In November 1999, the Institute of Medicine of the National Academy of Sciences issued a report entitled "To Err is Human: Building a Safer Health System."

The report began with alarming statistics: based on two sets of studies that reviewed hospital medical records, it is estimated that there are between 44,000 and 98,000 deaths per year in the U.S. attributable to "preventable medical errors." (Note that not all of these may meet the legal standard of negligence.) By comparison, the report points out, fewer people die each year from motor vehicle accidents (43,458), breast cancer (42, 297) or AIDS (16,516). Moreover, these figures only represent deaths attributable to errors that occur in hospitals and do not include deaths from errors in outpatient, nursing home, or home care, nor from medication errors that take place in ambulatory settings.

The IOM report offers nine recommendations for ways to improve the quality of health care. Most are non-controversial and, frankly, non-remarkable. These include creating a more focused research program on patient safety within the Department of Health and Human Services Agency for Health Care Policy and Research; encouraging accreditation bodies such as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) to focus even more on the problem; urging the FDA to improve regulation of drug labeling and appearance to reduce medication errors; promoting total quality improvement efforts; and implementing measures to reduce hospital medication errors.

Two Controversial Recommendations

Two of the IOM recommendations are more noteworthy, as well as more controversial. The first proposes that state licensing boards should periodically re-test health care professionals as a condition of licensure. While this has been previously recommended for physicians, most particularly in New York in the late 1980s, it has not been implemented. Several specialty boards require periodic reexamination, although none assess practice skills.

While re-testing intuitively seems to make sense, there are virtually no data on whether re-testing would significantly improve the quality of practice. Much would surely depend on the nature of the testing that would be required. (Speaking as a lawyer, for example, I doubt that having to retake the bar exam from time to time would improve the quality of legal services.) Would the licensing re-exam test basic skills, knowledge and application of new technologies, or both? Would it test practice skills?

The second notable IOM recommendation is that there should be a nationwide mandatory reporting system for serious adverse patient events, coupled with a greater effort to implement voluntary reporting systems. Under the IOM proposal, the mandatory adverse event reporting system would be administered by state governments and the information they receive would be available to the public. Information in voluntary systems, such as those run by health care organizations, not only would not be public but would also not be discoverable -- that is, plaintiffs' lawyers could not access the information in connection with a lawsuit.

The proposal for a mandatory reporting system met with widespread opposition, including, initially, from federal officials.(1) Part of the reason for this opposition is that a number of mandatory reporting systems already exist, including systems operated by states like New York and the JCAHO, and they are generally believed to suffer from serious levels of underreporting. For example, one study of a Chicago teaching hospital discovered 480 patient errors, only 113 of which were documented, mostly pertaining to less serious errors.(2) One commentator estimates that only 15 percent of patient injuries end up being noted in hospital incident reports.(3) Given that reporting would be spotty at best, how valuable would it be?

Another set of objections, principally from organized medical groups, raised the concern that mandatory reports would stimulate more lawsuits.

The IOM's solution both to underreporting and liability concerns is to prevent information in the voluntary reporting systems, as well as any reports stemming from internal investigations of patient injuries, from being accessible to patients and their zttorneys.

The President's Position

Despite the opposition, President Clinton recently endorsed the IOM's call for both mandatory and voluntary reporting systems.

In his remarks, however, the President seemed to embrace both confidentiality and public access in regard to reported information:

So we'll support legislation that protects provider and patient confidentiality, but that does not undermine individual rights to remedies when they have, in fact, been harmed. People should have access to information about a preventable medical error that causes serious injury or death of a family member, and providers should have protections to encourage reporting and prevent mistakes from happening again.

An account in the New York Times(4) explained this apparent paradox as follows: under the mandatory reporting system, the identity of hospitals where serious preventable events occurred would be disclosed to the public but not the names of individual physicians (or patients). Also, as proposed by the IOM, reports of hospital investigations into the incidents would be secret and protected from discovery in lawsuits.

Disclosable v. Non-Disclosable

Unfortunately, this division of information into disclosable and non-disclosable elements doesn't solve the basic problem with both the President's and the IOM's reporting proposals -- they embrace conflicting objectives. If the goal is to punish and deter preventable patient injuries, the proper tool is not a reporting system but some way in which the quality of patient care can be monitored and sanctioned by external watchdogs. (This was once a primary function of Peer Review Organizations under Medicare.) It follows from this goal that the resulting information should be made available in detail to injured patients and to the public, so that injured patients can pursue their private legal remedies (thereby, ideally, creating a deterrent effect) and the public can attempt to avoid obtaining health care from the offending providers (thereby, ideally, creating a market for better quality care).

On the other hand, if the objective is to identify potential causes of future injury so that they can be corrected, a reporting system might be helpful but only if individuals are given some reason to file reports. The incentives could be either positive or negative. A positive approach could be to provide a reward for reporting (or a bounty for reporting non-reporting), or to grant reporters immunity from certain repercussions stemming from patient injury, such as state or hospital disciplinary actions. A negative approach would be to audit a sample of medical records and punish anyone who knew or ought to have known of a preventable patient injury that they did not report.

It is unclear which if any inducements the IOM (or the President) have in mind. But some clearly would be highly controversial. An objection might be raised against immunity, for example, if it permitted individuals to continue to practice despite a pattern of causing patient harm.

Needed: Reporting without Repercussions

One thing that seems clear, though, is that a reporting system is only going to collect large amounts of accurate information if the reporters are convinced that the act of reporting itself will not lead to negative repercussions, whether in the form of lawsuits, government regulatory action, publicity or adverse hospital personnel actions. One such reporting system is the Aviation Safety Reporting System (ASRS) maintained by NASA (which the IOM praised but for various reasons did not fully endorse as a suitable model for health care). The ASRS receives confidential reports filed by individuals which are stored anonymously and which trigger general alerts to the aviation industry intended to improve airline safety. The ASRS has absolutely no enforcement powers. This distinguishes it from voluntary reporting systems operated by health care organizations, such as hospitals, health plans or accreditation agencies, as well as from mandatory reporting systems operated by state governments, all of which can take adverse actions against reporters.

The fact that the IOM and the President seem to want it both ways does, however, reflect an important point: in addressing preventable patient injuries, it is important not only to try to improve the overall quality of health care but also to identify and prevent repeats of individual misfeasance. The problem, then, isn't with the objectives but with the techniques proposed to achieve them.

What the IOM Did Not Recommend

It is also interesting to consider what the IOM did not recommend. It did not address the functioning of state medical boards, which, arguably, could be improved by increasing the investigative resources at their disposal and by mandating that they receive automatic reports of all malpractice claims, as is the case in California. It did not recommend that the information contained in the National Practitioner Data Bank be made available to the public, which might help patients select better quality providers.

Nor did the IOM explore the ways in which malpractice insurers might become more involved in the pursuit of quality. (A vexing issue continues to be why medical malpractice insurance does not exhibit more aspects of experience rating, so that premiums better reflect a practitioner's past liability experience. Both New York and Massachusetts have enacted laws requiring this but so far to little avail.) Finally, there is no discussion of the need to better identify which medical interventions provide net patient benefit and which do not, although the report suggests that this will be the subject of future work.