HICPAC Issues Guidance Document on Mandatory Reporting of HAIs
By Kelly Pyrek
The concept of mandatory reporting of healthcare-acquired infections (HAIs) has caught fire among legislators, healthcare policy-makers, and clinicians looking to address a long-standing public health threat and to give consumers more information with which to make informed choices about their healthcare providers. Currently, four states (Illinois, Florida, Missouri and Pennsylvania) have passed laws mandating reporting, while at least 32 other states have similar bills moving through the legislature.
In January 2005, the Association for Professionals in Infection Control and Epidemiology (APIC) convened a consensus conference on this issue, bringing together numerous stakeholders to discuss the development of a national standard before the United States ended up with 50 different pieces of legislation.
The conference, Healthcare-Associated Infections: Realizing the Benefits of Mandatory Public Reporting was intended to promote consensus on how to ensure that healthcare facilities nationwide report useable and reliable infection rate information. Joining APIC in presenting this conference were the Centers for Disease Control and Prevention (CDC), the American Hospital Association (AHA), Consumers Union, National Quality Forum (NQF), and the Society for Healthcare Epidemiology of America (SHEA). Conference discussion topics included current and pending legislative actions surrounding mandatory infection rate reporting, and the collection, interpretation and reporting of data. Most importantly, APIC called for consensus on the development of a standardized reporting system that addresses the needs of both consumers and healthcare facilities nationwide.
Mandatory public reporting of HAIs has been enacted in Florida, Illinois, Missouri and Pennsylvania, and this issue is on the current legislative agendas in Colorado, Kentucky, Iowa, Minnesota, Rhode Island, Virginia and Washington, says Denise Graham, director of government affairs for APIC. We are concerned that states will develop different reporting systems, making it more difficult for consumers to make effective comparisons.
APICs executive director, Kathy Warye, adds, We believe that consumers should have access to meaningful information for making informed healthcare decisions. Given the complexities of reporting, it is important that professionals in infection control and epidemiology spearhead this dialogue.
Warye says that participants in the consensus conference were very committed to moving forward but urged that this be done with great caution. Everyone in that room was committed to patient safety, but they also understood that this has to be done well; and if not, we run the risk of creating more public distrust rather than meaningful information upon which consumers can base decisions about their healthcare. Overall, we were very pleased with the results of the conference because we were able to convene stakeholders from every angle on the issue, which was our overarching goal.
We wanted to bring everyone involved in this issue to the table, because there are so many different organizations working on various components of this issue. We were concerned that the issue might not have been pursued in the most coordinated fashion, and we were worried about the prospect of having 50 different requirements or regulations in 50 different states. We had two goals at the beginning of the conference; to bring the various stakeholders together, and to determine if it would be in the best interest of the infection control community to have a national standard. We had overwhelming consensus that in fact that is how they prefer to proceed. So essentially, we now have our marching orders.
Kathleen Meehan Arias, MS, CIC, president-elect of APIC, explains that the consensus conference was set up to provide a forum for various key stakeholders so that they could present their perspectives on public reporting of HAIs. The goal of the conference was to create a foundation for developing a system of measurement thats accurate, meaningful and consistent nationwide and the conference provided an opportunity to explore the essential elements that are needed to develop an effective public reporting system and these are basically the elements that are discussed in the new HICPAC guidelines. The consensus conference allowed the attendees to gain insight from the lessons learned from our colleagues in the four states that have passed legislation already that requires public reporting on hospital infection data.
Arias continues, This issue is important for APIC because our goal is to reduce HAIs to an irreducible minimum. APIC is an organization that represents more than 10,000 infection control professionals, and infection control professionals manage the infection prevention programs in hospitals and other healthcare facilities, and one of their responsibilities is to collect data on HAIs. So they have expertise in doing this and are well aware that HAIs are difficult to manage. Because many states have introduced legislation already requiring public reporting of HAIs, infection control professionals have been working with legislators, hospital associations, health departments and others at the state level to develop public reporting programs that will provide meaningful information.
The CDCs Healthcare Infection Control and Prevention Advisory Committee (HICPAC) has released recommendations for policymakers who are seeking to create mandatory public reporting systems of healthcare-associated infections. (To view the guidance document, visit http://www.cdc.gov/ncidod/hip/PublicReportingGuide.pdf.) As the nations health protection agency, CDC is committed to helping ensure all Americans receive the best and safest care possible when they go to a hospital or other healthcare facility, says CDC director Julie Gerberding, MD, MPH. The recommendations released will go a long way to helping healthcare providers focus further on the importance of infection control and prevention. We are dedicated to helping make our healthcare facilities become even safer than they are now.
While HICPAC concluded there is currently not enough evidence to determine whether mandatory public reporting of HAIs will reduce infection rates, the advisory committee recommended that states implementing public reporting should strive to gather meaningful infection control data and use nationally recommended infection control measures.
To provide consumers and healthcare facilities with the best information, HICPAC recommends that states that are developing public reporting systems be sure to:
- Use established public health surveillance methods.
- Involve people with infection control expertise in the process.
- Track practices that prevent infections, in addition to measuring infection rates.
- Provide regular and confidential feedback to healthcare providers.
The goal of mandatory reporting is to provide consumers with information they can use to make informed healthcare choices, says Denise Cardo, MD, director of CDCs Division of Healthcare Quality Promotion. We dont know yet if public reporting will reduce the number of infections, but we do support collecting information that can lead to improvements in patient safety.
The CDC estimates that each year nearly 2 million patients in the United States contract infections in hospitals and about 90,000 of these patients die as a result of their infection. Bloodstream infections, urinary tract infections, pneumonia and surgical site infections comprise most HAIs. The percentage of healthcareassociated infections that are preventable is unknown. However, the CDC believes that adherence to recommended infection control strategies can reduce infections substantially.
We hope this guidance will be used by lawmakers and consumer advocacy organizations as a framework for designing systems that will provide helpful information for consumers and the places that give care, says Patrick J. Brennan, MD, chairman of HICPAC. The goal for everyone should be information that tells us how well we are doing in taking steps that can save lives.
Warye reports that APIC is pleased with the HICPAC guidance document. I would say we are very supportive of what HICPAC developed, and that it is a strong foundation upon which to move to the next level toward a national standard, she says.
This guidance was designed to provide direction and assistance to those states that have enacted or are considering legislation to require hospitals to make infection-rate data available to consumers. Infection prevention experts, acknowledging that consumers can and should play a larger role in their own healthcare, looked to HICPAC to help states, consumers and hospitals understand the complexities of public reporting. We support the idea of making meaningful information available to consumers, says Arias. We have dedicated our professional lives to preventing infections we just need to make sure that we do it right, so that patients have good, reliable information upon which to make sound decisions.
To that end, Warye says APIC is asking its members to get involved in the issue, or at the very least, to stay current on developments in their respective states. We are saying get involved, because if they dont, legislation will be crafted without the benefit of the people who are most knowledgeable, so we are encouraging them to get involved. The last count was 30-plus states that had introduced legislation since January, and I think in every state there are infection control practitioners (ICPs) working with Denise Graham, to help them provide input into the legislation so it doesnt move forward without them. ICPs and epidemiologists can be very effective in helping shape legislation in such a way that it is more meaningful for consumers and more manageable for the infection control community.
Warye says an unexpected byproduct of this issue is greater respect for ICPs. The great silver lining in this issue is that in addition to patients receiving meaningful information, it helps ICPs make a strong case about the importance and the economics of what they are doing, and ultimately, I think ICPs eventually will see more resources flow into the infection control department as a result of this high-profile issue. As consumer and lawmaker interest in mandatory reporting increases, hopefully it will mean an elevated position for ICPs as well as an increase in the resources they need to do the job.
When asked about additional resources that may be required for healthcare facilities to undertake public reporting, Brennan says, We didnt specifically address resources, but it is an important issue. We do mention the necessity for ensuring adequate resources we may need more infection control professionals and more information technology resources in order to accomplish this.
Some states have actually conducted studies of infection control programs in hospitals and they have found that some of the hospitals are going to have a hard time collecting some of the data thats currently proposed, just because the resources may not be there, Arias says. The resources arent necessarily just personnel resources; some of the resources that we need are technology, hardware and software programs that allow the data to be collected and accurately reported to the public.
We do indicate that the right resources need to be in place if public disclosure is to be carried out properly but the resources may include additional fulltime equivalent employees in the infection control professional category or the proper information system resources, Brennan adds. But resources are essential, and in fact I think the states that have implemented so far have really done this with the intention of raising the profile of this issue, raising the profile of infection control and prevention in hospitals and are really sending a challenge out to organizations and to their leadership to step forward and meet this challenge.
In a telebriefing held in late February, Cardo, Brennan and Arias gathered to discuss the recommendations contained in HICPACs guidance document. Cardo explained the impetus behind the suggested guidelines. CDC has been a national leader for surveillance and prevention of healthcare-associated infections for many years, Cardo said. Some states that were considering the public release of healthcare- associated infection data have contacted CDC for guidance. As a result, CDC asked HICPAC to look at this issue and provide guidance to states interested in making information on HAIs available to the public. We applaud HICPAC for taking on this issue and for working so quickly to put together this very important guidance document. We also want to thank the professional organizations that have contributed to and endorsed this document, APIC, the Council of State and Territorial Epidemiologists (CSTE), and SHEA.
Brennan explained that HICPAC began to explore this issue about a year ago, evaluating the evidence, and then producing the most useful guidance available. In the exploration of this topic, we discovered that there is insufficient evidence to recommend for or against public reporting of HAIs, Brennan said. Nonetheless, we realize that this is a process that is going forward. While we have not made a recommendation for or against these processes, we are providing our consensus opinion on the best way to pursue the public disclosure of HAIs. This document then is a guide to best practices. It is the consensus opinion of HICPAC and we believe it is a starting point in the process of public disclosure for HAIs. We have not put forward this document as model legislation.
Brennan added, Our intended audience is the policymakers, program planners and consumer advocacy organizations who are tasked with planning and implementing the public reporting systems for HAIs. We advocate the specification of goals, objectives and priorities as a starting point in developing these systems, the selection of measurable outcomes and the use of established methods. The reports that are generated should identify the endorsers of the indicators that are chosen and the sources of data, and we believe that tools such as public disclosure report cards should be useful processes for quality improvement and that that can be accomplished through feedback to the providers who really generate this data.
Regarding HICPACs four major recommendations in the document, Brennan explained that established public health surveillance methods should be used when designing and implementing mandatory reporting of HAIs. This means the selection of appropriate patient populations to monitor, the use of standardized case-finding methods and data validity checks, and importantly, the provision of adequate support and resources within organizations so that these processes can be carefully carried out. We do not advocate the use of hospital discharge diagnostic codes as a primary data source for healthcareassociated public reporting systems.
The second recommendation is to create a multi-disciplinary advisory panel and include persons with expertise in prevention and control of HAIs in the planning and oversight of these public reporting systems. We believe that there are many stakeholders in these processes. Controversies have existed over the methods but the methods are important in determining the outcomes of these processes. Since there are many stakeholders, the development process should be a multi-disciplinary one, Brennan commented.
Regarding the third recommendation, which is to choose appropriate process and outcome measures based on facility type, Brennan added, We believe these indicators should be phased in over time and this will maximize the usefulness of these indicators to consumers and the acceptability to providers. We have recommended three process measures and two outcome measures. The process measures include the practices used to insert central venous catheters that can lead to bloodstream infections, antimicrobial prophylaxis for surgical procedures, and influenza vaccination coverage for both healthcare workers and for patients. The outcome measures that we are recommending include central line-associated laboratory-confirmed bloodstream infections and surgical site infections, though there is a synergy or a linkage between the process measures and the outcome measures and those are the major points in the document.
During the February telebriefing, Brennan pointed out that this guidance document breaks from tradition of previous documents. The intended audience for past guidelines has been the professional community, physicians, epidemiologists, infection control professionals and clinicians. The intended audience for this document is those who are tasked with designing and implementing these systems. We hope that the professional community will serve as the conduit for this information as states and regulators attempt to design and implement these systems. But it does not establish a national policy on it. HICPACs guidance documents in the past have been highly regarded and have been relied upon as a standard in the industry and were hoping that this one can be adopted in the same way.
Cardo added, I think its important to note that this is the first step in the process to work together to collect information that can lead not just to release to the public, for the public to make decisions, but also to the healthcare institutions to prevent infection. The CDC believes that information about HAIs can lead to increased focus on infection control and prevention. We believe that tracking the processes that lead to infections, in addition to infection rates, can improve patient safety, and were very pleased with the HICPAC guidelines and the fact that the professional organizations have joined us in this effort.
And we want to remind you that the information that we recommend to be collected has to be useful for the public but also be useful for the facility in order to improve the quality of health they are providing to all the patients in the healthcare systems in the United States.
Identifying Appropriate Measures of Healthcare Performance
The following is an excerpt from HICPACs Guidance on Public Reporting of Healthcare- Associated Infections:
Monitoring both process and outcome measures and assessing their correlation is a comprehensive approach to quality improvement. Standardized process and outcome measures for national healthcare performance for hospitals, nursing homes, and other settings have been endorsed through the National Quality Forum (NQF) voluntary consensus process. NQF also has developed a model policy on the endorsement of proprietary performance measures. Several other agencies and organizations, including CDC, CMS, the Agency for Healthcare Quality and Research, JCAHO, the Leapfrog organization, and the National Committee for Quality Assurance, also have developed healthcare quality measures. Healthcare performance reports should identify the sources and endorsers of the measures and the sources of the data used (e.g., administrative or clinical).
Process measures are desirable for inclusion in a public reporting system because the target adherence rate of 100 percent to these practices is unambiguous. Furthermore, process measures do not require adjustment for the patients underlying risk of infection.
Process measures that are selected for inclusion in a public reporting system should be those that measure common practices, are valid for a variety of healthcare settings (e.g., small, rural vs. large, urban hospitals); and can be clearly specified (e.g., appropriate exclusion and inclusion criteria). Process measures meeting these criteria include adherence rates of centralline insertion practices and surgical antimicrobial prophylaxis and coverage rates of influenza vaccination for healthcare personnel and patients/residents. Collection of data on one or more of these process measures already is recommended by the NQF and required by CMS and JCAHO for their purposes.
Outcome measures should be chosen for reporting based on the frequency, severity, and preventability of the outcomes and the likelihood that they can be detected and reported accurately. Outcome measures meeting these criteria include central line-associated, laboratoryconfirmed primary bloodstream infections (CLA-LCBI) in intensive care units (ICU) and surgical site infections (SSIs) following selected operations. Although CLA-LCBIs and SSIs occur at relatively low rates, they are associated with substantial morbidity and mortality and excess healthcare costs. Also, there are well-established prevention strategies for CLA-LCBIs and SSIs. Therefore, highest priority should be given to monitoring these two HAIs and providers adherence to the related processes of care (i.e., central-line insertion practices for CLALCBI and surgical antimicrobial prophylaxis for SSIs).
Use of other HAIs in public reporting systems may be more difficult. For example, catheterassociated urinary tract infections, though they may occur more frequently than CLA-LCBIs or SSIs, are associated with a lower morbidity and mortality; therefore, monitoring these infections likely has less prevention effectiveness relative to the burden of data collection and reporting. On the other hand, HAIs such as ventilator-associated pneumonia, which occur relatively infrequently but have substantial morbidity and mortality, are difficult to detect accurately. Including such HAIs in a reporting system may result in invalid comparisons of infection rates and be misleading to consumers. Monitoring of process and outcome measures should be phased in gradually to allow time for facilities to adapt and to permit ongoing evaluation of data validity.