Health-Care-Associated Infections in Hospitals
Leadership Needed from HHS to Prioritize Prevention Practices and Improve Data on These Infections
Gao ID: GAO-08-283 March 31, 2008
According to the Centers for Disease Control and Prevention (CDC), health-care-associated infections (HAI) are estimated to be 1 of the top 10 causes of death in the United States. HAIs are infections that patients acquire while receiving treatment for other conditions. GAO was asked to examine (1) CDC's guidelines for hospitals to reduce or prevent HAIs and what the Department of Health and Human Services (HHS) does to promote their implementation, (2) Centers for Medicare & Medicaid Services' (CMS) and hospital accrediting organizations' required standards for hospitals to reduce or prevent HAIs and how compliance is assessed, and (3) HHS programs that collect data related to HAIs and integration of the data across HHS. GAO reviewed documents and interviewed officials from CDC, CMS, the Agency for Healthcare Research and Quality (AHRQ), and accrediting organizations.
CDC has 13 guidelines for hospitals on infection control and prevention, which cover a variety of topics, and in these guidelines CDC recommends almost 1,200 practices for implementation to prevent HAIs and related adverse events. Most of the practices are sorted into five categories--from strongly recommended for implementation to not recommended--primarily on the basis of the strength of the scientific evidence for each practice. Over 500 practices are strongly recommended. CDC and AHRQ have conducted some activities to promote implementation of recommended practices, but these activities are not based on a clear prioritization of the practices. Prioritization may consider not only the strength of the evidence, but also other factors that can affect implementation, such as cost and organizational obstacles. In addition to CDC, AHRQ has reviewed scientific evidence for certain HAI-related practices, but the efforts of the two agencies have not been coordinated. The infection control standards required by CMS and hospital-accrediting organizations--the Joint Commission and the Healthcare Facilities Accreditation Program of the American Osteopathic Association (AOA)--describe the fundamental components of a hospital's infection control program. These components include the active prevention, control, and investigation of infections. The standards are far fewer in number than the recommended practices in CDC's guidelines and generally do not require that hospitals implement all recommended practices in CDC's infection control and prevention guidelines. CMS, the Joint Commission, and AOA assess compliance with their infection control standards through direct observation of hospital activities and review hospital policy documents during on-site surveys. Multiple HHS programs collect data on HAIs, but limitations in the scope of information they collect and a lack of integration across the databases maintained by these separate programs constrain the utility of the data. Three agencies within HHS currently collect HAI-related data for a variety of purposes in databases maintained by four separate programs: CDC's National Healthcare Safety Network program, CMS's Medicare Patient Safety Monitoring System, CMS's Annual Payment Update program, and AHRQ's Healthcare Cost and Utilization Project. Each of the four databases presents only a partial view of the extent of the HAI problem because each focuses its data collection on selected types of HAIs and collects data from a different subset of hospital patients across the country. GAO did not find that the agencies were taking steps to integrate data across the four databases by creating linkages across the databases, such as creating common patient identifiers. Creating linkages across the HAI-related databases could enhance the availability of information to better understand where and how HAIs occur. Although CDC officials have produced national estimates of HAIs, those estimates derive from assumptions and extrapolations that raise questions about the reliability of those estimates.
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GAO-08-283, Health-Care-Associated Infections in Hospitals: Leadership Needed from HHS to Prioritize Prevention Practices and Improve Data on These Infections
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entitled 'Health-Care-Associated Infections In Hospitals: Leadership
Needed from HHS to Prioritize Prevention Practices and Improve Data on
These Infections' which was released on April 16, 2008.
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Report to the Chairman, Committee on Oversight and Government Reform,
House of Representatives:
United States Government Accountability Office:
GAO:
March 2008:
Health-Care-Associated Infections In Hospitals:
Leadership Needed from HHS to Prioritize Prevention Practices and
Improve Data on These Infections:
GAO-08-283:
GAO Highlights:
Highlights of GAO-08-283, a report to the Chairman, Committee on
Oversight and Government Reform, House of Representatives.
Why GAO Did This Study:
According to the Centers for Disease Control and Prevention (CDC),
health-care-associated infections (HAI) are estimated to be 1 of the
top 10 causes of death in the United States. HAIs are infections that
patients acquire while receiving treatment for other conditions. GAO
was asked to examine (1) CDC‘s guidelines for hospitals to reduce or
prevent HAIs and what the Department of Health and Human Services (HHS)
does to promote their implementation, (2) Centers for Medicare &
Medicaid Services‘ (CMS) and hospital accrediting organizations‘
required standards for hospitals to reduce or prevent HAIs and how
compliance is assessed, and (3) HHS programs that collect data related
to HAIs and integration of the data across HHS. GAO reviewed documents
and interviewed officials from CDC, CMS, the Agency for Healthcare
Research and Quality (AHRQ), and accrediting organizations.
What GAO Found:
CDC has 13 guidelines for hospitals on infection control and
prevention, which cover a variety of topics, and in these guidelines
CDC recommends almost 1,200 practices for implementation to prevent
HAIs and related adverse events. Most of the practices are sorted into
five categories”from strongly recommended for implementation to not
recommended”primarily on the basis of the strength of the scientific
evidence for each practice. Over 500 practices are strongly
recommended. CDC and AHRQ have conducted some activities to promote
implementation of recommended practices, but these activities are not
based on a clear prioritization of the practices. Prioritization may
consider not only the strength of the evidence, but also other factors
that can affect implementation, such as cost and organizational
obstacles. In addition to CDC, AHRQ has reviewed scientific evidence
for certain HAI-related practices, but the efforts of the two agencies
have not been coordinated.
The infection control standards required by CMS and hospital-
accrediting organizations”the Joint Commission and the Healthcare
Facilities Accreditation Program of the American Osteopathic
Association (AOA)”describe the fundamental components of a hospital‘s
infection control program. These components include the active
prevention, control, and investigation of infections. The standards are
far fewer in number than the recommended practices in CDC‘s guidelines
and generally do not require that hospitals implement all recommended
practices in CDC‘s infection control and prevention guidelines. CMS,
the Joint Commission, and AOA assess compliance with their infection
control standards through direct observation of hospital activities and
review hospital policy documents during on-site surveys.
Multiple HHS programs collect data on HAIs, but limitations in the
scope of information they collect and a lack of integration across the
databases maintained by these separate programs constrain the utility
of the data. Three agencies within HHS currently collect HAI-related
data for a variety of purposes in databases maintained by four separate
programs: CDC‘s National Healthcare Safety Network program, CMS‘s
Medicare Patient Safety Monitoring System, CMS‘s Annual Payment Update
program, and AHRQ‘s Healthcare Cost and Utilization Project. Each of
the four databases presents only a partial view of the extent of the
HAI problem because each focuses its data collection on selected types
of HAIs and collects data from a different subset of hospital patients
across the country. GAO did not find that the agencies were taking
steps to integrate data across the four databases by creating linkages
across the databases, such as creating common patient identifiers.
Creating linkages across the HAI-related databases could enhance the
availability of information to better understand where and how HAIs
occur. Although CDC officials have produced national estimates of HAIs,
those estimates derive from assumptions and extrapolations that raise
questions about the reliability of those estimates.
What GAO Recommends:
GAO recommends that the Secretary of HHS identify priorities among the
recommended practices in CDC‘s guidelines and establish greater
consistency and compatibility of the data collected across HHS on HAIs.
HHS generally agreed with GAO‘s recommendations. In response to
comments from the Joint Commission, GAO clarified its discussion of
Joint Commission activities; in addition, it incorporated technical
comments from the Joint Commission and AOA.
To view the full product, including the scope and methodology, click on
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-08-283]. For more
information, contact Cynthia A. Bascetta at (202) 512-7114 or
bascettac@gao.gov.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
CDC Has 13 Infection Control and Prevention Guidelines Containing
Almost 1,200 Recommended Practices, but Activities across HHS to
Promote Implementation Are Not Guided by Prioritization of Practices:
CMS's and Accrediting Organizations' Required Hospital Standards
Describe Components of Infection Control Programs, and Compliance with
These Standards Is Assessed through On-Site Surveys:
Multiple HHS Programs Collect Data on HAIs, but Lack of Integration of
Available Data and Other Problems Limit Utility of the Data:
Conclusions:
Recommendations for Executive Action:
Comments from HHS and Accrediting Organizations and Our Evaluation:
Appendix I: Other CDC Activities Designed to Reduce or Prevent Health-
Care-Associated Infections:
Appendix II: Centers for Medicare & Medicaid Services' (CMS) Condition
of Participation: Infection Control:
Appendix III: Comments from the Department of Health and Human
Services:
Appendix IV: GAO Contact and Staff Acknowledgments:
Tables:
Table 1: CDC's Infection Control and Prevention Guidelines, with Number
of Recommended Practices, Issued between 1981 and 2007:
Table 2: Number of Practices in the Seven CDC Infection Control and
Prevention Guidelines That Used the Five Categories, by Category:
Table 3: Selected Characteristics of HHS Databases That Contain HAI-
Related Information:
Abbreviations:
ABCs: Active Bacterial Core Surveillance:
AHRQ: Agency for Healthcare Research and Quality:
AOA: Healthcare Facilities Accreditation Program of the American
Osteopathic Association:
APIC: Association for Professionals in Infection Control and
Epidemiology:
APU: Annual Payment Update:
BSI: bloodstream infection:
CDC: Centers for Disease Control and Prevention:
CMS: Centers for Medicare & Medicaid Services:
COP: condition of participation:
DRA: Deficit Reduction Act of 2005:
DRG: diagnosis-related group:
FDA: Food and Drug Administration:
HAI: health-care-associated infection:
HCUP: Healthcare Cost and Utilization Project:
HHS: Department of Health and Human Services:
HICPAC: Healthcare Infection Control Practices Advisory Committee:
ICD-9: International Classification of Diseases, Ninth Revision:
MDRO: multidrug-resistant organism:
MPSMS: Medicare Patient Safety Monitoring System:
MRSA: methicillin-resistant Staphylococcus aureus:
NHSN: National Healthcare Safety Network:
NNIS: National Nosocomial Infections Surveillance:
PSI: Patient Safety Indicator:
PSO: Patient Safety Organization:
SCIP: Surgical Care Improvement Project:
SHEA: Society for Healthcare Epidemiology of America:
SSI: surgical site infection:
UTI: urinary tract infection:
VAP: ventilator-associated pneumonia:
VRE: vancomycin-resistant enterococci:
WHO: World Health Organization:
[End of section]
United States Government Accountability Office:
Washington, DC 20548:
March 31, 2008:
The Honorable Henry Waxman:
Chairman:
Committee on Oversight and Government Reform:
House of Representatives:
Dear Mr. Chairman:
According to the Centers for Disease Control and Prevention (CDC),
health-care-associated infections (HAI) are estimated to be 1 of the
top 10 causes of death in the United States. HAIs, as defined by CDC,
are infections that patients acquire while receiving treatment for
other conditions.[Footnote 1] For example, a patient may acquire an
infection from bacteria on a device used to treat them, such as a
needle or tube to deliver medicine, fluids, or blood. According to CDC,
the most common HAIs are urinary tract infection (UTI), surgical site
infection (SSI), pneumonia, and bloodstream infection (BSI). Some HAIs
can be caused by bacteria that have become resistant to multiple
antimicrobial drugs.[Footnote 2] One example of such a bacterium is
methicillin-resistant Staphylococcus aureus, or MRSA, which causes
infections that are resistant to treatment with usual antibiotics,
including methicillin, and can be serious and potentially life-
threatening. MRSA can cause a wide variety of infections, including
skin infections, BSIs, SSIs, and pneumonia.
HAIs can be expensive. In 2005 the average payment for a
hospitalization in Pennsylvania was over six times higher for patients
who contracted a hospital-acquired infection than for patients who did
not acquire infections, according to a report by the Pennsylvania
Health Care Cost Containment Council.[Footnote 3] A 2007 study of 1.69
million patients who were discharged from 77 hospitals found that the
additional cost of treating a patient with an HAI averaged
$8,832.[Footnote 4] The costs of HAIs are borne not only by the
patients who suffer infections, but also by those who pay for care,
such as the Centers for Medicare & Medicaid Services (CMS). According
to the American Hospital Association, Medicare paid for over one-third
of all hospital costs in 2005.[Footnote 5] Hospitals may also incur
some of the cost because they are not fully reimbursed for the cost of
the extra care attributable to HAIs.
Although not all HAIs are preventable, public and private organizations
have established standards and other activities aimed at controlling
and preventing them. CMS has established health and safety standards--
known as conditions of participation (COP)--with which hospitals must
comply in order to be eligible for payment by Medicare and Medicaid and
which include the COP for infection control.[Footnote 6] Hospitals may
choose one of two ways to show that they have met these or equivalent
standards: they may be certified by a state agency under agreement with
CMS to survey the hospital's compliance with the COPs or they may be
accredited by one of two private organizations--the Joint Commission or
the Healthcare Facilities Accreditation Program of the American
Osteopathic Association (AOA).[Footnote 7] Most hospitals are
accredited by the Joint Commission.[Footnote 8] Other activities within
the Department of Health and Human Services (HHS) aimed at addressing
the problem of HAIs in hospitals include the development of guidelines
by CDC, which contain recommended practices that hospitals may adopt,
and several databases in different parts of HHS that contain
information about HAIs in hospitals. According to the Institute of
Medicine, prevention of HAIs through implementation of evidence-based
guidelines can lead to improvements in quality of care.[Footnote 9]
Furthermore, the collection of national data on these infections can
provide a benchmark for individual hospitals to gauge their performance
and design targeted interventions.
Federal and state lawmakers are also concerned about HAIs and have
taken action to reduce them. With the passage of the Deficit Reduction
Act of 2005 (DRA),[Footnote 10] the Congress took steps to revise the
way Medicare pays hospitals so that beginning on October 1, 2008, they
would not receive higher payments for patients that acquire certain
preventable conditions (including any of three HAIs) during their
hospital stay.[Footnote 11] The HAI-related preventable conditions that
CMS identified in the final regulation implementing subsection 5001(c)
of the DRA were UTIs caused by catheters, infections caused by vascular
catheters, and mediastinitis following coronary artery bypass graft
surgery.[Footnote 12] According to Consumers Union--a nonprofit
organization that has a campaign to stop HAIs--23 state legislatures
have enacted laws that require public reporting of hospital HAI rates
or HAI-related information.[Footnote 13]
In light of congressional activity in this area and concerns you raised
about how to prevent or reduce HAIs in hospitals, we examined (1) CDC's
guidelines for hospitals to reduce or prevent HAIs, and what HHS does
to promote their implementation, (2) CMS's and the accrediting
organizations' required standards for hospitals to reduce or prevent
HAIs, and how compliance is assessed, and (3) HHS programs that collect
data related to HAIs in hospitals, and the extent the data are
integrated across HHS.
In general, to conduct our work, we reviewed documents and interviewed
HHS agency officials, including officials from CDC, CMS, the Agency for
Healthcare Research and Quality (AHRQ), and the Food and Drug
Administration (FDA).
To identify CDC's guidelines for hospitals related to HAIs as well as
assess their content, we reviewed CDC's infection control and
prevention guidelines issued between 1981 and 2007. To determine the
extent to which HHS promotes CDC's guidelines, we asked CDC officials
about the activities they undertake to promote their guidelines, and we
interviewed officials from AHRQ. We reviewed minutes of the Healthcare
Infection Control Practices Advisory Committee (HICPAC), a federal
advisory body appointed by the Secretary of HHS that provides
recommendations to the Secretary and CDC and includes members from
government agencies and private organizations.[Footnote 14] In
addition, we interviewed officials from CDC, CMS, FDA, and AHRQ. We
interviewed selected experts in the field of infection control,
including individuals from private organizations that represent health
professionals in infection control and develop materials to support
their work, such as the Society for Healthcare Epidemiology of America
(SHEA) and the Association for Professionals in Infection Control and
Epidemiology (APIC). We also reviewed the World Health Organization's
(WHO) guideline on hand hygiene.[Footnote 15]
To determine CMS's and the accrediting organizations' required
standards for hospitals to reduce or prevent HAIs and how compliance is
assessed, we reviewed CMS's COPs for hospitals and the Joint
Commission's and AOA's standards for hospitals and interviewed
officials from CMS, the Joint Commission, and AOA. We reviewed CMS's
interpretive guidelines, which describe the COPs and provide survey
procedures used to determine compliance with them and can be found
primarily in CMS's State Operations Manual.[Footnote 16] In addition,
we reviewed CMS's revised interpretive guidelines for the infection
control COP, which were published in November 2007, during the course
of our work.[Footnote 17] We also reviewed the Joint Commission's and
AOA's hospital standards manuals. For the purpose of this report, we
refer to the guidance that CMS provides about its COPs in the
interpretive guidelines, and that the Joint Commission and AOA provide
about their standards in their respective manuals, as "standards
interpretations." Our review focused on CMS's infection control COP and
the standards the Joint Commission and AOA have in the infection
control chapters of their respective manuals. We obtained the following
information from each organization: the number of hospitals surveyed by
each organization during the first quarter of 2007, and the number of
hospitals surveyed by each organization during the first quarter of
2007 that were cited as noncompliant with one of the standards on
infection control. Using the data we obtained from these officials, we
calculated the percentage of hospitals surveyed by each organization
that were noncompliant with at least one infection control standard for
the first quarter of 2007. Based on information obtained from and
discussions with each organization, we determined that the data CMS,
the Joint Commission, and AOA provided to us were sufficiently reliable
for the purposes of this report.
To identify HHS programs that routinely collect and maintain in
designated databases information that relates specifically to HAIs, we
interviewed officials at CDC, CMS, AHRQ, and FDA, and reviewed relevant
documents. To describe and assess the programs HHS has that collect
data related to HAIs and determine the extent to which the data are
integrated, we reviewed agency manuals and other relevant documents
that explain the programs that collect the data, examined related
publications and data analyses conducted by the agencies based on the
data collected, and reviewed HICPAC meeting minutes from March 2004 to
June 2007. We also interviewed officials of CDC, CMS, FDA, and AHRQ
responsible for each agency's HAI data collection efforts. We obtained
data reported from these HAI-related databases, and based on relevant
documents and discussion with agency officials we determined that the
data were sufficiently reliable for the purposes of this report.
We examined only guidelines, standards, and databases that apply to
HAIs in acute care hospitals other than critical access hospitals and
did not examine guidelines, standards, or databases that might apply to
community-acquired infections or health care workers. We did not
independently assess the clinical evidence that supports CDC's
infection control and prevention guidelines. We describe CMS's, the
Joint Commission's, and AOA's infection control standards, the
standards interpretations, and the survey process, but we did not
observe the survey process. We conducted this performance audit from
January 2007 to March 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:
CDC has 13 guidelines for hospitals on infection control and
prevention, and in these guidelines CDC recommends almost 1,200
practices for implementation to prevent HAIs and related adverse
events. The guidelines cover such topics as prevention of catheter-
associated UTIs, prevention of SSIs, and hand hygiene. An example of a
recommended practice in the hand hygiene guideline is the
recommendation that health care workers decontaminate their hands
before having direct contact with patients. Most of the practices are
sorted into five categories--from strongly recommended for
implementation to not recommended--primarily on the basis of the
strength of the scientific evidence for each practice. Over 500
practices are strongly recommended. CDC and AHRQ have conducted some
activities to promote implementation of recommended practices, such as
disseminating the guidelines and providing research funds. However,
these steps have not been guided by a prioritization of recommended
practices. One factor to consider in prioritization is strength of
evidence, as CDC has done. In addition to strength of evidence, an AHRQ
study identified other factors to consider in prioritizing recommended
practices, such as costs or organizational obstacles. Furthermore, the
efforts of the two agencies have not been coordinated. For example, we
found that CDC and AHRQ both conducted reviews of evidence for HAI-
related practices, such as hand hygiene. Although this could have been
an opportunity for coordination, an official from the HHS Office of the
Secretary told us that no one within the office is responsible for
coordinating infection control activities across HHS.
While CDC's infection control guidelines describe specific clinical
practices recommended to reduce HAIs, the infection control standards
that CMS and the accrediting organizations require as part of the
hospital certification and accreditation processes describe the
fundamental components of a hospital's infection control program. These
components include the active prevention, control, and investigation of
infections. Examples of standards and corresponding standards
interpretations that hospitals must follow include educating hospital
personnel about infection control and having infection control policies
in place. The standards are far fewer in number than the recommended
practices in CDC's guidelines--for example, CMS's infection control COP
contains two standards. Furthermore, CMS and the accrediting
organizations generally do not require that hospitals implement all
recommended practices in CDC's infection control and prevention
guidelines. Only the Joint Commission and AOA have standards that
require the implementation of certain practices recommended in CDC's
infection control guidelines. For example, the Joint Commission and AOA
require hospitals to annually offer influenza vaccinations to health
care workers, whereas CMS's interpretive guidelines, or standards
interpretations, are more general, stating that hospitals should adopt
policies and procedures based as much as possible on national
guidelines that address hospital-staff-related issues, such as
evaluating hospital staff immunization status for designated infectious
diseases. CMS, the Joint Commission, and AOA assess compliance with
their infection control standards through direct observation of
hospital activities and review of hospital policy documents during on-
site surveys.
Multiple HHS programs collect data on HAIs, but limitations in the
scope of information they collect and the lack of integration across
the databases maintained by these separate programs constrain the
utility of the data. Three agencies within HHS--CDC, CMS, and AHRQ--
currently collect HAI-related data for a variety of purposes in
databases maintained by four separate programs: CDC's National
Healthcare Safety Network (NHSN) program, CMS's Medicare Patient Safety
Monitoring System (MPSMS), CMS's Annual Payment Update (APU) program,
and AHRQ's Healthcare Cost and Utilization Project (HCUP). Each of
these databases presents only a partial view of the extent of the HAI
problem because each focuses its data collection on selected types of
HAIs and collects data from a different subset of hospital patients
across the country. Although officials from the various HHS agencies
discuss HAI data collection with each other, we did not find that the
agencies were taking steps to integrate any of the existing data by
creating linkages across the databases, such as creating common patient
identifiers. Creating linkages across the HAI-related databases could
enhance the availability of information to better understand where and
how HAIs occur. Although none of the databases collect data on the
incidence of HAIs for a nationally representative sample of hospital
patients, CDC officials have produced national estimates of HAIs.
However, those estimates derive from assumptions and extrapolations
that raise questions about the reliability of those estimates.
In order to help reduce HAIs in hospitals, we are calling for stronger
leadership from HHS by recommending that the Secretary of HHS take
action to prioritize prevention practices and improve data about HAIs.
In commenting on a draft of this report, HHS generally agreed with our
recommendations. In terms of our first recommendation, HHS's comments
indicated that CMS welcomed the opportunity to work with CDC to review
and prioritize recommendations for infection control and would consider
whether to incorporate some of the recommendations into CMS's hospital
COPs. HHS's comments also noted that the COPs currently lack the
specificity of guidance and recommendations issued by HHS agencies,
including CDC's recommendations for infection control. In terms of our
second recommendation, HHS's comments acknowledged the need for greater
consistency and compatibility of the data collected on HAIs and
identified some steps CMS would take to implement this recommendation.
HHS also provided technical comments, which we incorporated as
appropriate. In response to comments from the Joint Commission, we
clarified the discussion of Joint Commission activities; in addition,
we incorporated technical comments from the Joint Commission and AOA.
Background:
CDC has developed several guidelines for hospitals that describe and
recommend practices to prevent or control HAIs, such as hand washing or
the use of alcohol-based hand rubs, isolation of infected patients,
proper sterilization of equipment, provision of antibiotics to patients
before surgery, and annual vaccination of health care workers for
influenza. Standards from CMS and hospital accrediting organizations
provide a means for assessing hospital compliance with infection
control standards that are also aimed at preventing or controlling
HAIs.
CDC's Infection Control and Prevention Guidelines:
CDC issues both guidelines and guidance relevant to infection control
and prevention in hospitals. Guidelines are based on scientific
evidence, whereas guidance is usually provisional and limited in its
supporting evidence. CDC's infection control and prevention guidelines
set forth recommended practices, summarize the applicable scientific
evidence and research, and contain contextual information and citations
for relevant studies and literature.
Most of CDC's infection control and prevention guidelines are developed
in conjunction with HICPAC, an advisory body created in 1992 by the
Secretary of HHS. According to its charter, HICPAC provides CDC and the
Secretary with (1) advice and guidance on the practice of infection
control and strategies for surveillance,[Footnote 18] prevention, and
control of HAIs and related events in health care facilities; and (2)
advice on the periodic updating of existing HAI guidelines, the
development of new guidelines and evaluations, and other HAI policy
statements.[Footnote 19] HICPAC currently consists of 14 voting members
from various infection control disciplines throughout the United
States, a designated staff person from CDC, and 15 nonvoting liaison
members from government agencies and private organizations.
When CDC and HICPAC select a topic for an infection control and
prevention guideline, they begin with internal discussions. After
selecting a topic, HICPAC members and CDC conduct research on the
topic, which includes identifying and evaluating clinical studies
relevant to the topic and developing recommended practices, as
appropriate. The draft guidelines are written and reviewed by HICPAC
members; circulated to outside experts to validate the content; and
sent to other federal agencies for review and approval.[Footnote 20]
Afterward, HICPAC members resolve issues raised during review in face-
to-face meetings or conference calls with HICPAC members who wrote the
guideline. The approved document is published in the Federal Register
for a 45-to 60-day public comment period, after which comments are
reviewed by HICPAC members. CDC publishes the final guideline in its
Morbidity and Mortality Weekly Report, on its Web site, or through a
professional journal.
CMS's and the Accrediting Organizations' Standards for Hospitals:
Hospital compliance with CMS's or the accrediting organizations'
standards, including those related to infection control, is assessed on
a regular basis. Unannounced on-site surveys, conducted by surveyors
from CMS or the accrediting organizations, are a major component in the
process by which hospitals' compliance with health and safety standards
is assessed. Standards interpretations are given by CMS primarily in
its State Operations Manual,[Footnote 21] which is arranged by COP; by
the Joint Commission in its Comprehensive Accreditation Manual for
Hospitals: The Official Handbook, which identifies rationales and
performance expectations that are used to measure each standard and is
organized into 11 chapters of safety and quality standards such as
"Medication Management" and "Leadership;" and by AOA's standards
manual, Accreditation Requirements for Healthcare Facilities, which
provides explanations for surveyors and the scoring procedures along
with its standards and is organized into 32 chapters. Based on the
information documented during the survey, surveyors from each
organization assess a hospital's compliance with the standards.
[Footnote 22] Hospitals are required to correct instances of
noncompliance found during the survey. CMS's policy is to survey
hospitals every 3 years; however, this policy is contingent on CMS's
budget. In fiscal year 2007, CMS set a goal to survey hospitals on
average once every 4.5 years, with no more than 6 years elapsing
between surveys for any one hospital. Both the Joint Commission and AOA
survey hospitals at least once every 3 years.
The Joint Commission has additional components in its standards and
survey process. First, it issues National Patient Safety Goals, which
are requirements intended to promote specific improvements in patient
safety. Officials at the Joint Commission told us that the goals are
updated annually and derive primarily from informal recommendations
made in the Joint Commission's safety newsletter, Sentinel Event Alert,
recommendations from the Sentinel Event Advisory Group, sentinel events
reported to the Joint Commission, and a review of the patient safety
literature. The goals target problem areas in health care, such as
reducing the risk of patient injury resulting from a fall or
encouraging patients' active involvement in their own care. Each goal
is reviewed during the on-site survey to determine compliance with it.
Second, the Joint Commission conducts several "tracers" as part of its
hospital surveys, during which the care provided to selected patients
is followed or "traced" through the hospital in the same sequence in
which the patient received it. Other requirements that a hospital must
meet to be accredited by the Joint Commission include conducting an
annual self-assessment of the hospital's compliance with the Joint
Commission standards and submitting data for selected measures of
clinical performance, some of which are related to HAIs.
CDC Has 13 Infection Control and Prevention Guidelines Containing
Almost 1,200 Recommended Practices, but Activities across HHS to
Promote Implementation Are Not Guided by Prioritization of Practices:
CDC has 13 guidelines for hospitals on infection control and
prevention, and in these guidelines CDC recommends almost 1,200
specific clinical practices for implementation to prevent HAIs and
related adverse events. The practices generally are sorted into five
categories--from strongly recommended for implementation to not
recommended--primarily on the basis of the strength of the scientific
evidence for each practice. Over 500 practices are strongly
recommended. Within HHS, CDC and AHRQ conduct some activities to
promote the implementation of recommended practices, but the activities
are not based on clear prioritization of the practices, which may
consider not only the strength of the evidence, but also other factors
that can affect implementation, such as cost or organizational
obstacles.
CDC Has 13 Infection Control and Prevention Guidelines, Which Contain
Almost 1,200 Recommended Practices, and over 500 of Them Are Strongly
Recommended:
CDC has 13 infection control and prevention guidelines, which contain
1,198 specific clinical practices that CDC recommends for preventing
HAIs.[Footnote 23] (See table 1.) The hand hygiene guideline, for
example, strongly recommends that health care workers decontaminate
their hands before having direct contact with patients. The number of
recommended practices for each guideline varies. For example, the 2003
guideline outlining environmental infection control practices contains
329 recommended practices, whereas the 2006 guideline for influenza
vaccination of health care personnel has 6 recommended practices. The
earliest of the guidelines, which was on catheter-associated UTIs, was
published in February 1981, and as of December 2007, the most recent, a
revision of the guideline for isolation precautions, was published in
June 2007.
Table 1: CDC's Infection Control and Prevention Guidelines, with Number
of Recommended Practices, Issued between 1981 and 2007:
1; Guideline (issue date): Guideline for Prevention of Catheter-
associated Urinary Tract Infections (1981);
Total number of recommended practices: 24.
2; Guideline (issue date): Guideline for Infection Control in Health
Care Personnel (1998);
Total number of recommended practices: 183.
3; Guideline (issue date): Guideline for Prevention of Surgical Site
Infection (1999);
Total number of recommended practices: 63.
4; Guideline (issue date): Guidelines for Preventing Opportunistic
Infections among Hematopoietic Stem Cell Transplant Recipients (2000);
Total number of recommended practices: [A].
5; Guideline (issue date): Guidelines for the Prevention of
Intravascular Catheter-Related Infections (2002);
Total number of recommended practices: 111.
6; Guideline (issue date): Guideline for Hand Hygiene in Health-Care
Settings (2002);
Total number of recommended practices: 42.
7; Guideline (issue date): Recommendations for Using Smallpox Vaccine
in a Pre-Event Vaccination Program (2003);
Total number of recommended practices: [B].
8; Guideline (issue date): Guidelines for Environmental Infection
Control in Health-Care Facilities (2003);
Total number of recommended practices: 329.
9; Guideline (issue date): Guidelines for Preventing Health-Care-
Associated Pneumonia (2003);
Total number of recommended practices: 208.
10; Guideline (issue date): Guidelines for Preventing the Transmission
of Mycobacterium Tuberculosis in Health-Care Settings (2005);
Total number of recommended practices: [B].
11; Guideline (issue date): Influenza Vaccination of Health-Care
Personnel (2006);
Total number of recommended practices: 6.
12; Guideline (issue date): Management of Multidrug-Resistant Organisms
in Healthcare Settings (2006);
Total number of recommended practices: 80.
13; Guideline (issue date): Guideline for Isolation Precautions:
Preventing Transmission of Infectious Agents in Healthcare Settings
(2007);
Total number of recommended practices: 152.
Guideline (issue date): Total;
Total number of recommended practices: 1,198.
Source: GAO analysis of CDC guidelines.
[A] For the purpose of this table, we do not include a count of the
recommended practices in this guideline because the guideline is
targeted to a specific patient population that not all hospitals treat.
However, for the hospitals that do treat such patients, this guideline
provides at least another 164 recommended practices.
[B] The practices in these guidelines are not organized in a way that
supports counting the total number of practices.
[End of table]
The practices in these 13 guidelines are categorized primarily based on
the strength of the scientific evidence, and these categories have
changed over time. Basing the categories on the strength of the
evidence means that the more highly recommended practices have more and
better scientific support indicating their effectiveness than those
practices that are not as highly recommended. Seven of the guidelines
published between 2002 and 2007 used five categories: (1) strongly
recommended for implementation and strongly supported by well-designed
experimental, clinical, or epidemiological studies; (2) strongly
recommended for implementation and supported by some experimental,
clinical, or epidemiologic studies and a strong theoretical rationale;
(3) suggested for implementation by suggestive clinical or
epidemiologic studies; (4) additional practices, including federal,
state, and other requirements; and (5) not recommended due to
insufficient evidence or lack of consensus regarding efficacy.[Footnote
24] Over 500 practices in these 7 guidelines fall into one of the two
strongly recommended categories. Six of the 7 guidelines identify 82
practices that are not recommended, due to a lack of evidence
supporting a recommendation. (See table 2.) For example, the 2003
guideline for preventing health-care-associated pneumonia identifies 45
practices that are not recommended. The four guidelines issued between
1981 and 2000 ranked recommended practices into between three and five
categories.[Footnote 25] The 2003 guideline on smallpox vaccine and the
2005 guideline on mycobacterium tuberculosis contain recommended
practices, but they are not categorized.[Footnote 26]
Table 2: Number of Practices in the Seven CDC Infection Control and
Prevention Guidelines That Used the Five Categories, by Category:
Guideline: Guidelines for the Prevention of Intravascular Catheter-
Related infections (2002);
Recommended practices: Strongly recommended and strongly supported
(Category 1): 39;
Recommended practices: Strongly recommended and supported (Category 2):
39;
Recommended practices: Suggested for implementation (Category 3): 33;
Recommended practices: Total number of recommended practices: 111;
Additional practices including federal, state, and other
requirements[A] (Category 4): 3;
Not recommended practices (Category 5): 8.
Guideline: Guideline for Hand Hygiene in Health-Care Settings (2002);
Recommended practices: Strongly recommended and strongly supported
(Category 1): 9;
Recommended practices: Strongly recommended and supported (Category 2):
20;
Recommended practices: Suggested for implementation (Category 3): 13;
Recommended practices: Total number of recommended practices: 42;
Additional practices including federal, state, and other
requirements[A] (Category 4): 2;
Not recommended practices (Category 5): 2.
Guideline: Guidelines for Environmental Infection Control in Health-
Care Facilities (2003);
Recommended practices: Strongly recommended and strongly supported
(Category 1): 10;
Recommended practices: Strongly recommended and supported (Category 2):
134;
Recommended practices: Suggested for implementation (Category 3): 185;
Recommended practices: Total number of recommended practices: 329;
Additional practices including federal, state, and other
requirements[A] (Category 4): 94;
Not recommended practices (Category 5): 16.
Guideline: Guidelines for Preventing Health-Care-Associated Pneumonia
(2003);
Recommended practices: Strongly recommended and strongly supported
(Category 1): 28;
Recommended practices: Strongly recommended and supported (Category 2):
97;
Recommended practices: Suggested for implementation (Category 3): 83;
Recommended practices: Total number of recommended practices: 208;
Additional practices including federal, state, and other
requirements[A] (Category 4): 1;
Not recommended practices (Category 5): 45.
Guideline: Influenza Vaccination of Health-Care Personnel (2006);
Recommended practices: Strongly recommended and strongly supported
(Category 1): 1;
Recommended practices: Strongly recommended and supported (Category 2):
3;
Recommended practices: Suggested for implementation (Category 3): 2;
Recommended practices: Total number of recommended practices: 6;
Additional practices including federal, state, and other
requirements[A] (Category 4): 0;
Not recommended practices (Category 5): 0.
Guideline: Management of Multidrug-Resistant Organisms in Healthcare
Settings (2006);
Recommended practices: Strongly recommended and strongly supported
(Category 1): 2;
Recommended practices: Strongly recommended and supported (Category 2):
60;
Recommended practices: Suggested for implementation (Category 3): 18;
Recommended practices: Total number of recommended practices: 80;
Additional practices including federal, state, and other
requirements[A] (Category 4): 1;
Not recommended practices (Category 5): 4.
Guideline: Guideline for Isolation Precautions: Preventing Transmission
of Infectious Agents in Healthcare Settings (2007);
Recommended practices: Strongly recommended and strongly supported
(Category 1): 21;
Recommended practices: Strongly recommended and supported (Category 2):
83;
Recommended practices: Suggested for implementation (Category 3): 48;
Recommended practices: Total number of recommended practices: 152;
Additional practices including federal, state, and other
requirements[A] (Category 4): 3;
Not recommended practices (Category 5): 7.
Guideline: Total by category;
Recommended practices: Strongly recommended and strongly supported
(Category 1): 110;
Recommended practices: Strongly recommended and supported (Category 2):
436;
Recommended practices: Suggested for implementation (Category 3): 382;
Recommended practices: Total number of recommended practices: 928;
Additional practices including federal, state, and other
requirements[A] (Category 4): 104;
Not recommended practices (Category 5): 82.
Source: GAO analysis of CDC guidelines.
Notes: CDC has 13 infection control guidelines, of which about half are
categorized using the five categories displayed in this table.
[A] For the purpose of this table, Category 4 excludes a count of
practices that CDC also classified as recommended. More than 84 percent
of the practices in Category 4 are, for example, Occupational Safety
and Health Administration workplace standards, building and engineering
standards, or administrative plans or procedures.
[End of table]
In general, CDC took an average of about 3 years to develop each
guideline--ranging from less than 1 year to 6 years. CDC officials
agreed that the amount of time it took to prepare a guideline has been
long. CDC reported that it has been developing one guideline that is
still in draft form--the Guideline for Disinfection and Sterilization
in Healthcare Facilities--for over 7 years.[Footnote 27] This guideline
has taken a long time to develop, in part, according to CDC officials,
because the agency had to coordinate with other agencies involved in
the oversight of disinfection and sterilization products. CDC officials
said they were working to reduce the time it takes to develop
guidelines by issuing shorter and more focused guidelines.
CDC and AHRQ Have Taken Steps to Promote Implementation of Practices to
Reduce HAIs but Lack Prioritization of These Practices to Guide Their
Actions:
CDC officials identified some activities that the agency has undertaken
to promote the implementation of the recommended practices in its
guidelines.[Footnote 28] CDC disseminates its infection control
guidelines by publishing them in the Morbidity and Mortality Weekly
Report, posting them on CDC's Web site, and distributing training
videos. CDC has also provided some funding support to groups that are
developing ways to implement selected recommendations in CDC infection
control guidelines. For example, through its Prevention Epicenter
Program,[Footnote 29] CDC provided financial support and technical
assistance to a study that was assessing the effect of an intervention
to prevent catheter-associated BSIs. The researchers reviewed
participating hospitals' policies and procedures on a commonly used
catheter, updated them to reflect CDC's Guidelines for the Prevention
of Intravascular Catheter-Related Infections, and implemented an
intervention designed to educate staff about the importance of
implementing a group of selected recommendations in that
guideline.[Footnote 30] In a similar effort, CDC provided technical
support and funding to the Pittsburgh Regional Healthcare Initiative,
which reportedly has demonstrated a 68 percent decline in BSIs over a 4-
year period among intensive care unit patients.[Footnote 31]
AHRQ officials also reported undertaking some initiatives to promote
implementation of practices aimed at reducing HAIs. In 2007, AHRQ
issued a report that evaluated several strategies, such as clinician
and patient education, for possible use in hospitals to increase
implementation of specified infection prevention practices related to
catheterization, surgical antibiotic prophylaxis, central lines, and
ventilator-associated pneumonia (VAP) interventions.[Footnote 32]
Although researchers were unable to reach any firm conclusions
regarding actionable strategies to prevent HAIs, they identified four
strategies worth additional study.[Footnote 33] In addition, through
its Accelerating Change and Transformation in Organizations and
Networks program, in September 2007, AHRQ funded several studies to
improve the implementation of practices that are known to minimize HAIs
and to identify the challenges to implementing those
practices.[Footnote 34] The program will implement clinician training
at 72 hospitals that is designed to facilitate change in clinician
behaviors and habits, care processes, and the safety culture of the
participating hospitals. In a document summarizing this initiative,
AHRQ acknowledges that the problem is not the lack of knowledge of
infection control techniques, but rather the inability to translate the
knowledge into social and behavioral changes that can be sustained in
health care organizations.
While CDC and AHRQ have taken steps to promote the implementation of
practices to reduce HAIs, these steps have not been guided by a
prioritization of recommended practices. As WHO has indicated in its
hand hygiene guideline, when there is a large number of practices it is
important to prioritize them. One factor to consider in prioritization
is strength of evidence, which CDC has primarily relied on to
categorize its recommended practices. However, a 2001 AHRQ study
suggested other factors to consider in prioritizing recommended
practices. This study rated 79 patient safety practices--including 22
practices that were related to HAIs--on their potential to improve
patient safety. The study examined not only strength of the evidence,
but also such factors as:
* the potential magnitude of impact of the practice on mitigating
patient death or disability,
* the financial cost of implementing the practice,
* the complexity of implementing the practice,
* the organizational and technical obstacles, and:
* the risk that other negative consequences could occur if the practice
were put into place.
In addition to CDC, AHRQ has reviewed scientific evidence for certain
practices related to HAIs, but the efforts of the two agencies have not
been coordinated. For example, both agencies independently examined
various aspects of the evidence related to improving hand hygiene
compliance, such as the selection of hand hygiene products and health
care worker education. Although this could have been an opportunity for
coordination, an official from the HHS Office of the Secretary told us
that no one within the office is responsible for coordinating infection
control activities across HHS.[Footnote 35]
CMS's and Accrediting Organizations' Required Hospital Standards
Describe Components of Infection Control Programs, and Compliance with
These Standards Is Assessed through On-Site Surveys:
The infection control standards that CMS, the Joint Commission, and AOA
require as part of the hospital certification and accreditation
processes vary in number and content among the organizations, and
generally describe the fundamental components of a hospital infection
control program, that is, the active prevention, control, and
investigation of infections. Examples of standards and corresponding
standards interpretations that hospitals must follow include educating
hospital personnel about infection control and having infection control
policies in place. CMS, the Joint Commission, and AOA standards
generally do not require that hospitals implement all recommended
practices in CDC's infection control and prevention guidelines. Only
the Joint Commission and AOA have standards that require the
implementation of certain practices recommended in CDC's infection
control guidelines. For example, the Joint Commission and AOA require
hospitals to annually offer influenza vaccinations to health care
workers, which is recommended in CDC's Influenza Vaccination of Health
Care Personnel guideline. CMS, the Joint Commission, and AOA assess
compliance with their infection control standards through direct
observation of hospital activities and review of hospital policy
documents during on-site surveys.
Standards for Hospitals on Infection Control Required by CMS and
Accrediting Organizations Describe Components of Infection Control
Programs:
CMS, Joint Commission, and AOA standards for hospital certification and
accreditation include standards on infection control. In contrast to
CDC's infection control guidelines, which describe clinical practices
recommended to reduce HAIs, the CMS, Joint Commission, and AOA
standards and their interpretations--which include the performance
expectations and explain the standards--describe the fundamental
components of a hospital's infection control program, the overall goal
of which is the prevention, control, and investigation of infections.
CMS's infection control COP, the Joint Commission's chapter on
infection control, and AOA's chapter on infection control have varying
numbers of standards, some of which have been updated more recently
than others. (See app. II for CMS's, Joint Commission's, and AOA's
infection control standards for hospitals):
* CMS's infection control COP contains two standard-level requirements
and has not substantially changed since 1986.[Footnote 36] CMS's State
Operations Manual: Appendix A provides guidance to surveyors in
assessing compliance with the COP and explains its intent. CMS issued
revised guidance to surveyors for assessing the infection control COP
on November 21, 2007, with an immediate effective date.
* The Joint Commission has 10 infection control standards in the
infection control chapter of its manual, the Comprehensive
Accreditation Manual for Hospitals: The Official Handbook.[Footnote 37]
The Joint Commission describes its standards as broad, overarching
compliance principles. The Joint Commission manual provides hospitals
with information about the accreditation process, including how to
comply with the 10 standards in the infection control chapter, and
presents a rationale for each standard and "elements of performance,"
which describe the specific requirements for a hospital to be in
compliance with a standard. There are a total of 48 elements of
performance associated with the standards in the infection control
chapter, ranging from 2 to 8 per standard. In 2006 the Joint Commission
began revising its hospital standards, including the infection control
standards. These revisions, which the Joint Commission officials
described as clarifications to existing standards, will take effect on
January 1, 2009.[Footnote 38] The Joint Commission manual also
describes other requirements hospitals must meet to be accredited by
the Joint Commission, such as the eight National Patient Safety Goals
for 2008, one of which relates to HAIs and requires hospitals to (1)
comply with the current WHO hand hygiene guideline or CDC hand hygiene
guideline[Footnote 39] and (2) manage as a "sentinel event" all
identified cases of unanticipated death or major permanent loss of
function associated with an HAI.[Footnote 40]
* AOA has 51 standards in the "Infection Control" chapter of its
Accreditation Requirements for Healthcare Facilities manual, which also
provides guidance to surveyors in applying AOA's standards, and these
were last updated in 2005.[Footnote 41] AOA officials also told us they
anticipated updating this chapter to reflect CMS's revised infection
control COP guidance.
As a whole, the CMS, Joint Commission, and AOA standards and their
interpretations describe similar required elements of hospital
infection control programs. Similarities include the following:
* The infection control program is hospitalwide.
* The hospital designates a person or persons as responsible for the
infection control program.
* The hospital develops policies to control and reduce infections.
* The hospital educates health care personnel, patients, and family
members about infection control.
* The hospital conducts surveillance activities, which include
infection-related data collection and analysis.
* The hospital evaluates the effectiveness of infection control
activities and modifies or updates the infection control program as
needed.
However, there are also differences between the CMS, Joint Commission,
and AOA infection control standards and their interpretations. One
example is that the CMS and AOA standards specify that the hospital
should maintain a log of infections and communicable diseases detected
at the hospital, whereas the Joint Commission has several standards
whose elements of performance state that hospitals should collect
infection control surveillance data. Another difference is the extent
to which the standards and their interpretations require implementation
of practices recommended in CDC's infection control guidelines. The
CMS, Joint Commission, and AOA standards generally do not require that
hospitals implement all required practices in CDC's infection control
and prevention guidelines. While CMS's and the accrediting
organizations' standards interpretations make general references to
incorporating guidelines into the hospital's infection control
activities, only the Joint Commission and AOA have standards that
require the implementation of certain practices recommended in CDC's
infection control guidelines. The CMS standards interpretations have a
more general statement that a hospital with a comprehensive
hospitalwide infection control program should adopt policies and
procedures based as much as possible on national guidelines. For
example:
* As noted previously, a Joint Commission National Patient Safety Goal
requires hospitals to implement selected practices in either CDC's or
WHO's hand hygiene guideline.[Footnote 42] AOA has a standard on hand
washing that requires hospitals to have policies and procedures on
practices related to hand decontamination and the prevention of HAIs,
some of which are also recommended in CDC's guidelines, such as the
elimination of artificial nails for staff working in intensive care
units. The CMS standards interpretations are more general, stating that
hospitals should adopt policies and procedures based on national
guidelines that, among other things, address the mitigation of risks
that contribute to HAIs by, for example, promoting hand washing hygiene
among staff and employees, including use of alcohol-based hand
sanitizers.
* Two AOA standards require hospitals to comply with certain practices
recommended in CDC's guidelines that reduce surgical site infections
and prevent central venous catheter-related infections. The CMS and
Joint Commission standards and their interpretations are not as
specific. The CMS standards interpretations state that a hospital with
a comprehensive infection control program should adopt policies and
procedures that address the mitigation of risk associated with HAIs,
including surgery-related infections and device-associated infections.
The Joint Commission standards interpretations state that hospitals set
goals that include minimizing the risk of transmitting infections
associated with the use of procedures, medical equipment, and medical
devices and implement methods such as appropriate sterilization
techniques to reduce those risks.
* Both the Joint Commission and AOA standards incorporate
recommendations from CDC's guideline Influenza Vaccination of Health-
Care Personnel by requiring hospitals to annually offer influenza
vaccinations to health care workers. In contrast, the CMS standards
interpretations are more general, stating that hospitals should adopt
policies and procedures that address hospital-staff-related issues,
such as evaluating hospital staff immunization status for designated
infectious diseases, as recommended by CDC and its Advisory Committee
on Immunization Practices.
Compliance with Required Infection Control Standards Is Assessed
through Observation and Document Review during On-Site Surveys of
Hospitals:
During on-site surveys, CMS, Joint Commission, or AOA surveyors assess
compliance with their respective infection control standards by
directly observing patient care, interviewing hospital staff, and
reviewing key infection control documents, such as the hospital's
infection control plan. In addition, the Joint Commission's surveyors
assess compliance with the infection control standards by conducting an
infection control system tracer, which is designed to address a
hospital's overall system for detecting and preventing infections.
Joint Commission officials noted that they foster compliance with the
practices for reducing HAIs by using a "systems-based"
approach.[Footnote 43] Throughout each on-site survey, CMS, the Joint
Commission, and AOA surveyors document noncompliance with the standards
that they observe. For example, CMS, Joint Commission, and AOA
officials told us that surveyors document observations of poor hand
hygiene (e.g., a health care worker not washing his or her hands).
Based on the results of the surveys, CMS and the accrediting
organizations assess a hospital's compliance with the infection control
standards. CMS, Joint Commission, and AOA surveyors are required to
cite all instances of noncompliance. At the end of each survey, CMS
surveyors review the observations of noncompliance for each standard
and determine whether to cite the hospital at the condition level or
the standard level based on the nature (i.e., severity) and extent
(i.e., prevalence) of the noncompliance. A CMS-surveyed hospital is
required to develop a corrective action plan within 10 days of
receiving a report documenting the noncompliance found during a
survey.[Footnote 44] The Joint Commission assesses each of the elements
of performance that constitute the infection control standards as
satisfactory, partially compliant, or insufficient. The entire standard
is assessed as not compliant if the hospital has insufficient
compliance with any of the corresponding elements of performance or if
the hospital is partially compliant with 35 percent or more of the
elements of performance. Joint Commission-surveyed hospitals have 45
days from receipt of the survey results to submit a report to the Joint
Commission that describes the steps the hospitals took to become
compliant with any standards that were assessed as not
compliant.[Footnote 45] The AOA standards are assessed on a scale from
1 to 4, which varies by standard, where 1 indicates full compliance and
4 indicates noncompliance. AOA-surveyed hospitals have 30 days to
report to AOA on the steps they took to become compliant with standards
assessed as noncompliant that indicate immediate jeopardy or are at the
CMS condition level and 60 days to address other standards assessed as
noncompliant. Among the surveys conducted in the first quarter of 2007,
12.6 percent of state-agency-surveyed hospitals, 17.6 percent of Joint
Commission-surveyed hospitals, and 22.2 percent of AOA-surveyed
hospitals were cited as noncompliant with one of the respective
organizations' standards on infection control.[Footnote 46]
Between regular surveys, limited information about compliance with the
infection control standards may be identified through validation and
complaint surveys of hospitals conducted by state survey agencies.
State survey agencies conduct validation surveys for CMS on a small
number of Joint Commission-accredited hospitals within 60 days of their
last Joint Commission survey and compare the results of the two
surveys.[Footnote 47] For example, in fiscal year 2006, state agencies
conducted validation surveys at 67 hospitals. State survey agencies
conduct complaint surveys in response to complaints made by patients,
family members, or health care providers.[Footnote 48] In the first
quarter of calendar year 2007, state survey agencies conducted 1,119
complaint surveys in 828 hospitals, and infection control deficiencies
were found at 3.5 percent of the hospitals.
Information about hospital compliance with infection control standards
is generally not publicly reported on Web sites, although the Joint
Commission reports compliance with its National Patient Safety Goals on
its Web site. It reported that in calendar year 2006, 91.2 percent of
the hospitals surveyed that year were compliant with the goal related
to implementing CDC's hand hygiene guideline, and 100 percent were
compliant with the goal related to managing all identified cases of
unanticipated death or major permanent loss of function associated with
an HAI as a sentinel event. The rate reported by the Joint Commission
in 2006 for adherence to hand hygiene practices was much higher than
some studies had reported. For example, in the 2002 Guideline for Hand
Hygiene in Health-Care Settings, CDC cited several observational
studies of health care workers and reported the average adherence
across the studies to be 40 percent.[Footnote 49] The Joint
Commission's surveyors assess this requirement by interviewing and
observing hospital employees and would assess a hospital as
noncompliant with the requirement if the surveyors observed
noncompliance three or more times. Joint Commission officials
acknowledged that their assessment mechanism might not sufficiently
measure compliance because hospital staff could be on their best
behavior when surveyors were present. Joint Commission officials told
us they anticipated publishing in 2008 examples of different ways to
measure adherence to hand hygiene as well as tools and training
materials that hospitals could use to improve their hand hygiene
compliance.
Multiple HHS Programs Collect Data on HAIs, but Lack of Integration of
Available Data and Other Problems Limit Utility of the Data:
Three agencies within HHS--CDC, CMS, and AHRQ--currently collect HAI-
related data for a variety of purposes in four separate databases, but
each of these databases presents only a partial view of the extent of
the HAI problem. Each database focuses its data collection on selected
types of HAIs and collects data from a different subset of hospital
patients across the country. Although officials from the various HHS
agencies discuss HAI data collection with each other, we did not find
that the agencies were taking steps to integrate any of the existing
data by creating linkages across the databases such as standardizing
patient identifiers or other data items. Creating linkages across the
HAI-related databases could enhance the availability of information to
better understand where and how HAIs occur. Although none of the
databases collect data on the incidence of HAIs for a nationally
representative sample of hospital patients, CDC officials have produced
national estimates of HAIs. However, those estimates derive from
assumptions and extrapolations that raise questions about the
reliability of those estimates.
Multiple HHS Agencies Collect Different Data on HAIs, but These Data
Present Only a Partial View of the Extent of the Problem:
Three agencies within HHS currently collect HAI-related data in four
separate databases, which were created for a variety of purposes. These
are the databases associated with CDC's National Healthcare Safety
Network (NHSN), CMS's Medicare Patient Safety Monitoring System
(MPSMS), CMS's Annual Payment Update (APU) program, and AHRQ's
Healthcare Cost and Utilization Project (HCUP).
The most detailed source of information on HAIs within HHS is the NHSN
database.[Footnote 50] CDC established the NHSN database in 2005 to
combine the data it had previously collected on HAIs through the
National Nosocomial Infections Surveillance (NNIS) system with data
from two other related databases.[Footnote 51] CDC instituted NNIS as a
voluntary program in the 1970s to assist hospitals that wanted to
monitor their HAI rates. CDC analyzed the data submitted by those
hospitals--which tended to be disproportionately large hospitals, many
of them academic medical centers--in order to provide the hospitals
with a benchmark HAI rate against which to compare their own rates. In
addition, CDC drew on these data to publicly report aggregate trends in
selected HAIs, and it continues to do that with the data being
submitted to the NHSN database.[Footnote 52] Many of the hospitals that
voluntarily participated in the NNIS database have continued to submit
HAI data voluntarily to the NHSN database. CDC is working with a number
of states implementing mandatory programs for hospitals to submit HAI-
related data, using NHSN as the designated mechanism by which hospitals
must submit their data.[Footnote 53] As a result, by the end of
December 2007, approximately 1,000 hospitals were enrolled in the NHSN
database, some of which continued to participate by choice while others
enrolled in the NHSN program because of state mandates.[Footnote 54]
The NHSN program provides hospitals with substantial flexibility to
determine the scope of their HAI data collection efforts. Participating
hospitals can choose which types of HAIs they will submit data on from
among those for which the NHSN program has developed detailed
definitions and protocols, including such device-associated infections
as central-line-associated BSIs, catheter-associated UTIs, and VAP, as
well as procedure-related HAIs such as SSIs and postprocedure
pneumonia. Hospitals also choose the specific hospital units (typically
different kinds of intensive care units) to monitor for device-
associated HAIs and the specific surgical procedures to monitor for
SSIs and postprocedure pneumonia. Hospital staff are supposed to follow
the detailed definitions and protocols that the NHSN program specifies
to identify which patients currently under treatment have developed one
of the targeted infections. Hospitals also have to provide at least
some HAI data for 6 months of the year to maintain their enrollment in
the NHSN program.[Footnote 55]
The MPSMS database provides CMS with information on national trends in
the incidence of selected adverse events among hospitalized Medicare
beneficiaries, including a number of different types of HAIs. Beginning
with hospital discharges from 2002, CMS has collected these data from
the medical records selected for annual random samples of approximately
25,000 Medicare inpatients,[Footnote 56] though the list of specific
adverse events monitored has varied over time. A CMS contractor
receives copies of these medical records after the patients' discharge
from the hospital, and the contractor's abstractors[Footnote 57] follow
CMS's detailed protocols to extract and record specific information on
each patient in the sample. These data elements are then entered into
algorithms that determine which patients meet CMS's case selection
criteria for experiencing the adverse event and for being at risk for
the adverse event. For example, the abstractors would determine which
of the sampled patients had a central line catheter inserted during
that hospital stay and which of those patients had laboratory reports
indicating a BSI not present at admission, which together would allow
the calculation of the rate of central-line-associated BSIs.[Footnote
58] Since 2004, HHS has publicly reported some of the rates of adverse
events from the MPSMS database in the National Healthcare Quality
Report and National Healthcare Disparity Report, both of which are
issued annually by AHRQ.
The APU program implemented a financial incentive for hospitals to
submit to CMS data that are used to calculate hospital performance on
measures of the quality of care they provide. The APU program receives
quality-related data from hospitals on a quarterly basis for a range of
medical conditions and, in 2007, began to require submission of
information on three specific surgical infection prevention measures.
[Footnote 59] Hospitals paid under Medicare's inpatient prospective
payment system receive a higher rate of payment if they submit these
quality data that address their performance on recommended care
practices. During fiscal year 2008, 3,270 hospitals will receive this
higher level of payment, which represents 93 percent of hospitals
eligible to participate in the APU program.[Footnote 60] For patients
who underwent specified surgical procedures, hospital staff review
their medical records after discharge and, following detailed protocols
from CMS, extract and record items of information that relate to three
infection prevention practices that are associated with reduced risks
of acquiring an SSI: (1) providing antibiotics within 1 hour of the
surgery, (2) selecting appropriate antibiotics to prevent surgical
infections, and (3) stopping the administration of the antibiotics
within 24 hours of the end of the surgery. This information in turn is
entered into algorithms that determine what proportion of patients who
met CMS's criteria for designation as eligible for these infection
prevention measures actually received them. CMS publicly reports these
results for each hospital individually on its Web site, Hospital
Compare, along with state and national averages for
comparison.[Footnote 61]
AHRQ sponsored the development of the HCUP databases to create a
national information resource of patient-level health care data. One of
the HCUP databases assembles a sample of patient hospital discharge
data from 37 states and converts them to a uniform format that enables
the application of AHRQ's 20 Patient Safety Indicators (PSI)--including
two that relate to HAIs--to an approximate national sample of all
hospital patients.[Footnote 62] The two PSIs related to HAIs involve
(1) "selected infections due to medical care," which focuses on
infections caused by intravenous lines and catheters, and (2)
postoperative sepsis among patients undergoing elective surgery.
[Footnote 63] The PSIs are designed to identify patient safety issues
by using the kinds of data that are available in hospital discharge
data sets--specifically International Classification of Diseases, Ninth
Revision (ICD-9), diagnostic and procedure codes, as well as patient
demographics and admission and discharge status--and can be used with
the HCUP database without collecting any additional information from
patient medical records. However, these indicators are intended to be
used as quality improvement tools to highlight aggregate patterns, and
so they do not identify specific instances of adverse events with a
high degree of precision.[Footnote 64] AHRQ has posted national
estimates for these two indicators--along with the other PSIs-
-on its Web site, showing the trend from 1994 to 2004.[Footnote 65]
Two HHS agencies collect, or plan to collect, some limited additional
information about HAIs in other HHS databases. FDA obtains data on
deaths or serious injuries related to the use of medical devices and
stores them in the Manufacturer and User Facility Device Experience
Database. A small portion of these adverse events may involve
HAIs.[Footnote 66] FDA uses these data to identify devices whose safety
warrants closer scrutiny, such as might be warranted for heart valves
that were not properly sterilized by the manufacturer. AHRQ is
developing a database on adverse events, including HAIs, that will
assemble data voluntarily submitted by hospitals to multiple Patient
Safety Organizations (PSO).[Footnote 67] AHRQ officials told us that
they planned to disseminate aggregate results derived from the PSOs in
an annual report.[Footnote 68]
Each of the four main HHS databases that currently collect information
about HAIs presents only a partial view of the extent of the problem.
None of them can provide information on the full range of HAIs, because
each focuses its data collection on selected types of HAIs (see table
3).[Footnote 69] In addition, none of the databases can address the
frequency of even these selected HAIs for the nation as a whole,
because each collects data from different subsets of the nationwide
population of hospital patients. Although two databases--NHSN and
MPSMS--address many of the same types of HAIs, the former provides
information only from selected units of hospitals that participate in
the NHSN program (which do not represent hospitals nationwide) while
the latter provides information only on a representative sample of
Medicare inpatients (i.e., MPSMS does not provide information on non-
Medicare patients). The APU program does not collect information on
patients with HAIs, but instead tracks the implementation of practices
intended to prevent SSIs. The other three databases attempt to identify
patients who developed infections as a result of their hospital stay
using different data sources and varying approaches. The methods
employed by the NHSN, MPSMS, and HCUP databases range from concurrent
review of patient care as patients are treated in the hospital, to
retrospective review of patient medical records after patients are
discharged, to analyses of diagnostic codes recorded electronically in
patient billing data.
Table 3: Selected Characteristics of HHS Databases That Contain HAI-
Related Information:
Responsible agency and database: CDC's National Healthcare Safety
Network (NHSN);
HAI-related data collected: Infection types;
* central-line-associated BSI;
* catheter-associated UTI;
* VAP;
* postprocedure pneumonia;
* SSI; * MDRO[A];
* other[B];
Population for which data are collected: Most hospitals report on
patients in selected critical care units and those undergoing selected
procedures such as coronary bypass surgery and colon surgery;
Hospital role in collecting data: Hospital staff conduct medical review
of signs, symptoms, and laboratory and radiological test results while
patient is an inpatient. Hospital staff enter electronic information
into database over the Internet;
Type of HAI information published by HHS: CDC publishes rate of
infection by type of infection and type of hospital unit or procedure
for hospitals, in aggregate.
Responsible agency and database: CMS's Medicare Patient Safety
Monitoring System (MPSMS);
HAI-related data collected: Infection types[C];
* central-line-associated BSI;
* catheter-associated UTI;
* postoperative pneumonia;
* antibiotic-associated C. difficile;
* MRSA;
* VRE;
Population for which data are collected: National sample of
hospitalized Medicare patients;
Hospital role in collecting data: Hospital staff send a copy of sampled
medical records to CMS, which are reviewed by contract abstractors;
Type of HAI information published by HHS: AHRQ publishes national-level
data on percentage of Medicare patients who experience selected
infection types in two annual reports.[D].
Responsible agency and database: CMS's Annual Payment Update (APU)
database;
HAI-related data collected: Practices to prevent or reduce SSIs;
* providing antibiotics within 1 hour of surgery;
* selecting appropriate antibiotics to prevent surgical infections;
* stopping the administration of the antibiotics within 24 hours of end
of surgery;
Population for which data are collected: National inpatient population
for selected surgical procedures[E];
Hospital role in collecting data: Medical record review by hospital
staff after patient's discharge. The hospital sends data to a CMS
contractor;
Type of HAI information published by HHS: CMS posts on a public Web
site the proportion of patients receiving recommended practice, by
hospital, as well as the state and national average.
Responsible agency and database: AHRQ's Healthcare Cost and Utilization
Project (HCUP) database, Nationwide Inpatient Sample;
HAI-related data collected: Infection types;
* postoperative sepsis[F];
* "infection due to medical care" (focused on intravenous and catheter
infections);
Population for which data are collected: A sample of inpatients in
hospitals in 37 states;
Hospital role in collecting data: HCUP obtains hospital discharge data
with ICD-9 diagnostic and procedure codes from statewide data systems;
Type of HAI information published by HHS: AHRQ posts on its Web site
national-level data on the proportion of patients with ICD-9 codes
indicative of the two infection types.
Sources: GAO analysis of CDC, CMS, and AHRQ information.
Notes: BSI is bloodstream infection; C. difficile is Clostridium
difficile; ICD-9 is International Classification of Diseases, Ninth
Revision; MDRO is multidrug-resistant organism; MRSA is methicillin-
resistant Staphylococcus aureus; SSI is surgical site infection; UTI is
urinary tract infection; VAP is ventilator-associated pneumonia; and
VRE is vancomycin-resistant enterococci.
[A] For patients whose infections are laboratory-confirmed, NHSN
collects data on the pathogens identified, and for specified pathogens
(including those responsible for MRSA and VRE), the result of any
testing of their resistance to specific antibiotics. Participating
hospitals have the option to report separately the number of times in a
given month that they tested specimens of any of eight specified
organisms for resistance to selected antibiotics, as well as the
results of those tests. From these data, NHSN produces rates of
antimicrobial resistance relative to the number of nonduplicative
specimens tested (i.e., excluding multiple tests for the same organism
in the same patient). This part of NHSN does not distinguish between
MDRO infections acquired in the hospital and community-acquired
infections present at admission.
[B] Hospitals can choose to submit to NHSN data on other types of HAIs,
such as skin and soft tissue infections, cardiovascular system
infections, and gastrointestinal system infections. CDC does not
provide data collection protocols for these types of infections, but
they can be entered into NHSN as "custom events" using definitions
provided separately by CDC.
[C] In 2007, CMS added catheter-associated UTIs, VAP, MRSA, and VRE to
MPSMS and dropped insertion-site infections associated with central
vascular catheters, BSIs, and postoperative-associated UTIs.
[D] The two annual reports are The National Healthcare Quality Report
and The National Healthcare Disparities Report.
[E] The three practice measures are assessed for certain categories of
surgeries: coronary artery bypass graft; other cardiac surgery; colon
surgery; hip arthroplasty; knee arthroplasty; abdominal hysterectomy;
vaginal hysterectomy; and vascular surgery.
[F] The rate of postoperative sepsis is computed only for patients
undergoing elective surgeries.
[End of table]
The four databases also apply different sets of procedures to ensure
the validity of their data, and each set has its own limitations. For
the NHSN program, CDC requires participating hospitals to agree to its
detailed instructions for identifying patients with HAIs, but CDC
currently has no process in place to check how thoroughly and
consistently those instructions are followed.[Footnote 70] For the
MPSMS program, CMS relies on internal procedures performed by a
contractor that collects the data to routinely monitor the interrater
reliability of its abstractors. However, CMS has not assessed the
completeness or accuracy of the information in patient medical records
that the MPSMS database measures rely on and how that might affect the
HAI rates reported by the MPSMS program. CMS requires hospitals that
submit APU data to have a small sample of their cases checked each
quarter by a CMS contractor.[Footnote 71] The contractor assesses the
accuracy with which the hospital abstracted its APU data from patient
medical records. AHRQ's HCUP database relies on ICD-9 codes filed with
patient bills.[Footnote 72] Many hospitals have their ICD-9 coding
periodically checked by outside auditors, but the reason is to
determine accuracy for billing purposes, not whether patients
experienced HAIs.
Among the four databases, NHSN collects the most clinically detailed
information about HAIs, but those data nonetheless have important
limitations. Among the strengths of the NHSN database is that it
presents detailed information on HAI rates across different types of
hospital units and multiple types of HAIs. Moreover, its procedures for
identifying patients with HAIs draw on the wider range of clinical
information available while patients are still in the hospital, as
opposed to retrospective reviews of patient medical records after
discharge. On the other hand, the NHSN database is much more limited
than any of the other databases in terms of the patient population that
it represents. Because the hospitals that submit data either do so by
choice or, for a limited number of states, by mandate, this group of
hospitals is not representative of hospitals nationwide, as a random
sample would be. In addition, the data these hospitals supply do not
reflect the experience of many of their patients. For example, the
hospitals that participate in the NHSN program report device-related
HAIs such as central-line-associated BSIs and VAP for selected hospital
units such as different types of intensive care units (e.g., coronary,
burn, surgical, medical). In addition, most of the hospitals that
participate in the NHSN program report procedure-based HAIs such as
SSIs and postprocedure pneumonia for a relatively small number of
specific procedures. For example, during March 2007, 225 hospitals
reported SSIs for colon surgery and 133 did so for coronary bypass
surgery, but only 11 hospitals reported SSIs for appendix surgery and
10 for gallbladder surgery.
Available Data Are Not Integrated across Programs to Use Them to Their
Full Potential:
Although officials from the various HHS agencies discuss HAI data
collection with each other, we did not find that the agencies were
taking steps to integrate any of the existing data from the four
databases that collect HAI-related data. This integration could involve
creating linkages between existing data by, for example, creating
common patient identifiers in the different databases so that data on
the same individuals found in multiple databases could be pulled
together, or creating "crosswalks" that could specify in detail how
related data fields in the various databases are similar or different.
We found that the most extensive exchange of information across the
three HHS agencies that collect HAI data occurred through the
participation of their representatives in HICPAC. HICPAC generally
holds 2-day meetings three times per year, and at each meeting the
members from the participating HHS agencies typically provide a summary
of their HAI-related activities. Our review of HICPAC minutes from 2004
through 2007 identified numerous instances of officials describing what
their own agency was doing to collect HAI data, but we did not find in
the HICPAC meeting minutes any evidence that the agencies had taken
action to create greater compatibility among the databases or to
address gaps in information across the databases. Outside of HICPAC
meetings, HHS officials provided other examples of communication and
outreach among HHS agencies taking place in relation to various
databases. For example, the MPSMS program has a technical expert panel
that includes representatives from CDC and AHRQ. Similarly, CMS, CDC,
and AHRQ are represented on the steering committee for the public-
private Surgical Care Improvement Project (SCIP), which developed the
HAI-related measures used in the APU program.[Footnote 73] These group
discussions allow agency officials to discuss and explain their
different approaches for collecting HAI data, but the focus of these
meetings is still on the individual database, rather than on creating
linkages from one database to another.
Creating mechanisms for linking data across the HAI-related databases
could enhance the availability of information to better understand
where and how HAIs occur. A case in point concerns information
collected by two of the databases on surgical-related HAIs.
Approximately 500 hospitals already submit data to APU on surgical
processes of care and to NHSN on surgical infection rates for some of
the same patients, but these data are not currently linked. As a
consequence, the potential benefit of using the existing data to
monitor the extent to which compliance with the recommended surgical
care processes leads to actual improvements in surgical infection rates
has not been realized. Officials at CDC reported that they approached
CMS about developing mechanisms for linking NHSN data with APU data. To
do this, CDC officials suggested that CDC and CMS agree to collect
uniform patient identifiers. Officials at CMS reported that although
they recognized the potential benefits of linking the APU data with the
data in related HHS databases, CMS is currently focused on managing the
expansion of the APU program.
Data Limitations Preclude Development of Reliable National Estimates:
HHS cannot use its HAI-related databases to produce reliable national
estimates of HAI rates, even for the selected types of HAIs monitored,
because none of the databases collect data on the incidence of HAIs for
a nationally representative sample of hospital patients. Two of the
databases--APU and HCUP--come close to covering a national population
for selected HAIs, but the APU database collects data on practices
intended to prevent HAIs among surgery patients, not on the number of
HAIs that occur. In addition, although the information in HCUP relates
to the incidence of some HAIs, its reliance on diagnostic codes
recorded in claims data substantially reduces the reliability of that
information.[Footnote 74] The other two databases--NHSN and MPSMS--
collect clinical data on the incidence of selected HAIs, but their data
do not derive from a representative sample of the national hospital
patient population because NHSN is limited to selected units of
participating hospitals that do not represent hospitals nationwide and
MPSMS is limited to Medicare patients. (See table 3.)
Recent concerns about the magnitude of HAIs caused by the drug-
resistant pathogen MRSA have further highlighted limitations in HHS's
databases for estimating HAI rates. In June 2007, APIC, the
professional association for infection control professionals, released
the results of a survey it conducted that showed that 46 of every 1,000
patients in those hospitals had tested positive for MRSA.[Footnote 75]
This was a much higher rate than had previously been estimated by
clinicians. The NHSN database has some information about the frequency
of MRSA infections, as well as other MDROs, but this information is
limited to the subset of patients for whom each hospital submits data,
based on the particular hospital units, infection types, and procedures
that it has chosen to report to NHSN. Thus, the NHSN database does not
provide information on the overall proportion of patients in a given
hospital who were found to have a MRSA infection.[Footnote 76] The
MPSMS program has begun to collect, but has not yet reported, data on
the incidence of hospital-acquired MRSA infections within the Medicare
inpatient population.[Footnote 77] However, a CMS official responsible
for the program acknowledged that the ability of the MPSMS program to
detect patients with MRSA infections is limited by its reliance on
retrospective review of patients' medical records.
The varying content and methods used to collect and report data on HAIs
for HHS's four databases also preclude HHS from combining data from the
databases to produce reliable estimates on either selected HAIs or an
overall HAI rate. Even the databases that collect data on the same
types of HAIs calculate and report rates in different ways that cannot
be reconciled. For example, the MPSMS program reported that 1.7 percent
of all the Medicare patients that had a central line inserted in 2004
experienced a central-line-associated BSI. In contrast, the NHSN
program reported the mean number of central-line-associated BSIs
detected during 2006 by different types of intensive care units,
calculated as the number of infections per 1,000 days of central line
use. This ranged from 1.5 per 1,000 days in inpatient medical/surgical
wards to 6.8 per 1,000 days in burn intensive care units. HHS might be
able to develop approaches for linking data across its different
databases, such as by developing common data collection methods and
specifications or creating crosswalks between the specifications for
different databases. However, until that is done, the information on
HAI rates from each of the three databases collecting that information
stands alone.
CDC officials have produced national estimates of HAIs, but those
estimates derive from assumptions and extrapolations that raise
questions about the reliability of those estimates. Most recently, in
2007, CDC officials published estimates of the aggregate incidence of
HAIs and deaths attributable to HAIs in 2002--which included an
estimate of 99,000 HAI-related deaths per year.[Footnote 78] These
estimates rested on two key assumptions. The first assumption was that
data from 283 hospitals reporting to the NNIS program (the predecessor
program to NHSN) were indicative of hospital rates nationwide, even
though the authors acknowledged that the NNIS hospitals were not
randomly selected and their rates could differ from those of U.S. acute
care hospitals as a whole. The second assumption was that 2002 NNIS
data on SSIs could be used to estimate rates for all other types of
HAIs, based on the relative frequency of SSIs compared to other types
of HAIs observed in a portion of NNIS hospitals during the 1990s.
[Footnote 79] In 2004, CDC officials announced plans for conducting a
national survey designed to collect more up-to-date data on
hospitalwide incidence of all types of HAIs in a sample of hospital
discharges, but they subsequently decided not to proceed with those
plans. CDC officials told us they were developing plans to obtain
similar data by adding questions on HAIs to the National Hospital
Discharge Survey conducted by CDC's National Center for Health
Statistics.[Footnote 80] CDC officials said they planned to put
questions about HAIs into the National Hospital Discharge Survey
starting in 2010. However, CDC officials stated that they planned first
to pilot test several different approaches for collecting HAI data
through the National Hospital Discharge Survey, and it was too early to
say what specific information they would collect through this process.
Conclusions:
HAIs in hospitals can cause needless suffering and death. Federal
authorities and private organizations have undertaken a number of
activities to address this serious problem; however, to date, these
activities have not gained sufficient traction to be effective. Current
activities at the federal level include guidelines with recommended
practices issued by CDC, required standards for hospitals set by CMS,
and HAI-related data collected through multiple HHS databases. Private-
sector organizations, such as the Joint Commission and AOA, have also
set infection control standards for hospitals. With the passage of the
DRA by the Congress, hospitals will be encouraged to reduce certain
HAIs, because beginning in October 2008 CMS will stop paying hospitals
higher payments for patients that acquire them.
We identified two possible reasons for the lack of effective actions to
control HAIs to date. First, although CDC's guidelines are an important
source for its recommended practices on how to reduce HAIs, the large
number of recommended practices and lack of department-level
prioritization have hindered efforts to promote their implementation.
The guidelines we reviewed contain almost 1,200 recommended practices
for hospitals, including over 500 that are strongly recommended--a
large number for a hospital trying to implement them. A few of these
are required by CMS's or accrediting organizations' standards or their
standards interpretations, but it is not reasonable to expect CMS or
accrediting organizations to require additional practices without a
prioritization. Although CDC has categorized the practices on the basis
of the strength of the scientific evidence, there are other factors to
consider in developing priorities. For example, work by AHRQ suggests
factors such as costs or organizational obstacles that could be
considered. The lack of coordinated prioritization may have resulted in
duplication of effort by CDC and AHRQ in their reviews of scientific
evidence on HAI-related practices.
Second, HHS has not effectively used the HAI-related data it has
collected through multiple databases across the department to provide a
complete picture about the extent of the problem. Limitations in the
databases, such as nonrepresentative samples, hinder HHS's ability to
produce reliable national estimates on the frequency of different types
of HAIs. In addition, currently collected data on HAIs are not being
combined to maximize their utility. For example, data on surgical
infection rates and data on surgical processes of care are collected
for some of the same patients in two different databases that are not
linked. HHS has made efforts to use the currently collected data to
understand the extent of the problem of HAIs, but the lack of linkages
across the various databases results in a lost opportunity to gain a
better grasp of the problem of HAIs.
HHS has multiple methods to influence hospitals to take more aggressive
action to control or prevent HAIs, including issuing guidelines with
recommended practices, requiring hospitals to comply with certain
standards, releasing data to expand information about the nature of the
problem, and soon, using hospital payment methods to encourage the
reduction of HAIs. Prioritization of CDC's many recommended practices
can help guide their implementation, and better use of currently
collected data on HAIs could help HHS--and hospitals themselves--
monitor efforts to reduce HAIs. Unfortunately, leadership from the
Secretary of HHS is currently lacking to do this. Without such
leadership, the department is unlikely to be able to effectively
leverage its various methods to have a significant effect on the
suffering and death caused by HAIs.
Recommendations for Executive Action:
In order to help reduce HAIs in hospitals, the Secretary of HHS should
take the following two actions:
1. Identify priorities among CDC's recommended practices and determine
how to promote implementation of the prioritized practices, including
whether to incorporate selected practices into CMS's conditions of
participation (COP) for hospitals.
2. Establish greater consistency and compatibility of the data
collected across HHS on HAIs to increase information available about
HAIs, including reliable national estimates of the major types of HAIs.
Comments from HHS and Accrediting Organizations and Our Evaluation:
We obtained written comments on our draft report from HHS, which appear
in appendix III. HHS generally agreed with our recommendations and
noted its appreciation for our efforts in developing this report. The
comments addressed both of our recommendations.
In terms of our first recommendation, HHS's comments indicated that CMS
welcomed the opportunity to work with CDC to review and prioritize
recommendations for infection control and would consider whether to
incorporate some of the recommendations into CMS's hospital COPs. HHS
stated that COPs represent minimum health and safety requirements and
the two standards in the infection control COP have a broad reach for
assessing a hospital's infection control program. HHS's comments also
noted that the COPs currently lack the specificity of guidance and
recommendations issued by HHS agencies, including CDC's recommendations
for infection control.
In terms of our second recommendation, HHS's comments acknowledged the
need for greater consistency and compatibility of data collected on
HAIs and identified three actions CMS would take. First, CMS will work
with other HHS agencies to evaluate opportunities for consolidating and
coordinating national data collection programs. Second, CMS will
implement consensus-based measures whenever possible. Third, CMS will
require the collection of data that facilitate linkages between
databases, including Medicare beneficiary and hospital patient
identifiers in the APU program. HHS's comments also noted that CDC has
recently begun moving toward greater alignment with CMS.
HHS's comments also noted other activities under way that the
department believes would improve the collection of HAI-related data.
For example, as part of implementing section 5001(c) of the DRA,
hospitals are required to begin reporting "present on admission" data-
-diagnoses that are present in patients at the time of admission--in
order to determine whether the selected preventable conditions were
acquired prior to the hospitalization. We noted this activity in the
report, and we believe that it is too early to know the extent of
information that will be generated on HAIs or how it will be used by
HHS agencies. HHS's comments also indicated that CMS is evaluating an
update to the diagnostic and procedure coding system, which could offer
clearer and more detailed information than the current system, and also
noted the benefits of employing industry data standards for electronic
health care data exchanges to facilitate reporting of HAI-related data
to both CDC and CMS. In our report, we did not assess the effect of
these activities because they have not been implemented.
We also obtained comments on a draft of this report from
representatives of the Joint Commission and AOA. The Joint Commission
concurred with our findings that it would be beneficial to have more
accurate estimates of HAIs and that prioritization of practices to
guide actions in preventing HAIs is a valuable and necessary
undertaking. However, it noted that other actions, such as cultural
changes in health care organizations, clear strategies for
implementation, and a concerted, multifaceted effort by many
stakeholders, are needed to reduce HAIs. We agree that such actions are
important in reducing HAIs, and that better prioritization of the many
recommended practices would facilitate the process the Joint Commission
describes. The Joint Commission also provided two comments related to
the section of the report that discusses hospital infection control
standards. First, it commented that our report places too great a focus
on the number of standards, and pointed out the benefit of the Joint
Commission's systems-based approach. It expressed a concern that a
reader could perceive that the Joint Commission has fewer expectations
for hospitals than CMS or AOA. That was not our intention, and we have
modified the report to note the Joint Commission's systems-based
approach to foster compliance with practices to reduce HAIs. Second,
the Joint Commission said that the report indicates that their
standards are less specific in that they have not adopted certain CDC
recommendations, but they noted that many of the CDC guidelines cannot
be implemented without additional research or translation into
concrete, actionable steps. In the draft, we described some activities
being undertaken by CDC and AHRQ to promote implementation of
recommended practices to reduce HAIs, including studies funded by AHRQ,
and we added a clarification to the text to note the importance of
translating knowledge into social and behavioral changes that can be
sustained. Furthermore, we believe that clearer prioritization can help
efforts to promote the implementation of practices to reduce HAIs.
HHS, the Joint Commission, and AOA provided technical comments, which
we incorporated as appropriate.
As arranged with your office, unless you publicly announce the contents
of this report earlier, we plan no further distribution until 30 days
after its issuance date. At that time, we will send copies of this
report to the Secretary of HHS and other interested parties. We will
also make copies available to others on request. In addition, the
report will be available at no charge on GAO's Web site at [hyperlink
http://www.gao.gov].
If you or your staff 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 IV.
Sincerely yours,
Signed by:
Cynthia A. Bascetta:
Director, Health Care:
[End of section]
Appendix I: Other CDC Activities Designed to Reduce or Prevent Health-
Care-Associated Infections:
In addition to developing infection control and prevention guidelines
and recommendations, the Centers for Disease Control and Prevention
(CDC) provides leadership in outbreak investigations, surveillance, and
laboratory research and prevention of health-care-associated infections
(HAI). According to officials, CDC's work in the area of outbreak
investigations has led to new knowledge on ways to prevent HAIs. For
example, in 2006, CDC investigated an outbreak of eye inflammation that
was occurring in patients who recently had cataract surgery at a
hospital in Maine. The outcome of this investigation led to the
development of recommended practices for cleaning and sterilizing
intraocular surgical instruments developed by the American Society of
Cataract and Refractive Surgery and the American Society of Ophthalmic
Registered Nurses.
CDC's surveillance, research, and demonstration projects measure the
effect of HAIs, adverse drug events, and other complications of health
care. CDC has funded many activities through its Prevention Epicenter
Program, which began in 1997 and is devoted to improving the detection,
reporting, and prevention of HAIs, antimicrobial resistance, and other
adverse events in health care. For example, CDC funded a multicenter
trial research project and found that daily bathing with chlorhexidine,
an antiseptic, reduces the incidence of methicillin-resistant
Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE),
[Footnote 81] and bloodstream infection (BSI). In addition, CDC has
collaborated with three public hospitals in Chicago to develop a
clinical data warehouse using the hospitals' information systems, which
enabled the hospitals to develop a series of quality improvement
strategies to decrease antimicrobial resistance and improve antibiotic
prescribing and infection control practices.
Finally, CDC provides direct support and assistance to external groups
involved in many HAI prevention activities. CDC has funded and
collaborated with the Pittsburgh Veterans Affairs Medical Center to
reduce MRSA infections by more than 60 percent in its health care
units. The success of this project has led CDC and the Department of
Veterans Affairs to initiate similar efforts across all VA hospitals.
In addition, CDC is represented on the Surgical Care Improvement
Project (SCIP) steering committee. SCIP is a national public-private
partnership to reduce surgical complications that is sponsored by the
Centers for Medicare & Medicaid Services. CDC told us that they have
worked with SCIP to develop quality measures and market the project.
Finally, CDC has provided technical assistance to the Institute for
Healthcare Improvement, a not-for-profit organization working to
improve global health care, in the development of the institute's hand
hygiene "bundle" and MRSA infection prevention "bundle" guides.
[End of section]
Appendix II: Centers for Medicare & Medicaid Services' (CMS) Condition
of Participation: Infection Control:
The conditions of participation (COP) for hospitals, including the
infection control COP as well as the survey protocols and interpretive
guidelines that accompany the COPs, are contained in Appendix A of
CMS's State Operations Manual.[Footnote 82] CMS issued revised
interpretive guidelines for the infection control COP on November 21,
2007.[Footnote 83]
The COP on infection control (42 C.F.R. § 482.42) (2007) states that:
The hospital must provide a sanitary environment to avoid sources and
transmission of infections and communicable diseases. There must be an
active program for the prevention, control, and investigation of
infections and communicable diseases.
(a) Standard: Organization and policies. A person or persons must be
designated as infection control officer or officers to develop and
implement policies governing control of infections and communicable
diseases.
(1) The infection control officer or officers must develop a system for
identifying, reporting, investigating, and controlling infections and
communicable diseases of patients and personnel.
(2) The infection control officer or officers must maintain a log of
incidents related to infections and communicable diseases.
(b) Standard: Responsibilities of chief executive officer, medical
staff, and director of nursing services. The chief executive officer,
the medical staff, and the director of nursing services must--:
(1) Ensure that the hospital-wide quality assurance program and
training programs address problems identified by the infection control
officer or officers; and:
(2) Be responsible for the implementation of successful corrective
action plans in affected problem areas.
In addition, CMS officials said that the quality assessment and
performance improvement COP, which can be found at 42 C.F.R. § 482.21
(2007), can also affect infection control.[Footnote 84]
[End of section]
Appendix III: Comments from the Department of Health and Human
Services:
Department Of Health & Human Services:
Office of the Assistant Secretary for Legislation:
Washington, DC 20201:
February 19, 2008:
Ms. Cynthia A. Bascetta:
Director, Health Care:
U.S. Government Accountability Office:
Washington, DC 20548:
Dear Ms. Bascetta:
Enclosed are comments on the Government Accountability Office (GAO)
Draft Report, "Health-Care-Associated Infections in Hospitals:
Leadership Needed From HHS to Prioritize Prevention Practices and
Improve Data on These Infections" (GAO-08-283).
The Department appreciates the opportunity to review and comment on
this report before its publication.
Sincerely,
Signed by:
[Illegible] for:
Vincent Ventimiglia:
Assistant Secretary for Legislation:
General Comments Of The Department Of Health And Human Services (HHS)
On The U.S. Government Accountability Office's (GAO) Draft Report
Entitled: "Health-Care-Associated Infectins In Hospitals: Leadership
Needed From HHS To Prioritize Prevention Practices And Improve Data On
These Infections" (GAO-08-283).
The Department appreciates GAO's efforts to ensure that the Centers for
Medicare & Medicaid Services (CMS) collaborates with other Health and
Human Services (HHS) agencies to--(1) identify and potentially codify
infection control practices to prevent health-care-associated
infections (HAIs); and (2) develop linkages between the various HHS
data collection systems to facilitate the collection and analysis of
national HAI data.
As a condition of their participation in the Medicare and Medicaid
programs, hospitals must comply with all of CMS's minimum regulatory
health and safety requirements, called conditions of participation
(CoPs), including the CoP for infection control.
The CoP for infection control requires hospitals to provide a sanitary
environment to avoid sources and transmission of infections and
communicable diseases and to have an active program for the prevention,
control, and investigation of infections and communicable diseases.
Hospitals must designate at least one infection control officer to
develop and implement policies governing control of infections and
communicable diseases. That officer must develop a system for
identifying, reporting, investigating, and controlling infections and
communicable diseases of patients and personnel; and maintain a log of
incidents related to infections and communicable diseases. Further,
each hospital's chief executive officer, medical staff, and director of
nursing services is responsible for ensuring that the hospital-wide
quality and training programs address problems identified by the
infection control officer(s) and for implementation of successful
corrective action plans in affected problem areas.
As the GAO report notes, CMS has developed interpretive guidelines for
CoPs that describe the CoPs and provide survey procedures.
Medicare/Medicaid providers utilize these guidelines to determine how
to implement the requirements in the CoPs. The CMS guidelines for the
hospital infection control CoP (CMS State Operations Manual, Appendix A:
[hyperlink,
http://www.cms.hhs.gov/Manuals/IOMlitemdetail.asp?filtcrType=none&filter
BvDID=9&sortBvDID=1&sortOrder=ascending&itemlD=CMS1201984&intNumPerPage=
10)] reference some of the CDC recommendations that hospitals can use
to ensure they are in compliance with the requirements of the CoP. For
example, the Guidelines cite the CDC "Guidelines for Prevention and
Control of Nosocomial Infections" and "Guidelines for Preventing the
Transmission of Tuberculosis in Health Care Facilities." The Guidelines
state that hospitals should provide a safe environment, "consistent
with nationally recognized infection control precautions, such as the
current CDC recommendations for the identified infection and/or
communicable disease...."
Although CMS does not have specific infection control requirements,
such as hand hygiene or sterilization standards, we cite noted improper
practices that do not follow nationally recognized standards (such as
CDC strongly recommended practices) at our standard-level requirement
for preventing and controlling infections. In a plan of correction, we
would expect a hospital to demonstrate that it had implemented
recognized practices to address the improper practices and that it had
incorporated the corrective actions into its quality assessment and
performance improvement program to ensure sustainability.
Thus, although our CoPs have only two standards, the standards have an
extremely broad reach when it comes to assessing a hospital's infection
control program, and we routinely cite observed infection control
breaches, even when such breaches have not resulted in a known
infection.
In regard to the collection of HAI data, it is important to note that
these data collection programs are designed in some cases for very
different purposes. For example, the Reporting Hospital Quality Data
for Annual Payment Update (RHQDAPU) program is designed to produce
hospital level estimates. Under the RHQDAPU Program, participating
hospitals report several infection-related measures. These include SCIP-
Inf-1 Prophylactic Antibiotic Received Within One Hour Prior to
Surgical Incision, SCIP-Inf-2 Prophylactic Antibiotic Selection for
Surgical Patients, and SCIP-Inf-3 Prophylactic Antibiotics Discontinued
Within 24 Hours After Surgery End Time. These measures are currently
publicly reported on CMS's Hospital Compare website. 10n addition,
under Medicare's Quality Improvement Organization Program, selected
hospitals receive technical assistance to improve their performance for
these and additional measures. The rare nature of selected HAI measures
and the current burden of data collection preclude the production of
reliable hospital level estimates for these relatively rare events for
sampled data. Nevertheless, CMS acknowledges the need for greater
consistency and compatibility of the collected data on HAI's.
One advance in the collection of HA10 data will occur when we move from
the current coding system, ICD-9-CM to an updated system, ICD-10. CMS
is currently evaluating this move. Identifying hospital-acquired
conditions requires clear and detailed diagnosis codes. The current
coding system, ICD-9-CM, is three decades old. It is outdated, and has
numerous instances of broad and vague codes. Attempts to add this
detail to ICD-9-CM are constrained by a lack of room to expand. This
has a negative impact on CMS' attempts to identify cases with a
hospital-acquired condition. ICD-10 codes are more precise and capture
information using medical terminology used by current medical
practitioners. Examples of problems with ICD-9-CM that impact our
current effort with hospital-acquired conditions that have been
rectified with ICD-10 include the following examples.
* Pressure ulcers - We selected pressure ulcers as one of our hospital-
acquired conditions. This condition is both high cost and high
frequency. There are prevention guidelines for pressure ulcers.
Unfortunately, ICD-9-CM does not provide enough detail to clearly
identify the exact location, size, or depth of the pressure ulcer.
Using trend data, one cannot tell if the pressure ulcer is getting
better or worse (increasing in size or depth). ICD-9-CM has nine codes
that identify the generic part of the body with the pressure ulcer. It
provides no information of the size, depth, or exact location of the
pressure ulcer. ICD-10-CM has 60 codes that identify the size, depth,
and location of the pressure ulcer.
* Hospital-acquired Infections - ICD-9-CM does not have unique codes
that identify specific types of bacterial infections which are
resistant to antibiotics, such as MRSA infections. MRSA infections are
captured through a combination of at least three separate codes under
ICD-9-CM. This includes a vague code that captures all types of
infections that are resistant to antibiotics.
ICD-10 has more detail in each code as to the type and location of the
infection. The next draft of ICD-10 will have detailed codes that would
indicate whether the patient had a MRSA infection or was colonized with
MRSA, but suffering no current infection. The ability to expand ICD-10
to capture detailed information on additional conditions is also one of
the strengths of ICD-10.
* Septicemia - CMS is evaluating the selection of septicemia as one of
the hospital-acquired condition. ICD-9-CM codes are quite problematic
in capturing septicemia cases. Multiple, overlapping codes are required
to identify these cases. This makes coding, reporting, and data
analysis of septicemia difficult. ICD-10 codes are much improved and
clearly identify septicemia cases.
* Falls and trauma -ICD-9-CM codes are vague and do not describe
whether an injury, such as a leg fracture, occurs on the right or left
leg. ICD-9-CM also does not provide information on whether the
encounter is for the initial treatment of the fracture or for
subsequent care. ICD-10 0 has detailed codes that identify the nature
of the injury, whether it was to the left or right extremity, and
whether the treatment is toward a new or earlier fracture. ICD-10 D
also provides greater detail as to where the injury occurred (e.g., the
patient room, corridor, operating room, bathroom). This detail is not
present in ICD-9-CM.
* Foreign body left in after surgery (never event) - ICD-9-CM has one
vague code that captures the fact that a complication developed as a
result of a device being inadvertently left in a patient after surgery.
ICD-10 codes provides much greater detail and describes the type of
complication that results from this never event. The codes describe the
type of complication such as an obstruction, perforation, infection, or
adhesions. The codes also clearly describe the type of procedure
performed that resulted in the device being inadvertently left in a
patient, such as an endoscopic procedure or an open procedure. This
more detailed information provides a more definitive picture of the
nature of the complication resulting from the never event.
There are many other parts of ICD-10 that provide clear and concise
codes to capture events and conditions important for health care
delivery. ICD-10 has codes that describe under-dosing and over-dosing
patients. This information would provide valuable information on
patient outcomes. With more precise codes, CMS could add additional
hospital-acquired provisions to our proposals.
Another advance in the collection of HAI data is the recent requirement
for the collection of Present on Admission data as part of hospital
submitted Medicare claims. The Deficit Reduction Act (DRA) required CMS
to select certain conditions for which Medicare will no longer pay an
additional amount when that condition is acquired during a
hospitalization. The DRA further requires that the selected conditions
he reasonably preventable through the application of evidence-based
guidelines. CMS has closely collaborated with CDC on the selection of
these conditions, with particular attention to identifying evidence-
based guidelines that are consistent with CDC's recommended practices.
Thus, this Medicare payment provision is closely tied to CDC's
prioritized practices.
As a prerequisite for implementing this Medicare payment provision, the
DRA also requires hospitals to begin reporting present on admission
(POA) indicator data to identify whether the selected conditions are
acquired during a hospitalization. CMS' approach to POA indicator
reporting is consistent with the standards set forth in the ICD-9-CM
guidelines, which are maintained by CDC. CMS' collection of POA data
will generate increased information about hospital-acquired conditions,
including infections, which can be used by CDC and others to inform and
disseminate reliable national estimates of these conditions.
Finally, CMS, under its Quality Improvement Organization 9th Statement
of Work, will include as components of the Patient Safety Theme,
measures relevant to health-care associated infections in hospitals.
These measures will include a Surgical Care Improvement Project (SCIP)
measure on the use of prophylactic antibiotics and a measure on the
incidence of Methcillin-Resistant Staphylococcus aureus (MRSA). This
work is being conducted in collaboration with CDC.
CMS is committed to ensuring that all patients in Medicare and Medicaid
participating hospitals receive quality health care and appreciates the
GAO's support in helping HHS achieve that goal.
GAO Recommendations:
In order to reduce HAIs in hospitals, the Secretary should:
1. Identify priorities among CDC's recommended practices and determine
how to promote the prioritized practices, including whether to
incorporate selected practices into CMS's conditions of participation
for hospitals; and;
2. Establish greater consistency and compatibility of the data
collected across HHS on HAIs to increase information available about
HAIs, including reliable national estimates of the major types of HAIs.
CMS Response:
Medicare/Medicaid CoPs are broadly written, minimum health and safety
requirements that providers and suppliers must meet to participate in
Medicare and Medicaid. As a result, CoPs lack the specificity of the
guidance and recommendations issued by HHS agencies, including the CDC
recommendations for infection control. CMS continuously evaluates the
CoPs for all Medicare/Medicaid providers to determine whether they need
to be updated, for example, to reflect more current standards of
practice. We welcome the opportunity to work with the CDC to review and
prioritize its recommendations. When the recommendations are
prioritized, CMS will consider whether to incorporate some of the
recommendations into the hospital CoPs.
CMS will take the following actions to establish consistency and
compatibility of the data collected across HHS on HAIs:
(1) Work with other HHS agencies to evaluate opportunities for
consolidating and coordinating national data collection programs.
(2) Implement consensus-based measures definitions, such as using
National Quality Forum endorsed measures in the APU program, whenever
possible.
(3) Require collection of data that facilitate linkage between
databases, including Medicare beneficiary ID and Hospital patient ID in
the APU program.
CMS will be mindful of the burden to hospitals and the need for
collecting reliable national level HAI estimates in its national data
collection programs. We appreciate the GAO's efforts in developing this
report on prioritizing HAI prevention practices and improving HAI data
collection.
Page 35, Paragraph 3, Line 1: The GAO draft report states "Although
officials from the various HHS agencies discuss HAI data collection
with each other, we did not find that the agencies were taking steps to
integrate any of the existing data from the four databases that collect
HAI-related data."
* Most recently, CDC has taken steps toward definitional alignment with
CMS, and CDC has taken steps toward enabling CMS-SCIP data imports into
NHSN. Also, the HHS Patient Safety Task Force made efforts toward
integrating patient safety reporting to multiple agencies through a
common portal.
* In recent years, the Health Level Seven (HL7) data standards
organization has developed a XML file format for electronic exchanges
of structured clinical documents. The HL7 standard, known as Clinical
Document Architecture (CDA), is designed for use in exchange of
clinical records, such as continuity of care records and patient
history and physical examination findings. The versatility of the CDA
standard has led to additional uses, including HIPAA-mandated
electronic claims attachments that CMS has developed with HL7 for use
in claims processing. All electronic claims attachment documents
promulgated by CMS are CDA documents. CDC is using CDA as the file
format for information system developers to use in enabling their
systems to report healthcare associated infection (HAI) data from
hospitals to CDC's National Healthcare Safety Network (NHSN). The
clinical, financial, and public health uses of CDA are evidence of the
importance this industry standard has already achieved as a
specification for data exchanges between disparate systems.
* One important benefit of adopting an industry standard solution for
electronic healthcare data exchanges is that it facilitates
communication and reuse of data already collected for some other
purpose. CDA calls for use of standard healthcare vocabulary in the
documents that are exchanged. This requirement is an integral part of
enabling interoperability between sending and receiving systems.
Another important benefit is enabling technical features for importing
files from one system to another and distributing data into the second
system's database to be reused for a variety of files that conform to
the standard format. For example, CDA documents can be imported and
parsed into a database using the same technical features regardless of
whether the document carries data about a clinical outcome, such as a
healthcare associated infection, or a process of care, such as use of
an antimicrobial agent to prevent a surgical site infection.
* This latter benefit points to why adoption of an industry standard
file format, in particular CDA, would he advantageous for CDC in its
monitoring of HAIs through NHSN and CMS in its monitoring of process of
care, such as surgical care, through its CART tool and the Annual
Payment Update database. A CDA import function, under development for
the NHSN application, will enable CDC's system to be used to import HAI
data reported via a CDA document. The same function will lend itself
for use in importing a process of care measurement data if those data
are conveyed using the CDA file format. The CART tool generates
proprietary XML files, i.e., files that do not conform to
specifications of a standards development organization such as HL7. At
the relatively low cost of converting the proprietary format used in
the CART tool to the industry-standard CDA file format, the process of
care data collected for the Annual Payment Update database, including
Surgical Care Improvement Program (SCIP) data, would be available for
importation into NHSN and linkage with the outcome data. In other
words, migration to CDA across CDC and CMS systems will enable
hospitals participating in both systems to readily combine patient-
level process and outcome data.
[End of section]
Appendix IV: 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 Linda T. Kohn, Assistant Director; Donald Brown; Shaunessye Curry;
Shannon Slawter Legeer; Eric Peterson; Roseanne Price; and Keisha
Wilkerson.
[End of section]
Footnotes:
[1] In general, HAIs are distinct from community-acquired infections,
that is, infections that patients may have acquired before entering the
hospital.
[2] Antimicrobial resistance is the result of microbes changing in ways
that reduce or eliminate the effectiveness of drugs, chemicals, or
other agents to cure or prevent infections.
[3] See Pennsylvania Health Care Cost Containment Council, Hospital-
Acquired Infections in Pennsylvania (Harrisburg, Pa.: November 2006).
[4] See D. Murphy et al., Dispelling the Myths: The True Cost of
Healthcare-Associated Infections (Washington, D.C., Association for
Professionals in Infection Control and Epidemiology, February 2007).
[5] Medicare is a federal health insurance program that serves over 42
million elderly and certain disabled beneficiaries and pays for health
care needs, such as inpatient hospital stays and physician visits.
[6] See 42 C.F.R. § 482.1 (2007).
[7] Section 1865(b)(1) of the Social Security Act also provides that
any other national accreditation body that meets certain requirements
as determined by HHS may accredit hospitals.
[8] In calendar year 2007, about 81 percent of hospitals were
accredited by the Joint Commission, state survey agencies certified
approximately 16 percent of hospitals, and less than 2 percent were
accredited by AOA. Less than 1 percent of hospitals were accredited by
both the Joint Commission and AOA. The Joint Commission was formerly
known as the Joint Commission on Accreditation of Healthcare
Organizations or "JCAHO."
[9] See K. Adams et al., Priority Areas for National Action:
Transforming Health Care Quality, Institute of Medicine of the National
Academies (Washington, D.C.: The National Academies Press, 2003).
[10] Pub. L. No. 109-171, § 5001(c), 120 Stat. 4, 30.
[11] Under Medicare, hospitals generally receive fixed payments for
inpatient stays based on diagnosis-related groups (DRG), a system that
classifies stays by patient diagnoses and procedures. Some DRGs take
account of certain comorbidities or complications associated with a
diagnosis or procedure and pay at a higher rate than would otherwise be
paid for the diagnosis or procedure. In a final regulation implementing
section 5001(c) of the DRA, CMS identified certain preventable
conditions it would not consider as a comorbidity or complication that
would lead to the higher payment. See 72 Fed. Reg. 47130, 47200-217
(Aug. 22, 2007). The DRA also requires hospitals to indicate the
diagnoses that were present in patients at the time of admission in
order for CMS to determine if a preventable condition developed during
a patient's hospital stay.
[12] Mediastinitis is inflammation of the area between the lungs (the
heart, the large blood vessels, the trachea, the esophagus, the thymus
gland, and connective tissues). Additional preventable conditions that
will no longer result in higher payments to hospitals include hospital-
acquired injuries, such as fractures, pressure ulcers, objects left in
the body during surgery, air embolisms, and blood incompatibility. CMS
plans to propose additional conditions in the fiscal year 2009 Hospital
Inpatient Prospective Payment Systems proposed rule. See 72 Fed. Reg.
47130 (Aug. 22, 2007).
[13] See Consumers Union, "State Hospital Infection Disclosure Laws,"
available at [hyperlink,
http://www.consumersunion.org/campaigns/stophospitalinfections/learn.htm
l], accessed on March 10, 2008.
[14] Representatives from the following government agencies are
nonvoting members of HICPAC: CDC, CMS, AHRQ, FDA, the National
Institutes of Health, and the Health Resources and Services
Administration.
[15] See World Health Organization, WHO Guidelines on Hand Hygiene in
Healthcare (Advanced Draft): Global Patient Safety Challenge 2005-2006:
Clean Care Is Safer Care (Geneva, Switzerland, 2006).
[16] HHS officials noted that the interpretive guidelines are used by
Medicare and Medicaid providers, such as hospitals, critical access
hospitals, hospices, nursing homes, and home health agencies, to
determine how to implement the requirements in the COPs.
[17] Throughout this report, where we refer to the interpretive
guidelines for infection control we are referring to the most recent
revision.
[18] Public health surveillance is defined as the ongoing systematic
collection, analysis, and interpretation of health data for purposes of
improving health and safety.
[19] The creation of HICPAC is authorized under section 222 of the
Public Health Service Act (codified at 42 U.S.C. §217a). The committee
is governed by the provisions of the Federal Advisory Committee Act,
Pub. L. No. 92-463, 86 Stat. 770 (1972), (codified at 5 U.S.C. App. 2),
which sets forth standards for the formation and use of an advisory
committee.
[20] In addition, CDC circulates the draft guideline to experts outside
of CDC for comment as part of an Office of Management and Budget
initiative to respond to concerns about whether diverse experts and
members of the public are provided with sufficient opportunities to
comment on influential scientific information or highly influential
assessment documents. CDC's infection control and prevention guidelines
are considered highly influential documents.
[21] Appendix A of the State Operations Manual contains the COPs for
hospitals and is available at [hyperlink,
http://www.cms.hhs.gov/GuidanceforLawsAndRegulations/08_Hospitals.asp],
downloaded on May 14, 2007.
[22] As we noted in a previous report, due to the Joint Commission's
unique legal status, CMS has limited oversight authority over the Joint
Commission's hospital accreditation program. See GAO, Medicare: CMS
Needs Additional Authority to Adequately Oversee Patient Safety in
Hospitals, GAO-04-850 (Washington, D.C.: July 20, 2004).
[23] CDC has issued four infection control guidance documents for
hospitals: (1) Infection Control Guidance for the Prevention and
Control of Influenza in Acute-Care Facilities, (2) Interim Guidance for
the Use of Masks to Control Influenza Transmission, (3) Respiratory
Hygiene/Cough Etiquette, and (4) Guidelines on Public Reporting of
Healthcare-Associated Infections. While the title of this fourth
guidance document includes the word "guidelines," CDC officials
consider this document to be guidance.
[24] CDC placed some of the practices in these seven guidelines in two
categories.
[25] Recommended practices related to Guideline for Prevention of
Catheter-associated Urinary Tract Infections issued in 1981 were
categorized as (1) strongly recommended, (2) moderately recommended,
and (3) weakly recommended for adoption. Guideline for Infection
Control in Health Care Personnel issued in 1998 and Guideline for
Prevention of Surgical Site Infection issued in 1999 used a slightly
different four-tier ranking system of (1) strongly recommended and
strongly supported by well-designed experimental or epidemiologic
studies, (2) strongly recommended based on strong rationale and
suggestive evidence, (3) suggested for implementation based on
suggestive clinical or epidemiologic studies, and (4) no recommendation
or unresolved issue. Guidelines for Preventing Opportunistic Infections
among Hematopoietic Stem Cell Transplant Recipients issued in 2000 used
an evidence-based rating system to determine strength of
recommendations and another evidence-based system to determine quality
of evidence. Using the first system, the recommendations were
categorized as (1) strongly recommended, (2) generally recommended, (3)
optional, (4) generally not recommended, and (5) never recommended.
[26] These two guidelines were created outside of HICPAC by another CDC
advisory committee--the Advisory Committee on Immunization Practices--
and CDC's Division of Tuberculosis Elimination.
[27] CDC has been drafting this guideline since 2000, and CDC officials
told us they expected to publish the guideline in 2008.
[28] This section addresses efforts to facilitate or encourage
implementation of recommended practices, as distinct from requiring
hospitals to adopt these practices by incorporating them in the
standards set by CMS, the Joint Commission, and AOA.
[29] CDC began the Prevention Epicenter Program in 1997 as a way to
collaborate with academic institutions to investigate the epidemiology
and prevention of HAIs. More information on CDC's Prevention Epicenter
Program and other HAI-related activities can be found in app. I.
[30] Studies have demonstrated reductions in HAIs when selected
recommended practices are implemented as a group or "bundle." The
Institute for Healthcare Improvement and the Michigan Health and
Hospital Association Keystone Intensive Care Unit Project have also
employed the bundle approach with success. See P. Pronovost et al., "An
Intervention to Decrease Catheter-Related Bloodstream Infections in the
ICU," The New England Journal of Medicine, vol. 355, no. 26 (2006):
2725-2732.
[31] See C. Muto et al., "Reduction in Central Line-Associated
Bloodstream Infections among Patients in Intensive Care Units--
Pennsylvania, April 2001-March 2005," Morbidity and Mortality Weekly
Report, vol. 54, no. 40 (2005): 1013-1016.
[32] See S. R. Ranji et al., Closing the Quality Gap: A Critical
Analysis of Quality Improvement Strategies, Volume 6--Prevention of
Healthcare-Associated Infections, AHRQ Publication No. 04(07)-0051-6
(Rockville, Md., January 2007).
[33] The four strategies were (1) use of printed or computer-based
reminders with automatic stop orders to reduce unnecessary urethral
catheterization; (2) printed or computer-based reminders to improve
surgical antibiotic prophylaxis; (3) active educational interventions
with use of checklists to improve adherence to central line insertion
practices; and (4) active educational interventions such as tutorials
to improve adherence to preventive interventions for ventilator-
associated pneumonia.
[34] According to AHRQ, this program develops and diffuses scientific
evidence about what works and does not work to improve health care
delivery systems.
[35] Although HICPAC includes representation from multiple HHS agencies
as well as from private organizations, it is not responsible for
coordinating the activities of these groups and functions as an
advisory body to the Secretary of HHS.
[36] The infection control COP is found in 42 C.F.R. § 482.42 (2007).
CMS officials said that the quality assessment and performance
improvement COP, which can be found at 42 C.F.R. § 482.21 (2007), can
also affect infection control. The quality assessment and performance
improvement COP states that the hospital must develop, implement, and
maintain an effective, ongoing, hospitalwide, data-driven quality
assessment and performance improvement program that reflects all of the
hospital's departments and services.
[37] Joint Commission officials said that standards in other chapters
of their manual could also affect infection control, such as standards
in the "Provision of Care" chapter, the "Treatment and Services"
chapter, the "Medication Management" chapter, the "Improving
Organization Performance" chapter, the "Leadership" chapter, and the
"Management of the Environment of Care" chapter.
[38] Prior to the revisions that will take effect on January 1, 2009,
the Joint Commission added a standard requiring hospitals to immunize
staff and licensed independent practitioners against influenza. This
standard took effect on January 1, 2007.
[39] Prior to 2008, the Joint Commission's National Patient Safety Goal
included only the CDC hand hygiene guideline.
[40] The Joint Commission defines a sentinel event as an unexpected
occurrence involving death or serious physical or psychological injury,
or the risk thereof. To "manage as a sentinel event" for this goal is
to determine why the patient acquired the infection and why the patient
died or suffered serious injury as a result of the infection.
[41] AOA officials said that standards in other chapters of their
manual could also affect infection control, including the chapters on
"Medical Staff," "Physical Environment," "Quality Assessment and
Performance Improvement," "Cardiovascular Services," and "Special Care
Units." The "Medical Staff" chapter describes the activities of the
infection control committee, which is required in the "Infection
Control" chapter.
[42] The selected practices in CDC's and WHO's hand hygiene guidelines
are those in the categories of (1) strongly recommended and strongly
supported; (2) strongly recommended and supported; and (3) additional
practices, including federal, state, and other requirements.
[43] The Joint Commission officials noted that a systems-based approach
includes learning the root causes of infections and developing
processes to mitigate their recurrence, and uses an epidemiologic
approach that includes surveillance, control, and prevention.
[44] CMS told us that if the hospital is cited at the condition level,
surveyors revisit the hospital to determine if the hospital is in
compliance with the COPs, including whether the previously cited
noncompliance has been corrected. Hospitals that are cited for
condition-level noncompliance may lose their ability to participate in
Medicare if the noncompliance is not corrected. If a hospital is
noncompliant with a standard-level requirement, the state surveyors
review the hospital's corrective action plan to determine if the plan
is likely to correct the noncompliance and prevent reoccurrence.
[45] Joint Commission officials told us that a hospital's failure to
submit this report could eventually lead to the loss of accreditation.
[46] During the first quarter of 2007, state survey agencies surveyed
190 hospitals, the Joint Commission surveyed 329 hospitals, and AOA
surveyed 9 hospitals.
[47] In a prior GAO report, we recommended that CMS increase the number
of validation surveys it conducts to at least 5 percent of all Joint
Commission-accredited hospitals. See GAO-04-850.
[48] To evaluate complaints, CMS decides which COP(s) to assess during
an on-site survey; the state agency conducts the on-site survey of the
identified COP(s); and based on the results of the survey, CMS decides
whether a full hospital survey is needed.
[49] Adherence rates in the studies ranged from 5 to 81 percent. CDC
notes that the methods used for defining and observing adherence varied
by study. See J. M. Boyce et al., "Guideline for Hand Hygiene in Health-
Care Settings: Recommendations of the Healthcare Infection Control
Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene
Task Force," Morbidity and Mortality Weekly Report, vol. 51, no. RR-16
(2002): 1-44.
[50] CDC operates other databases that may collect some HAI-related
data, but they are not as comprehensive as NHSN. For example, the
Active Bacterial Core Surveillance (ABCs) program collects data on six
specific bacterial pathogens from 10 designated geographic locations.
In 9 of these locations, CDC collects data on the incidence of both
community-associated and health-care-associated (including hospital-
onset) infections through laboratory results and medical record review.
The 9 sites from which CDC collects MRSA data are the state of
Connecticut; eight counties in the Atlanta metropolitan area; three
counties in the San Francisco Bay area; one county in the Denver
metropolitan area; three counties in the Portland, Oregon, metropolitan
area; one county in the Rochester, New York, metropolitan area;
Baltimore, Maryland; Davidson County (Nashville), Tennessee; and Ramsey
County (St. Paul), Minnesota.
[51] The other two are the Dialysis Surveillance Network database and
the National Surveillance System for Healthcare Workers database. The
Dialysis Surveillance Network program was a voluntary national
surveillance system that monitored BSIs and vascular infections in
outpatient dialysis centers. The National Surveillance System for
Healthcare Workers program collected information on exposures and
infections among health care workers.
[52] Sections 304, 306, and 308(d) of the Public Health Service Act
restrict the disclosure of information reported by hospitals.
[53] CDC officials reported that, as of December, 2007, 14 states had
decided to use NHSN to collect data from hospitals on HAIs for state
reporting programs that were either under way or under development.
These states require or plan to require their hospitals to both enroll
in the NHSN program and authorize CDC to release the hospitals' HAI
data to the state.
[54] CDC officials told us that not all of the enrolled hospitals were
reporting data to NHSN.
[55] States that mandate hospital participation in NHSN could also set
their own requirements for the types of infections, hospital units, and
procedures reported on, as well as number of months of HAI data
required.
[56] The MPSMS sample is a subset of the random sample of patient
records that CMS initially selects for the Hospital Payment Monitoring
Program, which reviews patient records to estimate Medicare's payment
error rate.
[57] We use the term abstractor to indicate persons who are trained to
follow a detailed protocol in order to extract specified information in
a consistent fashion from the medical records of patients.
[58] The algorithm calculates a rate of central-line-associated BSIs
based on the number of patients with central line catheters who did not
have an infection when they were admitted to the hospital and who
subsequently tested positive for any of 16 designated BSI pathogens 2
or more days after the central line catheter was inserted.
[59] The Congress created the financial incentives that are implemented
through the APU program as part of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003. For more information on the
collection and analysis of quality data under the APU program, see GAO,
Hospital Quality Data: CMS Needs More Rigorous Methods to Ensure
Reliability of Publicly Released Data, GAO-06-54 (Washington, D.C.:
Jan. 31, 2006), and GAO, Hospital Quality Data: HHS Should Specify
Steps and Time Frame for Using Information Technology to Collect and
Submit Data, GAO-07-320 (Washington, D.C.: Apr. 25, 2007).
[60] Hospitals accredited by the Joint Commission are required to
report quality-related data to the Joint Commission quarterly using
third-party vendors, who also generally provide these data to CMS.
Hospitals accredited by AOA are also required to submit these quality-
related data to CMS.
[61] The Web site is [hyperlink, http://www.hospitalcompare.hhs.gov].
[62] HCUP encompasses a set of related databases, one of which is the
Nationwide Inpatient Sample, which AHRQ has used to generate national
estimates for its PSIs. According to AHRQ, the national sample
approximates a 20 percent stratified sample of U.S. community
hospitals. The sample is approximate because hospitals in the states
that do not participate in HCUP are not included in the sample.
[63] The indicator is limited to patients undergoing elective surgeries
to better capture patients for which sepsis is a potentially
preventable complication and exclude patients that either had sepsis
present on admission or had conditions predisposing them to sepsis.
[64] See K. M. McDonald et al., Measures of Patient Safety Based on
Hospital Administrative Data--The Patient Safety Indicators, Technical
Review 5, AHRQ Publication No. 02-0038 (Rockville, Md.: Agency for
Healthcare Research and Quality, August 2002), 76-77.
[65] See [hyperlink, http://www.hcupnet.ahrq.gov].
[66] FDA receives reports from manufacturers and hospitals regarding
these adverse events, including concerns related to disinfection. FDA
officials told us that they have received very few reports involving
medical devices that might identify contaminated devices that would
cause HAIs.
[67] Under the Patient Safety and Quality Improvement Act of 2005, Pub.
L. No. 109-41, 119 Stat. 424, PSOs are entities that collect,
aggregate, and analyze confidential information reported by health care
providers in part to identify patterns of failures and propose measures
to eliminate patient safety risks and hazards.
[68] AHRQ officials plan to release the first such reports once the
PSOs become operational, which they expect could occur early in 2009.
[69] CDC officials estimate that approximately 22 percent of HAIs do
not fall in the four types of infection currently addressed in whole or
part by the four HHS databases--BSIs, UTIs, SSIs, and pneumonia. See R.
M. Klevens et al., "Estimating Health Care-Associated Infections and
Deaths in U.S. Hospitals, 2002," Public Health Reports, vol. 122
(2007): 160-166. These other infections include bone and joint
infections; central nervous system infections; cardiovascular system
infections; eye, ear, nose, throat, or mouth infections; skin and soft
tissue infections; and gastrointestinal system infections.
[70] When the National Quality Forum examined the application of the
NHSN criteria for identifying patients with VAP, it found wide
variations in the results obtained. According to the National Quality
Forum, incidence could range from 4 to 48 percent, depending on which
NHSN criteria were selected to diagnose VAP.
[71] Every quarter, CMS draws a sample of five patients for each
hospital that submitted data for six or more patients in that quarter.
[72] Patient bills typically include one principal diagnosis code and
multiple other diagnosis codes, which are used in determining the
amount of payment that the hospital receives for treating that patient.
After the patient has been discharged, hospital staff trained in
medical record coding decide which ICD-9 diagnostic codes to enter on
the patient's bill based on their review of the patient's medical
record.
[73] The SCIP steering committee also includes representatives from the
Joint Commission, the American College of Surgeons, and the American
Hospital Association.
[74] See E. R. Sherman et al., "Administrative Data Fail to Accurately
Identify Cases of Healthcare-Associated Infection," Infection Control
and Hospital Epidemiology, vol. 27, no. 4 (2006): 332-337, and S. B.
Wright et al., "Administrative Databases Provide Inaccurate Data for
Surveillance of Long-term Central Venous Catheter-associated
Infections," Infection Control and Hospital Epidemiology, vol. 24, no.
12 (2003): 946-949. In addition, HCUP's two HAI-related indicators do
not correspond to the infection types usually tracked by hospital
infection control programs. Postoperative sepsis would include some,
but not all, central-line-associated BSIs, along with other BSIs not
related to the insertion of central lines. Infections due to medical
care would likewise include central-line-associated BSIs as well as
infections caused by other types of catheters and intravenous lines.
[75] Association for Professionals in Infection Control and
Epidemiology, "National Prevalence Study of Methicillin-Resistant
Staphylococcus aureus (MRSA) in U.S. Healthcare Facilities, Executive
Summary," released June 25, 2007. See also W. R. Jarvis et al.,
"National Prevalence of Methicillin-Resistant Staphylococcus aureus in
Inpatients at U.S. Health Care Facilities, 2006," American Journal of
Infection Control, vol. 35, no. 10 (2007): 631-637. This figure
represents the prevalence of MRSA on a given day in fall 2006, that is,
all the known MRSA cases on that day in proportion to the total number
of inpatients, across the 1,187 hospitals that responded to the survey.
[76] Another recent study using CDC's Active Bacterial Core
Surveillance (ABCs) database found the national rate of invasive MRSA
per 100,000 population to be 31.8 in 2005. However, the MRSA rates
generated from the APIC survey and ABCs database are not comparable for
several reasons. For example, the ABCs program collects data on
invasive MRSA, which are cases found in a normally sterile site such as
blood and are a subset of the cases of MRSA collected in the APIC
survey. In addition, the ABCs database assesses the rate of infections
with respect to populations residing in defined geographic areas,
rather than at the provider level. The researchers noted that the nine
sites in the ABCs database are largely urban areas and that they had no
information to establish that the MRSA incidence rates found in those
sites reflected the incidence of MRSA in other parts of the United
States. See R. M. Klevens et al., "Invasive Methicillin-Resistant
Staphylococcus aureus Infections in the United States," Journal of the
American Medical Association, vol. 298, no. 15 (2007): 1763-1771.
[77] According to AHRQ officials, the MPSMS data to be released in the
next National Healthcare Quality Report, which AHRQ expects to issue in
early 2008, will not include results on MRSA. Those may appear as early
as the subsequent National Healthcare Quality Report, due in early
2009.
[78] R.M. Klevens et al., "Estimating Health Care-Associated Infections
and Deaths in U.S. Hospitals, 2002," Public Health Reports, March-April
2007, vol. 122, 160-166.
[79] The proportion of NNIS hospitals reporting such comprehensive
surveillance data dropped from about half in 1991 to none in 1998, when
NNIS stopped collecting these data altogether.
[80] The mission of the National Center for Health Statistics is to
collect health statistics in order to guide actions and policies to
improve the health of the U.S. population. The National Hospital
Discharge Survey is a national probability survey that collects
information on the characteristics of inpatients discharged from
nonfederal short-stay hospitals in the United States.
[81] VRE are bacteria that have become resistant to vancomycin, an
antibiotic used to treat patients infected with bacterial pathogens.
VRE can cause urinary tract infections, BSIs, and wound infections.
[82] Appendix A of the State Operations Manual is available at
[hyperlink,
http://www.cms.hhs.gov/GuidanceforLawsAndRegulations/08_Hospitals.asp],
downloaded on May 14, 2007.
[83] These revised guidelines are titled "Revisions to the Hospital
Interpretive Guidelines for Infection Control" (memo number 08-04) and
were effective immediately upon issuance. These revisions are available
at [hyperlink, http://www.cms.hhs.gov/SurveyCertificationGenInfo/PMSR],
downloaded on November 29, 2007.
[84] The quality assessment and performance improvement COP states that
the hospital must develop, implement, and maintain an effective,
ongoing, hospitalwide, data-driven quality assessment and performance
improvement program that reflects all of the hospital's departments and
services.
[End of section]
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