The Leapfrog Group may be asking hospitals to leap into the great unknown.
Last week, a federal government study said the three patient-safety standards that the giant healthcare purchaser coalition has been pushing hospitals to adopt-each at great cost-lack sufficient clinical underpinnings.
The Agency for Healthcare Research and Quality unveiled what it described as an evidence-based handbook to help hospital administrators pick which patient-safety practices to implement. The 643-page report, Making Health Care Safer: A Critical Analysis of Patient Safety Practices, cited 11 practices as "clear opportunities for safety improvement" based on the strength of available clinical evidence. They included such things as the use of beta-blockers to lower the risk of cardiac events among surgery patients and having patients repeat back the contents of informed consent forms they sign so it's clear they understand the nature of the procedure they are about to undergo.
But the report identified a dozen other practices that the agency said needed more study. Those included the use of computers to monitor physicians' drug orders for appropriateness and potential errors, considered a "gold standard" for patient safety by the Leapfrog Group and other vested interests pushing the use of more technology in the patient-care setting.
"Clearly more research has to be done on whether or not these (computerized physician order-entry) systems, which have been shown to be remarkably effective in some hospitals, can be generalized to all hospitals," said Gregg Meyer, M.D., director of the AHRQ's Center for Quality Improvement and Patient Safety.
The Leapfrog Group, a consortium of healthcare purchasers representing 25 million covered workers and dependents, has made the use of order-entry systems one of three criteria that its members soon will begin using to select hospitals with which to contract. Such systems must be customized to individual hospitals and cost from $1 million to $15 million to implement, according to industry experts.
The other two Leapfrog standards-having critical care-credentialed physicians manage intensive-care units and using only high-volume hospitals to perform certain risky procedures such as coronary bypass surgery-also failed to make the report's top 11 safety practices. Leapfrog's research shows that it would cost a facility more than $500,000 annually to have physicians specially trained as "intensivists" run their ICUs.
AHRQ Director John Eisenberg, M.D., said he was confident that Leapfrog Group officials, with whom he said the AHRQ works closely, "will be updating their conclusions based upon this research."
But Suzanne Delbanco, executive director of the Leapfrog Group, said the organization would not scrap its three criteria. Instead, she said the group would use the AHRQ report as it develops future criteria. Delbanco said one of the reasons for sticking with the standards is that they are understandable to "the average American."
When the General Motors Corp.-backed Leapfrog Group announced its three standards in November 2000, it said they carried "strong scientific evidence" and were feasible for the hospital industry to implement in the near term. The coalition of more than 80 large employers said it would use its purchasing clout to "encourage" hospitals to adopt the standards, which it described as "great leaps" in basic patient safety.
"The report doesn't suggest that the three Leapfrog standards don't have huge potential for impact," Delbanco said.
The American Hospital Association said the AHRQ report validated concerns it has raised in the past about the Leapfrog standards. They are promising but "need a firmer evidence base," said Anne Berdahl, the AHA's senior associate director of policy development.
The report also said there is insufficient evidence to show that modifying hospital nurse-to-patient staffing ratios can enhance patient safety.
California is trying to implement legislation, passed in 1999, that mandates minimum nurse-staffing ratios for hospitals. The state has had difficulty developing a set of ratios acceptable to hospitals and nurses, partly because of the limited research on the clinical outcomes associated with nurse-to-patient ratios. The law goes into effect Jan. 1, 2002.
Eisenberg called the AHRQ report "the beginning of a major effort." The research on best safety practices is part of the government's response to the 1999 Institute of Medicine report To Err Is Human, which estimated that as many as 98,000 people die annually as a result of medical errors in hospitals. The AHRQ now will turn the report over to a steering committee of the National Quality Forum, a private, not-for-profit organization established by former President Bill Clinton to set a national agenda for healthcare quality. The committee will revise the list of best practices based on comments from hospitals, physicians, purchasers and others and release a final version next spring.