Patient safety and medical errors in infectious diseases

August 2001

The 1999 Institute of Medicine (IOM) report on patient safety and medical errors, “To Err is Human: Building a Safer Health System,” has been the subject of commentary in this column several times in the past. The first was following its publication in February 2000, and the next was in conjunction with the Fourth Decennial Conference on Nosocomial Infections, held in Atlanta in April 2000.

I have been critical of this report for several reasons. First was the apparent lack of epidemiological expertise in the IOM committee that prepared the report. Second was the report’s failure to recognize the discipline of hospital epidemiology and the pre-eminent expertise of the CDC in applying this discipline to the problem of medical “errors.” And finally, the recommended “fix” seemed to be largely regulatory in nature, consisting of rules and penalties. It was a “carrot and stick” approach, except that the carrot was conveniently omitted — more than a little reminiscent of the approach taken by HCFA to Medicare “fraud and abuse.”

Pre-emptive strike

On June 28-30, 2001, the IDSA, SHEA, CDC, and the University Medical Center of Hackensack and the University of Medicine and Dentistry of New Jersey jointly sponsored a conference entitled: Effective Strategies for Improving Patient Safety and Reducing Medical Errors in Infectious Diseases. The conference was attended by about 200 people, consisting of a mix of physicians, infection control nurses, pharmacists and the like. It was planned as a pre-emptive strike, to energize the participants, and to underscore the urgency of dealing with the issues, not only operationally within our hospitals, but — equally important — politically, in the federal legislative and executive arenas.

In my view, the conference was a great success. The planning committee, the folks who made it happen, consisted of Peter Gross, Julie Gerberding, David Gilbert and Bill Jarvis, among others, and they deserve congratulations. They succeeded in bringing together a mix of presenters from the IOM, JCAHO, the federal government, academic medicine, and industry that illuminated the issues from a variety of starting points in a striking fashion. This is not to say that an effective dialogue was begun; that remains to be seen.

Attendees heard, for example, from the director of purchasing of managed care health plans for General Motors, Bruce Bradley, who outlined some of the steps being taken to improve patient safety and reduce costs by a Michigan consortium of major employers. He further outlined some of the initiatives being undertaken by “The Leapfrog Group,” a consortium of major national and multinational companies to accomplish those same goals.

These initiatives include insistence on computerized physician order entry, staffing of ICUs by physicians trained in critical care medicine, and evidence-based hospital referral in which hospitals must have demonstrated volume and outcome data for given diagnoses or surgical procedures. The impact of these health care purchaser initiatives could be enormous.

Another striking presentation was that given by the president of the IOM, Dr. Kenneth Shine, who explained the IOM committee deliberations, and took the audience through the recommendations. It was clear that he was totally convinced of the accuracy of the committee report, and that the recommendations were appropriate. They would not be successful, however, unless the focus remained on the need to address the “systems” problems, rather than continuing to assess blame. His was a thoughtful and convincing presentation, although when asked directly by an audience member about the report’s failure to acknowledge the past and potential contributions of hospital epidemiology to issues of patient safety and medical errors, he resorted to the time-honored dodge of doing a verbal lateral arabesque, and answering a different question that had, in fact, not been asked!

Perhaps the most illuminating and — in a sense — depressing moments in the conference was a four-part panel presentation entitled “The Federal Government Responds.” Participating agencies included the Agency for Healthcare Research and Quality (AHRQ), the CDC, FDA, and HCFA. I wish I could report to you that the federal government presented a well structured and integrated response to the IOM report that maximally used the strengths and expertise of the participating agencies. Hardly. There were the obligatory platitudes about interagency cooperation, but little evidence that any substantive cooperative effort was going on. It’s clear that the AHRQ is in the driver’s seat, largely because that’s where the money went. The IOM report had requested $35 million for the Center for Quality Improvement and Patient Safety. Congress, evidently feeling that the IOM recommendation was too modest, funded the center for $50 million in FY01. I have not the foggiest notion of whether these tax dollars are being spent wisely or not. Next time you are on-line, go to www.quic.gov and make your own judgments.

More worrisome, perhaps, was the response from HCFA, now renamed the Center for Medicare/Medicaid Services (CMS). A Medicare Patient Safety Monitoring System (MPSMS) is being established with the laudable goal of monitoring rates of adverse patient events and the risk factors that contribute to them. The concerns here are twofold. One is that the program is tied to the Medicare Payment Error Prevention Program. Second is that it is not at all clear that there is the epidemiologic expertise in this agency to carry this out.

In his response on behalf of the CDC, Steve Solomon presented a nice summary of the activities of the Hospital Infections Program, now officially the Division of Healthcare Quality Promotion (DHQP). So rapidly that it caught many by surprise, he announced five-year goals of 50% reductions in major quality measures in infection control. Time did not permit adequate explanation of how these goals were to be achieved, and this is a topic to be filled in at a subsequent date.

Two additional points merit consideration. One is that this entire undertaking is based on what appears to be rational, not science. There is a considerable body of evidence supporting the efficacy of nosocomial infection surveillance and control programs; no comparable body of evidence supports the recommendations of the IOM committee, well-intentioned though they might be. Second, a very recent publication from the Ann Arbor, Mich., VA Hospital (Hayword RA & Hofer TP. JAMA:286:July 25, 2001) underscores the many variables in estimating “preventability” of hospital deaths, and suggests that this is a hugely subjective judgment. Thus, the IOM estimates may be greatly overestimated.

Finally, though, at the individual hospital level, there was a clear “take-home” message. That is simply that, all the uncertainties at the government level notwithstanding, hospital infection control programs, using the techniques of hospital epidemiology, are in by far the best position to address issues of patient safety and medical errors in our own hospitals. To wait for direction from JCAHO or from state or federal governments is to waste a huge opportunity. Rather, we need to seize the moment — while the window of opportunity is still open.

Just do it!