By James B. Conway and Saul N. Weingart, MD, PhD
On December 3, 1994, 39-year-old Boston Globe health reporter Betsy Lehman died of complications of an overdose of cyclophosphamide, a chemotherapeutic agent she received at the Dana-Farber Cancer Institute for treatment of breast cancer. The media reported the event intensively, with 28 front-page headlines over the next 3 years. During those years, another patient, Maureen Bateman, also had a cyclophosphamide overdose and suffered serious heart damage. The events devastated these patients’ families, the clinicians who cared for them, and leaders of the organization. Both errors involved breakdowns in standard processes, and both raised issues of trainee supervision, nursing competence, and order execution.
The Massachusetts Department of Public Health; the Boards of Registration responsible for licensing physicians, nurses, and pharmacists; and the Joint Commission on Accreditation of Healthcare Organizations conducted investigations of the Dana-Farber, and the results were widely publicized. The investigation identified numerous deficiencies, including protocol violations, ineffective drug error reporting, and oversight of quality assurance by hospital leaders.
Inside the institute, the consequences of the incident reverberated broadly. With high-profile resignations, reorganization of services, and regular media lashings, the mood was despondent. Then-president Christopher Walsh announced, “We are turning the place upside down.”(1) The burning platform of the overdose and a series of remediation plans, dictated in part by state regulators, prompted a critical reexamination of how the organization delivered care and conceived its own mission. The initial changes were sweeping:
- New rules were adopted mandating close supervision of physicians in fellowship training.
- Nurses were required to double-check high-dose chemotherapy orders and to complete specialized training in new treatment protocols.
- Interdisciplinary clinical teams reviewed new protocols and reported adverse events and drug toxicities.
- A trustee-level quality committee was reorganized and strengthened.
- Discussions were begun regarding the transfer of inpatient beds to nearby Brigham and Women’s Hospital.
Although these changes in training and organization were real and important, the ultimate changes wrought at Dana-Farber proved to be far more profound and sustained than one might have expected at the outset. The transformation had less to do with the reorganization of clinical care than of the acceptance and integration of several key principles into the life and work of the organization.
First, we learned that safety—if it was to be a core property of our system of care rather than an empty mantra—is the responsibility of clinical and administrative leaders and of our trustees. Rather than creating a patient safety office, we gave senior clinical leaders responsibility for critical roles in patient safety. We decided that patient safety was and is the work of the organization, not an activity that could be compartmentalized. In the same spirit, we decided that patient safety issues and problems would be reported directly up for board-level review, rather than to a staff-level subcommittee.
Second, we accepted the need for relentless vigilance for risk, error, and harm. We developed and refined error reporting through pharmacy interventions, incident reports, and patient safety rounds. We embedded in our practice a robust root cause analysis system to analyze critical incidents, report the results, and implement improvements. We also created monthly management meetings in which members review events and analyses and take responsibility for implementing improvements.
Third, we embraced the role of system design in the prevention of error and of information technology as a particularly powerful forcing function for delivering chemotherapy safely. We developed order set templates and created an electronic order-entry system for chemotherapy. We engaged interdisciplinary groups of front-line clinicians in the design and implementation of chemotherapy protocols, understanding that safe cancer care requires an extraordinarily high level of communication and coordination. To ensure ongoing information system improvements, we committed, and continue to commit, significant resources.
Fourth, we learned that we could not do this work alone. We developed durable partnerships with sister organizations in our community. We have shared information systems with Children’s Hospital and with our collaborating hospitals in the Partners Healthcare system, and we benefit from the quality improvement and patient safety initiatives that Partners’ leaders sponsor and support. We learned a lot from our colleagues in the Massachusetts Coalition for the Prevention of Medical Errors and from our participation with the Institute for Healthcare Improvement (IHI) and other organizations.
Fifth, we believed that we could restore the confidence of our patients and their families only if we made our decisions transparent and accessible and if we let patients into the process of leading the organization. Eight years ago, we established and nurtured adult and pediatric patient and family advisory councils, and these groups have flourished. Patient and family representatives sit on major decision-making bodies throughout the organization.
Sixth, and most important, we learned that the work of creating safe care is never finished. Cancer care is a particularly hazardous undertaking. Our patients are perilously ill, and their treatment requires the use of highly toxic therapies. The margin of cure and of harm is often razor thin; this is a fact of life for patients and clinicians alike. We recognize that mistakes will happen and that it is our responsibility to recognize them quickly, mitigate the harm, disclose any errors to our patients, and look after the staff’s psychological well being. We have a broad responsibility to learn from each mistake and to share the results of our learning.
There is a paradox here. Aggressively seeking errors and injuries, and relentlessly inquiring into the causes and solutions, increases our collective organizational anxiety. But it also fuels our drive for improvement. We believe that this fundamental paradox, so often avoided through a conspiracy of silence, is worth addressing. The patient safety enterprise has become our work, not a special project or occasional distraction. It creates a tension for change, an ongoing unease about error, and a common commitment to abate it. Indeed, leaders who fail to examine the ugly mistakes that occur in their hospitals every day allow these ulcers to fester and miss the opportunity to learn and heal. Executives who believe that accidents and injuries are confidential and hidden from the troops are deeply misguided.
After the tumultuous upheavals that followed the events of 1994 and 1995, the organization has prospered and grown. We have high levels of staff and patient satisfaction compared with peer organizations, with low staff turnover. We have adopted and promulgated model error disclosure practices and fair and just culture principles. In a November 2004 Boston Globe retrospective on the Lehman and Bateman overdoses, reporter Scott Allen described the Dana-Farber as “one of the most safety-conscious hospitals in America.”(2) In fact, we reported to the Globe 8 years of data from our confidential incident reporting system. Although it showed rare errors, there were no deaths or serious injuries from chemotherapy-related errors in more than 800,000 doses, a remarkable record of safety.
To what extent is progress at the Dana-Farber Cancer Institute due to the legacy of the Betsy Lehman tragedy and the relentless media attention that accompanied her death? The event surely drove the organization—which had always been committed to superior clinical care—to focus its attention and energy on medical errors and iatrogenic injuries. This wake-up call got the organization’s collective attention but might not have been sufficient to sustain our commitment over the long run. After all, denial is a powerful defense mechanism. Sustaining our commitment over time required tenacity among our leaders and the courage to face our own failures in order to learn the lessons they hold.
James B. Conway
Chief Operating Officer, Dana-Farber Cancer Institute
Saul N. Weingart, MD, PhD
Director, Center for Patient Safety, Dana-Farber Cancer Institute
1. Knox RA. Dana-Farber head quits 2d post, vows changes. Boston Globe. May 26, 1995:B1.
2. Allen S. With work, Dana-Farber learns from ’94 mistakes. Boston Globe. November 30, 2004:A1, A10-11.