Legal trouble: ICPs reeling from legislative, regulatory whirlwind

Legal trouble: ICPs reeling from legislative, regulatory whirlwind

Are MRSA active surveillance laws next?

Infection control professionals are facing an unprecedented wave of legislative and regulatory activity as individual states and federal agencies move beyond demands for data disclosure and actually threaten to dictate clinical practice.

For example, the unrelenting rise of state laws requiring public disclosure of infection rates appears to be sparking legislative interest in other infection control areas. Legislation was introduced earlier this year in Illinois that would require hospitals to screen all patients for methicillin-resistant Staphylococcus aureus( MRSA) in accordance with guidelines published by the Centers for Disease Control and Prevention.

"If positive, they are required to inform the patient and offer treatment — the bill doesn't define what treatment is — and to report all cases to the health department," said Shannon Oriola, RN, CIC, COHN, chair of the mandatory reporting task force at the Association for Professionals in Infection Control and Epidemiology (APIC). "This legislation is going to be addressed in the fall. I know there are several APIC members in Illinois working closely with the legislature on this effort," she adds.

Similar legislation was introduced in Maryland that goes a bit further, requiring the more aggressive "active surveillance" approach recommended by the Society for Healthcare Epidemiology of America (SHEA). "This bill did not pass in Maryland, but the sponsor plans to reintroduce it next year," Oriola recently said at the annual APIC educational conference in Tampa.

SHEA recommends active surveillance, which calls for culturing the nares of targeted patients on admission or periodically thereafter to detect and isolate the reservoir of resistant organisms.¹ The SHEA guidelines recommend the practice so colonized patients can be placed in contact isolation rather than serving as an undetected source to spread the pathogens to other patients. Draft patient isolation guidelines issued in 2004 by CDC's Healthcare Infection Control Practices Advisory Committee (HICPAC) — which remain unfinalized — establish a two-tiered approach that calls for more aggressive measures (e.g., active surveillance) only in the face of ongoing transmission or if prevalence exceeds institutional goals.²

Vancomycin-resistant enterococci (VRE) and Clostridium difficile also have been mentioned as possible targets for regulatory action, but MRSA appears to the one bug that could inspire a chain of state-by-state action a la infection rate reporting laws. Already an endemic nightmare in many U.S. hospitals, MRSA now is emerging in distinctly different community-acquired strains. In light of such activity, APIC and SHEA have created a joint task force to address the issue of MRSA legislation. The task force is expected to soon issue a joint position statement on legislation requiring surveillance for MRSA, Kathleen Arias, MS, MT, SM, CIC, president of APIC, said at the meeting in Tampa.

"This is a really complex issue," she said. "It has a lot of effect on consumers, health care quality and facilities. We really don't know exactly what is going to happen. There is lot of public activity right now related to public [infection rate] reporting, MRSA, VRE, and C. diff."

Rise of a new regulatory era

The growing influence of patient and consumer advocacy and the rise of a new regulatory era of infection prevention were hot topics of discussion at APIC. As this issue went to press, there were 14 states that had adopted laws requiring hospital infection rate disclosure and many others at some stage of legislative study or discussion.

"We understand consumers' desire for more information," said Arias, director of Arias Infection Control Consulting in Crownsville, MD. "We have to support that desire. We cannot fight that. It would not be right and we want to be a little more transparent. However, we do recognize that there is no standardized system. All of these states have come up with different methods. There is no standard method for collecting, analyzing, and preparing our data for public reporting of the infection data from hospitals. We recognize that such a system has to be developed if we want to be able to compare ourselves with each other."

APIC discussions were somewhat conflicted. On the one hand, there were the frustrating references to state infection rate reporting laws that use questionable and potentially misleading data collection methods linked to discharge diagnosis codes and billing data. On the other, there were the horror stories of infected patients presented by Lisa McGiffert, director of the Consumers Union's campaign to "Stop Hospital Infections." The fact that someone representing Consumer Reports — the union's nationally known publication — was even speaking at APIC revealed the changing nature of the times. In introducing McGiffert, Patti Grant, RN, BSN, CIC, an ICP at Medical City in Dallas, referenced the sometimes antagonistic relationship between consumer advocates and ICPs. "When I first heard her talk, I was so defensive it was like a cat with all the [fur] up," Grant said. "Here's the deal: She wants exactly what we work every single day for. The approaches are the same, the words are just different." McGiffert concurred, saying, "We're in this together. You are the closest professional allies that we have in this fight."

Indeed, ICPs have become increasingly involved in the process to ensure that state laws yield valid data and that a national standard eventually emerges from the chaos. "The goal is to reduce the occurrence of health care associated infections," Arias said. "We cannot and should not lose sight of that goal even though we are going crazy trying to figure out what's going on, what we are going to be reporting and how we are going to be reporting it," she said. "We have to keep our eyes right on that goal."

ICPs making presence known

ICPs have managed to work their way into a process that in many states began without their input. The most recent example comes from Colorado, where an infection rate disclosure bill was signed into law last month that will become effective in January 2008. "[The law] requires the person collecting the data to be certified in infection control for facilities that have greater than 50 beds," said Oriola, infection control coordinator at Sharp Metropolitan Medical Campus in San Diego. "That's a big win and we think that is pretty exciting. Also — in another big win — at least four ICPs must be appointed to the advisory committee that will assist in [developing] the methodology for collecting and disseminating the information."

Likewise, ICPs and epidemiologists have managed to wield influence even after states have passed laws. "We have seen that a lot of states are already starting to go back and look at what they have done," Arias said. "Two states have dropped ventilator-associated pneumonia [rate reporting] because it is so hard to measure. That is as a result of APIC members. I'm telling you [that is a result of] being out there and being proactive and telling the legislatures just what you really do."

For example, ICPs in Florida are currently working to revise their state requirements, which began when legislation was passed in 2004. More recently the state began requiring hospitals to report two infection measures recommended by the Agency for Healthcare Research and Quality (AHRQ): selected infections due to medical care and postoperative sepsis. To the dismay of ICPs, the measures are based on administrative coding data, said Barbara Russell, RN, MPH, CIC director of infection control at Baptist Hospital in Miami. Russell said 40%-60% of the identified infections gathered under the new AHRQ requirement do not "really meet what we would call in our surveillance criteria a hospital-acquired infection. Because administrative coding at this point in time does not account for people admitted with [community infections] and all other kinds of issues. I know other practitioners in other states are dealing with this. If you are in states where a panel has been formed . . . try to steer them away from administrative coding if at all possible."

The pros of using such data include that it does not require additional collection and reporting by hospitals. "It is a cheap way to do it is the way they felt," she said. "It would be already there and submitted to the state anyway, and they would just pull it out for this other report."

However, the downside of using such data is troubling. "It's not consumer-friendly, is not linked to specific procedures, and there is no actual rate data — only numbers," Russell told APIC attendees. In addition, coding guidelines may differ based on payer instructions and the data do not differentiate between community and hospital acquired infections.

In hopes of remedying the situation and averting similar ones in other states, APIC's research arm is funding a $100,000 study at Ohio State University to compare the use of administrative coding data to epidemiological surveillance for infection control. "There is some data in the literature but not enough," she said. "So we are hoping that with this and some other things that we can not only help those of us that are already in to administrative data coding but — for those of you in states that may want to go that way — you will have ammunition to go to them and say, 'Please let's not go there.'"

National standard by February '07?

Meanwhile, the ultimate goal of many — a unified national infection rate reporting system — remains a work in progress by the National Quality Forum (NQF), APIC and other stakeholders. "One of the reasons we are really trying to get something moving here through the NQF or through a national law is so that we can all get on the same page and do the same thing," Russell said.

NQF is a private nonprofit organization that endorses consensus-based national standards on a variety of health care issues. Looking at a completion date of February 2007, the NQF is currently working on national voluntary consensus standards for the reporting of health care-associated infection data. ICP input into the process is considerable, with some 26 APIC members serving on the steering committee and technical advisory panels, Arias emphasized.

"We don't know how public reporting of infection data will impact the quality of patient care or how it will affect consumers or hospitals," she said. "Therefore, we have been working real hard to implement quality measurement systems such as going through NQF to provide meaningful data for both consumers and hospitals so that we can use this in our performance improvement activities. It may be pie in the sky, but we certainly are shooting for it."

If that's not enough, a flurry of activity continues at the Congressional level, including an ongoing investigation into hospital infections by the U.S. Committee on Energy and Commerce's subcommittee on Oversight and Investigation. (See Hospital Infection Control, June 2006, under archives at www.ahcpub.com.) In addition, in March, U.S. Sen. Barack Obama (D-IL) introduced S. 2359, the Hospital Quality Report Card Act of 2006. The bill calls for report cards that would include — among many other measures — information on nurse staffing levels and rates of hospital acquired infections. All the while the Centers for Medicare & Medicaid Services (CMS) is moving ahead with "pay for performance" requirements that will inevitably ratchet up more demands for infection control quality data. For example, there is some discussion about including surgical infection prevention measures related to antibiotic prophylaxis (e.g., drugs given within 60 minutes of incision and discontinued with 24 hours) in CMS pay for performance measures, Arias noted, urging ICPs to remain vigilant amid the rapid changes.

"Each one of us has to understand the issues," she said. "We have to closely follow what is happening. Keep up to date on what is happening in your state. We have to know what agencies have requirements. Again, it is not just the legislation that is affecting us. CMS is not legislation — it's regulation. We have to be proactive. We cannot wait to be invited to the table. We have to get invitations ourselves so that we are sitting there when legislatures are talking about this. A lot of this happens not at public hearings, but behind closed doors."

References

1. Muto CA, Jernigan JA, Ostrowsky BE, et al. Special report: SHEA guideline for preventing nosocomial transmission of multidrug-resistant strains of Staphylococcus aureus and Enterococcus. Infect Control Hosp Epidemiol 2003; 24:362-386.
2. Centers for Disease Control and Prevention. Healthcare Practices Infection Control Advisory Committee (HICPAC). Draft Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings 2004. Atlanta; 2004. [Unpublished.]