Guidelines for Leading a Safe Medication Error Reporting Culture

Abstract

Background: A safe medication error reporting culture is one that promotes, fosters, and rewards the reporting of errors and events across the spectrum of harm (none to significant harm). For this culture to develop, leaders must key department cultural norms. These cultural norms include making employees feel psychologically safe to report errors, and to establish a culture of error review and follow-up that complies with best practices. Objective: This article reviews how pharmacy leaders can establish this environment by describing (1) setting an appropriate vision for safety as a priority; (2) establishing and actively supporting the concept of psychological safety; and (3) implementing medication error review that support an effective safety culture. Finally, the article discusses a case where the relationships between psychological safety, safety culture, and reporting culture are described. Methods: This article reviews the literature and authors’ experiences in designing a safety culture for a pharmacy department. Concluson: A safe reporting culture requires leaders to be humble, engage their staff in dialogue, objectively measure culture, consistently provide feedback, and empower its people. Employing these leadership traits with best practices can improve overall medication safety and the quality of patient-centered pharmacy services.

Introduction

In an effort to standardize the definition of medication error, the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) defines a medication error as “any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer.” ¹ Medication errors are common and have a variety of public health implications, including increased hospital length of stay and death. ² The type and frequency of medication errors vary substantially by setting. In the hospital, for example, medication errors are much more frequent in intensive care units where patients receive an average of 25 medications per day as compared to obstetrics where medications are typically avoided. ³ There are many more studies of hospitalized patients than of outpatients, but it is clear that medication errors are a problem in both settings. ⁴ The majority of medication errors are a result of system failure making it critical to move beyond placing blame on an individiaul. ² Non-punitive medication error reporting, including near misses is essential to identify system failures and build safer systems.

In 1996, The Joint Commission (TJC) adopted a formal Sentinel Event Policy in order to help hospitals improve safety and learn from sentinel events. ⁵ The ultimate goal of the Sentinel Event Policy is to protect patients, improve systems, and prevent further harm. ⁵ Sentinel events, however, are just one category of patient safety events. A patient safety event is an event, incident, or condition that could have resulted or did result in harm to a patient. ⁶ This article focuses on how leaders establish a safe reporting culture; one where wrongful blame avoided, accountability is properly managed, and patient safety events resulting in harm are eliminated. An error recently reported through TJC identifies examples for pharmacy leaders in reaching this goal. ⁷ The event involved a pharmacy technician who was preparing a pediatric nutritional solution. To finish preparing the solution, the technician obtained a second 2 L bag of sterile water; mistakenly the technician took a bag of amino acid resulting in a highly concentrated solution being prepared. The pharmacy technician realized the error, notified the supervisor, and all bags were removed preventing any serious patient harm. The point of the report was to demonstrate that a system of being transparent about errors can have a direct safety effect on the organization.

A safe medication error reporting culture is one that promotes, fosters, and rewards the reporting of errors and events across the spectrum of harm (none to significant harm). For this culture to develop, leaders must key department cultural norms. These cultural norms include making employees feel psychologically safe to report errors, and to establish a culture of error review and follow-up that complies with best practices. This article reviews how pharmacy leaders can establish this environment by describing (1) setting an appropriate vision for safety as a priority; (2) establishing and actively supporting the concept of psychological safety; and (3) implementing medication error review that support a just culture of safety. A safe reporting culture requires leaders to be humble, engage their staff in dialogue, objectively measure culture, consistently provide feedback, and empower its people. Employing these leadership traits with best practices can improve overall medication safety and the quality of patient-centered pharmacy services.

Setting a Leadership Vision for Patient Safety

The role of effective leaders involves clearly defining the goals and values of the organization: setting vision. First, safety and error prevention is communicated as a primary, non-negotiable goal. ⁸ This vision of non-negotiable should not be viewed as draconian—but rather as a baseline expectation that we “above all do no harm” as Hippocrates writes. Leaders can communicate this vision by stating and demonstrating behavioral norms for safety. They should describe what these behaviors look like and themselves act in ways that model and reinforce the desired behaviors. Actions that create unacceptable risk should not be tolerated and addressed appropriately. Finally, leaders must be consistent in holding senior leaders, physicians, nurses, and all other staff accountable and to the same standards, laying the foundation for a strong culture of safety within the organization. ⁸ The next several paragraphs outline some examples of leaders modeling and communicating behavioral norms to improve safety.

The Joint Commission requires that hospitals establish a code of conduct that “defines acceptable behavior and behaviors that undermine a culture of a safety.” ⁹ Verbal outburst, physical threats, refusal to answer questions, and condescending language are intimidating and disruptive behaviors. ¹⁰ Example of organizational behaviors that establish safety-mindfulness include transparency, effective teamwork, active communication, and direct and timely feedback. ¹¹

Pharmacy leaders should aim for total transparency by publicly sharing available information about events of harm. However, limits on transparency may exist. It is imperative for leaders to educate and explain to both the organization and the public what the organization will be transparent about. ¹¹ Leaders should also develop required processes for effective teamwork and active communication. Examples of tools include situation, background, assessment, recommendation (SBAR), read back, and briefings/de-briefings. Designing, promoting, and implementing a formal team training program can also help foster teamwork. Finally, safety huddles are another opportunity to build better teamwork and communication among staff. Direct and timely feedback comes with robust reporting systems. It is essential for leaders to provide their workforce results of what went wrong but also why it went wrong (e.g., explanation of a root cause analysis). This feedback should include strong action plans to prevent future occurrence. ¹¹

To create a compelling vision, leaders must first understand and communicate the current state of their organization. ¹¹ The key is for the vision to (1) encompass all organizational interests; (2) engage the entire workforce; and (3) offer long-term perspective. Leaders should clearly articulate the why, the how, and the when of the aspirational goal: zero harm both internally and externally. To establish the vision, leaders must display their own true commitment to safety through action and not simple statements about its importance. ¹² They may choose to designate a dedicated patient safety officer who promotes action through training of staff and implementation of proven methods can be considered. ¹² Whenever possible, leaders should also partake in full harm investigations and root cause analyses. By working directly with physicians, nurses, and other clinical and non-clinical staff, leaders will create a shared vision that motivates and inspires everyone within the organization. ¹¹

Establishing Psychological Safety

Psychological Safety Defined

Psychological safety is defined as the degree to which people view a work environment as conducive to perceived “risky” behaviors like speaking up or asking for help. ¹³ Data shows that some healthcare organizations may not promote psychological safety. The Agency for Healthcare Research and Quality (AHRQ) 2018 Patient Safety Survey reported that 47% of respondents felt unsafe event reports are held against them. Furthermore, 50% of respondents indicated that, after an event is reported, individuals are reprimanded and the event is not addressed. ¹⁴

Reason outlined the concept of psychological safety in his book, Managing the Risks of Organizational Accidents, ¹⁵ and furthered by Harvard Professor Edmondson. ¹⁶ The specific elements of psychological safety are:

• Anyone can ask questions without looking stupid.

• Anyone can ask for feedback without looking incompetent.

• Anyone can be respectfully critical without appearing negative.

• Anyone can suggest innovative ideas without being perceived as disruptive.

Trust, respect for others, and inclusion are essential to creating environments that are psychologically safe. ¹¹ Edmondson also describes four important outcomes of psychological safety in health care: learning, risk management, innovation, and job satisfaction/meaning. ¹⁷

Learning refers to individuals’ own learning as well as the organization. In a psychologically safe work environment, individuals are more able to listen, ask for help, and gain better data on what is happening around them. At an organizational level, learning allows people working together in interdependent work environments to speak openly with each other and to ask for help and input. Risk management allows people to discuss areas of risk thoughtfully and skillfully, improving the managing of risks overall. Innovation is transformed when people feel psychologically safe at work; they are better able to brainstorm and offer possibilities and solutions to problems without fear of reprisal. They can also better assess and test ideas as well as engage in rapid cycle learning processes. Finally, job satisfaction results when people who have a high sense of psychological safety at work feel better about their job more committed to keeping that job over time. ¹⁷

Psychological Safety is the Cornerstone of a Safety Culture

The concept of a safety culture is not new and originated in the nuclear energy and aviation industries.^18,19 The term “safety culture” is defined by AHRQ as one “in which healthcare professionals are held accountable for unprofessional conduct, yet not punished for human mistakes; errors are identified and mitigated before harm occurs; and systems are in place to enable staff to learn from errors and near-misses and prevent recurrence.” ¹¹ In addition, TJC lists the following traits of a safety culture as: ⁶

• Staff and leaders value transparency, accountability, and mutual respect.

• Safety is everyone’s first priority.

• Behaviors that undermine a culture of safety are unacceptable.

• Staff recognize that systems have the potential to fail and are, therefore, mindful of identifying hazardous conditions and close calls before a patient is harmed.

• Staff report errors because they know the information can be used to address system flaws that contribute to patient safety events.

• Staff create a learning organization by learning from patient safety events to continuously improve.

The American College of Healthcare Executives published a guide “Leading a Culture of Safety: A Blueprint for Success” in 2017 which was developed for CEOs and other executive leaders in order to provide a useful tool for assessing and advancing an organization’s culture of safety. ¹¹ The guide is divided into two levels: foundational and sustaining. While the foundational level provides basic tactics and strategies essential for the implementation of each domain, the sustaining level provides strategies for spreading and embedding a culture of safety throughout the organization. The six domains of a culture of safety are summarized below (Figure 1).

Figure 1.

A culture of safety: the six domains.

Note. Adapted from the American College of Healthcare Executives and IHI/NPSF Lucian Leape Institute. Leading a Culture of Safety: A Blueprint for Success.

In simple terms, a safety culture is the combination of attitudes and behaviors toward patient safety that are conveyed when walking into a health facility. ¹⁹ It is the sum of what an organization is and does in the pursuit of safety. According to Chassin and Loeb, there are five components of safety culture: trust, accountability, identifying unsafe conditions, strengthening systems, and assessment. ²⁰ A positive safety culture has been associated with reduced infection rates, fewer admissions, better surgical outcomes, reduced adverse events, and decreased mortality. ¹⁸ Additionally, studies have shown a positive effect on staff well-being, job satisfaction, and burnout, all of which can affect patient safety. ¹⁸

Related to the idea of safety culture is Just Culture. Developed by Marx in 2001, Just Culture ²¹ focuses on identifying and addressing systems issues that lead individuals to engage in unsafe behaviors, while maintaining individual accountability by establishing zero tolerance for reckless behavior. It distinguishes between human error (e.g., slips), at-risk behavior (e.g., taking shortcuts), and reckless behavior (e.g., ignoring required safety steps), which should be addressed differently. ²² The “no-blame” approach disappears, as staff are still held accountable for following protocols and procedures. ¹¹ When clearly defined, articulated, and implemented, Just Culture encourages the reporting of errors, lapses, near-misses, and adverse events. ¹¹

Relationship Between Psychological Safety, Safety Culture, and Reporting Culture

The ultimate goal in establishing psychological safety and a safety culture within an organization is to develop a reporting culture. A reporting culture exists when individuals not only report adverse events that led to patient harm, but also close calls, near-misses, and unsafe or hazardous conditions. Employees who feel psychologically safe in an environment with a positive safety culture will inevitably develop a reporting culture. In fact, experts say that a culture of safety is necessary before other patient safety practices can be successfully introduced. ¹⁹ Without psychological safety and a safety culture, staff may be insufficiently motivated to report events that did not cause harm.

Reporting close calls is important for several reasons. First, such events provide information on active failures, or potential weaknesses in the health care system. They are also more frequent than events that cause harm. Finally, analysis of high-frequency or high-potential-severity near miss reports makes it possible to identify system weaknesses before they reach the patient. ⁷

Case Example

The following case demonstrates how the concepts of psychological safety, safety culture, Just Culture, and reporting culture all come together to enhance patient safety. A nurse who has been working in the intensive care unit (ICU) for the past 5 years realizes that she almost made a huge mistake. It is her third 12-hour shift in a row and she is extremely fatigued. The intensivist just put an order in for potassium chloride 10 mEq/100 mL for a patient who has a mild potassium deficit. Since it is Saturday and the hospital does not have a 24-hour pharmacy service, the nurse must go to the secured area of the pharmacy where the potassium chloride vials are stocked. Unfortunately, she unknowingly picks the wrong vial and returns to the patient’s room with a vial of concentrated potassium chloride. She withdraws the medication and is about to administer it to the patient when she realizes that she should probably double check that this is the right medication. The nurse catches the close call and does not administer the medication to the patient.

In an institution that is psychologically safe, promotes a safety culture, and has a robust reporting culture, the following would result:

• The nurse trusts that her institution will fairly assess the causes of a close call and make just decisions without undue punitive action. ⁷ She feels psychologically safe.

• The nurse reports the event to the hospital safety system. She identified an unsafe condition, one of the five components of safety culture. ²¹

• The reporting system conducts a root-cause-analysis, demonstrating another component of safety culture: assessment. ²¹

• The results and lessons learned are shared with all staff at the institution, in a direct and timely manner. ¹¹

• The institution implements strong action plans to prevent future occurrence, such as:

  • Prohibiting nurse access to the pharmacy when it is closed.
  • Considering a 24-hour pharmacy service.
  • Using only premixed solutions.
  • Physically separating electrolytes and properly labeling them.

• The nurse is recognized and publicly rewarded for demonstrating positive safety behaviors and reporting. ¹¹

• The nurse is given information on how her report led to improvement in the institution. ⁷

The results of this case would be very different had the nurse been in a psychologically unsafe environment where a strong safety culture is not established. By fear of being fired or subject to disciplinary action, the nurse would not report this near miss to anyone since the medication was not administered to the patient and the patient was therefore not harmed. Due to low transparency within the institution, other nurses could make similar errors in the future, some of which may lead to patient harm. Not addressing the issue at the organizational level means not addressing the issue at all.

Leadership Strategies

Effective leaders understand the steps necessary to develop a reporting culture. The first step, establishing psychological safety, requires leaders to practice humility. By openly admitting their limitations and mistakes, appreciating their employees’ strengths and contribution, and modeling a learning mentality, employees feel psychologically safe to voice and express new ideas. Leaders should also consider mistakes as a normal and beneficial part of learning, be open to new ideas and suggestions, and actively seek feedback. ²³ Often, this requires a flat hierarchy and a solid learning system in which leaders act as coaches and role models. ¹⁶ The board of directors, which have traditionally had little direct engagement in evaluating and improving patient safety, should be involved. ²⁴ Outmoded views of hospital governance suggest that hospital boards are primarily responsible for the organization’s financial health and reputation. ²⁵ However, a 2013 review found that high-performing hospitals, defined as those ranking highly on objective measures of quality and safety, tended to have board members who were more skilled in quality and safety issues and who devoted more time to discussion of quality and safety during board meetings. While hospital boards can influence safety through strategic initiatives, they can also engage in more direct interactions with frontline workers through leadership walkrounds. ²⁵ Finally, establishing trust can be done by addressing staff by their names and consistently inviting team members into the conversation, both to benefit from their expertise and to address their concerns. ⁸

Once a safety culture is set as an organizational top priority, there is a fundamental need for leaders to measure and understand the culture at a clinical unit level. ⁸ This can be done using validated survey instruments with a response rate >60% to reflect the perceptions of individual caregivers. Units where caregivers have positive, concordant perceptions of psychological safety, teamwork, and leadership provide safer care environments. When scores are disparate and perceptions are different, that is a strong indicator of a dysfunctional culture. Leaders must look at the data, debrief in an open and safe manner, and translate these into appropriate actionable items. For example, units that have outstanding performance should be analyzed to see what can be learned and spread to other clinical areas. Partnering some of the highest performing units with the lower ones is a great way to enhance learning and improve culture. ⁸ The use of objective accountability evaluation and assessment tools can also be helpful in determining what happened and whether actions taken were blameless or blameworthy. ⁷

Simply stating that an organization supports a reporting culture is not enough. A reporting culture requires robust reporting systems with mechanisms that provide the workforce with timely feedback about what went wrong and why it went wrong. ¹¹ Staff may be unconvinced of the value of event reporting if there is no feedback about how the reports are used. ¹⁹ It is equally important for leaders to clearly define what incidents should be reported, as some may not be as obvious. For example, workarounds and daily annoyances should be reported as these can create unsafe environments. ⁷ While many organizations have begun to acknowledge staff members who report errors or recognize unsafe conditions, many still do not act on staff reports, fostering conditions that may result in harm. ⁷

Conclusion

Developing a reporting culture within an organization does not happen overnight. Two important concepts must first be established before any reporting culture can be developed: psychological safety and a culture of safety. Leaders must take actionable initiatives, engage staff in the dialogue, and consistently provide systematic feedback when issues are resolved. By building trust and encouraging reporting, leaders empower its people, an organization’s most valuable resource. ⁷