NCPA - National Center for Policy Analysis


January 15, 2008

Despite doctors' protests, the government has ruled that writing a checklist of safety procedures, making doctors follow it and methodically analyzing the results qualify it as a research project that requires formal patient consent and institutional reviews, says the Baltimore Sun.

At issue is a checklist designed by Dr. Peter Pronovost to prevent ventilator-assisted pneumonias and infections from central venous catheters, which are tubes inserted in most intensive care patients:

  • The study was part of an effort to improve overall Michigan ICU safety known as the Keystone Initiative.
  • Within 18 months after Michigan hospitals introduced the checklists in 2004, central line infections dropped by two-thirds.
  • However, to many of the doctors using the checklist, the biggest achievement was a permanent change in attitudes among medical personnel.

The government has not stopped the use of Dr. Pronovost checklists and no sanctions have been imposed, but the work must now be reviewed by independent oversight groups called institutional review boards, says the Sun.  In some cases, those reviews could take months, researchers said.  They suggested that federal officials misapplied regulations originally designed to protect patients in clinical trials of experimental drugs and procedures.

"I think it's ludicrous. It probably will kill people if they don't fix this soon," said Dr. Robert Wachter, a national expert on patient safety at the University of California, San Francisco. "This is regulation run amok."

Source: Dennis O'Brien, "Clear results, disputed method," Baltimore Sun, January 12, 2008.


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