Health-Care-Associated Infections: HHS Action Needed to Obtain Nationally Representative Data on Risks in Ambulatory Surgical Centers
Released: 2009-03-30T00:00:00

Letter

Background

An ASC patient may acquire an HAI from bacteria or viruses contaminating, for example, the hands of a health care worker or a needle or tube used to deliver medicine, fluids, or blood. These bacteria or viruses may include those responsible for such illnesses as staphylococcus infections and hepatitis.

Two agencies in HHS have activities under way to prevent, control, or monitor HAIs. CDC—a key HHS agency for research and programs designed to prevent HAIs—has issued 13 guidelines relevant to infection control and prevention in health care settings. In these guidelines, which are based on scientific evidence, CDC recommends practices for implementation to prevent HAIs. Practices recommended to prevent or control HAIs include, for example, appropriate isolation of infected patients in health care facilities, proper sterilization of equipment, appropriate provision of antibiotics to patients before surgery, annual vaccination of health care personnel for influenza, and hand washing or the use of alcohol-based hand rubs.

CMS is responsible for ensuring that ASCs that are certified as suppliers of Medicare-covered services comply with its requirements for infection control. For most ASCs, this occurs through the state-administered standard survey process conducted by state survey agencies under contract with CMS. ASCs may choose instead to undergo accreditation by a CMS-approved accrediting organization. CMS-approved accreditation programs for ASCs have standards that meet or exceed Medicare’s standards. Accrediting organizations are to conduct periodic surveys of ASCs to assess their compliance with the standards established by the accrediting organization, including those related to infection control. The state survey agency or accrediting organization assesses compliance through direct observation of activities in the facility and review of its policy documents. If an ASC opts for the CMS state-administered survey process, a state surveyor uses CMS’s survey guidance to conduct the state’s compliance review of the ASC.

Disparate Sources of Data on HAIs in ASCs Are Available, but None Provide Information on the Problem Nationwide

We identified five disparate sources of HAI data, all of which differed from one another in the types of HAI information they collected. However, none obtained its data from a nationally representative random sample of ASCs, and therefore none could be used to develop national estimates of HAI outcomes or compliance with infection control practices that affect the risk of acquiring HAIs in ASCs. Two federal data sources—CDC’s NHSN and CMS’s ASC pilot study—provided the most detailed information on HAI outcomes and infection control practices, respectively.

Five Sources of Data for Separate, Non-Nationally- Representative Patient Populations Provide Different Types of Information on HAIs in ASCs

We identified five disparate data sources that currently collect data on HAIs in ASCs. HHS operates two of these data sources—CDC’s NHSN and CMS’s ASC pilot study. Two are maintained by professional associations— the Ambulatory Surgery Center Association’s Outcomes Monitoring Project and the American Association for Accreditation of Ambulatory Surgical Facilities, Inc. (AAAASF) Internet-based Quality Assurance and Peer Review Reporting System. Finally, the state of Missouri collects data on HAIs in ASCs through its Missouri State HAI Reporting System. (See table 1.)

The five data sources do not provide nationally representative information on HAIs in ASCs. In order to provide a basis for a nationwide estimate of risks of HAIs in ASCs, a data source would need to collect its data from a nationally representative random sample. None of the five data sources does so, and therefore it is not possible to generalize from their results to the nationwide population of ASCs or patients that they treat. Consequently, each of these data sources provides information only about the facilities that actually submit data to it and cannot reliably be used to describe other facilities.

In terms of their coverage across ASCs, each of these data sources collects information on HAIs from a relatively small proportion of the 5,100 ASCs in the United States. The coverage ranges from the 26 ASCs that most recently reported data to the state of Missouri to about 650 ASCs reporting to the Ambulatory Surgery Center Association’s database. Moreover, which ASCs are included in each of the databases is determined by highly variable criteria. They include, depending on the database, a decision by the individual ASC to voluntarily participate, membership of the ASC in a particular professional association, and selection of an ASC based on its geographic location in a particular state. For example, all the ASCs in the ASC pilot study are from Maryland, North Carolina, or Oklahoma because those states volunteered to participate in the study, and the ASCs covered by the two professional organizations and the state source are taken from narrowly defined subsets of ASCs, that is, from member ASCs or from ASCs within a certain geographical area, respectively.

The five data sources also vary in the type and level of detail of the information they collect. NHSN, AAAASF, and Missouri’s system collect data on individual patients, and the ASC pilot study and the Ambulatory Surgery Center Association’s database collect data that are aggregated to the facility level. Four of the five data sources—all but the ASC pilot study—collect information on patient outcomes, specifically rates of SSIs. However, of those four, only the federal NHSN and state of Missouri databases employ standard CDC definitions to identify cases with SSIs based on these criteria. The two professional association databases leave identification of SSIs to individual physician judgment. Both professional association databases also collect information on one or more process measures. One of these databases focuses on a practice intended to prevent SSIs—the routine use of antibiotics prior to surgery—and the other collects information on the treatment of SSIs. The ASC pilot study collects data solely on process measures. The most detailed data are provided by the two federal data sources, NHSN—the most widely recognized source of outcome data on HAIs—and the ASC pilot study. The pilot study collects data on a broad range of process measures assessing the implementation of infection control practices, such as those intended to prevent the transmission of infections through appropriate hand hygiene, injection, and sterilization procedures.

NHSN Collects Clinically Sophisticated and Standardized Data on HAI Outcomes in ASCs, but It Is Not Set Up to Collect Nationally Representative Data

A key feature of NHSN is that it collects clinically sophisticated and standardized data on HAI outcomes. Facilities that participate in NHSN, including ASCs, agree to collect and submit information on HAI outcomes, such as SSIs, according to defined protocols and standardized definitions. CDC developed detailed protocols for NHSN that specify the medical record and laboratory data needed to identify and categorize HAIs in accordance with CDC’s standardized definitions. These protocols are widely accepted by infection control professionals because they make the data in NHSN clinically relevant and comparable across the facilities submitting data to NHSN. At the same time, the data collection procedures used by NHSN can be labor intensive and technically complex for some users. For example, one expert reported that ASCs found data submission to NHSN to be time-consuming and that an ASC might opt out of the program if its demands on staff time and other resources became excessive.

Although the number of ASCs currently submitting data to NHSN is unknown, it is likely to be small. NHSN has national open enrollment for multiple types of facilities. However, until September 2008 only hospitals and outpatient hemodialysis centers could enroll in NHSN. In September 2008, CDC launched a new release of NHSN that enabled freestanding ASCs that were separate from hospitals to enroll. Enrollment of ASCs may increase over time, especially if more states enact programs mandating public reporting of HAIs by ASCs using NHSN. According to a CDC official, CDC has a facility survey under way that will enable it to determine the number of ASCs that enroll in NHSN, but this official does not expect to have results available from this survey until spring 2009.

Nonetheless, independent of the number of ASCs that participate in NHSN, the processes by which ASCs enroll make NHSN data nonrepresentative of ASCs nationwide. Some ASCs enroll in NHSN voluntarily, and others are required to enroll by mandate of their state government. Because NHSN uses voluntary and mandatory selection procedures, the selection of ASCs for participation in NHSN is nonrandom. This lack of random selection precludes a projection of its results to any ASCs that do not participate and generalization to the national population of ASCs.

ASC Pilot Study Collected More Detailed Information on HAIs in ASCs Than CMS’s Standard Survey Process Alone, but Did Not Collect Nationally Representative Data

The ASC pilot study examined the potential for using CMS’s standard surveys to collect information on ASCs’ implementation of specific infection control practices. Under the pilot study, CMS modified the standard survey process by introducing two innovations—the incorporation of a CDC-developed infection control assessment tool and direct observation by the surveyor of a single patient’s care from start to finish of the patient’s stay. CDC officials also provided training for state surveyors on using the tool and developed plans to analyze the infection control data obtained with the tool. A CMS official told us that CMS would consider making changes to CMS’s standard survey process for ASCs after reviewing planned CMS and CDC analyses of the pilot study results.

The surveys conducted under the pilot study collected more detailed information on practices that affect the risk of HAIs in ASCs than have previous surveys of ASCs. CMS’s current survey process requires surveyors to ascertain whether an ASC’s written policies and procedures address certain general topics pertaining to infection control. In doing so, surveyors assess the implementation of these policies and procedures and an ASC’s overall maintenance of a sanitary environment through direct observation and interviews with ASC staff. If surveyors find that either the content of those policies and procedures or their implementation by ASC staff is insufficient to meet CMS’s infection control standard, they submit a deficiency report to CMS that provides a detailed narrative describing the particular conditions or activities in the ASC that created that deficiency. In contrast, the pilot study’s infection control assessment tool focused on specific CDC-recommended infection control practices. The tool is a 12-page document that includes dozens of specific infection control practices, involving such topics as environmental cleaning, disinfection, sterilization, and injection safety. CDC researchers who developed the tool included those practices that they had found were most critical for the prevention of HAIs in the ASC setting. CMS modified the tool to indicate when responses to the tool’s questions identified a violation of the ASC health and safety standards for infection control. During the course of the pilot study, surveyors recorded on the tool itself whether or not ASC staff appropriately implemented each of those practices, based on a combination of on-site interviews and observation. For each survey in the pilot, surveyors submitted a completed tool to CMS, along with the usual statements of deficiency for those ASCs where the surveyors found inadequate compliance with the infection control or other standards. Collecting completed tools for every surveyed ASC made it possible to produce standardized quantitative data on the extent of compliance with each of the practices assessed by the tool across all ASCs surveyed for the pilot study. The tool provides detailed guidance to surveyors on how to assess the implementation of these practices. In addition, the training provided by CDC officials on how to use the tool included the principles of disease transmission to prepare the state surveyors to observe ASC practices with a “sharp eye” for serious mistakes that could lead to the transmission of HAIs. State officials from the pilot states reported positive assessments of the pilot survey process and noted that during the pilot surveyors observed unsafe practices that they would not have detected using the current survey guidance. These practices included ASC staff using single-use medication vials for multiple patients and failing to properly sterilize equipment.

State officials reported that surveys conducted under the pilot study took additional time and staff resources, although specific amounts varied. In all three states, surveyors conducted a standard survey for a given ASC in addition to completing the infection control assessment tool and observing a patient’s care from start to finish. For the two states that had previously conducted standard surveys of ASCs, one found that implementing the pilot study’s two innovations required substantial additional staff resources, and the other found that, with practice, only a modest amount of additional resources was needed.

CMS and CDC officials reported that they intended to separately analyze the results of the pilot study, each agency having a different focus. Specifically, a CMS official reported that CMS would analyze the effect of the pilot study’s innovations on CMS’s ability to assess the level of compliance of ASCs in the pilot states with Medicare’s health and safety standards, including the standard pertaining to infection control. In addition, from its interviews with state officials, CMS has obtained information on what techniques were effective for using the infection control assessment tool and related CDC training. CMS’s review would identify where lapses in infection control practices were found by surveyors in the pilot states and use these data to strengthen CMS’s ASC survey guidance, which CMS is currently in the process of updating. CDC officials reported that their analysis of the pilot study would focus on deriving a baseline understanding of how safely care was being delivered in ASCs, by determining the prevalence of lapses in specific infection control practices. These officials stated that CDC would use the analysis to identify “hot spots” for infection control errors for which it could target future recommendations and trainings.

Neither CDC nor CMS officials have determined a timeline for the completion of their respective activities. As of October 2008, surveyors in the pilot states had finished their surveys and submitted the information they collected to CMS to be analyzed separately by CMS and CDC. Officials from both agencies estimated that their analyses of the survey results would be available in fiscal year 2009, but said they did not have any written plan or timeline for completing their analyses.

A CMS official reported that agency officials planned to consider making some changes to CMS’s standard survey process for ASCs after reviewing the CMS and CDC analyses but did not intend to continue the pilot study’s data collection. This official reported that CMS was considering adopting the practice of directly observing patients from start to finish that was tested in the pilot study. This official also stated that CMS was considering whether to use the infection control assessment tool simply as a prompt for surveyors in assessing compliance with its infection control standard. The official noted that the tool provided precise guidance that had previously been lacking on specific practices that surveyors should examine in assessing compliance with the infection control standard. Under the pilot study, the assessment tool allowed surveyors to record ASC compliance with specific infection control practices in a quantifiable manner. In contrast, if the tool is used as a prompt, the surveyors would report only the instances where ASCs were found to be out of compliance with the standard as a whole, giving a narrative description of the reasons why, as they currently do under the standard survey process. CMS officials told us that they did not intend to continue using the tool to collect data, as was done in the pilot study.

Even if CMS were to continue the pilot study’s data collection methods, it still would not be able to use these data to make estimates about the prevalence of safe and unsafe infection control practices in ASCs nationwide. CMS’s current policy for selecting ASCs to survey eschews random selection in favor of an approach that seeks to maximize the impact of limited survey resources, including targeting ASCs considered most likely to represent a greater risk for quality issues and selecting those that have not been surveyed within a given time interval. Specifically, in selecting ASCs for these surveys, CMS requires state survey agencies to give highest priority to ASCs that have not been surveyed in 6 years or more or that have had recent compliance problems. State survey agencies survey about half of ASCs every 3 to 4 years, but some ASCs go much longer between surveys—20 percent more than 6 years and 8 percent more than 10 years. CMS officials told us they were concerned that the level of ASC survey activity in recent years had not been sufficient to provide meaningful and current data on ASC performance across the board, including infection control issues. As a result, for fiscal year 2009 CMS increased the number of highest-priority surveys that it funded states to conduct on ASCs from 5 to 10 percent of ASCs each year. However, because this larger number of surveys does not include randomly selected ASCs, the results would still not provide information that could be generalized to ASCs nationwide.

Collecting Process Data on HAIs in ASCs Is More Feasible Than Collecting Data on Outcomes

Experts we interviewed noted that the ASC environment presented challenges to the feasibility of collecting outcome data. Some of these challenges relate to the difficulties in identifying ASC patients who develop HAIs. The experts told us that patients tend to be in outpatient facilities for a relatively short time because ASC procedures generally take little time to perform. Because HAIs are not likely to develop until after a patient leaves an ASC, the opportunity to observe patients and collect HAI data is limited. The experts also told us that the opportunity to collect HAI outcome data might be further limited because rather than returning to the ASC if a complication develops following a procedure, patients often seek follow-up care from their primary care physician, a hospital emergency department, or an urgent care center. Consequently, the ASC might never know that an HAI occurred, and so would be unable to report it.

Experts noted that a general lack of infection control professionals in ASCs presents a challenge to the feasibility of collecting either outcome or process data. According to the experts, ASCs rarely have a designated infection control professional, which is a health care worker trained to lead infection control efforts in a health care facility. CDC officials told us that, as with NHSN, data collection for HAIs has been historically designed for hospitals with the understanding that, unlike most ASCs, hospitals have infection control professionals responsible for collecting such data. The lack of such an individual presents a challenge to the feasibility of collecting either type of data, especially when such data are technically complex or the data collection processes are labor intensive. Employing an infection control professional would require ASCs to devote time and resources to an area that they have traditionally thought to be low risk.

The experts we interviewed generally agreed that collecting process data on HAIs in ASCs is more feasible and potentially more useful than collecting data on outcomes. Several experts said it was more feasible to collect data on HAIs by focusing on process measures rather than outcome measures because unsafe practices may be observed with less effort and technical training than is needed to identify individual cases of HAIs. A CMS official reported that because of the relatively short time that patients are in the facility, the ASC environment lends itself well to the methodology of tracing a patient through his or her entire experience at the ASC as a means for observing specific practices, such as those related to infection control. The experts also noted that gathering such process data could provide useful guidance to ASCs. For example, such data could point to areas for specific remedial training on preventive activities, such as training on the proper use of single-dose vials and the appropriate procedures for sterilizing equipment.

Conclusions

The increasing volume of procedures and evidence of infection control lapses in ASCs create a compelling need for current and nationally representative data on HAIs in ASCs in order to reduce their risk. Because HAIs generally only occur after a patient has left an ASC, data on the occurrence of these infections—outcome data—are difficult to collect. But data on the implementation of CDC-recommended infection control practices—process data—in ASCs can be collected more easily and can provide critical information on why HAIs are occurring and what can be done to help prevent them.

One federal data source, the ASC pilot study, has shown the potential for using process data to increase the understanding of HAIs in ASCs. The pilot study tested the addition of an infection control assessment tool to collect detailed data on recommended practices during the course of a CMS standard survey. With the tool, specially trained state surveyors were able to identify serious lapses in recommended practices. Such lapses, which increased patients’ risks of developing HAIs, had not previously been detected through CMS’s standard surveys. The pilot study had the added benefit of not relying on ASCs to submit HAI data themselves with their limited staff resources.

The results of the ASC pilot study demonstrate the feasibility of collecting data on the prevalence of specific infection control practices while conducting surveys of ASCs. Although detailed analyses of the data obtained during the pilot by CDC and CMS are pending, officials in the three pilot states and at CMS uniformly reported positive assessments of the process developed by CMS and CDC to collect these data during the course of standard ASC surveys by state surveyors. However, CMS has no plans to continue collecting such data following the completion of the ASC pilot surveys. If CMS and CDC do not build on their experiences with and analyses of the pilot to continue collecting such data from a subset of ASC surveys using an instrument such as the infection control assessment tool, then HHS is losing an opportunity to take advantage of the existing ASC survey process to collect information on the prevalence of infection control practices on an ongoing basis.

Collecting detailed data on the prevalence of infection control practices is only part of what is needed to increase the understanding of the problem of HAIs in ASCs nationwide. The ability of HHS to use CMS’s standard survey process to collect nationally representative process data on infection control practices in ASCs and to make estimates about the prevalence of safe and unsafe infection control practices in ASCs nationwide also depends on introducing random selection for ASC surveys. The larger the number of randomly selected ASCs surveyed, the greater the precision that would be achieved for those results. For standard surveys, CMS currently selects those ASCs deemed most likely to have quality problems or that have not been surveyed within a given time interval and does not select any randomly from the national population of ASCs. However, CMS has recently expanded the number of ASC surveys that it conducts, and HHS could choose to have CMS select some ASCs randomly for standard surveys while continuing to target others. In determining the number of ASCs to be randomly selected, HHS could weigh the value of obtaining more precise information from a larger number of randomly selected ASCs against the value of targeting surveys to those ASCs that may be more likely to have quality deficiencies. HHS could determine the number of ASCs it would need to select at random to generate meaningful national estimates to help identify where lapses in infection control practices by ASCs across the country were most likely to be putting patients at risk of contracting HAIs.

Recommendation for Executive Action

To obtain nationally representative and standardized information on the extent to which ASCs implement specific infection control practices that reduce the risk of transmitting HAIs to their patients, we recommend that the Acting Secretary of HHS develop and implement a written plan to use the data collection instrument and methodology tested in the ASC pilot study, with appropriate modifications based on the CDC and CMS analyses of that study, to conduct recurring periodic surveys of randomly selected ASCs.

Agency Comments

We provided a draft of this report to HHS for comment. In response, the Acting Administrator of CMS provided written comments, and we have reproduced these comments in appendix I. CMS also provided technical comments, which we have incorporated as appropriate.

In its written comments, CMS stated that it concurred with our recommendation to HHS. CMS stated that it would use the results from the pilot study to evaluate the value and feasibility of incorporating the infection control assessment tool into the standard ASC survey process. The agency stated that if its evaluation resulted in a decision to use the infection control survey tool on an ongoing basis, then it would explore with CDC whether CDC would be able to continue to provide training and data analysis of the completed infection control assessment tools, as CDC did for the pilot study. Given such support from CDC, CMS stated that it would be willing to establish a process for randomly selecting at least some ASCs in each state for ASC surveys. We agree that implementing our recommendation requires analysis of the pilot study to determine appropriate modifications to the data collection tool and collaboration within HHS. However, given the risks of HAIs in ASCs and the compelling need for current and nationally representative data on them, it is important that the department follow our recommendation to develop and implement a written plan to ensure that it collects such data using recurring periodic surveys of randomly selected ASCs.

As agreed with your offices, unless you publicly announce the contents of this report earlier, we plan no further distribution until 30 days from the report date. At that time, we will send copies to the Acting Secretary of HHS and other interested parties. The report also will be available at no charge on the GAO Web site at http://www.gao.gov.

If you or your staffs 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 II.

Appendix I: Comments from the Centers for Medicare & Medicaid Services

Appendix II: GAO Contact and Staff Acknowledgments

Acknowledgments

In addition to the contact named above, key contributors to this report were William Simerl, Assistant Director; Jennel Harvey; Eric Peterson; Roseanne Price; and Andrea E. Richardson.