IOM to HHS: Health Care IT Errors Should Be Reported

Health care organizations should report errors related to health IT, according to a report just released by the Institute of Medicine (IOM). Commissioned by the Department of Health and Human Services (HHS), the report offers 10 recommendations aimed at reducing potential medical errors associated with the use of health IT.These pertain to electronic health records (EHRs), secure patient portals, and health information exchanges (HIEs); medical device software is excluded. The report notes that if implemented appropriately, health care IT can help to improve health care providers’ performance while enhancing both patient/provider communication and patient safety. However, its authors caution, poorly designed systems can create new hazards in the already complex delivery of care. The report emphasizes that public and private entities alike play a role in mitigating patient safety risks, and that reporting of patient safety events should be voluntary, confidential, and non-punitive for health care providers, but obligatory for vendors. In the document, the IOM calls on HHS to ensure that vendors “support the free exchange of information about health IT experiences and issues and not prohibit sharing of such information.” Also contained in the report is a recommendation that the HHS Secretary request Congress to establish “an independent federal entity for investigating patient safety deaths, serious injuries, or potentially unsafe conditions associated with health IT." The entity would be similar to the National Transportation Safety Board (NTSB) and, as with the latter, would not possess any regulatory authority. Similarly, the IOM counsels HHS to develop, within one year, a plan to minimize patient safety risks associated with health care IT, monitor progress, develop approaches to compiling and addressing safety concerns, and provide stronger oversight of health care IT products. As proposed by the IOM, the plan would create a new Health Care IT Safety Council funded by HHS and tasked with evaluating criteria and developing methods for gauging and assessing patient safety related to the use of HIT. Recent occurrences have drawn attention to the gravity of health care IT errors that can be made, as well as the dire consequences. In October of 2010, an infant who had been born 16 weeks premature died at Advocate Lutheran General Hospital after having been intravenously administered a massive overdose of sodium chloride as a result of a technology-related error. A physician correctly entered the order into the hospital's computerized physician order entry (CPOE) system, but a pharmacy technician erred when re-entering the information into the IV compounding machine. In a related error, an “alerting” system that should have flagged the error had been turned off. Incidents of this type have been meticulously documented over the past few years. In 2005, a study published in the Journal of the American Medical Association revealed that a widely used CPOE system facilitated 22 types of error risks. Interviews with house staff at a major urban teaching hospital led the researchers to conclude that these CPOE-related errors occurred at least once a week. In another study, unintended consequences from CPOE were found to be the rule, rather than the exception. Meanwhile, there remains the question of whether, should the reporting recommendations take hold, IOM’s suggestion regarding the establishment of a supervisory agency is a viable one. In his blog, www.blogborygmi.blogspot.com, Nicholas Genes, MD, PhD, an emergency physician at Mount Sinai Medical Center in New York City, New York, observes that “expecting the creation of a new regulatory agency in the US in 2011, with an obstructionist Congress that's breaking filibuster records just to spite the administration, is a pipe dream.” He adds, “If no new regulatory agency is forthcoming, where does that leave the federal incentives for adoption and meaningful use of electronic health records? Already, the effort is stalled and seems likely be dragged out over an additional period. Now, critics…will point to this phantom health care IT safety board, which ought to exist but probably won't, as a further excuse to delay, delay, delay. The status quo is cheaper. It's familiar. And so we'll keep handwriting notes and shooting paper orders through pneumatic tubes, in the name of patient safety.” To read the study, click here: http://iom.edu/Reports/2011/Health-IT-and-Patient-Safety-Building-Safer-Systems-for-Better-Care.aspx