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Written Statement


National Summit on Medical Errors and Patient Safety Research

Panel 2: Broad-based Systems Approaches

Testimony by Saul N. Weingart, MD, for the Harvard Executive Session on Medical Error and Patient Safety

The first National Summit on Medical Errors and Patient Safety Research was held on September 11, 2000, in Washington, DC. Sponsored by the Quality Interagency Coordination Task Force (QuIC), the Summitís goal was to review the information needs of individuals involved in reducing medical errors and improving patient safety. More importantly, the summit set a coordinated and usable research agenda for the future to answer these identified needs.

Individuals were selected by the Agency for Healthcare Research and Quality (AHRQ) to testify at the summit as members of the witness panels. Each submitted written statements for the record before the event, documenting key issues that they confront with regard to patient safety as well as questions to be researched. Other applicants were invited to submit written statements.

Disclaimer and Copyright Statements

Thank you for the opportunity to testify on behalf of the Harvard Executive Session on Medical Error and Patient Safety. Those of you here today need no reminder of the extent of medical error in America and of the collective burden that patients bear. As a practicing internist, I've seen more than my share of preventable injuries. And like all clinicians, I am haunted by the fear that I could accidentally bring harm to those who trust me to keep them well.

This Summit is an important step in the revolution in patient safety that swept America since the December 1999 Institute of Medicine Report. By framing error as a problem of systems and processes of care, the authors helped to liberate clinicians from the burden of guilt and shame that made discussions of error taboo. Clinicians and patients are ensnarled in the same spider's web of often antiquated and ill-designed processes we call the health care delivery system.


Recognizing the crucial role that organizations play in perpetuating error and harm in health care, a group from the Harvard Schools of Public Health, Medicine, and Government, and the university—wide Division of Health Policy, Research, and Education, came together in 1996 to organize an Executive Session on Medical Error and Patient Safety. The Executive Session has met for the past 3 years, supported by the U.S. Agency for Health Research and Quality (AHRQ), Veterans Health Administration, National Patient Safety Foundation, American Society of Health-System Pharmacists, and the WK Kellogg and Robert Wood Johnson Foundation. Our membership includes many individuals who play leadership roles in American healthcare. A membership list is appended.

The Executive Session is a collaborative venture between researchers and practitioners that was developed at the John F. Kennedy School of Government 15 years ago. Kennedy School researchers recognized the limitation of the traditional view that useful knowledge moves smoothly from the university to the world of practice. As you can imagine, practitioners often share a common fund of knowledge and experience that can inform research - particularly research about policy and management. To date, we have organized Executive Sessions in policing, juvenile justice, prosecution, drug abuse, child protection, medical error, and several other areas of public concern.

An Executive Session is a confidential forum that brings together leaders from an industry to examine a difficult social problem. Members of the Session, selected for their leadership and ability to work creatively, aim to rethink conventional wisdom and to identify innovative solutions to difficult problems. The members meet several times over two or three years. We require a high level of personal involvement since no substitutes are permitted. A minority of members represent the academic community.

The Executive Session is a working group, rather than a commission or blue-ribbon panel. It does not disseminate its message at the end of the deliberations with a press release or final report. The objective is to engage its members in a way that accelerates progress. In the case of the Medical Error Executive Session, many of our members are CEOs of hospitals and health care systems. The goal is to help them to develop novel strategies for their organizations, to make progress as quickly as possible, and then to report back to the group on what they have learned. It is a mechanism that produces multiple concurrent demonstration projects. An Executive Session can help to bring a coherent national leadership to diverse efforts taking place across the nation, and contribute to the dissemination of technology.

Motivated in part by their participation in the Executive Session, many of our members have embraced patient safety as personal and organizational priorities. Gordon Sprenger, Executive Officer of Allina Health System. He has engrafted patient safety into the governance of Allina, articulated safety as a major organizational goal and integrated it into the strategic and operational plan. David Lawrence, CEO and Chairman of Kaiser Foundation Health Plan and Hospitals and Robert Waller, former President of the Mayo Foundation, have spoken out publicly on behalf of patient safety and fostered patient safety initiatives within his organization. Jim Reinertsen, CEO of Boston's CareGroup, made medication reliability one of 4 corporate priorities. Medication safety teams at each CareGroup hospital attempted to implement 16 best practices in one year and demonstrated measurable improvements in the safety of patients on anticoagulants and post-operative pain medications.

Harvard University and the members of the Executive Session have no inside track on how to make health care safe. We do share a sober appreciation of the difficulty of organizational change and of the obstacles to innovation that grow from our 3 years' experience. I will try to summarize the group's views about improving patient safety and some recommendations for a national research agenda.

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  1. Medical error is a problem of organizations. Members of the Executive Session embrace the view that medical error is an attribute of the systems and processes by which we deliver care. Scientific evidence and a wealth of experience from other industries demonstrate that human errors almost always result from defective systems. Improvement strategies that punish individual clinicians are misguided and do not work. Fixing dysfunctional systems, on the other hand, is the work that needs to be done. Research in patient safety, therefore, must attend to organizational obstacles and opportunities for change. Since improvements take place in real organizations, the laboratory for medical error research must encompass the clinical setting where patients receive care.
  2. Medical error is an executive responsibility. Because managers are responsible for organizing and shaping the systems and processes of care, hospital and health system executives share an essential and non-delegable responsibility for reducing medical error. Moreover, leadership lessons in patient safety can be learned and disseminated. To make progress, health care CEOs must commit their own time to working on behalf of patient safety. They must communicate its importance relentlessly. They must hold themselves personally accountable for patient safety in the same way they do for financial performance. Many important lessons about high-reliability performance can be adapted from manufacturing, aviation, and the service sector. Executives should assess their organizations' core processes for safety, inventory their organizations' patient safety activities, report the results, implement best practices, and create a culture of safety.
  3. Medical error is an urgent and strategic priority. Members of the Executive Session are impressed with the magnitude of harm represented by medical error. Ensuring that care is safe is a professional obligation for health care professionals and the organizations where they work. It is an urgent problem that requires the kind of immediate, focused, and sustained attention that motivated organizations to ensure Year 2000 (Y2K) compliance. Safety also makes good business sense. It builds consumer confidence and market share. Increased efficiencies and decreased re-work may contribute to the bottom line.
  4. Error reporting systems must be improved. Health care organizations must remain accountable to their patients and to the community by disclosing errors that result in harm, providing fair compensation for injuries, and introducing measures to prevent recurrence. Physicians have an ethical obligation to inform patients when they have been harmed because of an error in care.
  5. Gross negligence and unethical behavior should not be shielded. Professional misconduct is a grave threat to patient safety and should be dealt with accordingly. But errors that do not result in harm must be protected from discovery, so that we can learn from them. Fear of discovery and punishment of clinicians' accidents drives information underground and decreases organizational learning. We need to create robust non-punitive error reporting systems. Sharing information about errors with front-line workers will build a sense of collaboration and shared mission.

  6. The federal government should play an important role. The federal government should play an active role in patient safety, requiring pharmaceutical and device manufacturers to use human factors principles in naming, packaging, and labeling medications and to participate in post-market surveillance of adverse events.

Government should support research in patient safety. Research is needed in the management, implementation, and spread of efforts to improve patient safety, and in the development of model systems of care. The government should also help to build a broadly-based coalition for patient safety that includes health care executives, consumer groups, medical and surgical specialty societies, hospital associations, drug and device manufacturers, and employers. Many parties have a stake in promoting safe care, and should collaborate in making patient safety a national priority.

Legislation and regulation can contribute to patient safety by protecting information about near-miss errors that is useful for the improvement of systems and processes. Members of the Executive Session welcome regulatory and accreditation agencies' initiatives on behalf of patient safety, especially initiatives that encourage root cause analysis and facilitate non-punitive reporting. At the same time, they are wary of approaches that increase the regulatory burden of health care organizations and that distract clinicians from their patient care responsibilities.

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Because faulty systems perpetuate errors, it is critical to study the delivery of care in real-life, real-time settings. We need to know what aspects of care pose the most hazard to vulnerable patients, so that we can focus our resources there. But rather than focus exclusively on what's broken with the current system, we need to develop a methodologically robust approach to the study of innovation, the spread of innovation, and the leadership of organizations that are conducive to innovation. We need to answer the following research questions:

  1. What factors permit leading-edge innovators in patient safety to improve performance? At present, our collective knowledge about organizational improvements that enhance patient safety remains remarkably thin. In order to build a credible database, we need to begin at the beginning, using the most basic tools of the scientific method: observation and description. We should borrow a chapter from schools of business administration and collect case studies of cutting-edge innovators in patient safety. We need to document the organizational context where innovations occur, the market conditions and historical factors that existed, and the attributes of the leaders who guided the change.
  2. Once we develop a library of descriptive data about organizational improvements in patient safety, we can begin to compare one with another, generating hypotheses about the factors that permitted or obstructed improvements. We should pay as much attention to failed campaigns for patient safety as to successful ones, since we can glean lessons from both. We can learn also learn from organizations that dealt with patient safety tragedies, to understand the opportunities that these settings present for improvement.

  3. How do we improve the transfer of innovation? Although published research reports and best practices are useful mechanisms for dissemination of innovation, they are not enough. We need to explore other models. The experience of the Executive Session and of the Institute for Healthcare Improvement's Breakthrough Series suggests that active learning by members of a collaborative venture can stimulate and accelerate the pace of change. Collaborative learning builds a sense of comraderie and a commitment to change. Real-life stories from professional colleagues are more compelling than published reports.
  4. We need to explore other models for promoting improvements in patient safety. Can the Executive Session approach work on a local or regional level? Can we focus the scope of inquiry more narrowly, to address problem in error reporting, chemotherapy errors, or narcotic use, for example? Can we build collaborative relationships between industrial or aviation safety experts and hospital managers to promote patient safety?

    Moreover, we need to create models of technology transfer within healthcare organizations. Academic medical centers are famous for the narrow silos that separate professional groups from one another. We need to break down these barriers to allow learning to spread.

  5. What are the limits and opportunities for technological solutions to medical error? Technology extends human capabilities in ways that can enhance safety. Bates' work on physician computer order entry demonstrates the order-of-magnitude improvement that can be expected with state-of-the-art hospital based computer systems. Buyers' groups advocate widespread use of this approach, the development of bar coding, and other high-tech improvements.
  6. Technology has limitations. Computer order-entry and automated drug dispensing systems, for example, may be prohibitively expensive. Technology can also lead to error. In my hospital, for example, it is deceptively easy to enter and print out a correct prescription for the wrong patient.

    We need to study the cost and effectiveness of technology and its impact on the way we work, so that we can offer intelligent guidance about when and where it offers the most benefit.

  7. How can we ensure safe care at a time of tremendous competitive pressures and fiscal austerity? Clinicians tell us that they are asked to do more with less. They become cynical about exhortations from the executive suite to improve patient safety while the reality of daily work creates conditions that are dangerous for patients. Patients are apprehensive about the quality of care provided by overworked staff and understaffed facilities.
  8. To address patients' concerns, we need to study the impact of austerity on safety. Do high patient-to-nurse ratios increase the likelihood of error? Do competitive markets for health care lead hospitals to sacrifice safety for margin? To address executives' concerns, we need credible and compelling analyses of the economics of patient safety. Is there a business case for patient safety? Do safe organizations also deliver cheaper and better care?

  9. Can we create laboratories for innovation in patient safety? Many key processes of delivering care are so complex and fraught with opportunities for error that they require fundamental redesign. Laboratories for improvement should be created in the offices, clinics, and hospitals where care is delivered. Activities like providing medications, performing laboratory tests, and preparing patients for surgery are susceptible to error and worthy of soup-to-nuts redesign with safety in mind. We need multi-side research laboratories in safety, analogous to the oncology and cardiovascular research collaborations, that can test novel drug-delivery systems, reporting mechanisms, allergy alerts, order-entry systems, and so forth.
  10. How do we measure our progress in patient safety? Finally, we need to develop a set of shared yardsticks for measuring our progress in patient safety. We need standard metrics to assess the magnitude of improvements, to compare innovations, and to report on our progress to the public.

Mandatory reporting systems have been the subject of intense interest in the press and among policy makers since the IOM report. The members of the Executive Session believe that this attention is misplaced and distracts from the IOM committee's core message. We agree that providers and healthcare organizations must be held accountable for egregious misbehavior. But the real work of safety requires confidential voluntary reporting of non-consummated errors. These are the errors that can promote learning and improvement.

How do we design voluntary reporting systems that are non-punitive, that avoid heavy-handed regulatory requirements, and that build the trust and confidence of both patients and front-line workers? Once we create model voluntary reporting systems, we then need to find ways to use this data to drive improvement. Creating a cycle of learning and improvement requires both data and action.

I've outlined a different sort of agenda than is customary for federally funded research. It is an agenda that calls for a commitment of resources to the study of innovation at the organizational level. Organizational process deficiencies and process improvements are where the rubber hits the road in medical error. We need to begin with case studies of organizations that attempt to improve safety, develop reporting systems that allow us to measure the extent of error, create collaborative ventures that accelerate the pace of innovation, and focus specifically on the assessment of technological solutions and the dissemination of innovation. This is an ambitious and long-term agenda, about which we are cautiously optimistic. Despite the Executive Session's 3 years of activity on behalf of patient safety, we understand that our work has just begun.

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Current as of September 2000

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