Health-Care-Associated Infections In Hospitals: Continuing Leadership Needed from HHS to Prioritize Prevention Practices and Improve Data on These Infections
Published: 2009-03-18T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.

section_title: Letter
paragraphs: I am pleased to be here today to discuss our work on federal government  efforts to address the problem of health-care-associated infections (HAI)  in hospitals and to provide a summary of our March 2008 report entitled  Health-Care-Associated Infections in Hospitals: Leadership Needed from  HHS to Prioritize Prevention Practices and Improve Data on These  Infections. According to the Centers for Disease Control and Prevention  (CDC), HAIs are infections that patients acquire while receiving treatment  for other conditions and are estimated to be 1 of the top 10 causes of  death in the United States. HAIs can be acquired in several ways, such as  from bacteria on a needle or tube used to deliver medicine, fluids, or blood  to a patient. According to CDC, the most common HAIs are urinary tract  infections, surgical site infections, pneumonia, and bloodstream  infections. A reduction in the prevalence of HAIs through implementation  of practices that are based on the best available scientific evidence would  represent a substantial improvement in health care quality.
HAIs can be expensive. In 2005 the average payment for a hospitalization  in Pennsylvania was over six times higher for patients who contracted a  hospital-acquired infection than for patients who did not acquire  infections. A 2007 study of 1.69 million patients who were discharged  from 77 hospitals found that the additional cost of treating a patient with  an HAI averaged $8,832. The costs of HAIs are borne not only by the  patients who suffer infections, but also by those who pay for care, such as  the Centers for Medicare & Medicaid Services (CMS). According to the  American Hospital Association, Medicare paid for over one-third of all  hospital costs in 2007.
Although not all HAIs are preventable, the federal government and private  organizations have established standards and other activities aimed at  controlling and preventing them. CMS has established health and safety  standards—known as conditions of participation (COP)—with which  hospitals must comply in order to be eligible for payment by Medicare and  Medicaid and which include the COP for infection control. Hospitals may  choose one of two ways to show that they have met these or equivalent  standards: they may be certified by a state agency under agreement with  CMS to survey the hospital’s compliance with the COPs or they may be  accredited by a CMS-approved private organization, including the Joint  Commission or the Healthcare Facilities Accreditation Program of the  American Osteopathic Association (AOA). Most hospitals are accredited  by the Joint Commission. Other activities within the Department of Health  and Human Services (HHS) aimed at addressing the problem of HAIs in  hospitals include CDC’s development of guidelines, which contain  recommended practices that hospitals may adopt, and the management of  several databases in different parts of HHS that contain information about  HAIs in hospitals. According to the Institute of Medicine, prevention of  HAIs through implementation of evidence-based guidelines can lead to  improvements in quality of care. Furthermore, the collection of national  data on these infections can provide a benchmark for individual hospitals  to gauge their performance and design targeted interventions. In addition  to these activities, in January 2009 HHS released for public comment the  Action Plan to Prevent Healthcare-Associated Infections. This document  is designed as a road map for how the department plans to address HAIs.
Federal and state lawmakers are also concerned about HAIs and have  taken action to reduce them. With the passage of the Deficit Reduction Act  of 2005 (DRA), the Congress took steps to revise the way Medicare pays  hospitals so that beginning on October 1, 2008, they would not receive  higher payments for patients who acquire certain preventable conditions  (including any of three HAIs) during their hospital stays. The HAI-related  preventable conditions that CMS identified under subsection 5001(c) of  the DRA were urinary tract infections caused by catheters, infections  caused by vascular catheters, and surgical site infections following  selected types of surgery. In addition, 23 states were designing or had  implemented state-mandated public reporting of hospital HAI rates or HAI- related information as of February 2008.
My statement today is based largely on our March 2008 report, and  includes some updated information from the HHS Action Plan. In the  March 2008 report, we examined (1) CDC’s guidelines for hospitals to  reduce or prevent HAIs, and what HHS does to promote their  implementation; (2) CMS’s and the accrediting organizations’ required  standards for hospitals to reduce or prevent HAIs, and how compliance is  assessed; and (3) HHS programs that collect data related to HAIs in  hospitals, and the extent to which the data are integrated across HHS.
In carrying out this work for our March 2008 report, we interviewed  officials from CDC, CMS, the Agency for Healthcare Research and Quality  (AHRQ), the Food and Drug Administration, the Joint Commission, and  AOA. We also interviewed selected experts in the field of infection control.  In addition, we reviewed and analyzed CDC’s infection control and  prevention guidelines issued from 1981 through 2007; minutes of HHS’s  Healthcare Infection Control Practices Advisory Committee (HICPAC); the  World Health Organization’s guideline on hand hygiene; CMS’s COPs for  hospitals and interpretive guidelines, which describe the COPs and  provide survey procedures used to determine compliance with them; the  Joint Commission’s 2008 standards for hospitals and its hospital standards  manual; and AOA’s 2005 standards for hospitals and its hospital standards  manual. We refer to the guidance that CMS provides about its COPs in the  interpretive guidelines, and that the Joint Commission and AOA provide  about their standards in their respective manuals, as “standards  interpretations.” We also reviewed manuals and other documents that  explain the HHS programs that collect HAI-related data, and related  publications and data analyses conducted by the agencies based on the  data collected. We conducted the performance audit for the March 2008  report from January 2007 to March 2008, and updated certain information  from the report for this testimony in March 2009 by reviewing the HHS  Action Plan and other relevant HHS documents, in accordance with  generally accepted government auditing standards. Those standards  require that we plan and perform the audit to obtain sufficient, appropriate  evidence to provide a reasonable basis for our findings and conclusions  based on our audit objectives. We believe that the evidence obtained  provides a reasonable basis for our findings and conclusions based on our  audit objectives. A detailed explanation of our methodology is included in  our March 2008 report.
In brief, we found that federal authorities and private organizations had  undertaken a number of activities to address the problem of HAIs. We  reported that CDC had 13 guidelines for hospitals on infection control and  prevention, which contained almost 1,200 recommended practices.  However, activities across HHS to promote implementation of these  practices were 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, there were  other factors to consider in prioritizing, such as costs or organizational  obstacles. We concluded that a lack of department-level prioritization of  CDC’s large number of recommended practices had hindered efforts to  promote their implementation. While CDC’s guidelines describe specific  clinical practices recommended to reduce HAIs, the infection control  standards that CMS and the accrediting organizations require of hospitals  describe the fundamental components of a hospital’s infection control  program. We found that the standards were far fewer in number than  CDC’s recommended practices and generally did not require that hospitals  implement all recommended practices in CDC’s guidelines. We 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. Other HAI-related federal efforts included multiple HHS  programs that collect data on HAIs, but we found that limitations in the  scope of information collected and a lack of integration across the  programs’ databases constrained the utility of the data. We 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 and make progress in reducing HAIs.
In order to help reduce HAIs in hospitals, we recommended that the  Secretary of HHS take the following two actions: (1) identify priorities  among CDC’s recommended practices and determine how to promote  implementation of the prioritized practices, including whether to  incorporate selected practices into CMS’s conditions of participation  (COP) for hospitals, and (2) establish greater consistency and  compatibility of the data collected across HHS on HAIs to increase  information available about HAIs, including reliable national estimates of  the major types of HAIs. In commenting on a draft of our report, HHS  generally agreed with our recommendations. HHS’s Action Plan includes a  number of strategies, some of which are intended to address our  recommendations. 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.
subsections: section_title: CDC Had 13 Infection Control and Prevention Guidelines Containing Almost 1,200 Recommended Practices, and HHS’s Action Plan Includes Some Prioritized Practices to Promote Implementation
paragraphs: 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.
section_title: CMS’s and Accrediting Organizations’ Required Hospital Standards Described Components of Infection Control Programs, and Compliance with These Standards Was Assessed through On- Site Surveys
paragraphs: 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.
section_title: Multiple HHS Programs Collected Data on HAIs, but Lack of Integration of Available Data and Other Problems Limited Utility of the Data
paragraphs: 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.
section_title: Concluding Observations
paragraphs: 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.
section_title: Contacts and Acknowledgments
paragraphs: 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.
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