Tuesday, January 08, 2008

A New Hurdle

As if health care reform didn’t already face enough hurdles, the federal Office for Human Research Protection (OHRP) has created a new one.

As was mentioned in an earlier posting, doctors at the renowned Johns Hopkins Hospital in Baltimore have been actively promoting the use of checklists in hospitals as a means of preventing infections and other adverse events that plague health care. A major program was mounted in Michigan with spectacular results. The rate of bloodstream infections from IV lines fell by two-thirds. The average ICU cut its infection rate from 4% to zero. Over 18 months, the program saved more than 1,500 lives and nearly $200 million.

Last month, OHRP shut the program down. It claimed that scientific ethics regulations had been violated by failing to obtain written, informed consents from every patient and health care provider involved in the use of the checklists.

All this was reported in an article by Dr. Atul Gawande that appeared on the Op-Ed page of the Sunday, December 30 issue of the New York Times. As reported by Gawande, OHRP justified its decision on the grounds that the use of checklists is an alteration in medical care (like the use of an experimental drug) that could put patients and doctors at risk – by exposing how poorly some of them follow basic infection-preventing procedures.

No doubt this ridiculous turn of events will be remedied. Getting the consents that OHRP says that current regulations require would be both useless and impractical. In the meantime, the OHRP decision stands out as an example of how difficult it can be to make changes in established ways of doing things.

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