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HICPAC Issues Guidance Document on Mandatory Reporting of HAIs
By Kelly Pyrek
The concept of mandatory reportingof healthcare-acquired infections (HAIs) has caught fire among legislators,healthcare policy-makers, and clinicians looking to address a long-standingpublic health threat and to give consumers more information with which to makeinformed choices about their healthcare providers. Currently, four states(Illinois, Florida, Missouri and Pennsylvania) have passed laws mandatingreporting, while at least 32 other states have similar bills moving through thelegislature.
In January 2005, the Association for Professionals inInfection Control and Epidemiology (APIC) convened a consensus conference onthis issue, bringing together numerous stakeholders to discuss the developmentof a national standard before the United States ended up with 50 differentpieces of legislation.
The conference, Healthcare-Associated Infections: Realizingthe Benefits of Mandatory Public Reporting was intended to promote consensuson how to ensure that healthcare facilities nationwide report useable andreliable infection rate information. Joining APIC in presenting this conferencewere the Centers for Disease Control and Prevention (CDC), the American HospitalAssociation (AHA), Consumers Union, National Quality Forum (NQF), and theSociety for Healthcare Epidemiology of America (SHEA). Conference discussiontopics included current and pending legislative actions surrounding mandatoryinfection rate reporting, and the collection, interpretation and reporting ofdata. Most importantly, APIC called for consensus on the development of astandardized reporting system that addresses the needs of both consumers andhealthcare facilities nationwide.
Mandatory public reporting of HAIs has been enacted inFlorida, Illinois, Missouri and Pennsylvania, and this issue is on the currentlegislative agendas in Colorado, Kentucky, Iowa, Minnesota, Rhode Island,Virginia and Washington, says Denise Graham, director of government affairsfor APIC. We are concerned that states will develop different reportingsystems, making it more difficult for consumers to make effective comparisons.
APICs executive director, Kathy Warye, adds, We believethat consumers should have access to meaningful information for making informedhealthcare decisions. Given the complexities of reporting, it is important thatprofessionals in infection control and epidemiology spearhead this dialogue.
Warye says that participants in the consensus conference werevery committed to moving forward but urged that this be done with greatcaution. Everyone in that room was committed to patient safety, but they alsounderstood that this has to be done well; and if not, we run the risk ofcreating more public distrust rather than meaningful information upon whichconsumers can base decisions about their healthcare. Overall, we were verypleased with the results of the conference because we were able to convenestakeholders from every angle on the issue, which was our overarching goal.
We wanted to bring everyone involved in this issue to thetable, because there are so many different organizations working on variouscomponents of this issue. We were concerned that the issue might not have beenpursued in the most coordinated fashion, and we were worried about the prospectof having 50 different requirements or regulations in 50 different states. Wehad two goals at the beginning of the conference; to bring the variousstakeholders together, and to determine if it would be in the best interest ofthe infection control community to have a national standard. We had overwhelmingconsensus that in fact that is how they prefer to proceed. So essentially, wenow 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 forvarious key stakeholders so that they could present their perspectives on publicreporting of HAIs. The goal of the conference was to create a foundation fordeveloping a system of measurement thats accurate, meaningful and consistentnationwide and the conference provided an opportunity to explore the essentialelements that are needed to develop an effective public reporting system andthese are basically the elements that are discussed in the new HICPACguidelines. The consensus conference allowed the attendees to gain insight fromthe lessons learned from our colleagues in the four states that have passedlegislation already that requires public reporting on hospital infection data.
Arias continues, This issue is important for APIC becauseour goal is to reduce HAIs to an irreducible minimum. APIC is an organization that representsmore than 10,000 infection control professionals, and infection controlprofessionals manage the infection prevention programs in hospitals and otherhealthcare facilities, and one of their responsibilities is to collect data onHAIs. So they have expertise in doing this and are well aware thatHAIs are difficult to manage. Because many states have introduced legislation alreadyrequiring public reporting of HAIs, infection control professionals have beenworking with legislators, hospital associations, health departments and othersat the state level to develop public reporting programs that will providemeaningful information.
The CDCs Healthcare Infection Control and PreventionAdvisory Committee (HICPAC) has released recommendations for policymakers whoare seeking to create mandatory public reporting systems ofhealthcare-associated infections. (To view the guidance document, visithttp://www.cdc.gov/ncidod/hip/PublicReportingGuide.pdf.) As the nationshealth protection agency, CDC is committed to helping ensure all Americansreceive the best and safest care possible when they go to a hospital or otherhealthcare facility, says CDC director Julie Gerberding, MD, MPH. Therecommendations released will go a long way to helping healthcare providersfocus further on the importance of infection control and prevention. We arededicated to helping make our healthcare facilities become even safer than theyare now.
While HICPAC concluded there is currently not enough evidenceto determine whether mandatory public reporting of HAIs will reduce infectionrates, the advisory committee recommended that states implementing publicreporting should strive to gather meaningful infection control data and usenationally recommended infection control measures.
To provide consumers and healthcare facilities with the bestinformation, HICPAC recommends that states that are developing public reportingsystems be sure to:
The goal of mandatory reporting is to provide consumerswith information they can use to make informed healthcare choices, says Denise Cardo, MD, director of CDCs Division ofHealthcare Quality Promotion. We dont know yet if public reporting will reduce thenumber of infections, but we do support collecting information that can lead toimprovements in patient safety.
The CDC estimates that each year nearly 2 million patients inthe United States contract infections in hospitals and about 90,000 of thesepatients die as a result of their infection. Bloodstream infections, urinarytract infections, pneumonia and surgical site infections comprise most HAIs. Thepercentage of healthcareassociated infections that are preventable is unknown.However, the CDC believes that adherence to recommended infection controlstrategies can reduce infections substantially.
We hope this guidance will be used by lawmakers andconsumer advocacy organizations as a framework for designing systems that willprovide helpful information for consumers and the places that give care, saysPatrick J. Brennan, MD, chairman of HICPAC. The goal for everyone should beinformation that tells us how well we are doing in taking steps that can savelives.
Warye reports that APIC is pleased with the HICPAC guidancedocument. I would say we are very supportive of what HICPAC developed, andthat it is a strong foundation upon which to move to the next level toward anational standard, she says.
This guidance was designed to provide direction and assistanceto those states that have enacted or are considering legislation to requirehospitals to make infection-rate data available to consumers. Infectionprevention experts, acknowledging that consumers can and should play a largerrole in their own healthcare, looked to HICPAC to help states, consumers andhospitals understand the complexities of public reporting. We support theidea of making meaningful information available to consumers, says Arias. Wehave dedicated our professional lives to preventing infections we just needto make sure that we do it right, so that patients have good, reliableinformation upon which to make sound decisions.
To that end, Warye says APIC is asking its members to getinvolved in the issue, or at the very least, to stay current on developments intheir 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 getinvolved. The last count was 30-plus states that had introducedlegislation since January, and I think in every state there are infectioncontrol practitioners (ICPs) working with Denise Graham, to help them provideinput into the legislation so it doesnt move forward without them. ICPs andepidemiologists can be very effective in helping shape legislation in such a waythat it is more meaningful for consumers and more manageable for the infectioncontrol community.
Warye says an unexpected byproduct of this issue is greaterrespect for ICPs. The great silver lining in this issue is that in additionto patients receiving meaningful information, it helps ICPs make a strong caseabout the importance and the economics of what they are doing, and ultimately, Ithink ICPs eventually will see more resources flow into the infection controldepartment as a result of this high-profile issue. As consumer and lawmakerinterest in mandatory reporting increases, hopefully it will mean an elevatedposition for ICPs as well as an increase in the resources they need to do thejob.
When asked about additional resources that may be required forhealthcare facilities to undertake public reporting, Brennan says, We didntspecifically address resources, but it is an important issue. We do mention thenecessity for ensuring adequate resources we may need more infection control professionals and more informationtechnology resources in order to accomplish this.
Some states have actually conducted studies of infectioncontrol programs in hospitals and they have found that some of the hospitals aregoing to have a hard time collecting some of the data thats currentlyproposed, just because the resources may not be there, Arias says. Theresources arent necessarily just personnel resources; some of the resourcesthat we need are technology, hardware and software programs that allow the datato be collected and accurately reported to the public.
We do indicate that the right resources need to be in placeif public disclosure is to be carried out properly but the resources may includeadditional fulltime equivalent employees in the infection control professionalcategory or the proper information system resources, Brennan adds. Butresources are essential, and in fact I think the states that have implemented sofar have really done this with the intention of raising the profile of thisissue, raising the profile of infection control and prevention in hospitals andare really sending a challenge out to organizations and to their leadership tostep forward and meet this challenge.
In a telebriefing held in late February, Cardo, Brennan andArias gathered to discuss the recommendations contained in HICPACs guidancedocument. Cardo explained the impetus behind the suggested guidelines. CDChas been a national leader for surveillance and prevention ofhealthcare-associated infections for many years, Cardo said. Some statesthat were considering the public release of healthcare- associated infectiondata have contacted CDC for guidance. As a result, CDC asked HICPAC to look atthis issue and provide guidance to states interested in making information onHAIs available to the public. We applaud HICPAC for taking on this issue and for working soquickly to put together this very important guidance document. We also want to thank the professional organizations that havecontributed to and endorsed this document, APIC, the Council of State andTerritorial Epidemiologists (CSTE), and SHEA.
Brennan explained that HICPAC began to explore this issueabout a year ago, evaluating the evidence, and then producing the most usefulguidance available. In the exploration of this topic, we discovered thatthere is insufficient evidence to recommend for or against public reporting ofHAIs, Brennan said. Nonetheless, we realize that this is a process that isgoing forward. While we have not made a recommendation for or against theseprocesses, we are providing our consensus opinion on the best way to pursue thepublic disclosure of HAIs. This document then is a guide to best practices. It is the consensus opinion of HICPAC and we believe it is astarting point in the process of public disclosure for HAIs. We have not putforward this document as model legislation.
Brennan added, Our intended audience is the policymakers,program planners and consumer advocacy organizations who are tasked withplanning and implementing the public reporting systems for HAIs. We advocate thespecification of goals, objectives and priorities as a starting point indeveloping these systems, the selection of measurable outcomes and the use ofestablished methods. The reports that are generated should identify theendorsers of the indicators that are chosen and the sources of data, and webelieve that tools such as public disclosure report cards should be usefulprocesses for quality improvement and that that can be accomplished throughfeedback to the providers who really generate this data.
Regarding HICPACs four major recommendations in thedocument, Brennan explained that established public health surveillance methodsshould be used when designing and implementing mandatory reporting of HAIs. Thismeans the selection of appropriate patient populations to monitor, the use ofstandardized case-finding methods and data validity checks, and importantly, theprovision of adequate support and resources within organizations so that theseprocesses can be carefully carried out. We do not advocate the use of hospitaldischarge diagnostic codes as a primary data source for healthcareassociatedpublic reporting systems.
The second recommendation is to create a multi-disciplinaryadvisory panel and include persons with expertise in prevention and control ofHAIs in the planning and oversight of these public reporting systems. Webelieve that there are many stakeholders in these processes. Controversies have existed over the methods but the methodsare important in determining the outcomes of these processes. Since there aremany stakeholders, the development process should be a multi-disciplinary one, Brennan commented.
Regarding the third recommendation, which is to chooseappropriate process and outcome measures based on facility type, Brennan added,We believe these indicators should be phased in over time and this willmaximize the usefulness of these indicators to consumers and the acceptabilityto providers. We have recommended three process measures and two outcomemeasures. The process measures include the practices used to insert centralvenous catheters that can lead to bloodstream infections, antimicrobialprophylaxis for surgical procedures, and influenza vaccination coverage for bothhealthcare workers and for patients. The outcome measures that we arerecommending include central line-associated laboratory-confirmed bloodstreaminfections and surgical site infections, though there is a synergy or a linkagebetween the process measures and the outcome measures and those are the majorpoints in the document.
During the February telebriefing, Brennan pointed out thatthis guidance document breaks from tradition of previous documents. The intended audience for past guidelines has been theprofessional community, physicians, epidemiologists, infection controlprofessionals and clinicians. The intended audience for this document is thosewho are tasked with designing and implementing these systems. We hope that the professional community will serve as theconduit for this information as states and regulators attempt to design andimplement these systems. But it does not establish a national policy on it.HICPACs guidance documents in the past have been highly regarded and havebeen relied upon as a standard in the industry and were hoping that this onecan be adopted in the same way.
Cardo added, I think its important to note that this isthe first step in the process to work together to collect information that canlead not just to release to the public, for the public to make decisions, butalso to the healthcare institutions to prevent infection. The CDC believes thatinformation about HAIs can lead to increased focus on infection control andprevention. We believe that tracking the processes that lead to infections, inaddition to infection rates, can improve patient safety, and were verypleased with the HICPAC guidelines and the fact that the professionalorganizations have joined us in this effort.
And we want to remind you that the information that werecommend to be collected has to be useful for the public but also be useful forthe facility in order to improve the quality of health they are providing to allthe patients in the healthcare systems in the United States.
The following is an excerpt from HICPACs Guidance on PublicReporting of Healthcare- Associated Infections:
Monitoring both process and outcome measures and assessingtheir correlation is a comprehensive approach to quality improvement.Standardized process and outcome measures for national healthcare performancefor hospitals, nursing homes, and other settings have been endorsed through theNational Quality Forum (NQF) voluntary consensus process. NQF also has developeda model policy on the endorsement of proprietary performance measures. Severalother agencies and organizations, including CDC, CMS, the Agency for HealthcareQuality and Research, JCAHO, the Leapfrog organization, and the NationalCommittee for Quality Assurance, also have developed healthcare qualitymeasures. Healthcare performance reports should identify the sources andendorsers of the measures and the sources of the data used (e.g., administrativeor clinical).
Process measures are desirable for inclusion in a publicreporting system because the target adherence rate of 100 percent to thesepractices is unambiguous. Furthermore, process measures do not requireadjustment for the patients underlying risk of infection.
Process measures that are selected for inclusion in a publicreporting system should be those that measure common practices, are valid for avariety of healthcare settings (e.g., small, rural vs. large, urban hospitals);and can be clearly specified (e.g., appropriate exclusion and inclusioncriteria). Process measures meeting these criteria include adherence rates ofcentralline insertion practices and surgical antimicrobial prophylaxis andcoverage rates of influenza vaccination for healthcare personnel andpatients/residents. Collection of data on one or more of these process measuresalready is recommended by the NQF and required by CMS and JCAHO for theirpurposes.
Outcome measures should be chosen for reporting based on thefrequency, severity, and preventability of the outcomes and the likelihood thatthey can be detected and reported accurately. Outcome measures meeting thesecriteria include central line-associated, laboratoryconfirmed primarybloodstream infections (CLA-LCBI) in intensive care units (ICU) and surgicalsite infections (SSIs) following selected operations. Although CLA-LCBIs andSSIs occur at relatively low rates, they are associated with substantialmorbidity and mortality and excess healthcare costs. Also, there arewell-established prevention strategies for CLA-LCBIs and SSIs. Therefore,highest priority should be given to monitoring these two HAIs and providersadherence to the related processes of care (i.e., central-line insertionpractices for CLALCBI and surgical antimicrobial prophylaxis for SSIs).
Use of other HAIs in public reporting systems may be moredifficult. For example, catheterassociated urinary tract infections, though theymay occur more frequently than CLA-LCBIs or SSIs, are associated with a lowermorbidity and mortality; therefore, monitoring these infections likely has lessprevention effectiveness relative to the burden of data collection andreporting. On the other hand, HAIs such as ventilator-associated pneumonia,which occur relatively infrequently but have substantial morbidity andmortality, are difficult to detect accurately. Including such HAIs in areporting system may result in invalid comparisons of infection rates and bemisleading to consumers. Monitoring of process and outcome measures should bephased in gradually to allow time for facilities to adapt and to permit ongoingevaluation of data validity.