Michael Edmond
The movement to mandate that hospitals publicly disclose information on rates of healthcare-associated infections (HAIs) has gained momentum rapidly. In 2003, Illinois and Pennsylvania became the first states to enact legislation that mandated reporting. Since then, eight additional states have enacted legislation, and the vast majority of remaining states are evaluating the issue in their legislative bodies.
The incidence and impact of HAIs are primarily driven by progress in medical care. The development of invasive diagnostic and therapeutic modalities, which have revolutionized medical care, bypass anatomic and physiologic barriers and markedly increase the risk of HAIs. This is compounded by the increase in severity of illness in inpatients along with an increased proportion of these patients who are immunosuppressed via their underlying diseases or transplantation, or cytotoxic therapies. Problems in the healthcare delivery system have contributed to the problem as well. The decreasing profitability of hospitals has caused some to decrease funding for infection control programs, and the nursing shortage has had an impact on the quality of care delivered. Thus, for a myriad of reasons, the incidence of HAIs remains problematic.
Over the past few years, the once hidden magnitude of HAIs has been exposed by the popular press. In response to this and a grassroots campaign by Consumers Union, the organization that publishes Consumer Reports [1], states are enacting legislation mandating the reporting of HAIs and disclosure of infection rates to the public.
The concept of mandatory reporting of HAIs and other healthcare quality issues converges well with the emergence of consumer-driven health care, the newest paradigm to attempt to control healthcare costs. Unlike managed care that controls costs by limiting the supply of health care, consumer-driven health care attempts to control costs by limiting the demand for health care. This is accomplished through the use of health savings accounts and the provision of incentives for healthcare consumers to seek involvement in decisions about their health and their health care [2]. Thus, the well-informed consumer is an integral feature of consumer-driven health care.
Whether public reporting of healthcare quality data is effective remains unknown. In a systematic review of the literature performed by the Centers for Disease Control and Prevention (CDC), the authors found that few rigorous studies adequately addressed the issue of effectiveness and no conclusions could be drawn [3]. They also noted that no studies have addressed public reporting of HAIs.
Healthcare-Associated Infections: The Scope of the Problem
With any public policy issue, it is important to estimate the impact of the problem for which legislation is intended to address. It is estimated that 2 million persons [4],
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or 5–10% of hospitalized patients in the United States, develop HAIs each year [5,6]. These infections account for an estimated 90,000 deaths and have an attributable cost of $4.5 billion [7].
From the standpoint of public policy, it is important to point out that the focus should be on HAIs that are preventable because interventions and policies will have no impact on infections that cannot be prevented—but what fraction of HAIs can be prevented? In the only recent study designed to answer this question, Harbarth et al. performed a meta-analysis of 24 multimodal intervention studies to decrease HAIs reported in the medical literature from 1990–2002. They determined that the preventable proportion of HAIs ranges from 10–70%, with the best overall estimate at 20–30%[8]. Unfortunately, when HAIs are discussed in the popular press, it is seldom pointed out that many of these infections cannot be prevented, leading to unrealistic expectations on the part of healthcare consumers.
Table 46-1 illustrates the potential impact of mandatory reporting of HAIs. Each year, 7% of Americans are hospitalized [9]. If 5–10% of inpatients develop HAIs and 10–70% of these HAIs are preventable, the annual incidence of preventable HAIs is 0.0035% to 0.245%. Applied to 2006 census data (U.S. population 298 million) [10], we can estimate that the number of persons affected by preventable HAIs in the United States ranges from approximately 100,000 to 1.5 million yearly. Finally, by oxestimating the effect of a mandatory reporting and disclosure program at a range of 10–50% reduction in HAIs, we can determine that the estimated number of persons who will be affected ranges from approximately 10,000 to 700,000 annually.
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TABLE 46-1 |
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Assumptions Underlying the Policy of Mandatory Reporting and Disclosure
The mandatory reporting movement is predicated on 10 assumptions (Table 46-2), all of which must be true for a completely successful outcome. However, at the present time there is little reason to believe that all of these assumptions are true, as discussed, and for some, data are not currently available to either confirm or refute.
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TABLE 46-2 |
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accountability to the public and honors the public's right to know.
Given that HAI rates are among the newest metrics to be released to consumers, it is unknown at this point how frequently these specific data are used by consumers. However, two recent reviews concluded that consumers rarely seek out this information and that it has a modest impact on medical decision making [17,18].
A national survey of 2,102 adults in 2004 by the Kaiser Family Foundation assessed how consumers access and use healthcare quality information [19]. Only 19% of those surveyed stated that they had used quality information in the last year to make a healthcare decision. When asked which sources of information on hospital quality they are very likely to use, 65% of respondents reported friends, family, and co-workers, and 65% also reported their doctor or nurse. However, fewer said they would consult a Web site (37%), order a booklet (20%), contact a state agency (18%), or use a newspaper or magazine (16%). When asked which sources of information would have “a lot of influence” in selecting a new doctor, 61% reported their physician and 52% friends or family, but only 37% would use patient surveys; 17% would contact a government agency, 14% would use insurance company data, and only 10% would visit a Web site.
When asked if they would prefer a hospital that is familiar or one that is more highly rated, 61% of respondents preferred a hospital that is familiar. Similarly, when asked if they would prefer a surgeon who has treated family or friends versus a surgeon who is more highly rated, respondents were nearly evenly split.
In a survey of 474 patients who had undergone CABG surgery in Pennsylvania, a state that publishes a report card on CABG mortality, only 12% of the patients were aware of the quality report before surgery and only 2% stated that it had impacted their choice of surgeon [20]. A recent survey of 510 Medicare patients who underwent surgery found that only 11% looked for information to compare hospitals and 48% stated they would not use hospital performance data if they required surgery in the future [21]. Last, a survey of 1,500 persons in New York state found that 18.5% used available data on healthcare quality in medical decision making [22].
Although the public's desire to access healthcare quality data may change as consumers become more educated, more data become available, and more individuals have access to and are more comfortable with online information sources, at the present time it appears that a minority of individuals are interested in these data and prefer the recommendations of their healthcare providers, family, and friends.
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Thus, a significant proportion of the population has little choice in healthcare venue or may have some choice that comes with financial penalty.
A recent analysis of New York CABG quality data from 1989–2002 showed that public reporting of hospital performance had no impact on changes in market share for hospitals [24]. However, it could be argued that even if patients are unwilling to use healthcare quality reports or change their site of care, third-party payers will use the data to direct their members to hospitals that demonstrate higher quality. There is also little evidence to date, however, to support that argument [24,25,26,27]. It also could be argued that if public reporting is effective in improving the overall quality of care in a given state, even patients who are unwilling to change their site of care may experience a benefit [28].
Most of the data that support these assumptions come from observational studies. Some have cited the 21% reduction in CABG mortality in New York following public reporting of mortality rates as evidence of the positive effect of market forces [29] However, others believe that the decline in mortality was due to other factors, such as the avoidance of surgery on high-risk patients. Nonetheless, some low-volume surgeons with high mortality rates stopped performing CABGs after mortality rates were published [30]. One experimental study in Wisconsin compared the number of quality improvement activities in hospitals that had publicly reported quality data to those who received private reports on their performance without public reporting to those who had neither private nor public reporting. Hospitals with publicly reported quality data performed significantly more quality improvement activities than did the other two groups of hospitals [31]. The difference was even greater when the subset of hospitals that had received poor quality ratings were compared.
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In addition, it is important to consider the opportunity cost of public reporting. Given that public reporting is an unfunded mandate in almost all states that have enacted laws and that hospital budgets are a zero-sum game, diversion of resources from other programs and problems is of great concern.
Some striking examples of unintended consequences have been associated with public reporting of health quality data. A recent large, multicenter study compared patients in Michigan (where there is no public reporting for percutaneous coronary intervention [PCI] outcomes) to those in New York (where outcome reporting is mandated) [33]. The Michigan patients had a higher incidence of co-morbidities, a higher incidence of high-risk indications for PCI, and an observed mortality rate that was nearly 2-fold higher. When multivariate analysis was used to control for co-morbidities, there was no significant difference in mortality rates between the two states. The authors of this study postulated that the difference in mortality rates may have been due to physicians in New York avoiding PCI on high-risk patients due to fear of increasing their publicly reported mortality rates.
A separate study surveyed all interventional cardiologists in New York, and 65% responded [34]. Of those responding, 79% disclosed that the public reporting of mortality statistics influenced their decision on whether to perform PCI on individual patients, and 83% believed that some patients may not receive PCI because of public reporting of mortality rates. Two surveys of cardiothoracic surgeons in states reporting mortality rates following CABG revealed similar findings. In a survey of Pennsylvania surgeons, 63% reported they were less willing to operate on severely ill patients following public reporting [35]. When surgeons in New York were surveyed, 62% reported refusing to operate on high-risk patients due to public reporting of mortality rates [36].
Another phenomenon noted after public reporting started was that CABGs were performed on 19% fewer African Americans and Hispanics in New York [37]. These racial disparities lasted for 9 years. It is thought that the surgeons assumed that racial minorities were at higher risk for poor outcomes and thus avoided performing surgery on them.
In summary, with regard to CABG and PCI, several unintended consequences emerged. These included denial of aggressive therapy to high-risk patients, punishing physicians willing to treat high-risk patients, and racial profiling. As Hughes and Mackay note, the real question regarding the impact of public reporting is whether it results in better delivery of health care or in better risk avoidance via shifting of high-risk patients to other practitioners or hospitals [38].
Minority and low-income persons are overrepresented among those without health insurance. Some unique issues with regard to public reporting apply to these groups. Metrics addressing quality of health care typically emphasize diseases, procedures, and health status rather than more relevant issues to the underserved (e.g., proximity of services, availability of appointments, financial barriers, and navigability of bureaucracy) [39]. These patients are least likely to be able to choose their healthcare venue. In addition, vulnerable populations may be affected by unintended consequences. These include the avoidance of minority and low-income patients because they may decrease quality scores, the opportunity costs that affect these patients and increase their marginalization, and damage to institutions that care for a disproportionate number of vulnerable patients.
An inherent flaw in the U.S. healthcare system is that some nonemergency services for the uninsured are a discretionary component of hospitals' budgets at a time when fiscal stress is increasing in hospitals due to decreasing revenues and unfunded mandated programs. In 2004, one-third of U.S. hospitals posted an operating budget deficit [40]. Because ultimately a hospital's finances are a zero-sum game, we must examine the opportunity cost of mandatory reporting and disclosure. This raises important questions: From where will these resources be diverted? How can we ensure that an improvement in healthcare for those able to afford it does not result in denying it to those who cannot?
Options for Reporting
The ideal mandatory reporting and disclosure program is characterized by four important characteristics:
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To meet surveillance needs of individual hospitals, how HAI data are collected is not especially important provided that it is consistent. However, interhospital comparisons are impossible when hospitals use different methodologies [41]. Thus, requiring hospitals to report their data without a mandated methodology would do little to inform consumers and likely mislead them. In addition, there must be mechanisms to adjust the rates for risk factors and severity of illness; otherwise, hospitals that care for the sickest patients will appear to be poor performers when compared to hospitals that offer lower levels of care.
At the present time, there is no standard methodology used by U.S. hospitals to define or detect HAIs. Each hospital can choose which type of infection (e.g., urinary tract infection [UTI], BSI, pneumonia, surgical site infection [SSI]) to track, how to define the infection, and the methods to use to determine which patients have the infection.
The CDC's National Healthcare Safety Network (NHSN, formerly the National Nosocomial Infections Surveillance [NNIS] system) offers an excellent approach with standardized infection definitions utilizing multiple sources of data that are applied in a specified fashion [42]. However, only 5% of U.S. hospitals participate in the surveillance system [43], and the remaining 95% are free to track HAIs in any manner they choose.
Despite being the oldest, most highly developed, and the only U.S. national HAI surveillance system, an important problem with NHSN is that the sensitivity for detection of HAIs is suboptimal. For the major infections, the sensitivity is 59% for catheter-associated UTI, 67% for SSIs, 68% for nosocomial pneumonia, and 85% for nosocomial BSIs [44]. Moreover, with the added pressure of public disclosure, underreporting of HAIs may become even more problematic.
As states evaluate mandatory reporting legislation, several questions must be addressed: Which indicators will be included? What data sources will be used? What populations will be surveyed? How will the data be risk adjusted? How will the results be validated?
Indicators
To date, consumer advocates have focused on public reporting of outcome indicators. Although SSIs, ventilator-associated pneumonia (VAP), and central line-associated BSIs are relatively infrequent events, their impact in terms of morbidity, mortality, and cost are great. While nosocomial UTIs are associated with low mortality risk and are relatively inexpensive, they occur at higher frequency than the other infections. Validated definitions for each of these infections have been developed by CDC.
Because surveillance for BSIs is triggered by a positive blood culture and the case definition is relatively simple to apply, surveillance for these infections is straightforward. On the other hand, case definitions for VAP are complicated. The major difficulty with surgical site infection surveillance relates to case ascertainment. Because at least 50% of these infections occur after hospital discharge, capturing all SSIs is difficult, particularly in hospitals that do not have a centralized medical record or an electronic medical record. Thus, the validity of SSI rates may be questionable. Acknowledging the pitfalls associated with SSI surveillance, CDC's Healthcare Infection Control Practices Advisory Committee (HICPAC) recommends central line-related BSIs and SSIs as the best outcome indicators for public reporting [45].
It is important to note that as the interest in avoidance of HAIs has increased, in part due to an increased level of interest by healthcare consumers, analysis of surveillance data is becoming more intense. In an effort to prevent infections, each case identified via surveillance may undergo scrutiny by clinicians who may question the diagnosis from a clinical perspective. However, surveillance definitions are typically not developed for use by clinicians in making decisions regarding therapy. This was demonstrated in a study of VAP in trauma patients in which Miller et al. found that 31% of patients without pneumonia as clinically defined by bronchoalveolar lavage criteria were classified as having pneumonia using CDC definitions [46].
More recently, process indicators have gained attention. In general, process measures are practices proven to decrease HAI incidence. Thus, they provide direct measures of performance that have been linked to outcomes. Berenholtz et al. demonstrated spectacular decreases in catheter-related BSIs in a surgical ICU by focusing on the process of central venous catheter insertion. Other examples include head-of-bed elevation to prevent nosocomial pneumonia, avoidance of vascular catheters in the femoral area to prevent BSI, hand hygiene, and influenza vaccination of healthcare workers. As compared to outcome measures, process indicators are easier to define and measure and do not require risk adjustment. Monitoring these indicators can be accomplished by personnel with less training than outcome measures, which can require complex definitions and the review of multiple data sources. Feedback of process indicators has been shown to more forcefully drive compliance with best practices than does feedback of outcomes indicators [47]. The major disadvantage of process indicators is that they are less meaningful to consumers. The CDC's HICPAC recommends that states include both outcomes and process measures in their mandatory reporting programs.
Sources of Data
Clinical data from multiple sources (e.g., physician notes, laboratory data, radiology reports) collected by trained infection control practitioners in real time via active surveillance remains the gold standard data source. Through
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NNIS, there is more than three decades of U.S. experience with this methodology. Unfortunately, such data acquisition is labor intensive and costly. For this reason, most hospitals have limited surveillance for HAIs to their intensive care units and to selected surgical procedures.
Use of administrative claims data as a surrogate for clinical data collected via concurrent surveillance has been advocated by some and forms the basis for public reporting in Pennsylvania. The primary advantage of identifying HAIs via these data are low cost and high efficiency because the data already exist for every hospital discharge, and electronic reports searching for ICD-9 codes of interest can be generated rapidly. However, the use of coding data, which were designed for billing, not clinical purposes, is very problematic. Use of administrative data for HAI detection shifts case ascertainment from trained infection control practitioners (ICPs) to medical records abstractors with little medical knowledge. Thus, surveillance using these data is highly prone to misclassification bias.
Another problem is that this coding does not distinguish between conditions present on admission and those that develop after admission, which makes coding for complications of care, including HAIs, problematic. Moreover, the codes for complications are vaguely defined, often depend on physician documentation, and require interpretation by the coder, all of which produce variability in rates of complications among hospitals [48]. In a review of nearly 500 inpatient records from two different states, McCarthy et al. found that for surgical patients, 31% of the coded complications had no objective clinical evidence in the medical record to support the diagnosis; for medical patients, 44% of the complications lacked evidence [49]. An Italian study evaluated the use of ICD-9 codes for SSI surveillance and found that depending on the codes used, sensitivity for detection of infection ranged from 10–21%[50].
A recent study from a children's hospital in Pennsylvania compared active surveillance by ICPs to identification of HAIs via administrative data [51]. Active surveillance by ICPs had a sensitivity of 76%, positive predictive value of 100%, and a negative predictive value of 99%, whereas administrative data had a sensitivity of 61%, positive predictive value of 20%, and a negative predictive value of 99%. When cases were identified by administrative data only, further review revealed that 90% were misclassified because the infection originated before hospital admission, no infection was present, or no device predisposing the patient to infection had been in situ. One potential improvement in the use of ICD-9 codes would be to note whether each condition coded was present at admission (“date stamping”) [52], which is currently required only in California and New York [53].
Legislative Activity
Fourteen states have now enacted laws regarding mandatory reporting of HAIs (Table 46-3) with many differences in data sources, metrics to be reported, and mechanisms for reporting and release to the public. Four additional states (Alaska, Indiana, Texas, and Utah) have passed proposals to study the issue and recommend legislative actions. Twenty-one other states considered bills in their 2006 legislative sessions.
Many states evaluating legislation have adopted the Consumer's Union Model Hospital Infections Disclosure Act. This requires acute care hospitals to report quarterly to their state health departments infection rates for SSIs, VAP, nosocomial central line-related BSI, nosocomial UTIs, and other nosocomial infections at the discretion of the state's health department. It is recommended that patient race, ethnicity, and primary language be reported to assess racial and language disparities. The act requires state health departments to create an advisory committee with representatives from public and private hospitals, direct care nurses, physicians, epidemiologists with HAI expertise, academic researchers, consumer organizations, health insurers, health maintenance organizations, and purchasers of health insurance (e.g., employers). In addition, the act requires the state health department and advisory committee to validate the HAI rates and publish an annual report with comparative risk-adjusted HAI rates available to the public via Web site.
The advantages of the Consumers Union bill are that it focuses on the major HAIs and mandates risk adjustment and validation. The disadvantages are that it requires hospitalwide surveillance, which is resource intensive, and mandates the formation of a large advisory committee, which dilutes the expertise of healthcare epidemiologists and ICPs.
To achieve the goals of the Model Hospital Infections Disclosure Act as proposed by Consumers Union, most hospitals would need to significantly increase the resources provided to their infection control programs. A recent survey of acute care hospitals in Virginia revealed that 64% of hospitals had only one ICP full-time equivalent (FTE) and at 86% of hospitals, the ICPs had other major responsibilities [54]. Moreover, had Virginia mandated reporting of all HAIs, an estimated 160 ICPs would have been required statewide at an estimated cost of $11.5 million yearly.
Virginia, Colorado, and Tennessee chose to use an existing surveillance network, NHSN, to avoid the costs of establishing a surveillance system de novo and to be able to benchmark its hospitals against other hospitals nationally. Hospitals will submit raw HAI data to CDC and then report their risk-adjusted infection rates to the state department of health. Colorado's law also requires hospitals to submit their infection data to NHSN. Most of the states have developed an advisory committee to assist in the analysis of data and the methodology for public disclosure and most will post comparative data on HAI rates on a public Web site. Few of the states have made provisions for validation of the data or funding to offset costs. Some states have built in a delay (up to three years)
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before data submission is required to allow hospitals to gain experience with the surveillance methodology.
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TABLE 46-3 |
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Nevada's law is unique in that it mandates reporting of HAIs, but the data are not disclosed to the public. While this approach may be effective in improving the quality of care, it does not meet the needs of the consumer in acquiring the data needed to choose their site of care. Also, without public disclosure, hospitals may not be viewed as being held accountable to the public.
There has been some interest in the establishment of federal legislation on mandatory reporting and disclosure to establish a single national standard rather than have states develop varying standards. The National Quality Forum is currently in the process of developing national standards for reporting of HAIs, and a Congressional hearing explored the issue recently.
Conclusion
In the end, the benefit to the healthcare consumer due to the transparency provided by mandatory reporting and disclosure of HAIs should trump the risk to hospitals' reputations and finances, and states are increasingly enacting laws to ensure this. This is an excellent incentive for hospitals to commit resources to prevent HAIs. However,
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standardization of methodology for detecting infections, accurate risk adjustment, and validation of reported infection rates is paramount in providing consumers with reliable data. Last, the impact of such legislation, including intended and unintended consequences, should be evaluated after implementation.
References
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