Sunday
May 15, 2005
More than five years after the Institute of Medicine released "To Err is Human," the report's stark findings remain fresh in the public's consciousness and continue to roil the health care waters. Among other things, "To Err" recommended a nationwide mandatory reporting system for states to hold health care organizations accountable for maintaining safety, coupled with voluntary reporting systems to support performance-improvement efforts.
So far, those recommendations have gained traction most firmly in the realm of health care-associated infections, where a federally sponsored voluntary initiative is already in place and mandatory reporting bills are proliferating at the state level. As of early spring, four states had established mandatory reporting and legislation had been introduced in 31 others. At the same time, the majority of U.S. hospitals are participating in a voluntary initiative sponsored by the Centers for Medicare & Medicaid Services.
Hospitals, consumer groups and infection-control experts generally support the efforts but disagree about the best long-term strategy to reduce nosocomial infections. Even at this early stage, there are questions about whether a patchwork of state regulations is better than nationwide mandatory or voluntary systems. Also at issue is the difficulty states have had in developing robust measures that will provide meaningful information to the public without putting hospitals into "analysis paralysis," thus hindering their performance-improvement efforts.
Figures from the U.S. Centers for Disease Control and Prevention indicate that each year an estimated 2 million patients contract nosocomial infections and about 90,000 die. Resulting treatments and additional days of hospitalization add up to about $4.5 billion annually. What percentage of infections are preventable is unknown, according to the CDC. A 2002 Chicago Tribune, however, series reported that approximately 75 percent could be avoided.
Rising public awareness about health care-associated infections led three states--Florida, Missouri and Illinois--to enact mandatory reporting laws within the past two years. All three are in various stages of finalizing regulations and procedures, so hospitals in those states are not submitting data at this time.
Pennsylvania is the only state in which hospitals are currently reporting data on nosocomial infections. Reauthorizing language in 2003 for the state's Health Care Cost Containment Council, an independent agency that oversees mandated hospital performance reporting, included a proviso to collect and report hospital-associated infections. Hospitals began providing data in 2004 and the council is expected to release infection-related data for the first time later this year, according to Paula Bussard, senior vice president for policy and regulatory services at the Hospital and Healthsystem Association of Pennsylvania in Harrisburg.
Hospital-acquired infection measures that will be reported in the four states vary, and illustrate the potential drawbacks associated with state-by-state regulations. For instance, Pennsylvania requires reporting of surgical site infections for cardiovascular, orthopedic and neurosurgical procedures, while Missouri hospitals will report surgical site infections for C-sections, coronary artery bypass grafts and hip replacements.
Meanwhile, hospitals in neighboring Illinois will report Class I surgical site infections, which are primarily closed, clean wounds that can be drained with a closed wound drainage system.
The differences could pose challenges for consumers and providers alike. "If consumers live on a [state] border, they can go to hospitals in each state and it will not be possible to compare measures if they're all reported differently," says Kathleen Arias, owner of Infection Control Consulting in Crownsville, Md., and president-elect of the Association for Professionals in Infection Control and Epidemiology.
Likewise, hospital systems that operate in more than one state may end up reporting different measures to different regulatory bodies and run the risk of diminishing their performance-improvement efforts.
"As important as the reporting [is] is the quality improvement that must go on in connection with it--and you can't work on improvement when you do it one way for this group and another way for another group," contends Pat Merryweather, senior vice president at the Illinois Hospital Association in Naperville.
Arias says that analysis-paralysis is more than just a hypothetical concept.
"The main difficulty is that a lot of the information used to identify infections is not readily available electronically. It's in paper records, and personnel have to look through them manually," she says. "We need more data collected electronically to cut down on the time required to report and to improve accuracy."
Complicating matters is the fact there's no standard definition or methodology for figuring out what to measure. This despite the fact that organizations typically rely on CDC's National Nosocomial Infection Surveillance system for guidance. For instance, much of the original legislative language in Illinois "was modeled on what we thought existed with CDC," Merryweather explains. "If anything, it became clear after discussions moved along that the CDC measures were not well-defined in terms of operationalizing them and they weren't intended for hospital compliance purposes."
As an example, Merryweather says that when the association polled members on how they calculated central line-associated infections, "everyone said, 'we're doing it according to the CDC,' but we found they didn't have the exact definition of central line days or they calculated it starting at different times of the day. There was quite a bit of variation."
Largely in response to inquiries from states that have implemented or are considering mandatory reporting statutes, the CDC, through its Healthcare Infection Control Practices Advisory Committee, in March issued guidelines on public reporting of health care-associated infections. HICPAC found insufficient evidence to support or oppose mandated public reporting, but made several recommendations to guide legislators in states contemplating such actions. HICPAC suggested that states use existing public health surveillance methods and create multidisciplinary advisory groups to provide expertise in the development and implementation of public reporting systems. The panel also recommended selecting both process measures to track practices that prevent infections and outcome measures that calculate infection rates. Finally, HICPAC advised giving regular and confidential feedback to providers.
The panel used available scientific evidence and the collective judgment of its 14 infection control expert members to arrive at five recommended reporting measures. The process measures include central line insertion practices, influenza vaccination coverage for both patients and providers, and surgery-related antimicrobial prophylaxis. Two outcome measures were also advised: central line-associated bloodstream infections and surgical site infections following selected surgeries.
Three of the four states that enacted mandatory reporting before the HICPAC guidelines were issued included at least one measure HICPAC did not endorse, ventilator-associated pneumonia. The condition can be tricky to diagnose, and some organizations define it based on clinical findings while others use bronchoscopy test results. "It's a measure with a lot of caveats," says Denise Cardo, M.D., director of CDC's division of health care quality and promotion. In addition, many hospitals essentially don't have ventilator populations.
That discrepancy and others led advisory committees in Illinois and Florida to recommend that the states revise their just-passed mandatory reporting laws to be consistent with HICPAC's recommendations. In Illinois, Merryweather expects a bill to that effect to be introduced in the current legislative session. It appears that Florida may not make such a change at this time. "It's possible that the state will require the HICPAC recommendations in the future, but for right now it just wants something out there," says Kim Streit, vice president for research and information at the Florida Hospital Association in Orlando. Later this year, hospitals in the state will begin reporting selected care-related infections and surgical infection-prevention measures developed re- spectively by the Agency for Healthcare Research and Quality and CMS.
In the meantime, several of the 31 states with pending legislation drafted bills based on model hospital infection disclosure act language developed by Consumers Union, a nonprofit information and testing organization. The model language includes both VAP and urinary tract infections, another outcome measure that HICPAC did not recommend. Consumers Union does not intend to change its model language or to advocate that the states in question drop those measures in favor of the ones recommended by HICPAC. "The HICPAC recommendations are just a start, and VAP and urinary tract infections are measures CDC collects and that hospitals look at," says Lisa McGiffert, director of www.stophospitalinfections.org>, a Consumers Union campaign to educate the public about health care-associated infections and to win passage of state-mandated infection reporting.
Whether these states will incorporate the HICPAC guidelines or continue with other measures remains to be seen. Also unclear is how well state-by-state requirements ultimately will serve the public interest and boost hospital performance. Consumers Union views state-based mandatory reporting as the best approach. "We think it's a bad idea to create a standardized national reporting system when it's never been done before," McGiffert says. "The states have always been laboratories for experimentation and as different states implement different methods, it will be obvious which are better. Our ultimate goal is national reporting but it's bad to start that way."
On the other hand, the American Hospital Association sees nationwide voluntary standards as a better way to go. "National voluntary standards could obviate the need for state-level mandatory reporting," says Don Nielsen, M.D., senior vice president for quality leadership. "We have an example of a successful alliance using national standards for the development of data and reporting in a format that is accurate and reliable."
The AHA is a key partner in the voluntary Hospital Quality Alliance, a public-private partnership among CMS, the Joint Commission on Accreditation of Healthcare Organizations and numerous health care and patient safety associations.
Hospitals began submitting data on 10 performance measures involving three conditions in November 2003. An additional 12 measures will be reported starting this year, including three related to surgical infection prevention. Although the measures are voluntary, the Medicare Prescription Drug Improvement and Modernization Act of 2003 provided a strong incentive to report. Hospitals that don't submit the initial 10 measures will receive a 0.4 lower annual payment update in fiscal year 2005. According to CMS, more than 4,000 hospitals are participating.
Regardless of how the state versus national, mandatory versus voluntary debate plays out, public health officials worry that without industrywide collaboration, the benefit of public reporting will be lost.
"We don't know what is the best approach, but the states are issuing regulations now," says CDC's Cardo. "It's important that we work together with the states and they with each other so that what is recommended is consistent. Otherwise, we'll never be able to do benchmarking for the country."
Gina Rollins is a freelance writer based in Silver Spring, Md.
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