The Institute of Medicine Report on Medical Errors: Misunderstanding Can Do Harm

Quality of Health Care in America Committee*

In This Article

Error Reporting Systems

The IOM report recommends 2 types of reporting systems: voluntary reporting of errors that result in very minimal or no harm, and mandatory reporting of errors that result in death or serious permanent injury. This approach is modeled after highly successful reporting efforts in the aviation industry, where incidents or "near misses" are reported to a nonregulatory entity (NASA's Aviation Safety Reporting System), while accidents that result in death or serious injury or substantial damage to aircraft are reported to investigative and regulatory entities (the National Transportation Safety Board and the Federal Aviation Administration).[26] According to Charles Billings, MD, one of the architects of the system, "Incident reporting and accident reporting are not substitutes one for the other. They are complementary."[27]

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]