Federal Healthcare Agency Welcomes ASQ Help in Defusing Controversy
Washington, D.C. May 8, 2008 — The federal Office of Human Research Protections (OHRP) accepted an ASQ request and met with ASQ officials on April 21 to discuss ways to defuse controversy arising out of an earlier OHRP regulatory ruling. The ruling halted work on a Johns Hopkins-initiated quality improvement effort at hospitals in Michigan and sent shock waves through the healthcare quality community.
The meeting focused on ways that ASQ could provide assistance in establishing guidelines for application of OHRP’s regulatory authority over healthcare quality improvement activities.
“We are pleased that OHRP is open to engaging in dialog on this difficult subject, where there are many gray areas,” stated 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.”
Following the meeting, ASQ sent a set of guidelines to Dr. Ivor Pritchard, OHRP acting director. The guidelines document was written by Robert Burney, M.D., of the ASQ Healthcare Division, with input from several other Healthcare Division members. It classifies typical healthcare quality improvement and process improvement activities according to the degree of risk they pose to patients, using that as the criterion for deciding if these activities should be governed by the Institutional Review Boards that oversee patient safety in clinical research.
Burney pointed out that distinguishing between studies that should be reviewed by an Institutional Review Board and those that should not is a difficult undertaking. The task of OHRP and Institutional Review Boards is to protect patients who might participate in clinical research studies. But subjecting process management studies to the same review processes governing clinical research studies inappropriately hampers quality/process improvement activities and is wasteful of Institutional Review Board time.
