HHS Action Needed to Obtain Nationally Representative Data on Risks in Ambulatory Surgical Centers
GAO-09-213: Published: Feb 25, 2009. Publicly Released: Mar 30, 2009.
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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.
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.
Recommendation for Executive Action
Status: Closed - Implemented
Comments: In response to our recommendation, CMS required both state survey agencies (SAs) and accreditation organizations approved by CMS to use in their surveys of ambulatory surgical centers (ASCs) a revised version of the Infection Control Surveyor Worksheet developed for the ASC pilot study. This became a permanent part of the ASC survey process beginning October 1, 2009. In addition, to address our recommendation for a nationally representative sample, CMS identified a randomly selected subset of ASCs that each SA was required to survey in fiscal year 2010, and planned to conduct surveys on a comparable random subsample of ASCs in fiscal year 2011. HHS's actions led to a fourfold increase in the proportion of surveyed ASCs found to have deficient infection control practices, from 16.5 percent in fiscal year 2008 to 61 percent in fiscal year 2010.
Recommendation: 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, the Acting Secretary of HHS should 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 Affected: Department of Health and Human Services