Abstract
In the web of complex health care system, patient safety is one of the core components of quality health care, because medical errors not only cost human lives but cost trust in health care system also. Accountability for patient safety and quality is the current trend in health care management, though foundation for error free patient care, with active involvement of chief executives and health care leaders, have already been laid with Institute of Medicine’s (IOM’s) Committee recommendations of 1999. Patient Safety and Quality Improvement Act enacted in 2005 is in response to the growing concern about patient safety in the United States. A large volume of best practice recommendations for healthcare organizations to enhance patient safety has been generated by various government agencies, accreditation bodies, hospitals associations, and employer coalitions in the United States. Developing infrastructure to support patient safety goals, including electronic systems for data collection and analysis, efficient management structure, and a work culture that promote safety with contribution of governance bodies is fundamental to overcome these problems. An ideal leadership would be capable to anticipate potential problems, and well equipped to reduce errors or harm before they occur.
Introduction
Medical error is defined as “the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim.” (To ERR is human: Building a safer health system, 1999). It is observed that high medical error rates with serious consequences occur in intensive care units, operating rooms, and emergency departments. Adverse drug events and improper transfusions, surgical injuries and wrong-site surgery, restraint-related injuries or death, mistaken patient identity, hospital acquired infection, and falls are most common problems that occur while providing health care. Main reason for frequent medical error is attributed to ‘lack of a single designated government agency devoted to improving and monitoring safety throughout the health care delivery system’ and the inattention to developing and ensuring safety culture. The Institute of Medicine’s 1999 report ‘To Err is Human: Building a Safer Health System’ had already underscored the necessity of patient safety and issued guidelines in this respect.
Safety recommendation and legislation
Quality of Health Care in America Committee under Institute of Medicine (IOM) in its first report issued in September 1999, among other things, concluded that: “More commonly, errors are caused by faulty system, processes, and conditions that lead people to make mistakes or fail to prevent them.” (To err is human: Health care system odds with itself,1999). Whereas, hospital and health system leaders view the content of the safety programs imposing, and it offers “little guidance to executives about how to build the organizational infrastructure necessary to support a patient safety program within their organizations.” (Weingart & Page, 2004). It is argued that due to lack of empirical and theoretical research base to guide healthcare leaders, who are keen to create patient safety programs within their organization, it is cumbersome to make organizational change and transformation studies. With the publication of Committee recommendation in 1999, a new thrust was given to patient safety. The Executive Session on Patient Safety, created in the Harvard University Executive Session model, was a new initiative in the direction of understanding the challenge of promoting safe care envisaged by hospitals and health system executives. It is a working group of hospital and health system executives and other stakeholders whose members agree to work together over several years in order to understand and improve patient safety in their organizations and communities.” The goal was to assemble a working group of prominent and thoughtful individuals who could develop powerful ideas about important social problems, test the concepts they developed in their organizations, and then report back to the group on their successes and failures” (Weingart & Page, 2004). The Executives believed that patient safety standards are dependent on the organization of the hospital and clinic. The executives identified five major problems in patient safety, namely: (1) structuring the organization to deliver safe care; (2) monitoring and measuring their organization’s safety performance; (3) spreading and sustaining patient safety innovation; (4) managing the relationship with the external environment; and (5) managing the behavior of executives themselves for leading safety.
After IOM recommendation of 1999 specific law to improve patient safety has been enacted in 2005. Patient Safety and Quality Improvement Act of 2005 was signed into law on July 29, 2005, and enacted in response to growing concern about patient safety in the United States. The goal of the 2005 Act is to improve patient safety by encouraging voluntary and confidential reporting of events that adversely affect patients. It is viewed that “patient safety improvement efforts are hampered by the fear of discovery of peer deliberations, resulting in under-reporting of events and an inability to aggregate sufficient patient safety event data for analysis.” (The patient safety and quality improvement Act of 2005, 2008).To achieve transparency Patient Safety Organizations (PSOs) are created to collect, aggregate, and analyze confidential information reported by health care providers. The 2005 Act mandate patient safety organizations not only to collect reports of medical errors and adverse events, they should also disseminate lessons learned. From the feed back on error reports health care personnel can learn their mistakes and adopt corrective behavior. The final rule to implement the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) was issued by Department of Health and Human Services (HHS) on November 21, 2008, and the final rule will become effective on January 19, 2009 (Information regarding final rule, n.d).
Monitoring and measuring problems
Safety, to quote Clarke et al, “is a demonstrated commitment by leaders to create and maintain a system that provides adequate expertise, training, and resources to accomplish the task successfully and simplifies the workplace through standardization to increase the probability of reliability results.” (2007, p.312). Main hurdle in monitoring and measuring safety problems is the paucity of time tested reliable methods to evaluate the efficacy and efficiency of care provided by an organization. Though incident reporting has the potential to highlight errors and injuries, its reporting rate interpretation is difficult, as high rates may reflect a ‘receptive and non-punitive’ culture to improvement rather than an unsafe environment (Weingart & Page, 2004). It is viewed that among several techniques ‘prospective audits of high risk processes’ holds some hope. Under prospective audit leaders monitor high risk settings, such as the areas where the volume is large, the hazard is high, or the patient is vulnerable. Learned opinion of safety experts for persistent medical error management is to improving the system to make it more elastic to the workers’ inevitable mistakes, rather than blaming and cautioning the workers.
Mechanisms, such as the ‘rapid response and ad hoc investigative teams’, for making improvements based on the identification and analysis of specific problems, are found to improve the safety of health care. Though culture of safety is primary to safe care, experts opine that these system improvement measures are inadequate in many hospitals.
Vital steps to best practice
System improvement is proposed as vital step to best practice. “System improvement comes from looking at adverse events and the processes more commonly associated with those outcomes than with good outcomes.” (Clarke, et al, 2007). System improvement will be possible only after identifying the basic cause of risk and failure. “Failure mode” and “effect analysis” as well as “proactive hazard analyses” are considered suitable forms of identifying the likelihood of errors, calculating the risks, prioritizing the potential risks and failures, and redesigning the system to decrease the potential risks. Mandatory state medical error reporting system aims to document various types of medical errors that could be compiled and analyzed to produce feedback for guiding the health care leadership, and introducing changes in their system. Based on the effectiveness and acceptance of Pennsylvania Patient Safety Reporting System’s (PS-PSRS) Patient Safety Advisory, Clarke et al (2007) opines that “feedback seems to encourage reporting.” It is also stressed that with ‘near-miss reporting program’ patients and families will be able to provide valuable information about possible errors, and electronic capture of information will be capable to provide desired efficiency. Another strategic move is disclosing to patients the medical errors that have harmed them, which include an apology, a description of the system failure, and the plan to stop its recurrence.
Kaiser Permanent (KP) experience in overhauling health care environment
Drawing analogy between aviation and aerospace industries and health care environment Francis and colleagues (2001) of Kaiser Permanent (KP) opine that the proactive approach of aviation industry that collect essential data and focus on enhancing system safety and teamwork will help train health care practitioners to ensure the safety and protection of the patients. This approach is based on the concept that “outcomes are influenced by organizational, cultural, environmental, group, and individual dynamics.” The integrated approaches of Kaiser Permanent to improve and maintain patient safety are: leadership commitment; responsible reporting; education and training; communicating errors to patients and their families; adverse drug event error prevention program; and purchaser initiatives. From the deliberations of collaborative forum that include NASA Aviation Safety Reporting System, a critical action for error reporting system was proposed by the Kaiser Institute of Health Policy, in 2000. The actions proposed voluntary safety improvement reporting system that has the legal protection from Congress, and federal funding to test an expanded Veterans Administration prototype. Applying methods similar to aviation industry to develop attitudinal surveys of physicians, nurses and other unit staff members for evaluating the ‘blamefree environment’ is used to educate the organization and provide the members opportunities for development.
Avoiding adverse events for promoting patient safety
“Adverse events are estimated to affect up to 17% of hospitalized patients and cause up to 98,000 patient deaths per year in the United States” (Gould, 2007). Three main systemic issues contributing to adverse events are “(1) failure to plan; (2) failure to communicate; and (3) failure to recognize a patient’s deteriorating condition”. Lack of communication among hospital staff and inadequate patient assessments are identified as the major causes of adverse events. Kaiser Permanente initiative, under Transforming Care at the Bedside (TCAB) program, constituting a Rapid Medical Response Team (RMRT) is worth analyzing to understand how adverse events could be eliminated. RMRT is aimed at decreasing the number of ‘failure-to-rescue’ events. RMRT have been successfully used in Australia since 1990, though it is a new initiative in the U.S. Rapid Medical Response Team (RMRT) provides a “Systematic mechanism for medical-surgical staff to obtain immediate critical care expertise in evaluating patients and providing early intervention to minimize or prevent deterioration of patient’s conditions.” (Gould, 2007).
It is observed that RMRT’s reduced incidence of cardiac arrests outside the intensive care unit (ICU) by 50%, reduced rate of medical-surgical transfer to the ICU by 25% to 30%, and decreased hospital mortality by up to 26%. RMRT’s helps improve partnership between hospital units and enhance communication and clinical skills among hospital staff, in addition to improving safety, quality, and care for patients. A comparative analysis on the impact of RMRT against non-ICU code data, from 2004 to 2005, at Roseville Medical Centre showed that RMRT made complete cultural change for the center and positive impact on crisis management. It is also worth noting that the success of the project was possible with the solid support from executive leadership throughout the implementation of RMRT. Success of Roseville Medical Center RMRT, that too without additional cost, has prompted all of Northern California and several of KP Southern California Medical Centers to introduce RMRT in their centers.
Strategies to avoid mistakes
Most mistakes committed are easily corrected and generally cause no harm, but mistakes in the health care industry are irreversible. It is inherent in human to make mistakes, and through trial and error we are capable of near perfection. “Recognizing that humans make mistakes, high-risk industries other than the health care industry have gone to develop systems that take human factors into consideration” (Francis, 2001). Human factor training that provides various countermeasures against error is considered capable of addressing ‘human performance limiters’. Aviation industry model of training methodologies provides counter measures, such as role play, simulation, and case study that allow crews to practice error management in non-hazardous situations and to receive timely, specific feedback on their collective performance. Dr David Gaba and colleagues at the Palo Alto Veterans Hospital were among the pioneers in adopting error management training program model used in commercial aviation. The Anesthesia Crisis Resource Management course of KP imparts training in” understanding of human error patterns, factors that increase errors, practical strategies to manage errors, and formal training in teamwork and communication.” (Francis, 2001). Another initiative of KP in patient safety is aimed at preventing adverse drug events through ‘Smart Orders’, ‘High-alert medications’, ‘Look-alike/Sound-alike (LASA) drugs’, and ‘Standardization of intravenous medication’. Smart Orders monitor medication errors resulting from physician order transcription. High-alert medication identifies high risks of causing injury or fatality of medication misuse. Standardizing concentration of intravenous medications used in adult nursing units is another course to prevent adverse drug events. Entering partnership with ‘Leapfrog group,’ a consortium of Fortune 500 companies and other large purchasers of health care services is further step in improving patient safety. The experience of KP demonstrates that partnership with clinical, management, and labor groups provide highly reliable quality of care.
Advantages of Leadership WalkRrounds
It is argued that although health care industry “has made phenomenal advances in improving the care delivered, advances in the safety of delivery environment have not been comparable.” (Frankel et al, 2003). Since health care outcomes are directly linked with medication error, health care regulators and researchers are in search of successful models adopted in high-risk industries like nuclear power and aviation that could be integrated into health care industry. The safety culture of aviation industry is the consequence of the “influence of engineers, with their interest in human factors, and cognitive psychologists, with their interest in teamwork.” (as quoted by (Frankel et al, 2003, p.16). Only through mutual participation of individuals, both at the receiving end and delivery end of care, with skills to evaluate his or her environment for potential harm and prompt to act according to the situation warrants health care system could be made safe and errorless. Institute for Healthcare Improvement’s (IHI: Boston) concept of “WalkRounds” as a tool to connect senior leadership to patient safety and to inculcate safety ideas into the health care system is deemed to deliver a “self-sustaining process that would continue to engage leadership, educate clinicians and managers, and lead to continuous improvement.” (Frankel et al, 2003, p.16).
The objective of WalkRounds conceptualized by Allan Frankel is to: increase awareness of safety issues by all clinicians; making safety a high priority for senior leaders; educating staff about patient safety concepts; and responding to safety problems and issues. A core group comprising senior executives, besides hospital leaders, clinicians, pharmacists, and nurses and other staff visits different areas of the hospital weekly and enquires adverse events as well as factors and system issues associated with the events. The feedback on specific questions about adverse events or near misses are recorded, analyzed, and classified according to contributing priority factors. The efficacy of recommendations of weekly WalkRounds is monitored quarterly by a joint committee of vice presidents and executives, making it the ultimate responsibility of leadership to ensure accountability. Since WalkRounds are tied into peer review structure the results are reported to a peer review committee of hospital, clinical, and administrative leadership. With the involvement of executives having diverse knowledge and field of experience their combination in the core group of WalkRounds will provide a well-organized support structure that is helpful to exchange ideas for improvement. WalkRounds is visualized to “help educate leadership and frontline staff in patient safety concepts and will lead to cultural changes… and an improved rate of safety-based changes.” (Frankel et al, 2003, p.26).
What must leaders do to improve health care?
Leaders in health care comprise not only chiefs of medicine, nursing, quality control, risk and safety, and others, but also chief executive officers and board members. All the leaders and their medical and non-medical support staff have the responsibility to provide high quality care as per the mission of their institution. It is the prime responsibility of leaders to assert system improvement, and foster a culture of safety that ‘encourages identification of mistakes’ and ‘does not tolerate at-risk behavior’. Above all, “leaders need to strive for safe care, not just safer care than others” (Clarke, 2007). Major suggestions proposed by Clarke et al, for leadership initiative to demonstrate leadership in patient safety, among other things, include: educating board members and senior management about patient safety, and training all providers; having a commitment to patient safety incorporated in the institutional mission statement, constituting patient safety committee with designated leader, and demonstrating commitment in all interactions; maintaining transparency in dissemination of information and having confidential reporting system, devoid of individual victimization; and compiling and analyzing patient safety reports and monitoring patient safety improvement efforts ( Table 1, p. 315). Establishing a patient safety office in each institution, with patient safety committee that interact with other patient safety experts and advocates in patient safety program, will assist the health care leaders to monitor safety at the highest level.
New paradigm in quality care
According to Robert M. Wachter of University of California, San Francisco (UCSF), an expert in healthcare research and quality, IOM Report of 1999 “got the focus on quality and patient safety started, but governing boards “didn’t automatically jump up” and focus their efforts on quality” highlight the lethargy of health care leaders in adopting changes. In the words of Cara Nageli, Senior Healthcare Writer of Risk Management Reporter “governing boards focused more on financial performance than patient safety and quality of care” traditionally (Risk Management Reporter, 2008). Though the IOM recommendations on quality care was issued in 1999 critics point out that focus on board involvement in quality efforts began only recently, particularly in 2006 with IHI announcement of “5 Million Lives Campaign.” (Risk Management Reporter, 2008 ). The campaign envisages preventing five million cases of patient harm from December 2006 to December 2008 by recommending 12 interventions for participating healthcare facilities, of which one intervention is “getting the boards on board” (Risk Management Reporter, 2008). This initiative is to make the governing boards fully involved in the executive effort to improve safety and quality, and establishing executive accountability. In addition, the report “some facilities are holding chief executive officers (CEOs) and other senior executives accountable for meeting patient safety and quality goals by ensuring that some of their pay depends on it” emphasize that CEOs cannot escape from the moral responsibility of providing error free and safe patient care (Risk Management Reporter, 2008). Now the new slogan “Pay for performance” as an effective strategy for improving the quality of care is gaining momentum. The ‘Leapfrog Group’ has documented almost 100 private sector initiatives tying payment to quality measure and an Institute of Medicine Committee is carrying out a congressionally mandated study to adopt this strategy gives credential to the catch word “Pay for performance.” (What to do about health care costs: Rewarding performance to reduce prices. 2005).
Conclusion
It is generally accepted that a few bad providers make medical errors that could have been prevented if they had been more careful. On the contrary, those who study error say that “anyone is capable of making a mistake and systems need to be developed to produce reliable results that are not dependent on providers being perfect” (Clarke, JR; Lerner, JC; & Marella, W, 2007). Ensuring patient safety is more challenging than general hospital administration, because health care outcomes may occasionally act contrary to its intended aim of reducing pain and suffering. Unintentional harm is a troubling event for the patient, their family, and those who provide care and will tarnish the reputation of the institution and its chief executives as well. Integrating general management principles with safety leadership in the operation and execution of health care will help monitor the organizational culture and build trust with workers. Robust management principles will assist chief executive officers to estimate the acceptance level of any new program proposal and to anticipate source of resistance. Standardizing the expectations of stake holders, building trust with workers, and understanding the perceived self-interest of individuals are crucial for effective safety leadership. Setting explicit targets for safety managers and offering rewards for their achievements will help reduce adverse outcomes. To achieve this goal chief executive officers should allocate time for teaching and mentoring. Evaluating and espousing best practices and technology and exploring the advantages of electronic medical records for data analysis will help reduce the burden of chief executive officers.
References
Information regarding final rule: The patient safety and quality improvement act of 2005. (n.d.). PSO Home: Patient Safety Organizations.
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The patient safety and quality improvement Act of 2005. (2008). AHRQ Agency For Healthcare Research And Quality. Web.
To ERR is human: Building a safer health system. (1999). Institute of Medicine: Shaping the Future of Health.
To err is human: Health care system odds with itself. (1999). Institute of Medicine: Shaping the Future of Health. 2.
What to do about health care costs: Rewarding performance to reduce prices. (2005). The Common Wealth Fund.