HHS's "light regulatory approach" to a national patient safety plan draws qualified praise from industry trade groups.
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The American Hospital Association (AHA) and healthcare CIOs represented by the College of Healthcare Information Management Executives (CHIME) are offering qualified praise for a national health IT safety plan that relies on existing public and private patient safety frameworks, rather than creating a new federal entity. But the AHA went further, all but asking the U.S. Department of Health and Human Services (HHS) to lead development of a nationwide master patient index.
While the IOM said there needed to be an independent body tasked with tracking patient safety and adverse events linked to electronic health records (EHRs) and other health IT, the ONC plan dismissed that idea. CHIME commended ONC for taking a "light regulatory approach" in its proposal.
"In particular, we support the notion that pre-existing patient safety efforts across government programs and the private sector -- including those sponsored by providers, vendors and healthcare safety oversight bodies -- be used as foundational leverage to strengthen health IT and patient safety. While there certainly needs to be more coordination between agencies within HHS regarding health IT and patient safety, we do not believe that the creation of an entity, similar to the National Transportation Safety Board, is necessary," CHIME said in its comments.
CHIME said a distinct entity would wall off health IT safety from other aspects of patient safety. "Creating a safety reporting silo that only focuses on health IT would be duplicative, increase unnecessary reporting burden and also result in the failure to capture many relevant events," the Ann Arbor, Mich.-based group said in its official comments.
"The ONC plan makes more sense to us in addressing the concerns of the IOM," Jeffery Smith, CHIME's assistant director of advocacy, explained to InformationWeek Healthcare. He said the organization liked the fact that ONC wants to use established "policy mechanisms" and programs, not create a separate entity and a new bureaucracy.
CHIME said, however, ONC may have "somewhat overstated" its role in assuring the safety of health IT. "We believe that ONC is properly suited to help convene and coordinate other agencies inside HHS in developing an oversight framework for health IT safety," the group said, suggesting that federal agencies merely participate in a "stakeholder-driven organization" to monitor the safety of health IT systems. There already is legislative authority to create an independent "voluntary consensus body" that could work in concert with the existing network of patient safety organizations, the CIOs noted.
A lot is contingent upon the Patient Safety and Quality Improvement Act, a 2005 law that established a network of patient safety organizations and a mechanism for confidential reporting of events and hazards that compromise safety, according to Smith. "I do think that a large part of what we liked [about the draft plan] could be done without further legislation," he said.
In its own comments, the AHA praised ONC for encouraging EHR vendors to take responsibility for design, implementation and safe usage of their systems and for calling on vendors to establish a voluntary code of conduct. The hospital group suggested the code should discourage the practice of including "hold harmless" clauses in contracts that limit the liability of vendors should EHRs cause medical errors or other adverse events.
But the AHA also called on ONC to develop a "single, national approach to matching patients to their records." The 1996 Health Insurance Portability and Accountability Act (HIPAA) instructed HHS to create a national patient identifier system, but Congress voted in 1999 not to fund implementation of national IDs after privacy advocates complained.
The AHA framed its argument not in the form of an ID, rather in the context of a master patient index that would be central to health information exchange. "The inability to match patients across silos raises safety concerns about mismatches -- incorrectly matching patients, or missing a match that should have been made. In addition, without a single, national approach to patient matching, hospitals and health systems are forced to expend significant resources on expensive, proprietary solutions to develop master patient indexes that apply only to that particular hospital or health system's patients," the hospital group stated in its comments.
ONC stated in its December draft that: "The accurate and efficient matching of patients to their health information is critical to ensuring patient safety." CHIME lauded ONC for acknowledging the problem, but did not offer a specific means of achieving the goal.
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