In March 2008, we reported that CDC had 13 guidelines for hospitals on infection control and prevention, and in these guidelines CDC recommended almost 1,200 practices for implementation to prevent HAIs and related adverse events. (See table 1.) CDC’s infection control and prevention guidelines set forth recommended practices, summarize the applicable scientific evidence and research, and contain contextual information and citations for relevant studies and literature. Most of CDC’s infection control and prevention guidelines are developed in conjunction with HICPAC, an advisory body created in 1992 by the Secretary of HHS. CDC publishes the final guidelines in its Morbidity and Mortality Weekly Report, on its Web site, or through a professional journal. We found that CDC’s guidelines covered such topics as prevention of catheter-associated urinary tract infections, prevention of surgical site infections, and hand hygiene. An example of a recommended practice in the hand hygiene guideline is the recommendation that health care workers decontaminate their hands before having direct contact with patients. Most of the practices were sorted into five categories—from strongly recommended for implementation to not recommended— primarily on the basis of the strength of the scientific evidence for each practice. Over 500 practices were strongly recommended. We also found that CDC and AHRQ had conducted some activities to promote implementation of recommended practices, such as disseminating the guidelines and providing research funds. However, these steps were not guided by a prioritization of recommended practices. Our March 2008 report noted that one factor to consider in prioritization is strength of evidence, as CDC had done. In addition to strength of evidence, an AHRQ study identified other factors to consider in prioritizing recommended practices, such as costs and organizational obstacles. Furthermore, the efforts of the two agencies had not been coordinated. For example, we found that CDC and AHRQ independently examined various aspects of the evidence related to improving hand hygiene compliance, such as the selection of hand hygiene products and health care worker education. This could have been an opportunity for coordination. We found that no one in the HHS Office of the Secretary was responsible for coordinating infection control activities across HHS. The department subsequently established the Steering Committee for the Prevention of Healthcare-Associated Infections, with senior-level representation of HHS offices and operating divisions, to develop the HHS Action Plan. To facilitate implementation of recommended practices among health care organizations, the plan prioritized some recommended practices to address four of its six targeted HAIs. In March 2008, we reported that while CDC’s infection control guidelines described specific clinical practices recommended to reduce HAIs, the infection control standards that CMS and accrediting organizations require as part of the hospital certification and accreditation processes described the fundamental components of a hospital’s infection control program. These components included the active prevention, control, and investigation of infections. Examples of standards and corresponding standards interpretations that hospitals must follow included educating hospital personnel about infection control and having infection control policies in place. The standards were far fewer in number than the recommended practices in CDC’s guidelines—for example, CMS’s infection control COP contained two standards. We also found that as a whole, the CMS, Joint Commission, and AOA standards and their interpretations described similar required elements of hospital infection programs. For example, all required that the hospital designate a person or persons to be responsible for the infection control program. However, there were differences, including the extent to which the standards and their interpretations required implementation of practices recommended in CDC’s infection control guidelines. Although CMS and the accrediting organizations generally did not require that hospitals implement all recommended practices in CDC’s infection control and prevention guidelines, we reported that the Joint Commission and AOA had standards that required the implementation of certain practices recommended in CDC’s infection control guidelines. For example, we reported that the Joint Commission and AOA required hospitals to annually offer influenza vaccinations to health care workers, whereas CMS’s interpretive guidelines, or standards interpretations, were more general, stating that hospitals should adopt policies and procedures based as much as possible on national guidelines that address hospital-staff- related issues, such as evaluating hospital staff immunization status for designated infectious diseases. In our March 2008 report, we proposed that HHS determine how to promote implementation of prioritized practices, including whether to incorporate selected practices into CMS’s hospital standards. In its Action Plan, HHS indicates its preference not to include specific infection control practices in its hospital standards in order to keep its standards flexible and broad. In our March 2008 report, we also discussed how compliance with hospital standards is assessed. CMS, the Joint Commission, and AOA assessed compliance with their infection control standards during on-site surveys through direct observation of hospital activities and review of hospital policy documents. Among the surveys conducted in the first quarter of 2007, 12.6 percent of CMS-surveyed hospitals, 17.6 percent of Joint Commission–surveyed hospitals, and 22.2 percent of AOA-surveyed hospitals were cited as noncompliant with one of the respective organizations’ standards on infection control. In March 2008, we reported that multiple HHS programs collected data on HAIs but that limitations in the scope of information they collected and the lack of integration across the databases maintained by these separate programs constrained the utility of the data. Three agencies within HHS— CDC, CMS, and AHRQ—collect HAI-related data for a variety of purposes in databases maintained by four separate programs: CDC’s National Healthcare Safety Network (NHSN) program, CMS’s Medicare Patient Safety Monitoring System (MPSMS), CMS’s Annual Payment Update (APU) program, and AHRQ’s Healthcare Cost and Utilization Project (HCUP). (See table 2.) We found that the most detailed source of information on HAIs in HHS was the NHSN database. It began as a voluntary program in the 1970s to assist hospitals that wanted to monitor their HAI rates. CDC has drawn on these data to publicly report aggregate trends in selected HAIs, and we found that it was working with a number of states that were implementing mandatory programs for hospitals to submit HAI-related data through NHSN. We reported that the MPSMS database provided CMS with information on national trends in the incidence of selected adverse events among hospitalized Medicare beneficiaries, including a number of different types of HAIs. These data were collected from medical records selected for annual random samples of approximately 25,000 Medicare inpatients. We also reported that the APU program implemented a financial incentive for hospitals to submit to CMS data that were used to calculate hospital performance on measures of quality of care. The program received quality-related data quarterly for a range of medical conditions, including data on three surgical infection prevention measures. We noted that CMS reported the results of its analyses of these data on its Hospital Compare Web site. Finally, we reported that AHRQ sponsored the development of the HCUP databases to create a national information resource of patient-level health care data. Two of the 20 Patient Safety Indicators that AHRQ derived from these data were related to HAIs, one involving infections caused by intravenous lines and catheters, and the other postoperative sepsis. We found that each of these databases presented only a partial view of the extent of the HAI problem because each focused its data collection on selected types of HAIs and collected data from a different subset of hospital patients across the country. Although two databases—NHSN and MPSMS—addressed many of the same types of HAIs, the former provided information only from selected units of hospitals that participated in the NHSN program (which did not represent hospitals nationwide), while the latter provided information only on a representative sample of Medicare inpatients (i.e., MPSMS did not provide information on non-Medicare patients). In addition, the data collection methods employed by the NHSN, MPSMS, and HCUP databases ranged from concurrent review of patient care as patients were being treated in the hospital, to retrospective review of patient medical records after patients had been discharged, to analyses of diagnostic codes recorded electronically in patient billing data. Although we noted that officials from the various HHS agencies discussed HAI data collection with each other, we found that the agencies were not taking steps to integrate any of the existing data from the four databases. This integration could involve creating linkages across the databases by, for example, creating common patient identifiers so that data from the same individuals in multiple databases could be pulled together. Creating linkages across the HAI-related databases could enhance the availability of information to better understand where and how HAIs occur. For example, data on surgical infection rates and data on surgical processes of care were collected for some of the same patients in two different databases that were not linked. In our March 2008 report, we concluded that, as a consequence, the potential benefit of using the existing data to monitor the extent to which compliance with the recommended surgical care processes led to actual improvements in surgical infection rates had not been realized. In its January 2009 Action Plan, HHS proposes remedying this situation by undertaking a series of short- and longer-term initiatives to coordinate and align its various HAI-related data collection activities, under the guidance of a new interagency working group. In our March 2008 report, we reported concerns with the use of HAI data for providing a national picture of HAIs. Although none of the databases collected data on the incidence of HAIs for a nationally representative sample of hospital patients, CDC officials had produced national estimates of HAIs. However, those estimates derived from assumptions and extrapolations that raised questions about the reliability of those estimates. In its Action Plan, HHS proposes to draw on some of the same data sources—primarily NHSN—to track progress in reducing the incidence of five of its six targeted HAIs. HAIs in hospitals can cause needless suffering and death. Federal authorities and private organizations have undertaken a number of activities to address this serious problem; however, to date, these activities have not gained sufficient traction to be effective. In our March 2008 report, we identified two possible reasons for the lack of effective actions to control HAIs. First, although CDC’s guidelines are an important source for its recommended practices on how to reduce HAIs, the large number of recommended practices and lack of department- level prioritization hinder efforts to promote their implementation. The guidelines we reviewed contain almost 1,200 recommended practices for hospitals, including over 500 that are strongly recommended—a large number for a hospital trying to implement them. A few of these are required by CMS’s or accrediting organizations’ standards or their standards interpretations, but it is not reasonable to expect CMS or accrediting organizations to require additional practices without prioritization. Although CDC has categorized the practices on the basis of the strength of the scientific evidence, there are other factors to consider in developing priorities. For example, work by AHRQ suggests factors such as costs or organizational obstacles that could be considered. The lack of coordinated prioritization may have resulted in duplication of effort by CDC and AHRQ in their reviews of scientific evidence on HAI- related practices. Second, we reported that HHS had not effectively used the HAI-related data it had collected through multiple databases across the department to provide a complete picture of the extent of the problem. Limitations in the databases, such as nonrepresentative samples, hinder HHS’s ability to produce reliable national estimates on the frequency of different types of HAIs. In addition, data collected on HAIs are not being combined to maximize their utility. HHS has made efforts to use the currently collected data to understand the extent of the problem of HAIs, but the lack of linkages across the various databases results in a lost opportunity to gain a better grasp of the problem of HAIs. HHS has multiple methods to influence hospitals to take more aggressive action to control or prevent HAIs, including issuing guidelines with recommended practices, requiring hospitals to comply with certain standards, releasing data to the public to expand information about the nature of the problem, and using hospital payment methods to encourage the reduction of HAIs. Prioritization of CDC’s many recommended practices can help guide their implementation, and better use of currently collected data on HAIs could help HHS—and hospitals themselves— monitor efforts to reduce HAIs. In our March 2008 report, we concluded that leadership from the Secretary of HHS was lacking to do this and that without such leadership, the department would not be able to effectively leverage its various methods to have a significant effect on the suffering and death caused by HAIs. The recently released HHS Action Plan identifies strategies that are intended to address some of the reasons for the lack of effective actions to control HAIs, including some identification of priorities from among the 1,200 recommended practices, and plans to coordinate HAI-related data collection activities across HHS. HHS released the Action Plan for comment in early January 2009, with the intent of revising it based on the public input it received. Following the transition to the new presidential administration, HHS has continued to solicit public comments on the plan with no designated deadline for submissions. Consequently, it remains uncertain when or if the new administration will choose to implement this plan, and if so, with what modifications, to address our recommendations and reduce the serious problem of HAIs. Mr. Chairman, this completes my prepared remarks. I would be happy to respond to any questions you or other members of the subcommittee may have at this time. For further information about this statement, please contact Marjorie Kanof at (202) 512-7114 or kanofm@gao.gov or Cynthia A. Bascetta at (202) 512-7114 or bascettac@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this statement. Key contributors to this statement were William Simerl, Assistant Director; Mary Giffin; Shannon Slawter Legeer; Eric Peterson; and Roseanne Price. This is a work of the U.S. government and is not subject to copyright protection in the United States. The published product may be reproduced and distributed in its entirety without further permission from GAO. However, because this work may contain copyrighted images or other material, permission from the copyright holder may be necessary if you wish to reproduce this material separately.

Summary: According to the Centers for Disease Control and Prevention (CDC), health-care-associated infections (HAI)--infections that patients acquire while receiving treatment for other conditions-- are estimated to be 1 of the top 10 causes of death in the nation. The statement GAO is issuing today summarizes a March 2008 report, Health-Care-Associated Infections in Hospitals: Leadership Needed from HHS to Prioritize Prevention Practices and Improve Data on These Infections (GAO-08-283). In this report, GAO examined (1) CDC's guidelines for hospitals to reduce or prevent HAIs and what HHS does to promote their implementation, (2) Centers for Medicare & Medicaid Services' (CMS) and hospital accrediting organizations' required standards for hospitals to reduce or prevent HAIs, and (3) HHS programs that collect data related to HAIs and integration of the data across HHS. To conduct the work, GAO reviewed documents and interviewed HHS and accrediting organization officials. To update certain information for this statement, GAO reviewed relevant HHS documents released after GAO's March 2008 report. In its March 2008 report, which is summarized in this statement, GAO found that CDC has 13 guidelines for hospitals on infection control and prevention, which contain almost 1,200 recommended practices, but activities across HHS to promote implementation of these practices are not guided by a prioritization of the practices. Although most of the practices have been sorted into categories primarily on the basis of the strength of the scientific evidence for the practice, other factors to consider in prioritizing, such as costs or organizational obstacles, have not been taken into account. While CDC's guidelines describe specific clinical practices recommended to reduce HAIs, the infection control standards that CMS and the accrediting organizations require describe the fundamental components of a hospital's infection control program. The standards are far fewer in number than CDC's recommended practices and generally do not require that hospitals implement all recommended practices in CDC's guidelines. Multiple HHS programs have databases that collect data on HAIs, but limitations in the scope of information collected and a lack of integration across the databases constrain the utility of the data. GAO concluded that the lack of department-level prioritization of CDC's large number of recommended practices had hindered efforts to promote their implementation. GAO noted that a few of CDC's strongly recommended practices were required by CMS or the accrediting organizations but that it was not reasonable to expect CMS or the accrediting organizations to require additional practices without prioritization. GAO also concluded that HHS had not effectively used the HAI-related data it had collected through multiple databases across the department to provide a complete picture of the extent of the problem. Subsequent to GAO's report, HHS established a steering committee, with senior-level representation of HHS offices and operating divisions, to develop the HHS Action Plan to Prevent Healthcare-Associated Infections. This plan includes strategies that are intended to address some of the reasons for the lack of effective actions to control HAIs, including some identification of priorities from among the 1,200 recommended practices, and plans to coordinate HAI-related data collection activities across HHS. HHS released the Action Plan for comment in early January 2009, with the intent of revising it based on the public input it received. Following the transition to the new presidential administration, HHS has continued to solicit public comments. Consequently, it remains uncertain when or if the new administration will choose to implement this plan, and if so, with what modifications, to address GAO's recommendations and reduce the serious problem of HAIs.