Jane H. Barnsteiner, PhD, RN, FAAN Safety Competency Jane H. Barnsteiner, PhD, RN, FAAN

Safety Competency: As Used in this Module Minimize risk of harm to patients and providers through both system effectiveness and individual performance.

Key Message The key message of this module is: Safe, effective delivery of patient care requires understanding of the complexity of care delivery, the limits of human factors, safety design principles, characteristics of high reliability organizations, and patient safety resources.

Learner Objectives By the end of this module, the learner will be able to: Describe processes used in understanding causes of error and allocation of responsibility and accountability. Describe factors that create a culture of safety. Discuss potential and actual impact of national patient safety resources, initiatives and regulations. Identify opportunities to improve patient safety that minimize human factors.

Introduction

Institute of Medicine (IOM): Patient Safety The Institute of Medicine defined patient safety as freedom from accidental injury. It is estimated that upwards of 98,000 people die each year as a result of preventable harm from healthcare that is supposed to help them. The Institute of Medicine (1999).

Patient Safety: Role of Nurses Nurses in the executive suites and on the frontlines of care are instrumental in preventing harm to patients and improving patient outcomes.

Patient Safety: Role of Nurses While delivery of healthcare is extremely complex and there are tremendous systems challenges, nurses often have been held accountable for harm to patients . . . . . . even while they have not had input into system designs and have little understanding of how complex systems leave them vulnerable to making errors.

Patient Safety Organizations involved in working to make healthcare safer include: Institute for Healthcare Improvement The Joint Commission American Association of Colleges of Nursing American Nurses Association The issue of healthcare safety is so serious, the Institute of Medicine has produced 10 reports devoted to identifying the issues and recommending how to solve them (IOM 1999 – 2006).

Threats to Patient Safety There are numerous threats to patient safety, and errors can occur at all interfaces of care delivery. Table 1 lists common errors resulting from these threats to patient safety.

Threats to Patient Safety Obstacles to a safe system include: a complex and risk-prone system that can produce unintended consequences lack of comprehensive verbal, written, and electronic communication systems tolerance of stylistic practices and lack of standardization fear of punishment inhibiting reporting and lack of ownership for patient safety

Common Errors in Healthcare Medications – nurse is last line of defense Surgery – wrong site Diagnostic inaccuracy – wrong treatment Equipment failure – IV pump Transfusion error - blood type, wrong patient Laboratory – incorrect labeling System failure – no independent double check Environment – clean up spills Table 1

Culture of Safety

Culture of Safety An organizational culture of safety acknowledges the influence of complex systems and human factors within the healthcare delivery system in general and within nursing practice specifically. (Mayo, 2004) It is important to note that culture is not necessarily uniform within a single organization

Culture of Safety Within a healthcare setting, each discipline can have a different culture, as can each patient care area. In a culture of safety, the focus is on effective teamwork to accomplish the goal of safe, high-quality patient care. While differences may benefit the work of the organization, more frequently it results in communication difficulties particularly around patient handoffs (Lamb, 2003; Walsh, 2004).

Culture of Blame Within a culture of safety, when an adverse event occurs, the focus is on what went wrong, not who is the problem. A culture of blame has been pervasive in healthcare. The focus has often been to try to determine who has been at fault and, all too often, to mete out discipline. This approach leads to hiding rather than reporting errors and is the antithesis of a culture of safety. Recent efforts have been directed to changing this approach and to encourage people to report problems so they can be addressed (Lamb, 2003).

Elements of a Culture of Safety Elements of a culture of safety in an organization are establishment of safety as an organizational priority, teamwork, patient involvement, openness/transparency and accountability (Lamb, 2003). There are shared core values and goals, non-punitive responses to adverse events and errors, and promotion of safety through education and training. A balance needs to be achieved between not blaming individuals for errors and not tolerating egregious behavior. This is currently referred to as a “Just Culture” (Yates, 2005; Mitchell, 2008).

Elements of a Culture of Safety A patient safety culture should be non-punitive, and emphasize accountability, excellence, honesty, integrity and mutual respect. It incorporates safety principles such as designing jobs and working conditions for safety, standardizing and simplifying equipment, supplies and processes and avoiding reliance on memory. (AORN, 2006)

Elements of a Culture of Safety A safety culture requires strong, committed leadership, and engagement and empowerment of all employees. It entails periodic assessment of the culture and relationship between the organization culture and the quality and safety within the organization (Wachter, 2009)

Culture of Patient Safety Assessment Numerous tools are available for measuring the healthcare safety culture within an organization. The most widely used is the Culture of Patient Safety Assessment developed by the Agency for Healthcare Research and Quality (AHRQ). (Sorra, 2008; see Table 2).

IOM: How to Improve Patient Safety? The IOM described 9 categories that provide opportunities to improve patient safety: IOM (2001) The key question is how to improve patient safety. It is necessary to differentiate between the blunt end latent conditions and sharp end where the event takes place.

1. User-centered Design Approaches include making things visible so the user is able to see actions possible at any time, affordance, constraints and forcing-functions. For example, making something visible would be directions on a piece of machinery on how to return to an earlier step or how to change settings. Affordance indicates how something is to be used such as marking the correct limb before surgery and a sign on a door indicating which way to open it. A constraint makes it hard to do the wrong thing. Forcing function makes it impossible to do the wrong thing, such as put the active electrode of the bovey cautery machine into the grounding plate.

2. Avoid Reliance on Memory Standardizing and simplifying procedures and tasks decreases the demand on memory, planning, and problem-solving. The use of protocols and checklists reduces reliance on memory and serves as a reminder for the steps to be followed. Simplifying processes minimizes problem-solving. Having the usual dose of a medication as the default in an electronic order entry. Purchasing equipment that is easy to use and maintain are examples of simplification of processes.

3. Attend to Work Safety Work hours, work-loads, staffing ratios, distractions, and counterclockwise shift changes all affect patient safety.

4. Avoid Reliance on Vigilance Checklists, well-designed alarms, rotating staff and breaks decrease the need for remaining vigilant for long periods.

5. Training Concepts for Teams Training programs for effective interprofessional communication and collaboration include transitions in care and hand-offs.

6. Involve Patients in Their Care Patients and families should be in the center of the care process. This includes clinicians obtaining accurate information and including patients and families in decisions about treatments and comprehensive discharge planning and education.

7. Anticipate the Unexpected Reorganization and organization-wide changes result in new patterns and processes of care. Introduction of new processes and technologies depends on a chain of involvement of frontline users and the need for pilot testing before widespread implementation.

8. Design for Recovery Errors will occur despite the best of planning. Designing and planning for recovery will allow reversal or make it hard to carry out irreversible critical functions. Simulation training promotes the practice of processes and rescues using models and virtual reality.

9. Improve Access to Accurate, Timely Information Information for decision making needs to be available at the point of care. This includes easy access to drug formularies, evidence-based practice protocols, patient records, laboratory reports, and medication administration records.

Nursing is in a central position to improve quality of care through patient safety activities. Nurses are in the position to coordinate and integrate the multiple aspects of care while monitoring and identifying hazards and changes in patient conditions before errors and adverse events can occur. (AHRQ PSNet Patient Safety Network Error chain) Nursing is also in a position to impact high quality, safe care with strong leadership, adequate staffing, and strong interprofessional communication and collaboration

Work Environment

Workarounds Workarounds may present patient safety hazards. Clinicians encounter problems or impediments in delivering care and invent a quick workaround to solve those problems. This first-order change occurs because clinicians are really busy and need to get the problem solved. This frequently used approach to problem-solving leaves systemic problems untreated and potentially is a cause of error. Examples include using equipment for purposes it was not intended or bypassing the procedure for barcoding medication administration as the process has too many steps. Many organizations do not provide a way to report problems and have them solved in a timely or effective fashion.

Human Factors

Human Factors Human factors is the science of the interrelationship between humans, the technology they use, and the environment in which they work. Human factors engineering increases understanding of how people perform under various circumstances so that systems and technology can be designed to enhance performance. (IOM, 1999) Human factors engineering covers the human–machine and human-to-human interactions such as communication, teamwork, and organizational culture (Croskerry, 2000).

Systemic Preventable Healthcare Errors The majority of preventable healthcare errors that occur are systemic and are not the result of poorly performing clinicians. (Schyere, 2005)

Systemic Preventable Healthcare Errors Rather than being the cause of an accident, clinicians tend to be the recipients of system defects caused by decisions made in the external environment such as: economic reimbursement pressures poor management decisions the physical environment human-system interfaces the complexity of the work individual characteristics of the clinician (Ebright, 2003).

Thinking and Mental Models Actions often are a result of mental models that are based on recurrent aspects of our lives such as the way one drives to work or the routine for admitting a post-operative heart transplant patient. The ability to make logical and accurate decisions is associated with complex factors that include: the knowledge base system factors availability of essential information workload barriers to innovation Thinking is automatic, rapid, and effortless. (Ebright, 2003).

Thinking and Mental Models Fatigue, distraction and interruptions affect cognitive abilities and problem-solving. Errors result when one is tired, distracted, or interrupted and in turn deviates from safe operating procedures, standards, and policies, which can be routine and necessary. (Reason, 2003)

Human Factors: Errors Numerous types of errors can occur as a result of human factors. These include skill-based, rule-based, and knowledge-based errors. Skill-based errors are slips that are aberrations of patterns in a normal routine activity. Rule-based and knowledge-based errors are due to mistakes in conscious thought. (Balas, 2004; Halbesleben, 2008; Hughes, 2008; Mayo, 2004) A skill-based error can occur because of a distraction or interruption, such as being interrupted as one calculates a medication and then resumes at a different step. Rule-based and knowledge-based include workarounds and short cuts.

Human Factors: Mindfulness Everyone, regardless of the role they play in a healthcare system, needs to be mindful of the interdependent system factors and the role they play in shaping safe care. Five processes define mindfulness: preoccupation with failure reluctance to simplify interpretations sensitivity to operations commitment to resilience deference to expertise. (Vicente, 2004) Human factors considers the “human condition” or our inability to focus on multiple things at once and performing accurately A key characteristic of clinicians in HROs is mindfulness (Weick, 2001).

Human Factors: Mindfulness Understanding the complex and demanding clinical environment helps us be aware of the components and relationships that influence the safety of care. Systems need to be designed to protect against human errors hence the focus needs to be on system failures, not human failures and on meeting the needs of clinicians within the healthcare system.

Transitions in Care & Handoffs

Transitions in Care and Handoffs Handoff of patient care from one nurse to another is an integral part of nursing practice. Synonymous terms for handoffs include: handover sign-out signover cross-coverage change of shift report (Sexton, 2004; Dayton, 2007) Transitions in care and handoffs create vulnerabilities in health care that require special attention.

Transitions in Care and Handoffs: Effective Communication Central to effective handoffs is effective communication. Ineffective communication and inadequate handoffs have negative consequences for patients. Barriers to effective handoffs include: the physical setting the social setting language barriers the medium of communication

Transitions in Care and Handoffs: Effective Communication Standardization in the processes of handoffs with face-to-face communication remains key to addressing patient safety concerns. The Joint Commission (2005) defines handoff communication as “the realtime process of passing patient specific information from one caregiver to another or from one team of caregivers to another for the purpose of ensuring continuity and safety of the patient/client/resident’s care.” (Dayton, 2007; Friesen, 2008; Saint, 2005)

Joint Commission NPSG 2009 Expectations for Handoffs Opportunity for questioning between giver and receiver. Current information regarding patient care, treatment, services, condition, and any changes. Verification of information, including repeat-back, or read-back. Recipient of information opportunity to review relevant patient data. Limit interruptions during handoffs to minimize opportunities for information transfer failures. Table 5

Transitions in Care and Handoffs: Effective Communication SBAR SBAR (situation, background, assessment, and recommendation) has become a frequently used approach both for interprofessional communication and nurse to nurse communication. Handoffs may be facilitated through the use of standardized change of shift reporting checklists. (Barenfinger, 2004; Hanna, 2005; Haig, 2006).

Disclosure

Openness and a Culture of Safety Openness is a critical factor in a culture of safety. It indicates there is acceptance of human elements in error and a means of reporting any error or near miss or identified potential for error. Openness is important so that errors and potential problems are exposed and solved before they endanger others. Within a culture of openness there is a “just culture” where discipline is limited to reckless or egregious behavior. Many errors go unreported by health care workers. A major concern clinicians have is that self-reporting will result in repercussions.

Near-Misses Near-misses are more common than adverse events and provide valuable information regarding weaknesses in systems that predispose to adverse events. Discussions of near-misses usually do not generate the defensive reaction often associated with discussion of adverse events. (Bagin, 2001). Aggregate data from near-miss analyses is used to direct attention to critical safety issues. The reporting process should be uncomplicated and preferably electronic to lead to rapid analysis. The opportunity for anonymous reporting is thought to lead to greater willingness to report errors. Institutional reporting systems system should be nonpunitive and should keep reported information confidential and nondiscoverable. Information should be used for system improvements.

Reporting errors and near misses through established systems provides opportunities to prevent future similar, and perhaps even more serious, errors. Several factors are necessary to increase error reporting: having leadership committed to patient safety; eliminating a punitive culture and institutionalizing a culture of safety; increasing reporting of near misses; providing timely feedback and follow-up actions and improvements to avert future errors; and having a multidisciplinary approach to reporting. (Lawton, 2002; Nuckols, 2007; Thurman, 2001)

Second Victim- The Nurse

Second Victim Health care professionals report feeling worried, guilty, and depressed following serious errors, as well as being concerned for patient safety and fearful of disciplinary actions. They also are aware of their direct responsibility for errors. Many nurses accept responsibility and blame themselves for serious-outcome errors. Wu coined the phrase “second victim” to describe the impact of errors on professionals. (Rassin et al., 2005; Rossheim, 2009; Wolf, et al., 2000). Wu (2000)

Second Victim Healthcare professionals practice the art and science of healthcare delivery within very complex environments. Rather than suffering alone after an adverse event it is imperative that systems be developed to assist clinicians to understand the event and to stimulate healing, as well as opportunity to improve the healthcare system (Denham, 2007; White et al., 2008)

Summary Making progress on patient safety begins with learning how to learn about safety. Safe, effective delivery of patient care requires understanding of the complexity of healthcare systems, the limits of human factors, safety design principles, characteristics of high reliability organizations, patient safety resources. These components are critical to the preparation of safe clinicians and essential for 21st century healthcare delivery.