Federal Ruling a Potential Threat to Healthcare Quality Improvement Initiatives: ASQ Responds

Who would have thought that a simple little checklist of five basic hospital intensive care infection-control practices could ignite howls of protest within the healthcare community and threaten to disrupt quality initiatives in healthcare institutions across the country?  That’s what happened as a result of a ruling by a division of the U.S. Department of Health and Human Services (DHHS). The ruling effectively stopped work on a Johns Hopkins-directed initiative that was being implemented and studied in hospitals across the state of Michigan. 

The Office of Human Research Protections (OHRP) shut down data collection on the initiative.  It contended that the work constituted research on human patients that ought to be subject to the same kinds of safeguards taken when patients are given experimental drugs in clinical trials or are subjected to experimental procedures.  Those safeguards include obtaining written permission from each patient affected by the activity and getting prior approval from the review board that oversees clinical research in the institution. 

ASQ is concerned that the ruling applies an inappropriate and overly restrictive set of experimental research criteria to quality improvement initiatives.  The ruling could have a chilling effect on healthcare quality improvement initiatives in major research and teaching hospitals, and also in many smaller institutions across the country.

ASQ’s Healthcare Division became aware of the controversy and alerted its membership and ASQ leadership to the problem.  The Division prepared an analysis of the situation that gives more detail on the ruling and the reasons for concern.  The analysis is posted on the ASQ Healthcare Division Web site. 

ASQ’s Office of the President asked its issues advisory group—the Public Policy Advisory Council—to perform necessary due diligence and frame the issue for the membership.  Our Washington consultants are setting up meetings with officials of the Department of Health and Human Services and key members of Congress in order to effect change on the issue.  The Healthcare Division and ASQ staff are developing a position paper laying out ASQ’s concerns and remedies.  ASQ President Mike Nichols plans to send letters to DHHS officials and key members of Congress voicing concern and offering ASQ’s help in resolving the issue.