Threat of legislative mandates cloud debate on active surveillance cultures

Threat of legislative mandates cloud debate on active surveillance cultures

Resulting law could be the one of unintended consequences

Even as some health care epidemiologists are raising strong doubts about the cost-effectiveness of active surveillance cultures (ASCs), legislators in Illinois and Maryland are considering laws that would mandate the practice to detect methicillin-resistant Staphylococcus aureus (MRSA).

ASC has been successfully used in some institutions to detect the reservoir of MRSA, place colonized patients in contact isolation, and ultimately lower infection rates. However, there is considerable controversy about the practice within the infection control community. Some ICPs see ASC as an essential prevention measure, while others argue that it is expensive and unnecessary if other infection prevention measures, such as standard precautions, are practiced with high compliance by health care workers. Recent discussions about ASC revealed considerable consternation and divisiveness among the members of the organization best known for advocating the practice: the Society for Healthcare Epidemiology of America (SHEA).¹

"Calls for MRSA-specific infection control tactics such as universal screening and isolation of patients who have ever been colonized or infected with MRSA, have taken on an almost evangelical tone," Kathryn Kirkland, MD, a health care epidemiologist at Dartmouth-Hitchcock Medical Center in Lebanon, NH, recently said in Baltimore at the annual SHEA meeting. "At the same time, the continuing emergence of new infectious threats has caused some to question the risk that we are focusing too much of our resources on the enemy that we know."

Kirkland sensed she was in the minority opinion on the issue, titling her presentation "A Voice Crying Out in the Wilderness."² The Centers for Disease Control and Prevention also has only cautiously endorsed the practice, creating a rift with SHEA that now seems to be occurring within the association itself. The most recent CDC guidelines on multidrug-resistant organisms say that ASC "should be considered in some settings, especially if other control measures have been ineffective."³

The problem is that consumer advocates and some state legislatures have seized on the practice as something of a symbol of any given hospital's commitment — or lack thereof — to reduce the scourge of hospital infections. With legal mandates looming and some epidemiologists arguing ASC would be inappropriate and counterproductive at their facilities, even supporters of the practice may be wondering what they have unleashed.

"I'm actually a fan of active surveillance culturing," Steve Weber, MD, a health care epidemiologist at the University of Chicago told SHEA attendees. "We use ASC in my hospital in several units. Some of my best friends do active surveillance culturing. . . . [But] this is our clinical service. That's not just something I say [lightly] but is something I hold dear in my career development. Legislation mandating one particular infection control strategy for me as a clinician is no different than legislation that would insist on one particular operative approach by a cardiovascular surgeon, one particular pain regimen by a palliative care specialist or one particular chemotherapy agent by an oncologist."

But any debate about the wisdom of legislating clinical practice may be strictly academic in the near future in Illinois if the "MRSA Screening and Reporting Act" is approved. Under the proposed bill, hospitals would be required to screen for MRSA in all intensive care units and test other "at-risk" patients as designated by the hospital. Similar legislation is under consideration in Maryland, and both bills include some element of hospital reporting of MRSA infections to state health officials.

SHEA, APIC come out against laws

Though conceding there is considerable evidence to support the use of ASC, the nation's leading infection control organizations have come out against mandating the practice. "[T]o mandate the strategy as the single infection control intervention to be applied in all circumstances would preclude local risk assessment and the implementation of a broad range of interventions," according to a joint position statement by SHEA and the Association for Professionals in Infection Control and Epidemiology (APIC).⁴ "Moreover, legislation in general is not sufficiently flexible to permit rapid response to local epidemiological trends or changes in the understanding of the spread and consequences of antimicrobial resistance."

However, such arguments may not sway legislators emboldened by consumer groups and angry patients who have acquired MRSA. The debate within the epidemiology community about ASC does not seem to be helping matters. The aforementioned state efforts actually began with proposed laws in Illinois and Maryland last year, which prompted SHEA and APIC to jointly issue the position paper.

"Perceived disagreements between SHEA and APIC leaders and membership on ASC were picked up on by the legislatures in these states," said Weber, one of the authors of the position paper. "The disagreement regarding [ASC] and the tenor of that debate was perceived in Illinois as something suggestive of inaction on the part of our field."

Indeed, the issue now is sufficiently complicated and confusing enough that some advocates of ASC are taking the somewhat awkward position that they support the practice — but don't want to mandate it. At the same time, infection control professionals who have never been in the ASC camp face the prospect of being ordered to conduct a clinical practice to which they are philosophically opposed.

"First and foremost is the potential impact on infection control programs and health care epidemiologists," Weber told SHEA attendees. "It is very problematic that legislation fundamentally, as a tool, does not recognize the need for flexible allocation of resources to the most critical hospital challenges. In essence, this is taking away the autonomy of us as practitioners in our institutions or jurisdictions to decide what we think are the most important infection control risks. In some settings, it might be MRSA; in some, it might be C. diff; and in still others, it might be surgical-site or device-related infections."

Moreover, the SHEA meeting was marked by a wealth of updated information on MRSA and ASC, including reports of some unintended consequences of the latter. "Even among the strongest proponents you see quite a bit of variability about how procedures are done, what microbiology is used, what statistical measures are performed," Weber said. "Practically speaking, how can we legislate something [when there] is such an active, healthy debate about these issues? A mandatory program will have to conform to uniform standards, and if we can't agree to those, how can we establish mandatory programs?"

Despite his concerns — or perhaps because of them — Weber is not sitting this one out. He is working with the hospital association in Illinois and other forces in the state to try to guide the legislation toward some palatable final product. "It has been pointed out to us many times, legislators legislate," he said. "There will be a bill in Illinois. There probably will be a bill in Maryland and we will need to understand that is going to encompass and potentially include elements that will provide benefit to our entire field and not just an added burden for us."

However, such efforts are tricky because the issue of ASC has divided the infection control community. Even as laws are being considered based on data and recommendations underscoring the efficacy of ASC, epidemiologists such as Kirkland are arguing that health care infections can be dramatically reduced without the surveillance practice. "Control of MRSA can be achieved without screening or isolation of colonized or infected patients, at least in our setting," she argued during her SHEA presentation.

Kirkland's medical center in New Hampshire uses a universal approach to the prevention of clinical infection due to S. aureus — whether drug-resistant or susceptible — through hand hygiene and standard precautions for all patients. "More than 80% of our Staph aureus isolates are susceptible, [so] it seems inappropriate to focus our infection prevention program on MRSA alone," she explained. In addition, the system calls for syndrome-based expanded precautions to kick in for all patients with cough, uncontrolled secretions or diarrhea, regardless of the infecting organism. "For example, any patient with an uncovered wound or uncontained secretions is placed on contact precautions regardless of the culture results," Kirkland said. "A patient with MRSA growing from that source is not placed on contact precautions unless he or she meets syndrome criteria for expanded precautions."

The approach has kept infection rates flat for several years, even in the face of dramatically increasing community-acquired MRSA, she noted. From 2002 to 2006, the rate of health care-associated MRSA infections remained at just under one case per 1,000 patient days. The rate of health care-associated MRSA infection during the same time period decreased from 1.7 to 1.5 cases per 1,000 patient days, Kirkland said. Moreover, more bloodstream infections caused by all pathogens fell 27% during the period. "We feel that future studies on MRSA control measures really should evaluate the impact on infections due to other health care-associated pathogens," she said. "This strategy appears effectively to reduce the incidence of other [infections] as well."

Ambulance diversions an issue

Michael Edmond, MD, joined Kirkland in arguing at the same SHEA session that a focus on basic yet comprehensive infection control strategies such as hand hygiene, compliance with standard precautions, and special emphasis on areas such as optimal catheter insertion and line maintenance practices can reduce nosocomial infections without ASC.

"I believe, as do a number of other people, that there are a number of problems to this [ASC] approach," warned Edmond, a health care epidemiologist at Virginia Commonwealth University (VCU) Medical Center in Richmond. "The drive to mandate active surveillance with contact precautions would seem to be incongruent with the strength of the evidence we have. I believe there are questionable or unsupported arguments that have been made in regard to this, such as those hospitals without these types of programs are allowing multidrug-resistant organisms to simply spiral out of control."

Over the three-year study period, surveillance cultures were not performed but numerous initiatives aimed at broadly decreasing infections were implemented.⁵ Those included feedback of compliance with infection control process measures to ICU staff, education campaigns on and monitoring of optimal catheter insertion techniques, and line maintenance practices. Rates of catheter-associated bloodstream infections, catheter-associated urinary tract infections, and ventilator-associated pneumonias due to MRSA were determined from concurrent surveillance by trained infection control practitioners utilizing CDC definitions in a 16-bed medical ICU (MICU) and 18-bed surgical ICU (SICU). Cost of MRSA surveillance testing via PCR on nasal swabs was estimated at $25 per test and applied to 2006 census data for both ICUs assuming a strategy of testing all patients on admission and weekly thereafter, Edmond reported at SHEA.

Over the three-year period, the rate of nosocomial infections from all pathogens decreased 46% in the MICU, 56% in the SICU, and 49% across all ICUs. Cost of performing S. aureus testing on admission and weekly in the two ICUs would be $66,075 excluding labor for 2006, he calculated. Costly ASC for MRSA in the critical care setting is not required to reduce the incidence of MRSA infections, Edmond concluded, arguing that hospitals should not pursue active surveillance cultures until basic infection control efforts have been maximized and rates of infection thoroughly examined.

Interestingly, Edmond warned that the active surveillance practices could lead to unintended consequences for high-census hospitals such as VCU. The use of ASC to detect colonized patients triggers the implementation of contact precautions, meaning those patients will need to be in private rooms or gathered in cohorts. The reality of trying to do that in a hospital operating at full bed capacity is that you max out the system and create the risk of possible ambulance diversions, Edmond warned.

"On a given good day in my hospital, there are no beds," he told SHEA attendees. "Our ambulance diversion rate hours are so high. . . . It is already jammed to start with so if we have to start adding layers of complexity by saying, 'I need a private room,' or 'I need to cohort this patient with another patient,' it slows down the entire process. Patients in the ICU can't get out of the ICU. . . . The whole thing backs up to the ER."

Placing patients at risk is not without consequences, he added, noting that there have been documented reductions in contact with caregivers, potential increased patient anxiety and depression, and possible increases in noninfectious adverse events.

A healthy debate

Such findings had some health care epidemiologists rethinking the ASC question, though several pointed out the expectation of high compliance by health care workers with standard infection control measures may not be realistic.

"It generated a lot of discussion; when I left that session I talked to a lot of people. It made me quite introspective, really," said Leonard Mermel, MD, a health care epidemiologist at Rhode Island Hospital in Providence. "Did I make the wrong move four or five years ago, really pushing our active surveillance program?"

Though the program has resulted in sustained reduction of infections, Mermel is open to the idea that there are other paths to the same goal. "If you have good basic infection control and a very high level of compliance — which a lot of places don't currently have in the U.S. — could you reach the same goal? They suggest that you can. It was very thought-provoking."

Increased oversight and transparency through public reporting and other initiatives may have some benefits, but "allow the decision of how best to do this to be up to the infection control department rather than the legislature," he said.

In the question-and-answer session after Edmond's presentation, Carlene Muto, MD, argued that the adverse effects of contact isolation can be eliminated if they are anticipated and dealt with in advance. She also questioned whether the program described was truly effective, particularly since Edmond reported eight infections in a surgical intensive care unit.

"The problem with reporting just reductions in infections is that when you start out high, even a 50% reduction might be looked at as significant but it still is not zero," said Muto, a health care epidemiologist at the Pittsburgh VA Medical Center, which has received considerable publicity for its success with ASC and other efforts against MRSA.

Edmund conceded that the program was something of a work in progress — particularly in the surgical ICU — but he underscored the epidemiological achievements in the absence of ASC. "Our medical ICU had one infection the entire year — a urinary tract infection. I would be exceptionally pleased to do that for another year," he said. "If all of our units could do that, we would not need active surveillance cultures."

Such robust discussion among epidemiologists made for a strong scientific meeting, albeit somewhat clouded by the threat of legislative mandates that could render the debate moot.

"Constructive debate is absolutely appropriate," Weber said. "This is what we do in science. Maybe that is lost in the legislature and among the consumer advocacy groups, but we need to have a healthy debate about this."

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. Kirkland KB, Ptak JA, Dugan EA, et al. A voice crying out in the wilderness? Sustained control of healthcare-associated MRSA infection without screening or organism-based isolation. Abstract 23. Presented at the Society for Healthcare Epidemiology of America. Baltimore; April 14-17, 2007.
3. Centers for Disease Control and Prevention. Siegal JD, Rhinehart E, Jackson L, et al. The Healthcare Infection Control Practices Advisory Committee Management of Multidrug-Resistant Organisms in Healthcare Settings, 2006. On the web at: www.cdc.gov.
4. Weber SG, Huang SS, Oriola S, et al. Legislative Mandates for Use of Active Surveillance Cultures to Screen for Methicillin-Resistant Staphylococcus aureus and Vancomycin-Resistant Enterococci: Position Statement From the Joint SHEA and APIC Task Force. On the web at www.apic.org.
5. Edmond MB, Ober JF, Bearman G. Active surveillance cultures are NOT required to control MRSA infections in the critical care setting. Abstract 23. Presented at the Society for Healthcare Epidemiology of America. Baltimore; April 14-17, 2007.