To meet our study’s challenges, we used several methods from ethnography, and in certain cases we blended them with survey methods to provide in-depth knowledge of organizational culture from the perspective of VA’s frontline staff—its physicians, nurses, and others directly responsible for patient care. We intend this study to complement our earlier reports on organizational culture and changing organizations. We chose ethnography because several of its techniques and perspectives helped us study aspects of patient safety that would otherwise have remained overlooked or would not have been observed, such as informal mores, and to assist GAO in the development of new evaluation methods. These aspects were ethnography’s research traditions of (1) conversational interviews, enabling interviewers to explore a participant’s own view of and associations with an issue of interest, (2) the researchers’ observations of real processes to further understand the meaning behind patient safety from the natural environment of staff, and (3) systems thinking. Our study measures, at the facility level, the extent of familiarity with, participation in, and cultural support for the Program, and it complements a cultural survey VA conducted in 2000. VA expects to resurvey staff in the near future, using its past survey data as a baseline. VA’s original, nonrandom survey contained questions regarding shame and staff willingness to report adverse events when the safety of patients was at hazard during their care. The VA survey did not establish staff familiarity with key concepts of the Program, participation in VA safety activities, or the facilities’ levels of cultural support for the Program. We recognized that a tradition of fear of being blamed for adverse events and close calls might make staff reluctant to talk about their experience of potential harm to patients. Besides breaking through an emotional barrier, we wanted to understand the private views of staff on what facilitates patient safety. To achieve the informal, open, and honest discussions we needed, we conducted private, nonthreatening, conversational interviews with randomly selected clinicians and other staff in a judgmental sample. At each site, we chose one random and one judgmental (nonrandom) sample of staff to interview in a conversational manner, using similar semistructured questionnaires (see app. III). For the first sample, we interviewed a random selection of 10 physicians and 10 nurses at each of the four facilities. While this provided us with a representative sample of clinicians (physicians and nurses) from each facility, the sample size was too small to provide a statistical basis for generalizing our survey results to an entire facility. To give us a better understanding of the culture and context of patient safety beyond the clinicians involved in direct patient care at each facility, we also interviewed more than a hundred other staff in the four study sites, including medical facility leaders, Patient Safety Managers, and hospital employees from all levels—maintenance workers, security officers, nursing assistants, technicians, and service chiefs. (Appendix I contains more technical detail about our analysis.) Reporting adverse events and close calls is a highly sensitive subject and can successfully be explored with qualitative methods that allow respondents to talk privately and freely. When staff did not recognize a key element of the Program, our interviewers explained it to them. (We were not giving the respondents a test they could fail.) Selecting clinicians randomly at each of four facilities, and asking some close-ended questions such as those expecting “yes” or “no” answers, allowed us to analyze and present some issues as standard survey data. This combined survey and ethnographic approach afforded us most of the advantages of standard surveys while establishing an environment in which the respondents could talk, and did talk, at length about the cultural context of patient safety in their own facilities. Clinicians responded to a standard set of questions, many open ended, such as, To what extent do you perceive there to be trust or distrust within your unit or team? Among the advantages these questions had were that they allowed the clinicians to discuss issues spontaneously and they allowed us to discover what facilitates trust from their point of view. Thus, if clinicians thought leadership was important, we had an opportunity to see this from their viewpoint rather than starting from the premise that leadership would be important to them. An important part of our approach was content analysis, which we used to analyze answers to both the standard and open-ended questions. Content analysis summarizes qualitative information by categorizing it and then systematically sorting and comparing the categories in order to develop themes and summarize them. We determined, by intercoder reliability tests, that our content analysis results were trustworthy across different raters. (See app. I.) We added another ethnographic technique in order to more completely understand the culture within each facility. Since responses to surveys are sometimes difficult to understand out of context, our in-depth ethnographic observations of the patient care process gave us a more complete picture of how the elements of the Patient Safety Program interacted. They also gave us a better understanding of VA’s medical facility systems. We observed staff in their daily work activities at each medical facility, which helped us understand patient safety in context. For example, we attended staff meetings where the Program was discussed and we attended RCA meetings, and we followed a nurse on her rounds. We took detailed field notes from our observations, and we analyzed and summarized our notes. We reviewed files to examine data on adverse events, close calls, and RCA reports. We read files from administrative boards, reward programs, and patient safety committee minutes. And we interviewed high-level VA officials. Finally, our ethnographic research approach was systemic. This was to help us appreciate interactions between the elements of the Program and the facilities’ existing culture. Ethnography has traditionally been used to provide rich, holistic accounts of the way of life of a people or a community; in recent decades, it has also been used successfully to study groups in modern societies. A systems approach casts a wide net over the subject. In this case, we chose to study the Patient Safety Program in relation to other aspects of culture in VA’s medical facilities that might affect its adoption, such as the extent to which staff have mutual trust. We also developed a model, or flow chart, to guide our study of the Program and the culture of the facilities. The model, in figure 2, helped us conceptualize the important safety activities within the Program and analyze and present our results. We looked not only at the Program’s key elements, in the darkly shaded boxes in figure 2, but also at what surrounds them—the context of the medical facilities’ culture—and whether the culture supports the adoption of the Program. Our model illustrates that our primary focus was measuring clinicians’ supportive culture for reporting close calls and adverse events and their familiarity with and participation in reporting programs and RCAs. The model also depicts the interaction between clinicians’ receiving feedback and being rewarded and their desire to continue reporting close calls and adverse events. It also allows us to describe how clinicians’ reporting close calls and adverse events, and the subsequent investigation of the root causes of them, developed into system changes that in turn resulted in patients being safer. We conducted the study at three medical facilities that VA had recommended as being well managed. We selected a fourth facility for geographic balance. Thus, the four facilities were in different regions of the country. Using rapid assessment techniques, we conducted fieldwork for approximately a week at each of two facilities, for 3 weeks at a third, and for 25 days at the fourth. We did our work from November 2002 to August 2004 in accordance with generally accepted government auditing standards. “to make health care safe we need to redesign our systems to make error difficult to commit and create a culture in which the existence of risk is acknowledged and injury prevention is recognized as everyone’s responsibility. A new understanding of accountability that moves beyond blaming individuals when they make mistakes must be established if progress is to be made.” This vision of making patients safe through “redesign . . . to make errors difficult to commit” led to VA’s National Center for Patient Safety (NCPS), established to improve patient safety throughout the largest health care system in the United States. To transform the existing culture of patient care in VA’s medical facilities, VA’s leaders aimed to persuade clinicians and other staff in health care settings to adopt a new practice of reporting, free of fear and with mutual trust, identifying vulnerabilities, and taking necessary actions to mitigate risks. The Under Secretary had recognized risk to patients during care and that a focus on VA’s existing culture could improve patient safety. Related research shows that if complex decision making organizations are to change, they must modify their organizational culture. Traditionally, clinicians involved in an adverse event could be blamed or sued, but the roots of unintentional errors are now understood as originating often in the institutions and structures of medicine rather than in clinicians’ incompetence or negligence. Several contextual factors influence how the Patient Safety Program is experienced at the medical facilities we visited and show the increasingly complex world of patient care. Our study’s limitations meant that we could not study these factors, but health care facilities in general, as well as VA’s, are experiencing difficulty in hiring and retaining nurses, as well as potential staffing shortages. Patients admitted to VA medical facilities have more multiple medical problems that require more extensive care than in the past. VA’s eligibility reform allowed veterans without service- connected conditions to seek VA services, leading to a 70 percent increase in the number of enrolled veterans between 1999 and 2002. VA has provided funding of $37.4 million to NCPS for its Patient Safety Program operations and related grants and contracts for fiscal years 1999–2004. In fiscal year 1999, NCPS defined three major initiatives: (1) a more focused system for mandatory close call and adverse event reporting, including a renewed focus on close calls; (2) reviews of close calls and adverse events, including RCAs, using interdisciplinary teams at each facility to discover system flaws and recommends redesign to prevent harm to patients; and (3) staff feedback on system changes and communication about improvements to patient safety.