Health-Care-Associated Infections: HHS Action Needed to Obtain Nationally Representative Data on Risks in Ambulatory Surgical Centers
Published: 2009-02-25T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.

section_title: Letter
paragraphs: Health-care-associated infections (HAI) are 1 of the top 10 leading causes  of death in the United States, according to the Department of Health and  Human Services’ (HHS) Centers for Disease Control and Prevention  (CDC), and can cause needless suffering and expense. HAIs are infections  that patients may acquire in a health care setting while receiving treatment  for other conditions. One such setting is ambulatory surgical centers  (ASC), which are freestanding outpatient facilities where surgical  procedures such as endoscopies and orthopedic or plastic surgery are  performed. Both the number of ASCs and the number of surgeries  performed in ASCs have increased substantially since 1990. Currently,  there are over 5,100 ASCs nationwide that provide services to Medicare  beneficiaries. In 2007, more than 6 million surgeries were performed in  ASCs and paid for by Medicare.
Because patients in ASCs tended to be healthier than those in hospitals  and the procedures performed in ASCs were less invasive and less  complex, experts in infection control traditionally have considered the  risk of infection in outpatient settings such as ASCs to be low. However,  in recent high-profile cases of HAIs in ASCs, large numbers of patients  were put at risk and recommended to be tested for health-care-associated  HIV and hepatitis infections. In one such case, approximately 40,000  patients in Nevada were potentially exposed to hepatitis C and other  infectious diseases over a 4-year period because of lapses in adherence to  basic infection control practices. These lapses included reusing syringes  and drawing medication to be injected into multiple patients from single- dose vials. Subsequent inspections of other ASCs in the state found similar  problems, suggesting that such lapses are not isolated events but indicate  a larger, more widespread problem. However, the prevalence of such  unsafe practices is unknown.
Two federal agencies have established standards and conducted other  activities aimed at controlling and preventing HAIs in health care settings,  including ASCs. CDC has issued evidence-based guidelines containing  recommended practices, such as proper hand hygiene, to prevent HAIs.  HHS’s Centers for Medicare & Medicaid Services (CMS) has developed  health and safety standards with which ASCs must comply in order to be  certified as suppliers of Medicare-covered services. One of the health and  safety standards covers infection control and requires each ASC to  establish an infection control program for identifying and preventing  infections and maintaining a sanitary environment. CMS oversight of  certified ASCs includes a provision for conducting on-site standard  surveys of facilities to assess their compliance with the standards. State  survey agencies select ASCs for these surveys based on policies set by  CMS. About half of ASCs are surveyed every 3 to 4 years.
Other activities in HHS aimed at addressing the problem of HAIs include  maintaining several databases in different HHS agencies, such as the  database of CDC’s National Healthcare Safety Network (NHSN) program.  In response to demands for more public information on HAIs, at least 23  states have begun to develop and implement HAI public reporting  systems—with 17 using CDC’s NHSN—to collect and disseminate HAI  data from hospitals. In addition, some states plan to include HAI data  from ASCs in these reporting systems, with Missouri beginning to collect  data in 2006. These data sources collect information related to HAIs,  including process and outcome measures. Process measures record the  use of procedures or practices, such as hand hygiene and safe injection  practices, designed to reduce the incidence of infections. Outcome  measures record actual incidence of an active infection such as a surgical  site infection (SSI), or the transmission of an infectious agent such as  hepatitis following a procedure.
Previously, we reported that the extent of the HAI problem, while  significant, was unknown because the data that CDC and other HHS  agencies collect on HAIs in hospitals are limited in scope and lack  integration across multiple databases. We also found that resource and  technological challenges have affected the implementation of states’ HAI  public reporting systems. Data on the extent of the problem of HAIs  nationwide are useful for guiding federal actions and policies aimed at  preventing the lapses in infection control practices that can lead to  increased risk of infection for patients in medical facilities. Given your  continuing concern regarding HAIs and recent incidents involving HAIs in  ASCs, in this report we (1) examine the extent to which data are available  to understand the problem of HAIs in ASCs nationwide and (2) compare  the feasibility of collecting outcome versus process data on HAIs in ASCs.
To examine the extent to which data are available to understand the  problem of HAIs in ASCs nationwide, we interviewed subject-matter  experts and agency and organization officials knowledgeable about this  topic. We identified six subject-matter experts by conducting a literature  search to systematically find individuals who have published studies  related to HAIs in ASCs. We interviewed the six subject-matter experts  using a standard set of interview questions and received responses from  all six. We also interviewed officials from the three main accrediting  organizations; the ASC trade association; CDC and CMS; three  professional organizations and one advocacy organization identified as  having knowledge related to our research objectives; and three state  survey agencies that were identified by CMS officials as participating in a  pilot project involving infection control in ASCs. To compare the  feasibility of collecting outcome versus process data on HAIs in ASCs, we  asked all experts and CMS and CDC officials we interviewed to identify  the challenges in collecting such data and how these challenges can be  addressed. We conducted this performance audit from June 2008 through  December 2008, in accordance with generally accepted government  auditing standards. Those standards require that we plan and perform the  audit to obtain sufficient, appropriate evidence to provide a reasonable  basis for our findings and conclusions based on our audit objectives. We  believe that the evidence obtained provides a reasonable basis for our  findings and conclusions based on our audit objectives.
subsections: section_title: Background
paragraphs: 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.
section_title: Disparate Sources of Data on HAIs in ASCs Are Available, but None Provide Information on the Problem Nationwide
paragraphs: 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.
subsections: section_title: Five Sources of Data for Separate, Non-Nationally- Representative Patient Populations Provide Different Types of Information on HAIs in ASCs
paragraphs: 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.
section_title: NHSN Collects Clinically Sophisticated and Standardized Data on HAI Outcomes in ASCs, but It Is Not Set Up to Collect Nationally Representative Data
paragraphs: 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.
section_title: 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
paragraphs: 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.
section_title: Collecting Process Data on HAIs in ASCs Is More Feasible Than Collecting Data on Outcomes
paragraphs: 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.
section_title: Conclusions
paragraphs: 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.
section_title: Recommendation for Executive Action
paragraphs: 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.
section_title: Agency Comments
paragraphs: 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.
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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.
section_title: Appendix I: Comments from the Centers for Medicare & Medicaid Services
section_title: Appendix II: GAO Contact and Staff Acknowledgments
subsections: section_title: Acknowledgments
paragraphs: 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.