Health-Care-Associated Infections
HHS Action Needed to Obtain Nationally Representative Data on Risks in Ambulatory Surgical Centers Gao ID: GAO-09-213 February 25, 2009Health-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.
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Report to Congressional Requesters:
United States Government Accountability Office:
GAO:
February 2009:
Health-Care-Associated Infections:
HHS Action Needed to Obtain Nationally Representative Data on Risks in
Ambulatory Surgical Centers:
GAO-09-213:
GAO Highlights:
Highlights of GAO-09-213, a report to congressional requesters.
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.
What GAO Recommends:
To collect nationally representative and standardized information on
ASC compliance with infection control practices that reduce HAIs, GAO
recommends 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 to conduct recurring periodic surveys of
randomly selected ASCs. In response, CMS concurred with the
recommendation.
To view the full product, including the scope and methodology, click on
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-09-213]. For more
information, contact Cynthia A. Bascetta at (202) 512-7114 or
bascettac@gao.gov.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
Disparate Sources of Data on HAIs in ASCs Are Available, but None
Provide Information on the Problem Nationwide:
Collecting Process Data on HAIs in ASCs Is More Feasible Than
Collecting Data on Outcomes:
Conclusions:
Recommendation for Executive Action:
Agency Comments:
Appendix I: Comments from the Centers for Medicare & Medicaid Services:
Appendix II: GAO Contact and Staff Acknowledgments:
Table:
Table 1: Sources of Data on HAIs from ASCs:
Abbreviations:
AAAASF: American Association for Accreditation of Ambulatory Surgery
Facilities, Inc.
ASC: ambulatory surgical center:
CDC: Centers for Disease Control and Prevention:
CMS: Centers for Medicare & Medicaid Services:
HAI: health-care-associated infection:
HHS: Department of Health and Human Services:
NHSN: National Healthcare Safety Network:
SSI: surgical site infection:
[End of section]
United States Government Accountability Office:
Washington, DC 20548:
February 25, 2009:
Congressional Requesters:
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.[Footnote 1] 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.[Footnote 2] 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.[Footnote 3]
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.
[Footnote 4] 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[Footnote 5] 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.[Footnote 6] CMS oversight of certified ASCs includes a
provision for conducting on-site standard surveys of facilities to
assess their compliance with the standards.[Footnote 7] 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.[Footnote 8] 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.[Footnote 9] We also found that
resource and technological challenges have affected the implementation
of states' HAI public reporting systems.[Footnote 10] 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;[Footnote 11] the ASC trade association;
CDC and CMS; three professional organizations and one advocacy
organization identified as having knowledge related to our research
objectives;[Footnote 12] and three state survey agencies that were
identified by CMS officials as participating in a pilot project
involving infection control in ASCs.[Footnote 13] 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.
Results in Brief:
Disparate sources of data on HAIs in ASCs are available, but none
provide information on the extent of the problem nationwide. We
identified five sources of data on HAIs in ASCs--two administered 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
that they collect. In order to make nationwide estimates of HAIs and
lapses in related infection control practices in ASCs that could be
used in developing federal actions and policies designed to prevent
these infections, 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 only from member ASCs or from ASCs within a certain
geographical area, respectively. The most detailed data are provided by
the two federal sources. CDC's NHSN--the most widely recognized source
of data on HAIs--collects detailed, standardized data on HAI outcomes
that are comparable across 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, collected detailed process data on practices
that affect the risk of HAIs in ASCs. 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. These
innovations allowed surveyors to identify serious lapses in CDC-
recommended infection control practices. These lapses would not have
been detected during the course of CMS's standard surveys of selected
ASCs. CMS officials told us that they intended to 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 study's data collection methods, those
data would represent only the ASCs actually surveyed under CMS's
current selection policies. The data would not be generalizable to ASCs
nationwide--and thus could not provide information on the extent of the
problem--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 HHS could determine--could 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.
Experts we interviewed stated that it was more feasible for ASCs to
collect process data than outcome data. They noted that collecting
outcome data in ASCs was challenging because patients were typically in
ASCs for a relatively short period of time and would be more likely to
seek follow-up care at a physician's office or hospital emergency room
than to return to the ASC. Therefore the ASC might never know that an
HAI occurred, and so would be unable to report it. Several experts said
that it was more feasible to collect process data to detect unsafe
practices that might lead to HAIs than to track outcomes such as the
transmission of HAIs to individual patients. They added that process
data might also be more useful by pointing out areas for specific
remedial training.
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.
We provided a draft of this report to HHS for comment. In written
comments submitted by CMS, the agency concurred with our
recommendation. CMS stated that it would use the results from the pilot
study to determine whether it should incorporate the infection control
assessment tool into the standard ASC survey process. The agency stated
that if it decided to use the tool, then it would examine the potential
to draw on CDC to provide training on the use of the tool and data
analysis of the completed tools on an ongoing basis. Given such
support, CMS stated its willingness to begin random selection of at
least some ASCs in each state for ASC surveys.
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.[Footnote 14] 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.[Footnote 15]
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.)
Table 1: Sources of Data on HAIs from ASCs:
Data sources: CDC National Healthcare Safety Network (NHSN);
Number of ASCs; time period: Unknown; data from 2006 to present;
Patient population: Patients undergoing selected procedures in enrolled
facilities, some of which may be ASCs;[A] some facilities enroll in
NHSN voluntarily and others are required to do so under state law;
Data collection method: HAIs are detected by facility staff through
prospective and post-discharge surveillance, which may include patient
examination, medical record review, and/or communication with a patient
or physician[B];
Outcomes recorded: Procedure-specific SSIs[B];
Process/practices recorded: Central line insertion practices[C];
Data analysis: Rates of SSIs, controlling for procedure type and
patient risk factors.
Data sources: CMS ASC Pilot Study;
Number of ASCs; time period: Approximately 68;[D] data from June
through October 2008;
Patient population: Patients in ASCs certified for Medicare
participation in Maryland, North Carolina, and Oklahoma;
Data collection method: Surveyors use a CDC-developed instrument to
collect data during on-site inspections through interviews, document
inspection, and observation;
Outcomes recorded: None;
Process/practices recorded: Training policies; procedures used to
detect infections; practices for hand hygiene, injection,
sterilization, and environmental cleaning;
Data analysis: Facility compliance with specified infection control
practices.
Data sources: Ambulatory Surgery Center Association Outcomes Monitoring
Project;
Number of ASCs; time period: Approximately 650; data from the mid-1990s
to present;
Patient population: Patients treated in ASCs that are members of the
Ambulatory Surgery Center Association and choose to submit data;
Data collection method: ASCs report quarterly the total number of
patients who match specified descriptions, such as experiencing wound
infections or receiving antibiotics prior to surgery;
Outcomes recorded: Aggregate number of post-procedure wound infections
per quarter;
Process/practices recorded: Aggregate number of patients for whom
antibiotics were ordered and who received them within specified time
frames prior to surgery to prevent infection;
Data analysis: Performance benchmarking compared to other ASCs.
Data sources: American Association for Accreditation of Ambulatory
Surgery Facilities, Inc. (AAAASF) Internet-based Quality Assurance and
Peer Review Reporting System;
Number of ASCs; time period: 105 multi-specialty or Medicare-certified
ASCs;[E] data from 2001 to present;
Patient population: Patients treated in facilities accredited by
AAAASF[F];
Data collection method: Facilities are obligated to report all
infections;[G] a physician peer reviews each of these cases and
extracts from the patient's medical record key information, such as
type of infection, management, and outcome;
Outcomes recorded: Aggregate number and rate[H] of infections plus
eventual resolution of infection;
Process/practices recorded: Antibiotics administered, wound management,
length of stay if hospitalized;
Data analysis: Overall rate of infections and modes of treatment.
Data sources: Missouri State HAI Reporting System;
Number of ASCs; time period: 26 in 2006; data from 2006 to present;
Patient population: Patients undergoing hernia or breast surgery in
Missouri ASCs that performed at least 20 of those procedures during the
previous calendar year;
Data collection method: HAIs are detected by facility staff during 30-
day follow up, which may include patient exam, medical record review,
or patient or physician survey[B];
Outcomes recorded: Procedure-specific SSIs[B];
Process/practices recorded: None;
Data analysis: Rates of SSIs, controlling for procedure type and
patient risk factors.
Sources: Interviews, documents, and contacts with agency and
organization officials.
[A] Until recently, enrollment in NHSN had been limited to hospitals
and outpatient hemodialysis centers. CDC officials nonetheless stated
that they believed some ASCs had enrolled and entered HAI data into
NHSN but they could not determine how many. NHSN includes, under the
ASC category, surgical units within a hospital outpatient department.
CDC has initiated a new survey of facilities enrolled in NHSN that will
identify which are ASCs and distinguish between those located within
hospitals and those that are freestanding. By February 2009, all
enrolled facilities should have completed this survey.
[B] Database uses standard CDC definitions.
[C] Although central lines, which are intravenous lines inserted into a
large vein typically in the neck or near the heart, are commonly used
in hospitals, particularly in intensive care units, they can also be
used in ASCs.
[D] Maryland agreed to survey 32 ASCs, North Carolina 16, and Oklahoma
20. The ASCs surveyed were randomly selected by CMS.
[E] These numbers do not reflect the total number of facilities in the
AAAASF database, which includes both ASC and office-based surgery
facility data. The majority of AAAASF's accredited facilities are
office-based surgical facilities that do not fall under Medicare's ASC
classification.
[F] In 1992 the American Association for Accreditation of Ambulatory
Plastic Surgery Facilities expanded the scope of its accrediting
activities to include facilities operated by physicians from other
specialties and became the AAAASF. However, facilities performing
plastic surgery remain a majority of the approximately 1,200 facilities
accredited by AAAASF.
[G] Infections are one of the unanticipated sequelae that facilities
participating in this system are obligated to report.
[H] These data are collected only on patients with identified
infections. Overall infection rates are calculated by dividing the
aggregate number of identified infections by the total number of
procedures performed.
[End of table]
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.
[Footnote 16]
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.[Footnote 17] 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.[Footnote 18] 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.
[Footnote 19] 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.[Footnote 20] 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.
[Footnote 21] 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.
[Footnote 22] 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.
[Footnote 23]
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.[Footnote 24] 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.[Footnote 25] 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 [hyperlink,
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.
Signed by:
Cynthia A. Bascetta:
Director, Health Care:
List of Congressional Requesters:
The Honorable Henry Waxman:
Chairman:
Committee on Energy and Commerce:
House of Representatives:
The Honorable Frank Pallone, Jr.
Chairman:
Subcommittee on Health:
Committee on Energy and Commerce:
House of Representatives:
The Honorable Shelley Berkley:
House of Representatives:
[End of section]
Appendix I: Comments from the Centers for Medicare & Medicaid Services:
Department Of Health & Human Services:
Office Of The Secretary:
Assistant Secretary for Legislation:
Washington, DC 20201:
January 26, 2009:
Cynthia A. Bascetta:
Director, Health Care:
U.S. Government Accountability Office:
441 G Street N.W.
Washington, DC 20548:
Dear Ms. Bascetta:
Enclosed are comments on the U.S. Government Accountability Office's
(GAO) report entitled: "Health-Care-Associated Infections: HHS Action
Needed to Obtain Nationally Representative Data on Risks in Ambulatory
Surgical Centers (GAO-09-213).
The Department appreciates the opportunity to review this report before
its publication.
Sincerely,
Signed by:
Barbara Pisaro Clark:
Acting Assistant Secretary for Legislation:
Attachment:
[End of letter]
Department Of Health & Human Services:
Centers for Medicare & Medicaid Services:
200 Independence Avenue, SW:
Washington, DC 20201:
Date: January 26, 2009:
T0: Barbara Pisaro Clark:
Acting Assistant Secretary for Legislation:
Office of the Secretary:
From: [Signed by] Charlene Frizzera:
Acting Administrator:
Subject: Government Accountability Office (GAO) Draft Report: "Health-
Care-Associated Infections: NHS Action Needed to Obtain Nationally
Representative Data on Risks in Ambulatory Surgical Centers" (GAO-09-
213):
Thank you for the opportunity to comment on the subject GAO draft
report. The purpose of the report was to examine the availability of
data on health-care-associated infections (HAIs) in ambulatory surgical
centers (ASCs) nationwide. The report notes that recent high-profile
cases of HAIs in ASCs due to lapses in recommended infection control
practices may indicate a more widespread problem in ASCs. but that the
prevalence of such lapses is unknown.
The Centers for Medicare & Medicaid Services (CMS) recognizes that the
ASC segment of the health care delivery system has been growing very
rapidly and now represents a significant portion of the surgical
services provided to Medicare beneficiaries and other patients. We also
have been concerned about strengthening the Medicare Conditions for
Coverage for ASCs. which establish health and safety standards for
these entities, in order to better assure the quality of ASC services.
On November 18, 2008, we adopted comprehensive revisions to these
standards, including introducing more stringent requirements in the
area of infection control (73 Fed. Reg. 68502. 68813, November 18,
2008). These rule changes will take effect on May 18, 2009. At the same
time as we revised the ASC requirements. we also have sought to
strengthen our oversight of ASC compliance with Medicare's standards.
Unfortunately, due to resource limitations and competing statutorily
mandated survey priorities, we have not been able to fund periodic
routine resurveys of ASCs by State Survey Agencies as frequently as we
would like. with the result that enforcement of ASC conditions for
coverage is largely complaint driven. For fiscal year 2009, however,
CMS doubled the minimum percentage of annual resurveys the States are
expected to complete. from 5 percent of all Medicare-certified ASCs to
10 percent. Additionally, in the aftermath of the Nevada HAI case
referenced in the report and our subsequent determination that there
were widespread compliance problems in ASCs throughout the State. we
concluded that more information on the prevalence of compliance
problems in Medicare-certified ASCs was required in order to further
refine our ASC oversight policy.
On very short notice, the State Survey Agencies in Maryland, North
Carolina. and Oklahoma volunteered to participate in a pilot program
under which they agreed to survey a significant number of the ASCs in
their State within a compressed timeframe. CMS made available funds to
cover these additional surveys in the three States. The Centers for
Disease Control and Prevention (CDC) also volunteered. again on short
notice. to refine the infection control surveyor tool it had pioneered
in Nevada for use in the pilot and provided training to the pilot State
surveyors on the use of the tool. CMS and CDC also entered into an
agreement whereby copies of the tools completed for each pilot survey
would be furnished to CDC for data entry and analysis. Although the
evaluation of the pilot study is still underway. we have already found
the experience of this pilot to be very instructive. We appreciate the
GAO's recognition of the valuable information that is being developed
through this pilot.
The GAO report makes one recommendation for the Department of Health
and Human Services (HHS) consideration. This recommendation and our
response to it are discussed below.
GAO 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. HHS should
develop and implement a written plan to use the data collection
instruments 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.
CMS Response:
We concur. CMS will use the results of the pilot study to evaluate the
value and feasibility. given the increased costs associated with them.
of incorporating the instrument and methodologies employed in the pilot
into the standard ASC survey process. If that evaluation results in a
decision to use the infection control survey tool on all ongoing basis.
CMS will explore with CDC whether CDC has the interest and resources to
continue its coding, data entry, and analysis of completed infection
control survey tools on an ongoing basis. as well as to provide
training at regular intervals to surveyors in the use of the tool. In
the event that CDC is able to continue this work, then CMS would be
willing to establish within the annual ASC resurvey target for each
State Survey Agency a component for a random sample of ASCs within each
State. The exact size of the component sample remains to be determined.
We thank the GAO staff for their work in this important area of Federal
health care oversight.
[End of section]
Appendix II: GAO Contact and Staff Acknowledgments:
GAO Contact:
Cynthia A. Bascetta at (202) 512-7114 or bascettac@gao.gov:
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.
[End of section]
Footnotes:
[1] In general, HAIs are distinct from community-acquired infections,
that is, infections acquired before entering the health care setting.
The term health-care-associated infection is often used synonymously
with the terms hospital-acquired infection and nosocomial infection.
[2] In this report, we are concerned exclusively with freestanding ASCs
that participate in Medicare. These ASCs do not include hospital
outpatient departments or physicians' offices where surgeries are
performed. Some freestanding ASCs may be affiliated with a hospital,
however.
[3] Medicare is a federal health insurance program that serves over 42
million elderly and disabled beneficiaries and pays for certain health
care services. Approximately 85 percent of all ASCs in the United
States are approved to provide services to Medicare beneficiaries.
While there are other ASCs that do not treat Medicare beneficiaries, in
this report we focus on those approximately 5,100 ASCs that serve
Medicare beneficiaries.
[4] C. Friedman et al., "Requirements for Infrastructure and Essential
Activities of Infection Control and Epidemiology in Out-of-Hospital
Settings: A Consensus Panel Report," American Journal of Infection
Control (27:418-30), 1999.
[5] CMS calls these ASC standards "conditions for coverage."
[6] In response to the dramatic growth since 1990 in the number of ASCs
participating in Medicare and in the volume of procedures that they
perform, CMS issued a revised set of standards for ASCs in November
2008. See 73 Fed. Reg. 68502, 68719-20, 68813 (Nov. 18, 2008) (Adding
42 C.F.R. § 416.51). In addition to requiring ASCs to maintain a
sanitary environment and an infection control program, the infection
control standard requires ASCs to document that they have considered
nationally recognized infection control guidelines and implemented
those they have determined to be most relevant to their own operations.
It also requires that the infection control program be directed by a
designated and qualified professional with training in infection
control. Discussion in this rule states that ASC clinical staff such as
nurses and pharmacists could fill this role without additional training
specific to infection control, as long as they received approximately 4
hours of continuing education in infection control each year. This rule
is effective May 18, 2009.
[7] There are several types of CMS surveys, including standard and
validation surveys, initial certification, complaint investigations,
and revisits. In this report, we discuss only standard surveys.
[8] GAO, Health-Care-Associated Infections in Hospitals: An Overview of
State Reporting Programs and Individual Hospital Initiatives to Reduce
Certain Infections, [hyperlink, http://www.gao.gov/products/GAO-08-808]
(Washington, D.C.: Sept. 5, 2008), 2, 20.
[9] GAO, Health-Care-Associated Infections in Hospitals: Leadership
Needed from HHS to Prioritize Prevention Practices and Improve Data on
These Infections, [hyperlink, http://www.gao.gov/products/GAO-08-283]
(Washington, D.C.: Mar. 31, 2008).
[10] [hyperlink, http://www.gao.gov/products/GAO-08-808], 24.
[11] These three accrediting organizations are the American Association
for Accreditation of Ambulatory Surgery Facilities, Inc., the
Accreditation Association for Ambulatory Health Care, and The Joint
Commission.
[12] These four organizations are the American Association of Nurse
Anesthetists, the American Society for Gastrointestinal Endoscopy,
HONOReform, and the Association for Professionals in Infection Control
and Epidemiology, Inc.
[13] These are the Maryland, North Carolina, and Oklahoma state survey
agencies.
[14] [hyperlink, http://www.gao.gov/products/GAO-08-283], 12.
[15] The three primary accrediting organizations for ASCs are the
American Association for Accreditation of Ambulatory Surgical
Facilities, Inc., the Accreditation Association for Ambulatory Health
Care, and the Joint Commission. The American Osteopathic Association
also accredits a small number of ASCs.
[16] An exception applies to the three states that participated in the
ASC pilot. CMS officials reported that the ASCs surveyed as part of the
pilot were randomly selected by CMS in each of the three states. In
principle, this would make the findings from these surveys
generalizable to the ASCs in each of these states, but not to ASCs in
any other state.
[17] It is possible that some ASCs are included in more than one data
source.
[18] Although the Missouri state database uses definitions based on CDC
criteria, it collects its data over the Internet through a separate,
state-developed system rather than NHSN.
[19] According to CDC officials, a modest number of ASCs were enrolled
in NHSN when enrollment was limited to hospitals and outpatient
hemodialysis centers. These were ASCs within hospitals that had
enrolled and entered HAI data into NHSN, but CDC cannot determine how
many there were. The definition of ASCs that we use for this report
does not include such surgical units within a hospital.
[20] The pilot study was not solely focused on infection control, as
the surveys conducted under the pilot study examined ASCs' compliance
with all Medicare health and safety standards except for the life
safety standards.
[21] These topics include methods to minimize sources and transmission
of infection, including adequate surveillance techniques, sterilizing
techniques for supplies and equipment, procedures for isolation,
procedures for orienting new employees in infection control and
personal hygiene, and aseptic techniques.
[22] The ASC in turn must submit a corrective action plan that
describes how it will remedy those deficiencies.
[23] Officials from the remaining state's survey agency reported that
although the state had conducted standard surveys of ASCs seeking
enrollment for the first time in Medicare, it had not previously
resurveyed any existing ASCs due to a lack of available resources.
[24] There is, however, one group of ASCs that are selected through a
generally random process. State survey agencies conduct surveys on a
CMS-selected sample of accredited ASCs to validate the accrediting
organizations' survey results. According to CMS officials,
approximately 18 percent of Medicare-certified ASCs are accredited,
which means they are inspected by the accrediting organizations rather
than the state survey agencies to determine compliance with Medicare
requirements. Accreditation surveys take place approximately every 2 to
3 years, depending on the accrediting organization.
[25] Infection control professionals identify cases of HAIs and promote
infection control practices to help reduce the occurrence and spread of
HAIs.
[End of section]
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