home site map our company review board contact us update profile
| 
| 
| 
| 
| |
| News & Information » News » Articles » Interviews » Ask the Expert » Submissions |
| » 800.242.5183» Email Us |
| Home | Articles | Article Details |
  |
||||||||||
 4/26/2010 Prevention of Medical Errors: The Mandate for Change Paul R. Rao, Ph.D., CCC-SLP, CPHQ FACHE | |||||||||||
| This article is a written transcript of the course, “Prevention of Medical Errors: The Mandate for Change” presented by Paul R. Rao on November 17, 2008 Introduction What is the number one concern for hospital executives in the United States? The answer may be surprising given that we are firmly planted in the 21st century and healthcare has made great strides in the last several decades. However, one of healthcare’s biggest concerns remains patient safety. According to a report by the Institute of Medicine (Kohn, Corrigan, & Donaldson, 2000), hospital care is only 97.1% perfect. Even if hospital care were rated 99%, the error rate would still equate to 2,000 unsafe airplane landings per week, 22,000 checks withdrawn from the wrong account per day, 2,000,000 tax documents lost per year by the Internal Revenue Service, or 5,000 surgical procedures gone wrong. At 97.1% perfect, nearly 300 preventable deaths occur in hospitals each day. That is the equivalent of a packed 747 falling out of the sky every single day. There is at least a 2.9% chance of experiencing a totally preventable adverse event if hospitalized. For 100,000 people each year, this experience leads to death. This is more than AIDS, breast cancer, or motor vehicle accidents. Preventable adverse events resulting in death ought to be zero. In the U.S. healthcare system, the numbers speak for themselves. According to the Institute of Medicine report, patient safety means “Freedom from accidental injury” (p. 18, Kohn, Corrigan, & Donaldson, 2000). To paint an even more graphic and urgent picture, the IOM report suggests that the national cost of medical error is huge. The estimate of preventable medical errors ranges from $8.5 to $20 billion annually. Historical Changes in Healthcare To better understand patient safety in our current healthcare system, it is important to know the history of healthcare. For example, in our current healthcare system, a stroke patient stays 5-6 days in acute care versus a two-month stay 30 to 40 years ago. The treatment of new onset diabetes used to be three weeks in a hospital and two hours a day of diabetic education. Today, treatment consists of outpatient care, educational classes, reading materials, and possibly self-education by surfing the Internet. The continuum of care 30 years ago included hospitals, offices, homes for the aged, and one’s own home. Today there is a panoply of offerings including hospitals, assisted living centers, home care, group homes, rehabilitation centers, telemedicine, etc. The complexity of healthcare has changed dramatically over the last 30 to 40 years. The terminology has also changed over the years. Problems in the 1960s and 1970s were referred to as complications. In the 1990s, complications became known as adverse events. By the year 2000, the terms errors and patient safety were healthcare terms. Current terms regarding healthcare are medical errors and adverse events. These terms are not the same nor interchangeable when discussing patient safety. A medical error is the failure of a planned action to be completed as intended. An adverse event is an unexpected outcome caused by medical management rather than an expected outcome of the patient’s underlying condition. Although the terminology has changed over the years, the issues remain the same regarding complications, adverse events, and errors in patient safety. The 2000 IOM report (Kohn, Corrigan, & Donaldson, 2000), stated that over 100,000 deaths in hospitals were caused by reasons other than the initial cause for admittance. Two percent of all hospital admissions experience an adverse event (ADE) that usually results in an increase in the length of stay. This, in turn, increases the cost per event by an average of $4,700. In October of 2009, the Centers for Medicare and Medicaid stopped paying for acute care as a result of medical errors. In 2001, The National Academy of Sciences repeated the IOM study and in 2003 published a landmark report titled Crossing the Quality Chasm: A New Health System for the 21st Century. Again, the report stated that an additional 100,000 deaths annually are due to medical error. The report revealed no difference over two years in the area of resolving medical errors. In 2004, HealthGrades released a report on patient safety in American hospitals. They surveyed 37,000,000 patient records in retro audits. They found on average 195,000 Americans died annually between the years 2000-2002—over a two-year period—because of preventable medical errors. Most of the deaths found in the HealthGrades audit occurred because of system failures and not from incompetence (HealthGrades, 2004). Many employees have seen system failures from computers crashing to not having the tools to perform job duties correctly. The lack of recognition about the seriousness and urgency of the problem fosters a culture of denial and complacency. Added to that is the fact that our culture has typically viewed medical errors as a failure of people rather than systems. Leaders in the industry sometimes want to take names and blame individuals when an error occurs rather than looking at the process. This blaming prevents reporting of the error, consequent analysis of it, as well as problem solving to prevent re-occurrence. The New England Journal of Medicine (NEJM) fueled the debate on medical errors (Brennan, 2000) when stating that preventability is difficult to determine because it is often influenced by decisions on expenditures. If there were enough resources, every medical error, theoretically, could be prevented. Medicine can reduce errors by 50% by simply not reporting them in the first place. “No matter how much we might insist that physicians have an ethical duty to report injuries resulting from medical errors or to work in their prevention, fear of malpractice or litigation drags us back to the status quo” (p. 1125, Brennan, 2000). A Rand Study, also reported in the New England Journal of Medicine (McGlynn et. al, 2003), states that U.S. patients receive proper medical care from doctors and nurses about 55% of the time regardless of race, education, income or insurance status. However, a well-functioning healthcare system should provide recommended levels of care 80-90% of the time, not 55% of the time. Health Literacy Another issue in healthcare is health literacy of patients. Health literacy is defined as the ability to read, understand, and act on healthcare information. Why would this be in important in the 21st century? It may be surprising to know that 50 percent of the U.S. population can read instructions and brochures and ask questions; but 50 percent of the population cannot. The National Adult Literacy Survey (National Center for Education Statistics, 1993), conducted with 26,000 people, is an accurate portrait of literacy in the U.S. The survey is scored on five levels, which demonstrate significant disparities in literacy competence:
Another alarming statistic shows that healthcare illiteracy increases with age and the older generation is the fastest growing segment of the U. S. population. Inadequate health literacy is present in 70% of individuals over age 85. Effects of regression are seen with age and, hopefully, as improvements are made in education and training, the ability to improve literacy in this age group and across ethnicities will increase as well. Even when age or language barriers are removed, a patient presented with health information that is of high emotional salience, can still be unable to process or understand what is being said in spite of being a literate individual. One-third of low healthcare literate patients are re-admitted into healthcare institutions because of noncompliance—they did not understand how to follow the directions of their care. The actual cost of poor healthcare literacy is astounding. The National Academy on an Aging Society (a nonpartisan public policy institute that actively conducts and compiles research on issues related to population aging and provides information to the public, the press, policymakers, and the academic community) estimated (using 1998 figures) that up to $73 billion is lost in the system because of the failure to address health literacy and the disparity that is seen in various populations (2002). This, in turn, results in longer hospital stays, ineffective use of prescriptions, and misunderstood treatment plans. Low health literacy brings about certain risk management issues such as a failure to navigate through the healthcare system, therapeutic failures, and workforce issues. The following explains more. Failure to Navigate—The best people to help detect and guide a patient with healthcare literacy are the frontline medical reception staff. These are the people working with patients to fill out forms and questionnaires. They are the ones who can help when someone cannot process information. There needs to be an awareness of how patients are asked to comply with consents, health history, etc. Forms need to be clear and concise so the patient understands what is being asked of him or her as well as understanding the process for finding their way in the facility. Only confusion results when appointments are skipped, medical forms are incomplete and inaccurate, and when informed consents fail to “inform.”Healthcare Quality Problems that Intersect with Safety Three other common problems plague the healthcare industry: misuse, overuse, and under use. Misuse is defined as an avoidable complication of appropriate care. Overuse refers to providing services when the risk of harm exceeds the potential benefits. Under use is defined as failure to use a standard of practice. The IOM reports that misuse causes 44,000 to 98,000 deaths to occur annually (Kohn, Corrigan, & Donaldson, 2000). More patients die as a result of misuse each year than die from motor vehicle accidents or breast cancer. The IOM also reported that approximately 1,000,000 iatrogenic injuries (i.e., physician induced) that happen in facilities are underreported by a factor of 10 and there is an underreporting of errors by a factor of 10. Overuse explains why 40% of hysterectomies are inappropriate or of questionable value. In addition, 20% of all antibiotic prescriptions are written for viral infections amounting to 50,000,000 prescriptions written annually for children alone—another example of overuse. Under use is demonstrated in the treatment of depression. Of those individuals diagnosed with depression, 60% receive no medication. Beta-blockers used for heart attacks reduce death by 25%, but they are only prescribed 25% to 45% of the time. Patient Safety in Context The U.S. legal system has a means for addressing grievances, exerting vigorous discovery efforts, blaming providers, obtaining large monetary settlements, and imposing congressional reform. There is a national practitioner databank that requires the reporting of all settlements and judgments over $10,000 and this focuses blame on individuals. Physicians are very reluctant to be party to this process. Years ago, the Lexington, KY Veteran’s Administration (VA) realized that patients were having harm happen and there seemed to be silent agreement among the practitioners not to talk about it. The VA was being sued for major damages after the fact. However, the Medical Director of the KY-VA discovered that when practitioners were up front about the incident and they explained what had happened to the patient (with the advice to get an attorney), the VA’s litigation costs dropped by 50%. This process is now standard practice in the VA system-wide. Just as the Lexington VA’s damages in lawsuits were dramatically reduced, the Veterans Administration’s system-wide litigation costs dropped at least 50% and has remained stable for over a decade. Many courts will now accept a medical center apology without necessarily admitting blame while attempting to disclose the facts surrounding the medical error. The Pareto Principle In the area of performance improvement, one of the most important principles used is the Pareto Principle—also known as the 80-20 rule. The Pareto Principle explains that for many events roughly 80% of the effects come from 20% of the causes. Applied to healthcare, medical errors are a health system problem, not a problem with individuals. An example of this is the following: A young man in a Brain Injury Unit was barely conscious and responsive and was in terrible pain. His mother was with him 24/7. Because he was cringing in pain, a pain medication was ordered to make him more comfortable. The physician ordered Oxycontin to be administered. What was interesting was the packaging of the medication—when it was presented to the nurse to administer, the instructions weren’t visible. The medical center had put their logo over important administration information: “Do not crush.” The medication was crushed and then administered to this young man. After several minutes, his mother noticed a significant change in his affect—his respiration and his pulse rate increased. Luckily, his mother intervened and medical staff responded rapidly to his change in condition. The doctor was able pharmacologically to fix the situation. In this example, the error was not a person problem, it was a process problem. Thereafter, the hospital logo was placed on bottles so as not to block the critical cautionary information. Innovations in medical technology have made healthcare increasingly complex. Consequently most of the errors in hospitals are the result of a breakdown in these complex systems. Even when more advanced technologically based systems are in place, employees may not adhere to the requirements. For example, when administering medication, nursing staff are required to scan the wrist band ID, then the medication, and then administer the medication. However, the steps are so numerous, a work-around—skipping steps because the processs takes up too much time—occasionally occurs. To truly subscribe to the Pareto Principle, more time should be spent reviewing the process and less time trying to find a guilty person. According to Leonard and Frankel (2006), system-derived errors can occur when clinicians are tired after working long hours. (This is one of the reasons the hours per week requirements for medical residents have been capped at 80.) Environmental factors such as noise, lighting, and lack of standardized equipment can also create errors. Historically, the focus on healthcare has been on the operational side of errors; ignoring the organizational factors that contribute to the mistake. When scrutinizing places of employment, most would agree that it is not about people, it is about process. Likewise, anytime discoveries are made to improve something, it is not because of people, it is generally because of a better process. Learning Quality Improvement from Industry Car Industry There is a quality gap between healthcare and other industries that use methods of improving quality and service. Six Sigma is a another methodology known in industry—especially the auto industry—that identifies and continuously eliminates errors in a quest for excellence. It is sometimes called the Toyota Model. Six Sigma improves the quality of process outputs by identifying and removing the causes of defects (errors) and minimizing variability in manufacturing and business processes. It uses a set of quality management methods, including statistical methods, and creates a special infrastructure of people within the organization (e.g., “Black Belts,” “Green Belts,” etc.) who are experts in these methods. Each Six Sigma project carried out within an organization follows a defined sequence of steps and has quantified targets. These targets can be financial (e.g., cost reduction or profit increase) or whatever is critical to the customer of that process (e.g., cycle time, safety, delivery, etc.). In numeric terms, Six Sigma equates to 3.4 defects per million items produced. Aviation Industry Healthcare should also take a lesson from the aviation industry. The aviation industry has shown great improvements because of all that has been learned over the past 30 years. For example, in the crew management system, a co-pilot is totally empowered to speak to the pilot with authority and advise the pilot that something did or did not happen. Both the pilot and co-pilot go through a checklist before they take off; they examine the airplane together. There is a “crew routine” that reviews the entire step-by-step process. Other lessons can also be learned. In the late 1970s, a plane crashed into a hillside where Dulles airport now exists. The following week, another plane almost experienced the same crash. The FAA realized that information from the first crash was not shared and as other planes prepared to land in the new airport there was a high risk, especially during fog, of crashing into this nearby elevation. From that point on, every airline was required to share information about any near misses and accidents that occurred and the reports were stored centrally for all to learn from the industry’s mistakes. Yet another example comes from the Valujet crash in the Florida Everglades. When a root cause analysis of the crash was performed, it revealed that oxygen tubes had been stacked in the baggage area and they acted as bombs in flight. Now the airline industry no longer allows oxygen canisters in the baggage hold of any plane. In these events, the process encouraged a culture of reporting errors, incorporating methods to understand the errors, and a way to examine causes and establish potential remedies. Positive change is what happens when you share root cause findings with other industry experts. The aviation industry has quality improvement systems in place and they are frequently studied to understand safety in complex systems. They understand the importance of human factors and they try to minimize them. Improving the Quality of Healthcare The IOM has set a minimum goal to reduce medical errors by half over the next five years. In addition, the Institute of Healthcare Improvement (IHI; 2007) has set a goal of saving 100,000 lives by 2010 and is making tremendous progress in that regard. Many hospitals have subscribed to this IHI mantra and have engaged in all the prevention methodologies that are espoused by IHI. The Patient Safety and Quality Improvement Act (2005), signed by President Bush in July of 2005, created a federal voluntary system of reporting medical errors with protection when the report is made by a certified patient safety organization. Even though the law exists, it has taken three years to put in place mechanisms and organizations that can be used for reports. Many hospitals have subscribed to the IHI mantra and have engaged in all the prevention methodologies that are espoused by IHI. The Patient Safety and Quality Improvement Act of 2005 (Public Law 109-41), signed into law on July 29, 2005, was enacted in response to growing concern about patient safety in the United States and the Institute of Medicine’s 2000 report (U.S. Department of Health and Human Services, 2005). The goal of the Act is to improve patient safety by encouraging voluntary and confidential reporting of events that adversely affect patients. Even though the law exists it has taken three years to put in place mechanisms and organizations that can be used for reports. In an article in the Washington Post, Lucian Leape, MD, was quoted as saying, “Before the IOM report, healthcare did nothing about medical errors. Since the report, there has been lots of activity but little progress” (Boodman, 2002). The IOM report challenges us to create a new health system in the 21st century by establishing a set of new rules to guide patient-clinician relationships. It also outlines key steps to promote evidence-based practice and strengthen clinical information systems. The six quality aims suggested are:
Creating a Culture of Safety The IOM defines patient safety as “freedom from accidental injury” (p. 18, Kohn, Corrigan, & Donaldson, 2000). Pauker, Zane, & Salem (2005) and Longo, Hewett, Ge, and Schubert ( 2005) studied 107 acute care hospitals in Missouri and Utah from 2002-2004 to assess the status of patient safety systems and examine changes. The most important areas to patient safety were specific patient safety policies, use of data in patient safety programs, computerized test results, assessment of adverse events, drug storage, administration of safety procedures, manner of handling adverse events, prevention policies, root cause analyses, and computerized physician order entry systems. To create and nurture a culture of safety, a system should:
National patient safety goals (NPSGs) were first articulated by The Joint Commission (TJC), a national healthcare accreditation body, in the early 2000s; NPSGs continue to be enhanced and expanded to this very day (The Joint Commission, 2009). Unfortunately, each national patient safety goal has been established because one or more patients either died or suffered permanent harm because of a medical error in patient care. The following are goals suggested by The Joint Commission (2009).
Healthcare now recognizes the need for transparency, and organizations are taking steps to improve procedures used to collect and share information. The Joint Commission recognizes the importance of information disclosure and has made disclosure a requirement. This means when a potential adverse event or medical error has occurred, the patient involved is to be notified immediately. This is now an industry-wide standard practice. In addition, the U.S. Department of Health and Human Services (2010) developed a report card on nursing homes that looks at falls, bedsores, pneumonia, etc. to give consumers and physicians an accurate and objective snapshot of care. The Department of Health and Human Services also offers an informative website, www.hospitalcompare.hhs.gov, which allows patients to rate their experiences at various healthcare institutions and to share the information with others when comparing one institution to another. The survey is currently applicable only to acute care hospitals but CMS will soon begin requiring nursing homes and acute rehabilitation facilities to adopt the hospital compare mantra. In January 2009, a new tool was introduced to further the public’s need for more factual healthcare information. The Hospital Consumer Assessment of Health Plans Survey (HCAHPS; 2009) required by CMS as part of its “pay for performance” initiative, surveyed acute inpatients and covered topics such as communication with nurses and doctors, responsiveness of staff, pain management, noise, cleanliness, etc. It provides an overall rating of the facility and willingness to recommend it based on the key areas and experience. HCAHPS questions cover how frequently patients experienced key staff behaviors and hospital attributes. In an effort to jumpstart the healthcare industry in its move toward a culture of safety, the CMS unveiled its Quality Rules for Hospitals in March of 2003 as part of its Conditions of Participation in Medicare (i.e., if your organization wishes to participate in the Medicare program, your organization must be a part of the Quality Rules in order to qualify as a Medicare Provider). Among other issues the rules state, “Hospitals must develop and implement an organization-wide quality assessment and improvement program that reflects their size and complexity” (482.21 Subpart C; CMS, 2003). The report goes on to say these organizations “Must focus on maximizing the quality of care outcomes and employing preventive measures that foster patient safety” (482.21, Subpart C, a.1; CMS, 2003). Since 2005, the Agency for Healthcare Research and Quality (www.ahrq.gov) has a free culture of safety survey currently used by over 500 hospitals. The survey assesses 12 areas or dimensions of patient safety (Agency for Healthcare Research and Quality, 2009):
Healthcare Disparities A clear hierarchy of access to care is emerging in many communities. Recent healthcare investments and initiatives are focused on affluent communities and are accessible mainly to people with employer-based or Medicare coverage, while access to basic care for people with Medicaid or no coverage at all is worsening in the wake of stalled coverage expansions and service cuts. Fifty million Americans are without healthcare insurance. Many people across the divide are falling through the healthcare gaps (Pham, 2005). Quality and Safety Together The degree to which healthcare services for individuals and populations increase the likelihood of desired health outcomes and decreases the likelihood of undesirable outcomes is consistent with the constantly changing healthcare environment and the rapidly improving professional knowledge. As healthcare quality improves so will patient safety. A quality organization is by definition a safe organization. In 2009, the Joint Commission began requiring all hospitals to survey the organization for the culture of safety and also to collect and identify a plan of correction with time certain dates and an identified responsible party for addressing any deficiencies found. Is safety a core value of your organization? Be seriously committed to following safe practices and following through with them. Leadership involvement ensures that a non-negotiable respect for all exists throughout the organization by having an open door policy to any concern that is not resolved at a lower level & by being willing to remove disrespectful individuals if necessary, regardless of their productivity. In an environment characterized by strong leadership, disrespect is NOT tolerated, individuals have what they need to do their jobs, & their work is acknowledged. Leadership involvement thus insures that a complete and laser like focus on patient safety exists throughout the organization. Why is Patient Safety and Quality the next frontier of compliance? Quality and compliance are enmeshed because the wellbeing of a hospital’s patients and the facilities reputation are compelling enough reasons for trustees to keep safety in the forefront of their quality programs. The bottom line impact of not doing so is staggering. Since the 2000 IOM report, significant improvements have been made in some hospitals. However, nationwide the change is painstakingly slow and the death rate has not changed much. What we do now is pay for service but what we should be doing is paying for quality care and improved outcomes. We can never have a quality healthcare system as long as parts of it are unsafe. How is commitment to safety and quality evidenced? The following questions help determine an organization’s commitment.
References Agency for Healthcare Research and Quality (AHRQ). (2009). Hospital survey on patient safety culture. Retrieved from www.ahrq.gov Boodman, S.G. (December 3, 2002). Death by medicine. Washington Post. Brennan, T.A. (2000). The Institute of Medicine report on medical errors—Could it do harm? The New England Journal of Medicine, 342(15), 1123-1125. Centers for Medicare and Medicaid Services. (2003). Conditions of participation. Chapter IV Title 42—Public Health, Subpart C, PART 482.21. HCAHPS. (2009). Hospital consumer assessment of health plans survey. Retrieved from www.hcahpsonline.org HealthGrades. (2004). HealthGrades quality study: Patient safety in American hospitals. Retrieved from www.healthgrades.com/media/english/pdf/hg_patient_safety_study_final.pdf Institute for Healthcare Improvement (IHI). (2007). Protecting five million lives from harm campaign. Retrieved from IHI.org The Joint Commission. (2010). National patient safety goals. Retrieved from www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals Kohn, L., Corrigan, J., & Donaldson, M. (Eds.). (2000). To err is human: Building a safer health system. Washington, DC: Institute of Medicine, National Academy Press. Retrieved from www.nap.edu/openbook.php?isbn=0309068371 Leonard, M., and Frankel, A. (2006). Make safety a priority: Create and maintain a culture of patient safety. Healthcare Executive, 21(2), 12-4, 16-8. Longo, D., Hewett, L., Ge, B., & Schubert, S. (2005). The long road to patient safety: A status report on patient safety systems. Journal of the American Medical Association, 294, 2858-2865. McGlynn, A., Asch, S., Adams, J., Keesey, J., Hicks, J., DeCristofaro, A., & Kerr, E. (2003). The quality of health care delivered to adults in the United States. New England Journal of Medicine, 348, 2635-2645. Pauker, S., Zane, E., & Salem, D. (2005) Creating a safer health care system. Journal of the American Medical Association, 294, 2906-2908. The National Academy on an Aging Society. (2002). The State of Aging and Health In America, Gerontoloical Society of America, PDF File. The National Academy of Sciences. (2003). Crossing the quality chasm: A new health system for the 21st century. Washington, DC: The National Academy Press. National Center for Education Statistics. (1993). Adult literacy in America. Retrieved from www.nces.ed.gov/pubs93/93275.pdf Pham, H. (2005). A widening rift in access & quality: Growing evidence of economic disparities. Health Affairs, 10, 1377. Solet, D., Norvell, M.J., Rutan, G.H., & Frankel, R.M. (2005). Lost in translation: Challenges and opportunities in physician-to-physician communication during patient handoffs. Academic Medicine, 80(12), 1094-1099. U.S. Dept. of Health and Human Services. Agency for Healthcare Research and Quality. (2005). Patient Safety and Quality Improvement Act of 2005. Public Law 109-41. 109th Congress. Retrieved from www.ahrq.gov/qual/psoact.htm U.S. Dept. of Health and Human Services. Medicare. (2010). Find and compare nursing homes. Retrieved from www.medicare.gov | |||||||||||
|
|||||||||||
