Raise your hand if you can unravel these puzzles: Mandatory public reporting of healthcare-associated infection (HAI) rates and the electronic health record (EHR). No takers? No wonder. Both are complex issues that prove to be more of a conundrum the deeper you dig. Both are in their infancy, so those involved mostly are still trying to find their way. Once achieved, these changes are expected to contribute to improved patient care and outcomes, with the potential
for even better results when mandatory reporting of infection rates and the EHR can be used conjunctively. But how that’s going to be accomplished isn’t entirely clear at this point.

Mandatory public reporting
of HAIs

Only a handful of states have enacted legislation mandating healthcare facilities to publicly disclose HAI rates thus far, with others working diligently on it and some not so much yet. But the time definitely has come, and the feedback generally is positive.

Leonard A. Mermel, DO, ScM, AM(Hon), FACP, FIDSA, FSHEA; Medical Director, Department of Infection Control, Rhode Island Hospital told Healthcare Purchasing News, "I think such reporting will raise awareness of hospital-acquired infections and, in doing so, will likely improve patient safety." Mermel also serves as professor of medicine at Brown Medical School, Providence, RI; and as president of the Society for Healthcare Epidemiology of America (SHEA).

Mandatory reporting involves multiple players, each with their own agenda. SHEA’s position paper on public disclosure of HAIs states: "The debate over public disclosure often pits consumers, insurance carriers, and health maintenance organizations ("the payers") against healthcare providers. The payers want performance data made available so that they can be better purchasers of healthcare services. Healthcare providers are concerned that the data may be flawed and misleading. Personnel at healthcare institutions also are concerned about the additional cost for resources that will have to be expended to collect the required data. The stakes may be even higher because the results of these analyses can conceivably be used by health plans to choose among competing providers or incorporated into the reimbursement process ("pay for performance")." 1

Chicago-based Aon Corp. is a provider of risk-management services, insurance and reinsurance brokerage, human capital and management consulting, and specialty insurance underwriting, so they’re interested in the potential uses of EHRs and mandatory reporting of infection. Randy Vogenberg, senior vice president, life sciences practice, said there are pluses and minuses: "The downside is that better information as a result of using EHRs and better surveillance has the potential to lead to more penalties, but it also can lead to more incentives for better care."

The Centers for Disease Control and Prevention’s Healthcare Infection Control Advisory Committee (HICPAC) recently published recommendations in their "Guidance on Public Reporting of Healthcare-Associated Infections," which noted: "Advocates of mandatory public reporting of HAIs believe that making such information publicly available will . . . improve overall health care quality by reducing HAIs." It also indicated that some are not so confident: "However, others have expressed concern that the reliability of public reporting systems may be compromised by institutional variability in the definitions used for HAIs or in the methods and resources used to identify HAIs." 2

The HICPAC document emphasized the importance of using standardized methods so as "to reduce surveillance bias (ie, the finding of higher rates at institutions that do a more complete job of case-finding)." 2 As G.T. LaBorde, chief operating officer, MedMined, Birmingham, AL, indicated, "Hospitals with more or better-trained infection control (IC) personnel may find more infections, and that could make them look, unfairly, worse in comparison to other hospitals."

Thus the need for balanced, accurate reporting, as brought out in the HICPAC document: "A method to validate data should be considered in any mandatory reporting system to ensure that HAIs are being accurately and completely reported and that rates are comparable from hospital to hospital or among all hospitals in the reporting system. . . . The reports should provide useful information to the various users and highlight potential limitations of both the data and methods used for risk adjustment." 2

Mermel expounded, "Public reporting of risk-adjusted outcome data and process data, which doesn’t need risk adjustment, is a good thing and is an inevitable eventuality. Outcome data, such as an infection rate, is complex because of the necessity of risk-adjustment and because of statistical issues that arise from small numbers of events, making it difficult to determine if differences between institutions are due to chance variability and regression to the mean. Thus, process data is appealing as it circumvents such potential problems. Certainly, the thoughtfully prepared HICPAC guidelines should be used as the basis for mandatory reporting.

"What’s vitally important is the need to assure adequate information services/information technology support for data collection and adequate staff size of IC and quality assurance departments to assist in this endeavor," Mermel said. "It is, therefore, essential that the hospital leadership allocate adequate resources for this initiative."

The HICPAC document confirmed the need for sufficient resources to carry out the mission: "A reporting system can not produce quality data without adequate resources." 2 Resources outlined naturally include personnel but should also extend to computers, hardware, software, instruction manuals, training materials, data collection forms, methods for data entry and submission, databases to receive and aggregate the data, quality checks, computer programs for data analysis and standardized reports for dissemination of results. In short, said, Vogenberg, what’s needed is "an infusion of cash."

One thing’s for sure, according to W. Joseph Ketcherside, MD, vice president and chief medical officer, TheraDoc, Salt Lake City, UT, "With hospitals in many states now required to perform whole-house surveillance, it’s too much to be done by hand now."

Some companies performing surveillance are already working with healthcare facilities in states that require mandatory reporting of infections. Deborah Martin, R.N., MN, FSHEA, CEO of ICPA Inc., Austin, TX, explained how their AICE software works with it: "Mandatory reporting of HAI rates is required by law in Missouri. AICE has been approved as a method of reporting these data to the Missouri Department of Health and Senior Services. Only the required data is automatically exported from AICE to the state. AICE produces hundreds of highly flexible reports and graphs, as well as some commonly used statistical tests. This gives the infection control practitioner (ICP) the ability to collect and analyze data items and risk factors that are unique to their own hospital. They can also design their own studies and data entry screens to focus on a particular infection problem or outbreak."

The most important function of mandatory reporting is that it may lead to better patient care, possibly averting outbreaks in some cases, reducing morbidity and mortality due to infection. Mandatory reporting may make that possible because it could present a more accurate picture of a healthcare institution’s patterns of infection in a more timely fashion, which could provide for earlier intervention in infection’s progress.

Implementation of EHRs may enhance this capability by providing more complete and accurate patient information. Companies that perform surveillance and data mining will have more useful information at their fingertips with which to develop more accurate reports. Whereas the EHR has yet to be practiced widely, companies performing surveillance and data mining abound. They’re ready and willing to integrate their products and services with the EHR.

The EHR

The Healthcare Information and Management Systems Society (HIMSS) defined EHR as "a longitudinal electronic record of patient health information generated by one or more encounters in any care delivery setting. Included in this information are patient demographics, progress notes, problems, medications, vital signs, past medical history, immunizations, laboratory data, and radiology reports." HIMSS believes the "EHR automates and streamlines the clinician’s workflow . . . [and] has the ability to generate a complete record of a clinical patient encounter, as well as supporting other care-related activities, directly or indirectly via interface—including evidence-based decision support, quality management, and outcomes reporting."3

Another positive aspect, highlighted in the landmark report "Crossing the Quality Chasm: A New Health System for the 21st Century," is that "The automation and linking of data on services provided to patients . . . would provide a rich source of information for quality measurement and improvement purposes."4

Mermel also emphasized the benefits that may be reaped by integrating mandatory reporting of HAIs and the EHR: "I believe that EHRs will improve accuracy and more easily allow the data mining necessary to track process and outcome measures."

Noted Vogenberg: "The goal is for everyone to be on the same page, to avoid mishaps, to enhance patient safety, and to improve patient care. Ideally, EHRs would allow real-time reporting of and access to information, and so problems could be detected sooner, instead of after the fact. Use of EHRs would allow for a more systematic approach to patient safety. Entering information into and interacting with a fully integrated electronic system, instead of manually capturing information, would put ICPs on the leading edge of active intervention."

Ketcherside commented: "No question about it, the EHR gives a platform to provide better decisions in healthcare. The impact will be huge."

Studies focused on results of using electronically managed health records have demonstrated positive experiences. A study by James found that interoperable EHRs potentially could produce better patient outcomes while improving delivery of care and reducing costs.5

Martin observed: "The EHR will be a valuable tool in merging data from disparate data sources and linking all the data collected about each patient. A study by Frolick explored just that.6 Benefits experienced by St. Jude Children’s Research Hospital in Memphis, TN, when it implemented an electronic medical record system linking clinical treatment and research, included improvements in accessibility of information, improved communications between departments, and improved efficiency in managing clinical information, patient care, clinical research, and patient service and satisfaction.

"Another benefit cited is that ‘electronic records can not be misplaced as paper records can . . . the information in the record is more accurate as well as legible. The ultimate goal of this project was to provide a paperless patient medical record that linked research and clinical data. . . . provid[ing] a single point of access for all employees seeking information for both clinical treatment of patients and for research data collection. Improvements in the manner used to capture and store patient information and then relate the information to clinical treatment and research protocols has led to much better patient care. Successfully linking clinical treatment plans with research protocol information provides valuable information when assessing the effectiveness of particular treatment plans. Research efforts can move forward more rapidly when data is collected in an efficient manner as is provided by the electronic record. In addition, human error is less of a factor than it was when data was collected manually from paper charts.’" 6

No doubt, the move to EHRs has many potential benefits, but it’s financial gain that often serves as motivation for change. In its report, "The Value of Healthcare Information Exchange and Interoperability," the Center for Information Technology Leadership found that "[f]ully standardized HIEI [healthcare information exchange and interoperability] could yield a net value of $77.8 billion per year once fully implemented. Nonstandardized HIEI offers smaller positive financial returns. The clinical impact of HIEI for which quantitative estimates cannot yet be made would likely add further value. A compelling business case exists for national implementation of fully standardized HIEI."7

With such astounding dollar figures, it may seem puzzling as to why EHRs haven’t become the norm, but interoperability is an enormous impediment to implementation. Currently, there is no single standard for exchange of patient data between systems. HIMSS’s Health Record Vendors Association is one organization that’s working on it. Their "primary mission . . . is to provide a forum for the EHR vendor community relative to standards development, the EHR certification process, interoperability, performance and quality measures, and other EHR issues that may become the subject of increasing government, insurance, and physician association initiatives and requests."8

A study by Waegemann9 cited four main reasons why widespread implementation has been slow despite "an impressive list of benefits and capabilities": lack of a framework of standards; lack of motivation; lack of direct benefits for practitioners; and confusion about the concept.

"The problem with integration of EHRs," observed Vogenberg, is that "the details haven’t been worked out. Technology is not so much a problem as complying and knowing how to be compliant. Most hospitals don’t have the capability because there is no single standard to comply with and they don’t know to what they need to comply."

"The EHR is way more difficult to institute than anyone thought it would be," said Dan Peterson, MD, MPH, chief operating officer for Cereplex Inc., Germantown, MD. "Hospital-patient data is convoluted. There needs to be some way to integrate a hospital’s existing software with the EHR. The EHR needs to tie to primary data systems. The average hospital uses about 14 different kinds of software for different departments such as the operating room, maintenance department, radiology department, and so forth. A lot of rules will have to be written so that data will translate not only between departments but to different hospital systems."

In the meantime, companies performing surveillance and data mining are working with the situation as is and are positioning themselves for the advent of EHRs.

Ketcherside told HPN, "The EHR doesn’t really exist many places yet, but, it will be a source of data that surveillance software will use. The broader, more complete data available in the EHR, the broader, more complete surveillance will be. Standards for interoperability currently do not exist, but they are being developed at a national level now. Messaging standards such as HL7 and vocabulary standards such as SNOMED and LOINC have existed for several years, but their implementation by most vendors has been inconsistent. TheraDoc’s Expert System Platform is fully compliant with current messaging and vocabulary standards and is considered a model for effective use of SNOMED."

LaBorde cited an example to show how important standard vocabulary can be: "We’ve found 5,000+ ways of describing or misspelling urine. We need consistent data. The day when nomenclature is consistent across the board will be a glorious day. However, we’re not so inflexible as to tell hospitals they have to subscribe to certain nomenclature. MedMined makes use of data in its current state. The goal is to take existing collected data and turn it into something powerful, something useful for analysis.

"Data mining helps facilities by identifying emerging problems and patterns; it also provides guidance for best practice and links financial data. With a manual system, you can’t know how large the problem of HAIs is, so you can’t tie it to financial data," LaBorde continued. "MedMined helps the IC department prove their financial value to hospitals, and integration of mandatory infection reporting with the EHR could further help IC departments prove their worth. Most of the money hospitals lose is on a small percentage of patients who contract HAIs. IC personnel try to motivate and educate healthcare practitioners, so they need the right data, easily available, to convince others to use best practices to improve patient care. EHRs will make more data available; the more data available, the more efficiently you can do your job, the more patterns that can be identified by analytical tools. Germane, timely info builds wonderful credibility."

Referring to a study by Brossette,10 LaBorde, stated, "Our system eliminates problems related to objectivity and inconsistency inherent in manual surveillance, allowing for more accurate assessment of IC efforts and valid comparisons between hospitals." The study found that MedMined’s Nosocomial Infection Marker outperformed hospital-wide SENIC [Study of the Efficacy of Infection Control] nosocomial infection (NI) detection and also outperformed prospective and retrospective NNIS [National Nosocomial Infection Surveillance System]-based NI detection in ICU populations. "With hospital-wide, automated, and objective NI surveillance, the goal of many to reliably and comprehensively account for NIs — and reduce their incidence — becomes more attainable."10

Certainly, observed Martin, using the EHR with software such as ICPA’s AICE "would ensure better accuracy because important information would not be overlooked and would be easily accessible to the ICP." However, noted Martin, "Infection control is not a discipline that lends itself to total automation; that is, the ICP will never be replaced by a machine. ‘Shoe-leather epidemiology,’ going out on the units to monitor IC practices and to find infections, will probably always be required. There are many clues in the medical record that help the ICP identify HAIs, and data from multiple sources is often needed to confirm them; so, having the data in an EHR is not a panacea. Multiple methods for identifying HAI are needed, and the EHR needs to be designed in such a way that both the HAI and all the patients at risk of developing that type of HAI can easily be identified."

Peterson added: "The ICP has a dozen things to do such as purchasing and overseeing construction, employee health and surveillance. The CDC found that the single most important aspect of an IC program is how good their surveillance is; so, surveillance is the
most important thing they can do. If the EHR helps surveillance to be performed better, because it makes more complete data available, it can have an impact on infection rate and patient health. An EHR in place would make using surveillance software faster, more efficient, more accurate."
Peterson cited a study performed using Cereplex’s Set Net by Wright et. Al., which found, "Automated      
surveillance provides an IC department with the ability to reallocate its resources away from the office and onto the clinical unit.
 Furthermore, increased detection...
 allows for earlier interventions and has the capability of reducing the magnitude of a potential outbreak.













 Appropriate and timely interventions may in turn reduce the number of future healthcare-associated infections, thus saving more time in the long run. The time saved in using this technology is an obvious improvement from traditional IC methods in terms of gathering and evaluating raw data." 11

REFERENCES

1. Wong ES, Rupp ME, Mermel L, Perl TM, Bradley S, Ramsey KM, et al. Public disclosure of healthcare-associated infections: the role of the Society for Healthcare Epidemiology of America. Infect Control Hosp Epidemiol 2005;26:210-212.

2. McKibben L, Horan T, Tokars JI, Fowler G, Cardo DM, Pearson ML, et al. Guidance on public reporting of healthcare-associated infections: recommendations of the Healthcare Infection Control Advisory Committee. Am J Infect Control 2005;33:217-226. www.cdc.gov/ncidod/hip/
PublicReportingGuide.pdf.

3. Healthcare Information and Management Systems Society. Electronic health record. www.himss.org/ASP/topics_ehr.asp.

4. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: Institute of Medicine; 2001. Chapter 7, p. 165.

5. James B. E-health: steps on the road to interoperability. Health Aff (Millwood) 2005 Jan 19; [Epub ahead of print]. http://content.healthaffairs.org/cgi/
reprint/hlthaff.w5.26v1.

6. Frolick. Using electronic medical records to improve patient care: the St. Jude Children’s Research Hospital case. www.dcpress.com/frolick2.htm.

7. Walker J, Pan E, Johnston D, Adler-Milstein J, Bates DW, Middleton B. The value of healthcare information exchange and interoperability. Health Aff (Millwood) 2005 Jan 19; [Epub ahead of print]. http://content.healthaffairs.org/cgi/
reprint/hlthaff.w5.10v1.

8. HIMSS Electronic Health Record Vendors Association. www.himssehrva.org/ASP/index.asp.

9. Waegemann CP. EHR vs. CPR vs. EMR. Health Informatics Online. May 2003. www.healthcare-informatics.com/issues/2003/05_03/may.htm.

10.Brossette SE, Hacek DM, Gavin PJ, Kamdar MA, Gadbois KD, Fisher, AG, et al. A laboratory-based, hospital-wide, electronic marker for nosocomial infection: the future of infection control surveillance? Am J Clin Pathol 2006;125:34-39.

11.Wright M-C, Perencevich EN, Novak C, Hebden JN, Standiford, HC, Harris AD. Preliminary assessment of an automated surveillance system for infection control. Infect Control Hosp Epidemiol 2004;25:325-332.