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For Immediate Release
ASQ Aims to Help Defuse Healthcare Checklist Controversy
Guidelines Suggested for At-Risk Healthcare Quality Initiatives
Milwaukee, Wisconsin, June 10, 2008 — The American Society for Quality (ASQ) has submitted guidelines to the Office of Human Research Protections (OHRP) a division of the U.S. Department of Health and Human Services (DHHS) in response to a concern about a ruling which could threaten to disrupt quality initiatives in healthcare 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 Healthcare Division, with input from other Healthcare Division members. The guidelines classify typical healthcare 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,” said 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. Additional background information on the Michigan hospitals initiative is contained in an analysis by the ASQ Healthcare Division.
The American Society for Quality, www.asq.org, has been the world’s leading authority on quality for more than 60 years. With more than 93,000 individual and organizational members, the professional association advances learning, quality improvement and knowledge exchange to improve business results, and to create better workplaces and communities worldwide. As champion of the quality movement, ASQ offers technologies, concepts, tools and training to quality professionals, quality practitioners and everyday consumers, encouraging all to Make Good Great®. ASQ has been the sole administrator of the prestigious Malcolm Baldrige National Quality Award since 1991. Headquartered in Milwaukee, Wis., ASQ is a founding partner of the American Customer Satisfaction Index (ACSI), a prominent quarterly economic indicator, and also produces the Quarterly Quality Report.
