Two months after HHS Office for Human Research Protections told hospitals in Michigan to suspend quality activities it deemed were conducted illegally, quality proponents are worried the federal agencys ruling will create an unprecedented deterrent to improvement efforts at healthcare facilities nationwide.
The move, which was brought to national attention by an opinion piece in the New York Times, has led to calls for a full retraction of the OHRPs actions. The ruling said the study of a checklist used in intensive-care units in Michigan to determine whether they helped reduce infection rates was unethical and illegal because it did not seek patients consent and did not comply with research regulations.
Despite reassurances from HHS that quality checklists are OK to use, some in the industry arent so sure. Trent Haywood, chief medical officer of VHA, said the OHRPs decision creates confusion about healthcare leadership. Ultimately, the HHS secretary has the responsibility to ensure all its various agencies are on the same page, he said.
Already, the Michigan Health & Hospital Association said hospitals that were participating in the checklist study have suspended data-collection activities while it works with the OHRP to comply with regulations and ensure future projects are conducted according to the law (Jan. 7, p. 4).
The various departments under HHSindeed, nearly all federal and state healthcare agencieshave in some way pushed hospitals to implement quality improvement programs. The CMS this year will begin a reimbursement policy that ends payment for some hospital-acquired conditions, including certain infections. HHS said it encourages hospitals to take steps for improvement in care.
OHRPs regulations apply to federally funded research to develop new practices to improve quality, not the implementation of widely accepted practices to improve quality, the HHS wrote in an e-mailed statement. No one is suggesting that implementing the checklist constitutes research. However, doing work to develop a new checklist could very well qualify as research.
But the line between what is considered research and evidence-based practice has become a narrow battlefield, sparking frustration for consumers and patient-safety advocates. Consumers Union has been fighting to pass laws requiring public reporting of infection rates and has worked with hospitals to encourage practices that reduce infection, said Bill Vaughan, senior policy analyst for the health sector. To in any way make it harder or discourage hospitals efforts is foolishness, he said.
The OHRP is charged with protecting patients so they arent harmed by research activities, but the quality initiative they ruled against was a refinement of an evidence-based practicesomething all hospitals are encouraged to do by HHS, said Joe McCannon, vice president at the Institute for Healthcare Improvement. Its different than testing a new medicine, he said.
Greg Koski, associate professor of anesthesia at Harvard Medical School and former OHRP director, agreed that leadership at the top levels is lacking, but said the office should be out in front defining what constitutes research and quality initiatives. OHRP should be leading this effort, and they should be making it as easy as possible, he said.
The New York Times opinion piece prompted a strongly worded letter to HHS Secretary Mike Leavitt from the American Hospital Association, suggesting the agency should retract the research offices decision.
The article raises important questions about a misguided and potentially dangerous policy of the (OHRP) that would impose an unprecedented deterrent to quality improvement efforts across the country, Richard Umbdenstock, AHA president and chief executive officer, wrote in the Jan. 4 letter.
The Leapfrog Group wrote Leavitt, too, urging him to overturn the OHRP ruling to immediately allow hospitals to start using their checklists again.
But the editorial, the AHAs reaction and other responses amount to nothing more than a tempest in a teapot, according to Koski. The OHRP followed the law according to federal standards of researchthe systematic collection of data to create generalized useable knowledge. The office made a well-reasoned, careful determination on a study that had been conducted and published Dec. 28, 2006, in the New England Journal of Medicine, Koski said.
According to regulations, the OHRP said, the checklist study required institutional review board approval and informed consent. The office has said the hospitals in Michigan may resume activities related to the quality initiative once they have gained appropriate approval.
Koski called the AHAs response to Leavitt inappropriate. He added, It unnecessarily inflames emotions.