"It's a bit of a bump in the road," said Christine Goeschel, manager of operations for Pronovost's patient safety group. "Any time a group pushes the envelope, there are going to be cases where existing rules and guidelines are not always a good fit."
Federal officials say they're impressed with Pronovost's results and encourage hospitals to use checklists. All sides agree that the procedures involved - rigorous hand-washing, use of sterile masks, gowns and gloves, and proper handling of catheters - are accepted safety measures.
But the government said writing them down in a checklist, making doctors follow it and methodically analyzing the results involved a change of practice. That qualified it as a research project that requires formal patient consent and institutional reviews.
"If you're deliberately manipulating the way you deliver care and you study the effects for the purpose of gaining new knowledge from it, that's research," Pritchard said.
But some patient safety experts fear that the decision will delay or discourage a wide range of safety measures nationwide. For example, it could require patient consent before hospitals make such basic improvements as installing gel dispensers in hospital rooms to increase hand washing.
"We'll all be looking to see if we violated any rule by measuring any type of quality of care initiative," said UCSF's Wachter.
"It's just absurd on its surface," added Dr. Lucian Leape, an expert on preventing medical errors at the Harvard School of Public Health.
Leape formally asked the OHRP to rescind the decision in a letter that he also sent to his congressional delegation. "This ruling has the potential to cripple the truly impressive progress we are finally making in patient safety," his letter says.
The federal ruling could be "a big step backward," added Dr. William Minogue, executive director of the Maryland Patient Safety Center. Minogue said the state's hospital ICUs made checklists standard practice in 2005 with help from a expert panel that Pronovost chaired. He called the OHRP decision "shocking."
This week, the American Hospital Association asked the government to "immediately retract" statements implying that advance, independent reviews and patient consent are required for improvements such as checklists, computerized medical staff reminders and team approaches to patient care.
