As health care reimbursement models shift from volume-based to value-based models, orthopedic surgeons must provide patients with highly reliable care, while consciously minimizing cost, maintaining quality, and providing timely interventions. An established means of achieving these goals is by implementing a highly reliable care model; however, before such a model can be initiated, a safety culture, robust improvement strategies, and committed leadership are needed. This article discusses interdependent and critical changes required to implement a highly reliable care system. Specific operative protocols now mandated are discussed as they pertain to high reliability of orthopedic care and elimination of wrong-site procedures.
Key points
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A prerequisite for the establishment of a highly reliable organization is “collective mindlessness,” otherwise described as a team attitude.
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All team members should work together to eliminate systemic failures leading to sentinel events.
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The AAOS, Joint Commission, and World Health Organization have all developed protocols and checklists designed to reduce wrong-site procedures while delivering highly reliable care.
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Lack of proper leadership, safety culture, and quality improvement strategies make the safety protocols ineffective.
Introduction
Physicians face many hurdles when delivering care to patients, which inevitably affect outcomes and patient satisfaction. These hurdles are particularly evident within the current health care climate, as volume-based reimbursement models are replaced with value-based patient-centered approaches to health care. The three overarching obstacles currently affecting health care delivery are (1) cost, (2) quality, and (3) timely intervention. Clinicians are constantly faced with the challenges of providing the highest quality of care, within the shortest time frame, at the lowest possible cost. These basic principles are particularly relevant within orthopedics, because the field is responsible for an estimated 9% to 11% of all medical malpractice claims and an estimated 30% of these claims result in legal settlements costing the health care system billions of dollars annually.
High reliability of care, described as consistent performance at high levels of safety over long periods of time, may be implemented within orthopedic practices. If successfully integrated, the model may standardize treatment protocols, improve the quality of care, and aid in the development of clinically applicable guidelines, while minimizing resource expenditures. This article addresses three interdependent and critical changes that need to take place to adopt a high-reliability care model within an orthopedic practice. Also addressed are specific operative protocols that if implemented properly may reduce the risk for wrong-site surgery and improve the quality of care.
Introduction
Physicians face many hurdles when delivering care to patients, which inevitably affect outcomes and patient satisfaction. These hurdles are particularly evident within the current health care climate, as volume-based reimbursement models are replaced with value-based patient-centered approaches to health care. The three overarching obstacles currently affecting health care delivery are (1) cost, (2) quality, and (3) timely intervention. Clinicians are constantly faced with the challenges of providing the highest quality of care, within the shortest time frame, at the lowest possible cost. These basic principles are particularly relevant within orthopedics, because the field is responsible for an estimated 9% to 11% of all medical malpractice claims and an estimated 30% of these claims result in legal settlements costing the health care system billions of dollars annually.
High reliability of care, described as consistent performance at high levels of safety over long periods of time, may be implemented within orthopedic practices. If successfully integrated, the model may standardize treatment protocols, improve the quality of care, and aid in the development of clinically applicable guidelines, while minimizing resource expenditures. This article addresses three interdependent and critical changes that need to take place to adopt a high-reliability care model within an orthopedic practice. Also addressed are specific operative protocols that if implemented properly may reduce the risk for wrong-site surgery and improve the quality of care.
Scope of the problem
Efforts to improve the quality of health care began with Ignaz Semmelweis, the nineteenth-century obstetrician who introduced hand washing, and later with Ernest Codman, an early advocate for hospital standards and outcome registries. Although significant advancements have been made in the reliability and quality of health care, the Institute of Medicine reported that an estimated 44,000 to 98,000 patients die annually in US hospitals as a direct result of medical errors. Incorrect surgical procedures (wrong site, wrong side, wrong procedure, or wrong patient) account for a small but significant fraction of these errors and have been estimated to occur nationally at a rate of 5 to 10 events per day. Kwaan and colleagues examined a malpractice insurance database and reported that wrong-site procedures occurred at a rate of 1 in 112,994 nonspine procedures. In response to the unacceptably high rate of medical errors, regulatory bodies, such as the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO), and professional medical societies, such as the American Academy of Orthopaedic Surgeons (AAOS), have been charged with the task of analyzing medical errors and developing protocols that aim to prevent future errors.
Requirements for implementing high reliability of care
A prerequisite for highly reliable health care organizations is “collective mindfulness,” or a team attitude in which all members work together and are acutely aware of small failures or processes that can lead to sentinel events. The successful implementation of highly reliable care requires that three dependent factors be in place: (1) leadership must make a long-term commitment to implementing highly reliable care, (2) the organizational culture must embrace a safety culture, and (3) tools supporting a robust process improvement strategy must be adopted.
Leadership
Before implementation of care initiatives, the respective organization’s leadership must be fully committed to structural and cultural changes necessary to deliver highly reliable care. This commitment must be shared by all members of the leadership including board members, senior managers, administrators, physicians, and all other stakeholders. In addition, the organization’s management must recognize that it may take 10 to 15 years to fully transition to a high-reliability care model. To efficaciously implement institutional-wide changes the principles of high-reliability care should be embedded in the organization’s mission statement. Furthermore, measurable organization-wide standards should be established so that the execution of goals may be objectively monitored.
Safety Culture
As described by Reason and Hobbs, a “safety culture” comprised of trust, communication, and improvement is essential for the successful establishment and maintenance of highly reliable care systems. If an organization is to receive continuous information regarding possible failures and unsafe conditions, orthopedic surgeons may form trust among team members by two means. First, all personnel must trust organizational policies when identifying and uncovering problems that may implicate others. Moreover, if a team member exposes a management issue the team member must be confident that the organizations leadership will promptly fix the problem. Lack of trust among involved parties and management hinders the flow of information, resulting in organizational shortcomings and unsafe patient conditions.
Second, horizontal and vertical communication between orthopedic surgeons and all team members is required for effective execution of high-reliability care. To promote communication among the various stakeholders, administrators should establish several routes of communication, including anonymous means. An organizational culture promoting high-reliability care and patient safety can only be achieved if the philosophy is first instilled in all team members; as such, trust, communication, and the process of continuous improvement are necessary in all institutions striving to improve health care reliability.
Quality Improvement Strategy
Any organization seeking to implement high reliability of care must adopt a robust mechanism of quality improvement (QI). Since the 1990s health care organizations have been experimenting with industrial QI tools to continuously improve the quality of health care. Although some early health care organizations implementing industrial QI principles were able to appreciate improvements, most institutions implemented QI measures within nonclinical settings, limiting their effect on patient outcomes.
Within the last decade, orthopedic practices have led the way in the implementation of Lean and Six Sigma philosophies that address difficult safety- and quality-related issues. These industrial measures have standardized treatment protocols, streamlined surgical service lines, and integrated comanagement principles within patient populations undergoing elective and emergent orthopedic surgeries (total joint arthroplasty and hip fracture, respectively). Notably, the use of these industrial ideologies lies within their systematic approach, which eliminates waste while minimizing error.
Operating room interventions
Over the last two decades professional medical societies (AAOS) and large multinational organizations, such as the World Health Organization (WHO) and JCAHO, have developed several protocols aimed at reducing medical errors and improving patient safety. Although these QI initiatives have been developed by various societies and organizations, the common goal remains the same: to improve the reliability of orthopedic care.
American Academy of Orthopaedic Surgeons
As a recognized leader among professional medical societies, the AAOS commissioned the Wrong Site Surgery Task Force to undertake the society’s first major QI initiative. In 1998, the task force recommended the implementation of the Sign Your Site initiative (SYS) to reduce the unacceptably high rate of wrong-site procedures. The initiative encouraged orthopedic surgeons to routinely initial the surgical site before operative intervention. Although the recommendations were primarily aimed at reducing wrong-site surgery, it was also effective at reducing wrong-patient and wrong-procedure events. Since the SYS initiative 45% of orthopedic surgeons have changed their practice habits and almost all have routinely taken some action to prevent wrong-site surgery. A study by Meinberg and Stern evaluating 1560 active hand surgeons revealed that 21% (217) of hand surgeons reported performing wrong-site surgeries at least once in their career. A major limitation of the SYS initiative has historically been its voluntary status and lack of support among academy fellows. More recently, regulatory bodies, such as JCAHO and WHO, have implemented similar initiatives within their protocols. Hence, the SYS initiative can be credited with being the first of many steps implemented with the goal of reducing medical errors and improving the reliability of care.
Joint Commission on the Accreditation of Healthcare Organizations
In 2000 a report by the Institute of Medicine titled, To Err Is Human: Building a Safer Health System , brought widespread attention to the concept of medical errors within all specialties of care. At the same time, JCAHO, a nonprofit accreditation body originally formed by Ernest Codman on behalf of the American College of Surgeons, was already assessing medical errors through its Sentinel Events Program. Any event resulting in death, permanent harm, or severe temporary harm is considered a sentinel event, or an event requiring an immediate investigation and “root cause analysis.” Additionally, JCAHO also developed the Patient Safety Event Taxonomy for the analysis of additional medical errors. Although, JCAHO is not a regulatory body, endorsement by JCAHO or an equivalent accreditation body is mandated by the Centers for Medicare and Medicaid Services. Thus, initiatives developed by JCAHO may have far reaching effects. Table 1 reports a series of orthopedic-related initiatives currently investigated by JCAHO.
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