ASQ Seeks to Resolve DHHS Checklist Controversy

Business Wire, April 2, 2008

Healthcare Quality Initiatives Still at Risk

MILWAUKEE -- The American Society for Quality (ASQ) has submitted a letter and offered assistance to the U.S. Department of Health and Human Services (DHHS) over concern about a ruling by one of its divisions. ASQ believes the ruling could threaten to disrupt quality initiatives in healthcare institutions across the country.

The ruling in question, by the DHHS's Office of Human Research Protections (OHRP), 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 prompted the letter to DHHS Secretary Michael Leavitt.

The letter, signed by ASQ President Mike Nichols and officers of the ASQ Healthcare Division, states, "We would like to be able to assure healthcare quality and patient safety advocates that their initiatives are not still at risk of running afoul of the regulations."

Contacts made with OHRP by ASQ established that OHRP is open to meeting with ASQ to discuss concerns. They will also consider ASQ's offer to help resolve remaining issues. ASQ is now working to schedule those meetings.

ASQ's concerns are explained in a position statement on the issue. To see the complete statement, please visit www.asq.org/advocacy/issues-actions/ 20080212-healthcare-checklists.html. (Due to its length, this URL may need to be copied/pasted into your Internet browser's address field. Remove the extra space if one exists.) Additional background information on the Michigan hospitals initiative is contained in an analysis by the ASQ Healthcare Division at www.asq.org/health/articles/saving-lives-enshrining-bureaucracy.pdf.> 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([R]). 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.