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AHA urges HHS to change quality improvement policy

Quality Improvement Monitor, January 11, 2008

The president of the American Hospital Association (AHA) last week sent a letter to the secretary of Health and Human Services (HHS), urging him to immediately retract a policy requiring quality improvement initiatives to undergo review by Institutional Review Boards.

The letter cited a December 30 op-ed piece in The New York Times by Atul Gawande, MD. In the article, Gawande wrote about a checklist program used by Michigan hospitals that reduced bloodstream infections by two-thirds. The program also saved more than 1,500 lives and nearly $200 million, according to Gawande. However, the Office of Human Research Protections shut the program down in December, saying it violated scientific ethics violations. The decision, Gawande wrote, was "bizarre and dangerous."

AHA President Rich Umbdenstock agreed with those sentiments in his January 4 letter to HHS Secretary Mike Leavitt.

"Dr. Atul Gawande raises important questions about a misguided and potentially dangerous policy of the Office for Human Research Protections that would impose an unprecedented deterrent to quality improvement efforts across the country," Umbdenstock wrote. "I am writing to ask you to immediately retract any statements from the Office of Human Research Protections that imply that quality improvement efforts should undergo review by Institutional Review Boards (IRBs), and that consent should be obtained from all patients before changes could be incorporated."

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