Feds Clamp Down On Hospital Infection Effort

January 14, 2008
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LANSING — Hospitals across Michigan are working to reinstate a well-regarded infection-control effort for intensive care units that was suspended in November after the federal Department of Health and Human Services determined it failed to meet research guidelines.

The program’s results have been so promising that the nation of Spain is planning to implement the program in all its hospitals. Results in Michigan showed that use of a five-item checklist brought central venous catheter infections down to nil, and were published in The New England Journal of Medicine in December 2006.

The HHS Office for Human Research Protections decided last year that the Michigan Health and Hospital Association’s Keystone Center for Patient Safety & Quality ICU program constitutes research and that Michigan hospitals had failed to obtain consent from patients and staff members to participate. In November, the office suspended the program, specifically the collection and analysis of data from ICU patients and surveys of hospital staff, until institutional review boards at each hospital could review it and decide whether the requirement for individual consent should be waived.

“OHRP is interpreting a regulation in a vacuum – without regard for the larger societal and ethical needs to preserve life,” said Karen Linscott, acting CEO of The Leapfrog Group, a national association of large employers who provide health coverage for millions of Americans. “This simple checklist is already proven to save lives. While we wait for the way to be cleared for the widespread implementation of this program, lives will undoubtedly be endangered.”

Sam Watson, executive director of the Keystone Center for Patient Safety & Quality, said he expects all of the hospitals to have completed IRB reviews by the end of January. He said that in instances where program activities had been incorporated into an ICU care regimen, OHRP allowed those to continue, but reporting of data to the Keystone Center was halted until institutional board consent waivers are obtained.

“We have suspended activities for the interim until the hospitals have a chance to go through that,” Watson said. “We’re not testing new medicine or a new procedure. We’re applying evidence that that has been out there for some time. We’re not testing anything on people; we’re measuring the results of best practice.”

The Keystone Center worked with Michigan hospitals to implement the multi-faceted program aimed at several ICU procedures that have a high potential for hospital-associated infections. Among the measures are checklists, developed by Dr. Peter Pronovost of Johns Hopkins University, to remind doctors of steps that can reduce the potential for infection. Records are kept regarding the use of measures in the Keystone project and rates of infections in ICUs.

In December 2006, Pronovost and his colleagues published an article in The New England Journal of Medicine about the project’s results that focused on central venous catheters, which are placed in the neck, chest or groin for cardiovascular and fluid monitoring and for quick delivery of medicines.

Pronovost’s to-do list for medical personnel performing CVC insertions included: wash hands with soap; clean the patient’s skin with chlorhexidine, an antiseptic; cover the patient’s entire body with sterile drapes; wear a sterile mask, hat, gown and gloves; and cover the catheter site with a sterile dressing once the procedure is done.

“The processes on our checklist are practices that have been out there and are encouraged by the Centers for Disease Control and Prevention and others,” Watson said. “Not to be glib, but it’s not rocket science. It’s good, solid best practice.”

Dr. Tony Senagore, vice president of research at Spectrum Health, said a cautious approach has brought Keystone projects before Spectrum’s IRB. Spectrum has 100 ICU beds.

“We take the high road across the board with many of our quality improvement databases and get them IRB approved,” Senagore said. “You can use it for internal use, but if you want to transmit those experiences to the outside, you should have IRB approval before that. All existing programs of Keystone are either currently approved through the IRB or in the process.”

He called the risk to patients “minimal, if not zero. The problem really is the spirit of the law and the letter of the law being different.”

“These practices are not experimental,” added Dr. David Baumgartner, vice president of medical affairs for Saint Mary’s Health Care and an infectious disease specialist. The gains in Pronovost’s approach come from improving the consistency with which the measures are followed, he said.

Baumgartner said he understands the HHS concern about patient privacy and knowledge of the project, but wonders where the line can be drawn between what constitutes research — thus requiring institutional review board scrutiny — and what is improvement in patient care.

“I think it’s a very close reading of this,” Baumgartner said. “On the other hand, I do understand why the HHS is particularly sensitive to this.”

Baumgartner said the Saint Mary’s IRB may be considering the Keystone project this week. The Trinity Health-owned hospital has 14 ICU beds.

“It’s really not that big a deal to run this kind of a project through an IRB,” he said. “The bigger question to me, though, is: So where do you draw the line? Every time there’s a quality improvement project that takes place, does it have to go through an IRB? I would argue, in fact, that that could have a very stifling effect upon innovation.”

Susie Kampfert, nurse manager for Metro Health’s 16-bed ICU said Metro Health has seen a drop to near-zero for infections related to CVCs, and also for ventilator-associated pneumonia, since implementing the Keystone project. The implementation included not only checklists, but other approaches such as safety education for staff members.

“Honestly, I don’t believe it’s research-based and neither did Keystone,” Kampfert said.

“Even if they suspended the whole thing and we were no longer going to be submitting data to MHA Keystone, we would still be implementing these evidence-based solutions to improve patient outcomes. This is just the standard of care.

“We’re not choosing who we’re going to implement them on and who we’re not. That’s a huge difference when you’re doing research,” she added. “We implement this best practice on every patient — that is a big deal. So we don’t need consent.”

Kampfert said Metro Health’s institutional review board approved the consent waiver on Dec. 7.

 MHA has requested that OHRP clarify definitions of research and quality improvement to provide guidance for the future, according to a statement from MHA President Spencer Johnson.

In The New England Journal of Medicine article, Pronovost and his colleagues reported that, after three months, the median rate of infections per 1,000 days of catheter use had dropped from 2.7 to zero. Data was collected from 103 Michigan ICUs, amounting to 85 percent of ICU beds in the state. Prior to the project, the ICUs combined recorded a total 695 catheter-related bloodstream infections annually.

The report estimated that the U.S. sees nearly 80,000 such infections annually, and 28,000 deaths from them. It pegged the cost at $2.3 billion per year.

“The World Health Organization is interested in this work,” Watson said. “It’s caught not only national, but international attention.”

Blue Cross Blue Shield of Michigan has incorporated Keystone’s ICU initiatives on ventilator use and CVC infection rates into its pay-for-performance financial incentives for hospitals, BCBSM spokesman Jon Ogar said. BCBSM uses MHA’s analysis of Keystone: ICU data, he noted.

Added Baumgartner: “I think this whole project has been one of the real success stories in the improvement of care. I think they should be celebrating the successes.”

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