EXECUTIVE SUMMARY Clinical peer review is the dominant method of event analysis in U.S. hospitals. It is pivotal to medical staff efforts to improve quality and safety, yet the quality assurance process model that has prevailed for the past 30 years evokes fear and is fundamentally antithetical to a culture of safety. Two prior national studies characterized a quality improvement model that corrects this dysfunction but failed to demonstrate progress toward its adoption despite a high rate of program change between 2007 and 2009. This study's online survey of 470 organizations participating in either of the prior studies further assessed relationships between clinical peer review program factors, including the degree of conformance to the quality improvement model (the QI model score), and subjectively measured program impact variables. Among the 300 hospitals (64%) that responded, the median QI model score was only 60 on a 100-point scale. Scores increased somewhat for the 2007 cohort (mean pair-wise difference of 5.9 [2-10]), but not for the 2009 cohort. The QI model is expanded as the result of the finding that self-reporting of adverse events, near misses, and hazardous conditions—an essential practice in high-reliability organizations—is no longer rare in hospitals. Self-reporting and the quality of case review are additional multivariate predictors of the perceived ongoing impact of clinical peer review on quality and safety, medical staff perceptions of the program, and medical staff engagement in quality and safety initiatives. Hospital leaders and trustees who seek to improve patient outcomes should facilitate the adoption of this best practice model for clinical peer review. INTRODUCTION Clinical peer review has long been pivotal to physicians' efforts to improve quality and safety. Considering its importance to the profession and society, surprisingly little research has been directed toward optimizing the process. In the United States, the prevailing process model—quality assurance (QA)—emerged as an unintended consequence of Joint Commission standards promulgated in 1979 that called for an organized program of QA (Sanazaro & Mills, 1991). In order to comply, hospitals abruptly abandoned the clinical audit model, which had previously been promoted by professional standards review organizations. The resulting QA model has been widely criticized as being at best ineffective and at worst antithetical to true quality improvement (Berwick, 1990; Dans, 1993). By focusing narrowly on questions of individual competence to meet the standard of care, the QA model evokes fear of censure and loss of livelihood. It thereby contributes to the persistent culture of blame documented in the 6-year trend in Survey of Hospital Safety Culture data, in which the composite measure “nonpunitive response to error” has run consistently at an abysmal 44% positive (AHRQ, 2012). The associated unstructured methods of evaluation have low reliability (Goldman, 1994). Moreover, the use of generic screens for adverse events to identify cases for review is inefficient, particularly compared to the selfreporting process adopted by airlines and other types of high-reliability organizations (Sanazaro & Mills, 1991; O'Neil et al., 1993; Helmreich, 2000). A 2007 study was the first to report normative data about clinical peer review practices on a national scale (Edwards & Benjamin, 2009). Using a high-level process framework (see Figure 1), it collected data on 39 items from 339 institutions including 61 major teaching hospitals. The study identified wide variation in the scope of activities encompassed by peer review programs beyond the essential core process of retrospective medical record review (case review).FIGURE 1 Clinical Peer Review Process FrameworkThe findings from this study suggest that medical staff peer review may be the dominant method of adverse event analysis in U.S. hospitals. The median case review volume (1-2% of hospital inpatient volume) is an order of magnitude closer to the known rate of preventable adverse events than is formal root cause analysis, the mandated method for the most serious occurrences. A high rate of program change was observed due to dissatisfaction with the QA model and changes in Joint Commission requirements. Most importantly, the 2007 study revealed a set of practices that are strongly associated with the belief that the program has a significant ongoing impact on the quality and safety of care. Such practices include standardization of process, recognition of clinical excellence, attentive program governance, trustee involvement, integration with other hospital quality improvement activity, timely performance feedback, and identification of clinician-to-clinician issues and other process problems during case review (Edwards & Benjamin, 2009). These practices define a new approach to clinical peer review best described as the quality improvement (QI) model. The QI model contrasts sharply with the QA model (see Table 1) and can be understood as the product of consistent application of quality improvement methods to peer review program process, structure, and governance. It highlights the extent to which the QA model has disconnected the ends and means of peer review activity.TABLE 1: Comparison of QA and QI Models for Clinical Peer ReviewIn 2009, the QI model was validated in a separate cohort of hospitals against both subjective and objective measures of quality and safety (Edwards, 2010, 2011). The validation study demonstrated that important differences among clinical peer review programs can predict up to 18% of variation on 32 standardized performance measures. It also suggested that organizational factors, such as leadership and openness to change, influence program effectiveness. In addition, it showed a persistently high rate of change, wherein many programs were shifting from clinical depart-ment-based review to multispecialty committee-based review. However, the 2009 study yielded no clear evidence of advancement of the QI model. These studies raised important new questions. Does the QI model better serve to engage physicians in quality and safety? Has any benefit been derived from the trend toward the multispecialty committee process? Is self-reporting of adverse events being encouraged in hospitals? If so, what is its influence on peer review program outcomes? The present study was undertaken to answer these questions and to further assess the evolution of peer review practices and their impact on quality and safety. The above questions acquire added importance in the context of theories of quality improvement and patient safety. The pioneering work of Juran (1989), Deming (1982), Crosby (1979), and others launched the heyday of total quality management in the 1980s and contributed to the concept of the learning organization (Senge, 1990). While the methods and tools for quality improvement have continued to proliferate, all share a focus on business processes in the context of the organizational system in which they occur. They also emphasize the essential responsibility of leadership to shape organizational culture and performance by communicating the vision and the performance standard, organizing for quality improvement, and providing adequate supports (attention, resources, tools, and training). Defects are most often a property of the system and are infrequently the fault of individual workers. Therefore, the blame commonly cast on individuals found at the “sharp end” of an adverse event is demoralizing to staff, leaving the organization powerless to improve performance. More recently, attention has been given to identifying the factors that have fostered high reliability and safety in complex, dynamic, high-risk environments (Reason, 2000; Weick & Sutcliffe, 2001). Healthcare leaders have begun to champion high reliability as a worthwhile goal, if not a mandate (Chassin & Loeb, 2011; Denham et al., 2009). High reliability demands a culture of safety characterized by trust; the imperative to report and improve; and the collective mindfulness of the high cost of process failure, the inevitability of human error, and the need to identify, contain, and recover from errors as early as possible. It combines the systematic pursuit of quality improvement with constant vigilance for the unexpected. The skill of managing the unexpected well is underdeveloped in most organizations, largely because it requires a counterintuitive act: a strong response to a weak signal (Weick & Sutcliffe, 2001). METHODS The present survey was conducted under the auspices of a patient safety organization listed by the Agency for Healthcare Research and Quality. The sample was constructed from the records of the two prior national studies cited earlier. The 2007 study was sponsored by the American College of Physician Executives (ACPE); the University HealthSystem Consortium; Premier Inc.; and hospital associations in Arkansas, California, Florida, Michigan, Missouri, South Carolina, and Wisconsin. Each organization used its own process for inviting those with working knowledge of their hospital's clinical peer review program to participate in an anonymous online survey. On the basis of voluntarily provided e-mail and/or phone contact information, 158 organizations participating in the 2007 study could be positively identified retrospectively. One of these organizations subsequently merged with another participating facility. The ACPE alone sponsored the 2009 study. From 362 complete responses, 330 unique organizations were identified, two of which have since closed; 15 had also participated in the 2007 study. Thus, the combined data sets yielded 470 unique organizations broadly representative of U.S. hospitals. The survey instrument incorporated the QI model and those items previously used that had the greatest expected value for comparative purposes. It also collected information on additional factors potentially related to program effectiveness, such as the perceived quality of case review. Several physician leaders assessed the draft for clarity and completeness. The survey is reproduced in the online supplement to this article (www.ache.org/Publications/SubscriptionPurchase.aspx). The degree of conformance to the QI model (the QI model score) was calculated on a 100-point scale on the basis of the responses to specific survey items according to the method previously developed (Edwards & Benjamin, 2009) (illustrated in the online supplement). Key program outcome variables included the following: Study participants' perceptions of their program's ongoing impact on quality and safety Medical staff's perceptions of the peerreview process Physician engagement in quality and safety improvement Overall physician-hospital relations. A total of 40 items were captured via four web-based forms. Prior participants received e-mail solicitations. Phone calls were made to nonresponding organizations to identify alternative contacts. Data were collected from September 15, 2011, through January 26, 2012, as patient safety work product under the terms of the federal Patient Safety and Quality Improvement Act of 2005. In accord with its statutory protections, only aggregate, nonidentifiable data are disclosed in this article. A response was considered complete if all four pages of the survey were submitted and partial if two or three pages were submitted. A response with fewer than two pages was considered a breakoff. Both complete and partial responses were included in the analyses. In the few situations in which multiple responses were received from a given facility, one set of responses was chosen according to organizational titles of respondents. The longitudinal change in QI model scores was characterized by the mean difference using a two-sample t-test. Ordinal logistical regression was used to define the primary factors contributing to program impact on quality and safety, medical staff perceptions, medical staff engagement, physician-hospital relations, and reviewer participation. Alternative models were developed that either allowed for or excluded other outcome variables as predictors. For comparative purposes, at least one model was developed for each outcome that included the QI model score as a predictor. Outlier values were retained. A regression equation was accepted only if all the factor coefficients and intercepts were significant at p < .05 and if the goodness-of-fit test met p > .1. Response levels were selectively collapsed as guided by this goal. The estimate of variance explained by each model was taken from the equivalent linear regression model R2. Statistical analysis was carried out using Minitab version 15 (2007). RESULTS The survey process yielded 297 complete responses, three partial responses, and four The response rate was Among these were and hospitals. 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QI model scores from 1 to with a median of A in the score was associated with an in quality and safety impact with an of of programs a that to the QI model. For the 2007 QI model scores The mean difference was 5.9 quality impact and medical staff perceptions of the program also For the 2009 a in perceived quality impact was but no change in QI model scores or medical staff perceptions was Table a of regression models program and organizational variables to The QI model score a factor impact on quality and medical staff Self-reporting and the quality of case review in regression models that for of the variation in the perceived ongoing program impact on quality and safety, of the variation in medical staff perceptions of the program, and of the variation in physician engagement in quality and safety. 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Marc T. Edwards (2013) studied this question.
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