Quality of Healthcare in America Committee
[MedGenMed, September 19, 2000. Medscape, Inc.]
The ensuing debate around the findings and recommendations of the IOM report has been thoughtful and informative, and has stimulated additional thinking. Unfortunately, it has also led to some misunderstandings. Because of the urgency of moving ahead promptly with the substantial changes that are needed to make our healthcare system safe, it is important that those misunderstandings be cleared up as quickly as possible. The IOM report carried 4 core messages: first, the magnitude of harm that results from medical errors is great; second, errors result largely from systems failures, not people failures; third, voluntary and mandatory reporting programs are needed; and fourth, a concerted national effort is needed now to improve patient safety.
The IOM figures regarding injuries and deaths are estimates, but they are reasonable estimates. It is important to understand how they were obtained. The higher estimate, that nationwide 98,000 people die annually as the result of errors in medical management, is a 1998 extrapolation from the findings of the medical record review study conducted using 1984 data and released by the Harvard Medical Practice Study (MPS) in 1991.[5] The lower figure of 44,000 is based on a study conducted in Colorado and Utah hospitals about 8 years later.[6] In a recent Sounding board piece, it was asserted that "neither study ...involved judgments by the physicians reviewing medical records about whether the injuries were caused by errors."[4] This is not so.
The MPS study found that 3.7% of patients hospitalized in New York State in 1984 suffered an adverse event (AE), defined as a disabling injury caused by treatment, and that 13.6% of these patients died as a result of the AE. Physician reviewers did, in fact, make judgments as to the presence of an error. In the same issue of The New England Journal of Medicine that reported these results is the companion paper from the MPS, The Nature of Adverse Events,[7] which states: "In addition, the reviewers were asked to indicate whether each adverse event could have been caused by a reasonably avoidable error, defined as a mistake in performance or thought." Of all AEs identified, 58% were judged by 2 physician reviewers to be due to an error. This is the figure IOM used. The study conducted in Colorado and Utah in 1992 used methods similar to the MPS (except that only 1 physician review was used).[6]
Unfortunately, the IOM numbers, shocking as they are, probably underestimate the extent of preventable medical injury, for 2 important reasons. First, they are based on data extracted from medical records. Many injuries, and most errors, are not recorded in the medical record, either by intent or by inattention, or, more likely, because they are not recognized.[8-10]
The second reason the IOM estimates are probably low is that they exclude outpatient injuries. We know very little about the extent of AEs in ambulatory care, but there is no evidence the error rate is less. In fact, absent hospital safeguards, regulation, and peer supervision it might well be higher. A recent study reported that 10% of office prescriptions had significant errors.[11] Recent reports of deaths of inpatients undergoing a supposedly routine procedure, liposuction, are not reassuring.[12] None of these injuries or deaths are included in the IOM estimates. In 1996, 31.5 million ambulatory surgeries and procedures were performed.[13] Even if only one half of 1% of these patients experienced a preventable AE (one fifth the inpatient rate), that alone would impact over 100,000 individuals.
The limitations of population-based studies become evident when in-depth studies "drill down" into specific clinical areas. Almost invariably, error and injury rates are found to be much higher. DuBois found that 20% (14% to 27%) of deaths from acute myocardial infarction, pneumonia, or cerebrovascular accident were preventable.[14] Bedell reported that 64% of in-hospital cardiac arrests were preventable.[15] Andrews found that 17% of ICU patients had preventable serious or fatal AE.[16] Autopsy studies have repeatedly shown fatal diagnostic error rates of 20% to 40%.[17-21] The Centers for Disease Control and Prevention (CDC) estimates that 2.7% of surgical operations are complicated by surgical-site infections, accounting for nearly 500,000 nosocomial infections each year.[22] One large controlled study found the excess mortality rate of surgical-site infections to be 4.3%, suggesting 20,000 deaths annually from this cause alone.[23]
Some maintain that the change from 98,000 in 1984 to 44,000 in 1992 indicates that patient safety has improved.[4] This is not justified. The studies differed enough with regard to site and methodology to make comparisons inappropriate.
Furthermore, the continuing pace of innovation makes it unlikely that total number of injuries due to errors has significantly declined. The last 15 years has witnessed an unprecedented acceleration in the creation and implementation of new technologies. Each one carries both benefits and new opportunities for error. Recall the many reports of complications attributed to the "learning curve" of laparoscopic cholecystectomy,[24] which still is associated with a higher complication rate than the open procedure.[25] In addition, hundreds of new drugs have been introduced during this period. Many are more effective than the ones they replaced, but this potency increases the risk of severe injuries when they are misused, and the increasing variety of medications leads to more opportunities for confusion.
Taking the lead from cognitive psychology and human factors, the IOM defined error as a failure of action or plan, not as a failure of a person. Since the release of the report, some have offered alternative definitions that ignore this fundamental concept.[4]
Judgmental terms, such as "blunder," reinforce the stereotype of error as personal failing, the very stereotype the IOM (and the title of the report) are arguing against. Other terms, such as "bloopers," serve to trivialize an issue that is of critical concern to all Americans, both patients and healthcare professionals alike. Such terms demonstrate insensitivity to the serious, sometimes devastating consequences of medical errors that far too many patients and their families have suffered. Furthermore, attributing errors to systems failures does not absolve physicians and nurses of their responsibility to be careful. In fact, it adds to that responsibility the duty to admit errors, investigate them, and participate in redesign of systems for safety. This is a much more difficult challenge than punishing wrongdoers.
Voluntary error reporting is at the heart of any safety improvement strategy. The vast majority of errors result in no harm, or have only very minimal temporary effects. These types of errors represent very important opportunities to identify systems' weaknesses and institute improvements before serious harm occurs.
To facilitate the development of voluntary reporting systems, the IOM Committee recommended that Congress extend peer review protections to the information included in voluntary systems, and that seed monies and technical support be provided by the National Center for Patient Safety, an applied research center to be created within the Agency for Healthcare Research and Quality. Some excellent voluntary reporting programs already exist; the Institute for Safe Medication Practices, for example, collects information on medication errors, but reporting is believed to be hampered by liability concerns.
The IOM Committee stopped short of recommending the creation of a publicly supported, national voluntary reporting system, because of the belief that with federal legislative protections and financial assistance, existing private sector voluntary reporting systems will grow and new ones will emerge. But the report does recommend that this assumption be periodically re-examined by the National Center for Patient Safety, and that additional steps be taken if voluntary reporting systems do not thrive.
The more controversial (and misunderstood) recommendation was the call for mandatory reporting of egregious events. The main purpose of this recommendation was to hold hospitals accountable for taking actions to improve safety. The report calls for hospitals (not doctors) to be required to report serious events (not all errors). These egregious events are ones that result in death or serious, permanent injury, and ones that everyone agrees "should not happen." We see this as ensuring a minimal level of accountability, one that 15 states already have to some degree, and another 6 states have pending legislation to create such systems.[28]
Claims that mandatory reporting of these egregious events will vastly increase malpractice liability are inflated. These events are widely known to patients and hospital personnel, so public disclosure is not the way lawyers find out about them. Lastly, it should be pointed out that the AMA Code of Ethics states that: "Situations occasionally occur in which a patient suffers significant medical complications that may have resulted from the physician's mistake or judgment. In these situations, the physician is ethically required to inform the patient of all the facts necessary to ensure understanding of what has occurred.... Concern regarding legal liability which might result following truthful disclosure should not affect the physician's honesty with a patient."[29]
The 50% reduction that IOM called for is a "stretch goal" -- but achievable if healthcare organizations were to implement all of the practices we already know will improve safety -- and if hospitals were to make safety a priority by creating nonpunitive environments where people are free to report and examine their errors and remedy the systems failures. While some may say it won't happen, it has already begun in many places. We are on the ascending limb of the adoption curve of safety practices.
Calls for purchasers and insurers to step up to the plate to pay for safety changes are appropriate and welcome. Some have already indicated their willingness to do so.[30] However, hospitals need not wait for payers. Traditionally, they have always found ways to pay for capital equipment they thought was essential; few forgo having a new MRI, for example, or the latest percutaneous transluminal coronary angioplasty stents, when their doctors call for them. As safety is increasingly recognized as an important corporate objective, the money may be found. There are also convincing data about the cost-effectiveness of safety measures. Computerized physician order entry systems have been shown to reduce adverse drug events by more than 50%, thus generating substantial savings in healthcare expenditures.[31-33]
Finally, with regard to malpractice, some have called the IOM to task for not addressing the "dead weight of a litigation system that induces secrecy and silence."[4] The IOM report specifically notes the deleterious effect of the risk of litigation and its deterrent effect on reporting. It articulates the need to "change the legal environment in which healthcare organizations and providers operate." The report goes on to suggest that enterprise liability and no-fault compensation might produce a more conducive legal environment and notes that "the issue merits further analysis."
But malpractice concerns should not, and must not, be a barrier to progress in improving patient safety. Indeed, in addition to reducing accidental injuries due to errors, one of the most important things hospitals can do right now to reduce liability is to take steps to improve patient safety, thereby decreasing the occurrence of serious AEs. Some organizations are making progress even in today's environment.[34]
The time for a serious effort to improve safety in healthcare has come at last. Throughout this nation, healthcare organizations are re-examining what they do, and multidisciplinary teams in many hospitals are redesigning their work and their environments to make it harder for mistakes to happen. Recognizing that errors come from faulty systems, not from faulty people, has been an immensely empowering concept. We have just scratched the surface of its possibilities for improving safety for our patients. We have much to do. We should celebrate our successes, be clear-eyed about our failures, and get on with the job of improvement.
|
Contact NYSHCA NY SHCA | Events Links | Members| Discussion boards at National SHCA New York Proxy Law | Patients' Bill of Rights email NY SHCA Copyright 2000 NY SHCA.
All rights reserved
|