CHAPTER 18

Patient Safety

Joan Renaud Smith; Ann Donze

Patient safety has become a national priority, and improvement in patient safety has accelerated since an Institute of Medicine (IOM) report concluded that up to 98,000 lives are lost annually in U.S. hospitals as a result of error (Kohn et al., 1999). Many of these errors are preventable and have resulted in both death and an economic consequence as high as $29 billion annually (Kohn et al., 1999). Yet, more than a decade later, measurable improvement and sustainability are lacking, resulting in continued harm that remains common in today’s complex health care system (Landrigan et al., 2010). Medically fragile infants are at high risk for encountering errors during their stay in the neonatal intensive care unit (NICU) and are defenseless compared with physiologically more mature newborns, leaving little margin for error. Infants receiving care in the NICU have been shown to experience wide variation in clinical care and outcomes (Profit et al., 2012). It is the responsibility of health care organizations and neonatal care providers to provide the best clinical care and ensure the safety of these vulnerable infants. While some errors occur at the point of service (e.g., a nurse administering the wrong medication), most errors occur as a result of flaws within the health care system or facility design (e.g., excessive noise levels or miscommunication) (Joseph and The Center for Health Design, 2006). Identifying and eliminating sources of patient harm are critical in delivering safe patient care. Mitigating harm is achieved by a line management approach, which means that everyone in the organization is responsible for the safety of the patient. To keep patients safe, all risk of hazards must be identified proactively by use of local resources, such as incident reports and near-miss reports, and external sources, such as Joint Commission Sentinel Events, networks such as the Vermont Oxford Network, and the literature. Once hazards are identified, it is important for the institution to commit resources to eliminate them (Handyside and Suresh, 2010).

Using evidence-based clinical practice interventions and strict adherence to protocols every time care is delivered, errors can be substantially reduced (Bizzarro et al., 2010). It is now possible to eliminate or nearly eliminate adverse events, and neonatal nurses are on the forefront of providing safe and efficient quality care. As neonatal nurses recognize and understand the causes of errors and rely on strict adherence to evidence-based interventions and improvement strategies, dramatic reductions of errors are possible. The knowledge and skills associated with safety must become routine nursing practice. Improving patient safety requires assimilation of knowledge from other disciplines and industries, and application of safety knowledge to health care. Since 2002, National Patient Safety Goals have been formulated by the Joint Commission to improve patient safety. These goals are drawn from recommendations by the Sentinel Event Advisory Group to spotlight problems in health care and focus on how to solve them. All Joint Commission–accredited health care organizations are surveyed for implementation of the goals (Table 18-1).

This chapter offers an introduction to basic patient safety principles and includes selected improvement strategies and resources for neonatal nurses to build a patient safety toolkit. Selected neonatal errors and improvement strategies are included and are by no means an exhaustive list. Box 18-1 includes definitions of selected improvement strategies. Neonatal nurses need to equip themselves with the best possible safety resources and knowledge in order to provide a safe and caring environment.

A. Organizational and Individual Approaches to Developing and Sustaining a Culture of Safety.

1. Establish patient safety as a strategic priority (Botwinick et al., 2006). The Joint Commission (2011) holds senior leaders accountable for routinely assessing the culture of safety within their organization. Each organization should have a Patient Safety Officer (PSO) who is a senior leader and should report directly to the organization’s top executive (e.g., Chief Executive Officer [CEO], Chief Operating Officer [COO], Chief Medical Officer [CMO], etc.). The Board of Directors should be actively involved in patient safety reports and routinely track patient safety goals and areas needed for improvement. For safety to be seen as a priority for all staff members, senior leaders need to make safety a key focus for the organization. Senior leaders and frontline staff need to discuss adverse events and near misses and develop strategic plans for future safety.

a. Selected strategies for incorporating a safe culture within the organization. (See Box 18-1 for selected definition of strategy terms.)

■ Executive walk rounds (used for the sole purpose of discussing safety with frontline staff).

It is important that leaders recognize that methods of improvement should be clearly outlined and a planned process should be in place to accelerate improvement in practice (Botwinick et al., 2006). Promoting a safe culture can begin by integrating multidisciplinary patient safety teams into preexisting committees at both the departmental and unit levels to implement safety initiatives at the bedside. NICU safety teams may include frontline professional and support staff, medical and nursing leadership, advanced practice nurses (APNs), pharmacy, and respiratory therapy. These interdisciplinary teams are responsible for identifying and responding to unit-specific safety concerns and risks, ensuring that safety efforts are integrated into the overall unit structure, and educating staff and faculty about the science of safety. One program designed to promote safety teams is the TeamSTEPPS program (Team Strategies and Tools to Enhance Performance and Patient Safety) (Samra et al, 2011).

2. Establish a culture that supports safety (Botwinick et al., 2006). It is the responsibility of individual health care organizations to assess their current state of patient safety. Fostering a culture of safety involves understanding and anticipating human limitations, anticipating the unexpected, and creating a nonpunitive learning environment for improvement and error reduction. Traditionally, health care organizations responded to errors by naming and blaming individuals, known as a person-centered approach. This approach is focused on the individual and does not help to prevent future errors. An organization that seeks to blame and punish and lacks teamwork, communication, and transparency of errors is a culture that places patients in harm’s way. A systems approach recognizes that the system is complex and that most errors reflect predictable human failings in the context of poorly designed systems. A shared accountability among health care organizations and individual practitioners is promoted in a just culture. A just culture recognizes that individuals should not be held responsible for system failures and that competent professionals make mistakes and may even adopt unhealthy shortcuts in their practice, but has a zero tolerance for their reckless behavior (Marx, 2001). It also provides a safe environment in which errors may be reported without fear of retribution in events in which there was no harm intended. In a just culture, individuals are encouraged to report errors that result in harm to patients as well as near misses, resulting in an environment in which to learn. Staff must experience a just culture in order to sustain self-disclosure of adverse events. Although a just culture seeks potential system failures and does not seek to blame individuals, it does include a well-established system of shared accountability.

3. Engage key stakeholders. Senior leaders need to engage key stakeholders in establishing a safe culture.

a. Nurses. Neonatal nurses, APNs, and clinicians are highly educated, organized, skilled, and experienced and are typically the first line of defense in keeping patients safe. Frontline staff can identify firsthand the issues affecting patient safety and are the primary source of care. Their inclusion in the process is essential to the success of implementing patient safety factors.

d. Board of trustees (Botwinick et al., 2006). The Board plays a crucial role in moving the organization toward a higher level of patient safety and effectiveness. Board members may establish goals for organization improvements, integrate patient safety goals into the organization’s strategic goals and business plans, review adverse reports and root cause analyses, and provide monetary resources for patient safety education and staffing.

e. Patients and families. Patient-centered care is pivotal in the prevention of medical errors. Families are at the core of delivering patient-centered care in the NICU, and family-centered care (FCC) is vital to promoting patient safety. Families should be invited to collaborate with the health care team as partners. Improving quality and safety by bringing families into the planning, delivery, and evaluation of health care is the foundation of FCC (Institute for Family-Centered Care, 2008). The American Academy of Pediatrics’ (AAP’s) policy statement, Patient- and Family-Centered Care and the Pediatrician’s Role (2003, reaffirmed in 2007 and 2012), provides a summary of the core principles of FCC and includes specific recommendations for how pediatricians can integrate FCC in hospitals, clinics, and their community. Studies have shown that, when health care providers and administrators partner with patients and families, the quality and safety of health care rise, the costs decrease, and provider and patient satisfaction increase (Institute for Family-Centered Care, 2008). The core concepts of FCC as outlined by the Institute for Family-Centered Care (2008) include the following:

(1) Dignity and respect: Health care professionals need to listen, honor, value, and respect families as partners in the daily planning and delivery of care.

(4) Collaboration: Families, practitioners, and organizational leaders should collaborate in policy and program development, implementation, and evaluation; facility design; professional education; and delivery of care.
Establishing a family-centered environment and empowering families to promote patient safety and quality takes a long-term commitment. This approach requires a transformation of the health care organization, including infusing FCC principles into the organization’s mission statement and philosophy. Health care organizations can promote FCC by inviting families to participate in hospital and unit committees; setting up patient and family advisory councils; creating an environment that is welcoming and inviting to families and provides privacy, comfort, and the ability to access information; including families in education and training programs as well as research; and developing human resources policies to promote a family-friendly environment. Specific steps to assist health care organizations in developing an FCC environment are available (Institute for Family-Centered Care, 2008).
Both the AAP (AAP and Committee on Hospital Care and Institute for Patient- and Family-centered Care, 2012) and the Vermont Oxford Network’s (VON) Neonatal Intensive Care Quality Improvement Collaborative (NIC/Q) (Dunn et al., 2006; VON, 2013) provide recommendations supporting the integration of families into high-quality patient care delivery. Families are encouraged to report concerns and to be actively involved in their infant’s care as part of a patient safety strategy. National initiatives outlining strategies to encourage family participation in error prevention are available. Some of these initiatives include the Joint Commission’s “Speak Up” initiatives (2013a), the National Patient Safety Foundation’s “National Agenda for Action” (2013), and the Agency for Healthcare Research and Quality’s “20 Tips” (2013).

4. Teamwork and communication. According to the IOM, health care providers tend to be trained as individuals even though they function almost exclusively as teams, and patient safety programs that promote team training and functioning need to be adopted (Kohn et al., 1999). Neonatal care has become increasingly complex, requiring teamwork and collaboration among multiple disciplines in order to achieve a common goal: to improve patient outcomes (Smith and Cole, 2009). Communication and teamwork are vital to creating and sustaining a culture of safety. More than two thirds of sentinel events reported to the Joint Commission were primarily caused by failures in communication (Joint Commission, 2013c). Communication among team members must flow freely regardless of their authority gradient. Patient care decision making should be shared among all members of the health care team. Mutual respect, trust, confidentiality, responsiveness, empathy, effective listening, and communication among all clinical team members are necessary for promoting shared decision making (Roberts and Perryman, 2007). Organizations need to adopt a zero-tolerance policy for abusive behaviors among all members of the health care team.

a. Simulation and debriefing. “Simulation refers to the recreation of an actual event that has previously occurred or could potentially occur” (Hunt et al., 2007, p. 306). Simulation and debriefing have been used in the Neonatal Resuscitation Program since its inception in 1987, but their use in the NICU has expanded to include many technical and interpersonal skills (Pilcher et al., 2012). The IOM suggests the use of simulation exercises focused on improving teamwork and communication as an important mechanism to improve patient safety (Kohn et al., 1999). Debriefing after a team simulation experience allows recognition of areas of appropriate performance and lessons learned as to where and how the errors could potentially be prevented. Simulation in conjunction with debriefing is necessary so errors can be identified and team members are made aware of their role in the error. Simulation can provide a replication of the neonatal environment, equipped with the technology and the models of equipment that will be encountered in the NICU as well as complex scenarios that require successful team interactions. Procedural and technical skills can also be simulated, allowing for teamwork and competency checks. Leadership skills during emergent situations can also be enhanced through the use of role simulation by improving communication skills as they relate to discussions about the futility of medical care, end-of-life decision making, and the chronicity of medical care. Rapid response teams, transport teams, and trauma teams are all high-functioning teams that rely on effective communication and have benefited from the use of simulation.
Incorporating simulation and debriefing methods into Neonatal Resuscitation Program training can promote effective communication and teamwork and potentially reduce the rate of errors (Thomas et al., 2007). There is now good evidence that simulation and debriefing improves self-confidence, knowledge, and operational performance in simulated settings. Emerging evidence supports that simulation and debriefing can improve performance in clinical settings and can result in safer patient outcomes (Griswold et al., 2012).

b. Effective methods of teamwork and communication.

(1) Crew resource management (CRM). CRM is a communication methodology used to promote team-centered decision making; it was developed by the aerospace industry to promote effective communication and teamwork (Sundar et al., 2007). CRM teaches team communication and highlights errors in a simulated setting in the hope of avoiding the same error in a real-life setting involving humans. It teaches that all members of a team are vital and that, if a team member at any level believes that something is not being done appropriately or in the best interest of the team or other people who have put their trust in the team, then that member must speak up (Hunt et al., 2007). Recent evidence shows CRM has the potential to positively impact the health care culture by producing safer patient care environments (Ricci and Brumsted, 2012).

(2) SBAR (situation, background, assessment, and recommendation) (Haig et al., 2006). SBAR is a method to improve hand-offs. The NICU is often chaotic and hurried, so critical information can fall through the cracks at hand-offs, and communication can be misunderstood. For example, a potential for error can occur when a verbal order for medication is written down by someone other than the order giver and transcribed onto an order form by a third person. Used extensively in medicine, and originating from the nuclear submarine service, SBAR is a communication tool to standardize discussion and information sharing among caregivers to ensure that patient information is consistently and accurately being delivered, especially during critical events, shift hand-offs, and patient transfers. As part of the National Patient Safety Goals, the Joint Commission (2013b) requires organizations to implement a standardized approach to hand-off communications. SBAR provides a shared mental model for all clinicians to use during hand-offs or transfers (Institute for Healthcare Improvement, 2011):

Situation: What is happening at the present time?

5. Human factor engineering and the environment. Human factor engineering (HFE) is a science that studies the interactions between workers and their work system to determine if the workplace design meets the needs of the people working in it. Since 2002, human factors design has been promoted in NICUs through the VON’s collaborative project to improve the quality and safety of neonatal care. A Human Factors Checklist Series was developed to allow NICUs to educate users on HFE principles and assess whether their units are optimally designed and to identify opportunities for improvement. The Checklist includes workplace topics such as staff alertness and fatigue, unit design and space, physical ergonomics, clinical alarms and warnings, labels and displays, procedures, devices, paper forms, and team performance (Handyside and Suresh, 2010). When units are well-designed using the science of HFE, the workplace facilitates efficient, accurate, and error-free performance by the health care team.

a. Fatigue and shift work. The IOM report Keeping Patients Safe: Transforming the Work Environment of Nurses identifies that research findings on overtime practices indicate that long work hours, without adequate and quality rest time, are associated with impaired performance and human errors (IOM and Committee on the Work Environment for Nurses and Patient Safety, 2004). The effects of fatigue as a result of long work hours, working at night, and insufficient sleep are often underestimated. Fatigue has been linked with slowed reaction time, lapses of attention, errors of omission, decreased ability to problem-solve, and reduced motivation and energy (American Nurses Association, 2013).
Studies linking fatigue with medical errors have been reported for pediatric critical care nurses and residents (Montgomery, 2007). Nurses who have good sleep habits, minimize their shift rotations and excessive work hours, and use strategic naps can reduce the adverse effects of fatigue that could potentially put patients at risk. Other strategies to reduce fatigue include rest breaks, exercise, and bright lights (Rogers, 2008). Although limited research has been conducted in the area of fatigue, specifically related to neonatal nurses and neonatal nurse practitioners, the National Association of Neonatal Nurses, separately (2011) and in conjunction with the National Association of Neonatal Nurse Practitioners (2012), has developed position statements recommending that all health care employers implement guidelines to minimize staff fatigue. These recommendations encourage close collaboration between staff and their employers in order to develop and implement risk reduction strategies to reduce the risk of fatigue-related incidents.

b. NICU environment. Human factors that have contributed to errors include fatigue, communication failure, poor hand-offs, problems with cross-coverage, workload, and staffing patterns. Addressing these factors can aid in reducing medical errors. The NICU environment is a complex adaptive system conducive to human error. Frequently, the NICU is chaotic and prone to many unanticipated interruptions and life-threatening events, leaving care providers with very little time to make thoughtful and sound decisions. Patients in the NICU often require complex multidisciplinary care; each layer of this complex system presents additional opportunities for error (Morriss, 2008).

(1) The physical environment (Braithwaite, 2008; Joseph and The Center for Health Design, 2006; White, 2005). The NICU directly affects not only the highly vulnerable and sensitive preterm infant but also the caregiver within the environment. Overcrowded and poorly designed workspaces and work flow areas, excessive noise, inadequate lighting, poor ventilation and air flow filtration systems, and insufficient family space can all affect patient and staff health and safety. Inadequate lighting, excessive noise, and a disorganized environment are likely to compound the burden of stress for nurses and lead to errors. Providing caregivers with a physical environment that lowers stress and improves job performance, safety, and satisfaction is the key for health care organizations. Lighting and sound levels often conflict for the neonate and caregiver. While dim lighting is appropriate for nighttime circadian cycles for the infant, dim lighting is difficult for night staff to provide direct physical care as well as to maintain a level of alertness and comfort. Providing night-shift workers with task lighting or short periods of bright-light exposure levels can improve mood, sleep, and levels of alertness. Many NICUs are designing or redesigning their units; efforts should focus on the individual needs of babies, families, and caregivers. Human engineers should be included in the design process to promote a safe environment.

(2) Social environment. The NICU is a complex, demanding environment and NICU nurses can experience high levels of stress resulting in burnout. Job satisfaction, emotional support, and self-care are important components for preventing burnout in staff (Braithwaite, 2008). Autonomy, supervisor and peer support, and inclusion of families and patients in the care process have been cited as aspects of the social environment that can contribute to staff satisfaction and decreased levels of burnout (Joseph and The Center for Health Design, 2006).

c. Aging workforce. Nurses are aging and their work is becoming more complex with changing technology, evolving work practices, and increasing documentation requirements. There is a need to redesign workplaces using ergonomic work principles in order to reduce the physical demands on nurses (Joseph and The Center for Health Design, 2006). Although the 2008 U.S. Department of Health and Human Services survey found that the share of registered nurses (RNs) less than 40 years of age grew for the first time since 1980, the mean age of a registered nurse in the United States is still 47 years. Ergonomic evaluation of the work area specific to the NICU may provide solutions to problems encountered by neonatal care providers. For instance, an ergonomic evaluation of the work area at an infant’s bedside to reduce a care provider’s neck and back problems may include a height-adjustable footstool and better monitor placement as potential solutions. More ergonomics research is needed in the area of computer workstations as they affect nurses’ posture, readability, and level of fatigue (Joseph and The Center for Health Design, 2006).

d. Staffing (Kane et al., 2007). Increases in staff workload and age, coupled with a decrease in the number of RNs, can threaten patient safety. Nurses are vital in providing patients with high-quality and safe care. Researchers have examined the impact of nurse staffing levels and incidence of bloodstream infections and have found greater nurse-hours per patient day significantly reduce the incidence of infection in the NICU (Cimiotti et al., 2006; Leistner et al., 2013). In a meta-analysis of 94 observational studies, greater numbers of nursing staff members were associated with better patient outcomes in intensive care units and in surgical patients, but this association did not show a causal relationship and the majority of participating centers cared for adults (Kane et al., 2007). Staffing levels vary greatly across facilities, and methods for promoting safer staffing are needed. Skill mix and acuity are two additional factors that contribute to nurse staffing and its relationship to patient outcomes. A validated neonatal acuity tool is needed to determine appropriate nurse–patient ratios, followed by a large neonatal multicenter rigorous trial to conclude whether a relationship exists between increased nurse staffing (including skill mix and acuity) and improved patient outcomes.

6. Health information technology (Congressional Budget Office, 2008; Shekelle et al., 2006). In its 2001 report, Crossing the Quality Chasm, the IOM identified health information technology (HIT) as one of the most significant interventions to improve health care quality in the United States. Many national agencies support the use of HIT because of its promising improvement in the efficiency, cost-effectiveness, quality, and safety of medical care and delivery in the nation’s health care system. Despite these recommendations, the majority of health care organizations have been slow to adopt HIT. Information technology strategies have proven effective in reducing human errors in industries such as aviation and banking. Technology eliminates duplicate work and illegible handwriting. HIT may improve care providers’ decision making with integrating relevant automated decision-making and knowledge acquisition tools along with evidence-based clinical practice guidelines. Communication among caregivers, accessibility and availability of patient information, medication prescribing and use, and adherence to clinical practice guidelines can all be improved through the use of HIT. Some of the technologies that improve medication delivery and provide decision support for medication therapy include computerized provider order entry, bar coding, handheld computers, and a first generation of smart pumps and automated dispensing machines.
Limited evidence exists to support the use of HIT in the NICU and its effectiveness in reducing errors. Technology alone does not eliminate medication errors, and there are also concerns about the potential introduction of new errors or unintended consequences (Cochran et al., 2007). The cost of implementing HIT is a significant barrier for many health care organizations. Besides cost, there is also an element of human interface between good technology and user-friendly equipment. Health care professionals who adopt workaround strategies to override an inflexible system in order to achieve the desired task defeat the software-designed safeguards. Although HIT has grown exponentially, it may contribute to system complexity and additional opportunities for errors. Further research is needed to evaluate the efficacy of HIT and its impact on neonatal patient safety outcomes.

a. Clinical Decision Support System (CDSS). Clinical decision making has become extremely complex, requiring health care providers to use their knowledge and experience combined with rapidly emerging clinical diagnostic techniques, treatment regimens, drug therapies, and clinical practice guidelines. CDSS is an information system that can assist health care providers in making clinical decisions by providing standardized, evidence-based practice (EBP) resources to the bedside caregiver (Mack et al., 2009; Neonatology on the Web, 2010). Human errors increase when care providers rely on memory to complete a task. According to the IOM (2007), the growing amount of information required to make sound clinical and reliable decisions is surpassing unassisted human capacity, and CDSS offers a practical solution as an EBP resource.

b. Computerized Provider Order Entry (CPOE). CPOE is an electronic application for writing orders that provides clinical guidance during the ordering process and intercepts potential errors at the point of order origination. Implementation of a CPOE system is one of the 30 safe practices identified by the National Quality Forum (2009) to facilitate transfer of clear communication. The majority of CPOE systems interface with CDSS, which provides much of the value of implementing CPOE. The CDSS component provides clinical guidance such as notifying clinicians of inappropriate dosages through dose range checking, drug allergies, and the potential for adverse effects based on other known aspects of an infant’s condition, such as concurrent medications or renal impairment. CDSS can also notify clinicians of high-cost laboratory tests and suggest alternatives, alert them that a redundant diagnostic test was performed recently, or bundle groups of orders based on best practice guidelines and evidence-based order sets (Palma et al., 2011). Both CPOE and CDSS promote safety by improving legibility; reducing or eliminating transcription errors; using standard names, catalogs, and dictionaries; automating calculations; providing alerts and reminders; monitoring for adherence to best practice; and screening for populations at risk (Lehmann and Kim, 2006). CPOE is one of the most frequently used systems for reducing error and managing patient care more safely. Many national organizational bodies recommend CPOE as a strategy to reduce medication errors; however, there is limited pediatric and neonatal-specific evidence with adequate power to support its ability to reduce errors and prevent adverse drug events (ADEs) in the NICU (Miller et al., 2007; Morriss, 2008; Walsh et al., 2008).
There are barriers in adopting CPOE within an organization. Barriers include cost for start-up and maintenance, changes to work flow process and design affecting all health care personnel and departments throughout the organization, and the challenge of implementing a system that is reliable and user-friendly. The majority of CPOE systems are designed for adult patients and require alteration in order to address the special needs of the NICU population. Many medications prescribed in the NICU are off-label or unlicensed (Kimland and Odlind, 2012), making it difficult to determine a CPOE standard based on best evidence. Although CPOE may decrease the frequency of ADEs, evidence suggests that computerized systems cannot prevent all errors or ADEs and may, in some cases, be responsible for new types of errors, such as juxtaposition errors, in which the clinician inadvertently chooses the incorrect patient or medication name from a drop-down menu (Abramson and Kaushal, 2012; Chuo and Hicks, 2008; Metzger et al., 2010; Palma et al., 2011). An evidence-based methodology for evaluating CPOE systems implemented and operating in hospitals does exist (Kilbridge et al., 2006). More research is needed to evaluate the efficacy of implementing CPOE in the NICU.

c. Smart infusion pumps. Medication errors related to intravenous (IV) infusion present the greatest potential for harm. Neonatal nurses program infusion pumps routinely in order to deliver parenteral fluids and high-risk medications such as dopamine, morphine, fentanyl, and insulin. Smart infusion pumps decrease the chance of error by using a drug formulary that is individualized for a particular patient population. Medications, advisories, usual concentrations, dosing units (e.g., mcg/kg/min, units/hr), and dosing limits are specific to that population. Smart pumps have both soft and hard alerts or stops. Soft alerts can be overridden based on unit guidelines; hard alerts are programmed in and cannot be changed without reprogramming the pump. Smart pumps can also collect and store data for many variables, such as alerts, medications given, and overrides (Lemoine and Hurst, 2012). Both continuous and bolus infusions can be programmed with the expanded drug dose calculator. The formularies or libraries are designed and managed by the hospital pharmacy department but require interdisciplinary collaboration to ensure safe and appropriate parameters are programmed.
IV pumps rely heavily on human factors and depend on error-free programming. Most smart pumps are not intuitive, and extensive training is required for proper implementation. Keypads allow double-value entry and are sometimes difficult to read from a distance. Smart pump technology contains computerized medication software to ensure appropriate dosage and flow rates based on safety parameters and is designed to reduce human fallibility and ADEs. However, overriding the soft alerts can also bypass the “smart” functionality. The storage function could be helpful in reviewing ADEs and near misses, but is rarely used in practice (Scanlon, 2012).

d. Automated drug-dispensing units (ADUs) or automated dispensing machines (ADMs). ADMs are computerized cabinets containing stock medications and supplies and are located on the patient unit. These automated machines provide quick access and tracking from the point-of-care entry to removal from the cabinet, leading to an elimination of possible errors within the phases of medication administration (from ordering to transcribing, dispensing, and administering). They are used for the purpose of automating access, distribution, management, and control of medications, fluids, and supplies. Guidelines for the safe use of ADMs have been developed by the American Society of Health-Care Pharmacists (2010). There are workaround or override concerns with the use of ADUs and ADMs; limiting the use of workarounds is necessary, otherwise the safety features become ineffective and staff may become complacent and not read the alert information when selecting overrides (Kester et al., 2006; Miller et al., 2008). Drug dose errors related to stocking are also a concern requiring the need for double checks.

e. Bar-code medication administration (BCMA) technology or bar-code scanning medication administration (BSMA) is used to prevent medication errors by placing a unique identifier (bar code) that is machine readable by an optical scanner on each medication. The effectiveness of BCMA to prevent medication errors before they reach the patient has been documented (Cochran et al., 2007). Before the medication is administered, BCMA matches the right medication with the right patient at the right time. BCMA has not yet been installed in many hospitals, and no reports exist regarding its effectiveness in preventing ADEs in the NICU.
Bar coding is associated with fewer patient identification errors by using a system of machine-readable codes that uniquely identify an item (Gray et al., 2006). Misidentification errors are not limited only to medication; these errors affect diagnosis and therapeutics and are also commonly seen when a mother’s expressed breast milk has been given to the wrong infant (Suresh et al., 2004). Point-of-care bar coding systems have been identified as a technology used to decrease patient identification error. Radio frequency identification systems, which do not require line-of-sight access to patient identification bands, may also be reliable. Despite the potential benefits of either of these autoidentification technologies, it is the responsibility of the clinician to ensure that such technologies are adequately tested in the NICU environment (Gray et al., 2006).

f. Radio frequency identification (RFID) is expected to replace bar-code scanning because of its ability to read identification tags with greater versatility. RFID tags are used in newborn security systems and have the capability to track individuals in order to identify their location. Infant security systems are crucial to the design of both maternity and neonatal units, with the alarming mechanism at every point of entry to prevent infant abduction.

g. Additional HIT. Personal digital assistants, handheld computers, and cellular phones can integrate with electronic health records. Care providers work in a mobile environment, and these handheld devices can document and retrieve information at the point of care without delay, including evidence-based clinical practice guidelines (CPGs), pharmacy database and assessment guides, and diagnostic tests (Mack et al., 2009).

7. Evidence-based practice (EBP). According to the A’s Roundtable on Evidence-Based Medicine (2007), EBP serves as a necessary and valuable tool for future progress; as a projected goal, by the year 2020, 90% of all clinical decisions will be supported by accurate, timely, and up-to-date clinical information that is supported by the best available evidence. EBP is the integration of the best available evidence with clinical expertise and patient values (Sackett et al., 2000). All three of these components are vital to the process. While nurses may feel confident in their clinical expertise and, to some extent, patient/family values, many nurses are not aware of the most recent research findings available to optimize their nursing care (Brady and Lewin, 2007; Cadmus et al., 2008; Pravikoff et al., 2005). Neonatal nurses are encouraged to use EBP to guide daily decision making in order to provide the highest quality of care for individual patients and to decrease variations in practice (Smith et al., 2007). The EBP process requires nurses to be able to search for the evidence and apply the findings to practice. For nurses to integrate EBP into their practice, they need to value the importance of research and health care organizations need to commit to promoting EBP by allowing nurses time and the wherewithal to foster an EBP culture. Neonatal nurses need to be taught how to implement EBP and health care organizations need to accommodate convenient computer access to online EBP resources, including online journal articles and clinical practice guidelines (CPG) websites.

a. Clinical practice guidelines. One form of evidence increasing in volumes internationally, mainly in the adult patient population, is the use of CPGs (Kent and Fineout-Overholt, 2007). Evidence-based CPGs are systematically developed based on the strongest evidence, contain statements to guide practitioners, and include recommendations to assist in decision making (Kent and Fineout-Overholt, 2007). These evidence-based guidelines assist practitioners by reducing variability in practice and standardizing treatment. This standardization has been shown to improve quality in health care settings. Librarians or APNs trained in EBP can champion or mentor individual clinicians in using the EBP process.
The following organizations foster development of high-quality evidence-based CPGs, Best Practice Sheets, or Potentially Better Practices (PBPs):

■ The Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN) provides CPGs specific to newborns and their families, including breastfeeding support and neonatal skin care (www.awhonn.org/awhonn/category.products.do?catid=6).

■ The National Guideline Clearinghouse (NGC) is an initiative of the Agency for Healthcare Research and Quality (AHRQ) and is a free public resource for evidence-based CPGs. The NGC site contains abstracts and full-text CPGs, guideline comparisons, a searchable bibliography database for literature citations, and a discussion forum for exchanging ideas about guidelines (www.guideline.gov).

■ The Joanna Briggs Institute (JBI) is an interdisciplinary, not-for-profit, international research and development agency in Australia. The role of the JBI is to improve the feasibility, appropriateness, meaningfulness, and effectiveness of health care practices and health care outcomes by facilitating international collaborating centers, groups, expert researchers, and clinicians. Although their website targets the adult population, it does include good resources for neonatal nurses. Multiple EBP tools and resources as well Best Practice Sheets (or clinical practice guidelines) are also available on this website (www.joannabriggs.edu.au/pubs/best_practice.php).

■ The American Academy of Pediatrics offers an online practice management website, including a brief description of CPGs, their own developed CPG (specifically, Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation), and a list of CPG resources (http://www.aap.org/en-us/professional-resources/practice-support/quality-improvement/Pages/Guidelines-and-Policy-Development.aspx).

■ The Vermont Oxford Network offers PBPs, which are practices that are developed and tested by multidisciplinary neonatal teams that participate in the VON. The practices are considered “potentially better” because VON members believe that, until the practices can be evaluated, customized, and implemented into individual NICUs, it is unknown whether they are the best possible practice. Some practices may be controversial because there is limited or no evidence available. Members of the VON are given tools to assess the quality and strength of each PBP. PBPs are published and topics include, but are not limited to, neonatal pain management, family-centered care, reduction of bronchopulmonary dysplasia in very low birth weight infants, staffing in the NICU, and more. A list of publications related to the VON can be found at http://www.vtoxford.org/.

■ The National Association of Neonatal Nurses offers guidelines on the topics of pain, skin care, genetics, and peripherally inserted central catheters. A list of publications can be found at www.nann.org.

8. Reporting methods. A number of reporting methods exist and have been used to identify medical errors and adverse events (AEs), including chart review (both focused or trigger-based and nonfocused), direct observation, voluntary reporting by health care providers, and review of medical malpractice claims. Multiple methods may be necessary to effectively measure harm associated with hospital-based health care.

a. Voluntary reporting systems are used by many health care organizations, although this is limited owing to its voluntary nature. Reporting systems can be performed at the unit level (incident reports) or at the national level (multi-institutional specialty-based reports). The majority of incident reporting systems in the NICU use a voluntary, nonpunitive approach to incidents, and these reporting systems elicit many more incidents in the NICU than a mandatory system (Snijders et al., 2007). A voluntary system is key to reporting medical errors and AEs because health care providers may fear being stigmatized or punished for their actions. However, once a culture of safety is developed, reporting of errors and near misses by health care providers has been shown to increase (Snijders et al., 2009). It is important to include near misses when reporting in order to learn how to prevent errors. Automated reporting systems that allow quick and easy access are necessary for busy clinicians. Although voluntary reporting only provides a glimpse into a complex cause of error, system factors responsible for many errors can be identified in a voluntary reporting system. Using an Internet-based, voluntary, anonymous reporting system from 54 NICUs, members of the VON revealed large numbers of errors in virtually all domains in NICUs and identified factors contributing to the occurrence of errors. Among these factors, nearly half (47%) of reports were associated with a failure to follow a hospital policy or protocol, 27% with inattention, 22% with a communication problem, and 12% with distraction (Suresh et al., 2004). These findings suggest that adding new policies or protocols does not improve patient safety; rather, the responsibility lies within the system itself, monitoring processes, and identifying system-wide improvements to effectively understand errors and improve patient safety. Once errors are identified, improvement strategies are implemented, and future errors are prevented, health care providers will recognize the benefit of reporting.

b. Patient triggers. Measuring the overall level of harm within a health care organization has been performed through the identification of “triggers,” or clues, of AEs during manual chart review. A trigger is defined as an “occurrence, prompt, or flag” found on review of the medical chart that “triggers” a further investigation to determine the presence or absence of an AE. Historically, efforts to identify AEs have relied on voluntary reporting and tracking of errors. This method is often limited and may be unreliable because of a small percentage of errors ever being reported. Trigger methodology provides a more focused and efficient review of charts that may lead to identifying more AEs (Sharek, 2012). An example of a neonatal trigger would be the patient’s use of naloxone, prompting a focused chart review for opioid-induced respiratory depression. In an effort to develop and test an NICU-specific trigger tool, members of the VON and the Child Health Corporation of America (CHCA) participated in a collaborative funded by the AHRQ. In a retrospective chart review, 749 charts from 15 different NICUs were examined for NICU-associated AEs. Results of this study identified low birth weight and early-gestational-age infants as most susceptible to AEs, with the most common AEs being nosocomial infections (27.8%), catheter infiltrates (15.5%), abnormal cranial imaging (10.5%), and accidental extubations requiring reintubation (8.3%) (Sharek et al., 2006). More than half of all identified AEs were classified as preventable, with 40% falling into the severe-harm group. Specific limitations of this study exist; however, the authors concluded that the NICU trigger tool is superior to identifying AEs compared with nontrigger methods, and the NICU trigger tool can potentially be automated, allowing identification of AEs in real time as well as providing the ability to track AE rates (Sharek et al., 2006). This kind of proactive search for problems is more effective than responding to reports of injuries and accidents after they occur.

c. Additional methods of identifying errors. Traditional chart reviews or health care provider interviews are additional methods of identifying errors. Often these methods are labor intensive, costly, inefficient, and variable. Direct observation using real-time audits during team rounds or routine nursing care can provide immediate feedback to frontline staff, which is key to behavior change for focused improvements in patient safety (Ursprung and Gray, 2010). Checklists with real-time surveillance methods identify care processes especially prone to error that are important safety areas, including mislabeled medications (tubing or syringes), absence of wristbands for patient identification, failure to follow hand hygiene practices, and inappropriate pulse oximeter settings (Ursprung and Gray, 2010). A culture of safety involves promoting practices that are evidence-based and safe and should be part of any NICU’s quality improvement efforts. Families are also encouraged to participate in the process of identifying errors in order to provide a different perspective from most health care providers and to enhance the opportunity to learn about error prevention.

9. Transparency and full disclosure (Massachusetts Coalition for the Prevention of Medical Error [MCPME], 2006). Transparency is a process in which errors are fully disclosed to patients/families. It is a process that can be very challenging for health care providers. Disclosure refers to providing information to a patient and/or family about an incident. Data suggest that most patients/families wish to be informed of AEs; however, nurses and physicians may find it difficult to acknowledge their mistakes, whether due to fear of litigation or just an intense shame or guilt. Health care professionals hold themselves to very high standards and, as a result, may find it difficult to deal with failure. Because of the emotional effects of these events on both the patients/families and the caregiver, communication failures are often the reason patients/families file malpractice suits. Support to both families and caregivers are essential in disclosing errors. Error disclosure training has become part of the curricula at many medical schools and residency training programs (Stroud et al., 2013). It has also been incorporated in interprofessional training programs (University of Washington, 2013) and bedside nurses’ training (Wayman et al., 2007). The Harvard teaching institutions have developed a consensus statement for use at the Harvard hospitals that provides a template for responding consistently and ethically to medical errors (MCPME, 2006).

a. Strategies to support families after an AE through disclosure by care providers:

■ Provide prompt (within 24 hours after the event is discovered), compassionate, and honest communication with families following an incident, telling them what happened.

1. Patient misidentification (Gray et al., 2006). Misidentification is a specific area of concern for NICU patients. Accurate patient identification is necessary for providing safe and effective services specifically related to medication and blood product administration, laboratory specimen collection, performance of diagnostic procedures, and administration of treatments. Unlike adults and many pediatric patients, neonates cannot participate in the process of identifying themselves. Methods used to differentiate individuals (age, size, sex, and hair color) are not readily available in the neonatal population. Frequently, names are similar and, in some cases, identical along with similar medical record numbers, resulting in an increased chance for misidentification. Wristbands are another tool used to verify patient identification in the NICU. However, wristbands are often inaccurate, incomplete, missing, or are affixed to the patient’s bedside because of concern that they can lead to lacerations or abrasions to the preterm infant’s fragile skin.

a. Improvement strategies to reduce misidentification include:

■ Two patient identifiers

a. Improvement strategies (use the same strategies as used for misidentification and medication errors). Six Sigma is a process improvement strategy and has been used to reduce the incidence of incorrectly administering EBM (Drenckpohl et al., 2007). The Six Sigma methodology has been used in the manufacturing industry for years and its goal is performance excellence, stating that perfection is possible. The Six Sigma approach reduces variability within a process, ultimately reducing opportunities for failures. The steps are to define, measure, analyze, improve (DMAI), and control a problem (Kubiak and Benbow, 2009). Administration of human milk is complex and involves many people handling, transporting, storing, preparing, and administering the milk, resulting in the potential for error. The primary goal of Six Sigma is to eliminate the number of defects that can occur in a process (Kubiak and Benbow, 2009). This same method can be used as an effective strategy for improving other processes related to errors within an organization.

b. Selected strategies to avoid wrong administration of human milk (Drenckpohl et al., 2007).

(1) Label pumped breast milk.

(a) Have mother label milk after pumping, using labels with the infant’s first and last name, birth date, medical record number, and date and time pumped.

(a) Read label to be sure it is complete.

(a) Each infant should have his or her own storage bin. In the case of multiple births and infants with similar names, consider specialized labels to alert staff of risk of misidentification.

(a) Never leave the milk at an infant’s bedside unless the bedside RN has verified that this is the correct milk and the correct infant.

(c) Many institutions have instituted bar coding for verification of patient identity prior to administration of breast milk (Dougherty and Nash, 2009; Fleischman, 2013).

(5) Develop an institution-specific policy outlining the steps to take if there is an error in breast milk administration.

3. Medication errors. Neonates are highly vulnerable to medication errors because of their extensive exposure to medications in the NICU, the lack of evidence on pharmacotherapeutic interventions in neonates, and the lack of neonate-specific formulations (Chedoe et al., 2007). Medication errors can occur throughout any stage of drug delivery and include preventable and nonpreventable ADEs. More research is needed regarding the epidemiology of medication errors in the NICU, and evidence-based interventions are needed to reduce medication errors and improve patient safety. In an effort to reduce the rate of pediatric medication errors, the AAP has developed recommendations uniquely pertinent to children and/or neonates (Stucky, 2003, reaffirmed 2007, retired 2011; AAP and Committee on Quality Improvement and Management and Committee on Hospital Care, 2011).

a. Common stages of medication ordering and delivery where errors occur.

(1) Prescribing. Incorrect dosing is the most common medication error in the NICU, related either to the prescribing phase or the administration phase (Chedoe et al., 2007). Deficiencies in prescribing medications contribute to nearly 14% of ADEs in hospitalized children (Sorrentino and Alegiani, 2012; Stavroudis et al., 2010). The most common cause of medication errors at the prescribing stage is the deficiency in performance or knowledge of the prescriber, physician, or nurse practitioner. Neonates are a heterogeneous group, and prescribing decisions must be made on an individual basis. Pharmacokinetic and pharmacodynamic parameters change continuously because of changes in the neonate’s weight, length, and renal function (Chedoe et al., 2007; Dabliz and Levine, 2012). Incorrect recording of the patient’s weight, dosage regimen, and units (e.g., milligrams and micrograms), and misplacement of decimal points when calculating, resulting in 10- or 100-fold overdoses, all contribute to dose errors at the prescribing phase (Chedoe et al., 2007). Specific to the NICU population is the rapid change in weights requiring frequent dosing recalculations in order to maintain therapeutic drug levels. The use of abbreviations, verbal orders, and poor handwriting can also lead to medication errors at the prescribing stage. Review of the prescribed orders, by a nurse or pharmacist, is critical at this stage of the medication process in order to detect or prevent an ADE (Dabliz and Levine, 2012).

(2) Transcribing. CPOE has reduced or eliminated transcription errors for medications and other ordered treatments. However, as of 2010, only an estimated 21.7% of U.S. hospitals had CPOE (Abramson and Kaushal, 2012). Systems that continue to rely on multiple transcriptions and “hand-offs” of written information increase the chance of an error in the transcription phase. In handwritten processes, each transcription is an opportunity for error (Lehmann and Kim, 2006). Transcription accounts for as much as 18% of medication errors (Stavroudis et al., 2010). Errors related to similarly spelled drug names and similarly sounding drug names are common. Equally problematic are ambiguous abbreviations. The Joint Commission (2012) affirmed its official “Do Not Use” list of abbreviations (Table 18-2). Prior to dispensing medications, it is the responsibility of the pharmacist to review all orders confirming the name of the drug, patient, dose, quantity, directions for use, and route and time of administration.

Stay updated, free articles. Join our Telegram channel

Join