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. 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. 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. 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. 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. 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. CMS officials  told us that they did not intend to continue using the tool to collect data,  as was done in the pilot study. 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. 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. 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. 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. 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.
Why GAO Did This Study

Health-care-associated infections (HAI) are a leading cause of death. Recent high-profile cases of HAIs in ambulatory surgical centers (ASC) due to lapses in recommended infection control practices may indicate a more widespread problem in ASCs, but the prevalence of such lapses is unknown. The Department of Health and Human Services' (HHS) Centers for Medicare & Medicaid Services (CMS) and other entities collect data on HAIs, including process data on the use of recommended practices and outcome data on HAI incidence. CMS conducts standard surveys on about half of ASCs every 3 to 4 years, assessing compliance with its standard on infection control. In this report, GAO examines the availability of data on HAIs in ASCs nationwide. GAO interviewed subject-matter experts, agency officials, and trade and professional group officials.

What GAO Found

Disparate sources of data on HAIs in ASCs are available, but none provide information on the extent of the problem nationwide. Such data are useful for guiding federal policies aimed at preventing the lapses in infection control practices--such as reusing syringes and drawing medication to be injected into multiple patients from single-dose vials--that can lead to increased risk of HAIs for patients. GAO identified five data sources--two operated by HHS, two by professional organizations, and one by a state government--all of which differ from one another in the type of HAI information they collect. In order to make nationwide estimates of HAIs and lapses in related infection control practices in ASCs, a data source would need to collect its data from a nationally representative random sample of ASCs. However, none of the five sources does so. The two professional organizations and the state source collect data from narrowly defined subsets of ASCs. The most detailed data are provided by the two federal sources, one of which collects outcome data and the other process data. Experts GAO interviewed said it was more feasible for ASCs to collect process data than outcome data. The Centers for Disease Control and Prevention's (CDC) National Healthcare Safety Network collects detailed, standardized data on HAI outcomes that are comparable across hospitals and other health care facilities, but it has only recently begun to collect data on ASCs and it is not set up to collect nationally representative data. The other HHS data source, a CMS ASC pilot study conducted in three states, collects detailed process data on practices that affect the risk of HAIs. The pilot study tested the application of two innovations--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--during the course of CMS's standard surveys of selected ASCs. These innovations allowed surveyors to identify serious lapses in CDC-recommended infection control practices that would not have been detected during CMS's standard surveys of selected ASCs. A CMS official told GAO that CMS officials would consider making changes to CMS's standard survey process after reviewing planned CMS and CDC analyses of the pilot study results but did not expect to collect standardized quantitative data on the extent of compliance with specific infection control practices using a data collection instrument, as was done with the assessment tool for the pilot. Even if CMS were to continue the pilot's data collection methods, the data would not be generalizable to ASCs nationwide--and thus could not provide information on the extent of the lapses--because ASCs are selected for surveys on the basis of their perceived risk for quality issues and the length of time since they were last surveyed, rather than through random selection. A random sample--the size of which CMS could determine--could generate national estimates that would identify those infection control practices where lapses by ASCs across the country were most likely to put their patients at risk of contracting HAIs.