Health-Care-Associated Infections in Hospitals: Leadership Needed from HHS to Prioritize Prevention Practices and Improve Data on These Infections
Released: 2008-04-16T00:00:00

Letter

Background

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.

CDC’s Infection Control and Prevention Guidelines

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.

CMS’s and the Accrediting Organizations’ Standards for Hospitals

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.

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

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.

CDC Has 13 Infection Control and Prevention Guidelines, Which Contain Almost 1,200 Recommended Practices, and over 500 of Them Are Strongly Recommended

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.

CDC and AHRQ Have Taken Steps to Promote Implementation of Practices to Reduce HAIs but Lack Prioritization of These Practices to Guide Their Actions

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.

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

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.

Standards for Hospitals on Infection Control Required by CMS and Accrediting Organizations Describe Components of Infection Control Programs

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.

Compliance with Required Infection Control Standards Is Assessed through Observation and Document Review during On-Site Surveys of Hospitals

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.

Multiple HHS Programs Collect Data on HAIs, but Lack of Integration of Available Data and Other Problems Limit Utility of the Data

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.

Multiple HHS Agencies Collect Different Data on HAIs, but These Data Present Only a Partial View of the Extent of the Problem

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.

Available Data Are Not Integrated across Programs to Use Them to Their Full Potential

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.

Data Limitations Preclude Development of Reliable National Estimates

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.

Conclusions

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.

Recommendations for Executive Action

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.

Comments from HHS and Accrediting Organizations and Our Evaluation

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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Appendix I: Other CDC Activities Designed to Reduce or Prevent Health-Care-Associated Infections

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.

Appendix II: Centers for Medicare & Medicaid Services’ (CMS) Condition of Participation: Infection Control

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.

Appendix III: Comments from the Department of Health and Human Services

Appendix IV: GAO Contact and Staff Acknowledgments

Acknowledgments

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.