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PREVENTING MEDICAL ERRORS AN INDEPENDENT CE/CME STUDY COURSE FOR HEALTH CARE PROFESSIONALS By Paul R. Elliott, PhD Paul D. Hammond, M.S. Tinton Falls, New Jersey A Subsidiary of Arc Communications Inc. PREVENTING MEDICAL ERRORS ARCMESA EDUCATORS www.arcmesa.com ABOUT THE AUTHORS Paul R. Elliott, Ph.D., noted lecturer and author on the HIV/AIDS epidemic, is a recently retired Professor of Biological Science at Florida State University in Tallahassee. His background includes graduate study at the University of Michigan where he earned his Ph.D. in Zoology and postdoctoral research at Johns Hopkins, followed by faculty positions at the University of Florida (1963-1971) and Florida State (since 1971). Dr. Elliott was Assistant Dean of the College of Medicine at Gainesville, Florida and was the first Director of Florida State’s innovative Program in Medical Sciences, a joint MD degree program with the University of Florida now grown into the FSU College of Medicine. Dr. Elliott continues his teaching on the biology of AIDS and the ecology of disease. He maintains a continuing interest in the role of science in society. Paul D. Hammond, Educational Consultant, was the former Director of Continuing Education at ArcMesa Educators from 1993 until his retirement in August 2001. He received his M.S. degree in Political Science from Florida State University with undergraduate study in philosophy and journalism. He has several decades of experience in composition, editing, and review of articles & journals for publication. Paul is now residing in Thailand but remains active, via the Internet, in the field of professional continuing education. By reviewing the course content and completing the post test at the end of this continuing medical education activity, you are entitled to receive two credit hours if you achieve a score of 70% or greater. Estimated time to complete this activity is two hours. ArcMesa Educators is accredited by the Accreditation Council for Continuing Medical Education to sponsor continuing medical education for physicians. ArcMesa designates this activity for two (2) credits in Category I towards the AMA Physician’s Recognition Award. Each physician should only claim those hours of credit that he/she actually spent in the educational activity. Authors are expected to disclose any real or apparent conflict(s) of interest regarding the content or subject matter of this activity. Dr. Elliott and Mr. Hammond have indicated they have nothing to disclose relative to this activity. Date of original release: June 2002 Date of most recent review/approval: Medium used: Home Study Booklet © 2002 – ArcMesa Educators/Paul Elliott and Paul Hammond All rights reserved. This CE/CME course, or any part thereof, may not be duplicated or reproduced without the permission of the authors. ❖ i PREVENTING MEDICAL ERRORS ARCMESA EDUCATORS www.arcmesa.com OVERVIEW Early in this 21st Century a relatively little known and quite negative characteristic of the American Health Care system was furnished broad exposure by a report of the National Academy of Science’s Institute of Medicine (IOM) showing the horrific numbers of medical errors resulting in significant patient injury and even death. The report, entitled To Err is Human: Building a Safer Health System, delivered a shock to an unaware public by demonstrating that an estimated 44,000 to 98,000 Americans die each year as a result of medical errors!1 The report called for immediate corrective actions to be taken to improve patient health and safety. This CE course will address the main issues surrounding the problems of medical errors. We hope to update health care professionals on steps being taken toward reduction of errors and improving the safety and well-being of those entrusted to their care. It is hoped that this course can contribute to the reduction of medical errors by any doctor, nurse, pharmacist, or other health care professional; or even by patients themselves. There is a growing and pervasive mistrust of our health care system that must be rectified soon for the good of the patients, the health care providers, the professional staffs, and for every one of our health care institutions. COURSE OBJECTIVES Upon successful completion of this course, the participant will: 1. Become aware of the various types of medical errors 2. Understand factors & conditions that contribute to errors 3. Be introduced to existing processes to improve patient outcomes 4. Appreciate the responsibilities of proper reporting of errors 5. Be alert to the safety needs of special populations, and 6. Realize the benefits & importance of patient education. ❖ ii PREVENTING MEDICAL ERRORS ARCMESA EDUCATORS www.arcmesa.com TABLE OF CONTENTS ABOUT THE AUTHOR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .ii COURSE OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .ii TABLE OF CONTENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iii COURSE INSTRUCTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iv INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 THE OCCURRENCE OF MEDICAL ERRORS . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 INFLUENCING FACTORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 RECOGNIZING ERROR-PRONE SITUATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . .5 IMPROVEMENTS IN PATIENT SAFETY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 REPORTING RESPONSIBILITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 SPECIAL POPULATION NEEDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 PATIENT EDUCATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14 COURSE EXAMINATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16 ❖ iii PREVENTING MEDICAL ERRORS ARCMESA EDUCATORS www.arcmesa.com COURSE INSTRUCTIONS FOR INTERNET AND HOME STUDY PARTICIPANTS! • Read the course material carefully. Internet participants may study online or print a copy of the course for off-line study. Start when you are fresh and take your time. • This course includes an "open book" exam. You may review the text at any time as a learning aid or to check the accuracy of your responses before submitting your completed exam. • Be sure to answer each exam question; blanks are counted as incorrect answers. A minimum score of 70% is required for successful completion of this exam. • The processing fee for this course entitles only one person to receive a certification of completion. A history of courses taken and certificates earned is kept on file at ArcMesa for six years. • After successful completion of the course exam, Internet users can return to their "Member History" page and print their own Certificate of Completion. Home study exams are processed the day they are received by ArcMesa and certificates are posted for return by 1st Class mail the next day. • If you fail an exam, you may retest for $10.00 by calling ArcMesa Educators and requesting another examination. Note: To re-test online, you must either call or email our customer service center to request an online Re-test, or purchase the course again. • Please complete the brief course evaluation form at the end of the exam. Your responses and suggestions will allow us to upgrade our procedures and course materials to serve you more effectively in the future. PROBLEMS OR QUESTIONS? If you have any questions about your examination or your Certificate of Completion, please call ArcMesa at 1-800-597-6372 Your Certificate of Completion will reflect the following data: Date of completion, name, profession/occupation, license number (if provided), course title, CE/CME hours awarded, provider name and approval number (if applicable). Internet users receive an online grade report. Home study users may request a grade report. Thank you for choosing ArcMesa Educators! ❖ iv PREVENTING MEDICAL ERRORS ARCMESA EDUCATORS www.arcmesa.com INTRODUCTION Most of the American public is aware of at least some of the more publicized cases of medical mistakes: Betsy Lehman, a respected health reporter for the Boston Globe, died from a medical overdose during chemotherapy; Ben Kolb died at the age of eight during minor surgery due to a drug mix-up; Willie King had the wrong leg amputated.1 Although not in the United States, a recent account of medical error, printed in the June 15, 2002 London newspaper, The Independent, is instructive. They reported the death of a patient from whom a healthy kidney was removed, leaving the diseased one. The proximate medical error was by the chief surgeon who read the X-Ray backward and removed the wrong kidney. But the normal redundant safety system of comparing the X-Ray reading with the diagnostic medical notes was not carried out by the chief surgeon, the assistant surgeon, the chief anesthesiologist, the assistant anesthesiologist, nor any of the surgical nursing staff. And by the way, Great Britain is now undergoing the same types of effort to improve patient safety that are reviewed in this course. The medical error report, To Err is Human: Building a Safer Health System, was issued in the year 2000 by the Institute of Medicine (IOM). It revealed that the headline cases were only a small fraction of an alarmingly large problem. It has prompted justifiable concern in the general public, increased scrutiny by healthcare governance, legislative review, and some promising self-assessment by health care professionals and organizations. The high estimates of erroneous deaths per year (44,000- 98,000) were extrapolated from the results of two Harvard Medical Practice Studies that examined large samples of hospital admissions in the States of Colorado and Utah using 1992 data, and another in the State of New York based upon 1984 records. “Adverse events” occurred in 2.9 percent of New York’s admissions and in 3.7 percent in Colorado/Utah. The proportion of those adverse events caused by medical error was 53% and 58% respectively! Very few potential patients are aware that serious adverse events occur in up to 12% of all hospital admissions.2 An adverse event is an unexpected incident, injury, “near miss”, or other wrongful occurrence directly associated with care or services provided within a health care environment. A medical error has been 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 errors are adverse events that should have been preventable within the current state of medical knowledge.3 Medical errors, as estimated in the IOM report, rank as the eighth leading cause of death in the United States, killing more people yearly than motor vehicle accidents, breast cancer, or AIDS.4 Not only are the number of deaths appalling, the annual cost of errors is staggering. Annual national costs (lost income, lost household production, disability, & health care costs) are estimated to be between $17 billion and $29 billion, with health care costs representing more than half of that total.5 Hospital medication errors alone account for 7,000 deaths annually6 and the estimated increase in hospital costs of preventable adverse drug events is about $2 billion.7 ❖ 1 PREVENTING MEDICAL ERRORS ARCMESA EDUCATORS www.arcmesa.com THE OCCURRENCE OF MEDICAL ERRORS There are two basic types of medical errors: errors of “commission” where an improper action is taken, and errors of “omission” resulting from actions not taken. Medical errors can generally be assigned to one of four categories: • adverse events, • intentional unsafe acts, • near misses • sentinel events. 1. Adverse Events (See previous definition) Proper reporting and documentation is required for all adverse events. An incident report must be filled out and all proper parties informed. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) also requires health care agencies to report sentinel events as well as the following types of adverse events: • Assault and/or Rape • Suicide of a patient in a setting where the patient receives 24 hour care • Infant abduction or discharge to the wrong family or facility • Wrongful surgery; either wrong patient or body part • Hemolytic transfusion reaction involving administration of blood or blood products having major blood group incompatibilities8 2. Near Misses Near misses (or close calls) are adverse events that could have caused harm but did not, whether by chance or by timely intervention. Too frequently these events are not reported but revealing them can improve a safety system or procedure and avoid repetitions. 3. Intentional unsafe acts These are defined as an event resulting from a criminal act, a purposefully unsafe act, an event involving alcohol or substance abuse by an impaired provider or staff, or any act or allegation of patient abuse of any kind. 4. Sentinel events As defined by the JCAHO, a sentinel event is an unexpected occurrence or variation that involves death or serious physical or psychological injury to a patient.9 Serious injury specifically includes loss of limb or function (sensory, motor control, physiologic or intellectual impairment not previously present that requires further treatment and/or lifestyle change). ❖ 2 PREVENTING MEDICAL ERRORS ARCMESA EDUCATORS www.arcmesa.com Medication Errors Since “medication errors are one of the most common causes of avoidable harm to patients in health care organizations”,10 this type of adverse event deserves special attention. A study published in 2000 reported that medication errors occur in 6%-10% of all hospitalized patients. Most of those were harmless but 1%-2% caused injury and an additional 5% were near-misses.11 Another report stated that 1% of medication errors were fatal.12 A medication error is defined as any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer (The National Coordinating Council for Medication Error Reporting and Prevention). Types of medication errors include: omission, wrong time, improper dose, prescribing error, improper administration, deteriorated drugs, improper preparation, improper monitoring and compliance, and any product, process, or human error causing an adverse event. The three major steps in the medication administration process are: (1) point-of-entry written order; (2) dispensing of medication or herbal therapies; and (3) administration of medication to the patient. The point-of-entry written order prescribes the drug or therapy to be administered, the route, and the dosage. Interruptions, distractions, background noise on the recording, and incomplete or illegible orders can cause errors at this stage if the transcriber does not clarify and correct any unclear orders. Dispensing errors might occur if the clinician tries to do to many orders at one time and becomes distracted or confused. Administration errors can also be influenced by a variety of factors. A 2001 study found that medication errors were most frequent during administration.13 However, proper preadministration assessment of the patient and use of the five “rights” can prevent such errors. They are: right patient; right drug, right dose, right route, and right time. ❖ 3 PREVENTING MEDICAL ERRORS ARCMESA EDUCATORS www.arcmesa.com INFLUENCING FACTORS Medical errors are usually the result of a complex set of factors rather than a simple careless act by one professional.14 An example of this complexity can be seen in a report on wrong-site surgery: • 19% of the wrong procedures were attributed to emergency cases; • 16% to unusual physical characteristics, including morbid obesity or physical deformity; • 13% to extreme time pressures to start or complete the procedure; • 13% to unusual equipment or set-up in the operating room; • 13% due to multiple surgeons involved in the case; and • 10% due to multiple procedures being performed during a single surgical visit.15 A similar study of other operative and postoperative complications found six primary factors that impacted the occurrence of medical error: • Necessary personnel not available when needed • Deficient credentialing and privileges • Failure to question inappropriate orders • Incomplete preoperative assessment • Inadequately supervised house staff • Inconsistent postoperative monitory procedures16 Many other factors are more arbitrary and general in nature. These would include: • Poorly organized & chaotic work area (Nursing station, OR, Admin. Office) • Inadequate performance or knowledge • Lack of personnel • Incompetent or impaired personnel • Ignoring policies or procedures • Poor handwriting; verbal orders; typographical errors; math errors • Use of misleading names or abbreviations • Improper or unprepared medical supplies • Over-worked and exhausted staff ❖ 4 PREVENTING MEDICAL ERRORS ARCMESA EDUCATORS www.arcmesa.com RECOGNIZING ERROR-PRONE SITUATIONS The IOM report on medical errors, To Err is Human…, noted that most adverse events were not the result of negligence, lack of education, or poor training. Instead, they are mostly attributable to poor systems design and organizational factors. Many institutions have complex systems designed to achieve certain goals but, by their very complexity, the system increases the level of errors. As the complexity of a procedure or healthcare process increases, so too does the likelihood of medical error. Economics and egos are too often of greater concern to the institution than a true dedication to patient safety. Most healthcare practitioners are aware of error-prone situations, but time constraints and distractions frequently dull the fine edge needed to remain vigilant and avoid an adverse event. Good examples of error-prone situations are the care of patients with impaired strength, flexibility, and/or cognition; blood product transfusion; and, the order & delivery process for medications--especially high-risk drugs like potassium chloride, insulin, heparin, lidocaine, and chemotherapeutic agents.17 JCAHO, one of the clear leaders for patient safety in health care settings, released a study of 1,541 sentinel events reviewed since 1995. The report, which defines error-prone situations, along with percentages of occurrence (see below), merits careful examination by healthcare professionals:9 Patient suicides (17%) Operative/postoperative complications (12%) Medication errors (12%) Wrong-site surgery (11%) Delays in treatment (5%) Patient falls (5%) Patient deaths or injuries in restraints (5%) Assault, rape, or homicide (4%) Transfusion errors (3%) ❖ 5 PREVENTING MEDICAL ERRORS ARCMESA EDUCATORS www.arcmesa.com IMPROVEMENTS IN PATIENT SAFETY In the report Making Health Care Safer18, the authors define a “patient safety practice” as: “A type of process or structure whose application reduces the probability of adverse events resulting from exposure to the health care system across a range of diseases and procedures.” This definition fits with the assumption that the reduction of medical errors will be achieved more effectively by systematic change in the health care system than by targeting and punishing individual providers. It also assumes that actions that cut across diseases and procedures allow a sharper focus on patient safety, and differentiates those efforts from already existing “quality improvement” practices. We should expect, however, that there will be and should be overlap of patient safety and quality care procedures. They reinforce each other. Reduction in Medical Errors There is no single process or “fix” that will drastically reduce medical errors in the short term but the IOM report, To Err is Human…, attempted to get some corrective actions started. It raised public awareness of the real threat to patient safety, stimulated some health institute administrators to initiate meaningful quality control (QC) programs to improve conditions, encouraged a flood of studies and scholarly reviews on the topic, and has resulted in significant peer review of various processes and systems for improvement. Despite some progress by individual institutions in reducing errors with various quality control measures and revised safety nets, the complexity and fragmentation of the overall health care system has made it extremely difficult to make any coordinated advances against error reductions. The IOM report noted that healthcare is “a decade or more behind other high-risk industries in its attention to ensuring basic safety.”19 Annual job-related deaths in America are considerably fewer than those resulting from medical errors! About 6,000 Americans die from workplace injuries20 each year but medication errors alone are estimated to account for more than 7,000 deaths.3 Reviewing some of the error-reduction steps taken by non healthcare industries furnishes insight into possible changes to reduce medical errors. Examples include: • Not tolerating high error rates, and setting ambitious targets for error-reduction initiatives • Developing tracking mechanisms that expose errors • Relying on the abundant reports of errors and “near misses” • Thoroughly investigating errors, including a root cause analysis • Applying to error reduction a systems approach that embraces a wide array of human factors, technical, and organizational remedies ❖ 6 PREVENTING MEDICAL ERRORS ARCMESA EDUCATORS www.arcmesa.com • Focusing on systems solutions that do not seek to find individual fault and blame • Changing the organizational culture so that it enhances safety and error-reduction • Allocating adequate resources to error prevention initiatives and the development of the knowledge base to support them • Recognizing that solutions often come from unexpected sources, “out of the box” thinking, and new combinations of disciplines3 In Making Health Care Safer18 the authors cite some specific procedures from non-healthcare industries. These include incident reporting (Ch. 4 in the report) and Root Cause Analysis (Ch. 5) as well as the following: • Computerized physician order entry for reduction of medication errors (Ch. 6) • Automated medication dispensing systems (Ch. 11) • Bar coding technology to avoid misidentification errors (Ch 43.1) • Aviation-style preoperative checklists for anesthesia equipment (Ch 23) • Crew resource management, a teamwork training and crisis response model from aviation (Ch. 44) • Simulators of patients or clinical scenarios as a training tool (Ch. 45) • Human factors theory in the design of medical devices and alarms (Ch. 41) It is worth noting the number of these procedures taken from aviation, an industry with a safety record far superior to healthcare. It will take a multi-faceted approach and some little-seen coordination and cooperation among healthcare professionals on all levels---national, state, and local---to get the job done. The traditional “name, blame, & shame” approach to reporting medical errors has proven counter-productive and is merely a bad reaction to a single event rather than a link to a possible solution of one aspect of a system-wide error problem. Dr. C. Everett Koop, former Surgeon General of the U.S., stated that the traditional approach had driven the patient safety problem underground, leading to an implicit “conspiracy of silence” where problems and close calls are not discussed due to fear of reprisal.21 Adverse event reporting has been going on for years but not all states participate and many question if all errors are being reported by those that do. Nevertheless, progress is being made and two specific quality control tools for analysis are being utilized to strengthen efforts toward patient safety improvement. These are Root Cause Analysis (RCA) and Failure Mode Effect Analysis (FMEA). ❖ 7 PREVENTING MEDICAL ERRORS ARCMESA EDUCATORS www.arcmesa.com Root Cause Analysis (RCA) This is a process used to identify factors contributing to variations in performance, especially those related to a sentinel event. The occurrence of an event that results in serious injury or death prompts an investigation aimed at improving the system or process to prevent or reduce the likelihood of recurrence.9 JCAHO requires affiliated healthcare agencies to conduct an RCA for all reports of sentinel events.22 The RCA process utilizes a team of people from all areas of the institute involved in the event. It is a ‘barn-storming’ analysis that examines every facet of the process or procedure leading to the error and repeatedly explores all steps by asking “why” questions until no additional logical answers can be identified.12 The team uses a standardized template called an Ishikawa diagram. It is also known in QC terms as a fishbone or cause and effect diagram. Major headings that are possible causes of the event, even those remotely possible, are added to the ‘bones’ of the diagram. For each cause listed the team asks “why?”. Those reasons are written down as smaller branches on the diagram and, typically, each team member tries to write five “why” causal questions. Once the diagram is complete, the underlying causes of the event are discussed and summarized. Changes to systems and processes that would reduce the risk of similar adverse events are suggested.23 FISHBONE OR CAUSE AND EFFECT CHART Patient Patient Treatment Treatment Plan Plan History Size Shape Mobility Concern Procedures Procedures Medication (List Surgery of Diet Causal Recovery Factors) Discharge INCIDENT INCIDENT (List of Causal Factors) Facilities Facilities Personnel Personnel (List of Causal Factors) (List of Causal Factors) Communication Communication Figure 1 - Sample "cause & effect" chart for RCA of medical error. (Choose major headings and causal subheadings as appropriate.) ❖ 8 PREVENTING MEDICAL ERRORS ARCMESA EDUCATORS www.arcmesa.com Failure Mode Effect Analysis (FMEA) This is another evaluation tool being used in the healthcare industry that promotes safety in systems and seeks the prevention of accidents. It is similar to RCA but is more proactive rather than reactive. FMEA assumes that errors are likely to occur, even to knowledgeable and attentive healthcare professionals, and tries to anticipate problems before they occur. This approach removes the burden of preventing errors from individuals by using an interdisciplinary group to engage in a never-ending process of quality improvement to assess and correct areas where errors are likely to occur.21 At checkpoints in each step of a potential problem process, FMEA strategies build redundancies that serve as ‘safety nets’ or error traps. For example, in the “wrong kidney” case of the introductory paragraph, one could imagine the development of checklists for each professional in preoperative and postoperative mode, much as pilots use in takeoff and landing of an airplane. Insufficiency of Existing Programs Effective error prevention systems need to be utilized by locally directed programs within health care organizations, complemented by coordinated external support and guidance from Federal, State, and non-governmental agencies and professional organizations. Within such a framework, a comprehensive approach to error reduction would require specifically designated personnel working in or consulting with each health care setting to: • Identify and monitor the occurrence of errors in targeted patient populations at greatest risk, and understand their root causes, especially those that are preventable. • Analyze, interpret, and disseminate data to clinicians and other stakeholders. • Implement error reduction strategies based on reanalysis and reworking of health care systems. • As necessary, call upon experts with clinical, epidemiological, and management training and experience for technical support and to conduct on-site investigations. • Evaluate the impact of such programs on patient safety.8 ❖ 9 PREVENTING MEDICAL ERRORS ARCMESA EDUCATORS www.arcmesa.com REPORTING RESPONSIBILITIES A “Statement of Principle” for informing patients of medical errors was approved by the National Patient Safety Foundation Board of Directors on November 14, 2000: Talking to Patients About Health Care Injury: Statement of Principle When a health care injury occurs, the patient and the family or representative is entitled to a prompt explanation of how the injury occurred and its short- and long-term effects. When an error contributed to the injury, the patient and the family or representative should receive a truthful and compassionate explanation about the error and the remedies available to the patient. They should be informed that the factors involved in the injury will be investigated so that corrective steps can be taken to reduce the likelihood of similar injury to other patients. Health care professionals and institutions that accept this responsibility are acknowledging their ethical obligation to be forthcoming about health care injuries and errors. The National Patient Safety Foundation urges all health care professionals and institutions to embrace the principle of dealing honestly with patients. After a medical error has occurred, the health care professional responsible is obligated to inform the patient and his/her family---but only as authorized by applicable confidentiality statutes. Generally the attending physician or institution designate will initially speak with the patient or family regarding adverse or sentinel events and the options available to them. Medical errors and/or adverse events also need to be reported to institution authorities, state regulatory agencies, and Federal accreditation organizations. This is almost always performed by completing an Incident Report. Sentinel events and other designated adverse events are mandatory reports. Traditionally, mandatory reports are systems whose primary purpose is to hold health care providers accountable for reporting errors associated with serious injury or death. Most “mandatory report systems” are managed by state regulatory agencies that have the authority to investigate the error and issue penalties or fines for wrongful acts. Most “voluntary report systems” are concerned with safety improvement and examine errors that are close calls or cause minimal patient harm. Legal Barriers to Reporting A system that supports learning from errors is dependent upon reporting, but fear of reprisal or legal action often discourages potential reporters. Assurances that the identity of reporters will be masked or never collected at all have been shown to enhance reporting in other industries. There will remain instances, however, where criminal or negligent acts demand appropriate disclosure. The legal issues surrounding patient safety will have to be examined carefully to determine the best mechanisms to promote learning from errors while protecting the public.8 ❖ 10 PREVENTING MEDICAL ERRORS ARCMESA EDUCATORS www.arcmesa.com SPECIAL POPULATION NEEDS Certain patients are more vulnerable to medical errors than others and require more attention. Patients can be included in this category due to age (very young or very old), size (obese or anorexic), disability, psychiatric problems, severe illness, and other special medical conditions, such as infectious disease, anesthetized, restrained, suicidal, etc. Anesthetized patients, both pre-operative (for wrong surgical procedures) and post-operative (possible complications) are at risk and must be monitored until full recovery. Babies and infants are in danger because they cannot participate in decision-making regarding their own care. Their cognitive and language skills prohibit recognition and reporting of changes in symptoms and reactions to treatments. Critically ill patients are extremely vulnerable and require careful monitoring to prevent complications and death. Preventable deaths in the ICU have been attributable to management errors, drug/electrolyte errors, monitoring errors, and procedural/technical errors. Elderly patients, especially those with sensory impairments, are susceptible to medication errors, falls, and skin breakdown. Patients in rehabilitation settings are prone to falls as they gain independence.24 Many try to walk to the bathroom without assistance, despite instructions to the contrary, and they are alone when they fall and frequently are unable to call for help. Patients with developmental disabilities are limited in their ability to understand medical instructions or communicate their concerns. Psychiatric patients admitted to a hospital on an involuntary basis are likely at risk for elopement or other bizarre behavior and must be monitored frequently. Suicidal patients may actually attempt self-harm or just exhibit signs of depression. Such patients can usually be kept safe by assessment, frequent monitoring and/or one-on-one arms-length suicide watch. ❖ 11 PREVENTING MEDICAL ERRORS ARCMESA EDUCATORS www.arcmesa.com PATIENT EDUCATION Patients need to be informed about their condition, treatment plan, and the possibility of medical error. An informed patient becomes an involved partner in the quest for error prevention. Patient safety was defined by the IOM report as “freedom from accidental injury.”3 A patient who appreciates that definition and is aware of the potential for harm will become an additional ‘safety net’ while receiving care and also be more aware of the potential for medical error after returning home. The Quality Interagency Coordination Task Force (QuIC) developed a “Patient Fact Sheet”25 that should be required reading for all incoming patients and handed out freely in all doctor’s offices: Five Steps to Safer Health Care 1. Speak up if you have questions or concerns. Choose a doctor who you feel comfortable talking to about your health and treatment. Take a relative or friend with you if this will help you ask questions and understand the answers. It's okay to ask questions and to expect answers you can understand. 2. Keep a list of all the medicines you take. Tell your doctor and pharmacist about the medicines that you take, including over-the-counter medicines such as aspirin, ibuprofen, and dietary supplements like vitamins and herbals. Tell them about any drug allergies you have. Ask the pharmacist about side effects and what foods or other things to avoid while taking the medicine. When you get your medicine, read the label, including warnings. Make sure it is what your doctor ordered, and you know how to use it. If the medicine looks different than you expected, ask the pharmacist about it. 3. Make sure you get the results of any test or procedure. Ask your doctor or nurse when and how you will get the results of tests or procedures. If you do not get them when expected— in person, on the phone, or in the mail—don't assume the results are fine. Call your doctor and ask for them. Ask what the results mean for your care. 4. Talk with your doctor and health care team about your options if you need hospital care. If you have more than one hospital to choose from, ask your doctor which one has the best care and results for your condition. Hospitals do a good job of treating a wide range of problems. However, for some procedures (such as heart bypass surgery), research shows results often are better at hospitals doing a lot of these procedures. Also, before you leave the hospital, be sure to ask about follow-up care, and be sure you understand the instructions. ❖ 12 PREVENTING MEDICAL ERRORS ARCMESA EDUCATORS www.arcmesa.com 5. Make sure you understand what will happen if you need surgery. Ask your doctor and surgeon: • Who will take charge of my care while I'm in the hospital? • Exactly what will you be doing? • How long will it take? • What will happen after the surgery? • How can I expect to feel during recovery? Tell the surgeon, anesthesiologist, and nurses if you have allergies or have ever had a bad reaction to anesthesia. Make sure you, your doctor, and your surgeon all agree on exactly what will be done during the operation. ❖ 13 PREVENTING MEDICAL ERRORS ARCMESA EDUCATORS www.arcmesa.com REFERENCES At various points in this course we have quoted from three particular sources, the IOM, the QuIC, and the AHRQ. It is worth emphasizing those three agencies and their reports as references for any health care professional wishing to learn more about particular aspects of patient safety. 1. The IOM report, To Err is Human: Building a Safer Health System is the report that initiated the increase in public concern for patient safety and the legislative and regulatory actions that led to courses such as this. 2. The QuIC report is: Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact. The QuIC is an interagency Federal government group formed at the request of the President to develop a response to the IOM report listed in 1. 3. The AHRQ report, Making Health Care Safer: A Critical Analysis of Patient Safety Practices, was developed in response to one of the QuIC proposals. The report was prepared by UCSF and Stanford medical schools under the leadership of Robert M. Wachter, M.D., Kathryn McDonald, M.M., and five editors from those two institutions. All of these organizations have excellent web sites from which the various reports can be downloaded. The URL addresses will be found in the reference list below. 1. Cook, Richard; Woods, David; Miller, Charlotte, A Tale of Two Stories: Contrasting Views of Patient Safety. Chicago: National Patient Safety Foundation, 1998. 2. Brennan, Troyen A.; Leape, Lucian L.; Laird, Nan M., et al. Incidence of adverse events and negligence in hospitalized patients: Results of the Harvard Medical Practice Study I. N Engl J Med. 324:370–376, 1991. 3. Kohn, L.T., Corrigan, J.M., & Donaldson, M.S. (Eds.) To Err is Human: Building a Safer Health System. Washington, DC: National Academy Press, 2000. Reviewed in May, 2002 on the Internet at http://www.nap.edu/books/0309068371/html 4. Centers for Disease Control and Prevention (National Center for Health Statistics). Births and Deaths: Preliminary Data for 1998. National Vital Statistics Reports. 47(25):6, 1999. 5. Thomas, Eric J.; Studdert, David M.; Newhouse, Joseph P., et al. Costs of Medical Injuries in Utah and Colorado. Inquiry. 36:255–264, 1999. See also: Johnson, W.G.; Brennan, Troyen A.; Newhouse, Joseph P., et al. The Economic Consequences of Medical Injuries. JAMA. 267:2487–2492, 1992. 6. Phillips, David P.; Christenfeld, Nicholas; and Glynn, Laura M. Increase in US Medication-Error Deaths between 1983 and 1993. The Lancet. 351:643–644, 1998. 7. Bates, David W.; Spell, Nathan; Cullen, David J., et al. The Costs of Adverse Drug Events in Hospitalized Patients. JAMA. 277:307–311, 1997. 8. Report of the Quality Interagency Coordination Task Force (QuIC) to the President, February 2000. Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact. Reviewed in May, 2002 on the Internet at http://www.quic.gov/report/fullreport.htm ❖ 14 PREVENTING MEDICAL ERRORS ARCMESA EDUCATORS www.arcmesa.com 9. JCAHO. Sentinel event policy and procedures. Available online at www.jcaho.org/sentinel/se_pp.html 10. High-Alert Medications and Patient Safety, Sentinel Event Alert, JCAHO. Nov. 19, 1999, Issue 11. 11. Leape, L., et al: Reducing Adverse Drug Events: Lessons from a Breakthrough Series Collaborative. The Joint Commission Journal on Quality Improvement. June 2000, Vol. 26, Number6, 321-331. 12. Rex, J., et al: Systematic Root Cause Analysis of Adverse Drug Events in a Tertiary Referral Hospital. The Joint Commission Journal on Quality Improvement. June 2000, Vol. 26, Number 6, 563-575. 13. Prager, L.O. (2001, Jan. 15). Database tracks causes of hospital medication errors. AMNews. Chicago: American Medical News. Internet source at http://www.ama-assn.org/scipubs/amnews/pick_01/prsd0115.html 14. Pape, T., Searching for the Final Answers: Factors Contributing to Medication Administration Errors. The Journal of Continuing Education in Nursing. July/August 2001, Vol. 32, Number 4, 152-160. 15. JCAHO. A follow-up review of wrong site surgery. Sentinel Event Alert. 2001;24. Internet source at http://jcaho.org/ptsafety_frm.html 16. JCAHO. Operative and postoperative complications: lessons for the future. Sentinel Event Alert. 2000;12. Internet source at http://jcaho.org/ptsafety_frm.html 17. Council on Graduate Medical Education & National Advisory Council on Nurse Education and Practice. Collaborative Education to Ensure Patient Safety. Washington, DC: US Department of Health and Human Services; 2000. 18. AHRQ (Agency for Healthcare Research and Quality). Making Health Care Safer: A Critical Analysis of Patient Safety Practices. The full report is available at http://www.ahrq.gov/clinic/ptsafety 19. Occupational Safety and Health Administration. The New OSHA: Reinventing Worker Safety and Health [Web Page]. Dec. 16, 1998. Available at: www.osha.gov/oshinfo/reinvent.html. 20. Phillips, David P.; Christenfeld, Nicholas; and Glynn, Laura M. Increase in US Medication-Error Deaths between 1983 and 1993. The Lancet. 351:643–644, 1998. 21. Koop CE. An ounce of error prevention. The Washington Post. Thursday, December 23, 1999; Page A21. 22. JCAHO. Root Cause Analysis in Health Care: Tools and Techniques. Oakbrook Terrace, IL: JCAHO; 1998. 23. Gaucher, R., et al: Total Quality in Healthcare: From Theory to Practice. San Francisco, CA, Jossey-Bass Inc., 1993, 418-424. 24. Rogers, S., Reducing falls in a rehabilitation setting: a safer environment through team effort. Rehabil Nurs. 1994;19(5). 25. The Quality Interagency Coordination Task Force. Five Steps to Safer Health Care. Internet source at: http://www.ahrq.gov/consumer/5steps.htm ❖ 15 PREVENTING MEDICAL ERRORS ARCMESA EDUCATORS www.arcmesa.com COURSE EXAMINATION To complete the examination, please circle the appropriate answer for each question on the Examination Answer Sheet provided. If purchasing the course exam online, to avoid errors, use the Examination Answer Sheet to mark your answers prior to taking the exam. 1. A sentinel event is medical terminology for the day you leave the hospital after a complete recovery. True 2. Patient safety has been defined as freedom from accidental injury. True 3. False An “adverse event” is a relatively harmless medical error & seldom reported. True 5. False Accurate reporting of medical errors is important so that future errors may be prevented. True 4. False False Too frequently “near misses” are not reported but revealing them can improve a safety system or procedure. True 6. Root Cause Analysis (RCA) is a system evaluation tool to help prevent future medical errors. True 7. False Sexual assault or rape in a hospital is a criminal matter to be handled by the police and is not considered as a medical error. True 10. False One big drawback to accurate and complete reporting of medical errors in America is the fear of reprisal or legal action. True 9. False The highest percentage of medication errors occur at your local pharmacy. True 8. False False Medical Errors kill more people yearly than motor vehicle accidents, breast cancer, or AIDS. True False ❖ 16 PREVENTING MEDICAL ERRORS ARCMESA EDUCATORS www.arcmesa.com 11. The traditional administrative reaction to medical errors was to “name, blame, and shame”. True 12. Fatalities from medical errors are the eighth leading cause of death in America. True 13. False Estimates say that 6,000 Americans die in workplace accidents each year but 7,000 die from medication errors. True 20. False It is considered improper for a patient to ask questions about his physician’s treatment plan. True 19. False Extrapolated figures from the results of two Harvard Medical Practice Studies estimate that 44,000 – 98,000 Americans die each year from medical errors. True 18. False JCAHO requires mandatory reporting and RCA analysis of adverse events. True 17. False Medical errors are adverse events that should have been preventable within the current state of medical knowledge. True 16. False Failure mode effect analysis (FMEA) is considered a “reactive” evaluation tool. True 15. False Overworked staff, poor communication, and bad handwriting are known as “influencing factors” to the occurrence of medical errors. True 14. False False A health care professional that is responsible for a medical error is required to report the error right away and complete an Incident Report listing the details. True False ❖ 17 ARCMESA EDUCATORS www.arcmesa.com Examination Answer Sheet Personal Data ( P L E A S E P R I N T C L E A R LY ) Required information for proper certification and individual record retention. THIS SPACE FOR OFFICE USE ONLY First Name Last Name Address City State Zip Telephone Fax Profession Email State of Licensure License # Validation: I certify that I have studied the course materials and have personally completed the course examination. Please sign for proper CE/CME certification: ____________________________________________ ANSWER SHEET FOR: PREVENTING MEDICAL ERRORS Completing the Examination: Use a dark pen or pencil to circle the appropriate answer for each of the questions from the examination. If you wish to FAX your answer sheet back to ArcMesa, it is best to use a dark pen. If using the Internet, this page is intended to assist you in fast and accurate testing when you purchase the online exam. 1. True False 11. True False 2. True False 12. True False 3. True False 13. True False 4. True False 14. True False 5. True False 15. True False 6. True False 16. True False 7. True False 17. True False 8. True False 18. True False 9. True False 19. True False 10. True False 20. True False ArcMesa Educators • 788 Shrewsbury Ave, Tinton Falls, NJ 07724 • Voice: 732-224-9595 Fax: 732-224-9594 ARCMESA EDUCATORS www.arcmesa.com Course Evaluation COURSE TITLE: PREVENTING MEDICAL ERRORS Please provide us with your candid evaluation so that we can continue to improve these continuing education materials. We thank you for your comments and appreciate your suggestions for future courses. Comments 1. After participating in this course do you feel that A. the learning objectives were met? ❑ Yes ❑ No ____________________________ B. your knowledge has been enhanced? ❑ Yes ❑ No ____________________________ C. your skills have been improved? ❑ Yes ❑ No ____________________________ D. the course was effective in meeting identified needs? ❑ Yes ❑ No ____________________________ E. you are satisfied with the course content? ❑ Yes ❑ No ____________________________ F. ❑ Yes ❑ No ____________________________ ❑ Yes ❑ No ____________________________ the information gained applies to your profession? G. the information gained will assist in improving your professional performance? 2. Your overall rating of this course ("A" being the best): A B C D 3. Please estimate the number of hours spent to complete the course and examination. No. of hours? __________ Please add any other comments about this course or your suggestions for future courses: __________________________________________________________________________________________________________ __________________________________________________________________________________________________________ __________________________________________________________________________________________________________ __________________________________________________________________________________________________________ __________________________________________________________________________________________________________ Credit Card Information: If you have not yet purchased this course, and would like to complete the course traditionally, Mail or Fax both the Answer Sheet and Evaluation form with your credit card information to: ArcMesa Educators, 788 Shrewsbury Ave, Tinton Falls, NJ 07724 or Fax to: 732-224-9594. 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