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Quest for excellence hits ethical impasse; landmark prevention program shut down
'Lives will undoubtedly be endangered'
A recent controversial move by a federal health agency to shut down a highly successful infection prevention program because it appeared to be involved in human research rather than quality improvement has ominous implications for traditional infection control activities, a leading epidemiologist tells Hospital Infection Control.
"This is an example of the road to 'you know where' is paved with good intentions," says William Schaffner, MD, chairman of the department of preventive medicine at Vanderbilt University Medical Center in Nashville. "It will have very little benefit to the individual patient, and could actually work to the detriment of patients."
The action was taken by the Office for Human Research Protections (OHRP), a branch of the Department of Health and Human Services (HHS) charged with overseeing and approving research involving human subjects.
Developed at Johns Hopkins Hospital in Baltimore and implemented by 108 intensive care units in the Michigan Keystone project, the program in question has dramatically reduced catheter-related bloodstream infections (CR-BSIs). Indeed, it was heralded as a prime example of the new emphasis on zero tolerance for infections, as the median participating ICU went from an infection rate of 4% to zero over an 18-month period. Overall, the intervention led to a 66% reduction in CR-BSIs, saving a substantial toll in lives and dollars.1
"The results speak for themselves," says Gary Stephenson, MS, senior associate director of media relations and public affairs at Johns Hopkins. "They are nothing short of astounding."
Moreover, the program is addressing a huge problem at a time when health care-acquired infections are increasingly viewed as preventable errors by the news media, public, and legislators. It is estimated that some 80,000 CR-BSIs occur annually, causing up to 28,000 deaths. Given that the average cost of care for a patient with the infection is $45,000; such infections could cost up to $2.3 billion annually.2 Thus, federal interference with a cutting-edge CR-BSI prevention program — even if prompted by ethical concerns — drew some strong reactions.
"OHRP is interpreting a regulation in a vacuum — without regard for the larger societal and ethical needs to preserve life," Karen Linscott, acting CEO of the Leapfrog Group told HIC. "While we wait for the way to be cleared for the widespread implementation of this program, lives will undoubtedly be endangered." The influential Washington, DC-based group — which works with both employers and the health care system to promote high-quality care — fired off a strongly worded letter to the HHS secretary demanding that the OHRP action be immediately rescinded.
Checklist or checkmate?
The CR-BSI prevention program emphasizes hand hygiene, full-barrier precautions during catheter insertion, skin cleansing with chlorhexidine, avoiding the femoral insertion site, and removal of unnecessary catheters. A checklist for proper catheter insertion — which includes the patient's name or room number — also is a key part of the program. (See checklist.) The program also calls for rigorous data collection and analysis to determine if patient safety and clinical outcomes are improved. To the OHRP, the program appeared to be more of a human research project, which means hospital institutional review boards (IRBs) must approve the activity and patients must be given informed consent.
"They are interpreting the rules that govern this as research and under their interpretation you have to go through a formal IRB review process and you have to have consent," Stephenson says. "We look at the same language in the regulations and we do not see this as research; therefore, you would not have to go though the same process as you would with human subject research. We have complied with what we think their request is — we resubmitted everything for IRB review with a consent waiver. We are still waiting to hear back from them, so this is still hanging in the air."
Spencer Johnson, president of the Michigan Health & Hospital Association (MHA), released a statement noting that to "comply with the OHRP ruling, each participating . . . hospital, for a temporary period of time, has suspended certain activities related to the collaborative. The OHRP ruling did not require hospitals to discontinue patient safety and quality practices previously associated with the . . . project that are now implemented as normal patient care. However, the ruling did result in the halting of certain activities, including collection and reporting of data to the MHA Keystone Center, until such time as the participating hospitals are able to have the project reviewed and approved by their respective [IRBs]."
After a request for more specific information on what has been discontinued and what remains in use in the project (e.g., the checklist), HIC was provided the following statement by Sam Watson, executive director of the Keystone Project. "Over the years, some of the ICU Initiative activities have become the standard of practice and care at hospitals, and that such standards are, and would be, implemented regardless of the current conduct of the ICU Initiative. Thus it may be the case that hospitals continue to, as a standard of care, implement activities also covered by the ICU Initiative. However, such activities are not being conducted under the ICU Initiative itself, no data are being recorded or collected, and hospitals have been instructed that they may not resume ICU Initiative activities until such time as IRB approval has been gained."
According by Atul Gawande, MD, a surgeon at Brigham and Women's Hospital in Boston, the checklist is the primary point of contention. In a recent New York Times op-ed piece, he wrote that the OHRP shut the program down because "by introducing a checklist and tracking the results without written, informed consent from each patient and health care provider, they had violated scientific ethics regulations. Johns Hopkins had to halt not only the program in Michigan but also its plans to extend it to hospitals in New Jersey and Rhode Island. . . . The government's decision was bizarre and dangerous."3
Contacted by HIC, Gawande, declined further comment. The Leapfrog Group seized on the checklist issue in its letter to HHS. "This simple checklist is already proven to save lives," Linscott tells HIC. Asked to respond to the charges, Rebecca Ayer, a spokeswoman in the HHS Office of Public Health and Science says "the OHRP in no way prohibits hospitals from implementing a checklist and other measures that have been shown to prevent certain hospital-acquired infections. OHRP regulations do not apply when institutions are only implementing practices to improve the quality of care. Recently, some have interpreted the application of these policies differently. We are aware of these concerns and are actively reviewing the facts of this particular case."
Indeed, the HHS strongly encourages hospitals to take steps to improve the quality of care, she adds. "Current research regulations in no way prohibit the adoption of this [checklist] by hospitals whose only goal is to improve the quality of care, "Ayer says.
Move part of larger change
If this all seems a bit confusing, consider that the move to stop the program comes as part of a much larger ongoing effort to draft new human research regulations by the OHRP and its advisors, the Secretary's Advisory Committee on Human Research Protections (SACHRP). A comment period will be allowed after the draft regulations are issued, but the action taken on the CR-BSI prevention project may be a strong indication of which way the wind is blowing. Citing concerns among both the public health and health care epidemiology communities, Schaffner would like to see open hearings with expert testimony before the draft is completed.
"In my opinion, these well-intentioned people [at OHRP and SACHRP], unfortunately, are not very aware of the extraordinary diversity of current public health practice at the state and local level," he says. "Nor are they attuned to issues regarding quality assurance activities — which very much include infection control activities within the health care system. Speaking personally, it is my impression that because they are unacquainted with this large background of activity, they are 'overcalling' what is research."
As a result, traditional public health and infection control activities such as case control studies of outbreaks may be undermined, Schaffner warns. "If a case control study was used to investigate a disease problem this guidelines group might view that as a research methodology," he says. "You would have to put it through an IRB and give individuals informed consent. The whole notion of how you do your work becomes curtailed. You become much less effective, much less incisive. We won't be able to respond as quickly."
While the strong reaction to the incident makes it something of a test case, it remains to be seen whether the OHRP guidelines will ultimately give infection prevention more leeway or codify the view that some of its activities are subject to human research requirements. If it's the latter, there could be a "profound change" in the way infection control has traditionally been practiced, Schaffner warns.
"Infection control has traditionally done a variety of things using techniques that a committee such as this [may view as research]," he says. "The activities being undertaken in Michigan are quality assurance activities. It has nothing to do with research. This is a huge potential issue that has all kinds of insidious ramifications."