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Page 155 8— Creating Safety Systems in Health Care Organizations Unsafe acts are like mosquitoes. You can try to swat them one at a time, but there will always be others to take their place. The only effective remedy is to drain the swamps in which they breed. In the case of errors and violations, the "swamps" are equipment designs that promote operator error, bad communications, high workloads, budgetary and commercial pressures, procedures that necessitate their violation in order to get the job done, inadequate organization, missing barriers, and safeguards . . . the list is potentially long but all of these latent factors are, in theory, detectable and correctable before a mishap occurs.1 Safety systems in health care organizations seek to prevent harm to patients, their families and friends, health care professionals, contract-service workers, volunteers, and the many other individuals whose activities bring them into a health care setting. Safety is one aspect of quality, where quality includes not only avoiding preventable harm, but also making appropriate care available—providing effective services to those who could benefit from them and not providing ineffective or harmful services.2 As defined in Chapter 3, patient safety is freedom from accidental injury. This definition and this report intentionally view safety from the perspective of the patient. Accordingly, this chapter focuses specifically on patient safety. The committee believes, however, that a safer environment for patients would also be a safer environment for workers and vice versa, because both
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Page 156 are tied to many of the same underlying cultural and systemic issues. As cases in point, hazards to health care workers because of lapses in infection control, fatigue, or faulty equipment may result in injury not only to workers but also to others in the institution. This chapter introduces what has been learned from other high-risk industries about improving safety. It then discusses key concepts for designing systems and their application in health care. This is followed by a discussion of five principles to guide health care organizations in designing and implementing patient safety programs. Lastly, the chapter discusses a critical area of safety, namely medication safety and illustrates the principles with strategies that health care organizations can use to improve medication safety. Recommendations The committee is convinced that there are numerous actions based on both good evidence and principles of safe design that health care organizations can take now or as soon as possible to substantially improve patient safety. Specifically, the committee makes two overarching recommendations: the first concerns leadership and the creation of safety systems in health care settings; the second concerns the implementation of known medication safety practices. RECOMMENDATION 8.1 Health care organizations and the professionals affiliated with them should make continually improved patient safety a declared and serious aim by establishing patient safety programs with a defined executive responsibility. Patient safety programs should: (1) provide strong, clear, and visible attention to safety; implement nonpunitive systems for reporting and analyzing errors within their organizations; (2) incorporate well-understood safety principles, such as, standardizing and simplifying equipment, supplies, and processes; and (3) establish interdisciplinary team training programs, such as simulation, that incorporate proven methods of team management. Chief executive officers and boards of trustees must make a serious and ongoing commitment to creating safe systems of care. Other high-risk industries have found that improvements in safety do not occur unless there is commitment by top management and an overt, clearly defined, and continuing effort on the part of all personnel and managers. Like any other program, a meaningful safety program should include senior-level leadership,
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Page 157 defined program objectives, plans, personnel, and budget, and should be monitored by regular progress reports to the executive committee and board of directors. According to Cook,3 Safety is a characteristic of systems and not of their components. Safety is an emergent property of systems. In order for this property to arise, health care organizations must develop a systems orientation to patient safety, rather than an orientation that finds and attaches blame to individuals. It would be hard to overestimate the underlying, critical importance of developing such a culture of safety to any efforts that are made to reduce error. The most important barrier to improving patient safety is lack of awareness of the extent to which errors occur daily in all health care settings and organizations. This lack of awareness exists because the vast majority of errors are not reported, and they are not reported because personnel fear they will be punished. Health care organizations should establish nonpunitive environments and systems for reporting errors and accidents within their organizations. Just as important, they should develop and maintain an ongoing process for the discovery, clarification, and incorporation of basic principles and innovations for safe design and should use this knowledge in understanding the reasons for hazardous conditions and ways to reduce these vulnerabilities. To accomplish these tasks requires that health care organizations provide resources to monitor and evaluate errors and to implement methods to reduce them. Organizations should incorporate well-known design principles in their work environment. For example, standardization and simplification are two fundamental human factors principles that are widely used in safe industries and widely ignored in health care. They should also establish interdisciplinary team training programs—including the use of simulation for trainees and experienced practitioners for personnel in areas such as the emergency department, intensive care unit, and operating room; and incorporating proven methods of managing work in teams as exemplified in aviation (where it is known as crew resource management). RECOMMENDATION 8.2 Health care organizations should implement proven medication safety practices. A number of practices have been shown to reduce errors in the medication process and to exemplify known methods for improving safety. The committee believes they warrant strong consideration by health care organi-
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Page 158 zations including hospitals, long-term-care facilities, ambulatory settings, and other health care delivery sites, as well as outpatient and community pharmacies. These methods include: reducing reliance on memory; simplification; standardization; use of constraints and forcing functions; the wise use of protocols and checklists; decreasing reliance on vigilance, handoffs, and multiple data entry; and differentiating among products to eliminate look-alike and sound-alike products. Introduction Errors occur in all industries. Some industrial accidents involve one or a few workers. Others affect entire local populations or ecosystems. In health care, events are well publicized when they appear to be particularly egregious—for example, wrong-site surgery or the death of a patient during what is thought to be a routine, low-risk procedure. Generally, however, accidents are not well publicized; indeed, they may not be known even to the patient or to the family. Because the adverse effects may be separated in time or space from the occurrence, they may not even be recognized by the health care workers involved in the patient's care. Nevertheless, we know that errors are ubiquitous in all health care settings.4 Harms range from high-visibility cases to those that are minimal but require additional treatment and time for the patient to recuperate or result in a patient's failure to receive the benefit of appropriate therapy. In aggregate, they represent a huge burden of harm and cost to the American people as described in Chapter 2. To date, however, those involved in health care management and delivery have not had specific, clear, high-level incentives to apply what has been learned in other industries about ways to prevent error and reduce harm. Consequently, the development of safety systems, broadly understood, has not been a serious and widely adopted priority within health care organizations. This report calls on organizations and on individual practitioners to address patient safety. Health care is composed of a large set of interacting systems—paramedic, emergency, ambulatory, inpatient care, and home health care; testing and imaging laboratories; pharmacies; and so forth—that are connected in loosely coupled but intricate networks of individuals, teams, procedures, regulations, communications, equipment, and devices that function with diffused management in a variable and uncertain environment.5 Physicians in community practice may be so tenuously connected that they do not even
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Page 159 view themselves as part of a system of care. They may see the hospitals in which they are attendings as platforms for their work. In these and many other ways, the distinct cultures of medicine (and other health professions) add to the idiosyncrasy of health care among high-risk industries. Nevertheless, experience in other high-risk industries has provided wellunderstood illustrations that can be used in improving health care safety. Studies of actual accidents, incident-reporting systems, and research on human factors (i.e., the interface of human beings and machines and their performance in complex working environments) have contributed to our growing understanding about how to prevent, detect, and recover from accidents. This has occurred because, despite their differences from health care, all systems have common characteristics that include the use of technologies, the users of these technologies, and an interface between the users and the technologies.6 The users of technology bring certain characteristics to a task such as the quality of their knowledge and training, level of fatigue, and careful or careless habits. They also bring characteristics that are common to everyone, including difficulty recalling material and making occasional errors. Safety Systems in High-Risk Industries The experience in three high-risk industries—chemical and material manufacturing and defense—provides examples of the information and systems that can contribute to improved safety and of the safety achievements that are possible. Claims that health care is unique and therefore not susceptible to a transfer of learning from other industries are not supportable. Rather, the experiences of other industries provide invaluable insight about how to begin the process of improving the safety of health care by learning how to prevent, detect, recover, and learn from accidents. E.I. du Pont de Nemours and Company E.I. du Pont de Nemours and Company has one of the lowest rates of occupational injury of any company, substantiation of an 11-point safety philosophy that includes the tenets that all injuries are preventable; that management is responsible and accountable for preventing injury; that safety must be integrated as a core business and personal value; and that deficiencies must be corrected promptly. In 1994, Conoco Refining, a subsidiary, reported only 1.92 work-loss days per 200,000 hours of exposure. In 1998,
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Page 160 this rate was further reduced to 0.39. Some of DuPont's plants with more than 2,000 employees have operated for more than 10 years without a losttime injury, and one plant producing glycolic acid celebrated 50 years without a lost workday.7 DuPont credits its safety record, at least in part, to its implementation of a nonpunitive system to encourage employees to report near-miss incidents without fear of sanctions or disciplinary measures and its objective to create an all-pervasive, ever-present awareness of the need to do things safely.89 Alcoa, Inc. Another industry example is Alcoa, which is involved in mining, refining, smelting, fabricating, and recycling aluminum and other materials. Alcoa uses a worldwide on-line safety data system to track incidents, analyze their causes, and share preventive actions throughout all of its holdings. One of its principles is that all incidents, including illnesses, injuries, spills, and excursions, can be prevented whether they are immediate, latent, or cumulative. Although Alcoa reduced its international lost work day rate per 200,000 hours worked from 1.87 in 1987 to 0.42 in 1997, it has recently gone even further and announced a plan to eliminate fatalities and reduce the average injury rate by 50 percent by the end of the year 2000.10 Several aspects of these two examples are striking. In comparison to the health care industry, DuPont, Alcoa, and others systematically collect and analyze data about accidents. They have been tracking their own performance over time and are able to compare themselves to others in their industries. They are willing to publish their results as information to which stockholders and employees are entitled and as a source of pride, and their efforts have achieved extremely low and continuously decreasing levels of injury. The importance of a strong culture of safety, as nurtured by both DuPont and Alcoa, is viewed by many in the safety field as being the most critical underlying feature of their accomplishments. U.S. Navy: Aircraft Carriers People are quick to point out that health care is very different from a manufacturing process, mostly because of the huge variability in patients and circumstances, the need to adapt processes quickly, the rapidly changing knowledge base, and the importance of highly trained professionals who must use expert judgment in dynamic settings. Though not a biological sys-
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Page 161 tem, the performance of crews and flight personnel on aircraft carriers provides an example that has features that are closer to those in health care environments than manufacturing. On an aircraft carrier, fueling aircraft and loading munitions are examples of the risks posed when performing incompatible activities in close proximity. On the flight deck, 100 to 200 people fuel, load munitions, and maintain aircraft that take off and are recovered at 48- to 60-second intervals. The ability to keep these activities separate requires considerable organizational skill and extensive ongoing training to avoid serious injury to flight and nonflight personnel, the aircraft, and the ship. Despite extremely dangerous working conditions and restricted space, the Navy's "crunch rate" aboard aircraft carriers in 1989 was only 1 per 8,000 moves which makes it a very highly reliable, but complex, social organization.* Students of accident theory emphasize how the interactive complexity of an organization using hazardous technologies seems to defy efforts of system designers and operators to prevent accidents and ensure reliability. In part, this is because individuals are fallible and in part because unlikely and rare (and thus unanticipated) failures in one area are linked in complex systems and may have surprising effects in other systems—the tighter the "coupling," generally, the more likely that failure in one part will affect the reliability of the whole system. Nevertheless, even in such systems, great consistency is achievable using four strategies in particular: the prioritization of safety as a goal; high levels of redundancy, the development of a safety culture that involves continuous operational training, and high-level organizational learning.11 Weick and Roberts12 have studied peacetime flight operations on aircraft carriers as an example of organizational performance requiring nearly continuous operational reliability despite complex patterns of interrelated activities among many people. These activities cannot be fully mapped out beforehand because of changes in weather (e.g., wind direction and strength), sea conditions, time of day and visibility, returning aircraft arrivals, and so forth. Yet, surprisingly, generally mapped out sequences can be carried out with very high reliability in novel situations using improvisation and adaptation and personnel who are highly trained but not highly educated. *A crunch occurs when two aircraft touch while being moved, either on the flight or hangar deck, even if damage is averted.
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Page 162 Naval commanders stress the high priority of safety. They understand the importance of a safety culture and use redundancy (both technical and personnel) and continuous training to prepare for the unexpected. The Navy also understands the need for direct communication and adaptability. Because errors can arise from a lack of direct communication, the ship's control tower communicates directly with each division over multiple channels. As in health care, it is not possible in such dynamic settings to anticipate and write a rule for every circumstance. Once-rigid orders that prescribed how to perform each operation have been replaced by more flexible, less hierarchical methods. For example, although the captain's commands usually take precedence, junior officers can, and do, change these priorities when they believe that following an order will risk the crew's safety. Such an example demonstrates that even in technologically sophisticated, hazardous, and unpredictable environments it is possible to foster real-time problem solving and to institute safety systems that incorporate a knowledge of human factors. In summary, efforts such as those described in the three examples have resulted neither in stifled innovation nor loss of competitive benefit; nor have they resulted in unmanageable legal consequences. Rather, they are a source of corporate and employee pride. Characteristics that distinguish successful efforts in other industries include the ability to collect data on errors and incidents within the organization in order to identify opportunities for improvement and to track progress. The companies make these data available to outsiders. Other notable features of these efforts include the importance of leadership and the development of a safety culture, the use of sophisticated methods for the analysis of complex processes, and a striving for balance among standardization where appropriate, yet giving individuals the freedom to solve problems creatively. Key Safety Design Concepts Designing safe systems requires an understanding of the sources of errors and how to use safety design concepts to minimize these errors or allow detection before harm occurs. This field is described in greater detail in Chapter 3 which includes an error taxonomy first proposed by Rasmussen13 and elaborated by Reason14 to distinguish among errors arising from (1) skill-based slips and lapses; (2) rule-based errors; and (3) knowledge-based mistakes. Leape has simplified this taxonomy to describe what he calls ''the pathophysiology of error." He differentiates between the cognitive mechanisms
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Page 163 used when people are engaging in well-known, oft-repeated processes and their cognitive processes when problem solving. The former are handled rapidly, effortlessly, in parallel with other tasks, and with little direct attention. Errors may occur because of interruptions, fatigue, time pressure, anger, anxiety, fear, or boredom. Errors of this sort are expectable, but conditions of work can make them less likely. For example, work activities should not rely on weak aspects of human cognition such as short-term memory. Safe design, therefore, avoids reliance on memory. Problem-solving processes, by contrast, are slower, are done sequentially (rather than in parallel with other tasks), are perceived as more difficult, and require conscious attention. Errors are due to misinterpretation of the problem that must be solved, lack of knowledge to bring to bear, and habits of thought that cause us to see what we expect to see. Attention to safe design includes simplification of processes so that users who are unfamiliar with them can understand quickly how to proceed, training that simulates problems, and practice in recovery from these problems. As described in Chapter 3, instances of patient harm are usually attributed to individuals "at the sharp end" who make the visible error. Their prevention, however, requires systems that are designed for safety—that is, systems in which the sources of human error have been systematically recognized and minimized.15, 16 In recent years, students of system design have looked for ways to avoid error using what has been called by Donald Norman17 "user-centered design." This chapter draws on six strategies that Norman outlines. They are directed at the design of individual devices so that they can be used reliably and safely for their intended purposes. Although these strategies are aimed at the human-machine interface, they can also be usefully applied to processes of care. The first strategy is to make things visible—including the conceptual model of the system—so that the user can determine what actions are possible at any moment—for example, how to turn off a piece of equipment, how to change settings, and what is likely to happen if a step in a process is skipped. The second strategy is to simplify the structure of tasks so as to minimize the load on working memory, planning, or problem solving. A third strategy is what Norman calls the use of affordances and natural mappings. An affordance is a characteristic of equipment or workspace that communicates how it is to be used, such as a push bar on an outward opening door that indicates where to push. Another example is a telephone handset that is uncomfortable to hold in any position but the correct one.
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Page 164 Natural mapping refers to the relationship between a control and its movement; for example, in steering a car to the right, one turns the wheel right. Natural mapping takes advantage of physical analogies and cultural knowledge to help users understand how to control devices. Other examples of natural mapping are arranging light switches in the same pattern as lights in a lecture room; arranging knobs to match the arrangement of burners on a stove; or using louder sound, an increasingly brighter indicator light, or a wedge shape to indicate a greater amount. A fourth important strategy is the use of constraints or "forcing functions" to guide the user to the next appropriate action or decision. A constraint makes it hard to do the wrong thing; a forcing function makes it impossible. A classic example of a forcing function is that one cannot start a car that is in gear. Norman's fifth strategy is to assume that errors will occur and to design and plan for recovery by making it easy to reverse operations and hard to carry out nonreversible ones. An example is the Windows® computer operating system that asks if the user really intends to delete a file, and if so, puts it in a "recycle" folder so that it can still be retrieved. Finally, Norman advises that if applying the earlier strategies does not achieve the desired results, designers should standardize actions, outcomes, layouts, and displays. An example of standardization is the use of protocols for chemotherapy. An example of simplification is reducing the number of dose strengths of morphine in stock. Safety systems can be both local and organization wide. Local systems are implemented at the level of a small work group—a department, a unit, or a team of health care practitioners. Such local safety systems should be supported by, and consistent with, organization-wide safety systems. Anesthesiology is an example of a local, but complex, high-risk, dynamic patient care system in which there has been notably reduced error. Responding to rising malpractice premiums in the mid-1980s, anesthesiologists confronted the safety issues presented by the need for continuing vigilance during long operations but punctuated by the need for rapid problem evaluation and action. They were faced with a heterogeneity of design in anesthesia devices; fatigue and sleep deprivation; and competing institutional, professional, and patient care priorities. By a combination of technological advances (most notably the pulse oximeter), standardization of equipment, and changes in training, they were able to bring about major, sustained, widespread reduction in morbidity and mortality attributable to the administration of anesthesia.18
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Page 165 Organization-wide systems, on the other hand, are implemented and monitored at the level of a health care organization. These include programs and processes that cross departmental lines and units. In hospitals, infection control and medication administration are examples of organization-wide systems that encompass externally imposed regulations, institutional policies and procedures, and the actions of individuals who must provide potentially toxic materials at the right time to the right patient. Principles for the Design of Safety Systems in Health Care Organizations Hospitals and other institutions have long-standing efforts to ensure patient safety in a variety of areas. Appendix E provides an overview of some of these efforts in hospitals. Some have been very effective in certain units or certain hospitals. These activities have not, however, succeeded in eliminating error or injury, and they have not been part of national or even institution-wide, high-priority efforts. Compared to hospital care, out-of-hospital care—whether in institutions, homes, medical offices or other settings, both the knowledge of the kind and magnitude of errors and the development of safety systems are rudimentary. Safety tends to be addressed narrowly by reliance on education and training, policies, and procedures. There are undoubtedly many reasons for the lack of attention to safety including: small staff size, lack of technical knowledge of effective ways to improve quality or an infrastructure to support deploying this knowledge; lack of recognition of error (because the harm is removed in time or space from the error and because individuals are unharmed); lack of data systems to track and learn from error (most of the adverse drug events studies use emergency visits or hospital admissions to establish a denominator); the speed of change and the introduction of new technologies; and clearly, the same cultural barriers that exist in hospitals—namely, the high premium placed on medical autonomy and perfection and a historical lack of interprofessional cooperation and effective communication. With the rise in outpatient and office-based surgery, attention is turning to anesthesia safety in settings such as private physician offices, dental, and podiatry offices. For example, guidelines for patient assessment, sedation, monitoring, personnel, emergency care, discharge evaluation, maintenance of equipment, infection control, and the like have been developed by an ad hoc committee for New York State practitioners.19
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Page 194 most powerful and useful medications in the therapeutic armamentarium. Examples are heparin, warfarin, insulin, lidocaine, magnesium, muscle relaxants, chemotherapeutic agents, and potassium chloride (see below), dextrose injections, narcotics, adrenergic agents, theophylline, and immunoglobin.65,66 Both to alert personnel to be especially careful and to ensure that dosing is appropriate, special protocols and processes should be used for these "high-alert" drugs. Such protocols might include written and computerized guidelines, checklists, preprinted orders, double-checks, special packaging, and labeling. Do Not Store Concentrated Potassium Chloride Solutions on Patient Care Units Concentrated potassium chloride (KCl) is the most potentially lethal chemical used in medicine. It is widely used as an additive to intravenous solutions to replace potassium loss in critically ill patients. Each year, fatal accidents occur when concentrated KCl is injected because it is confused with another medication. Because KCl is never intentionally used undiluted, there is no need to have the concentrated form stocked on the patient care unit. Appropriately diluted solutions of KCl can be prepared by the pharmacy and stored on the unit for use. After enacting its sentinel event reporting system, JCAHO found that eight of ten incidents of patient death resulting from administration of KCl were the result of the infusion of KCl that was available as a floor stock item.67 This has also been reported as a frequent cause of adverse events by the U.S. Pharmacopoeia (USP) Medication Errors Reporting Program.68 Ensure the Availability of Pharmaceutical Decision Support Because of the immense variety and complexity of medications now available, it is impossible for nurses or doctors to keep up with all of the information required for safe medication use. The pharmacist has become an essential resource in modern hospital practice. Thus, access to his or her expertise must be possible at all times.69,70 Health care organizations would greatly benefit from pharmaceutical decision support. When possible, medications should be dispensed by pharmacists or with the assistance of pharmacists. In addition, a substantial number of errors are made when nurses or other nonpharmacist personnel enter pharmacies during off hours to obtain drugs. Although small hospitals cannot afford and do not need to have a
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Page 195 pharmacist physically present at all times, all hospitals must have access to pharmaceutical decision support, and systems for dispensing medications should be designed and approved by pharmacists. Include a Pharmacist During Rounds of Patient Care Units As the major resource for drug information, pharmacists are much more valuable to the patient care team if they are physically present at the time decisions are being made and orders are being written. For example, in teaching hospitals, medical staff may conduct "rounds" with residents and other staff. Pharmacists should actively participate in this process and be present on the patient care unit when appropriate. Such participation is usually well received by nurses and doctors, and it has been shown to significantly reduce serious medication errors. Leape et al.71 measured the effect of pharmacist participation on medical rounds in the intensive care unit. They found that in one large, urban, teaching hospital the rate of preventable adverse drug events related to prescribing decreased significantly—66 percent—from 10.4 per 1,000 patient-days before the intervention to 3.5 after the intervention; the rate in the control group was unchanged. Make Relevant Patient Information Available at the Point of Patient Care Many organizations have implemented ways to make information about patients available at the point of patient care as well as ways to ensure that patients are correctly identified and treated. With medication administration, some inexpensive but useful strategies include the use of colored wristbands (or their equivalent) as a way to alert medical staff of medication allergies. Colored wristbands or their functional equivalent can alert personnel who encounter a patient anywhere in a hospital to check for an allergy before administering a medication. Using computer-generated MARs, can minimize transcription errors and legibility problems as well as provide flow charts for patient care. Improper doses, mix-ups of drugs or patients, and inaccurate records are common causes of medication errors in daily hospital practice. Bar coding (or an electronic equivalent) is an effective remedy.72 It is a simple way to ensure that the identity and dose of the drug are as prescribed, that it is being given to the right patient, and that all of the steps in the dispensing and administration processes are checked for timeliness and accuracy. Bar
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Page 196 coding can be used not only by drug manufacturers, but also by hospitals to ensure that patients and their records match. The Colmercy-O'Neil VA Medical Center in Topeka, Kansas, reports, for example, a 70 percent reduction in medication error rates between September, 1995 and April, 1998 by using a system that included bar coding of each does, use of a hand-held laser bar code scanner, and a radio computer link.73 Improve Patients' Knowledge About Their Treatment A major unused resource in most hospitals, clinics, and practices is the patient. Not only do patients have a right to know the medications they are receiving, the reasons for them, their expected effects and possible complications, they also should know what the pills or injections look like and how often they are to receive them. Patients should be involved in reviewing and confirming allergy information in their records. Practitioners and staff in health care organizations should take steps to ensure that, whenever possible, patients know which medications they are receiving, the appearance of these medications, and their possible side effects.74 They should be encouraged to notify their doctors or staff of discrepancies in medication administration or the occurrence of side effects. If they are encouraged to take this responsibility, they can be a final "fail-safe" step. At the time of hospital discharge, patients should also be given both verbal and written information about the safe and effective use of their medications in terms and in a language they can understand. Patient partnering is not a substitute for nursing responsibility to give the proper medication properly or for physicians to inform their patients, but because no one is perfect, it provides an opportunity to intercept the rare but predictable error. In addition to patients' informing their health care practitioner about their current medications, allergies, and previous adverse drug experiences, the National Patient Safety Partnership has recommended that patients ask the following questions before accepting a newly prescribed medication:75 • Is this the drug my doctor (or other health care provider) ordered? What are the trade and generic names of the medication? • What is the drug for? What is it supposed to do? • How and when am I supposed to take it and for how long? • What are the likely side effects? What do I do if they occur?
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Page 197 • Is this new medication safe to take with other over-the-counter or prescription medication or with dietary supplements that I am already taking? What food, drink, activities, dietary supplements, or other medication should be avoided while taking this medication? Summary This chapter has proposed numerous actions based on both good evidence and principles of safe design that health care organizations could take now or as soon as possible to substantially improve patient safety. These principles include (1) providing leadership; (2) respecting human limits in process design; (3) promoting effective team functioning; (4) anticipating the unexpected; and (5) creating a learning environment. The committee's recommendations call for health care organizations and health care professionals to make continually improved patient safety a specific, declared, and serious aim by establishing patient safety programs with defined executive responsibility. The committee also calls for the immediate creation of safety systems that incorporate principles such as (1) standardizing and simplifying equipment, supplies, and processes; (2) establishing team training programs; and (3) implementing nonpunitive systems for reporting and analyzing errors and accidents within organizations. Finally, drawing on these principles and on strong evidence, the committee calls on health care organizations to implement proven medication safety practices. References 1. Reason, James T. Forward to Human Error in Medicine, Marilyn Sue Bogner, ed. Hillsdale, NJ: Lawrence Erlbaum Associates, 1994, p. xiv. Though ecologically unsound, the analogy is apt. 2. Chassin, Mark R.; Galvin, Robert W., and the National Roundtable on Health Care Quality. The Urgent Need to Improve Health Care Quality. Institute of Medicine National Roundtable on Health Care Quality. JAMA. 280:1000–1005, 1998. 3. Cook, Richard I. Two Years Before the Mast: Learning How to Learn About Patient Safety. Invited presentation. "Enhancing Patient Safety and Reducing Errors in Health Care," Rancho Mirage, CA, November 8–10, 1998. 4. Senders, John. "Medical Devices, Medical Errors and Medical Accidents," in Human Error in Medicine, Marilyn Sue Bogner, ed. Hillsdale, NJ: Lawrence Erlbaum Associates, 1994. 5. Van Cott, Harold. "Human Errors: Their Causes and Reduction," in Human Error in Medicine, Marilyn Sue Bogner, ed., Hillsdale, NJ: Lawrence Erlbaum Associates, 1994. 6. Van Cott, 1994.
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Page 198 7. MacCormack, George. Zeroing in on Safety Excellence—It's Good Business. http://www.dupont.com/safety/esn97-1/zeroin.html 5/27/99. 8. DuPont Safety Resources. Safety Pays Big Dividends for Swiss Federal Railways. http://www.dupont.com/safety/ss/swissrail22.html 5/3/99. 9. From "Executive Safety News" DuPont Safety Resources. http://www.dupont.com/safety/esn98-3.html 5/3/99. 10. Alcoa. Alcoa Environment, Health and Safety Annual Report. 1997. 11. Sagan, Scott D. The Limits of Safety. Organizations, Accidents, and Nuclear Weapons. Princeton, N.J.: Princeton University Press, 1993. 12. Weick, Karl E. and Roberts, Karlene H. Collective Mind in Organizations: Heedful Interrelating on Flight Decks. Administrative Science Quarterly. 38:357–381, 1993. 13. Rasmussen, Jens. Skills, rules, Knowledge: Signals, Signs, and Symbols and Other Distinctions in Human Performance Models. IEEE Transactions: Systems, Man & Cybernetics (SMC-13): 257–267, 1983. 14. Reason, James. Human Error. New York: Cambridge University Press, 1990. 15. Moray, Nevill. "Error Reduction as a Systems Problem," in Human Error in Medicine, ed., Marilyn Sue Bogner, Hillsdale, NJ: Lawrence Erlbaum Associates, 1994. 16. Van Cott, 1994. 17. Norman, Donald A. The Design of Everyday Things. NY: Doubleday/Currency, 1988. 18. Gaba, David; Howard, Steven K., and Fish, Kevin J. Crisis Management in Anesthesiology. NY: Churchill-Livingstone, 1994. 19. Committee on Quality Assurance in Office-Based Surgery. A Report to New York State Public Health Council and New York State Department of Health, June, 1999. 20. Berwick, Donald M. "Taking Action to Improve Safety: How to Increase the Odds of Success," Keynote Address, Second Annenberg Conference, Rancho Mirage, CA, November 8, 1998. 21. Haberstroh, Charles H. "Organization, Design and Systems Analysis," in Handbook of Organizations, J.J. March, ed. Chicago: Rand McNally, 1965. 22. Leape, Lucian L.; Kabcenell, Andrea; Berwick, Donald M., et al. Reducing Adverse Drug Events. Boston: Institute for Healthcare Improvement, 1998. 23. Institute of Medicine. Guidelines for Clinical Practice. From Development to Use. Marilyn J. Field and Kathleen N. Lohr, eds. Washington, D.C.: National Academy Press, 1992. 24. Leape, et al., 1998. 25. Leape, et al., 1998. 26. Leape, et al., 1998. 27. Leape, et al., 1998. 28. Leape, et al., 1998. 29. Hwang, Mi Y. JAMA Patient Page. Take Your Medications as Prescribed. JAMA. 282:298, 1999. 30. Blumenthal, David. The Future of Quality Measurement and Management in a Transforming Health Care System. JAMA. 278:1622–1625, 1997. 31. Sheridan, Thomas B. and Thompson, James M. "People Versus Computers in Medicine," in Human Error in Medicine, Marilyn Sue Bogner, ed., Hillsdale, NJ: Lawrence Erlbaum Associates, 1994.
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Page 203 Appendixes
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