"Do No Harm": Can Healthcare Live Up to It?

ABSTRACT

The healthcare sector is a very important one in many countries and faces numerous quality and performance problems of great significance to all citizens who live there. Although there are many performance parallels between healthcare and other sectors, there are also numerous special issues and terminology, as well. Recent publications on medical errors have put the spotlight on the issue of safety in healthcare. There are opportunities for the healthcare sector to learn from other industries where many techniques and practices for preventing errors have already proved their worth. It is important and beneficial to encourage healthcare specialists to learn from other sectors the concepts, best practices, and tools for preventing errors and improving safety. This topic addresses the key issues and challenges relating to the management and transfer of such knowledge and places them in the context of quality and knowledge management.

INTRODUCTION

Public spending on healthcare in Germany, France, Canada, UK, US, Australia, and Japan is at least 5% of their respective Gross Domestic Products (GDPs). In the US, UK, Australia, and Canada major health reforms have been proposed (The Economist, 2003). The total spending (public and private) in the healthcare sector in the US accounts for roughly 14% of its national income. In the US, the federal and state governments are the largest payers for healthcare services. The last decade has witnessed increasing attention to the healthcare-related issues such as widening coverage for access to healthcare, cost containment, quality of care, and regulation. These issues have been debated in legislative, academic, and professional forums. Issues concerning safety and quality have recently been in the public limelight. Recent publications have increased public awareness of safety or lack thereof in healthcare systems. They are the Institute of Medicine’s (IOM) study titled To Err is Human: Building A Safer Health System (Institute of Medicine, 2000) and the follow-up report that was triggered by it, Report of the Quality Interagency Coordination (QuIC) Task Force to the President (Quality Interagency Coordination Task Force, 2000). The second report of the IOM, Crossing the Quality Chasm: A New Health System for the 21st Century (Institute of Medicine, 2001) goes beyond safety and identifies other areas where the need for improvement is urgent. Safety is viewed as one of the dimensions of healthcare performance. Effectiveness, patient-centeredness, timeliness, efficiency, and equity are the other dimensions. One of the ten recommended principles to guide the design of health systems is that safety should be system property (Institute of Medicine, 2001). The patient safety issue is not confined to the US. In the UK, a report published in June 2000 estimated 840,000 incidents and errors occur in the National Health Service (NHS) every year (BBC News, 2001).

QUALITY MANAGEMENT IN HEALTHCARE

The traditional approach to quality management in healthcare has relied on licensure, certification and accreditation, and the use of chart review methods. Over the years, a number of organizations have been involved in the development and deployment of these structural quality assurance mechanisms. Most notable are the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), Commission on Professional and Hospital Activities (CPHA), Regional Medical Programs (RMPs), Experimental Medical Care Review Organizations (EMCROs), Professional Standards Review Organizations (PSROs), and Peer Review Organizations (PROs). In one sense, these organizations form the backbone of the regulatory structure of the healthcare industry. Thus, the traditional quality management was externally driven. The positive aspect of this system is that it provides safeguards to the public in terms of standards of healthcare and minimal competence of the healthcare professionals and ensures at least minimal participation of those professionals in quality management activities (Williamson, 1991). Its shortcomings are that it uses the negative incentive of punishment in the cases of non-compliance, and the underlying premise seems to be that sanctions are needed to ensure quality. It does not promote learning. It also involves a lot of paperwork, absorbing time and effort while achieving only modest improvements.

In the last 15 years or so, there have been many instances where the healthcare organizations have used the principles that underlie the industrial quality control model (Chesanow, 1997). These are the principles of total quality management (TQM) and continuous quality improvements (CQI) that have been successfully implemented in the manufacturing sector.

Briefly, these principles can be summarized as follows (Berwick, Godfrey & Roessner, 1990a): (1) productive work is accomplished through processes; (2) sound customer-supplier relationships are absolutely necessary for sound quality management; (3) the main source of quality defects is problems in the process; (4) poor quality is costly; (5) understanding the variability of processes is a key to improving quality; (6) the modern approach to quality is thoroughly grounded in scientific and statistical thinking; (7) total employee involvement is critical; (8) quality management employs three basic interrelated activities: quality planning, quality control, and quality improvement.

There have been many case studies of applications of CQI in healthcare (Carey & Lloyd, 1995). However, the concepts and tools of CQI did not always find acceptance among healthcare administrators and providers. Skepticism such as: “How do we define and measure quality, which is a more subtle concept in healthcare?”, “Isn’t quality mainly a matter of the physician making the correct decision?”, “Where is the uniform product in medical care when every patient is different?” were expressed.

It is difficult to generalize about the effects of TQM in healthcare from isolated examples. Fortunately, the National Demonstration Project (NDP) on Quality Improvement in Healthcare provides a collection of experimental projects whose purpose was to study if the TQM model will work in the healthcare setting (Berwick, Godfrey & Roessner, 1990a). The NDP brought together 21 experts in quality management to work with a leadership team in 21 healthcare organizations represented by health maintenance organizations (HMOs), hospitals, and group practices in the US. The experts (who were from major US companies, consulting firms, and universities) were to offer their expertise in transferring quality management concepts and tools to these organizations that were willing to try them out. The participating organizations were to report on the results eight months later. Even though not all of the 21 teams completed the projects and reported back, the experiences of all of them contributed to the following important lessons learned (Berwick, Godfrey & Roessner, 1990b): (1) quality improvement tools can work in healthcare; (2) cross-functional teams are valuable in improving healthcare processes; (3) data useful for quality improvement abound in healthcare; (4) costs of poor quality are high, and savings are within reach; (5) involving doctors is difficult; (6) training needs arise early; (7) non-clinical processes draw early attention; (8) healthcare organizations may need a broader definition of quality; (9) in healthcare, as in other industries, the fate of quality improvement is first of all in the hands of leaders.

Despite these important insights that were gleaned from these projects, as acknowledged by the initiators of the project, there were two major gaps that were associated with these projects (Berwick, Godfrey & Roessner, 1990b). First, only a few project teams addressed core clinical processes such as physician decision-making, diagnostic strategies, and medical treatments. This seems to be in agreement with other research findings on the application of TQM in healthcare (Shortell, Levin, O’Brien & Hughes, 1995). Most teams worked on business and service support processes such as appointment waiting times, Medicare billing, patient discharge processes, and the hiring and training of nurses. Here the problems were similar to the quality problems in other industries. Interestingly enough, not even one of the teams measured success in terms of improved health status of the patient! Another gap was that the projects did not try to change the organizational cultures. Clearly, both these gaps have to be addressed in any effort to reduce or eliminate medical errors.

ERRORS IN HEALTHCARE

It is instructive to consider some findings about the occurrence and the impact of errors in healthcare. These stylized facts bring home in a compelling way the significance and the enormity of the tasks that lie ahead in the prevention of these errors. According to the IOM report (Institute of Medicine, 2000):

• Preventable adverse events (see the following below) are a leading cause of death in the United States. When extrapolated to the more than 33.6 million admissions to US hospitals in 1997, the results of two studies (involving large samples of hospital admissions, one in New York and the other in Colorado and Utah) imply that at least 44,000 and perhaps as many as 98,000 Americans die in hospitals each year as a result of medical errors. Deaths due to preventable adverse events exceed the deaths attributable to motor vehicle accidents (43,458), breast cancer (42,297) or AIDS (15,516).

• The rate of healthcare errors is far higher than the error rate in other industries. In one study of intensive care units (ICU), the correct action was taken 99.0% of the time, translating to 1.7 errors per day. One out offive ofthese errors was serious and/or potentially fatal. If performance levels even substantially better than those found in the ICU (for example, 99.9%, a 10-fold reduction in errors) were applied to the airline and banking industries, it would still equate to two dangerous landings per day at O’Hare International Airport and 32,000 checks deducted from the wrong account per hour (Leape, 1994)! In these industries, such error rates would not be tolerated.

• Errors occur not only in hospitals but in other healthcare settings, such as physicians’ offices, nursing homes, pharmacies, urgent-care centers, and care delivered in the home. Unfortunately, very little data exist on the extent of the problem outside of hospitals. The IOM report indicated, however, that many errors are likely to occur outside the hospital. For example, in a recent investigation of pharmacists, the Massachusetts State Board of Registration in Pharmacy estimated that 2.4 million prescriptions are filled improperly each year in the state (Agency for Healthcare Research and Quality, 2003b).

Errors in healthcare do not lend themselves to commonly agreed-upon definition and classification. This poses a challenge in the design and implementation of measures to prevent them. For instance, according to IOM, an 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. However, QuIC (Quality Interagency Coordination Task Force, 2000), in order to address all the relevant issues, has expanded the IOM definition as follows: An 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. Errors can include problems in practice, products, procedures, and systems.


Medical error is defined through adverse events. An adverse event is an injury caused by medical management rather than the underlying condition of the patient. An adverse event attributable to error is a “preventable adverse event.” Negligent adverse events represent a subset of preventable adverse events that satisfy legal criteria used in determining negligence, i.e., whether the care provided failed to meet the standard of care reasonably expected of an average physician qualified to take care of the patient in question (Institute of Medicine, 2000).

Medical error is an adverse event or near miss that is preventable with the current state of medical knowledge. Note that consideration of errors is broadened beyond preventable adverse events that lead to actual patient harm to include “near misses,” sometimes known as “close calls.” A “near miss” is an event or situation that could have resulted in an accident, injury, or illness, but did not, either by chance or through timely intervention. The broader definition of error allows learning from close calls as well as from incidents leading to actual harm (Quality Inter-agency Coordination Task Force, 2000). Such learning has proved to be very valuable in other industries, such as aviation and nuclear power. It is also worth noting that not all adverse errors are preventable. Unpreventable adverse event is defined as an adverse event resulting from a complication that cannot be prevented given the current state of knowledge.

The implication of these definitions and classifications is that a single approach to error reduction and prevention is not fruitful. Different types of errors call for different approaches.

Error Prevention in Other Industries

Error prevention strategies in other industries have been part of an overall strategy for process improvement. The important features of these strategies can be summarized as follows:

1. They have emphasized the control of the variation in the process. Sets of tools that help to monitor, identify, and eliminate the root causes of process variations were utilized. How the responses of management can reduce or amplify the variation in the process was understood by considering the common and special causes of variation. The important lesson was that only management could and must do something about common causes of variation. Control charts were used to monitor process stability and signal the presence of special causes of variation. It must be pointed out that in Complex Adaptive Systems (CAS) like healthcare one has to carefully distinguish between meaningful variation resulting from innovation and variation which leads to waste.

2. Processes were simplified; standards were developed, documented, and adhered to. One of the principles of lean manufacturing is to simplify the process and make it transparent to the workers (Womack, Jones & Roos, 1990). Simple and visual signals like kanban cards and a system of lights are used in the pull system of Just-in-Time (Schon-berger, 1986). Errors can be easily detected and prevented in a visual factory. Standardization of work methods — which implies reduction of variation — is considered an important aspect of kaizen or continuous improvement. Once a process is improved using tools like the Plan Do Check/Study Act (PDC/SA) cycle, it is documented for future use. Standardization encompassed all aspects of the process. For instance, a system like the 5S encompassed housekeeping and promoted safety in the work place (Shaw & Gillard, 1996). Food production and service is an industry where safety is of paramount importance. As part of its efforts to enhance the safety of food supply system in the US, the Food and Drug Administration (FDA) has mandated Hazard Analysis and Critical Control Point (HACCP) systems as a prevention standard. HACCP systems represent a systematic approach to the identification and control of the biological, chemical, and physical hazards that are reasonably likely to occur in a particular food in a particular production process.

3. Inexpensive but effective solutions were used to design errors out. Poka-yoke or error proofing is a powerful, simple, and often inexpensive technique for eliminating mistakes from occurring in the first place or to provide early warning that a mistake is about to occur. The basic ideas behind mistake-proofing were first developed and applied by Shigeo Shingo under the rubric of Zero Quality Control (Shingo, 1986). Shingo felt that defects have to be prevented by preventing the mistakes that cause them. And this has to be designed into the elements of the process, i.e., into the equipment, procedures, the operating environment, and training of the employees. Of late, the principles of mistake-proofing have also been applied to service processes. An application in healthcare is the use of indented trays in surgical procedures to prevent surgeons from leaving any particular instruments inside the patient! It is important to note that, in services, often the customer is an active participant in the service creation and delivery processes. Customer mistakes can occur at the stages of: (1) preparing for the service encounter; (2) during the encounter; and (3) post-encounter resolution (Chase & Stewart, 1995). This has important implication for application in healthcare—mistake-proofing efforts must be directed not only at the equipment and employees of the providers but customers of healthcare as well. For example, if you are a patient in a hospital, consider asking all healthcare workers who have direct contact with you whether they have washed their hands (Agency for Healthcare Research and Quality, 2003a). There is great potential for the application of mistake-proofing in healthcare.

4. Automation, information, and simulation technologies were used to reduce and prevent defects. It is well known that computer-based automation in manufacturing has led to increased process consistency enabling much tighter tolerances to be met. For instance, robots can weld and paint more uniformly than humans. Information technology has been used in service industries to improve quality and customer service, e.g., by Ritz Carlton hotel chain (Bounds, 1996). Simulation and modeling has also proved to be very valuable in providing insights about the functioning of processes. Flight simulators are routinely used in aviation for training and education. Healthcare organizations can learn from the military as well. The healthcare profession can use computer simulation and military-based teamwork training as a means of training. Human factors engineering and ergonomics is incorporated into the design of processes and systems in industries such as nuclear power. By designing jobs, machines and operations that take into account human limitations, human errors can be prevented or reduced (Rooney, Heuvel & Lorenzo, 2002).

5. Trained and empowered employees implemented error prevention methods. They often worked in a multi-disciplinary team structure. There was a cultural shift. Process improvement was no longer the responsibility of management alone. Employees were now responsible for not only doing the job but also improving it. The leadership in the organization provided the support. Employees were encouraged to report on errors and devise solutions. In some of the companies that implemented Just-in-Time (JIT), the workers were given the authority to stop the line to prevent defects from being passed down stream. Once the line was stopped, problem-solving teams were formed on the spot to address the problem (Suzaki, 1987). The aviation reporting system, which the IOM and others have suggested as a model that healthcare should emulate, depends on the collection of as much information as possible about close calls as well as errors that actually resulted in harm. In the aviation industry, the identity of those who report and those who are involved in the incident are protected. This encourages people to report errors and makes the information available quickly.

6. Organizations have benchmarked their processes to identify and close performance gaps in critical processes. The best-in-class processes — which were not necessarily in the same industry — were benchmarked. For instance, the activities of pit crews during pit stops in the motor racing circuit have been studied to benchmark worker changes on assembly lines (Walleck, O’Halloran & Leader, 1991). Granite Rock, a building materials supplier, has benchmarked its concrete mix delivery process with Domino’s pizza delivery process (Bounds, 1996)!

7. Process improvement strategies focused on multiple dimensions of process performance. The Six Sigma approach that was pioneered by Motorola in the 1980s and now being utilized by many manufacturing and service companies aims at simultaneous reduction of defect rates, cost, and cycle time in the process (Bounds, 1996). Six Sigma has been applied to manufacturing and non-manufacturing (service and business) processes (Chassin, 1998). Linking costs to quality and cycle times is a relatively new concept in healthcare (Castaneda-Mendez, 1996).

What is Different About Healthcare?

There are some characteristics of the healthcare industry that distinguish it from other industries. Although the managerial processes in the healthcare industry are similar to those of other industries, the prevalent norms, culture, practices, and the regulatory framework can promote or hinder efforts to improve safety. These characteristics also influence the extent to which the best practices for error prevention in other industries are relevant and transferable to the healthcare sector.

1. Healthcare systems are very complex systems in terms of its constituent elements (e.g., patients, physicians and other healthcare professionals, purchasers of healthcare, payers, insurers, regulators, accrediting and licensing bodies, healthcare administrators, and professional groups), the web of relationships between them, and the knowledge, skills, and technologies that are utilized (Institute of Medicine, 2000). These groups have their own definition of errors and quality in healthcare. The interests of some of these groups are also in conflict.

2. It is difficult in healthcare systems to establish precise linkages between the inputs and the resulting outcomes (Garvin, 1990). Therefore, it is not always possible to study and model the delivery of clinical care as a “process” as it is done in manufacturing. The outcomes in terms of patients’ physiological and psychological states lag —sometimes in years—the treatments they receive. The outcomes are also dependent on the cooperation and the compliance of patients themselves. In this sense, healthcare systems are quite different from other industries such as airlines, nuclear power, and food supply where safety is a critical issue. Hence, it becomes quite difficult to implement the principle that quality gurus like Dr. Deming have emphasized — quality can be improved only by improving the process. Lack of process knowledge could also be one of the factors that lead to litigation being viewed as the only recourse in the case of adverse outcomes. In fact, many legal cases in healthcare involve scrutiny of the underlying clinical processes in the courtroom.

3. In healthcare, there is an information asymmetry between the care provider and the patient. The professional judgment of the caregiver determines the nature of the clinical care that is provided. Thus, the patient often cannot judge the quality or the safety of clinical care that he or she is receiving. In this respect, healthcare may not be very different from other professional services (e.g., accounting, legal, education) where such asymmetry exists and professional judgment influences the outcomes. Nevertheless, it underscores the difficulties in developing and monitoring quality and safety standards for clinical practices. This makes the healthcare market one in which the consumers do not have the requisite information about quality, safety, and utility to make informed choices. Thus consumers cannot adequately exert their power in the market place — as it happens in other industries — to bring about changes in healthcare providers.

4. In many healthcare institutions, there are dual lines of authority — one involving the medical staff and the other the administrative staff. This complicates decision-making concerning design and implementation of safety improvement projects. In other industries, the managerial core has control over the technical core.

5. Healthcare organizations are concerned about litigation in the context of tracking and reporting medical errors. This inhibits the relevant information from being shared within and between healthcare organizations. Legal constraints on access to and sharing of information relating to patients also prevent the dissemination of the information, which could be useful in preventing errors.

6. In other industries like the automotive, large customers routinely exert pressure on their suppliers for continuous improvements in quality and costs. This is just beginning to happen in healthcare as large group purchasers want the healthcare organizations to improve their performance, but this has not become standard industry practice so far.

7. Mechanisms and institutions for research and dissemination of research on safety in healthcare are still in a developmental stage (Institute of Medicine, 2000; Quality Interagency Coordination Task Force, 2000). The difficulties are compounded by the fact that advances in clinical knowledge, medications, and technologies in healthcare are taking place very rapidly.

8. There are powerful subcultures in healthcare organizations based on occupation and specialization, e.g., physicians, nurses, and pharmacists. Their interests and functional orientations do not facilitate a systems approach to the promotion of safety (Zabada, Rivers & Munchus, 1998).

Prospects for Improving Safety in Healthcare

In the 1990s, many healthcare facilities and health plans placed an increasing emphasis on improving healthcare quality. Since 1999, it has become a requirement for managed care plans that contract directly with Medicare (Scott, 1998). However, these programs have not sufficiently addressed the problem of medical errors.

There are a number of factors that reduce the effectiveness of existing programs to prevent medical errors (Institute of Medicine, 2000). Performance measurement and improvement programs within healthcare organizations do not directly address the problem of medical errors. Programs that have been specifically developed to prevent medical errors often operate in isolation. Efforts by external organizations to monitor errors also face limitations. For example, JCAHO has experienced significant difficulty in securing hospitals’ participation in its “sentinel events” reporting system because of concerns about legal vulnerabilities or punitive actions. A number of different programs exist to detect adverse health events, although no one system is designed to detect the full scope of medical errors. Systems designed to hold organizations or individuals accountable for bad outcomes are commonly limited by underreporting of adverse events.

Clearly, the quality improvement programs within healthcare organizations could be enhanced or adapted to address errors. However, there are serious obstacles such as: (1) a lack of awareness that a problem exists; (2) a traditional medical culture of individual responsibility and blame; (3) the lack of protection from legal discovery and liability. This causes errors to be concealed; (4) the primitive state of medical information systems, which hampers efficient and timely information collection and analysis; (5) inadequate allocation of resources for quality improvement and error prevention throughout the healthcare system. No insurer pays hospitals for safety initiatives, no matter how beneficial they are. And in most hospitals, revenues are declining as private and government insurers try to cut reimbursements; (6) inadequate knowledge about the frequency, causes, and impact of errors, as well as effective methods for error prevention; (7) a lack of understanding of systems-based approaches to error reduction (such as those used in aviation safety or manufacturing); (8) there are even greater barriers to error reduction in non-hospital settings, where the general absence of organized surveillance systems and lack of adequate personnel hinder local data collection, feedback, and improvement.

The IOM report and the action agenda developed by QuIC will go a long way in addressing these barriers. The QuIC report identified the actions that have already been taken and will be taken to reduce medical errors. They included, among others, plans of Department of Defense (DoD) to implement a new reporting system in its 500 hospitals and clinics serving approximately 8 million patients. This confidential reporting system will be modeled on the system in operation at the Department of Veterans Affairs and will be used to provide healthcare professionals and facilities with the information necessary to protect patient safety. DoD providers will inform affected patients or their families when serious medical errors occur.

The Food and Drug Administration (FDA) will develop new standards to help prevent medical errors caused by proprietary drug names that sound similar or packaging that looks similar, making it easy for healthcare providers to confuse medications. The agency will also develop new labeling standards that highlight common drug-drug interactions and dosage errors related to medications.

The Department of Veterans Affairs is considered as one of the nation’s leaders in patient safety, having instituted patient safety programs in all of its healthcare facilities serving 3.8 million patients nationwide. The Veterans Administration (VA) healthcare system will form an innovative alliance with NASA to develop a medical error reporting system similar to the system NASA has operated successfully for the Federal Aviation Administration (FAA) since 1975. Aviation errors are reported by pilots, air-traffic controllers, mechanics, and all others involved in air transportation, to the Aviation Safety Reporting System (ASRS).

In 2001, the Department of Defense (DoD), investing $64 million, began the implementation of a new computerized medical record, including an automated order entry system for pharmaceuticals, that makes all relevant clinical information on a patient available when and where it is needed. It will be phased in at all DoD facilities over three years.

The QuIC member agencies, including DoD, Veterans Administration (VA), and the Agency for Healthcare Research and Quality (AHRQ), began a collaborative project with the QuIC Task Force and the Institute for Healthcare Improvement (IHI) to reduce errors in “high hazard areas,” such as emergency rooms, operating rooms, intensive care units, and labor and delivery units.

Information Technology

The federal government has played a pivotal role in the application of information technology to healthcare. It has some of the earliest research on computerized patient records, studies evaluating the impact of computer reminder systems on laboratory testing errors, and research on the effect of computers on drug ordering. VA and DoD are recognized national leaders in the implementation of electronic medical records and decision-support tools.

QuIC can have an impact through its participants’ activities in the area of electronic records and order entry. Most healthcare providers currently work with handwritten patient notes, which are often difficult to read, not readily available, incomplete, and prone to alteration, destruction, and loss. Structured, electronic order entry systems that require complete data entry remove ambiguities that arise from incomplete information or illegible writing. Real-time decision support is a powerful technological tool for error proofing. Decision-support systems can intercept errors, such as interactions between incompatible medications and the prescription of drugs to which the patient’s electronic medical record notes an allergy. Bar-coding of medications and use of robotics in dispensing medications can ensure that the appropriate medication is provided to the right patient at the right time.

Information technology can also play a very important role in preventing errors in the delivery of clinical care itself. Electronic medical records and interactive decision-support tools have the potential to allow healthcare providers timely knowledge of a patient’s health history and improve clinical care. Often physicians are overwhelmed with the changes in the knowledge base and find it hard to keep up with the literature — now they can turn to information technology for help. New England Medical Center has done work in the areas of Decision Support Systems (DSS) and Expert Systems (ES) that help physicians in making accurate diagnosis in emergencies and in selecting the best course of treatments for individuals and groups. Choices are developed by ES in the form of decision trees which incorporate individual risk preferences and special medical conditions (Grossman, 1994).

steps in the right direction

• One hospital in the Department of Veterans Affairs uses hand-held, wireless computer technology and bar-coding, which has cut overall hospital medication error rates by 70% (Agency for Healthcare Research and Quality, 2003b). This system is to be implemented in all VA hospitals. VA has an exemplary patient safety program, and the DoD is developing one that is modeled after that of VA.

• The specialty of anesthesia has reduced its error rate by nearly seven-fold, from 25 to 50 per million to 5.4 per million, by using standardized guidelines, protocols and simple mistake-proofing devices, redesigning and standardizing equipment (Agency for Healthcare Research and Quality, 2003b).

• In the UK, a missed diagnosis that almost resulted in the death of a three-year-old spurred her parents to set up a charity to develop a computer system to prevent such mistakes. The online system, called ISABEL, is free to all doctors. The rapid system uses pattern recognition software to search for information in pediatric textbooks, once it is given the symptoms. It even builds in other doctors’ experiences of making mistakes (News Telegraph, 2002).

• The VA/Stanford simulation center for crisis management in healthcare at Palo Alto, California, uses a simulator that can execute all the physiological functions and mimic many complex and realistic clinical crisis scenarios. Instructors can alter these scenarios. By simulating an actual patient during surgery as much as possible, doctors can get quick feedback on if they injected the wrong drug, made incorrect interpretations and other errors. In the future, such simulators are likely to be part of medical education (Institute for Healthcare Improvement, 2000).

• SSM Healthcare became the first winner of the Baldrige award in the healthcare sector (National Institute of Standards and Technology, 2003). Sister Mary Jean Ryan, the CEO of SSM for last 17 years, said she once failed to report her own error in medicating a patient, so SSM has created a “blame-free” zone for reporting not only errors but near-misses. “Half the reported incidents lead directly to system improvements,” she said (Broder, 2002).

• General Motors (GM), which has 1.25 million people in its health plans, is the largest private purchaser of healthcare in the US. It is working with partners in the healthcare industry to teach them principles of lean organization such as standardized work; workplace organization and visual controls; error proofing; employee process control; planned maintenance; and reduction of variation (Shapiro, 2000). Some hospitals have tried to be proactive in adapting such best practices from manufacturing by implementing patient-focused care teams analogous to manufacturing cells (Taylor, 1994).

• “The Medical Center of Ocean County has embraced an approach that has put the facility in Brick, New Jersey, on the cutting edge of medication system developments” (Darves, 2002). The new system involves using pharmacy technicians both on nursing units and in the emergency department and implementing Just-in-Time (JIT) delivery of medications to replace the traditional 24-hour cart system. Patient safety has improved, time savings have accrued, and nurse and patient satisfaction has increased.

• In an important development in the dissemination of comparative data, the federal centers of Medicare and Medicaid have developed a massive database, including in it every one of the 17,000 Medicare and Medicaid-certified nursing homes in every state in the US. This data is now available online (Medicare, 2003) and also on a toll-free telephone number, 1-800-MEDICARE (Medicare, 2003). For the first time, objective comparisons on several quality measures and inspection results can be made. It also provides individual nursing homes a database to benchmark, learn, and improve quality of care.

Other than the initiatives spawned by the above-mentioned federal agencies and taskforces, a number of other non-governmental programs have also been launched. For instance, the Leapfrog group was formed by the Business Roundtable in 2000. Leapfrog is a coalition of more than 135 public and private healthcare organizations and a voluntary program which has as part of its mission “… to help save lives and reduce preventable medical mistakes by mobilizing employer purchasing power to initiate breakthrough improvements in the safety of healthcare and by giving consumers information to make more informed hospital choices” (Leapfrog Group, 2003). It has focused on three patient safety practices that it believes have the potential to save lives by reducing preventable medical mistakes in hospitals. They are: Computer Physician Order Entry, Evidence-Based Hospital Referral, and Intensive Care Unit Physician Staffing. The group gathers data from hospitals on their status with regard to these practices and makes the information available to the consumers and communities.

The American Society for Quality (ASQ) is partnering with the National Patient Safety Foundation (NPSF) to offer solutions for reducing errors and increasing patient safety. Successful applications of methods such as Six Sigma will be shared in the events organized by them. ASQ is also influencing public policy in this area. It has presented a paper to the congressional health policy staff advocating the wider adoption of proven quality methods in an effort to reduce medication errors (American Society for Quality, 2002).

In the UK, where the National Health Service (NHS) is the major provider of healthcare, the National Public Safety Agency (NPSA) has been created. It is a special health authority created in July 2001 to coordinate the efforts of the entire country to report, and more importantly to learn from, adverse events occurring in NHS-funded care. The NPSA will collect and analyze incident and other patient safety information and provide timely and relevant feedback to healthcare organizations, clinicians, and other healthcare professionals, and patients (National Patient Safety Association, 2003).

While these success stories and developments contribute to the application of knowledge management systems to improve patient safety, a word of caution may be in order. The success stories may indicate what has worked in specific instances, but given the nature of the industry not too much is going to be heard about failures. The knowledge about what does not work may be lacking.

In one sense, the task of transferring best practices is made easier in the case of healthcare. In the 1980s, when the manufacturing sector in the US faced a crisis with respect to product quality and competitiveness, not many role models and forums for sharing best practices were available. The Baldrige Award was set up to address that gap. But today, there is no shortage of knowledge or the mechanisms to disseminate that knowledge. The Baldrige framework has been extended to the healthcare sector. Award winners such as SSM Healthcare can serve as role models. There are many other state and local quality award programs that provide avenues for sharing best practices. Within healthcare itself, organizations like the National Coalition for Healthcare, Institute for Healthcare Improvement, Leapfrog Group, and The National Patient Safety Foundation disseminate the best practices.

These forums and mechanisms are indeed necessary, but they are not sufficient to ensure the actual transfer of these best practices. For instance, it has been noted that the National Safety Partnership publicized a list of 16 proven and accepted best practices in medication safety. Many of them have been known for years but most are not used in a majority of hospitals. The case of the health care industry in Japan also reinforces this point. Despite having a manufacturing industry known for its world class quality management system, the healthcare system in Japan did not undergo a similar quality revolution (Wocher, 1997). The reasons for this are rooted in the institutional characteristics of the Japanese healthcare sector. According to Wocher, the Japanese healthcare sector lags far behind US in terms of efficiency, overall management, and the application TQM and CQI ideas (Wocher, 1997).

All this leads one to conclude that there has to be a “felt need” for industry-wide, effective prevention of errors, and improving patient safety. At the level of an individual healthcare organization, this “felt need” will be generated by a mixture of factors. They are: (1) the organizational leadership that is willing and able to overcome the internal obstacles; (2) economic incentives from the market place that affect the bottom-line; (3) external compulsions by the consumers, purchasers, payers, accreditors, and regulators; and (4) the leadership role and the role models of the federal agencies. Earlier discussion of the above issues suggests that, of late, there are encouraging signs that some traction for improving patient safety has been created by these factors. And that portends well for patient safety and knowledge management for patient safety as well.

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