ASQ Moves Forward to Resolve Federal Healthcare Controversy

March 21, 2008 — ASQ has sent a letter to Michael Leavitt, Secretary of the U.S. Department of Health and Human Services, seeking to defuse lingering controversy and confusion over a ruling by the department’s Office of Human Research Protections (OHRP).

The letter was signed by ASQ President Mike Nichols and co-signed by Douglas Dotan and James Levett, chair and chair-elect, respectively, of the ASQ Healthcare Division.

The OHRP ruling halted data collection on a John Hopkins-led program being carried out in Michigan hospitals to determine the effectiveness of activities designed to reduce central venous catheter-related infections in hospital ICU patients. OHRP characterized the intervention as research carried out on human patients that should have been subject to OHRP regulations. The researchers and other interested parties contend that their work was a process improvement initiative that was not subject to the patient experimentation regulations.

On February 15, OHRP announced that it had reached a settlement with Johns Hopkins and the Michigan hospitals and inferred that the case was closed. They stated 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.

The letter to Secretary Leavitt 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.”

ASQ’s concerns are more fully laid out in a statement on the issue. Additional background information on the Michigan hospitals initiative is contained in an analysis by the ASQ Healthcare Division (PDF, 56 KB).

Contacts made with OHRP by ASQ’s Washington consultants established that OHRP was 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 set up those meetings.