[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]
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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.
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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 (http://www.ahrq.gov/professionals/quality-patient-safety/hais/index.html).
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
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Number of
Form name Number of responses per Hours per Total burden
respondents respondent response hours
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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
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Total....................................... 14,022 .............. .............. 27,030
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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
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Number of Total burden Average hourly Total cost
Form name respondents hours wage rate * burden
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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
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Total....................................... 14,022 27,064 .............. 1,311,096
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* National Compensation Survey: Occupational wages in the United States May 2016 ``U.S. Department of Labor,
Bureau of Labor Statistics:'' http://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]
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