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Health Care

ASQ Aims to Help Defuse Health Care Checklist Controversy

Published: Tuesday, July 8, 2008 - 06:35

(American Society for Quality: Milwaukee, Wisconsin) -- The American Society for Quality has submitted guidelines to the Office of Human Research Protections (OHRP), a division of the U.S. Department of Health and Human Services in response to a concern about a ruling that could threaten to disrupt quality initiatives in health care institutions across the country.

The ruling put a stop to data collection on a Johns Hopkins-led program being carried out in Michigan hospitals. The program was to determine the effectiveness of a simple checklist of five basic intensive care infection-control practices designed to reduce central venous catheter-related infections in hospital ICU patients. In a February 15 announcement, OHRP stated that it had reached a settlement with Johns Hopkins and the Michigan hospitals and concluded that the case was closed, stating that they had offered new guidance for future quality improvement research. But ASQ’s reading of the statements left doubts that the issue was settled and led to a meeting with and an invitation from OHRP to develop recommendations on how to best provide regulatory authority over healthcare quality initiatives.

Following a meeting with OHRP, a guidelines document was prepared by Dr. Robert Burney, M.D., of the ASQ health care division, with input from other health care division members. The guidelines classify typical health care quality improvement and process improvement activities according to the degree of risk they pose to patients, using this as the criterion for deciding if these activities should be governed by the Institutional Review Boards that oversee patient safety in clinical research.

“We are pleased that OHRP is open to engaging in dialog and reviewing our recommendations on this difficult subject where there are gray areas,” says ASQ president Mike Nichols. “ASQ and its Healthcare Division believe our input will help OHRP in its challenging task of applying its regulations to protect patients while not impeding quality improvement initiatives.”
ASQ’s concerns are explained in a position statement on the issue. To see the complete statement, please visit ASQ OHRP statement at www.asq.org/advocacy/issues-actions/20080212-healthcare-checklists.html.


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