Agency Information Collection Activities: Proposed Collection; Comment Request, 27123-27126 [2019-12306]
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Federal Register / Vol. 84, No. 112 / Tuesday, June 11, 2019 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued
Number of
respondents/
POCs
Form name
Total ..........................................................................................................
Total burden
hours
N/A
N/A
Average
hourly
wage rate *
Total cost
burden
N/A
26,572
* Mean hourly wage of $57.89 for Medical and Health Services Managers (SOC code 11–9111) was obtained from the May 2017 National Industry-Specific Occupational Employment and Wage Estimates NAICS 622000—Hospitals, located at https://www.bls.gov/oes/current/naics3_
622000.htm.
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.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2019–12312 Filed 6–10–19; 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.
ACTION: Notice.
khammond on DSKBBV9HB2PROD with NOTICES
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 the proposed
information collection project: ‘‘The
AHRQ Safety Program for Improving
Antibiotic Use.’’ In accordance with the
SUMMARY:
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Paperwork Reduction Act, AHRQ
invites the public to comment on this
proposed information collection.
This proposed information collection
was previously published in the Federal
Register on April 1, 2019 and allowed
60 days for public comment. AHRQ did
not receive substantive comments. The
purpose of this notice is to allow an
additional 30 days for public comment.
DATES: Comments on this notice must be
received on or before 30 days after date
of publication.
ADDRESSES: Written comments should
be submitted to: AHRQ’s OMB Desk
Officer by fax at (202) 395–6974
(attention: AHRQ’s desk officer) or by
email at OIRA_submission@
omb.eop.gov (attention: AHRQ’s desk
officer).
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
Proposed Project
The AHRQ Safety Program for
Improving Antibiotic Use
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
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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 these data, and that
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
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Federal Register / Vol. 84, No. 112 / Tuesday, June 11, 2019 / Notices
antibiotics) across all healthcare
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
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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
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Sfmt 4703
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
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
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Federal Register / Vol. 84, No. 112 / Tuesday, June 11, 2019 / Notices
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
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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 ............................................................................................
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Total burden
hours
Average
hourly wage
rate *
Total cost
burden
343
167
337
137
67
7,583
a $98.83
83
4,167
4,167
4,167
83
4,167
4,167
4,167
b 27.87
b 27.87
2,313
116,134
116,134
116,134
30
60
a 98.83
5,930
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a 98.83
a 98.83
b 27.87
b 27.87
$13,540
6,622
749,428
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Federal Register / Vol. 84, No. 112 / Tuesday, June 11, 2019 / Notices
EXHIBIT A.2—ESTIMATED ANNUALIZED COST BURDEN—Continued
Number of
respondents
Form name
Total burden
hours
Average
hourly wage
rate *
Total cost
burden
b. Other Health Practitioners ....................................................................
5. EHR data (Cohorts 1, 2, and 3) ..................................................................
6. EHR data (Cohort 4) ...................................................................................
60
334
167
120
4,008
2,505
b 27.87
b 27.87
3,344
111,703
69,814
Total ..........................................................................................................
14,022
27,064
........................
1,311,096
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
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2019–12306 Filed 6–10–19; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
khammond on DSKBBV9HB2PROD with NOTICES
[Docket Nos. FDA–2017–E–6741 and FDA–
2018–E–0046]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; BAXDELA IV INJECTION—
NDA 208611
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
17:36 Jun 10, 2019
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for BAXDELA IV INJECTION under new
drug application (NDA) 208611 and is
publishing this notice of that
determination as required by law. FDA
has made the determination because of
the submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
DATES: Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by August 12, 2019.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
December 9, 2019. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before August 12,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of August 12, 2019.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
SUMMARY:
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.
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Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket Nos. FDA–
2017–E–6741 and FDA–2018–E–0046
for ‘‘Determination of Regulatory
Review Period for Purposes of Patent
Extension; BAXDELA IV INJECTION.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
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]]>Agencies
[Federal Register Volume 84, Number 112 (Tuesday, June 11, 2019)]
[Notices]
[Pages 27123-27126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12306]
-----------------------------------------------------------------------
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 the proposed information collection
project: ``The AHRQ Safety Program for Improving Antibiotic Use.'' In
accordance with the Paperwork Reduction Act, AHRQ invites the public to
comment on this proposed information collection.
This proposed information collection was previously published in
the Federal Register on April 1, 2019 and allowed 60 days for public
comment. AHRQ did not receive substantive comments. The purpose of this
notice is to allow an additional 30 days for public comment.
DATES: Comments on this notice must be received on or before 30 days
after date of publication.
ADDRESSES: Written comments should be submitted to: AHRQ's OMB Desk
Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by
email at [email protected] (attention: AHRQ's desk officer).
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by email at
[email protected].
SUPPLEMENTARY INFORMATION:
Proposed Project
The AHRQ Safety Program for Improving Antibiotic Use
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 these data, and that
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
[[Page 27124]]
antibiotics) across all healthcare 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 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
[[Page 27125]]
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)............
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
[[Page 27126]]
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.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2019-12306 Filed 6-10-19; 8:45 am]
BILLING CODE 4160-90-P
