U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

The U.S. Department of Health and Human Services (DHHS) is the agency charged with protecting the health of all Americans and providing services for those that cannot provide for themselves. As a part of this responsibility, the DHHS has initiated several programs with the specific goal of improving patient safety. Table 20-1 outlines agencies within DHHS that play key roles in defining and regulating patient safety initiatives. DHHS agencies work with the health care team to coordinate and collaborate on initiatives to improve the health and safety of Americans. The Agency for Healthcare Research and Quality (AHRQ) serves as the lead organization for quality of care and patient safety research (both the provision of research and the synthesis of published research evidence). One of the goals of AHRQ is to promote the use of evidence-based practice in everyday care. Therefore AHRQ partners with key regulatory agencies such as the Centers for Medicare and Medicaid (CMS), TJC, and other partners such as the National Quality Forum to move research into health care practice (Couig, 2005).

PATIENT SAFETY AND QUALITY IMPROVEMENT ACT OF 2005

Learning from health care errors is a foundational principle to mitigate and prevent future occurrences of errors. A key way of learning from errors is for practitioners and organizations to share information with others. Unfortunately, providers remain cautious about sharing information regarding errors and the lessons learned from those errors. This caution arises out of fear of litigation, potential professional sanctions, and potential damage to professional reputations (Catalano, 2008). Recognizing the importance of designing systems to mitigate errors, the Patient Safety and Quality Improvement Act of 2005 was signed into law on July 29, 2005. The primary purpose of the act was to amend Title IX of the Public Health Service Act, encouraging a culture of safety by facilitating the sharing of information through patient safety organizations (PSOs) that are administered through AHRQ. PSOs create a secure environment where information can be shared, aggregated, and analyzed, thus improving patient care by identifying trends and patterns amenable to risk prevention and reduction and program improvement. Participation in a PSO is highly encouraged; in fact, many states require participation in a PSO in order to strengthen the state patient safety program.

The Patient Safety and Quality Improvement Act of 2005 is divided into three distinct divisions. First, all PSOs must be certified and meet patient safety criteria in order to influence the learning from numerous patient safety events. Second, PSOs must maintain strict confidentiality of patient safety work products. Patient safety work products are protected from any proceedings and legal actions against providers and health care facilities. Finally, PSOs report to the Secretary of Health and Human Services, who is then responsible to report to Congress all successful strategies that have reduced medical errors, thus increasing patient safety across the United States (Catalano, 2008).

The professional nurse is the primary advocate for the patient and is responsible for ensuring that all regulatory requirements are met during patient care activities. The professional nurse can identify key patient care process improvements to meet and exceed regulatory requirements. When key processes are not carried out as intended, the professional nurse has been described as the clinician on the “sharp end” of patient care or the clinician closest to the patient care delivery—thus often the last line of defense to potentially mitigate or avoid medical errors (Hughes, 2008).

JUST CULTURE

Human factors science, simply stated, is the science of determining how human beings interact with the environment (e.g., devices, policies and procedures, work space). Human factors research has assisted health care practitioners to shift focus when medical errors occur, from the individual person to the system or processes that led to the error. Despite several years working on human factors in health care, health care organizations continue to lack progress toward an error-free care delivery system. Many argue that this is a result of the fact that most organizations have not devoted adequate resources and attention to analyzing organizational and system processes but have continued to focus on the individual (Henriksen, Dayton, Keyes, Carayon, & Hughes, 2008; Kaissi, 2006). Focusing on the individual creates a culture of blame in which practitioners become more reluctant to report errors and failures of the system. To overcome the culture of blame and to increase organizational learning from health care errors, just culture philosophies are increasing across health care. Just culture philosophy encourages open and active reporting of errors and learning from mistakes, while holding practitioners and organizations accountable as indicated (Gorzeman, 2008; IOM, 2000).

There are two primary types of failures or errors within the health care literature. First is an active failure, which is an unsafe act committed by a clinician who is in direct contact with the patient—“the sharp end.” The second type is a latent failure, which is a system problem that is not within the direct control of the clinician—for instance, poor system design, organizational structure, and policies and procedures, often referred to as the “blunt end” (Henriksen et al., 2008). Latent failures lead to organizational accidents or medical errors more often than do active failures. Latent failures in health care may include building design, communication, management/leadership, policies and procedures, and bypassed defenses or safeguards (Kaissi, 2006).

The fundamental challenge for health care organizations and nurses, in particular, is to move prevention of medical errors from a system focusing on active failures or the individual to a system approach focusing on latent failures or the organization. Organizations that have achieved inspiring safety records are referred to as high reliability organizations (HROs). An HRO is an organization that recommends systems to produce consistent results and to quickly detect deviations and/or potential errors within the system before the error reaches the patient (Hughes, 2008). A defining factor for an HRO is mindfulness, keeping all practitioners acutely aware of all processes that could potentially go wrong and ways to quickly identify and recover from errors when they occur.

There are five mindful processes that comprise the core of an HRO. As a key member of the health care team, the professional nurse has a key role in all five processes. First, the nurse must have a constant preoccupation with failure. Nurses must confidently share their inner voice of concern with the rest of the health care team. Often, prior to a patient becoming extremely unstable, a nurse has reported “a feeling” that something is not right with the patient. Unfortunately, many nurses do not confidently act on these concerns (Henriksen et al., 2008; Weick & Sutcliffe, 2001). Second, nurses must be reluctant to simplify interpretations and not accept conventional explanations that are obvious. The professional nurse who has strong collaborative relationships is in a position to facilitate the health care team’s performance of thorough investigations when errors occur. Third, nurses must maintain situational awareness during all clinical exchanges. Situational awareness, term commonly used in the airline industry, means that the entire team demonstrates an understanding of all people’s roles and responsibilities and of the progress the team is making toward the ultimate outcome. Nurses have a full understanding of the complex roles outside of their own role; therefore they serve as “clinical glue,” helping the team maintain situational awareness. Fourth, nurses must be committed to resilience. Resilience is the ability to quickly recover when an error does occur, thus mitigating any adverse consequences of the error. Nurses continuously demonstrate their commitment to resilience in numerous ways—for example, maintaining supplies and equipment in key locations and maintaining continual competency in using such devices for the safety of their patients. Fifth, nurses in HROs show deference to expertise, allowing decisions to be made by those clinicians with the expertise, resources, and ability to assist the patient. HROs that demonstrate deference to expertise have less rigid hierarchical structure, and team members are treated with mutual respect. Typically, nurses can cite several examples of how misplaced deference is granted to physicians; on the other hand, it is not uncommon for nurses to automatically assume that those with “less experience” are unable to make decisions for patients (Henriksen et al., 2008; Weick & Sutcliffe, 2001).

High reliability organizations place emphasis on strategies to develop a just culture where practitioners are encouraged to report errors and concerns free from blame, humiliation, and retaliation. Recently, critics have raised the concern that a blame-free culture is risky and could lead to unsafe clinical practice. However, the purpose of a just culture is to balance the need to learn from mistakes with the need to hold practitioners accountable (Marx, 2001). In a just culture, nurses are protected from disciplinary action both within the facility and within regulatory agencies when reporting injuries, errors, and near misses in which they are personally involved (Gorzeman, 2008). Such protection should not be granted in three important exceptions. These exceptions are criminal behavior (e.g., a nurse who treats a patient while under the influence of drugs or alcohol), active malfeasance (e.g., a nurse who actively or purposely violates safety protocols), and an injury or incident that has not been reported in a timely manner (IOM, 2004b).