Correspondence
The Institute of Medicine Report on Medical Errors
N Engl J Med 2000; 343:663-665August 31, 2000
- Article
To the Editor:
Brennan (April 13 issue)1 misrepresents several of the important messages of the Institute of Medicine (IOM) report entitled “To Err is Human.”2 He implies that the studies used by the IOM exaggerated the extent of preventable medical injuries because “neither study . . . involved judgments by the physicians reviewing medical records about whether the injuries were caused by errors.” This is not so. In the same issue of the Journal that contained the report of the results of the 1984 Harvard Medical Practice Study3 is a companion paper on the nature of adverse events in hospitalized patients.4 It states that, “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.”4 The study conducted in Colorado and Utah in 1992, which was cited in the IOM report, used similar methods.5
The figures used in the IOM report probably underestimate the extent of preventable medical injuries because they are based on data extracted from medical records and pertain only to hospitalized patients. Many injuries are not recorded in medical records, either deliberately or as a result of inattention, or because they are not recognized. With regard to injuries outside the hospital, if only one half of 1 percent of the 31.5 million annual outpatient procedures resulted in a preventable adverse event, more than 100,000 people would be affected.6 The IOM did not rely on these large population studies alone. The report cited more than 30 studies published in leading peer-reviewed journals over the past 10 to 12 years, many of which reported even higher rates of error and injury.
Brennan's assertion that the rates of injury and death have been reduced by improvements in care ignores the converse: the increasing hazards associated with the use of new forms of technology, which has accelerated in the past 15 years. Recall the complications of laparoscopic cholecystectomy attributed to the learning curve; this procedure still has a higher complication rate than the open procedure.7 The large number and variety of new medications introduced during this period have also substantially increased the opportunities for error.
Finally, we are concerned by Brennan's referring to errors as “blunders” and “bloopers.” These judgmental terms reinforce the stereotype of error as a personal failing, the very stereotype the IOM report argued against. Taking a cue from the field of cognitive psychology, the IOM report defined an error as a failure of an action or a plan.
The main message of the IOM report — and the conceptual underpinning of its recommendations — is that most errors are the result of faulty systems, rather than faulty people. This has been an immensely empowering concept. It is time to move beyond a fixation on the numbers and get on with the job of improvement.
7 ReferencesWilliam C. Richardson, Ph.D.
Donald M. Berwick, M.D.
J. Cris Bisgard, M.D.
Institute of Medicine Quality of Health Care in America Committee, Washington, DC 200071
Brennan TA . The Institute of Medicine report on medical errors -- could it do harm? N Engl J Med 2000;342:1123-1125
Full Text | Web of Science | Medline2
Kohn LT, Corrigan JM, Donaldson MS, eds. To err is human: building a safer health system. Washington, D.C.: National Academy Press, 2000.
3
Brennan TA ,Leape LL ,Laird NM , et al. Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice Study I. N Engl J Med 1991;324:370-376
Full Text | Web of Science | Medline4
Leape LL ,Brennan TA ,Laird N , et al. The nature of adverse events in hospitalized patients: results of the Harvard Medical Practice Study II. N Engl J Med 1991;324:377-384
Full Text | Web of Science | Medline5
Thomas EJ ,Studdert DM ,Newhouse JP , et al. Costs of medical injuries in Utah and Colorado. Inquiry 1999;36:255-264
Web of Science | Medline6
National Center for Health Statistics. FASTATS. Atlanta: Centers for Disease Control, 1999.
7
Stewart L ,Way LW . Bile duct injuries during laparoscopic cholecystectomy: factors that influence the results of treatment. Arch Surg 1995;130:1123-1128
Web of Science | Medline
To the Editor:
Brennan's spin on the IOM report struck me as one that ignored the facts and conclusions generated by Brennan himself and his colleagues in earlier studies. Brennan states that “neither study cited by the IOM as the source of data on the incidence of injuries due to medical care . . . involved judgments by the physicians reviewing medical records about whether the injuries were caused by errors.” He then uses that assertion to justify his criticism of the IOM report and to assert that “the reliability of identifying errors is methodologically suspect.” These statements strangely ignore the use of such methods in his own studies to determine the rate of adverse events resulting from negligence; this statistic was then extrapolated in those studies to justify the conclusion that malpractice litigation rarely compensates a patient who has been injured as a result of negligence.
If voluntary reporting of errors is inhibited by the possibility of public scrutiny, as Brennan asserts, then mandatory reporting and investigation is the better approach. Such investigations, conducted impartially, would most likely have an effect opposite from the one Brennan fears. Instead of resulting in more litigation, a well-conducted investigation of serious error, with public revelation of the method and results, would reduce litigation by creating a disincentive to bring cases that were found not to result from negligence. Furthermore, hospitals and physicians, confronted with an impartial report identifying their culpability, might be more willing to compensate the injured person fairly and avoid the route of expensive litigation that injured parties are now forced to choose.
As a lawyer and physician, I have observed and participated in both sides of this battle over just compensation for medical injury. I know that the closed system of peer review will never serve any interests other than those of physicians, particularly pecuniary interests; that doctors who “get along” with their colleagues are never effectively called to account for negligent acts; that hospitals that engage in sloppy care are shielded from redress and corrective action by a mutual dependence with respect to their own medical staffs; and that the attempts to introduce a systematic method of detecting and correcting errors are stymied by physicians' arrogant labeling of any system as “cookbook medicine.”
Clark Newhall, M.D., J.D.
10150 S. Centennial Pkwy., Sandy, UT 84090-1296To the Editor:
Reaction to the IOM report on medical errors has been swift and sweeping. Virtually every health care organization has voiced support for the recommendations; almost all have included a proviso concerning the need for mandatory reporting. Unfortunately, protection from legal discovery is the foundation of both the IOM recommendations and the report of the Quality Interagency Coordination Task Force.1 Thus, far-reaching change is unlikely, save possibly within the Department of Veterans Affairs system. A recent article regarding the potential for medical-malpractice reform to occur is particularly chilling and sobering, making it clear that universal reporting is a pipe dream.2 Additional legislation is already before Congress, including a requirement for the timely disclosure of medical “errors” to the patient and family.3
Brennan misses the target. Because we do not have the equivalent of cockpit flight recorders, we have no reliable data on the basis of which to determine the numbers or rates of errors. The Federal Aviation Administration has recommended that video cameras be installed in cockpits to provide additional information that might help determine the causes of mishaps. The IOM report focused on medication errors because they are relatively easy to document.
What disturbs me is that we know the causes of, as well as the solutions to, many errors, but for compelling reasons (such as lack of funding for residents and cutbacks in personnel), we turn a blind eye. For example, the IOM report mentions sleep deprivation only twice in passing (the report of the Quality Interagency Coordination Task Force mentions it only once). Need I say more? Would you want to fly with a pilot who has been awake for 72 hours?
3 ReferencesRichard J. Melker, M.D., Ph.D.
University of Florida College of Medicine, Gainesville, FL 326101
Quality Interagency Coordination Task Force. Doing what counts for patient safety: federal actions to reduce medical errors and their impact: report of the Quality Interagency Coordination Task Force (QuIC) to the President. February 2000.
2
Mohr JC . American medical malpractice litigation in historical perspective. JAMA 2000;283:1731-1737
CrossRef | Web of Science | Medline3
Medical Error Reduction Act of 2000, 106th Congress, 2nd session, S. 2038.
Author/Editor Response
Dr. Brennan replies:
To the Editor: Richardson and colleagues, of the IOM Quality of Health Care in America Committee, should be congratulated and thanked for the impact their work is having on attempts to improve the quality of health care. Therefore, I am especially concerned that they believe I have misrepresented their report on errors in medicine. I do not think that is the case.
I do believe that the use of the term “errors,” although helpful when used to refer to a corpus of work from the engineering literature, does have perjorative overtones that the press has amplified. Berwick and I have written about the corrosive effect of heavy-handed regulation on attempts to improve quality.1 I have feared that the conflation of the meaning of “error” with the meaning of “blunder,” combined with the IOM's call for mandatory, public reporting, would engender just that sort of regulation. Fortunately, the major bills on error reduction in the Senate eschew mandatory public reporting and endorse voluntary, confidential systems.2,3
Richardson et al. do not address my concern about the costs of error reduction. Perhaps they see this as a “fixation on the numbers,” but it is clear that in an ever-tightening market, administrators will scrutinize the costs of improvement efforts and expect clear results.
This expectation of results goes to the heart of the contentions of Richardson et al. about the counting of errors. The reliability of the Medical Practice Study's classification of errors was never tested, and in fact, my colleagues and I allowed reviewers to use their own criteria for identification.4 Moreover, we counted the judgment of any one physician and so could not calculate the incidence rate of errors. The IOM would have done better to rely on a subsequent paper of ours in which the connection between preventable adverse events and errors is first made.5 In that paper we calculated that 68 percent of adverse events were preventable.
This point may again make it seem as though I am fixated on numbers, but it leads to my last point, which is the difficulty of demonstrating improvement when the identification of errors is subjective. A recent Japanese study of maternal mortality in which reviews were conducted by a committee of 42 specialists has set a new standard for assessing reliability.6 Unless we develop methods that reliably identify adverse events, we will not know whether we have improved care. I think our patients deserve no less.
6 ReferencesTroyen A. Brennan, M.D.
Brigham and Women's Hospital, Boston, MA 021151
Brennan TA, Berwick DM. New rules: regulation, markets, and the quality of American health care. San Francisco: Jossey-Bass, 1996.
2
S. 2743, Voluntary Error Reduction and Improvement in Patient Safety Act of 2000 (Introduced by Senators Kennedy and Dodd).
3
S. 2738, The Patient Safety and Errors Reduction Act (Introduced by Senators Jeffords and Frist).
4
Leape LL ,Brennan TA ,Laird N , et al. The nature of adverse events in hospitalized patients: results of the Harvard Medical Practice Study II. N Engl J Med 1991;324:377-384
Full Text | Web of Science | Medline5
Leape LL ,Lawthers AG ,Brennan TA ,Johnson WG . Preventing medical injury. QRB Qual Rev Bull 1993;19:144-149
Medline6
Nagaya K ,Fetters MD ,Ishikawa M , et al. Causes of maternal mortality in Japan. JAMA 2000;283:2661-2667
CrossRef | Web of Science | Medline
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Joel A. DeLisa. (2004) Physiatry: Medical Errors, Patient Safety, Patient Injury, and Quality of Care. American Journal of Physical Medicine & Rehabilitation 83:8, 575-583
CrossRef4
Volpp, Kevin G.M., Grande, David, . (2003) Residents' Suggestions for Reducing Errors in Teaching Hospitals. New England Journal of Medicine 348:9, 851-855
Full Text5
Alexander Kratz, Michael Laposata. (2002) Enhanced clinical consulting—moving toward the core competencies of laboratory professionals. Clinica Chimica Acta 319:2, 117-125
CrossRef6
Joy L. Hawkins, David J. Birnbach. (2001) Maternal Mortality in the United States: Where Are We Going and How Will We Get There?. Anesthesia and Analgesia1-3
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