The epidemic of medical errors Thursday, August 15, 2013
The epidemic of medical errors: Emerging expectations under health reform legislation
By Bob Ruch, MHA, FACHE
In 2006, I published a series of two articles relating to the epidemic of medical errors in hospitals and other medical settings. There was both good news and bad news. Today, seven years later, there is still both good and bad news. What has changed is the presence of a large number of quality enhancement initiatives along with health reform legislation and its main product – Medicare – serving 47 million Americans. Collectively, these initiatives have created a medical tsunami recasting the American healthcare delivery system at breakneck speed.
As consumers, health care professionals and influencers on health policy, we have to acknowledge that patients die or are further debilitated by the very system that is supposed to help them heal or be cured. As explained in the book, The Checklist Manifesto: How to Get Things Right, the reason is simple: The volume and complexity of knowledge today has exceeded our ability as individuals to properly deliver it to people – consistently, correctly, safely. We train longer, specialize more, use ever-advancing technologies, and still we fail.(1)
Recent trends in medical errors
This article will review recent trends in medical errors, the economic and personally harmful impact of those errors, and the influence of health reform legislation on key stakeholder groups. We begin by updating the four leading causes of medical errors. They include:
1. Medication errors;
2. Hospital induced (nosocomial) infections;
3. Lack of technical skills and physician impairment; and,
4. Surgical errors including wrong body parts and patients.
1. Medication errors
An estimated 7,000 deaths and 1.3 million injuries occur each year because of medication errors in America’s hospitals. Research by the Institute of Medicine suggests that a typical hospital patient is subjected to an average of at least one medication error per day. While 41 percent of all medication errors involve an improper dose of medication, 16 percent are the result of hospital staff administering the wrong drug altogether. Recently-conducted analyses of medication errors have been traced to hospital nurses and physicians not gathering complete information on patient’s allergies, medical conditions or other medications. Similarly, dangerous medication errors occur when doctors and nurses have incomplete information about the drug to be administered to the patient. A tragic case of medication error in which I was involved as an expert witness, occurred when a physician administered an off-label drug into the patient’s bladder at a concentration level ten times that of the accepted level of dilution. The resulting damage to the patient was severe, requiring ongoing kidney dialysis and a reconstructed bladder.
Adults 60 and over are particularly vulnerable to medication errors and account for nearly half the medication errors that were fatal. Multiple prescriptions and confusion on the part of the patient contribute to the high incidence of error. Research indicates that medication errors are less likely to occur at hospitals with higher nurse-to-patient ratios than at those that are understaffed. In addition, hospitals with interactive information systems in place along with supportive and collaborative work environments, tend to have lower rates of medication error.
Electronic medical records have shown some promise in reducing hospital medication errors. However, there is evidence that interactive pharmacy dispensing systems and computer physician order entry have created a new type of medication error vulnerability.
2. Hospital-induced infections
Patients contracting hospital infections represent a second major source of harm and death. Unfortunately, since my last report in 2006 the rate of nosocomial infections has risen to epidemic proportions.(2) Ten percent of patients on general hospital units will acquire a nosocomial infection during their hospital stay. The risk for infection escalates to 15 to 20% for those patients on intensive care units, according to the Centers for Disease Control and Prevention. Hospitals infections kill as many as AIDS, breast cancer and auto accidents combined in a given year. The most prevalent hospital induced infection, known as MRSA – accounting for 60% of all hospital induced infections – is generally spread through direct contact with the hands of a health care worker or a patient who is infected or carrying the organism.
This past summer my neighbor, a 62-year-old healthy retired teacher, coach and school bus driver, had his prostate removed at one of our local hospitals. He developed a nosocomial infection which resulted in four subsequent “bounce back” admissions to the hospitals along with a traumatic extended 120-day recovery that should have taken only 30 days and no readmissions. Nosocomial infections not only affect patient health and safety, but also the health care system as a whole. It is estimated that nosocomial infections increase the cost of health care between $4.5 and $5.7 billion in patient care.
3. Lack of technical skills and physician impairment
There is new evidence that physicians who have practiced 30 years or more are experiencing significant burnout, frustration with changes in the practice of health care and overall fatigue due to increased expectations of productivity. These circumstances lead to increased mistakes in medication ordering, lack of follow-up in administration of patient care plan elements and increased surgical errors. A fifth of the nation’s physicians are over 65, and that proportion is expected to rise. As doctors in the baby boom generation reach 65, many are under increasing financial pressures that force them to remain in practice. Patient advocates note that commercial pilots, who are also responsible for the safety of others, must retire at age 65 and are required to undergo physical and mental exams every six months starting at age 40.
The medical profession has only recently begun to address the delicate subject of when and how to monitor older physicians to assure patient safety. Only 5% of hospitals have age-based medical-staff policies in place, according to Jonathan H. Burroughs, MD, president and CEO of The Burroughs Healthcare Consulting Network in New Hampshire. He recommends that hospitals make annual renewal of privileges for physicians older than 70 contingent on their securing a fitness-for-duty evaluation from a doctor who specializes in vocational or occupational medicine.
In 2006, a Time magazine cover story asked, “What scares doctors?” The answer was “being the patient.” In a Newsweek article in September 2012, titled “Hospitals Can Kill You.” the author, Dr. Marty Makary, quoted well known Harvard surgeon Dr. Lucian Leape. Dr. Leape asked an audience of over 1,000 physicians to “raise your hand if you know of a physician you work with who should not be practicing because he or she is too dangerous.” Every hand went up! Mr. Makary went on in the article to point out that if only two percent of the nation’s 1 million doctors are seriously impaired, that would mean 20,000 impaired or fraudulent doctors are practicing medicine in America today.
4. Surgical errors including wrong body parts and patients
In December 2012, The Wall Street Journal reported that 9,744 malpractice payments were issued for surgical errors between 1990 and 2010 resulting from “Never Events” – more recently renamed Serious Reportable Events (SREs). These are mistakes that never should have happened, like operating on the wrong patient or performing the wrong surgical procedure. The Wall Street Journal reported that new research suggest “that they happen with alarming frequency.”(3) A breakdown of the 9,744 surgical errors is identified below:
• Foreign object left behind 49.8%
• Wrong procedure 25.1%
• Wrong site 24.8%
• Wrong patient 0.3%
Malpractice payments for the above claims totaled $1.3 billion with a mean payment of $133,055. Surgeons make such mistakes more than 4,000 times a year in the U.S., according to a study led by Johns Hopkins University School of Medicine, published online in the journal Surgery.
Recently, the trend in surgical errors has been on the rise. In Minnesota, where never-events are a mandatory part of a public reporting law, 18 wrong surgeries were reported in 2004. Since then, the number has risen every year, reaching 50 in 2011. For retained surgical instruments, 270 cases were reported in Minnesota between 2004 and 2011. For the last year reported, 2011, there was an 8% rise in retained object events.
Dr. Atul Gawande, a practicing surgeon and faculty member, published a landmark book in 2010 entitled The Checklist Manifesto: How to Get Things Right. Dr. Gawande writes about the avoidable surgical failures that continue to plague our health care system asserting that we can do better using the simplest of methods: a surgical checklist.(4) Just within the past two years this simple surgical checklist has been promoted by the World Health Organization and adopted by more than twenty countries as a standard of care. A number of scholars in the field of quality health care research heralded Dr. Gawande’s work as “the biggest clinical invention in thirty years.”
An additional initiative designed to reduce surgical errors had been launched by the Joint Commission on Hospital Accreditation, a body that accredits 19,000 U.S. hospitals, ambulatory surgery facilities and other health care organizations. Universal protocols were developed for hospital operating room implementation. Pre-surgical time-out briefings, marking the surgical site and confirming the patient’s identity were among the tools that were initiated. For the eight health systems participating in the initial study, significant reductions in surgical errors were realized. However, communication failures, breeches in protocols and less-than-whole-hearted support by operating room staffs have prevented this initiative from achieving its goal. Mark R. Chassin, MD, MPH, president of the Joint Commission, notes that sometimes the surgical site is marked too far away from the incision spot to be clearly seen or the ink used to mark the spot fades when the skin is cleaned and prepped for surgery. Dr. Chassin states, “There are about 300 ways that timeouts can fail, from not having everyone stop what they’re doing and paying attention…to having a bad safety culture where somebody knows something’s wrong but is too scared to speak up.”(5)
The impact of health reform on patient error rates
Although the primary focus of the Affordable Care Act (health reform legislation) signed into law in March 2010 is to provide access to affordable health insurance for all Americans, the legislation has a number of provisions that may reduce the incidence of medical errors. Based on my review of the literature along with active engagements with medical group practices and hospital clients, there are four distinct areas of impact on hospital errors. These include:
1. Improved disclosure to the public;
2. Expanded oversight by certifying and licensure bodies;
3. Application of economic disincentives for poor quality performance;
4. Adoption of protocols designed to prevent errors.
1. Improved disclosure to the public
The Affordable Care Act calls for public reporting of performance measures on quality, cost, and other metrics. Reports are prepared on hospitals, physicians, and other healthcare providers who participate in Medicare’s new “value-based purchasing” program, which will base hospital payment, in part, on whether providers achieve targets for delivering higher-quality care. For Medicaid, the law requires the U.S. Department of Health and Human Services (HHS) to adopt a core set of quality measures, develop a standardized format for reporting by states and make the information publicly available beginning in 2014. Both the HHS and state Medicaid administrators will provide web-based sites for the public to review and compare facilities and medical providers.
In addition, more than 30 states currently have public reporting programs in place for hospital patient safety. A commonly used source for this information is the Leapfrog Group, an independent hospital assessment organization issuing “report cards” for individual hospital safety. The Leapfrog Hospital Survey assigns hospitals a grade of A, B, C, D or F using data from the Leapfrog Hospital Survey, the Agency for Healthcare Research and Quality (AHRQ), the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS). Twenty-six measures for safety are assessed on the hospital’s ability to keep patients safe from infections, injuries, and medical and medication errors. Criteria include breathing failure after surgery, wounds splitting after surgery, stage 3 and 4 pressure ulcers and central-line-associated infections. Recently the Leapfrog Group has created a smart phone application that directs consumers to their local hospital report card based on GPS coordinates.
2. Expanded oversight by certifying and licensure bodies
The Joint Commission on Hospital Accreditation, through its Division of Healthcare Quality Evaluation, has recently launched an initiative to foster “High Reliability Organizations” (HROs). The core belief of HROs is that small failures in safety protocols or processes can lead to catastrophic adverse outcomes. An example of a HRO protocol is found at Owensboro (Kentucky) Medical Health System, where 50 hospital leaders gather every morning to discuss safety events from the previous 24 hours and anticipate events within the next 24 hours. These daily check-ins help uncover potential safety issues while they are still developing. This commitment to preventive safety will likely become a patient safety standard for future Joint Commission certification.
State licensure bodies have begun drawing information from online entities for licensing physicians and hospitals in their state. Healthgrades Inc. based in Denver, Colorado, is an online resource for comprehensive information about physicians and hospitals and collects comprehensive information on clinical outcomes, patient satisfaction, and patient safety. Consumers have free access to this information as well. More than 200 million consumers use Healthgrades websites to find, compare, select, and connect with a doctor or hospital. This statistic reveals the overwhelming interest on the part of consumers to obtain health information for themselves.
3. Application of economic disincentives for poor quality performance
A key component of health reform is the government’s effort to shift away from paying hospitals and doctors based on the quantity of care they provide with no regard to that hospital’s record of medical quality. The program is one of several Medicare is launching to make hospitals and doctors accountable for quality and more careful stewards of public money. Seventy percent of the scores are based on how frequently hospitals followed 12 basic clinical standards of care, such as controlling heart surgery patients’ blood sugar levels and giving them beta blockers to lower their blood pressure. The other 30 percent is determined by how well hospitals are rated by former patients in surveys asking about the communication and responsiveness of doctors and nurses and the cleanliness and quietness of their environment. Medicare currently publishes the scores for individual facilities on its Hospital Compare website. Hospitals were scored both on how well they performed compared to their peers from July 2011 through March 2012, and how much they improved over time.
Last fall, Medicare also began reducing payments to 2,217 hospitals because too many of their patients were readmitted within a month. In 2015, the health law calls for the government to begin a quality payment program for physician groups of 100 professionals or more, and that is to be expanded to all doctors by 2017.
4. Adoption of protocols designed to prevent errors
The focus here is mostly on physician decision making. The authors of health reform acknowledge that physicians can be the biggest obstacle to transforming the way we deliver care in this country. Based on the landmark Dartmouth Atlas of Health Care study (6), physicians’ discretionary decisions are a primary driver of unwarranted health care spending that drives up healthcare cost. Recent national health reform legislation (the Patient Protection and Affordable Care Act or PPACA) has several quality improvement provisions believed to be correlated with better patient outcomes. In the past, physicians have generally considered standard protocols an infringement of their patient care authority. However, a number of medical group practices within my client base have taken steps to standardize their physician member operating room and post-acute care protocols. As a result significant cost savings have been realized as well as more objective quality monitoring.
The New York Times recently reported that the country’s largest public health care system, Health and Hospital Corporation, will begin tying their doctors’ raises to performance on quality measures. Medicare has also announced it will apply quality performance measures directly to physicians starting 2015, by aligning doctors’ pay to the same benchmarks. Accountable Care Organizations (ACOs) created by health reform legislation have already begun aligning physician and hospital protocols for more enhanced universal clinical protocols.
It has often been said that, in America, we have the best and the worst healthcare system in the world. With dedicated practitioners, up-to-date health facilities and third party coverage for millions of Americans, we consume an unprecedented 17% of gross national product on health services annually. Yet our healthcare system collectively injures or kills more than 100,000 patients every year, and many of these injuries and deaths are preventable. Dr. Atul Gawande makes a compelling argument that we can do better. In his book The Checklist Manifesto, Dr. Gawande makes a distinction between errors of ignorance (mistakes we make because we don’t know enough), and errors of ineptitude (mistakes we made because we don’t make proper use of what we know). Failure in the modern world, he writes, is really about the second of these errors and offer simple remedies that achieve astounding results.(7)
There is still both “good” news and “bad” news in our quest to provide an error-free healthcare culture in this country. The good news is that healthcare providers have universally acknowledged the serious nature of the problem and are taking steps to reduce and eliminate preventable medical errors. The bad news is that small successes have kept us from seeing the bigger picture and not anticipating what the future requires of us. Wayne Gretzky, the famed hockey player, was once asked what separated his performance from other NHL players. While others skated to where the puck was, he noted, he skated to where the puck was going to be.
American healthcare stakeholders need to take Gretzky’s advice by moving their sightline from the present to the future. The work by leaders of the Owensboro Medical Health System, who spend a part of each of their day anticipating what is likely to happen in the next 24 hours to patients served by their system, develops both foresight and insight into sustainable patient quality improvement.
Health reform initiatives will likely have a positive impact on the quality performance of both hospitals and physician practices. However, state and federal mandates, taken alone, will likely create a “push-back” by those healthcare providers desiring fewer regulations and oversight of their authority. To avoid this, all stakeholders will need to dedicate their efforts to make proper use of what is already known. With such a commitment, medical errors will decline and confidence in our health delivery system will be restored.
(1) The Checklist Manifesto: How to Get Things Right, Atul Gawande, M.D., St. Martin’s Press (paperback) Jan. 2011.
(2) “Hospital-Acquired Infections: Beating Back the Bugs,” Scientific American, May 14, 2011.
(3) “Thousands of surgical errors happening with ‘alarming frequency,’” The Wall Street Journal, Dec. 21, 2012.
(4) The Checklist Manifesto: How to Get Things Right, Atul Gawande, M.D., St. Martin’s Press (paperback) Jan. 2011.
(5) “Surgical errors: In ORs, “never events” occur 80 times a week,” Kevin B. O’Reilly, amednews staff. Posted Jan. 21, 2013.
(6) The Dartmouth Atlas of Health Care, 1996 by John E. Wennberg, M.D., M.P.H., Dartmouth Institute for Health Policy and Clinical Practice.
(7) The Checklist Manifesto: How to Get Things Right, Atul Gawand, M.D., St. Martin’s Press (paperback) Jan. 2011.
Bob Ruch, MHA, FACHE, is president of Ruch Enterprises Inc. a healthcare consulting company based in Des Moines, Iowa, with hospital and medical group practice clients. In addition to providing strategic planning and leadership support, Mr. Ruch offers expert witness research and depositions to attorneys in medical negligence cases. Bob Ruch can be reached at (515) 276-7262 or at Rmruch@msn.com