemiology of etrot can occur only if sectecy tegatding the information is assured.

As recommended, this proposal has been introduced into legislation under the "Patient Safety and Quality Im- provement Act," introduced into the Senate 5 June 2002, and the Patient Safety Improvement Act of 2002, intro- duced into the House 6 June 2002. Accotding to the bills, all information collected fot the purpose of patient safety and quality improvement will be confidential and pto-

tected ftom subpoena, legal discovery. Freedom of Infor- mation Act requests, and othet potential disclosures.̂ ^

There are a numbet of ethical ptoblems with this ap- proach. First, the proposed legislation allows information about adverse medical events (which it calls "lesser in- juties") to be concealed from hatmed parties. It is not clear how the legislation squares with accteditation re- quirements fot disclosure that ate mandated by the JCAHO ot that may be part of a hospital's institutional policy. Second, peet review protections formalize and re- infotce the conflict between the provider's intetest in self- protection and patients' legitimate intetest in information about theit cate. In so doing, the resttiction of access to infotmation about adverse events undercuts fiduciaty obligations and patients' tight to know about infotmation pertinent to their care. Third, the enhancement of peet review ptotection is premised on the assumption of the status quo with regard to the current malpractice system. Peer review ptotection is made to do all of the heavy lift- ing to circumvent what Ttoyen Btennan has called the "the dead weight of the litigation system." '̂* Brennan is critical of the IOM recommendations and othet tefotm proposals that fail to addtess the ways in which the cut- tent malptactice system is ethically and ptactically coun- terproductive as a response to medical harms. The struc- tures and incentives of the tott system ate inconsistent with accountability fot ttuth telling, and safety improve- ment (a point taken up again below).̂ 5

As we have pointed out, the notion of accountability is central to patient safety tefotm. It guides out expectations and judgments tegatding the petfotmance of health cate ptovidets. Mote challenging, the causal story now being told about medical ettots ftom the systems perspective fundamentally challenges those conventional expectations and judgments; that is, the assumption of individual ac- countability that fotms the fabtic of medicine and law. So, in otdet to hold health cate ptovidets accountable undet a systems apptoach, we have to teinvent not only our undetstanding of accountability, but also the sttuc- tutes of accountability institutionalized in out legal and cultutal apptoaches to medical ettot.

SPECIAL SUPPLEMENT / Promoting Patient Safety; An Ethical Basis for Policy Deliberation

etting clear on the notion of accountability re- ,quires that we sort out and appraise two different • causal explanations for medical error. Further, in

examining one of these explanations—the story of com- plex causation in a systems approach to error—we will need to dstinguish between two different senses of ac- countability—a backward-looking sense and a forward- looking sense—and consider the implications of each for both how we compensate those who have been harmed and for safety improvement.

Two CaiuisaO Stlooes

With the emergence of the systems approach to pa-tient safety, a paradigm shifi: has occurred in the causal story of why errors occur and how they can be pre- vented. According to the conventional story, medical error, and specifically harmful medical error, is the result of individual actors and their individual actions—the slip of a scalpel, a wrong diagnosis, a failure to wash one's hands, the failure to check a hematocrit. As far as respon- sibility for such errors is concerned, the earliest modern codes of medical ethics by Thomas Percival in 1803 and by the AMA in 1847, state that the doctor's conscience is the "only tribunal" and his responsibility is to learn from his mistake and to make sure it does not recur.̂ "̂ As Ken- neth De Ville has observed, afi:er the late 1800s, when medical malpractice emerged as a new public "tribunal," this causal story became the basis for negligence claims against physicians.̂ ^ Tort law remains the dominant nar- rative of responsibility in the arena of medical error, and it operates on the basis of a notion of simple causation. Poor or unsafe care is attributable to the actions or inactions of individual health care providers who are cast as "bad ap- ples."'̂ * The shadow of liability reflects and reinforces a "shame and blame culture" within which people hide their mistakes.

Starting about four decades ago, W. Edwards Deming and J.M. Juran's work in human factors research and in- dustrial engineering, Charles Perrow's book Normal Acci- dents, and James Reason's Human Error, all offered a new causal story about quality and quality failure. That story, which has been told in the medical context by Donald Berwick, Lucien Leape, and the National Patient Safety Foundation,^' among others, is that human error should not be regarded narrowly as the cause of harm; it should be regarded as the effect of complex causation. Why? Be- cause the majority of errors do not produce harm, but they have the potential to reveal latent errors or potential- ly harmful failures within a complex system. Unless we look in greater detail at the causal web, we will be ignorant

of the weaknesses in the system and powerless to prevent their causing future harm.

The lesson of human factors research and cognitive psychology is that to understand error causation it is not enough to examine one's own actions or to look for the "smoking gun" or proximate cause of the active error; we must also examine the interrelationships between humans, technology, and the environment in which we work.̂ " Ap- plying this research to accidents involving the leaking of radioactive material at Three Mile Island and the explo- sion of the space shuttle Challenger, psychologist James Reason determined that most accidents were caused by mismatches between the design of complex systems and the ways humans process information. In the medical context, a system failure in drug administration, for exam- ple, might involve look-alike packaging or sound-alike drug names—situations that are literally "accidents wait- ing to happen."

According to safety experts in aerospace, atomic energy, and other complex, technology-based industries, the most constructive approach to error reduction is the creation of a blame-free environment that sees every error as "a trea- sure."^' There are at least two justifications for this coun- terintuitive approach to responsibility or accountability (which for the purposes of this report are interchangeable terms). The first is, again, that error-prevention depends on information that will be forthcoming only if individu- als feel free enough from liability concerns to provide it. The second is based on the principle of justice. As Merry and McCall Smith point out in their book Errors, Medi- cine, and the Law, errors are by definition exculpatory be- cause they are involuntary.'^ So, holding individuals re- sponsible for errors is wrong on two counts. First, a true accident, whether it is an act or an omission, is not blame- worthy because it is not intentional, and its result was ei- ther unforeseeable or could not have reasonably been pre- vented. Second, most errors cannot be causally attributed solely to an individual actor.

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This new causal story has understandably given rise toa number of concerns about accountability for harm- fijl mistakes.

The first worry is that a systems explanation gives peo- ple permission to pass the buck by saying that their own actions were so controlled by "the system" that they sim- ply were not free to do otherwise. In this sense, appeals to the "system" provide a convenient pretext for moral shirk- ers. In its most extreme form, this is the problem of free will and determinism in a new context. Appealing to the "system" in the broadest metaphysical sense, one's actions

September-October 2003 / HASTINGS GENTER REPORT

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are seen to be determined by forces outside of all human agency. Responsibility is located outside the individual actor. But this sort of defense against responsibility is not really plausible in the case of health care practitioners, whose self-understanding includes the ability to influence the course of illness. As long as freedom of the will pro- vides one of the guiding justifications of their work, they cannot also reject it whenever they make a mistake. That said, however, the literature on the history and sociology of medical law indicates that a fatalistic belief in divine providence was one of the key exculpating factors in med- ical harm until the early nineteenth century and that it continues to be an important, if sometimes disingenuous one today." In her book Wrongfiil Death, Sandra Gilbert, whose husband died as the result of a medical error, re- counts a story about the benefactor of a Catholic hospital whose wife's doctors repeatedly assured him that it was "God's will" that she was comatose and later died after routine surgery. Her husband sued to fmd out what every- one had "known all along," namely, that the patient's coma was the result of an identifiable error.'''

A related worry about a systems approach is the "Dil- bert problem." Unlike the metaphysical problem of deter- minism that implicates the human condition, the "Dil- bert problem" implicates the conditions under which hu- mans work and is implicit in the problem of learned help- lessness.35 "phe worry is that the systems approach so min-

Trajectory of

accident opportunity imizes the role of individual

agency that it will choke off the motivation to sustain high- quality performance, encourage poor performance, and lead to an erosion of the trustworthi- ness of health professionals.^^

This worry is based on the assumption that individual ac- tors are morally and practically disempowered w i t h i n such a system, or that individuals can

step "outside" a system and claim moral immunity. As we shall see, however, the kind of responsibility envisioned within the systems approach is based on the empower- ment of individuals to contribute to system improvement.

Another, more practical concern about the systems ap- proach to medical error is that it will make assigning re- sponsibiliry for preventable adverse events difficult if not impossible. This worry about the loss of an identifiable target of blame is fostered, in part, by the very h u m a n de- sire for vengeance.37 T h e invocation of a "system" renders faceless and anonymous the perpetrator of harm, and vic- tims are lefi: powerless. Also at play here is the assumption that justice to harmed parties requires being able to point to a wrongdoer. This is an assumption fostered by the ev- identiary requirements of malpractice, which link com- pensable negligence to an identifiable lapse in the stan- dard of care. If a wrongdoer is able to take refuge in the "system," then harmed parties may be denied access to compensation.

This concern is directly linked to a worry that the practical demands of the systems approach—that is, the need to collect information about errors and adverse events—^will be possible only at the expense of the pa- tient's right to know. If protections against subpoena and legal discovery are extended to information regarding harmful quality failures, then accountability to individu-

SPECIAL SUPPLEMENT / Promoting Patient Safety: An Ethical Basis for Policy Deliberation

als will be subordinated to the ostensible aims of safety improvement.

Two WoilDoinis off Accoiuiini4albiDBily

We may allay both these speculative and practicalconcerns by distinguishing two different ways in which we think about accountability. Ascribing responsi- bility depends for its sense on the purposes or ends to which we put it and the information that we take or do not take to be directly relevant. Put differently, when we talk about responsibility we need to be clear not only about the information that we take to be relevant, or not, but also about what we hope to accomplish in assigning responsibility. With that in mind, we can make a distinc- tion between two types of responsibility ascription: re- sponsibility in the backward-looking or retrospective sense, and responsibility in the forward-looking or prospective

In the backward-looking sense, responsibility is linked to practices of praising and blaming and is typically cap- tured in expressions such as "she was responsible for harming the patient" or "he made a mistake and he should be held responsible for it." When we speak of "holding someone accountable" we tend to be using this phrase after some action has gone awry.

The forward-looking or prospective sense of responsi- bility is linked to goal-setting and moral deliberation. It is expressed in phrases such as "as parents, we are responsi- ble for the welfare of our child," or "democratic citizen- ship involves both tights and responsibilities." Responsi- bility in this sense is about the particular roles that a per- son may occupy, the obligations they entail, and how those obligations are best fulfilled. But whereas responsi- bility in the retrospective sense focuses on outcomes, prospective responsibility is oriented to the deliberative and practical processes involved in setting and meeting goals.35

Currently, the dominant view of responsibility regard- ing medical error is grounded in tort liabiliry, that is, mal- practice. The aim of responsibility ascription in this con- text is compensation to harmed parties and deterrence of further malpractice. Through the lens of malpractice, error is germane only as the cause of harm, and informa- tion about errors that do not cause harm is irrelevant. Re- sponsibility ascription in this context is retrospective; its point is the assignment of blame.

A systems approach to error emphasizes responsibility in the prospective sense. It is taken for granted that errors will occur in complex, high-risk environments, and par- ticipants in that system are responsible for active, com- mitted attention to that fact. Responsibility takes the form of preventive steps to design for safety, to improve on poor system design, to provide information about po- tential problems, to investigate causes, and to create an environment where it is safe to discuss and analyze error.

Although there is much disagreement in the medical ethics literature about the source of moral norms in med- icine,̂ " it is generally accepted that, at minimum, health care is guided by the imperative "to help, or at least to do no harm.""" Traditionally, this role responsibility has been associated exclusively with clinicians—those who have a direct relationship with patients. In part, this stems from the historical origins of healing, which until the emer- gence of the modern hospital was the domain largely of solitary practitioners. It also refiects the ethical standards established to legitimate professional self-regulation. Given the complexity in the dimensions both of the fi- nancing and the delivery of today's health care system in the United States, a strong case can be made that this role responsibility should also be extended to those who have indirect but significant control over decisionmaking that affects patient welfare. This includes health care managers and administrators who have not traditionally been held accountable to standards of medical professionalism.

Since prospective responsibility is linked to practices and roles, it applies to collectives as well as to individuals. To the extent that a group of people contributes to a prac- tice and the goals that define it, they can be said to have "collective responsibility"—in the prospective sense. In health care, helping and avoiding harm is one of the pri- mary bases on which physicians, nurses, and other health care providers find solidarity in their work. Collective re- sponsibility in this uncontroversial sense has been largely overlooked because, like most discussions of responsibili- ty in the philosophical and legal literature, discussions of collective responsibility have focused almost exclusively on the retrospective question of blame and whether and how collectives can properly be held accountable for harmful events.̂ -̂

An emphasis on prospective responsibility is helpful because it forces us to re-examine, in light of the com- plexities of institutionally delivered health care, the con- tent and scope of responsibility. This is something we have lost sight of in our narrow reliance on the malprac- tice paradigm as an explanatory framework for medical error. We need new structures to account for what we now know about the occurrence of error in complex sys-

tems. In the context of health care delivery, the aim of

prospective responsibility ascription is to orient everyone who has an effect on patient care (including clinicians, health care administrators, hospital managers and boards, technicians, computer data specialists) toward safety im- provement. Through the lens of patient safety, error is germane as an indicator of vulnerabilities in a system and as an opportunity to prevent harm. The point of forward- looking responsibility ascription is to specify the obliga- tions entailed in creating a safer health care environment. Given a systems approach to error, these obligations entail a high degree of transparency about errors, analysis of er- rors to determine their causes, and the implementation of

September-October 2003 / HASTINGS GENTER REPORT

systemic improvements. To the extent that current struc- tures prevent health care providers from meeting these re- sponsibilities, the structures are inconsistent with the ethics of professionalism.

But what is the patient's own responsibility for safety? If, as Leape and others have argued, a system is "an inter- dependent group of items, people or processes with a common purpose,"''^ and responsibility in the prospective sense belongs to all who contribute to the healing enter- prise, isn't it reasonable to include patients in this collec-

tive: For some, the suggestion is offensive because it can very

easily shade into blaming the victim. If the patient is re- sponsible for assuring safety, and she does not ask about a medication she knows to be unfamiliar, will we say that she somehow failed?'*'* On the other hand, if patients sup- ply information and insights essential to their care—and indeed they must provide information regarding their his- tory—then should they not be considered as members of the team?

We can all agree that patients are de facto central to their care. The sticking point is whether this centrality im- plies that they are morally responsible for the safety or quality of their health care.'*' Unlike clinicians and others who deliver health care, patients have not committed themselves to the practice of health care delivery and the goals that define it. Most people do not freely choose to become patients. That said, the rise of the patient advoca- cy movement has been based on the call for patients to be- come more active in their care. Patient safety advocate Roxanne Goela, whose brother Mike died as a result of a medical error, has argued forceflilly that patients and their families should take active measures to assure that their care is delivered safely. This includes having a friend or family with the hospitalized patient twenty-four hours a day, seven days a week.'*'' Bryan Liang has also argued that

patients are responsible at least for supplying health care providers with personal information that is as complete and accurate as possible.'*^

An axiom of responsibility ascription is "ought implies can." In order to say that someone is responsible, he or she has to be in a position to act on that obligation. In the case of patients, taking responsibility for the quality or safety of their care will often be out of the question. For those pa- tients who can be actively involved, their positive contri- bution to their health care delivery should be facilitated and commended, but required only in the provision of in- formation that is as accurate and complete as possible and in following, as much as possible, the treatment regimen. The onus of responsibility for patient involvement is on institutional and individual health care providers.'*^ Re- spect for patient self-determination requires that providers involve patients in their care, and the lessons of safety im- provement indicate that including patients (or their fami- lies) as members of the health care team (by asking them to confirm their surgical site, by paying attention to their reports on themselves) may be one of the most effective and commonsensical ways of improving care.

If we fmd that most preventable harms are caused by complex factors involving latent failures at the managerial level, system defects, unsafe acts, and psychological pre- cursors, and if we agree that an essential moral responsi- bility of health care providers is "to help or at least to do no harm," then meeting that responsibility will require conditions under which these causal factors can be brought to light, assessed, and improved. Currently, the system of liability for medical harms makes meeting that responsibility possible only through exceptional acts of courage.'" Likewise, it makes respect for patients through disclosure almost impossible because it discourages hon- esty and openness on the part of health care professionals.

SPECIAL SUPPLEMENT / Promoting Patient Safety: An Ethical Basis for Policy Deliberation

Tp^rospective accountability means creating safe condi- -^tions for patient care. Retrospective accountability

J L means achieving justice for harmed parties. As a pol- icy matter, both forms of accountability must be under- stood in light ofthe ethical pros and cons of compensation schemes for adverse patient outcomes: tort liability, no- fault liability, and mediation. No-fault and mediation seem likeliest to meet the demands of justice without in- hibiting safety improvement. Traditional tort liability is the least ethically viable means of achieving these two goals, although it is the most deeply entrenched system, politically speaking.

Tocil Ln

'"[port liability is a fault-based system of compensation JL for those who sustain injury as a result of their med-

ical care. To qualify for payment, the injured party must prove that his or her injury was the result of negligence on the part of the health care provider. A second goal of tort liability is deterrence. The expectation is that the threat of legal action will keep providers from straying from stan- dards of due care.

As David Studdert, Edward Dauer, and Bryan Liang each argue, tort liability not only fails in respect of both compensation and deterrence, but also inhibits safety im- provement. 5° They point out that malpractice law falls short in at least six ways. First, it is a haphazard compen- sation mechanism. According to fmdings from the Har- vard Medical Practice Study, one of the largest insurance industry-sponsored studies of medical error, only one in seven patients who are negligently harmed ever gain access to the malpractice system, with those who are older and poorer disproportionately excluded from access.'' For those patients who do sue, the severity of the injury ap- pears to be a more powerful predictor of compensation than the fact of negligence.'^ And because of that, physi- cians believe that liability correlates not with the quality of the care they provide, but with outcomes over which they have little control. As a result, "risk management" has be- come an effort to avoid liability rather than error.

A second problem with malpractice law is that it deliv- ers compensation inefficiently. Administrative costs ac- count for more than 50 percent of total system costs," and a successful plaintiff recoups only one dollar of every $2.50 spent in legal and processing costs. '̂' Third, mal- practice claims offer only a monetary outcome, ignoring the harmed party's need for noneconomic remediation, such as a guarantee of corrective action, an apology, or an expression of regret and concern. Fourth, the negligence standard, because it is embedded in an adversarial process, is inconsistent with attempts to learn from errors and im-

prove quality. Malpractice claims, including pre-trial dis- covery, are shrouded in secrecy, with legal rules governing disclosure and protection of information. This means that institutions and individual providers typically forego op- portunities to learn from the problems that lawsuits can sometimes help illuminate.

Fifth, as Dauer points out, the adversarial process is based on the belief that the presentation of relentless, one- sided arguments to an impartial judge or jury is the best way to discern the truth. This process necessarily rules out the prospect of collectively analyzing information to dis- cern what happened. The malpractice system thus "exter- nalizes" responsibility for truth by selectively taking infor- mation out of the hands of involved parties—a process that is emotionally brutal for patients and families trying to reconstruct their lives after medical harm.'5 Finally, re- garding its deterrence function, evidence indicates that malpractice stimulates defensive medicine rather than high quality care,''' and that the stress and isolation that physicians experience while subject to malpractice claims can impair their performance.'^

These shortcomings reveal the moral flaws of tort lia- bility. With regard to the claims of justice, tort system fails to deliver compensation in a fair and timely way to harmed parties. Those with lesser claims are kept out of a prohibitively expensive malpractice system; those who are compensated may spend years obtaining this result; those who are old and poor may be excluded from the system al- together. For Sandra Gilbert, who settled under the shad- ow of malpractice, the adversarial process guaranteed that the plaintiffs would never know the case's fiill details and would never receive an apology or recognition from the defendant. The tort system creates incentives against truth telling on the part of health care providers. Also, with re- gard to justice for clinicians, the tort system overlooks the system dimensions of error and thus may unfairly target individual providers for acts, omissions, and outcomes for which they cannot fairly be held culpable. When it comes to harm prevention, the tort system stifles safety improve- ment, and, by externalizing responsibility for truth, en- genders a defensive rather than a constructive posture to- ward error prevention. Viewed from the perspective of utility, the tort process is inefficient.

No-fault liability is a compensation scheme that doesnot base the award of damages on proof of provider fault. As Studdert observes, "to qualify for compensation in these schemes, claimants must still prove that they suf- fered an injury and that it was caused by an accident in a specific domain, such as the workplace, road, or hospital.

September-October 2003 / HASTINGS CENTER REPORT

but it is not necessary to demonstrate that the party who caused the accident acted negligently. "'̂ No-fault liability is consistent with the prospective assignment of responsi- bility. It is predicated on a high risk of hazard in a partic- ular industry and assigns absolute liability in advance re- gardless of contributory fault. In other words, no-fault lia- bility is based on the presumption that harms will occur in a particular setting, and it incorporates provisions for compensation.

Studdert cites empirical research indicating that no- fault has led to increases in average monetary compensa- tion for injured workers as well as gains in worker safety. Although more evidence will be needed, Studdert and others are optimistic that similar benefits would be ob- tained by implementing no-fault in health care. No-fault has a number of potential moral advantages. First, since it suspends the fault requirement, no-fault could remove in- centives to conceal information, thereby supporting fidu- ciary obligations of disclosure and creating the conditions for the collection and analysis of error information. Sec- ond, no-fault could overcome some of the inequities in ac- cess to compensation under malpractice law. Unlike the tort system, which distributes compensation haphazardly, no-fault, as an administrative scheme, could determine remedies in advance and distribute them according to the severity of injury. One potential problem, however, is in the calctilation of loss. If a person's loss is determined by the person's salary, for example (as it was for victims of the September 11 attacks), then age-based, gender-based, or income-based inequities could be repeated in a no-fault scheme.

This weakness is also related to the health care financ- ing system that we have in this country. As Haavi Mor- reim points out, countries where no-fault schemes for medical harm have been implemented also offer their citi- zens universal health care coverage and other social welfare programs, so that ongoing health care and other needs are already covered and need not be obtained through no- fault compensation.5' Without this and other social wel- fare programs to support the needs of the injured and in- firm, the efficiencies of no-fault will quite likely not be re- alized.

Nonetheless, the potential for no-fault to remove barri- ers to information access both for patients and for safety improvement, along with its potential for fairer distribu- tion of compensation, make it a promising context in which justice, fiduciary responsibility to patients, and safe- ty improvement can thrive.

Ynterest-based mediation is a means of opening direct JLcommunication between parties in a dispute. Its aim is to address the parties' actual interests and needs rather than the infiated interests and needs evoked by the adver- sarial arrangement of malpractice law. Empirical research

indicates that patients who suffer injury often have non- economic motivations—such as a desire for information and communication—in bringing a claim.'̂ ° Likewise, it has been argued that what physicians want out of litiga- tion (whether that means winning a malpractice suit or a subsequent defamation claim that they have brought as plaintiff) is not monetary repair, but repair of reputa- tion.*"' Mediation is a means of addressing these interests in a "restorative" way that is impossible within the context of traditional tort litigation.

Another potential advantage of mediation is that, al- though it takes place within the existing fault-based sys- tem, its confidentiality is ostensibly assured through statu- tory legal privilege in almost every state.'̂ ^ Although the degree to which legal privilege does actually guarantee a "safe harbor" against subsequent litigation has been ques- tioned,'̂ ^ mediation has the advantage of "internalizing" responsibility for the resolution so that the parties are able to communicate direcdy rather than through legal inter- mediaries. As a result, the parties may all benefit from the resolution. Health care providers can avoid a costly law- suit, consequent reporting to the National Practitioner Data Bank, and loss of reputation, while patients and fam- ilies can make a human connection following a loss, and patients can be brought into the peer review process by re- questing follow-up or remedial actions in lieu of or in ad- dition to monetary damages. Although mediation does not offer a direct avenue to information collection about adverse events and errors, it may create a less adversarial context in which safety, rather than money, can be pur- sued as a mutual goal and the patient's experience can be explicitly used to improve care.

Mediation can also provide a much-needed context that supports truth-telling as an avenue to justice. Patients are routinely excluded from rituals of forgiveness in the medical context. In Charles Bosk's description of forgive- ness for the technical and moral errors committed by sur- gical residents,'̂ '* analogs of "confession" and "repentance" take place in the "hair shirt" ritual of the morbidity and mortality conference. Here, physicians report to peers and superiors on the circumstances surrounding their involve- ment in an adverse event, and forgiveness is conferred by the superior. A second ritual involves peer support for clin- icians confronting the emotional trauma of harmful er- rors. Absent from all of these contexts is the patient. All of these rituals serve important purposes; justice to specific patients is not one of them.

In her work on religious and cultural perspectives on error and forgiveness, Nancy Berlinger argues that such rituals are incomplete.'̂ ^ Jn ĥg Jewish and Christian tradi- tions that have helped to shape Western cultural norms, argues Berlinger, the possibility of forgiveness or reconcili- ation in the service of justice to harmed parties—in this case, patients—involves repairing one's relationship with the patient, not with one's superordinates or peers. Repair- ing the relationship requires appropriate actions of confes-

SPECIAL SUPPLEMENT / Promoting Patient Safety: An Ethical Basis for Policy Deliberation

sion and repentance. Practices that could be described as confession in the Jewish and Christian traditions would include (to list only a few possibilities Berlinger mentions) promptly acknowledging error and disclosing to the pa- tient a cogent and complete narrative of what happened; accepting personal accountability even in cases of systems error, bearing in mind that some patients may always un- derstand error as an individual rather than a systemic fail- ure; and giving clinicians opportunities to process inci- dents and receive counseling in an environment that is neither punitive nor demoralizing. Practices that could be described as repentance could include (again listing only a few examples) apologizing and expressing remorse to an injured patient (and allowing oneself to feel remorseful); offering injured patients and family members pastoral care or other counseling services; and covering the cost of treat- ing injuries resulting from error. Berlinger also details practices that might promote forgiveness or reconciliation. For example, forgiveness might be promoted by inviting patients to be part of the hospital's quality improvement process, to allow them, if they wish, to take an active role in working with clinicians and administrators to create a patient-centered culture of safety by sharing their experi- ences of medical harm and their perspectives on hospital culture (although injured patients are not to be made to feel that they ought participate in QI).

Berlinger also notes that forgiveness might be promot- ed by challenging aspects of institutional culture that deny the fallibility, and therefore the humanity, of clinical staff, or that work against truth-telling, accountability, compas- sion, and justice in dealing with medical error and pro- moting patient safety.

It is important to remember that the IOM report in- cludes both errors that cause no harm (near misses) and errors that cause "lesser injuries" within its recommenda- tion for voluntary reporting.'''= The recommendation should not be regarded as a substitute for the established professional obligation for disclosure of harmful errors, be they serious, moderate, or minor. Regardless of the policy recommendations, the ethical obligation for disclosure of harmful error stands. The challenge, therefore, will be to create a context in which this obligation can be honored despite seemingly contradictory policy proposals.

As Berlinger's recommendations about disclosure make clear, delivering justice to harmed parties entails the insti- tutionalization of new norms and practices of disclosure. The greater openness potentially afforded by no-fault or mediation and voluntary compensation in the context of existing tort liability may provide environments in which such norms and practices can take hold and harmonize with the long-established fiduciary obligations of disclo-

sure.

July-August 2003 / HASTINGS GENTER REPORT

The chief premise of a systems approach to error isthat overall safety improvement requires that oldforms of individual interrogation (shame and blame) be replaced by new forms of "system interroga- tion" (that is, root cause analysis). Another premise of a systems approach is that success depends on the collection and analysis of information gleaned from real life health care delivery. The IOM report recommends that informa- tion about error not associated with serious harm be pro- tected from all uses not connected with safety improve- ment, including uses requiring access to information by such methods as subpoena, legal discovery, and the Free- dom of Infotmation Act.

As we have just noted, the recommended protection of infotmation about "lesser harms" is incompatible with professional obligations of disclosure. Equally if not more disturbing, both the IOM recommendations and ensuing legislation (the "Patient Safety and Quality Improvement Act" in the Senate, and the "Patient Safety Improvement Act of 2002" in the House'''') make safety improvement contingent on patients being harmed—even though the harms in question can be of "lesser" severity. The effort to protect infotmation that is part of a voluntary repotting scheme is a "workaround" in the malptactice status quo. It pits the value of safety improvement against the values of nonmaleficence and truthtelling. As Btennan points out, the IOM sought to assure accountability through its pro- posed mandatory reporting of serious, preventable adverse events. Not surprisingly, however, the dominance of mal- practice has made this tecommendation politically unten- able.''̂ Thus, teconsideration of the malptactice system it- self, in favot of no-fault and mediation, may be necessary to overcome the antagonism between safety improvement and the values of nonmaleficence and truth-telling, as well as to achieve accountability in the prospective as well as the retrospective sense.

The tecently fmalized Health Insurance Portability and Accountability Act (HIPAA) has also given rise to con- cerns about the extent to which data collection for safety improvement will be hampered by HIPAA provisions to safeguard the privacy of patient records. At issue is whether patient records—primarily intended to support the health cate needs of the patient—can also be used fot

the secondary purpose of improving safety or quality. As Bryan Liang points out, HIPAA was not designed with safety improvement research in mind and may present some obstacles to the use of patient infotmation in this arena.''' In the original version of the regulation, before it was modified in August 2002, patient consent was re- quired for the release of personal, identifiable information that could be used for safety improvement. The modifica- tions eliminate the consent requirement for the disclosure of personal infotmation fot "health cate operations," which may include quality improvement activities. Undet the rubric of "quality," data collection for safety without patient consent appears to be allowable in the final rule. But if quality- ot safety- improvement rises to the level of "research"—if it involves the production of "generalizable knowledge"—the activities will fall undet the require- ments of human subjects ptotection requiring Institution- al Review Board approval or HIPAA authorization. The modifications to HIPAA also allow for researchers to have access, without patient consent, to a "limited data set," that is, to information that has been partially de-identi- fied. It is not cleat whethet this limited infotmation will be useful in fine-gtained safety improvement wotk.

The final privacy rule goes some way towards harmo- nizing patient privacy and the promotion of safety-im- provement activities. Still, safety improvement activities ought not to be conducted on the basis of information to which harmed patients themselves are denied access, ei- ther because of the structure of peer review protections or because providers ate reluctant to disclose due to liability feats.̂ " No-fault liability offers one way around this con- flict. Under such a system, existing obstacles to patient ac- cess to infotmation about the delivery of theit health cate would be largely removed, and this secondary use of health infotmation would not be contingent on depriving patients of theit tights to know about problems associated with their health care. Although the HIPAA privacy pto- visions have been finalized and compliance is now te- quired, it is likely that definitive answers to questions re- garding privacy and "research" will be obtained only as the rule is tested or as advocates seek amendments to it.

SPECIAL SUPPLEMENT / Promoting Patient Safety: An Ethical Basis for Policy Deliberation BUS

chief goal of this report has been explore and clarify both the ethical considerations that enter into patient safety reform and the ethical implica-

tions of various reform proposals at federal state and insti- tutional levels. Elucidating the ethical basis of policy de- liberation leads to several important recommendations:

• Federal officials, privacy advocates and advocates of safety improvement should work together to clarify the implications of the HIPAA privacy rule for the collection of safety data.

• Policymakers should look for alternatives to the tort system to serve the purposes of compensation and safety improvement.

• Institutional change depends on understanding how a cultural context shapes perceptions about why errors hap- pen and how actors within a culture learn to think about and deal with them. Institutional leaders in health care will need more self-consciously to examine the "hidden curriculum" in medical and nursing education; that is, the practices that are taught and rewarded through example, rather than through what is conveyed in the official cur- riculum.

• Errors cannot be eliminated. We can, however, reduce them, learn from them, improve the way we handle them, and deal more justly with all those (including clinicians) touched by them.

September-October 2003 / HASTINGS CENTER REPORT

References

1. L T Kohn, J.M. Corrigan, M.S. Don- aldson, eds. To Err is Human: Building a Safer Health System (Washington, D C : Na- tional Academy Press, 2000).

2. Ibid., p. 18.

3. V.A. Sharpe and A.I. Faden, Medical Harm: Historical, Conceptual and Ethical Dimensions of latrogenic Illness (New York: Cambridge U. Press, 1998); T.L. Beauchamp and J.F. Childress, Principles of Biomedical Ethics 4th ed. (New York: Ox- ford University Press, 1994).

4. E.D. Pellegrino, "Toward a Recon- struction of Medical Morality: The Primacy of the Act of Profession and the Fact of Ill- ness," Journal of Medicine and Philosophy A (1979):32-55; E.D. Pellegrino ED, D.C. Thomasma, Eor the Patient's Good: The Restoration of Beneficence in Health Care (New York: Oxford, 1988).

5. E.D. Pellegrino, "Prevention of Med- ical Error: Where Professional and Organi- zational Ethics Meet," in Promoting Patient Safety: An Ethical Basis for Policy Reform, ed. V.A. Sharpe (Washington, D C : George- town University Press, in press).

6. Kohn, et al.,. To Err is Human, p. 4.

7. Kohn, et al.,. To Err is Human, p. 4.

8. See T. Brennan, "The Institute of Medicine Report on Medical Errors— Could it do Harm?" New England Journal of Medicine 342 (2000): 1123-1125.

9. Kohn, et al.. To Err is Human, p. 87- 88; 133.

10. Kohn, et al.. To Err is Human, p. 102.

11. It is well known that the threat of medical malpractice has created a culture of silence in medicine, discouraging health care providers from telling patients about problems associated with their care. Even claimants who settle a lawsuit may never know the events surrounding an injury. See, S. Gilbert, Wrongful Death (New York, Norton & Norton, 1997)

12. Liang has indicated the multiple ways in which such confidentiality can, in fact, be breached, by legal maneuvers. See Bryan Liang, "Error Disclosure for Quality Improvement: Authenticating a Team of Patients and Providers to Promote Patient Safety," in Promoting Patient Safety: An Eth- ical Basis for Policy Reform, ed. V.A. Sharpe (Washington, D C : Georgetown University Press, in pres.s).

13. Kohn, et al.. To Err is Human, p. 102.

14. F Rosner, J.T. Berger, P Kark, J. Potash, A.J. Bennett, "Disclosure and Pre- vention of Medical Error," Archives of Inter- nal Medicine 160 (2000):2089-2092; American Medical Association, Council on Ethical and Judicial Affairs. Code of Medical

Ethics: Current Opinions with Annotations. Chicago: AMA, 1997, sec. 8.12:125.

15. Joint Gommission on Accreditation of Health Gare Organizations: 2002 Com- prehensive Accreditation Manual for Hospi- tals: The Official Handbook (Oakbrook Ter- race, IL, J G A H O , 2001). See standard RI. 1.2.2: "Patients and, when appropriate, their families are informed about the out- comes of care, including unanticipated out- comes."

16. S.S. Kraman and G. Hamm, "Risk Management: Extreme Honesty May Be the Best Policy," Ann Intern Med 131 (1999):963-967.

17. N . Osterweil, "Truth or Gonse- quences: Does Disclosure Reduce Risk Ex- posure?: Admitting Errors Makes Process Less Adversarial, M D s , Lavvyers Agree," WebMD Medical News, 20 December 1999. http://my.webmd.com/content/arti- cle/1728.53548.

18. L.L. Leape, "Error in Medicine," Journal of the American Medical Association 111 (1994):1851-7.

19. D . Maurino, J. Reason, R. Lee. Be- yond Aviation Human Eactors. (Aldershot UK: Avery Press, 1995); James Reason, Human Error (New York: Cambridge Uni- versity Press, 1990); James Reason,. "Human Error: Models and Management," British Medical Journal 320 (2000):768- 70; James Reason. Managing the Risks of Or- ganizational Accidents (Aldershot, UK: Ash- gate, 1998).

20. L . L Leape, D . D . Woods, M.J. Hatlie, K.W. Kizer, S.A. Schroeder, G.D. Lundberg, "Promoting Patient Safety by Preventing Medical Error," Journal of the American Medical Association 280 (1998):1444-1447.

2 1 . Thanks to Janlori Goldman for pointing out this important ambiguity.

22. W E . Deming, Out of the Crisis, (Gambridge, Mass.: M I T Genter for Ap- plied Engineering Studies, 1986); D . M . Berwick, "Gontinuous Improvement as an Ideal in Health Gare," New England Journal of Medicine 320 (1989):53-56; J. Reason J. Human Error.

23. See the text of the bills, S. 2590, and H.R. 4889 on Thomas, the federal govern- ment's legislative information site on the In- ternet, http://thomas.loc.gov/

24. T Brennan, "The Institute of Medi- cine Repon on Medical Errors—Gould it do Harm?" New England Journal of Medi- cine 5A2 {20QQ):\\25-\\2'b.

25. E.A. Dauer, "Ethical Misfits: Media- tion and Medical Malpractice Litigation," in Promoting Patient Safety: An Ethical Basis for Policy Reform, ed. V.A. Sharpe (Washing- ton, D.G.: Georgetown University Press, in press).

26. T. Percival, Medical Ethics or A Code of Institutes and Precepts adapted to the Pro- fessional Conduct of Physicians and Surgeons (Manchester: S. Russell, 1803).

27. K.A. De Ville, "God, Science, and History: The Gultural Origins of Medical Error," in Promoting Patient Safety: An Ethi- cal Basis for Policy Reform, ed. V.A. Sharpe (Washington, DG: Georgetown University Press, in press); K.A. De Ville, Medical Mal- practice in Nineteenth-Century America: Ori- gins and Legacy (New York: NYU Press, 1990).

28. D . M . Berwick, "Gontinuous Im- provement as an Ideal in Health Gate"; J. Reason Human Error.

29. R.I. Gook, D . D . Woods, G. Miller. "A Tale of Two Stories: Gontrasting Views of Patient Safety. Report from a Workshop on Assembling the Scientific Basis for Progress on Patient Safety." (Ghicago: Na- tional Patient Safety Foundation, 1998) hn:p://www.npsf.org/exec/front.html.

30. J. Reason. Mana^ng the Risks of Or- ganizational Accidents (Aldershot, UK: Ash- gate, 1998).p. 208.

3 1 . D . Blumenthal, "Making Medical Errors into "Medical Treasures." Journal of the American Medical Association 272 (1994):1867-68. Karl E. Weick, Kathleen M. SutclifFe, Managing the Unexpected: As- suring High Performance in an Age Of Com- plexity (San Francisco: Jossey-Bass, 2001).

32. A. Merry, A.M. Smith, Errors, Med- icine and the Law. (Gambridge, UK: Gam- bridge University Press. 2001). It is also worth noting that in his Nicomachean Ethics, Aristotle observes that responsibility is only properly ascribed to actions that are voluntary. See (Aristotle, 1999, 1110a flf).

33. K.A. De Ville, "God, Science, and History: The Gultural Origins of Medical Error."

34. S. Gilbert, Wrongful Death (New York, Norton & Norton, 1997), p. 218-9.

35. J. Reason. Managing the Risks of Or- ganizational Accidents, p. 192.

36. Edmund Pellegrino, "Prevention of Medical Error: Where Professional and Or- ganizational Ethics Meet."

37. Edward A. Dauer, "Ethical Misfits: Mediation and Medical Malpractice Litiga- tion," in Promoting Patient Safety: An Ethi- cal Basis for Policy Reform, ed. V.A. Sharpe (Washington, D.G.: Georgetown Universi- ty Press, in press).

38. The discussion of this distinction is drawn from V. A. Sharpe, "Taking Respon- sibility For Medical Mistakes," in S. Rubin and L. Zoloth, eds. Margin Of Error: The Ethics Of Mistakes in the Practice of Medi- cine. (Hagerstown, Md.: University Pub- lishing Group, 2000): 183-94.

39. Of course, failures of prospective re- sponsibility often result in holding someone

SPECIAL SUPPLEMENT / Promoting Patient Safety: An Ethical Basis for Policy Deliberation

responsible retrospectively. The systems ap- proach is an attempt to expand the scope of prospective responsibility so that concerted steps toward safety can be taken and re- warded before there are specific outcomes to be assessed.

40. For example, are moral norms inher- ent to medicine, residing in the fiduciary nature of the healing relationship? Are they grounded in a pragmatic concern to pro- duce "patient satisfaction?" Are they based in theories of democratic citizenship? Or is medicine simply like other market transac- tions that are based on contracts stipulating specific expectations and obligations?

4 1 . Hippocrates. Epidemics I. In Hip- pocrates, trans., W.H.S. Jones. Loeb Classi- cal Library. (Cambridge, Mass.: Harvard University Press, 1923-1988): 165.

42. L. May and S. HofiFman, Collective Responsibility: Five Decades of Debate in The- oretical and Applied Ethics (SsMd^e, M: Row- man and Littlefield, 1991).

43. L.L Leape, D.W. Bates, D.J. Cullen, et al for the ADE Prevention Study Group. Systems Analysis of Adverse Drug Events. Journal ofthe American Medical Association 274 (1995):35-43.

44. E. Pellegrino, "Prevention of Medical Error: Where Professional and Organiza- tional Ethics Meet."

45. There is a large literature on the ex- tent to which people are responsible for their health and their health behaviors. Our question is much narrower and concerns only whether patients are responsible for the safety and quality of health care deliv- ery.

46. R. Goeltz, "In Memory of My Broth- er, Mike," in Promoting Patient Safety: An Ethical Basis for Policy Reform, ed. V.A. Sharpe (Washington, D . C : Georgetown University Press, in press).

47. B. Liang, "Error Disclosure for Qual- ity Improvement: Authenticating a Team of Patients and Providers to Promote Patient Safety," in Promoting Patient Safety: An Eth- ical Basis for Policy Reform, ed. V.A. Sharpe (Washington, D . C : Georgetown Universi- ty Press, in press).

48. This point is reflected in the Joint Commission's 2002 standards #3.7 on pa- tient education. Joint Commission on Ac- creditation of Health Care Organizations: 2002 Comprehensive Accreditation Manual for Hospitals: The Official Handbook (Oak- brook Terrace, IL, J C A H O , 2002).

49. D. Hilfrker, Facing O u r Mistakes. New England Journal of Medicine 310 (1984):118-122.

50. D . Studdert, " O n Selling "No- Fault," in Promoting Patient Safety: An Ethi- cal Basis for Policy Reform, ed. V.A. Sharpe (Washington, D . C : Georgetown Universi- ty Press, in press); Edward A. Dauer, "Ethi-

cal Misfits: Mediation and Medical Mal- practice Litigation," in Promoting Patient Safety: An Ethical Basis for Policy Reform, ed. V.A. Sharpe (Washington, D . C : George- town University Press, in press); Bryan Liang, "Error Disclosure for Quality Im- provement: Authenticating a Team of Pa- tients and Providers to Promote Patient Safety."

5 1 . F. A. Sloan and C R . Hsieh, "Vari- ability in Medical Malpractice Payments: Is The Compensation Fair?" Law and Society Review 24 (1990):997-1039; N . Vidmar, Medical Malpractice and the American Jury: Confronting the Myths About Jury Incompe- tence, Deep Pockets, and Outrageous Damage Awards (Ann Arbor: University of Michigan Press, 1995); P C Weiler H . H . Hiatt, J.P. Newhouse , et al. ^ Measure of Malpractice: Medical Injury, Malpractice Litigation and Patient Compensation (Cambridge, Mass.: Harvard University Press, 1993); H.R. Burstin, W.G. Johnson, S.R. Lipsitz, T.A. Brennan. "Do the Poor Sue More? A Case- Control Study Of Malpractice Claims and Socioeconomic Status." Journal ofthe Amer- ican Medical Association 13 (1993):1697- 1701.

52. T.A. Brennan, C A . Sox, H.R. Burstin, "Relation Between Negligent Ad- verse Events and the Outcomes of Medical Malpractice Litigation," New England Jour- nal of Medicine 335 (1996): 1963-1967.

53. J.S. Kakalik and N . M . Pace, Costs and Compensation Paid in Tort Litigation (Santa Monica, CA: R A N D , 1986 (R- 3391-ICJ)).

54. P Weiler, et al., A Measure of Mal- practice (Cambridge, Mass.: Harvard Uni- versity Press, 1993).

55. C Levine. "Life But No Limb: The Aftermath of Medical Error." Health Afairs 21 (2002):237-4l. Reprinted in Promoting Patient Safety: An Ethical Basis for Policy Re- form, ed. V.A. Sharpe (Washington, D . C : Georgetown University Press, in press).

56. D. Kessler and M. McClellan. "Do Doctors Practice Defensive Medicine?" Quarterly Journal of Economics 111 (1996):353-390.

57. S.C Charles, "Sued and Non-Sued Physicians' Self-Reported Reactions to Mal- practice Litigation," American Journal of Psychiatry 142 (1985):437-440; T. Passineau, "Why Burned-Out Doctors Get Sued More Often," Medical Economics 75 (1998):210-218; B.A. Liang, "The Effec- tiveness of Physician Risk Management: Potential Problems for Patient Safety," Risk Decision Policy 5 (2000): 183-202.

58. D . Studdert, " O n Selling "No- Fault."

59. H. Morreim, "Medical Errors: Pin- ning the Blame versus Blaming the Sys- tem," in Promoting Patient Safety: An Ethical Basis for Policy Reform, ed. V.A. Sharpe

(Washington, D . C : Georgetown Universi- ty Press, in press).

60. E.A. Dauer and L.J. Marcus, "Adapt- ing Mediation to Link Resolution of Med- ical Malpractice Disputes with Health Care Quality Improvement," Law and Contem- porary Problems 60 (1997): 185-218; W. Levinson, "Physician-Patient Communica- tion. A Key to Malpractice Prevention," Journal ofthe American Medical Association. 272 (1994):1619-2O; W Levinson, D.L. Roter, J.P Mullooly, V.T. Dull, R.M. Frankel, "Physician-Patient Communica- tion. The Relationship with Malpractice Claims Among Primary Care Physicians And Surgeons," Journal of the American Medical Association. Ill (1997):553-9.

6 1 . W.M. Sage, "Reputation, Malprac- tice Liability, and Medical Error," in Pro- moting Patient Safety: An Ethical Basis for Policy Reform, ed. V.A. Sharpe (Washington, D . C : Georgetown University Press, in press); J. Soloski and R.P Bezanson. Re- forming Libel Law. (New York: Guilford Press, 1992).

62. E.A. Dauer, L.J. Marcus, and S.M. Payne, "Prometheus and the Litigators: A Mediation Odyssey." Journal of Legal Medi- i l Q (

63. B. Liang, "Error Disclosure for Qual- ity Improvement: Authenticating a Team of Patients and Providers to Promote Patient Safety."

()^. C L . Bosk, Eorgive and Remember: Managing Medical Eailure (Chicago: Uni- versity of Chicago Press, 1979).

65. N.S. Berlinger, "'Missing the Mark': Medical Error, Forgiveness, and Justice," in Promoting Patient Safety: An Ethical Basis for Policy Reform, ed. V.A. Sharpe (Washington, D . C : Georgetown University Press, in press).

GG. Kohn, et al.. To Err is Human, p. 101, 110.

67. These bills can be found on Thomas, the federal government's legislative informa- tion site on the Internet, http://thomas.loc.gov/

68. Troyen Brennan, "The Institute of Medicine Report on Medical Errors— Could it do Harm?"

69. Bryan Liang, "Error Disclosure for Quality Improvement: Authenticating a Team of Patients and Providers to Promote Patient Safety." Troyen A. Brennan and Michelle M . Mello, "Patient Safety and Medical Malpractice: A Case Study" Annals of Internal Medicine 139 (2003): 267-273.

70. T A. Brennan, "The Ethics of Confi- dentiality: The Special Case of Quality As- surance Research," Clinical Research 38 (1990):551-557.

September-October 2003 / HASTINGS CENTER REPORT

• Raymond S. Andrews, Jr.

Trustee

The Patrick and Catherine Weldon

Donaghue Foundation

• Mary Ann Baily

Associate for Ethics and Health Policy

The Hastings Center

• Carol Bayley

Vice President, Ethics and Justice Education

Catholic Healthcare West

• Nancy Berlinger

Deputy Director and Associate for Religious Studies

The Hastings Center

• Charies Bosk

Professor, Department of Sociology

University of Pennsylvania

• Maureen Connor

Director of Risk Management and Infection Control

Dana-Farber Cancer Institute

n James Conv/ay

SVP and Chief Operations Officer

Dana-Farber Cancer Institute

s Edward Dauer

Dean Emeritus and Professor of Law

University of Denver College of Law

D Kenneth De Ville

School of Medicine

Department of Medical Humanities

East Carolina University

• Allan Frankel

Director of Patient Safety

Partners Health Care System, Inc.

a Lynne Garner

Executive Director

The Patrick and Catherine Weldon

Donaghue Foundation

B Sandra Gilbert

Professor, Department of English

University of Californis, Davis

• Roxanne Goeltz

Air Traffic Controller

Minneapolis, Minn.

• Doni Haas

Former Risk Manager, Martin Memorial Hospital

Stuart, FL

n Curtis Hart

Director of Pastoral Care and Education

New York-Presbyterian Hospital

Weill Cornell Center

• BryanA. Liang, M.D., Ph.D., J.D.

Professor, Law, Health Law & Policy Institute

University of Houston Law Center

Professor of Medicine,

University of Texas School of Medicine

• Larry I. Palmer, LLB

Professor of Law

Cornell Law School

• Edmund D. Pellegrino, M.D.

Emeritus Professor of Medicine

and Medical Ethics

Center for Clinical Bioethics

Georgetown University Medical Center

• E. Haavi Morreim

College of Medicine

University of Tennessee

Health Science Center

n Erik Parens

Associate for Philosophical Studies

The Hastings Center

D William S. Sage

Professor of Law

Columbia Law School

Q Virginia Ashby Sharpe

Former Deputy Director and Associate

for Biomedical and Enviornmental Ethics

The Hastings Center

Q Scott A. Snook

Associate Professor

Harvard Business School

• David Studdert

Assistant Professor for Law & Public Health

Department of Health Policy & Management

Harvard School of Public Health

n Karen Titlow

Program Director

The Leapfrog Group

D Albert Wu

Associate Professor

Health Policy & Management

School of Hygiene S Public Health

Johns Hopkins University

SPECIAL SUPPLEMENT / Promoting Patient Safety: An Ethical Basis for Policy Deliberation