Health-Care-Associated Infections in Hospitals: Leadership Needed from HHS to Prioritize Prevention Practices and Improve Data on These Infections
Published: 2008-03-31T00:00:00

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) are estimated to be 1 of the top 10 causes of death in the United States. HAIs are infections that patients acquire while receiving treatment for other conditions. GAO was asked to examine (1) CDC's guidelines for hospitals to reduce or prevent HAIs and what the Department of Health and Human Services (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 how compliance is assessed, and (3) HHS programs that collect data related to HAIs and integration of the data across HHS. GAO reviewed documents and interviewed officials from CDC, CMS, the Agency for Healthcare Research and Quality (AHRQ), and accrediting organizations.
section_title: What GAO Found
paragraphs: CDC has 13 guidelines for hospitals on infection control and prevention, which cover a variety of topics, and in these guidelines CDC recommends almost 1,200 practices for implementation to prevent HAIs and related adverse events. Most of the practices are 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 are strongly recommended. CDC and AHRQ have conducted some activities to promote implementation of recommended practices, but these activities are not based on a clear prioritization of the practices. Prioritization may consider not only the strength of the evidence, but also other factors that can affect implementation, such as cost and organizational obstacles. In addition to CDC, AHRQ has reviewed scientific evidence for certain HAI-related practices, but the efforts of the two agencies have not been coordinated. The infection control standards required by CMS and hospital-accrediting organizations--the Joint Commission and the Healthcare Facilities Accreditation Program of the American Osteopathic Association (AOA)--describe the fundamental components of a hospital's infection control program. These components include the active prevention, control, and investigation of infections. The standards are far fewer in number than the recommended practices in CDC's guidelines and generally do not require that hospitals implement all recommended practices in CDC's infection control and prevention guidelines. CMS, the Joint Commission, and AOA assess compliance with their infection control standards through direct observation of hospital activities and review hospital policy documents during on-site surveys. Multiple HHS programs collect data on HAIs, but limitations in the scope of information they collect and a lack of integration across the databases maintained by these separate programs constrain the utility of the data. Three agencies within HHS currently collect HAI-related data for a variety of purposes in databases maintained by four separate programs: CDC's National Healthcare Safety Network program, CMS's Medicare Patient Safety Monitoring System, CMS's Annual Payment Update program, and AHRQ's Healthcare Cost and Utilization Project. Each of the four databases presents only a partial view of the extent of the HAI problem because each focuses its data collection on selected types of HAIs and collects data from a different subset of hospital patients across the country. GAO did not find that the agencies were taking steps to integrate data across the four databases by creating linkages across the databases, such as creating common patient identifiers. Creating linkages across the HAI-related databases could enhance the availability of information to better understand where and how HAIs occur. Although CDC officials have produced national estimates of HAIs, those estimates derive from assumptions and extrapolations that raise questions about the reliability of those estimates.

section_title: Letter
paragraphs: According to the Centers for Disease Control and Prevention (CDC),  health-care-associated infections (HAI) are estimated to be 1 of the top 10  causes of death in the United States. HAIs, as defined by CDC, are  infections that patients acquire while receiving treatment for other  conditions. For example, a patient may acquire an infection from bacteria  on a device used to treat them, such as a needle or tube to deliver  medicine, fluids, or blood. According to CDC, the most common HAIs are  urinary tract infection (UTI), surgical site infection (SSI), pneumonia, and  bloodstream infection (BSI). Some HAIs can be caused by bacteria that  have become resistant to multiple antimicrobial drugs. One example of  such a bacterium is methicillin-resistant Staphylococcus aureus, or MRSA,  which causes infections that are resistant to treatment with usual  antibiotics, including methicillin, and can be serious and potentially life- threatening. MRSA can cause a wide variety of infections, including skin  infections, BSIs, SSIs, and pneumonia.
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, according to a report by the Pennsylvania Health Care Cost  Containment Council. 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 2005. Hospitals may also incur some of the cost because  they are not fully reimbursed for the cost of the extra care attributable to  HAIs.
Although not all HAIs are preventable, public 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 one  of two private organizations—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 the  development of guidelines by CDC, which contain recommended practices  that hospitals may adopt, and 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.
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 that acquire certain preventable conditions  (including any of three HAIs) during their hospital stay. The HAI-related  preventable conditions that CMS identified in the final regulation  implementing subsection 5001(c) of the DRA were UTIs caused by  catheters, infections caused by vascular catheters, and mediastinitis  following coronary artery bypass graft surgery. According to Consumers  Union—a nonprofit organization that has a campaign to stop HAIs—23  state legislatures have enacted laws that require public reporting of  hospital HAI rates or HAI-related information.
In light of congressional activity in this area and concerns you raised  about how to prevent or reduce HAIs in hospitals, 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 the data are integrated across  HHS.
In general, to conduct our work, we reviewed documents and interviewed  HHS agency officials, including officials from CDC, CMS, the Agency for  Healthcare Research and Quality (AHRQ), and the Food and Drug  Administration (FDA).
To identify CDC’s guidelines for hospitals related to HAIs as well as assess  their content, we reviewed CDC’s infection control and prevention  guidelines issued between 1981 and 2007. To determine the extent to  which HHS promotes CDC’s guidelines, we asked CDC officials about the  activities they undertake to promote their guidelines, and we interviewed  officials from AHRQ. We reviewed minutes of the Healthcare Infection  Control Practices Advisory Committee (HICPAC), a federal advisory body  appointed by the Secretary of HHS that provides recommendations to the  Secretary and CDC and includes members from government agencies and  private organizations. In addition, we interviewed officials from CDC,  CMS, FDA, and AHRQ. We interviewed selected experts in the field of  infection control, including individuals from private organizations that  represent health professionals in infection control and develop materials  to support their work, such as the Society for Healthcare Epidemiology of  America (SHEA) and the Association for Professionals in Infection Control  and Epidemiology (APIC). We also reviewed the World Health  Organization’s (WHO) guideline on hand hygiene.
To determine CMS’s and the accrediting organizations’ required standards  for hospitals to reduce or prevent HAIs and how compliance is assessed,  we reviewed CMS’s COPs for hospitals and the Joint Commission’s and  AOA’s standards for hospitals and interviewed officials from CMS, the  Joint Commission, and AOA. We reviewed CMS’s interpretive guidelines,  which describe the COPs and provide survey procedures used to  determine compliance with them and can be found primarily in CMS’s  State Operations Manual. In addition, we reviewed CMS’s revised  interpretive guidelines for the infection control COP, which were  published in November 2007, during the course of our work. We also  reviewed the Joint Commission’s and AOA’s hospital standards manuals.  For the purpose of this report, 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.” Our review focused on CMS’s  infection control COP and the standards the Joint Commission and AOA  have in the infection control chapters of their respective manuals. We  obtained the following information from each organization: the number of  hospitals surveyed by each organization during the first quarter of 2007,  and the number of hospitals surveyed by each organization during the first  quarter of 2007 that were cited as noncompliant with one of the standards  on infection control. Using the data we obtained from these officials, we  calculated the percentage of hospitals surveyed by each organization that  were noncompliant with at least one infection control standard for the  first quarter of 2007. Based on information obtained from and discussions  with each organization, we determined that the data CMS, the Joint  Commission, and AOA provided to us were sufficiently reliable for the  purposes of this report.
To identify HHS programs that routinely collect and maintain in  designated databases information that relates specifically to HAIs, we  interviewed officials at CDC, CMS, AHRQ, and FDA, and reviewed relevant  documents. To describe and assess the programs HHS has that collect data  related to HAIs and determine the extent to which the data are integrated,  we reviewed agency manuals and other relevant documents that explain  the programs that collect the data, examined related publications and data  analyses conducted by the agencies based on the data collected, and  reviewed HICPAC meeting minutes from March 2004 to June 2007. We also  interviewed officials of CDC, CMS, FDA, and AHRQ responsible for each  agency’s HAI data collection efforts. We obtained data reported from these  HAI-related databases, and based on relevant documents and discussion  with agency officials we determined that the data were sufficiently reliable  for the purposes of this report.
We examined only guidelines, standards, and databases that apply to HAIs  in acute care hospitals other than critical access hospitals and did not  examine guidelines, standards, or databases that might apply to  community-acquired infections or health care workers. We did not  independently assess the clinical evidence that supports CDC’s infection  control and prevention guidelines. We describe CMS’s, the Joint  Commission’s, and AOA’s infection control standards, the standards  interpretations, and the survey process, but we did not observe the survey  process. We conducted this performance audit from January 2007 to  March 2008, 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.
subsections: section_title: Background
paragraphs: CDC has developed several guidelines for hospitals that describe and  recommend practices to prevent or control HAIs, such as hand washing or  the use of alcohol-based hand rubs, isolation of infected patients, proper  sterilization of equipment, provision of antibiotics to patients before  surgery, and annual vaccination of health care workers for influenza.  Standards from CMS and hospital accrediting organizations provide a  means for assessing hospital compliance with infection control standards  that are also aimed at preventing or controlling HAIs.
subsections: section_title: CDC’s Infection Control and Prevention Guidelines
paragraphs: CDC issues both guidelines and guidance relevant to infection control and  prevention in hospitals. Guidelines are based on scientific evidence,  whereas guidance is usually provisional and limited in its supporting  evidence. 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. According to its charter, HICPAC provides CDC and the  Secretary with (1) advice and guidance on the practice of infection control  and strategies for surveillance, prevention, and control of HAIs and  related events in health care facilities; and (2) advice on the periodic  updating of existing HAI guidelines, the development of new guidelines  and evaluations, and other HAI policy statements. HICPAC currently  consists of 14 voting members from various infection control disciplines  throughout the United States, a designated staff person from CDC, and 15  nonvoting liaison members from government agencies and private  organizations.
When CDC and HICPAC select a topic for an infection control and  prevention guideline, they begin with internal discussions. After selecting  a topic, HICPAC members and CDC conduct research on the topic, which  includes identifying and evaluating clinical studies relevant to the topic  and developing recommended practices, as appropriate. The draft  guidelines are written and reviewed by HICPAC members; circulated to  outside experts to validate the content; and sent to other federal agencies  for review and approval. Afterward, HICPAC members resolve issues  raised during review in face-to-face meetings or conference calls with  HICPAC members who wrote the guideline. The approved document is  published in the Federal Register for a 45- to 60-day public comment  period, after which comments are reviewed by HICPAC members. CDC  publishes the final guideline in its Morbidity and Mortality Weekly Report,  on its Web site, or through a professional journal.
section_title: CMS’s and the Accrediting Organizations’ Standards for Hospitals
paragraphs: Hospital compliance with CMS’s or the accrediting organizations’  standards, including those related to infection control, is assessed on a  regular basis. Unannounced on-site surveys, conducted by surveyors from  CMS or the accrediting organizations, are a major component in the  process by which hospitals’ compliance with health and safety standards is  assessed. Standards interpretations are given by CMS primarily in its State  Operations Manual, which is arranged by COP; by the Joint Commission  in its Comprehensive Accreditation Manual for Hospitals: The Official  Handbook, which identifies rationales and performance expectations that  are used to measure each standard and is organized into 11 chapters of  safety and quality standards such as “Medication Management” and  “Leadership;” and by AOA’s standards manual, Accreditation  Requirements for Healthcare Facilities, which provides explanations for  surveyors and the scoring procedures along with its standards and is  organized into 32 chapters. Based on the information documented during  the survey, surveyors from each organization assess a hospital’s  compliance with the standards. Hospitals are required to correct  instances of noncompliance found during the survey. CMS’s policy is to  survey hospitals every 3 years; however, this policy is contingent on CMS’s  budget. In fiscal year 2007, CMS set a goal to survey hospitals on average  once every 4.5 years, with no more than 6 years elapsing between surveys  for any one hospital. Both the Joint Commission and AOA survey hospitals  at least once every 3 years.
The Joint Commission has additional components in its standards and  survey process. First, it issues National Patient Safety Goals, which are  requirements intended to promote specific improvements in patient safety.  Officials at the Joint Commission told us that the goals are updated  annually and derive primarily from informal recommendations made in the  Joint Commission’s safety newsletter, Sentinel Event Alert,  recommendations from the Sentinel Event Advisory Group, sentinel events  reported to the Joint Commission, and a review of the patient safety  literature. The goals target problem areas in health care, such as reducing  the risk of patient injury resulting from a fall or encouraging patients’  active involvement in their own care. Each goal is reviewed during the on- site survey to determine compliance with it. Second, the Joint Commission  conducts several “tracers” as part of its hospital surveys, during which the  care provided to selected patients is followed or “traced” through the  hospital in the same sequence in which the patient received it. Other  requirements that a hospital must meet to be accredited by the Joint  Commission include conducting an annual self-assessment of the  hospital’s compliance with the Joint Commission standards and submitting  data for selected measures of clinical performance, some of which are  related to HAIs.
section_title: CDC Has 13 Infection Control and Prevention Guidelines Containing Almost 1,200 Recommended Practices, but Activities across HHS to Promote Implementation Are Not Guided by Prioritization of Practices
paragraphs: CDC has 13 guidelines for hospitals on infection control and prevention,  and in these guidelines CDC recommends almost 1,200 specific clinical  practices for implementation to prevent HAIs and related adverse events.  The practices generally are 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 are strongly recommended. Within HHS, CDC and AHRQ  conduct some activities to promote the implementation of recommended  practices, but the activities are not based on clear prioritization of the  practices, which may consider not only the strength of the evidence, but  also other factors that can affect implementation, such as cost or  organizational obstacles.
subsections: section_title: CDC Has 13 Infection Control and Prevention Guidelines, Which Contain Almost 1,200 Recommended Practices, and over 500 of Them Are Strongly Recommended
paragraphs: CDC has 13 infection control and prevention guidelines, which contain  1,198 specific clinical practices that CDC recommends for preventing  HAIs. (See table 1.) The hand hygiene guideline, for example, strongly  recommends that health care workers decontaminate their hands before  having direct contact with patients. The number of recommended  practices for each guideline varies. For example, the 2003 guideline  outlining environmental infection control practices contains 329  recommended practices, whereas the 2006 guideline for influenza  vaccination of health care personnel has 6 recommended practices. The  earliest of the guidelines, which was on catheter-associated UTIs, was  published in February 1981, and as of December 2007, the most recent, a  revision of the guideline for isolation precautions, was published in June  2007.
The practices in these 13 guidelines are categorized primarily based on the  strength of the scientific evidence, and these categories have changed over  time. Basing the categories on the strength of the evidence means that the  more highly recommended practices have more and better scientific  support indicating their effectiveness than those practices that are not as  highly recommended. Seven of the guidelines published between 2002 and  2007 used five categories: (1) strongly recommended for implementation  and strongly supported by well-designed experimental, clinical, or  epidemiological studies; (2) strongly recommended for implementation  and supported by some experimental, clinical, or epidemiologic studies  and a strong theoretical rationale; (3) suggested for implementation by  suggestive clinical or epidemiologic studies; (4) additional practices,  including federal, state, and other requirements; and (5) not recommended  due to insufficient evidence or lack of consensus regarding efficacy. Over  500 practices in these 7 guidelines fall into one of the two strongly  recommended categories. Six of the 7 guidelines identify 82 practices that  are not recommended, due to a lack of evidence supporting a  recommendation. (See table 2.) For example, the 2003 guideline for  preventing health-care-associated pneumonia identifies 45 practices that  are not recommended. The four guidelines issued between 1981 and 2000  ranked recommended practices into between three and five categories.  The 2003 guideline on smallpox vaccine and the 2005 guideline on  mycobacterium tuberculosis contain recommended practices, but they are  not categorized.
In general, CDC took an average of about 3 years to develop each  guideline—ranging from less than 1 year to 6 years. CDC officials agreed  that the amount of time it took to prepare a guideline has been long. CDC  reported that it has been developing one guideline that is still in draft  form—the Guideline for Disinfection and Sterilization in Healthcare  Facilities—for over 7 years. This guideline has taken a long time to  develop, in part, according to CDC officials, because the agency had to  coordinate with other agencies involved in the oversight of disinfection  and sterilization products. CDC officials said they were working to reduce  the time it takes to develop guidelines by issuing shorter and more focused  guidelines.
section_title: CDC and AHRQ Have Taken Steps to Promote Implementation of Practices to Reduce HAIs but Lack Prioritization of These Practices to Guide Their Actions
paragraphs: CDC officials identified some activities that the agency has undertaken to  promote the implementation of the recommended practices in its  guidelines. CDC disseminates its infection control guidelines by  publishing them in the Morbidity and Mortality Weekly Report, posting  them on CDC’s Web site, and distributing training videos. CDC has also  provided some funding support to groups that are developing ways to  implement selected recommendations in CDC infection control guidelines.  For example, through its Prevention Epicenter Program, CDC provided  financial support and technical assistance to a study that was assessing  the effect of an intervention to prevent catheter-associated BSIs. The  researchers reviewed participating hospitals’ policies and procedures on a  commonly used catheter, updated them to reflect CDC’s Guidelines for  the Prevention of Intravascular Catheter-Related Infections, and  implemented an intervention designed to educate staff about the  importance of implementing a group of selected recommendations in that  guideline. In a similar effort, CDC provided technical support and funding  to the Pittsburgh Regional Healthcare Initiative, which reportedly has  demonstrated a 68 percent decline in BSIs over a 4-year period among  intensive care unit patients.
AHRQ officials also reported undertaking some initiatives to promote  implementation of practices aimed at reducing HAIs. In 2007, AHRQ issued  a report that evaluated several strategies, such as clinician and patient  education, for possible use in hospitals to increase implementation of  specified infection prevention practices related to catheterization, surgical  antibiotic prophylaxis, central lines, and ventilator-associated pneumonia  (VAP) interventions. Although researchers were unable to reach any firm  conclusions regarding actionable strategies to prevent HAIs, they  identified four strategies worth additional study. In addition, through its  Accelerating Change and Transformation in Organizations and Networks  program, in September 2007, AHRQ funded several studies to improve the  implementation of practices that are known to minimize HAIs and to  identify the challenges to implementing those practices. The program will  implement clinician training at 72 hospitals that is designed to facilitate  change in clinician behaviors and habits, care processes, and the safety  culture of the participating hospitals. In a document summarizing this  initiative, AHRQ acknowledges that the problem is not the lack of  knowledge of infection control techniques, but rather the inability to  translate the knowledge into social and behavioral changes that can be  sustained in health care organizations.
While CDC and AHRQ have taken steps to promote the implementation of  practices to reduce HAIs, these steps have not been guided by a  prioritization of recommended practices. As WHO has indicated in its hand  hygiene guideline, when there is a large number of practices it is important  to prioritize them. One factor to consider in prioritization is strength of  evidence, which CDC has primarily relied on to categorize its  recommended practices. However, a 2001 AHRQ study suggested other  factors to consider in prioritizing recommended practices. This study rated  79 patient safety practices—including 22 practices that were related to  HAIs—on their potential to improve patient safety. The study examined  not only strength of the evidence, but also such factors as  the potential magnitude of impact of the practice on mitigating patient  death or disability, the financial cost of implementing the practice, the complexity of implementing the practice, the organizational and technical obstacles, and the risk that other negative consequences could occur if the practice were  put into place.
In addition to CDC, AHRQ has reviewed scientific evidence for certain  practices related to HAIs, but the efforts of the two agencies have not been  coordinated. For example, both agencies 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. Although this could have been an opportunity for coordination,  an official from the HHS Office of the Secretary told us that no one within  the office is responsible for coordinating infection control activities across  HHS.
section_title: CMS’s and Accrediting Organizations’ Required Hospital Standards Describe Components of Infection Control Programs, and Compliance with These Standards Is Assessed through On- Site Surveys
paragraphs: The infection control standards that CMS, the Joint Commission, and AOA  require as part of the hospital certification and accreditation processes  vary in number and content among the organizations, and generally  describe the fundamental components of a hospital infection control  program, that is, the active prevention, control, and investigation of  infections. Examples of standards and corresponding standards  interpretations that hospitals must follow include educating hospital  personnel about infection control and having infection control policies in  place. CMS, the Joint Commission, and AOA standards generally do not  require that hospitals implement all recommended practices in CDC’s  infection control and prevention guidelines. Only the Joint Commission  and AOA have standards that require the implementation of certain  practices recommended in CDC’s infection control guidelines. For  example, the Joint Commission and AOA require hospitals to annually  offer influenza vaccinations to health care workers, which is  recommended in CDC’s Influenza Vaccination of Health Care Personnel  guideline. CMS, the Joint Commission, and AOA assess compliance with  their infection control standards through direct observation of hospital  activities and review of hospital policy documents during on-site surveys.
subsections: section_title: Standards for Hospitals on Infection Control Required by CMS and Accrediting Organizations Describe Components of Infection Control Programs
paragraphs: CMS, Joint Commission, and AOA standards for hospital certification and  accreditation include standards on infection control. In contrast to CDC’s  infection control guidelines, which describe clinical practices  recommended to reduce HAIs, the CMS, Joint Commission, and AOA  standards and their interpretations—which include the performance  expectations and explain the standards—describe the fundamental  components of a hospital’s infection control program, the overall goal of  which is the prevention, control, and investigation of infections.
CMS’s infection control COP, the Joint Commission’s chapter on infection  control, and AOA’s chapter on infection control have varying numbers of  standards, some of which have been updated more recently than others.  (See app. II for CMS’s, Joint Commission’s, and AOA’s infection control  standards for hospitals.)
CMS’s infection control COP contains two standard-level requirements  and has not substantially changed since 1986. CMS’s State Operations  Manual: Appendix A provides guidance to surveyors in assessing  compliance with the COP and explains its intent. CMS issued revised  guidance to surveyors for assessing the infection control COP on  November 21, 2007, with an immediate effective date.
The Joint Commission has 10 infection control standards in the infection  control chapter of its manual, the Comprehensive Accreditation Manual  for Hospitals: The Official Handbook. The Joint Commission describes  its standards as broad, overarching compliance principles. The Joint  Commission manual provides hospitals with information about the  accreditation process, including how to comply with the 10 standards in  the infection control chapter, and presents a rationale for each standard  and “elements of performance,” which describe the specific requirements  for a hospital to be in compliance with a standard. There are a total of 48  elements of performance associated with the standards in the infection  control chapter, ranging from 2 to 8 per standard. In 2006 the Joint  Commission began revising its hospital standards, including the infection  control standards. These revisions, which the Joint Commission officials  described as clarifications to existing standards, will take effect on  January 1, 2009. The Joint Commission manual also describes other  requirements hospitals must meet to be accredited by the Joint  Commission, such as the eight National Patient Safety Goals for 2008, one  of which relates to HAIs and requires hospitals to (1) comply with the  current WHO hand hygiene guideline or CDC hand hygiene guideline and  (2) manage as a “sentinel event” all identified cases of unanticipated death  or major permanent loss of function associated with an HAI.
AOA has 51 standards in the “Infection Control” chapter of its  Accreditation Requirements for Healthcare Facilities manual, which also  provides guidance to surveyors in applying AOA’s standards, and these  were last updated in 2005. AOA officials also told us they anticipated  updating this chapter to reflect CMS’s revised infection control COP  guidance.
As a whole, the CMS, Joint Commission, and AOA standards and their  interpretations describe similar required elements of hospital infection  control programs. Similarities include the following:    The infection control program is hospitalwide.
The hospital designates a person or persons as responsible for the  infection control program.
The hospital develops policies to control and reduce infections.
The hospital educates health care personnel, patients, and family members  about infection control.
The hospital conducts surveillance activities, which include infection- related data collection and analysis.
The hospital evaluates the effectiveness of infection control activities and  modifies or updates the infection control program as needed.
However, there are also differences between the CMS, Joint Commission,  and AOA infection control standards and their interpretations. One  example is that the CMS and AOA standards specify that the hospital  should maintain a log of infections and communicable diseases detected at  the hospital, whereas the Joint Commission has several standards whose  elements of performance state that hospitals should collect infection  control surveillance data. Another difference is the extent to which the  standards and their interpretations require implementation of practices  recommended in CDC’s infection control guidelines. The CMS, Joint  Commission, and AOA standards generally do not require that hospitals  implement all required practices in CDC’s infection control and prevention  guidelines. While CMS’s and the accrediting organizations’ standards  interpretations make general references to incorporating guidelines into  the hospital’s infection control activities, only the Joint Commission and  AOA have standards that require the implementation of certain practices  recommended in CDC’s infection control guidelines. The CMS standards  interpretations have a more general statement that a hospital with a  comprehensive hospitalwide infection control program should adopt  policies and procedures based as much as possible on national guidelines.  For example:    As noted previously, a Joint Commission National Patient Safety Goal  requires hospitals to implement selected practices in either CDC’s or  WHO’s hand hygiene guideline. AOA has a standard on hand washing that  requires hospitals to have policies and procedures on practices related to  hand decontamination and the prevention of HAIs, some of which are also  recommended in CDC’s guidelines, such as the elimination of artificial  nails for staff working in intensive care units. The CMS standards  interpretations are more general, stating that hospitals should adopt  policies and procedures based on national guidelines that, among other  things, address the mitigation of risks that contribute to HAIs by, for  example, promoting hand washing hygiene among staff and employees,  including use of alcohol-based hand sanitizers.
Two AOA standards require hospitals to comply with certain practices  recommended in CDC’s guidelines that reduce surgical site infections and  prevent central venous catheter–related infections. The CMS and Joint  Commission standards and their interpretations are not as specific. The  CMS standards interpretations state that a hospital with a comprehensive  infection control program should adopt policies and procedures that  address the mitigation of risk associated with HAIs, including surgery- related infections and device-associated infections. The Joint Commission  standards interpretations state that hospitals set goals that include  minimizing the risk of transmitting infections associated with the use of  procedures, medical equipment, and medical devices and implement  methods such as appropriate sterilization techniques to reduce those risks.
Both the Joint Commission and AOA standards incorporate  recommendations from CDC’s guideline Influenza Vaccination of Health- Care Personnel by requiring hospitals to annually offer influenza  vaccinations to health care workers. In contrast, the CMS standards  interpretations are more general, stating that hospitals should adopt  policies and procedures that address hospital-staff-related issues, such as  evaluating hospital staff immunization status for designated infectious  diseases, as recommended by CDC and its Advisory Committee on  Immunization Practices.
section_title: Compliance with Required Infection Control Standards Is Assessed through Observation and Document Review during On-Site Surveys of Hospitals
paragraphs: During on-site surveys, CMS, Joint Commission, or AOA surveyors assess  compliance with their respective infection control standards by directly  observing patient care, interviewing hospital staff, and reviewing key  infection control documents, such as the hospital’s infection control plan.  In addition, the Joint Commission’s surveyors assess compliance with the  infection control standards by conducting an infection control system  tracer, which is designed to address a hospital’s overall system for  detecting and preventing infections. Joint Commission officials noted that  they foster compliance with the practices for reducing HAIs by using a  “systems-based” approach. Throughout each on-site survey, CMS, the  Joint Commission, and AOA surveyors document noncompliance with the  standards that they observe. For example, CMS, Joint Commission, and  AOA officials told us that surveyors document observations of poor hand  hygiene (e.g., a health care worker not washing his or her hands).
Based on the results of the surveys, CMS and the accrediting organizations  assess a hospital’s compliance with the infection control standards. CMS,  Joint Commission, and AOA surveyors are required to cite all instances of  noncompliance. At the end of each survey, CMS surveyors review the  observations of noncompliance for each standard and determine whether  to cite the hospital at the condition level or the standard level based on the  nature (i.e., severity) and extent (i.e., prevalence) of the noncompliance. A  CMS-surveyed hospital is required to develop a corrective action plan  within 10 days of receiving a report documenting the noncompliance  found during a survey. The Joint Commission assesses each of the  elements of performance that constitute the infection control standards as  satisfactory, partially compliant, or insufficient. The entire standard is  assessed as not compliant if the hospital has insufficient compliance with  any of the corresponding elements of performance or if the hospital is  partially compliant with 35 percent or more of the elements of  performance. Joint Commission–surveyed hospitals have 45 days from  receipt of the survey results to submit a report to the Joint Commission  that describes the steps the hospitals took to become compliant with any  standards that were assessed as not compliant. The AOA standards are  assessed on a scale from 1 to 4, which varies by standard, where 1  indicates full compliance and 4 indicates noncompliance. AOA-surveyed  hospitals have 30 days to report to AOA on the steps they took to become  compliant with standards assessed as noncompliant that indicate  immediate jeopardy or are at the CMS condition level and 60 days to  address other standards assessed as noncompliant. Among the surveys  conducted in the first quarter of 2007, 12.6 percent of state-agency- 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.
Between regular surveys, limited information about compliance with the  infection control standards may be identified through validation and  complaint surveys of hospitals conducted by state survey agencies. State  survey agencies conduct validation surveys for CMS on a small number of  Joint Commission–accredited hospitals within 60 days of their last Joint  Commission survey and compare the results of the two surveys. For  example, in fiscal year 2006, state agencies conducted validation surveys  at 67 hospitals. State survey agencies conduct complaint surveys in  response to complaints made by patients, family members, or health care  providers. In the first quarter of calendar year 2007, state survey agencies  conducted 1,119 complaint surveys in 828 hospitals, and infection control  deficiencies were found at 3.5 percent of the hospitals.
Information about hospital compliance with infection control standards is  generally not publicly reported on Web sites, although the Joint  Commission reports compliance with its National Patient Safety Goals on  its Web site. It reported that in calendar year 2006, 91.2 percent of the  hospitals surveyed that year were compliant with the goal related to  implementing CDC’s hand hygiene guideline, and 100 percent were  compliant with the goal related to managing all identified cases of  unanticipated death or major permanent loss of function associated with  an HAI as a sentinel event. The rate reported by the Joint Commission in  2006 for adherence to hand hygiene practices was much higher than some  studies had reported. For example, in the 2002 Guideline for Hand  Hygiene in Health-Care Settings, CDC cited several observational studies  of health care workers and reported the average adherence across the  studies to be 40 percent. The Joint Commission’s surveyors assess this  requirement by interviewing and observing hospital employees and would  assess a hospital as noncompliant with the requirement if the surveyors  observed noncompliance three or more times. Joint Commission officials  acknowledged that their assessment mechanism might not sufficiently  measure compliance because hospital staff could be on their best behavior  when surveyors were present. Joint Commission officials told us they  anticipated publishing in 2008 examples of different ways to measure  adherence to hand hygiene as well as tools and training materials that  hospitals could use to improve their hand hygiene compliance.
section_title: Multiple HHS Programs Collect Data on HAIs, but Lack of Integration of Available Data and Other Problems Limit Utility of the Data
paragraphs: Three agencies within HHS—CDC, CMS, and AHRQ—currently collect  HAI-related data for a variety of purposes in four separate databases, but  each of these databases presents only a partial view of the extent of the  HAI problem. Each database focuses its data collection on selected types  of HAIs and collects data from a different subset of hospital patients  across the country. Although officials from the various HHS agencies  discuss HAI data collection with each other, we did not find that the  agencies were taking steps to integrate any of the existing data by creating  linkages across the databases such as standardizing patient identifiers or  other data items. Creating linkages across the HAI-related databases could  enhance the availability of information to better understand where and  how HAIs occur. Although none of the databases collect data on the  incidence of HAIs for a nationally representative sample of hospital  patients, CDC officials have produced national estimates of HAIs.  However, those estimates derive from assumptions and extrapolations  that raise questions about the reliability of those estimates.
subsections: section_title: Multiple HHS Agencies Collect Different Data on HAIs, but These Data Present Only a Partial View of the Extent of the Problem
paragraphs: Three agencies within HHS currently collect HAI-related data in four  separate databases, which were created for a variety of purposes. These  are the databases associated with CDC’s National Healthcare Safety  Network (NHSN), CMS’s Medicare Patient Safety Monitoring System  (MPSMS), CMS’s Annual Payment Update (APU) program, and AHRQ’s  Healthcare Cost and Utilization Project (HCUP).
The most detailed source of information on HAIs within HHS is the NHSN  database. CDC established the NHSN database in 2005 to combine the  data it had previously collected on HAIs through the National Nosocomial  Infections Surveillance (NNIS) system with data from two other related  databases. CDC instituted NNIS as a voluntary program in the 1970s to  assist hospitals that wanted to monitor their HAI rates. CDC analyzed the  data submitted by those hospitals—which tended to be disproportionately  large hospitals, many of them academic medical centers—in order to  provide the hospitals with a benchmark HAI rate against which to  compare their own rates. In addition, CDC drew on these data to publicly  report aggregate trends in selected HAIs, and it continues to do that with  the data being submitted to the NHSN database. Many of the hospitals  that voluntarily participated in the NNIS database have continued to  submit HAI data voluntarily to the NHSN database. CDC is working with a  number of states implementing mandatory programs for hospitals to  submit HAI-related data, using NHSN as the designated mechanism by  which hospitals must submit their data. As a result, by the end of  December 2007, approximately 1,000 hospitals were enrolled in the NHSN  database, some of which continued to participate by choice while others  enrolled in the NHSN program because of state mandates.
The NHSN program provides hospitals with substantial flexibility to  determine the scope of their HAI data collection efforts. Participating  hospitals can choose which types of HAIs they will submit data on from  among those for which the NHSN program has developed detailed  definitions and protocols, including such device-associated infections as  central-line-associated BSIs, catheter-associated UTIs, and VAP, as well as  procedure-related HAIs such as SSIs and postprocedure pneumonia.  Hospitals also choose the specific hospital units (typically different kinds  of intensive care units) to monitor for device-associated HAIs and the  specific surgical procedures to monitor for SSIs and postprocedure  pneumonia. Hospital staff are supposed to follow the detailed definitions  and protocols that the NHSN program specifies to identify which patients  currently under treatment have developed one of the targeted infections.  Hospitals also have to provide at least some HAI data for 6 months of the  year to maintain their enrollment in the NHSN program.
The MPSMS database provides 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. Beginning  with hospital discharges from 2002, CMS has collected these data from the  medical records selected for annual random samples of approximately  25,000 Medicare inpatients, though the list of specific adverse events  monitored has varied over time. A CMS contractor receives copies of these  medical records after the patients’ discharge from the hospital, and the  contractor’s abstractors follow CMS’s detailed protocols to extract and  record specific information on each patient in the sample. These data  elements are then entered into algorithms that determine which patients  meet CMS’s case selection criteria for experiencing the adverse event and  for being at risk for the adverse event. For example, the abstractors would  determine which of the sampled patients had a central line catheter  inserted during that hospital stay and which of those patients had  laboratory reports indicating a BSI not present at admission, which  together would allow the calculation of the rate of central-line-associated  BSIs. Since 2004, HHS has publicly reported some of the rates of adverse  events from the MPSMS database in the National Healthcare Quality  Report and National Healthcare Disparity Report, both of which are  issued annually by AHRQ.
The APU program implemented a financial incentive for hospitals to  submit to CMS data that are used to calculate hospital performance on  measures of the quality of care they provide. The APU program receives  quality-related data from hospitals on a quarterly basis for a range of  medical conditions and, in 2007, began to require submission of  information on three specific surgical infection prevention measures.  Hospitals paid under Medicare’s inpatient prospective payment system  receive a higher rate of payment if they submit these quality data that  address their performance on recommended care practices. During fiscal  year 2008, 3,270 hospitals will receive this higher level of payment, which  represents 93 percent of hospitals eligible to participate in the APU  program. For patients who underwent specified surgical procedures,  hospital staff review their medical records after discharge and, following  detailed protocols from CMS, extract and record items of information that  relate to three infection prevention practices that are associated with  reduced risks of acquiring an SSI: (1) providing antibiotics within 1 hour of  the surgery, (2) selecting appropriate antibiotics to prevent surgical  infections, and (3) stopping the administration of the antibiotics within   24 hours of the end of the surgery. This information in turn is entered into  algorithms that determine what proportion of patients who met CMS’s  criteria for designation as eligible for these infection prevention measures  actually received them. CMS publicly reports these results for each  hospital individually on its Web site, Hospital Compare, along with state  and national averages for comparison.
AHRQ sponsored the development of the HCUP databases to create a  national information resource of patient-level health care data. One of the  HCUP databases assembles a sample of patient hospital discharge data  from 37 states and converts them to a uniform format that enables the  application of AHRQ’s 20 Patient Safety Indicators (PSI)—including two  that relate to HAIs—to an approximate national sample of all hospital  patients. The two PSIs related to HAIs involve (1) “selected infections  due to medical care,” which focuses on infections caused by intravenous  lines and catheters, and (2) postoperative sepsis among patients  undergoing elective surgery. The PSIs are designed to identify patient  safety issues by using the kinds of data that are available in hospital  discharge data sets—specifically International Classification of Diseases,  Ninth Revision (ICD-9), diagnostic and procedure codes, as well as patient  demographics and admission and discharge status—and can be used with  the HCUP database without collecting any additional information from  patient medical records. However, these indicators are intended to be  used as quality improvement tools to highlight aggregate patterns, and so  they do not identify specific instances of adverse events with a high degree  of precision. AHRQ has posted national estimates for these two  indicators—along with the other PSIs—on its Web site, showing the trend  from 1994 to 2004.
Two HHS agencies collect, or plan to collect, some limited additional  information about HAIs in other HHS databases. FDA obtains data on  deaths or serious injuries related to the use of medical devices and stores  them in the Manufacturer and User Facility Device Experience Database.
A small portion of these adverse events may involve HAIs. FDA uses  these data to identify devices whose safety warrants closer scrutiny, such  as might be warranted for heart valves that were not properly sterilized by  the manufacturer. AHRQ is developing a database on adverse events,  including HAIs, that will assemble data voluntarily submitted by hospitals  to multiple Patient Safety Organizations (PSO). AHRQ officials told us  that they planned to disseminate aggregate results derived from the PSOs  in an annual report.
Each of the four main HHS databases that currently collect information  about HAIs presents only a partial view of the extent of the problem. None  of them can provide information on the full range of HAIs, because each  focuses its data collection on selected types of HAIs (see table 3). In  addition, none of the databases can address the frequency of even these  selected HAIs for the nation as a whole, because each collects data from  different subsets of the nationwide population of hospital patients.  Although two databases—NHSN and MPSMS—address many of the same  types of HAIs, the former provides information only from selected units of  hospitals that participate in the NHSN program (which do not represent  hospitals nationwide) while the latter provides information only on a  representative sample of Medicare inpatients (i.e., MPSMS does not  provide information on non-Medicare patients). The APU program does  not collect information on patients with HAIs, but instead tracks the  implementation of practices intended to prevent SSIs. The other three  databases attempt to identify patients who developed infections as a result  of their hospital stay using different data sources and varying approaches.  The methods employed by the NHSN, MPSMS, and HCUP databases range  from concurrent review of patient care as patients are treated in the  hospital, to retrospective review of patient medical records after patients  are discharged, to analyses of diagnostic codes recorded electronically in  patient billing data.
The four databases also apply different sets of procedures to ensure the  validity of their data, and each set has its own limitations. For the NHSN  program, CDC requires participating hospitals to agree to its detailed  instructions for identifying patients with HAIs, but CDC currently has no  process in place to check how thoroughly and consistently those  instructions are followed. For the MPSMS program, CMS relies on  internal procedures performed by a contractor that collects the data to  routinely monitor the interrater reliability of its abstractors. However,  CMS has not assessed the completeness or accuracy of the information in  patient medical records that the MPSMS database measures rely on and  how that might affect the HAI rates reported by the MPSMS program. CMS  requires hospitals that submit APU data to have a small sample of their  cases checked each quarter by a CMS contractor. The contractor  assesses the accuracy with which the hospital abstracted its APU data  from patient medical records. AHRQ’s HCUP database relies on ICD-9  codes filed with patient bills. Many hospitals have their ICD-9 coding  periodically checked by outside auditors, but the reason is to determine  accuracy for billing purposes, not whether patients experienced HAIs.
Among the four databases, NHSN collects the most clinically detailed  information about HAIs, but those data nonetheless have important  limitations. Among the strengths of the NHSN database is that it presents  detailed information on HAI rates across different types of hospital units  and multiple types of HAIs. Moreover, its procedures for identifying  patients with HAIs draw on the wider range of clinical information  available while patients are still in the hospital, as opposed to  retrospective reviews of patient medical records after discharge. On the  other hand, the NHSN database is much more limited than any of the other  databases in terms of the patient population that it represents. Because the  hospitals that submit data either do so by choice or, for a limited number  of states, by mandate, this group of hospitals is not representative of  hospitals nationwide, as a random sample would be. In addition, the data  these hospitals supply do not reflect the experience of many of their  patients. For example, the hospitals that participate in the NHSN program  report device-related HAIs such as central-line-associated BSIs and VAP  for selected hospital units such as different types of intensive care units  (e.g., coronary, burn, surgical, medical). In addition, most of the hospitals  that participate in the NHSN program report procedure-based HAIs such  as SSIs and postprocedure pneumonia for a relatively small number of  specific procedures. For example, during March 2007, 225 hospitals  reported SSIs for colon surgery and 133 did so for coronary bypass  surgery, but only 11 hospitals reported SSIs for appendix surgery and 10  for gallbladder surgery.
section_title: Available Data Are Not Integrated across Programs to Use Them to Their Full Potential
paragraphs: Although officials from the various HHS agencies discuss HAI data  collection with each other, we did not find that the agencies were taking  steps to integrate any of the existing data from the four databases that  collect HAI-related data. This integration could involve creating linkages  between existing data by, for example, creating common patient  identifiers in the different databases so that data on the same individuals  found in multiple databases could be pulled together, or creating  “crosswalks” that could specify in detail how related data fields in the  various databases are similar or different. We found that the most  extensive exchange of information across the three HHS agencies that  collect HAI data occurred through the participation of their  representatives in HICPAC. HICPAC generally holds 2-day meetings three  times per year, and at each meeting the members from the participating  HHS agencies typically provide a summary of their HAI-related activities.  Our review of HICPAC minutes from 2004 through 2007 identified  numerous instances of officials describing what their own agency was  doing to collect HAI data, but we did not find in the HICPAC meeting  minutes any evidence that the agencies had taken action to create greater  compatibility among the databases or to address gaps in information  across the databases. Outside of HICPAC meetings, HHS officials provided  other examples of communication and outreach among HHS agencies  taking place in relation to various databases. For example, the MPSMS  program has a technical expert panel that includes representatives from  CDC and AHRQ. Similarly, CMS, CDC, and AHRQ are represented on the  steering committee for the public-private Surgical Care Improvement  Project (SCIP), which developed the HAI-related measures used in the  APU program. These group discussions allow agency officials to discuss  and explain their different approaches for collecting HAI data, but the  focus of these meetings is still on the individual database, rather than on  creating linkages from one database to another.
Creating mechanisms for linking data across the HAI-related databases  could enhance the availability of information to better understand where  and how HAIs occur. A case in point concerns information collected by  two of the databases on surgical-related HAIs. Approximately 500  hospitals already submit data to APU on surgical processes of care and to  NHSN on surgical infection rates for some of the same patients, but these  data are not currently linked. As a consequence, the potential benefit of  using the existing data to monitor the extent to which compliance with the  recommended surgical care processes leads to actual improvements in  surgical infection rates has not been realized. Officials at CDC reported  that they approached CMS about developing mechanisms for linking  NHSN data with APU data. To do this, CDC officials suggested that CDC  and CMS agree to collect uniform patient identifiers. Officials at CMS  reported that although they recognized the potential benefits of linking the  APU data with the data in related HHS databases, CMS is currently  focused on managing the expansion of the APU program.
section_title: Data Limitations Preclude Development of Reliable National Estimates
paragraphs: HHS cannot use its HAI-related databases to produce reliable national  estimates of HAI rates, even for the selected types of HAIs monitored,  because none of the databases collect data on the incidence of HAIs for a  nationally representative sample of hospital patients. Two of the  databases—APU and HCUP—come close to covering a national  population for selected HAIs, but the APU database collects data on  practices intended to prevent HAIs among surgery patients, not on the  number of HAIs that occur. In addition, although the information in HCUP  relates to the incidence of some HAIs, its reliance on diagnostic codes  recorded in claims data substantially reduces the reliability of that  information. The other two databases—NHSN and MPSMS—collect  clinical data on the incidence of selected HAIs, but their data do not derive  from a representative sample of the national hospital patient population  because NHSN is limited to selected units of participating hospitals that do  not represent hospitals nationwide and MPSMS is limited to Medicare  patients. (See table 3.)
Recent concerns about the magnitude of HAIs caused by the drug-resistant  pathogen MRSA have further highlighted limitations in HHS’s databases  for estimating HAI rates. In June 2007, APIC, the professional association  for infection control professionals, released the results of a survey it  conducted that showed that 46 of every 1,000 patients in those hospitals  had tested positive for MRSA. This was a much higher rate than had  previously been estimated by clinicians. The NHSN database has some  information about the frequency of MRSA infections, as well as other  MDROs, but this information is limited to the subset of patients for whom  each hospital submits data, based on the particular hospital units,  infection types, and procedures that it has chosen to report to NHSN.  Thus, the NHSN database does not provide information on the overall  proportion of patients in a given hospital who were found to have a MRSA  infection. The MPSMS program has begun to collect, but has not yet  reported, data on the incidence of hospital-acquired MRSA infections  within the Medicare inpatient population. However, a CMS official  responsible for the program acknowledged that the ability of the MPSMS  program to detect patients with MRSA infections is limited by its reliance  on retrospective review of patients’ medical records.
The varying content and methods used to collect and report data on HAIs  for HHS’s four databases also preclude HHS from combining data from the  databases to produce reliable estimates on either selected HAIs or an  overall HAI rate. Even the databases that collect data on the same types of  HAIs calculate and report rates in different ways that cannot be  reconciled. For example, the MPSMS program reported that 1.7 percent of  all the Medicare patients that had a central line inserted in 2004  experienced a central-line-associated BSI. In contrast, the NHSN program  reported the mean number of central-line-associated BSIs detected during  2006 by different types of intensive care units, calculated as the number of  infections per 1,000 days of central line use. This ranged from 1.5 per 1,000  days in inpatient medical/surgical wards to 6.8 per 1,000 days in burn  intensive care units. HHS might be able to develop approaches for linking  data across its different databases, such as by developing common data  collection methods and specifications or creating crosswalks between the  specifications for different databases. However, until that is done, the  information on HAI rates from each of the three databases collecting that  information stands alone.
CDC officials have produced national estimates of HAIs, but those  estimates derive from assumptions and extrapolations that raise questions  about the reliability of those estimates. Most recently, in 2007, CDC  officials published estimates of the aggregate incidence of HAIs and deaths  attributable to HAIs in 2002—which included an estimate of 99,000 HAI- related deaths per year. These estimates rested on two key assumptions.  The first assumption was that data from 283 hospitals reporting to the  NNIS program (the predecessor program to NHSN) were indicative of  hospital rates nationwide, even though the authors acknowledged that the  NNIS hospitals were not randomly selected and their rates could differ  from those of U.S. acute care hospitals as a whole. The second assumption  was that 2002 NNIS data on SSIs could be used to estimate rates for all  other types of HAIs, based on the relative frequency of SSIs compared to  other types of HAIs observed in a portion of NNIS hospitals during the  1990s. In 2004, CDC officials announced plans for conducting a national  survey designed to collect more up-to-date data on hospitalwide incidence  of all types of HAIs in a sample of hospital discharges, but they  subsequently decided not to proceed with those plans. CDC officials told  us they were developing plans to obtain similar data by adding questions  on HAIs to the National Hospital Discharge Survey conducted by CDC’s  National Center for Health Statistics. CDC officials said they planned to  put questions about HAIs into the National Hospital Discharge Survey  starting in 2010. However, CDC officials stated that they planned first to  pilot test several different approaches for collecting HAI data through the  National Hospital Discharge Survey, and it was too early to say what  specific information they would collect through this process.
section_title: Conclusions
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. Current  activities at the federal level include guidelines with recommended  practices issued by CDC, required standards for hospitals set by CMS, and  HAI-related data collected through multiple HHS databases. Private-sector  organizations, such as the Joint Commission and AOA, have also set  infection control standards for hospitals. With the passage of the DRA by  the Congress, hospitals will be encouraged to reduce certain HAIs,  because beginning in October 2008 CMS will stop paying hospitals higher  payments for patients that acquire them.
We identified two possible reasons for the lack of effective actions to  control HAIs to date. 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 have hindered 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 a  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, HHS has not effectively used the HAI-related data it has collected  through multiple databases across the department to provide a complete  picture about 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,  currently collected data on HAIs are not being combined to maximize their  utility. For example, data on surgical infection rates and data on surgical  processes of care are collected for some of the same patients in two  different databases that are not linked. 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 expand information about the nature of the  problem, and soon, 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. Unfortunately, leadership from the Secretary of HHS is  currently lacking to do this. Without such leadership, the department is  unlikely to be able to effectively leverage its various methods to have a  significant effect on the suffering and death caused by HAIs.
section_title: Recommendations for Executive Action
paragraphs: In order to help reduce HAIs in hospitals, the Secretary of HHS should  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.  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.
section_title: Comments from HHS and Accrediting Organizations and Our Evaluation
paragraphs: We obtained written comments on our draft report from HHS, which  appear in appendix III. HHS generally agreed with our recommendations  and noted its appreciation for our efforts in developing this report. The  comments addressed both of our recommendations.
In terms of our first recommendation, HHS’s comments indicated that  CMS welcomed the opportunity to work with CDC to review and prioritize  recommendations for infection control and would consider whether to  incorporate some of the recommendations into CMS’s hospital COPs. HHS  stated that COPs represent minimum health and safety requirements and  the two standards in the infection control COP have a broad reach for  assessing a hospital’s infection control program. HHS’s comments also  noted that the COPs currently lack the specificity of guidance and  recommendations issued by HHS agencies, including CDC’s  recommendations for infection control.
In terms of our second recommendation, HHS’s comments acknowledged  the need for greater consistency and compatibility of data collected on  HAIs and identified three actions CMS would take. First, CMS will work  with other HHS agencies to evaluate opportunities for consolidating and  coordinating national data collection programs. Second, CMS will  implement consensus-based measures whenever possible. Third, CMS will  require the collection of data that facilitate linkages between databases,  including Medicare beneficiary and hospital patient identifiers in the APU  program. HHS’s comments also noted that CDC has recently begun moving  toward greater alignment with CMS.
HHS’s comments also noted other activities under way that the  department believes would improve the collection of HAI-related data. For  example, as part of implementing section 5001(c) of the DRA, hospitals are  required to begin reporting “present on admission” data—diagnoses that  are present in patients at the time of admission—in order to determine  whether the selected preventable conditions were acquired prior to the  hospitalization. We noted this activity in the report, and we believe that it  is too early to know the extent of information that will be generated on  HAIs or how it will be used by HHS agencies. HHS’s comments also  indicated that CMS is evaluating an update to the diagnostic and  procedure coding system, which could offer clearer and more detailed  information than the current system, and also noted the benefits of  employing industry data standards for electronic health care data  exchanges to facilitate reporting of HAI-related data to both CDC and  CMS. In our report, we did not assess the effect of these activities because  they have not been implemented.
We also obtained comments on a draft of this report from representatives  of the Joint Commission and AOA. The Joint Commission concurred with  our findings that it would be beneficial to have more accurate estimates of  HAIs and that prioritization of practices to guide actions in preventing  HAIs is a valuable and necessary undertaking. However, it noted that other  actions, such as cultural changes in health care organizations, clear  strategies for implementation, and a concerted, multifaceted effort by  many stakeholders, are needed to reduce HAIs. We agree that such actions  are important in reducing HAIs, and that better prioritization of the many  recommended practices would facilitate the process the Joint Commission  describes. The Joint Commission also provided two comments related to  the section of the report that discusses hospital infection control  standards. First, it commented that our report places too great a focus on  the number of standards, and pointed out the benefit of the Joint  Commission’s systems-based approach. It expressed a concern that a  reader could perceive that the Joint Commission has fewer expectations  for hospitals than CMS or AOA. That was not our intention, and we have  modified the report to note the Joint Commission’s systems-based  approach to foster compliance with practices to reduce HAIs. Second, the  Joint Commission said that the report indicates that their standards are  less specific in that they have not adopted certain CDC recommendations,  but they noted that many of the CDC guidelines cannot be implemented  without additional research or translation into concrete, actionable steps.  In the draft, we described some activities being undertaken by CDC and  AHRQ to promote implementation of recommended practices to reduce  HAIs, including studies funded by AHRQ, and we added a clarification to  the text to note the importance of translating knowledge into social and  behavioral changes that can be sustained. Furthermore, we believe that  clearer prioritization can help efforts to promote the implementation of  practices to reduce HAIs.
HHS, the Joint Commission, and AOA provided technical comments,  which we incorporated as appropriate.
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If you or your staff have any questions about this report, please contact me  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 report. GAO staff who made major contributions to this report are  listed in appendix IV.
section_title: Appendix I: Other CDC Activities Designed to Reduce or Prevent Health-Care-Associated Infections
paragraphs: In addition to developing infection control and prevention guidelines and  recommendations, the Centers for Disease Control and Prevention (CDC)  provides leadership in outbreak investigations, surveillance, and  laboratory research and prevention of health-care-associated infections  (HAI). According to officials, CDC’s work in the area of outbreak  investigations has led to new knowledge on ways to prevent HAIs. For  example, in 2006, CDC investigated an outbreak of eye inflammation that  was occurring in patients who recently had cataract surgery at a hospital  in Maine. The outcome of this investigation led to the development of  recommended practices for cleaning and sterilizing intraocular surgical  instruments developed by the American Society of Cataract and Refractive  Surgery and the American Society of Ophthalmic Registered Nurses.
CDC’s surveillance, research, and demonstration projects measure the  effect of HAIs, adverse drug events, and other complications of health  care. CDC has funded many activities through its Prevention Epicenter  Program, which began in 1997 and is devoted to improving the detection,  reporting, and prevention of HAIs, antimicrobial resistance, and other  adverse events in health care. For example, CDC funded a multicenter trial  research project and found that daily bathing with chlorhexidine, an  antiseptic, reduces the incidence of methicillin-resistant Staphylococcus  aureus (MRSA), vancomycin-resistant enterococci (VRE), and  bloodstream infection (BSI). In addition, CDC has collaborated with three  public hospitals in Chicago to develop a clinical data warehouse using the  hospitals’ information systems, which enabled the hospitals to develop a  series of quality improvement strategies to decrease antimicrobial  resistance and improve antibiotic prescribing and infection control  practices.
Finally, CDC provides direct support and assistance to external groups  involved in many HAI prevention activities. CDC has funded and  collaborated with the Pittsburgh Veterans Affairs Medical Center to reduce  MRSA infections by more than 60 percent in its health care units. The  success of this project has led CDC and the Department of Veterans  Affairs to initiate similar efforts across all VA hospitals. In addition, CDC is  represented on the Surgical Care Improvement Project (SCIP) steering  committee.  SCIP is a national public-private partnership to reduce  surgical complications that is sponsored by the Centers for Medicare &  Medicaid Services. CDC told us that they have worked with SCIP to  develop quality measures and market the project. Finally, CDC has  provided technical assistance to the Institute for Healthcare Improvement,  a not-for-profit organization working to improve global health care, in the  development of the institute’s hand hygiene “bundle” and MRSA infection  prevention “bundle” guides.
section_title: Appendix II: Centers for Medicare & Medicaid Services’ (CMS) Condition of Participation: Infection Control
paragraphs: The conditions of participation (COP) for hospitals, including the infection  control COP as well as the survey protocols and interpretive guidelines  that accompany the COPs, are contained in Appendix A of CMS’s State  Operations Manual. CMS issued revised interpretive guidelines for the  infection control COP on November 21, 2007.
The hospital must provide a sanitary environment to avoid sources and transmission of  infections and communicable diseases. There must be an active program for the  prevention, control, and investigation of infections and communicable diseases.  (a) Standard: Organization and policies. A person or persons must be designated as  infection control officer or officers to develop and implement policies governing control of  infections and communicable diseases. (1) The infection control officer or officers must develop a system for identifying,  reporting, investigating, and controlling infections and communicable diseases of  patients and personnel.  (2) The infection control officer or officers must maintain a log of incidents  related to infections and communicable diseases.  (b) Standard: Responsibilities of chief executive officer, medical staff, and director of  nursing services. The chief executive officer, the medical staff, and the director of nursing  (1) Ensure that the hospital-wide quality assurance program and training  programs address problems identified by the infection control officer or officers;  (2) Be responsible for the implementation of successful corrective action plans in  affected problem areas.
In addition, CMS officials said that the quality assessment and  performance improvement COP, which can be found at 42 C.F.R. § 482.21  (2007), can also affect infection control.
section_title: Appendix III: Comments from the Department of Health and Human Services
section_title: Appendix IV: GAO Contact and Staff Acknowledgments
subsections: section_title: Acknowledgments
paragraphs: In addition to the contact named above, key contributors to this report  were Linda T. Kohn, Assistant Director; Donald Brown; Shaunessye Curry;  Shannon Slawter Legeer; Eric Peterson; Roseanne Price; and Keisha  Wilkerson.