Agency Information Collection Activities: Proposed Collection; Comment Request, 12251-12254 [2019-06193]
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HISTORY:
81 FR 7,106 (Feb. 10, 2016).
[FR Doc. 2019–06165 Filed 3–29–19; 8:45 am]
BILLING CODE 6760–01–P
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Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:
This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve a revision and to
extend the time period of the proposed
information collection project ‘‘The
AHRQ Safety Program for Improving
Antibiotic Use.’’
DATES: Comments on this notice must be
received by May 31, 2019.
ADDRESSES: Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by
email at doris.lefkowitz@AHRQ.hhs.gov.
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ Reports
Clearance Officer.
SUMMARY:
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12251
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
emails at doris.lefkowitz@
AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
Proposed Project
The AHRQ Safety Program for
Improving Antibiotic Use
In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3521,
AHRQ invites the public to comment on
this proposed information collection.
The Agency for Healthcare Research and
Quality (AHRQ) requests to revise and
extend the currently approved AHRQ
Safety Program for Improving Antibiotic
Use. The AHRQ Safety Program for
Improving Antibiotic Use (the ‘‘AHRQ
Safety Program’’) aims to help facilities
implement antibiotic stewardship
programs and to reduce unnecessary
antibiotic prescribing. The AHRQ Safety
Program has already been implemented
in a pilot of integrated delivery systems
and a national cohort of 400 acute care
hospitals, and is currently being
implemented in a national cohort of 500
long-term care facilities. The AHRQ
Safety Program was last approved by
OMB on September 25, 2017 and will
expire on September 30, 2020. The
request for extension is to allow for
completion of activities and data
collection in the AHRQ Safety Program,
which are scheduled to occur through
March 30, 2021. The OMB control
number for the AHRQ Safety Program is
0935–0238. All of the supporting
documents for the current AHRQ Safety
Program can be downloaded from
OMB’s website at https://
www.reginfo.gov/public/do/
PRAViewICR?ref_nbr=201707-0935-003.
The 2017 OMB clearance included
one response for the Structural
Assessment and the Medical Office
Survey on Patient Safety Culture
(MOSOPS), but did not include
electronic health record (EHR) data or a
second response for the Structural
Assessment or MOSOPS for the 4th
cohort planned for ambulatory settings.
This was because the original OMB
clearance expiration date fell in the
middle of the planned 4th cohort, so the
second Structural Assessment and
MOSOPS were not within the approved
information collection period, and EHR
data collection would have been
incomplete. In addition, the project
team was not certain that the
ambulatory care practices would be able
to access EHR data. Based on the
experience of the pilot cohort, however,
it is believed that many ambulatory
practices can access this data, and that
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these practices are more likely to
feasibly participate in the AHRQ Safety
Program. The revision also updates the
estimated annual burden accordingly,
and includes changes to the data
collection forms which will be used for
the ambulatory care cohort based on
lessons learned during the pilot cohort.
Background for This Collection
As part of the Department of Health
and Human Services (DHHS) Hospital
Acquired Infection (HAI) National
Action Plan (NAP), AHRQ has
supported the implementation and
adoption of the Comprehensive Unitbased Safety Program (CUSP) to reduce
Central-Line Associated Bloodstream
Infections (CLABSI) and CatheterAssociated Urinary Tract Infections
(CAUTI), and subsequently applied
CUSP to other clinical challenges,
including reducing surgical site
infections and improving care for
mechanically ventilated patients. As
part of the National Action Plan for
Combating Antibiotic-Resistant Bacteria
(CARB NAP) to increase antibiotic
stewardship (defined as organized
efforts to promote the judicious use of
antibiotics) across all health care
settings, AHRQ is applying the
principles and concepts that have been
learned from these HAI reduction efforts
to antibiotic stewardship (AS).
Antibiotic therapy has saved
countless lives over the past several
decades. However, bacterial resistance
to antibiotics has followed closely on
the heels of each new agent’s
introduction. This has led to an
epidemic of antibiotic resistance, with
drug choices for some bacterial
infections becoming increasingly
limited, expensive, and in some cases
nonexistent. While antibiotics remain a
vital and necessary cornerstone to the
treatment of infections, it is estimated
that 20–50% of all antibiotics prescribed
in U.S. acute care hospitals are either
unnecessary or inappropriate. When
antibiotics are used inappropriately,
bacterial development of resistance is
supported in the absence of any
therapeutic benefit, and patients
receiving unnecessary or inappropriate
antibiotics are also exposed to the risk
of adverse effects such as rash or renal
injury as well as the risk of
Clostridioides difficile infection which
can cause a deadly diarrhea. Unlike
misuse of other medications, the misuse
of antibiotics can adversely impact the
health of patients who are not even
exposed to them because of the
potential for spread of resistant
organisms. The Centers for Disease
Control and Prevention (CDC) estimates
that each year at least two million
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illnesses and 23,000 deaths are caused
by drug-resistant bacteria in the United
States alone.
While approaches including
development of new antibiotic agents,
increased surveillance for antibiotic
resistance, prevention of HAIs, and
prevention of transmission of resistant
infections are important efforts to
combat antibiotic resistance, it is critical
to curb the inappropriate use of
antibiotics to slow the emergence of
antibiotic resistance and to preserve
efficacy of existing antibiotics and those
under development.
As of January 1st, 2017, The Joint
Commission (TJC)’s new Antimicrobial
Stewardship Standard requires that all
acute care hospitals have robust
antibiotic stewardship programs. In
addition, starting on November 28,
2017, the Centers for Medicare &
Medicaid Services (CMS) required that
all long-term care facilities that receive
reimbursement from CMS have
antibiotic stewardship programs in
place.
The Comprehensive Unit-Based
Safety Program (CUSP), developed at
the Armstrong Institute at Johns
Hopkins University, combines
improvement in patient safety culture,
teamwork, and communication together
with a technical bundle of interventions
to improve patient safety. CUSP is a
powerful culture change tool, which has
been successfully utilized to reduce
CLABSI in ICUs in Michigan and Rhode
Island and subsequently to reduce
CLABSI by 41% in more than 1,000
ICUs in 44 states, Puerto Rico and the
District of Columbia. Although
evidence-based recommendations for
prevention of CLABSI had existed for
years, the combination of safety culture
change on units and implementation of
technical interventions resulted in
significant reductions in CLABSI and
introduced the concept that a rate of
zero CLABSIs is achievable. CUSP is
also being used to reduce other HAIs in
multiple settings (https://www.ahrq.gov/
professionals/quality-patient-safety/
hais/).
This project will assist hospitals,
nursing homes, and ambulatory care
sites across the United States in
adopting and implementing AS
programs and interventions.
This project has the following goals:
• Identify best practices in the
delivery of antibiotic stewardship in the
acute care, long-term care and
ambulatory care settings
• Adapt the CUSP model to enhance
antibiotic stewardship efforts in the
health care settings
• Develop a bundle of technical and
adaptive interventions and associated
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tools and educational materials
designed to support enhanced antibiotic
stewardship efforts
• Provide technical assistance and
training to health care organizations
nationwide (using a phased approach)
to implement effective antibiotic
stewardship programs and interventions
• Improve communication and
teamwork between health care workers
surrounding antibiotic decision-making
• Improve communication between
health care workers and patients and
families surrounding antibiotic
decision-making
• Conduct a comprehensive
evaluation to assess the adoption of the
CUSP for AS in acute care, long-term
care and ambulatory care settings to
identify the effectiveness of the
program, process outcomes, and lessons
learned
The project will be implemented in
four cohorts; (1) Cohort 1 is a pilot
limited to 10 facilities each in three
integrated delivery systems spanning
acute care, long-term care, and
ambulatory settings; (2) Cohort 2 will
expand to include 250–500 acute care
hospitals; (3) Cohort 3 will include 250–
500 long-term care facilities; and (4)
Cohort 4 will include 250–500
ambulatory care facilities.
The AHRQ Safety Program is being
undertaken pursuant to AHRQ’s mission
to enhance the quality, appropriateness,
and effectiveness of health services, and
access to such services, through the
establishment of a broad base of
scientific research and through the
promotion of improvements in clinical
and health systems practices, including
the prevention of diseases and other
health conditions. 42 U.S.C. 299.
Method of Collection
To achieve the goals of the AHRQ
Safety Program, the following data
collections will be implemented:
(1) Structural Assessments: A brief,
eight question, online Structural
Assessment Tool will be administered at
baseline (pre-intervention) and at the
end of the intervention period to obtain
general information about facilities and
stewardship infrastructure and changes
to stewardship infrastructure and
interventions that are anticipated to be
sustained as a result of the AHRQ Safety
Program (one response per facility for
the 4th cohort in ambulatory settings
was included in the original OMB
review, this revision adds an additional
response per facility, relevant changes
made to line 1.b. in Exhibits A.1. and
A.2.).
(2) Team Antibiotic Review Form: The
Stewardship Team in hospitals and
nursing homes will conduct monthly
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reviews of at least 10 patients who
received antibiotics and fill out an
assessment tool in conjunction with
frontline staff to determine if the ‘‘four
moments of antibiotic decision-making’’
are being considered by providers. The
four moments can be summarized as: (1)
Is an infection present requiring
antibiotics? (2) Are appropriate cultures
being ordered and is the most optimal
initial choice of antibiotics being
prescribed? (3) (after at least 24 hours)
Is it appropriate to make changes to the
antibiotic regimen (e.g., stop therapy,
narrow therapy, change from
intravenous to oral therapy)? (4) What
duration of therapy is appropriate?
(3) The AHRQ Surveys on Patient
Safety Culture: The appropriate versions
of these surveys and the MOSOPS will
be administered to all participating staff
at the beginning and end of the
intervention. Each survey asks questions
about patient safety issues, medical
errors, and event reporting in the
respective settings. The surveys will be
administered to all participating staff at
the beginning and end of the
intervention. (One response per
respondent for the 4th cohort in
ambulatory settings was included in the
original OMB review, this revision adds
an additional response per respondent,
relevant changes made to line 3.d. in
Exhibits A.1. and A.2.).
a. The Hospital Survey on Patient
Safety Culture (HSOPS) will be utilized
to evaluate safety culture for acute care
hospitals.
b. The Nursing Home Survey on
Patient Safety Culture (NHSOPS) will be
administered in long-term care.
c. The Medical Office Survey on
Patient Safety Culture (MOSOPS) will
be administered in ambulatory care
centers.
(4) Semi-structured qualitative
interviews: During the project pilot
period with Cohort 1, in-person and/or
telephone discussions will be held
before and after implementation with
stewardship champions/organizational
leaders, physicians, pharmacists, nurse
practitioners, physician assistants,
nurses, certified nursing assistants and
others deemed relevant, to learn about
the facilitators and barriers to a
successful antibiotic stewardship
program. Specific areas of interest
include stakeholder perceptions of
implementation process and outcomes,
including successes and challenges with
carrying out project tasks and perceived
utility of the project; staff roles,
engagement and support; and antibiotic
prescribing etiquette & culture (i.e.,
social norms and local cultural factors
that contribute to prescribing behavior
at the facility/unit-level).
(5) Electronic Health Record (EHR)
data: Unit-level antibiotic therapy
prescriptions and antibiotic use for
diagnosed respiratory conditions will be
extracted from the Electronic Health
Records (EHRs) of participating units
and used to assess the impact of the
AHRQ Safety Program. (4th cohort in
ambulatory settings portion is new from
original OMB review, noted in line 6 in
Exhibits A.1. and A.2.).
Estimated Annual Respondent Burden
Exhibit A.1 shows the estimated
annualized burden hours for the
respondents’ time to complete the
Structural Assessments, Team
Antibiotic Review Forms, AHRQ Patient
Safety Culture Surveys, semi-structured
qualitative interviews, and EHR data
extractions. Data will be collected from
30 acute care, long-term care, and
ambulatory care sites during the Cohort
1 one-year pilot period; up to 500 acute
care hospitals in Cohort 2; up to 500
long-term care facilities in Cohort 3; and
up to 500 ambulatory care sites in
Cohort 4. With this revision, the total
estimated annualized burden hours for
the data collection activities are 27,064.
EXHIBIT A.1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
1. Structural Assessments:
a. Structural Assessments—Cohorts 1, 2 and 3 (baseline, post-intervention) .................................................................................................
b. Structural Assessments—Cohort 4 (baseline and endline) .................
2. Team Antibiotic Review Form (Cohorts 1, 2, and 3) ..................................
3. AHRQ Patient Safety Culture Surveys:
a. HSOPS, NHSOPS, MOSOPS (Cohort 1) ............................................
b. HSOPS (Cohort 2) ................................................................................
c. NHSOPS (Cohort 3) .............................................................................
d. MOSOPS (Cohort 4) ............................................................................
4. Semi-structured qualitative interviews (Cohort 1):
a. Physicians ............................................................................................
b. Other Health Practitioners ....................................................................
5. EHR data (Cohorts 1, 2, and 3) ..................................................................
6. EHR data (Cohort 4) ............................................................................
Total ...................................................................................................
Exhibit A.2 shows the estimated
annualized cost burden based on the
respondents’ time to complete the data
Number of
responses per
respondent
Hours per
response
Total burden
hours
343
167
337
2
2
90
0.2
0.2
0.25
137
67
7,583
83
4,167
4,167
4,167
2
2
2
2
0.5
0.5
0.5
0.5
83
4,167
4,167
4,167
30
60
334
167
2
2
12
15
1
1
1
1
60
120
4,008
2,505
14,022
........................
........................
27,030
collection forms. The total cost burden
is estimated to be $1,311,096.
EXHIBIT A.2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
Form name
1. Structural Assessments:
a. Structural Assessments—Cohorts 1, 2 and 3 (baseline, post-intervention) .................................................................................................
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Total burden
hours
343
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137
01APN1
Average hourly wage rate *
a $98.83
Total cost
burden
$13,540
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Federal Register / Vol. 84, No. 62 / Monday, April 1, 2019 / Notices
EXHIBIT A.2—ESTIMATED ANNUALIZED COST BURDEN—Continued
Number of
respondents
Form name
Average hourly wage rate *
167
337
67
7,583
a 98.83
83
4,167
4,167
4,167
83
4,167
4,167
4,167
b 27.87
30
60
334
167
60
120
4,008
2,505
14,022
27,064
b. Structural Assessments—Cohort 4 (baseline and endline) .................
2. Team Antibiotic Review Form (Cohorts 1, 2, and 3) ..................................
3. AHRQ Patient Safety Culture Surveys:
a. HSOPS, NHSOPS, MOSOPS (Cohort 1) ............................................
b. HSOPS (Cohort 2) ................................................................................
c. NHSOPS (Cohort 3) .............................................................................
d. MOSOPS (Cohort 4) ............................................................................
4. Semi-structured qualitative interviews (Cohort 1):
a. Physicians ............................................................................................
b. Other Health Practitioners ....................................................................
5. EHR data (Cohorts 1, 2, and 3) ..................................................................
6. EHR data (Cohort 4) ...................................................................................
Total ...................................................................................................
Total burden
hours
a 98.83
b 27.87
b 27.87
b 27.87
a 98.83
Total cost
burden
6,622
749,428
2,313
116,134
116,134
116,134
b 27.87
5,930
3,344
111,703
69,814
........................
1,311,096
b 27.87
b 27.87
* National Compensation Survey: Occupational wages in the United States May 2016 ‘‘U.S. Department of Labor, Bureau of Labor Statistics:’’
https://www.bls.gov/oes/current/oes_stru.htm.
a Based on the mean wages for 29–1069 Physicians and Surgeons, All Other.
b Based on the mean wages for 29–9099 Miscellaneous Health Practitioners and Technical Workers: Healthcare Practitioners and Technical
Workers, All Other.
Request for Comments
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ’s health care
research and health care information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) of information; (c) ways to
enhance the quality, utility and clarity
of the information to be collected; and
(d) ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Gopal Khanna,
Director.
[FR Doc. 2019–06193 Filed 3–29–19; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
AGENCY:
ACTION:
Notice.
This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project ‘‘Online
Submission Form for Supplemental
Evidence and Data for Systematic
Reviews for the Evidence-based Practice
Center Program.’’
SUMMARY:
Comments on this notice must be
received by May 31, 2019.
DATES:
Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by
email at doris.lefkowitz@AHRQ.hhs.gov.
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ Reports
Clearance Officer.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
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Proposed Project
Online Submission Form for
Supplemental Evidence and Data for
Systematic Reviews for the EvidenceBased Practice Center Program
In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3521,
AHRQ invites the public to comment on
this proposed information collection.
The AHRQ Evidence-based Practice
Center (EPC) Program develops
evidence reports and technology
assessments that summarize evidence
for federal and other partners on topics
relevant to clinical and other health care
organization and delivery issues—
specifically those that are common,
expensive, and/or significant for the
Medicare and Medicaid populations.
Better understanding and use of
evidence in practice, policy, and
delivery of care improves the quality of
health care.
These reports, reviews, and
technology assessments are based on
rigorous, comprehensive syntheses and
analyses of the scientific literature on
topics. EPC reports and assessments
emphasize explicit and detailed
documentation of methods, rationale,
and assumptions. EPC reports are
conducted in accordance with an
established policy on financial and
nonfinancial interests.
This research has the following goals:
Æ Use research methods to gather
knowledge on the effectiveness or
comparative effectiveness of treatments,
screening, diagnostic, management or
health care delivery strategies for
specific medical conditions, both
published and unpublished, to evaluate
the quality of research studies and the
evidence from these studies.
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]]>Agencies
[Federal Register Volume 84, Number 62 (Monday, April 1, 2019)]
[Notices]
[Pages 12251-12254]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06193]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Agency for Healthcare Research and Quality, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the intention of the Agency for
Healthcare Research and Quality (AHRQ) to request that the Office of
Management and Budget (OMB) approve a revision and to extend the time
period of the proposed information collection project ``The AHRQ Safety
Program for Improving Antibiotic Use.''
DATES: Comments on this notice must be received by May 31, 2019.
ADDRESSES: Written comments should be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by email at
[email protected].
Copies of the proposed collection plans, data collection
instruments, and specific details on the estimated burden can be
obtained from the AHRQ Reports Clearance Officer.
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by emails at
[email protected].
SUPPLEMENTARY INFORMATION:
Proposed Project
The AHRQ Safety Program for Improving Antibiotic Use
In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-
3521, AHRQ invites the public to comment on this proposed information
collection. The Agency for Healthcare Research and Quality (AHRQ)
requests to revise and extend the currently approved AHRQ Safety
Program for Improving Antibiotic Use. The AHRQ Safety Program for
Improving Antibiotic Use (the ``AHRQ Safety Program'') aims to help
facilities implement antibiotic stewardship programs and to reduce
unnecessary antibiotic prescribing. The AHRQ Safety Program has already
been implemented in a pilot of integrated delivery systems and a
national cohort of 400 acute care hospitals, and is currently being
implemented in a national cohort of 500 long-term care facilities. The
AHRQ Safety Program was last approved by OMB on September 25, 2017 and
will expire on September 30, 2020. The request for extension is to
allow for completion of activities and data collection in the AHRQ
Safety Program, which are scheduled to occur through March 30, 2021.
The OMB control number for the AHRQ Safety Program is 0935-0238. All of
the supporting documents for the current AHRQ Safety Program can be
downloaded from OMB's website at https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201707-0935-003.
The 2017 OMB clearance included one response for the Structural
Assessment and the Medical Office Survey on Patient Safety Culture
(MOSOPS), but did not include electronic health record (EHR) data or a
second response for the Structural Assessment or MOSOPS for the 4th
cohort planned for ambulatory settings. This was because the original
OMB clearance expiration date fell in the middle of the planned 4th
cohort, so the second Structural Assessment and MOSOPS were not within
the approved information collection period, and EHR data collection
would have been incomplete. In addition, the project team was not
certain that the ambulatory care practices would be able to access EHR
data. Based on the experience of the pilot cohort, however, it is
believed that many ambulatory practices can access this data, and that
[[Page 12252]]
these practices are more likely to feasibly participate in the AHRQ
Safety Program. The revision also updates the estimated annual burden
accordingly, and includes changes to the data collection forms which
will be used for the ambulatory care cohort based on lessons learned
during the pilot cohort.
Background for This Collection
As part of the Department of Health and Human Services (DHHS)
Hospital Acquired Infection (HAI) National Action Plan (NAP), AHRQ has
supported the implementation and adoption of the Comprehensive Unit-
based Safety Program (CUSP) to reduce Central-Line Associated
Bloodstream Infections (CLABSI) and Catheter-Associated Urinary Tract
Infections (CAUTI), and subsequently applied CUSP to other clinical
challenges, including reducing surgical site infections and improving
care for mechanically ventilated patients. As part of the National
Action Plan for Combating Antibiotic-Resistant Bacteria (CARB NAP) to
increase antibiotic stewardship (defined as organized efforts to
promote the judicious use of antibiotics) across all health care
settings, AHRQ is applying the principles and concepts that have been
learned from these HAI reduction efforts to antibiotic stewardship
(AS).
Antibiotic therapy has saved countless lives over the past several
decades. However, bacterial resistance to antibiotics has followed
closely on the heels of each new agent's introduction. This has led to
an epidemic of antibiotic resistance, with drug choices for some
bacterial infections becoming increasingly limited, expensive, and in
some cases nonexistent. While antibiotics remain a vital and necessary
cornerstone to the treatment of infections, it is estimated that 20-50%
of all antibiotics prescribed in U.S. acute care hospitals are either
unnecessary or inappropriate. When antibiotics are used
inappropriately, bacterial development of resistance is supported in
the absence of any therapeutic benefit, and patients receiving
unnecessary or inappropriate antibiotics are also exposed to the risk
of adverse effects such as rash or renal injury as well as the risk of
Clostridioides difficile infection which can cause a deadly diarrhea.
Unlike misuse of other medications, the misuse of antibiotics can
adversely impact the health of patients who are not even exposed to
them because of the potential for spread of resistant organisms. The
Centers for Disease Control and Prevention (CDC) estimates that each
year at least two million illnesses and 23,000 deaths are caused by
drug-resistant bacteria in the United States alone.
While approaches including development of new antibiotic agents,
increased surveillance for antibiotic resistance, prevention of HAIs,
and prevention of transmission of resistant infections are important
efforts to combat antibiotic resistance, it is critical to curb the
inappropriate use of antibiotics to slow the emergence of antibiotic
resistance and to preserve efficacy of existing antibiotics and those
under development.
As of January 1st, 2017, The Joint Commission (TJC)'s new
Antimicrobial Stewardship Standard requires that all acute care
hospitals have robust antibiotic stewardship programs. In addition,
starting on November 28, 2017, the Centers for Medicare & Medicaid
Services (CMS) required that all long-term care facilities that receive
reimbursement from CMS have antibiotic stewardship programs in place.
The Comprehensive Unit-Based Safety Program (CUSP), developed at
the Armstrong Institute at Johns Hopkins University, combines
improvement in patient safety culture, teamwork, and communication
together with a technical bundle of interventions to improve patient
safety. CUSP is a powerful culture change tool, which has been
successfully utilized to reduce CLABSI in ICUs in Michigan and Rhode
Island and subsequently to reduce CLABSI by 41% in more than 1,000 ICUs
in 44 states, Puerto Rico and the District of Columbia. Although
evidence-based recommendations for prevention of CLABSI had existed for
years, the combination of safety culture change on units and
implementation of technical interventions resulted in significant
reductions in CLABSI and introduced the concept that a rate of zero
CLABSIs is achievable. CUSP is also being used to reduce other HAIs in
multiple settings (https://www.ahrq.gov/professionals/quality-patient-safety/hais/).
This project will assist hospitals, nursing homes, and ambulatory
care sites across the United States in adopting and implementing AS
programs and interventions.
This project has the following goals:
Identify best practices in the delivery of antibiotic
stewardship in the acute care, long-term care and ambulatory care
settings
Adapt the CUSP model to enhance antibiotic stewardship
efforts in the health care settings
Develop a bundle of technical and adaptive interventions
and associated tools and educational materials designed to support
enhanced antibiotic stewardship efforts
Provide technical assistance and training to health care
organizations nationwide (using a phased approach) to implement
effective antibiotic stewardship programs and interventions
Improve communication and teamwork between health care
workers surrounding antibiotic decision-making
Improve communication between health care workers and
patients and families surrounding antibiotic decision-making
Conduct a comprehensive evaluation to assess the adoption
of the CUSP for AS in acute care, long-term care and ambulatory care
settings to identify the effectiveness of the program, process
outcomes, and lessons learned
The project will be implemented in four cohorts; (1) Cohort 1 is a
pilot limited to 10 facilities each in three integrated delivery
systems spanning acute care, long-term care, and ambulatory settings;
(2) Cohort 2 will expand to include 250-500 acute care hospitals; (3)
Cohort 3 will include 250-500 long-term care facilities; and (4) Cohort
4 will include 250-500 ambulatory care facilities.
The AHRQ Safety Program is being undertaken pursuant to AHRQ's
mission to enhance the quality, appropriateness, and effectiveness of
health services, and access to such services, through the establishment
of a broad base of scientific research and through the promotion of
improvements in clinical and health systems practices, including the
prevention of diseases and other health conditions. 42 U.S.C. 299.
Method of Collection
To achieve the goals of the AHRQ Safety Program, the following data
collections will be implemented:
(1) Structural Assessments: A brief, eight question, online
Structural Assessment Tool will be administered at baseline (pre-
intervention) and at the end of the intervention period to obtain
general information about facilities and stewardship infrastructure and
changes to stewardship infrastructure and interventions that are
anticipated to be sustained as a result of the AHRQ Safety Program (one
response per facility for the 4th cohort in ambulatory settings was
included in the original OMB review, this revision adds an additional
response per facility, relevant changes made to line 1.b. in Exhibits
A.1. and A.2.).
(2) Team Antibiotic Review Form: The Stewardship Team in hospitals
and nursing homes will conduct monthly
[[Page 12253]]
reviews of at least 10 patients who received antibiotics and fill out
an assessment tool in conjunction with frontline staff to determine if
the ``four moments of antibiotic decision-making'' are being considered
by providers. The four moments can be summarized as: (1) Is an
infection present requiring antibiotics? (2) Are appropriate cultures
being ordered and is the most optimal initial choice of antibiotics
being prescribed? (3) (after at least 24 hours) Is it appropriate to
make changes to the antibiotic regimen (e.g., stop therapy, narrow
therapy, change from intravenous to oral therapy)? (4) What duration of
therapy is appropriate?
(3) The AHRQ Surveys on Patient Safety Culture: The appropriate
versions of these surveys and the MOSOPS will be administered to all
participating staff at the beginning and end of the intervention. Each
survey asks questions about patient safety issues, medical errors, and
event reporting in the respective settings. The surveys will be
administered to all participating staff at the beginning and end of the
intervention. (One response per respondent for the 4th cohort in
ambulatory settings was included in the original OMB review, this
revision adds an additional response per respondent, relevant changes
made to line 3.d. in Exhibits A.1. and A.2.).
a. The Hospital Survey on Patient Safety Culture (HSOPS) will be
utilized to evaluate safety culture for acute care hospitals.
b. The Nursing Home Survey on Patient Safety Culture (NHSOPS) will
be administered in long-term care.
c. The Medical Office Survey on Patient Safety Culture (MOSOPS)
will be administered in ambulatory care centers.
(4) Semi-structured qualitative interviews: During the project
pilot period with Cohort 1, in-person and/or telephone discussions will
be held before and after implementation with stewardship champions/
organizational leaders, physicians, pharmacists, nurse practitioners,
physician assistants, nurses, certified nursing assistants and others
deemed relevant, to learn about the facilitators and barriers to a
successful antibiotic stewardship program. Specific areas of interest
include stakeholder perceptions of implementation process and outcomes,
including successes and challenges with carrying out project tasks and
perceived utility of the project; staff roles, engagement and support;
and antibiotic prescribing etiquette & culture (i.e., social norms and
local cultural factors that contribute to prescribing behavior at the
facility/unit-level).
(5) Electronic Health Record (EHR) data: Unit-level antibiotic
therapy prescriptions and antibiotic use for diagnosed respiratory
conditions will be extracted from the Electronic Health Records (EHRs)
of participating units and used to assess the impact of the AHRQ Safety
Program. (4th cohort in ambulatory settings portion is new from
original OMB review, noted in line 6 in Exhibits A.1. and A.2.).
Estimated Annual Respondent Burden
Exhibit A.1 shows the estimated annualized burden hours for the
respondents' time to complete the Structural Assessments, Team
Antibiotic Review Forms, AHRQ Patient Safety Culture Surveys, semi-
structured qualitative interviews, and EHR data extractions. Data will
be collected from 30 acute care, long-term care, and ambulatory care
sites during the Cohort 1 one-year pilot period; up to 500 acute care
hospitals in Cohort 2; up to 500 long-term care facilities in Cohort 3;
and up to 500 ambulatory care sites in Cohort 4. With this revision,
the total estimated annualized burden hours for the data collection
activities are 27,064.
Exhibit A.1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of
Form name Number of responses per Hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
1. Structural Assessments:
a. Structural Assessments--Cohorts 1, 2 and 343 2 0.2 137
3 (baseline, post-intervention)............
b. Structural Assessments--Cohort 4 167 2 0.2 67
(baseline and endline).....................
2. Team Antibiotic Review Form (Cohorts 1, 2, 337 90 0.25 7,583
and 3).........................................
3. AHRQ Patient Safety Culture Surveys:
a. HSOPS, NHSOPS, MOSOPS (Cohort 1)......... 83 2 0.5 83
b. HSOPS (Cohort 2)......................... 4,167 2 0.5 4,167
c. NHSOPS (Cohort 3)........................ 4,167 2 0.5 4,167
d. MOSOPS (Cohort 4)........................ 4,167 2 0.5 4,167
4. Semi-structured qualitative interviews
(Cohort 1):
a. Physicians............................... 30 2 1 60
b. Other Health Practitioners............... 60 2 1 120
5. EHR data (Cohorts 1, 2, and 3)............... 334 12 1 4,008
6. EHR data (Cohort 4)...................... 167 15 1 2,505
---------------------------------------------------------------
Total................................... 14,022 .............. .............. 27,030
----------------------------------------------------------------------------------------------------------------
Exhibit A.2 shows the estimated annualized cost burden based on the
respondents' time to complete the data collection forms. The total cost
burden is estimated to be $1,311,096.
Exhibit A.2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Number of Total burden Average hourly Total cost
Form name respondents hours wage rate * burden
----------------------------------------------------------------------------------------------------------------
1. Structural Assessments:
a. Structural Assessments--Cohorts 1, 2 and 343 137 \a\ $98.83 $13,540
3 (baseline, post-intervention)............
[[Page 12254]]
b. Structural Assessments--Cohort 4 167 67 \a\ 98.83 6,622
(baseline and endline).....................
2. Team Antibiotic Review Form (Cohorts 1, 2, 337 7,583 \a\ 98.83 749,428
and 3).........................................
3. AHRQ Patient Safety Culture Surveys:
a. HSOPS, NHSOPS, MOSOPS (Cohort 1)......... 83 83 \b\ 27.87 2,313
b. HSOPS (Cohort 2)......................... 4,167 4,167 \b\ 27.87 116,134
c. NHSOPS (Cohort 3)........................ 4,167 4,167 \b\ 27.87 116,134
d. MOSOPS (Cohort 4)........................ 4,167 4,167 \b\ 27.87 116,134
4. Semi-structured qualitative interviews
(Cohort 1):
a. Physicians............................... 30 60 \a\ 98.83 5,930
b. Other Health Practitioners............... 60 120 \b\ 27.87 3,344
5. EHR data (Cohorts 1, 2, and 3)............... 334 4,008 \b\ 27.87 111,703
6. EHR data (Cohort 4).......................... 167 2,505 \b\ 27.87 69,814
---------------------------------------------------------------
Total................................... 14,022 27,064 .............. 1,311,096
----------------------------------------------------------------------------------------------------------------
* National Compensation Survey: Occupational wages in the United States May 2016 ``U.S. Department of Labor,
Bureau of Labor Statistics:'' https://www.bls.gov/oes/current/oes_stru.htm.
\a\ Based on the mean wages for 29-1069 Physicians and Surgeons, All Other.
\b\ Based on the mean wages for 29-9099 Miscellaneous Health Practitioners and Technical Workers: Healthcare
Practitioners and Technical Workers, All Other.
Request for Comments
In accordance with the Paperwork Reduction Act, comments on AHRQ's
information collection are requested with regard to any of the
following: (a) Whether the proposed collection of information is
necessary for the proper performance of AHRQ's health care research and
health care information dissemination functions, including whether the
information will have practical utility; (b) the accuracy of AHRQ's
estimate of burden (including hours and costs) of the proposed
collection(s) of information; (c) ways to enhance the quality, utility
and clarity of the information to be collected; and (d) ways to
minimize the burden of the collection of information upon the
respondents, including the use of automated collection techniques or
other forms of information technology.
Comments submitted in response to this notice will be summarized
and included in the Agency's subsequent request for OMB approval of the
proposed information collection. All comments will become a matter of
public record.
Gopal Khanna,
Director.
[FR Doc. 2019-06193 Filed 3-29-19; 8:45 am]
BILLING CODE 4160-90-P
