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December 26, 2006

New Approaches to Reduce Medical Errors
By Patrice L. Spath, BA, RHIT
For The Record
Vol. 18 No. 26 P. 18

To truly effect change, a healthcare organization must erase prejudices and change its culture from the top down. And you’re right, it’s not easy.

Conventional approaches to improving patient safety are not sufficient to reduce the risk of adverse events. New methods for understanding what contributes to medical mishaps and taking preventive actions are needed.

Traditionally, following a major patient care disaster, the questioning process would begin. For example: How and why did competent personnel make the errors necessary to cause the event? Could something like this happen again? A root cause analysis team examined the chain of events or circumstances that ultimately led to someone doing something inappropriate.

This inappropriate behavior may have been an error in judgment, an error due to inattention, or a deliberate violation of the rules. In keeping with tradition, the investigation’s focus was more often than not about finding someone to blame for the incident. At best, efforts to prevent future incidents of a similar type concentrated on finding ways of reducing the risk that such unsafe acts would be committed in the first place.

Contemporary patient safety thinking suggests that further in-depth analysis of adverse events will most likely find that the situation prior to the incident set up people to make an error. Healthcare organizations are beginning to understand that front-line caregivers are but part of a larger system. Prevention of medical mishaps requires an understanding of accident causation, one that depends on examining the total context (eg, the system) in which people work.

The human element is the most flexible and adaptable part of the healthcare delivery system, but it is also the most vulnerable to influences that can adversely affect its performance. With the majority of sentinel events resulting from less-than-optimum human performance, there has been a tendency to merely attribute incidents to human error. However, the fact that a human error occurred is of little help in understanding why it occurred.

An error attributed to humans may have been stimulated by inadequate equipment or training, badly designed procedures, or poor layout of checklists or procedures. In contemporary patient safety thinking, human error is the starting point rather than the stopping point in incident investigation and prevention. Incident investigations must focus on finding ways to minimize or prevent human errors that may jeopardize patient safety. This requires an understanding of the factors and conditions affecting human performance in the healthcare workplace.

Factors Influencing Performance
The workplace typically involves a complex set of interrelated factors and conditions which may affect human performance. One factor is the workplace culture, which influences the values, beliefs, and behaviors that individuals share with other work team members.

Culture serves to bind people together as members of groups and provides clues as to how members will behave in both normal and unusual situations. It is a complex social dynamic that serves as a framework for all interpersonal interactions.

Patient safety is not immune to cultural considerations as human behavior is subject to cultural influences. The following individual cultural considerations are relevant to patient safety improvement initiatives:

• National culture differentiates the national characteristics and values system of particular nations. People of different nationalities vary, for example, in their response to authority, how they deal with uncertainty and ambiguity, and how they express their individuality. They are not all attuned to the collective needs of the group (work team or organization) in the same way. For example, in some national cultures, there is deference to leaders. This factor may affect the willingness of individuals from these cultures to question the decisions or actions of other team members—an important patient safety intervention in some situations.

• Professional culture differentiates the behavior and characteristics of particular professional groups (eg, the typical behavior of physicians vs. nurses or HIM professionals). Through personnel selection, education and training, on-the-job experience, etc, professionals tend to adopt the value system and develop behavior patterns consistent with their peers. Professionals that exhibit a sense of personal invulnerability (eg, they do not make errors in situations of high stress) can create patient safety risks.

As previously seen, individual cultural factors influence human behavior in the workplace. These culturally diverse individuals also work within an organization that has a cultural component. Organizational culture sets the boundaries for accepted human behavior in the workplace by establishing the behavioral norms and limits. People are influenced in their day-to-day behavior by their organization’s values.

Does the organization recognize merit? Promote individuality? Encourage problem solving? Tolerate lapses in procedure? Promote open two-way communication? Thus, the organizational culture is a major determinant of employee behavior.

The tone for patient safety culture is set and nurtured by the words and actions of senior management. These words and actions shape workers’ attitudes toward patient safety and error prevention. Patient safety culture is affected by factors such as the following:

• management’s action and priorities;

• policies and procedures;

• supervisory practices;

• patient safety planning and goals;

• actions in response to unsafe behaviors;

• employee training and motivation; and

• employee involvement or “buy-in.”

Although compliance with standard operating practices is fundamental to the prevention of unintended patient harm, much more is required. It is important that employees work in a positive patient safety culture—one in which everyone is responsible for considering how their job affects patient safety. This way of thinking must be so deep-rooted that it truly becomes a “culture.” The patient safety implications of all decisions and actions, whether by the board of trustees, a nurse on the surgical unit, or maintenance staff, should be carefully considered.

A positive safety culture must be generated from the top down. Workers must believe they will be supported in all decisions made in the interests of patient safety. They must also understand that intentional breaches of safe practices that jeopardize a patient will not be tolerated. To ensure a positive safety culture, management must convince employees that while productivity and costs are important, patient safety is paramount. A positive safety culture demonstrates attributes such as the following:

• Senior management places strong emphasis on patient safety as part of the strategic planning process.

• Decision makers, managers, and staff understand the short- and long-term patient safety hazards involved in providing patient care.

• Those in leadership positions foster a climate in which there is a positive attitude toward criticism, comments, and feedback from lower levels.

• The board of trustees and senior leaders implement measures to reduce the consequences of identified patient safety deficiencies.

• Senior management promotes a nonpunitive working environment; they tolerate legitimate errors and systematically attempt to derive patient safety lessons from them.

• There is an awareness of the importance of communicating relevant patient safety information to all levels of the organization.

• Staff are well-trained and fully understand the consequences of unsafe acts.

Figure 1 summarizes three organizational responses to patient safety issues ranging from a poor patient safety culture, through the bureaucratic approach which meets only minimum acceptable requirements, to the ideal positive patient safety culture.

Positive safety cultures typically are the following:

• Informed cultures. Management fosters a culture where people understand the patient safety hazards and risks inherent in their job responsibilities. Staff are provided with the necessary knowledge, skills, and job experience to provide safe patient care and are encouraged to identify threats to patient safety and seek out ways to overcome them.

• Learning cultures. People are encouraged to develop and apply their own skills and knowledge to enhance patient safety. Management updates staff on safety issues and patient safety reports are fed back to staff so everyone can learn the pertinent lessons.

• Reporting cultures. Managers and front-line staff freely share critical patient safety information without threat of punitive action. Staff are able to report concerns as they become aware of them without fear of retribution or embarrassment.

• Just cultures. The workforce must know and agree on what is acceptable and unacceptable behavior. Deliberate violations of sound patient care practices must not be tolerated by management or staff members. A culture that recognizes that, in certain circumstances, there may be a need for punitive action is considered a just culture.

Error Tolerance
An important dimension of a positive patient safety culture is the organization’s attitude toward errors and the perceptions it creates among staff in how it responded to errors. Error tolerance is a term used to describe a system’s ability to accept an error without serious consequence. The concept is often applied to the design of equipment or software which incorporates physical defenses or safeguards against inappropriate human acts. An example is a checking or confirmation function such as the “Are you sure?” dialogue box in computer software for an action that could have severe consequences if made in error. In addition, procedural actions, such as checklists, cross-checks, and read-backs, provide error tolerance by identifying unsafe conditions before a mishap occurs.

The concept of error tolerance can also be applied to the organization’s patient safety culture. Creating a positive safety culture is dependent on effective two-way communication between management and front-line personnel. Healthcare organizations are increasingly recognizing the value of voluntary incident reporting systems that provide immunity to the reporter. However, the effectiveness of such reporting systems depends largely on the organization’s error tolerance.

Punishment may play a role in dealing with violations where staff members or physicians intentionally break patient care “rules.” The threat of disciplinary action may deter the violator (or others in similar circumstances) from jeopardizing patient safety. It is important that disciplinary action be taken regardless of the outcome of the violation. People should not be disciplined only when the violation results in patient harm. Any intentional violation of the rules should be dealt with sharply.

However, if the adverse event was the result of an error in judgment or technique, it is almost impossible to effectively punish that error. Change could be made in the training processes or the system made more tolerant of such errors.

If disciplinary action is taken against an individual in such situations, two outcomes are almost certain. First, no further incident reports of such errors will be completed by staff. Second, since nothing has been done to change the situation which is setting up people to make mistakes, the same or similar incident will likely happen again.

Except in willful cases of negligent behavior, punishment serves little purpose from a patient safety perspective.

In contemporary patient safety thinking, human errors (as opposed to violations) are viewed as the result of some situation or circumstance, not necessarily the cause of them. Healthcare organizations are learning how to uncover and resolve the unsafe conditions that facilitate patient care mistakes. Finding and fixing organizational weaknesses and system deficiencies pay a much higher dividend for improved patient safety than punishing individuals.

The cultural factors described above are important to safe patient care practices. They determine how staff members will relate to their bosses, how information is shared, how people will react under stress, how particular innovations will be embraced and used, and how people react to human errors (eg, punish offenders or learn from experience). In other words, culture impacts virtually every element that affects patient safety. The challenge is to understand how culture influences both individuals and healthcare organizations and how that relationship can put patient safety at risk or serve to enhance it.

Contemporary View of Causation
According to contemporary patient safety thinking, adverse events require the coming together of a number of enabling factors. Major equipment failures or caregiver errors are seldom the sole cause of medical mishaps. Often these breakdowns are the consequence of human failures in decision making. These breakdowns may occur at the workplace or front-line level or result from management or board decisions. Most adverse events include failures at all levels.

Figure 2 (see page 22) portrays an adverse event causation model that assists in understanding the interplay of organizational and management factors in prevention of medical mishaps. Various “safeguards” are built into the healthcare system to protect against inappropriate performance or poor decisions at all levels of the system: the front-line workers, the supervisory levels, and senior management. This model shows that while organizational factors, including management decisions, can create conditions that could lead to an adverse event, they also contribute to the system safeguards.

Errors and violations having an immediate adverse effect can be viewed as unsafe acts; these are generally associated with front-line staff (physicians, nurses, therapists, etc). These acts may penetrate the various safeguards put in place to protect patients from harm and may be unintended errors or deliberate violations of standard procedures or practices.

Various conditions in the work environment can affect individual or team behavior. Front-line staff often work within defective systems, such as those created by poor equipment or task design; conflicting goals (eg, productivity vs. safety); defective organizations (eg, poor internal communications); or imperfect management decisions (eg, deferral of an equipment purchase). Often, unsafe acts are merely symptoms of safety problems within the work environment, not causes.

These unsafe conditions may only become evident once an adverse event has occurred. The conditions were most likely present in the environment well before an incident and are generally created by decision makers and other people far removed from the incident.

The work environment can be made unsafe by line-management decisions resulting in inadequate procedures, poor staff scheduling, or neglect of recognizable hazards. This may lead to inadequate staff knowledge and skills or inappropriate patient care procedures.

How well management and the organization perform their oversight functions sets the stage for errors or violations on the front lines. For example, how effective is management in organizing patient care tasks and resources, managing day-to-day activities, and communicating internally and externally? Identifying and validating these unsafe conditions requires an objective, in-depth root cause analysis. Effective patient safety improvement efforts must focus on identifying and mitigating these unsafe conditions on an organizationwide basis rather than relying on localized efforts to minimize unsafe acts by individuals.

In investigations of adverse patient incidents, it is often impossible to determine causes with absolute certainty. Following an investigation, some stakeholders are primarily interested in the cause of the incident. Contemporary patient safety thinking focuses more on understanding all the causes.

The investigation should go deep enough to uncover the systematic safety deficiencies that must be corrected to prevent future incidents of a similar type. A thorough investigation will reveal many findings, perhaps including unsafe work environment issues that had no role whatsoever in the cause of the specific incident under evaluation. From a prevention point of view, significant unsafe conditions found in a root cause analysis that may be completely unrelated to the incident of interest should also be eliminated or reduced.

Adverse patient incidents occur within a defined set of circumstances and conditions that create human error and violation-producing conditions that include individual and organization climate, work environment, operational procedures, and the like. At any given time, some of these factors may converge to create conditions that are ripe for a significant adverse event. Understanding the context in which incidents occur is fundamental to patient safety improvement.

— Patrice L. Spath, BA, RHIT, is a healthcare quality specialist, author of Leading Your Health Care Organization to Excellence, a partner in Brown-Spath & Associates (www.brownspath.com), and an assistant professor in the department of health services administration at the University of Alabama in Birmingham.



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