Hard on the heels of an Institute of Medicine report on regulating the safety of electronic health records (EHRs) and related health IT tools, Ashish K. Jha, MD, and David C. Classen, MD, two of the report's coauthors, called for patient safety measures to be included in Meaningful Use requirements. In a New England Journal of Medicine article, they also proposed that certified EHRs be required to have modules for documenting adverse events.

Citing several studies showing that hospital safety has not improved significantly in the past decade, Jha and Classen argued, "The primary reason for insufficient progress is the lack of a robust measurement program: there are still no nationally agreed-on methods for systematically identifying, tracking, and reporting adverse events."

If there were reliable, standardized measures and clinical data on adverse events were documented in EHRs, these experts contended, real advances in safety might occur. Just as quality measurement has improved the quality of inpatient care in some ways, measurement of adverse events could also contribute to better safety.

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The data on adverse events could be exported from EHRs to the patient safety organizations (PSOs) that now collect such data from hospitals on behalf of the Agency for Healthcare Research and Quality (AHRQ), said Classen in an interview with InformationWeek Healthcare. That is also the mechanism that the IOM recommends for safety reporting in general, he noted. In addition, he said, hospitals could use the data in their own safety improvement programs.

But why would hospitals and physicians want to expose themselves to liability by documenting adverse events in an EHR, even if it were required for Meaningful Use?

Classen responded by noting that forthcoming studies will show that adverse events in the hospital are correlated with an increased length of stay, an increased mortality risk, and a heightened risk of having another adverse event during the same hospitalization. Also, he noted, having an inpatient adverse event increases one's chance of readmission at 30 days, six months, and a year.

So, if hospitals want to form accountable care organizations or take bundled payments, he said, a high rate of adverse events will cost them money by increasing length of stay, readmissions, and the amount of post-discharge care provided. Moreover, the Centers for Medicare and Medicaid Services (CMS) will penalize them for excessive readmissions and factor inpatient complications into their reimbursement under CMS' value-based purchasing program. All of this gives hospitals a strong incentive to improve their safety performance, he said.

As for the liability risk, he noted, the EHR-generated data could be de-identified and pooled for reporting purposes.

Classen agreed with Mark Chassin, president of the Joint Commission, that the Agency for Healthcare Research and Quality's patient safety indicators-- some of which CMS recently published on its HospitalCompare website--are "dangerously flawed" because they're based on billing data. In a recent study, Classen noted, he and other researchers found that these measures picked up less than 10% of the adverse events.

Clinical data is much better for measuring and analyzing safety issues, Classen said. "Once you have an EHR in place, you could relatively easily leverage that to detect these safety problems in real time."

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