Commitment of Leadership to Safety

The commitment of leadership to safety is critical to the development of a culture of safety within an organization (Carnino, undated; Manasse et al., 2002; Spath, 2000). Although management has the strongest ability to influence and unite all groups in the organization (by articulating values, reinforcing norms, and providing incentives for desired behaviors), this commitment is needed from all organizational leaders—governing boards and clinical leaders as well as management.

Words alone are an ineffective leadership tool. Leadership commitment must be expressed through actions observable to employees (Carnino, undated; Spath, 2000). Boards of directors can demonstrate this commitment by regular and close oversight of patient safety in the institutions they oversee (IOM, 2000). Leadership actions that management can take include the following:

• Undergoing formal training to gain an understanding of safety culture concepts and practices (Carnino, undated).
• Ensuring that safety is addressed as a priority in the strategic plans of the organization (Carnino, undated; Shrivastava, 1992).
• Having facility-wide patient safety policies and procedures that delineate clear plans for supervisor responsibility and accountability and enable each employee to explain how his or her performance affects patient safety (Spath, 2000).
• Regularly reviewing the safety policies of the organization to ensure their adequacy for current and anticipated circumstances (Carnino, undated).
• Including safety as a priority item on the agenda for meetings (Carnino, undated).
• Encouraging employees to have a questioning attitude on safety issues (Carnino, undated).
• Having personal objectives for directly improving aspects of safety in managers' areas of responsibility (Carnino, undated).
• Monitoring safety trends to ensure that safety objectives are being achieved (Carnino, undated; Spath, 2000).
• Taking a genuine interest in safety improvements and recognizing those who achieve them—not restricting interest to situations in which there is a safety problem (Carnino, undated).
• Reviewing the safety status of the organization on a periodic (e.g., yearly) basis and identifying short- and long-term safety objectives (Pizzi et al., 2001; Spath, 2000).

Finally, leadership's commitment to safety is evidenced by a willingness to direct resources for improved safety, as reflected in the organization's budget (Pizzi et al., 2001; Shrivastava, 1992).

All Employees Empowered and Engaged in Ongoing Vigilance

Organizations with higher rates of accidents tend to believe that managers and system designers will anticipate potential problems in production systems and to assume that workers will always perform in accordance with performance expectations. In contrast, high-reliability organizations and other organizations committed to a safety culture know that system designers, managers, and organizational planners, as well as workers “at the sharp end” (see Chapter 1), are fallible. They know that system designers and managers cannot plan for the infinite variations that can occur within work systems, and that bad things sometimes happen in spite of best efforts to design a “fail-safe” system. Consequently, organizations with a strong safety culture encourage all employees to be on the lookout for any odd or unusual events instead of assuming that the odd or unusual is insignificant (Roberts and Bea, 2001). While management may set the tone, responsibility for safety is acknowledged as the responsibility of all employees. In a safety culture, all who work within the organization are actively involved in identifying and resolving safety concerns and are empowered to take appropriate action to prevent an adverse event (Spath, 2000).

Creating such attitudes and behaviors in workers requires many of the same practices recommended in the preceding chapters—ongoing, effective, multidirectional communication; the adoption of nonhierarchical decision-making practices; empowering of employees to adopt innovate practices to enhance patient safety; and a substantial commitment to employee training)—as well as alignment of employee incentives and rewards to promote safety.

Organizational Learning from Errors and Near Misses

In organizations with strong safety cultures, all errors are considered learning opportunities. Any event related to safety, especially a human or organizational error, is viewed as a valuable opportunity to improve the safety of operations through feedback. High-reliability organizations use accident analysis to:

• Build organizational memory of what happened and why.
• Develop an understanding of accidents that can happen in that particular organization.
• Communicate organizational concern about accidents to reinforce the cultural values of safety.
• Identify parts of the system that should have redundancies (Roberts and Bea, 2001).

This attitude toward safety is one of the hallmarks of knowledge management and is possessed by “learning organizations” (DeLong and Fahey, 2000) as described in Chapter 4. Learning in this way requires a fair and just reporting system of near-misses as well as errors, analysis of reported events, and feedback.

A Nursing Culture That Fosters Unrealistic Expectations of Clinical Perfection

Nurses are trained to believe that clinical perfection is an attainable goal (Jones, 2002) and that “good” nurses do not make errors (Banister et al., 1996). Like the general public, they perceive errors to be due to carelessness, inattention, indifference, or uninformed decisions. Requiring high standards of performance for nurses is both appropriate and desirable, but becomes counterproductive when it creates an expectation of perfection. Because they regard clinical perfection as a professional goal, nurses feel shame when they make an error (Leape, 1994), which in turn creates pressure to hide or cover up errors (Osborne et al., 1999; Wakefield et al., 1996) (see the example presented at the beginning of Chapter 1).

It is difficult to transform thinking associated with the blame and shame mentality (Banister et al., 1996; Manasse et al., 2002). In a study conducted to assess safety culture transformation over time at six VA medical centers, the first change noted was the realization that errors are the result of a systemic rather than an individual problem. Within a year, health care providers were reporting that they would not think less of coworkers who made errors. One of the last changes to occur was that providers did not think worse of themselves when an error occurred.¹ Such a transformation requires extensive education and training and support at all levels of the organization.

Litigation and Regulatory Barriers

Unfortunately, regulatory boards and litigation practices reinforce the myth of clinical perfection, as illustrated by the two cases presented in Box 7-1.

BOX 7-1

Litigation and Regulatory Barriers to Effective Safety Cultures: Two Case Examples. In the investigation of a widely publicized fatal chemotherapy overdose in 1994 of a health columnist for the Boston Globe, the state department of public health, the (more...)

These two cases (Cook et al., 2000; Grant, 1999; Knox, 2000; Schneider, 1999; Senders, 1999) illustrate a persisting focus on individuals rather than systems as the sources of error among licensing boards in medicine, nursing, and pharmacy; regulatory bodies, such as health departments; and sometimes the judicial system (Grant, 1999; Manasse et al., 2002). Malpractice litigation reinforces this perception. One result of this situation is that the consequences of litigation for the nurses involved in these and similar adverse events, in which nurses were fined, fired, sued, or otherwise punished (Serembus et al., 2001; Sexton, 1995), create serious disincentives to disclosure of errors or near misses on the part of nurses and other health professionals. The threat of legal liability is a strong barrier to voluntary reporting of errors (Schneider, 1999) and to the design of measures to prevent additional errors in the future.

The IOM report To Err Is Human speaks directly to these disincentives and identifies two steps HCOs can take to counteract them when designing their internal error-reporting systems: pledging the confidentiality of the reporter and the information contained in the report, and obtaining and maintaining data in a manner that prevents identification of the reporter or the specific event even if access to the report is obtained. This latter strategy can be pursued by adopting anonymous reporting of adverse events and near misses, or by deidentifying information once reported, as discussed earlier (IOM, 2000).

To Err Is Human also cites the need for federal legislation to extend peer review protections to data collected and analyzed by HCOs for purposes of improving safety and quality. It notes that all but one of the states have passed such legislation, but that these state laws vary in scope and strength. Federal legislation could remedy this situation, providing uniform national protection for the creation of cultures of safety in HCOs (IOM, 2000). This concept also has been endorsed by the Medicare Payment Advisory Commission, which has recommended that Congress enact legislation to protect the confidentiality of individually identifiable information relating to errors in health care delivery when that information is reported for quality improvement purposes (Medicare Payment Advisory Commission, 1999). Australia and New Zealand currently offer such legal protection for reporters of health care errors (Barach and Small, 2000).

To Err Is Human suggests that a combination of federal legislation and internal protections for the reporter and reported data is best. Each alone is imperfect, but together they offer stronger assurance of confidentiality (IOM, 2000).

Another strategy is being tested in the United Kingdom to guide decisions regarding culpability in unsafe acts in which health care professionals are involved. An “incident decision tree,” based on the decision tree in Reason's (1997) publication Managing the Risks of Organizational Accidents (see Figure 7-1), has been developed to help health care organizations to discriminate fairly and justly among willful acts of wrongdoing, inadvertent human error, and system contributions to error. Doing so can help a health care organization determine the appropriate response to an error in which an individual “at the sharp end” is involved.

FIGURE 7-1

A Decision Tree for determining the culpability of unsafe acts. SOURCE: Reason, 1997. Reprinted with permission of Ashgate Publishing.

The incident decision tree is based on the premise that while the vast majority of unsafe acts involve “honest” or nonculpable errors, a small minority of individuals commit reckless unsafe acts, and will continue to do so if left unchecked. To create a just culture, it is necessary to reach a collective agreement on where the line should be drawn between acceptable and unacceptable errors. To assist in differentiating between blameworthy and blameless acts, the model incorporates the following “substitution” test:

Substitute the individual involved in the adverse event or near miss with another individual possessing comparable qualifications and experience. Then ask the following question: “In light of how events unfolded and were perceived by those involved in real time, is it likely that this new individual would have behaved any differently?”

If the answer is “probably not,” blaming the individual at the sharp end of the error is an inappropriate response. Similarly, blame is not assigned to the individual if his/her peers respond “probably not” to the question “Given the circumstances that prevailed at that time, could you be sure that you would not have committed the same or similar type of unsafe act?” (Reason, 1997: 208).

Ensuring confidential reporting of errors, using fair and just procedures for assessing causation, and extending peer review protections to data collected by HCOs together can reduce the disincentives to error reporting that thwart the detection and prevention of error-producing situations.

Good Samaritan Hospital, Dayton, Ohio

In early 2000, Good Samaritan Hospital's (GSH) Vice President of Clinical Effectiveness and Performance Improvement, an early champion of patient safety, began an initiative to create a culture of safety within the hospital. This leader, as well as the director of the hospital's Center of Outcomes Research and Clinical Effectiveness, presented to the quality committee of the hospital's board of trustees a summary of the significance of patient safety and recommendations to institutionalize the vision that safety is essential to the hospital's mission. The vice president also engaged in one-on-one and group discussions with hospital leaders on the importance and benefits of being a safety-reliable organization. Through this consensus process, key hospital leaders committed their support to and agreed to guide the initiative.

To implement this initiative, GSH modified organizational structures and committed resources to the effort. Rather than assigning the project to a preexisting committee, it added a new Safety Board to its administrative infrastructure. This board is composed of physician, nursing, and administrative leaders, including the chief executive officer (CEO) and hospital communications staff. It serves as an oversight body to ensure the advancement of the safety program and to create the policies and procedures needed to implement the program. The Safety Board is also responsible for medical management, risk management, and quality management.

GSH adopted three early aims for its initiative:

• Demonstrate that patient safety is a top leadership priority.
• Promote a nonpunitive culture for sharing information and lessons learned.
• Implement an integrated patient safety program throughout the organization.

GSH evaluates its progress in meeting these aims on a bimonthly basis using a self-assessment tool adapted from such a tool developed as part of a Voluntary Hospital Association collaborative. The Safety Board formulated criteria for each aim. Specific actions undertaken by GSH to achieve these aims have included the following:

• Educational programming for all hospital staff on sentinel events, root-cause analysis, incident reporting, the hospital's safety initiative, and the roles of all employees in patient safety.
• Initiation of an incident and near miss reporting system, supported by automated database software to facilitate the tracking, aggregation, and analysis of incident data.
• Creation of a policy to forego corrective action against an employee if an error is reported within 48 hours.
• Initiation of specific safety improvement projects in such areas as medication safety, blood transfusions, and the transport of critically ill patients.
• Participation in state and local initiatives in patient safety, which has led to the exchange of ideas for improved practice and research.

As a result of this initiative, the hospital has experienced a significant increase in reported errors that has guided system improvements. It further reports a growing awareness that “committing resources to support patient safety initiatives is not in conflict with cost-effective practices. Eliminating rework and errors reduces the cost of providing care and the costs of resolving litigation…” (Wong et al., 2002: 372).

Kaiser Permanente

Kaiser Permanente, the largest not-for-profit health maintenance organization (HMO) in the United States, undertook the creation of a culture of safety throughout the organization as part of a Patient Safety Plan initiated in 2001. This initiative is aimed at:

• Creating a strong patient safety culture, with patient safety embraced as a shared value.
• Creating an environment that encourages responsible reporting of near misses and errors and that focuses on fixing systems and not assigning blame.
• Implementing strategies for improvement in patient safety performance.
• Identifying, sharing, and implementing best practices from other parts of the organization and other industries.
• Providing routine patient safety and error prevention training and education for individuals and groups.
• Developing new knowledge and understanding of safety in the delivery system.
• Identifying, assessing, and implementing indicators and measures of safety.

The above activities are focused on instituting the following six strategic themes:

• Safe culture—Creating and maintaining a strong patient safety culture, with patient safety and error reduction embraced as shared organizational values.
• Safe care—ensuring that the actual and potential hazards associated with high-risk procedures, processes, and patient care populations are identified, assessed, and controlled in a way that demonstrates continuous improvement and ultimately ensures that patients are free from accidental injury or illness.
• Safe staff—Ensuring that staff possess the knowledge and competence to perform required duties safely and improve system safety performance.
• Safe support systems—Identifying, implementing, and maintaining support systems—including knowledge-sharing networks and systems for responsible reporting—that provide the right information to the right people at the right time.
• Safe place—Designing, constructing, operating, and maintaining the environment of health care to enhance its efficiency and effectiveness.
• Safe patients—Engaging patients and their families, as appropriate, in reducing medical errors, improving overall system safety performance, and maintaining trust and respect.

Kaiser Permanente formed an internal National Patient Safety Advisory Board to guide this initiative, provide a forum for information sharing, and help integrate safety into the fabric of the organization. Membership includes a representative of Kaiser Permanente's labor–management partnership with the Coalition of Kaiser Permanente Unions. Kaiser Permanente has engaged and educated its labor partners in patient safety through a number of mechanisms, including their participation in patient safety executive walkarounds. In a survey of unit personnel at one facility 6 months following visits from senior executives, 90 percent of respondents stated that things related to patient safety were being done differently, 44 percent indicated that their reporting or discussion of errors and near misses had increased, and 90 percent indicated that they had a better understanding of patient safety. Human factors training and projects have also been launched in the medical center operating room, neonatal intensive care unit, perinatal units, and emergency department to integrate human factors into the provision of care. A National Patient Safety website is available to all Kaiser Permanente employees to increase their knowledge about patient safety.

Benchmarking Organizational Safety Culture

A number of health care organizations have surveyed themselves to benchmark their culture-of-safety status (Pizzi et al., 2001), using a variety of surveys and checklists that assess the attitudes and perceptions of workers (Cooper, 2000; Pizzi et al., 2001; Spath, 2000). The Agency for Healthcare Research and Quality and the federal government's Quality Interagency Coordination Task Force are developing a public-domain instrument for assessing issues of patient safety, medical error, and event reporting as they relate to an organization's safety culture. This instrument—the Hospital Survey on Patient Safety—is in the final stages of testing and validation and is scheduled to be available in the public domain in early in 2004. It will allow health care institutions to understand the varying safety cultures within their own institutions, how staff view the commission of errors and error reporting, and the extent to which staff perceives the institution to be a safe place for patients.²

By themselves, however, surveys of the safety climate (i.e., the aggregation of individuals' attitudes and perceptions about safety) within organizations are believed to be inadequate in evaluating the extent to which a culture of safety has been created (Cooper, 2000). While appraisal of the products or outcomes of the safety culture in operating organizations is a challenge, measurable indicators of the culture's effectiveness are viewed as essential (Cooper, 2000; Spath, 2000).