Feds Allow Hospital Infection Program

February 23, 2008
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LANSING — A Michigan program that shows dramatic results in preventing intensive care unit infections can continue without meeting protocol for human research, the federal Department of Health and Human Services has decided.

The department’s Office for Human Research Protections announced Feb. 15 that the program, which uses checklists to help medical personnel take infection-preventing measures, does not fall under regulations governing human subjects research. In November, the office ruled the program required approval from Institutional Review Boards at more than 100 participating Michigan hospitals, including Spectrum Health, Metro Health and Saint Mary’s Health Care in Grand Rapids.

The decision could have nationwide implications as Health and Human Services hammers out guidelines that determine whether a program is considered clinical quality improvement or research involving human subjects, said Sam Watson, of the Michigan Health & Hospital Association.

Now HHS is urging every hospital in America to adopt the five-step checklist, developed by a Johns Hopkins University doctor and implemented by the Michigan Health & Hospital Association’s Keystone Center for Patient Safety and Quality.

“HHS strongly encourages hospitals nationwide to adopt the program, which can save thousands of lives and millions of dollars each year,” according to the HHS statement.

“We do not want to stand in the way of quality improvement activities that pose minimal risks to subjects,” said Dr. Ivor Pritchard, acting director of the Office for Human Research Protections. “HHS regulations provide great flexibility and should not have inhibited this activity.”

The five-item checklist was part of Keystone’s multi-faceted initiative to reduce infections associated with central venous catheters. Devised by Dr. Peter Pronovost of Johns Hopkins, the checklist reminds medical personnel of basic infection-preventing measures such as washing hands and covering the patient with sterile drapes. Pronovost’s study of results from the first 18 months of implementation in 103 Michigan ICUs, published in the New England Journal of Medicine, showed that CVC-related infections were reduced to virtually zero.

“It looks like common sense has prevailed here,” said Dr. David Baumgartner, vice president of medical affairs for Saint Mary’s and an infectious disease specialist. He said the checklist is a proven, low-tech, low-cost and high-impact measure, and considering it research was “maybe more than a little excessive.”

Watson, executive director of the Keystone Center, said that while “a fair amount” of Michigan hospitals did obtain IRB approval since the  November action by HHS, those that have not yet accomplished that don’t have to.

“I don’t think this has done anything to help clarify what initially brought us into this,” Watson said. He said he expects that discussion will continue at the national level.

“We want to find a way to allow this sort of work with an eye to make sure patients are protected, but not put up barriers,” he said.

“There is still a lot of work to be done to help clear for the field what to do. We are going to operate at this point for our other collaboratives that they are going to go through IRB review because at this point, there’s not other guidance not to.”

The Keystone Center also has projects focusing on hospital-associated infections, surgery-related infections and organ donations.

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