Patient safety is a worldwide priority aimed at preventing medical errors before they cause death, harm, or injury. Medical errors impact 1 in 10 patients worldwide,1 and their implications may include death, permanent or temporary harm, financial loss, and psychosocial harm to the patient and in some cases to the caregiver. The purposes of this article are to (1) provide an overview of medical errors, (2) discuss factors leading to medical errors and, (3) discuss evidence-based strategies aimed at improving patient safety in the neonatal intensive care unit (NICU). In particular, improving the team process is a pivotal focus in this review as well as practice and research implications related to patient safety.
SCOPE OF THE PROBLEM
Medication errors occur more frequently in premature neonates especially those born less than 30 weeks gestation and weighing less than 1500 gm. These infants are at great risk because of their severity of illness and the need for more medical support including pharmacologic measures, cardiovascular monitoring, and support and nutritional measures. Recent reports show that 57% of medical errors occur in 24 to 27 weeks gestation infants compared with only 3% in hospitalized full-term newborns.2 Adverse drug events occur at a rate of 13 to 91 events/100 neonatal intensive care admissions.2,3 Using the trigger method or an "occurrence" to prompt a focused chart review, high rates of medical errors are often revealed in hospitalized adults and children. A review of 749 randomly selected charts from 15 NICUs (14 in the United States and 1 in Canada) showed that adverse events (AE) (Table 1 for definitions) occur at a rate of 74 events per every 100 patients (0-11 AE/patient).4,5 Of the reported events, 10% resulted in death, 23% resulted in permanent harm, 40% resulted in temporary harm, and 7% required life-saving interventions. Overall, the report stated that 56% of the events could have been prevented.4 Reports of AE in the NICU include, but are not limited to, nosocomial infection (28%), intravenous catheter infiltrates (16%), accidental extubations (8%), and intracranial hemorrhage and ischemia (10.5%). Misidentification errors are also common in the NICU. For example, 11% of all errors submitted to the Vermont Oxford Network (VON) are classified as misidentification errors. One study showed that only 9% of NICU patients wear identification bands as specified by the Joint Commission (formerly Joint Commission on Accreditation of Healthcare Organization: JCAHO) unit policy.6 This policy infraction has implications for diagnostic, medication, treatment, and documentation errors. Other countries such as Switzerland, England, the Netherlands, Canada, and Australia report similar error rates.3
BACKGROUND AND SIGNIFICANCE
In 1999, the Institute of Medicine (IOM) released its landmark report, To Err is Human: Building a Safer Health System, which stated that up to 98 000 deaths/year are attributable to medical errors with an estimated cost of $17 to $29 billion. In addition to its call on healthcare professionals to adopt evidence-based strategies to improve teamwork and communication, the report heightened the awareness of the public, as well as policy makers, to patient safety issues. Although it diminished consumer confidence in the healthcare industry, the IOM report called for Congress to investigate medical errors and improve patient safety.7 During the last decade and since the release of the IOM report, patient safety has become the focus of several professional organizations and regulatory and accrediting agencies, as evidenced by the release of several patient safety initiatives, statements, goals, and campaigns. The Joint Commission National Safety Goals, the Institute of Health Improvement 100 k lives Campaign, and the Safety and Quality Improvement Act of 2005 are among those initiatives. In 2001, the IOM released another report Crossing the Quality Chasm: A New Health System for the 21st Century that highlighted 6 safety and quality aims for the 21st Century.8 According to the report, healthcare providers should offer effective, evidenced-based, patient centered, timely, efficient, and equitable care and patients should not be harmed by the care that they receive.8 A third report by the IOM in 2003 Keeping Patients Safe: Transforming the Work Environment of Nurses, called on nurses to create a culture of safety and to construct safe workplace environments. Fatigue and quality of staffing were highlighted as factors affecting patient safety.9 This priority for nursing is congruent with the Nurses' Code of Ethics that holds nurses accountable for participating in the creation of work environments that are conducive to safe and quality care.
FACTORS LEADING TO MEDICAL ERRORS AND REASON'S "SWISS CHEESE" MODEL
Reliable work processes and constant vigilance by healthcare professionals are crucial for safe provision of care in any NICU. Despite best efforts, an error can still occur and error prevention requires more than just good intentions. Medical errors in the workplace leading to adverse events in the NICU are rarely intentional or the result of one single factor. System structure and processes that are not well designed and that do not take into account human factors and workplace hazards are prone to fail and therefore, leave people vulnerable to committing errors. Multiple factors at several levels including point of care, organization, patient, individual, or team levels exist in patient care and management. Because of the interconnectedness of these factors, failure at one level of the system may affect reliability and performance at other levels.10 Factors at the point of care may include equipment and medical device poor design or malfunction. At the organization level, inadequate staffing, look alike and sound alike drug names, inadequate information sharing, cost-cutting measures, poor climate and environmental design, and management practices contribute to medical error.
The unique aspects and the complexity of the NICU environment, in addition to the vulnerability of the neonatal population increase the risk for medical errors. Medication errors pose a significant risk to the neonatal patient for a number of reasons. Fragile neonates have limited capacity in buffering the unintended consequences of their medical treatment and therefore can be easily harmed. Prolonged lengths of hospital stay (ie, sicker and more complicated patients) means longer exposure to potential harm. The neonate's rapidly changing body size and the use of off-label medications pose challenges to healthcare professionals on a daily basis. In addition, the neonate's inability to communicate what he or she is experiencing adds to the risk of suffering from a severe adverse effect of a drug that has been administered. Finally, premature and underdeveloped body systems of the neonate who is admitted to the NICU interfere with drug absorption, distribution, metabolism, and excretion, making the risk of being exposed to toxic drug levels exponential compared to an adult patient.11 Results from 20 community hospitals participating in the Healthcare Utilization Project (HCUP) of the Agency for Healthcare Research and Quality (AHRQ) showed that risk for medical error is higher with longer length of stay, emergency type admissions, and for publically insured pediatric patients.12
Human factors at an individual level include fatigue, burnout, lack of expertise and false sense of security with technology, complacency, and lack of cultural competence. Human factors at the team level are related to team performance and to lack of effective leadership and team focus, failure to share information and provide task assistance and breakdown in communication, which is believed to be the most significant barrier to patient safety. According to the Joint Commission, 70% to 80% of medical errors are due to dysfunctional interactions.13 Cultural and sex differences may exacerbate communication problems and lead to a greater potential for breakdowns in communication. Certain behaviors that are displayed by individuals and by groups lead to communication breakdown, compromise the team process, and therefore weaken the system defenses against medical errors. Such behaviors include "excessive professional courtesy" (when team members are reluctant to challenge someone of higher status), "hidden agendas", "halo effect", and "passenger syndrome" ("just along for the ride"), and "task fixation" or failure to see the big picture.14 In a large study of healthcare providers, 7% of study participants reported making a medication error in the last year with intimidation by a coworker being the contributing factor.15
To sum it up, work environments are complex and so is how and why medical errors occur. Reason's Swiss Cheese Model (Figure 1) is the most widely used model to explain system failure and to analyze medical errors.16 Every system has hazards that are inherent in its structure. Every system also has defenses or barriers that prevent harm from a hazard reaching the patient. Hazards are conditions or events that are not related to the patient's course of illness and have the potential to cause harm if there is a failure in the system defenses. System defenses or barriers, like Swiss cheese slices, have holes in them and if due to some random event those holes align, they form an open path for harm from a workplace hazard or a medical error to reach the patient. Medical errors or unsafe acts can be seen as holes in the system defenses. Humans are fallible and medical errors are inevitable. However by adding layers of defense and by plugging the holes and preventing them from aligning to form a path, harm can be stopped from reaching the patient.
STRATEGIES TO IMPROVE PATIENT SAFETY
Patient safety is a comprehensive approach that uses human factors science to improve system processes and structure and to ensure patient safety. Several strategies have been developed and adopted by healthcare organizations to strengthen barriers to medical error and to eliminate workplace hazards. Table 2 for a list of such strategies.17-29 Among those strategies, Electronic Medication Ordering or Computerized Provider Order Entry and Safety Medication Systems (Bar Coding) have made the most significant impact on reducing the rate of AE. It is believed that 93% of adverse drug events are prevented due to the implementation of Computerized Provider Order Entry. For example, barcode medication administration has led to a 47% reduction in the rate of preventable adverse drug events.20
Technology alone cannot rectify all of the problems leading to medical errors. Error management that includes reporting, monitoring, tracking, and prevention is the cornerstone for building safe patient environments. Error reporting and tracking is an effective strategy in identifying trends and patterns of harmful events and "near misses." In addition to providing information on how effective certain strategies are in improving patient safety, error reporting creates opportunities for the staff and administration to learn from mistakes and to improve existing practices or create new strategies for decreasing the probability of harm. Several systems for error reporting exist (Table 2). Voluntary reporting whether external or internal generates most of the existing information on factors leading to error. Anonymous and specialty-based external reporting systems such as the Neonatal Intensive Care Quality (NICQ) Collaborative sponsored by the Vermont Oxford Network (web-based) provides opportunities for incident monitoring and generates a significant amount of important information on trends and contributing factors. Internal reporting systems increase awareness and create learning opportunities within the healthcare organization. Some states require healthcare organizations to have patient safety plans in place and report serious events and incidents to state safety authorities. The majority of states prohibit punitive actions against healthcare workers reporting such events. Despite the availability of multiple reporting systems, existing data show that the majority of incidents or events are not reported and patient safety remains of great concern. Barriers to error reporting include cost, access to databases and lack of standardized terminology, and fear of punitive actions. Building work cultures that support information sharing, encourage and promote transparency, and acknowledge human fallibility requires commitment, trust, and resources.
A common understanding on how and why medical errors occur is needed. Safety interventions should not be perceived as additional work or external mandates. Instead, individuals must feel empowered to identify hazards in the work place and to implement strategies that would eliminate or minimize those hazards. This can be best achieved by building high performance teams and maximizing the team process.14,31-33
TEAMWORK, LEADERSHIP, WORK CULTURE AND PATIENT SAFETY
Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) is an evidence-based program developed by the Department of Defense (DoD) in collaboration with the Agency of Health Research and Quality (AHRQ) to improve patient safety and build high efficiency reliable teams. Implementation of this program has gained some momentum in the past few years, is built on over 3 decades of research in the military and offers a comprehensive approach to effective teamwork.14,33 The TeamSTEPPS program is based on both the "Just Culture Model" and the Crew Resources Management (CRM) concepts. Just Culture encourages everyone who is involved in patient care to voice his or her safety concerns regardless of his or her position or status. The CRM has been used in the aviation industry for more than 2 decades. The aim is to improve teamwork knowledge, skills, and attitudes of the crew; and to promote effective use of resources through the use of checklists, structured briefs or team events, advocacy and assertion. Even though the use of CRM in the healthcare industry is still in its infancy, promising results in improving patient safety has been reported.14 TeamSTEPPs emphasizes 4 core competencies with tools and scripts specific to each competency that are essential for reliable and high level team performance. The competencies are leadership, situation awareness (mutual performance monitoring), mutual support (back-up behavior), and communication (Table 3). A paradigm shift from individual focus to team focus is believed to occur with TeamSTEPPS training. The outcomes include focus on team competencies, information sharing, and task assistance.14 Various teams exist in a healthcare organization with different professional backgrounds, responsibilities, and clinical focus. Patient safety requires that teams and individuals within an organization be committed to coordination, collaboration, mutual accountability, acknowledgment, recognition, mutual respect, and partnership with the patient and the family. Partnering with the NICU family is crucial for patient safety. The family needs to be asked about their desire to be involved in their infant's care, and their preferences must be respected. Families need to have access to relevant information about their infants, and their feedback should be solicited. Leaving the family out may leave out valuable information that is crucial for providing safe care.34
PRACTICE RECOMMENDATIONS
Work culture is the sum of individual values, behaviors, and beliefs that are constantly displayed by the team. Communication and behavior patterns exhibited by healthcare teams determine the workplace culture. One of the initial steps toward building a culture of patient safety is to create a vision that strives to achieve the highest level of team competence. Buying into such a vision, implementing it, and sustaining the changes can be challenging and requires resources and organizational commitment. However, physicians and nurses have the obligation to provide the highest level of care possible, do no harm, and maximize patient benefits. By adopting the strategies that are shown in Table 4, physicians and nurses can take the initiative to improve teamwork and ensure patient safety.
RESEARCH IMPLICATIONS
Even though during the last decade technological advances and evidence-based practices have made positive impact on patient safety, the goal to build a safer healthcare system has yet to be realized. The AHRQ's 2010 National Quality Report showed improvement in patient safety over the last 6 years, however, gaps in how medical errors, handoffs and patient care transitions are managed exist.35 A great need remains in understanding what contributes to such gaps and what the best strategies are to remove the barriers to safe care. There is also the need to translate science and existing evidence into practice. Future research needs to focus on implementing and evaluating new evidence-based interventions and practices that promote patient safety and this includes improving workload under severe nursing shortage, designing valid and reliable measures of safety and quality and sustaining improvements in culture change and teamwork. Finally, the need for comparative effectiveness research with cost-benefit analysis of safety practices and programs is critical.
CONCLUSION
The influence of work culture on patient safety cannot be underestimated. Many elements that constitute what we call work culture directly affect how healthcare professionals perform their jobs and how patient safety is perceived and achieved. Beliefs, norms, and attitudes exhibited by healthcare professionals are expressed through the way in which team members interact with one another and perform patient care. Therefore, creating a culture of safety through evidenced-based team training and enabling healthcare professionals to discuss, analyze, and report medical errors and "near misses" is a major step in the right direction. Working together to improve care for infants and their families must be a priority not just a slogan!
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