Government Study Finds Many Deaths Due to Health Care Errors and Recommends a New Federal Agency to Improve Quality of Care

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TO: Medical Professional Liability Clients and Friends
RE: Government Study Finds Many Deaths Due to Health Care Errors and Recommends a New Federal Agency to Improve Quality of Care
DATE: December 3, 1999

A new report by the Institute of Medicine (“IOM”) on the quality of medical care became available this week. It is highly critical of health care providers and sure to become a favorite source for the medical malpractice plaintiffs’ bar and other parties interested in portraying the health care system in the U.S. as error-prone, dangerous, and in need of reform. Fortunately, the authors do not appear to view private litigation as the best means of preventing errors, but instead recommend a new federal agency for medical safety, mandatory reporting of medical errors, and periodic retesting of health care professionals.

The report is entitled To Err Is Human: Building a Safer Health System (Linda Kohn, Janet Corrigan, and Molla Donaldson, Editors). It was prepared by the IOM’s Committee on Quality of Health Care in America, which calls the text released this week a “prepublication version” of the forthcoming report. It appears that the advance copies were issued primarily to allow the press to summarize the report prior to its official publication. Several newspapers have already picked up on it, including the New York Times, Washington Post, and Wall Street Journal.

The prepublication version of the report is available in its entirety (over 200 pages) on the Internet at this URL – http://www.nap.edu/catalog/9728.html – as part of a web site operated by the National Academy Press. It can be read on line or printed in Adobe Acrobat format. Also found on that site is the press release announcing the report, which contains a good summary of its contents.

The IOM is an affiliate of the National Academy of Sciences, which is chartered by Congress but operated as a private, non-profit institution. It renders health policy advice to the federal government, ordinarily by producing extensive, peer-reviewed documents like this one, funded either by federal grants or by private foundations. Thus this report is not quite in the nature of a government white paper, because it does not express the policy of the current administration. It would be fair, however, to call it an expression of the opinion of at least a major part of the U.S. health care establishment. The press release lists the members of the committee that produced the report, and they form a cross-section of leaders from academic medicine, major hospitals, and managed care providers. We therefore expect this report to have a major influence in shaping health care policy, even if it is not a blueprint for immediate action by the Clinton administration.

The main items that the press has picked up from the advance copies of the report are a pair of estimates of preventible deaths caused by medical errors. The report contains no new research on this subject, but relies for its figures on two well-known studies that it says corroborate one another, but that others might argue are inconsistent. The best known of these is the so-called Harvard Medical Practice Study, based on a review of medical records from a group of New York City hospitals in 1982. It is claimed that the results of this study, if extrapolated to the nation as a whole, imply that there are 98,000 deaths due to medical errors in hospitals each year. (The methodology of this study has been heavily criticized.) The second study cited by the IOM is a recently published analysis of 1992 Colorado and Utah hospital records. The latter study is said to imply only 44,000 preventible deaths nationally each year. Despite the differences between these figures, the IOM report does not conclude that deaths from medical errors were halved over a ten-year period.

In a statement releasing the IOM report, William C. Richardson, who chaired the committee that produced it, called the statistics cited above “stunningly high rates of medical errors” that are “simply unacceptable in a medical system that promises first to ‘do no harm.'” The report claims that this situation has developed because the health care system is a decade behind other high-risk industries in addressing safety concerns, and therefore has not shared in the gains achieved by transportation and manufacturing, for example.

The report describes in detail the committee’s plan for reducing the number of medical errors. It calls “fingerpointing” a pointless exercise and recommends instead a systemic strategy involving government, industry, consumers, and providers. The main governmental effort would come from a new center for patient safety within the U.S. Department of Health and Human Services that would set national safety goals, track progress, and fund research. The report also recommends a nationwide, mandatory system of reporting medical errors. It would, however, allow medical mistakes that do not result in serious consequences to remain confidential, so that the data base could not be used for lawsuits, which might discourage participation by practitioners and health care organizations. Other recommendations include periodic retesting of health care practitioners and clearer FDA requirements for the labeling of pharmaceuticals.

Mr. Richardson’s statement summarized the committee’s vision:

Health care organizations must create an environment in which safety will become a top priority. This culture of safety means designing systems geared to preventing, detecting, and minimizing hazards and the likelihood of error – not finding and attaching blame to individuals. That requires creating and adequately funding systems to monitor safety. We urge the adoption of well-understood safety principles such as designing jobs and working conditions for safety; standardizing and simplifying equipment, supplies, and processes; and avoiding reliance on memory.

Because the know-how exists to prevent many of these mistakes, we strongly believe it is possible to achieve at least a 50 percent reduction in errors over five years. The majority of medical errors do not result from individual recklessness, but from basic flaws in the way the health system is organized. Equipment controls that differ from one manufacturer to another, or from year to year, can contribute to errors. Stocking patient-care units in hospitals with drugs that are potentially lethal unless diluted before being administered has resulted in deadly overdoses. Illegible writing in the medical record has resulted in the administration of a drug for which the patient has a known allergy. More generally, medical knowledge and technology advance so rapidly that it is difficult for practitioners to keep up.

From the perspective of medical liability insurers, the most interesting thing about the IOM report may be that it almost completely ignores private tort litigation as a potential solution to the problem of medical error. The authors clearly have a bias in favor of planning and regulation as solutions to medical safety problems, and their proposals are predominantly rule-based and bureaucratic in nature. The only real attention paid to litigation is worry about how to limit access to data gathered for the purpose of improving safety so as not to cause providers to resist participation out of fear of liability.

The corrective actions recommended in this report could be viewed as functional substitutes for private medical malpractice litigation as a way of reducing mistakes, and thus as consistent with some national form of tort reform. It is by no means inevitable that Congress will make this connection, and a political compromise might produce the worst of both worlds – no tort reform and a system of error reporting and open physician data bases that could make life even more difficult for health care providers than it is today. However, we believe that the intent of the authors of the IOM report is to recommend more intensive regulation, not more liberal private recovery, as the solution to the problem of death and injury caused by medical error. It is therefore entirely possible that legislation incorporating this point of view would include a measure of medical malpractice tort relief to compensate health care providers for adding to their regulatory burden. In addition, if a plan of the type recommended in this report were actually to succeed in reducing medical errors, hospitals and their insurers would benefit from lower levels of recovery. Therefore a report that is being treated by the press primarily as another indictment of the U.S. health care system could, in the end, produce some benefits for patients, health care providers, and medical liability insurers alike.

If you have any questions, please call Paul Turner at 312-923-4114.