Agency Information Collection Activities: Proposed Collection; Comment Request, 91753-91755 [2024-27108]
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Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices
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: Information collection 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 the proposed
information collection project (new):
‘‘The AHRQ Safety Program for
Healthcare Associated Infection
Prevention.’’
SUMMARY:
Comments on this notice must be
received by January 21, 2025.
ADDRESSES: Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by
email at REPORTSCLEARANCE
OFFICER@ahrq.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at REPORTSCLEARANCE
OFFICER@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION:
DATES:
Proposed Project
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The AHRQ Safety Program for
Healthcare Associated Infection
Prevention
Healthcare-associated infections
(HAIs) are a major cause of illness in the
U.S., affecting one out of every 31
hospital inpatients (3% of all
hospitalized patients) daily and
resulting in as many as 700,000
infections per year. Some of the most
predominant HAIs include catheterassociated urinary tract infections
(CAUTI), central line-associated blood
stream infections (CLABSI), and
ventilator-associated pneumonia and
ventilator-associated events (VAP/VAE).
The current estimated incidence in
hospitalized patients is approximately
27,000 CAUTI cases annually and
30,000 CLABSI cases annually. VAE
cases affect between 5–40% of patients
requiring mechanical ventilator support
for more than two days. VAE cases are
considered the deadliest HAI, with allcause mortality rates associated with
VAE as high as 50% and a direct
attributable mortality rate of 9%.
To help hospitals reduce HAIs, AHRQ
created the Comprehensive Unit-based
Safety Program (CUSP). CUSP is
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designed to engage clinical teams to
make healthcare safer by combining
improved teamwork, clinical best
practices, and the science of safety. The
CUSP approach improves safety culture
at the unit level, enables harm
prevention, and engages providers who
are on the front lines while integrating
technical and adaptive/cultural
approaches to making sustainable
change. The Core CUSP Toolkit
provides teams with training resources
and tools to apply the CUSP method
and build their capacity to address
safety issues. This publicly available
Toolkit is modular and modifiable to
meet individual unit needs (https://
www.ahrq.gov/hai/cusp/modules/
index.html).
AHRQ has had success across
numerous national CUSP
implementation programs, including
CUSP for CLABSI, which showed a 41%
CLABSI reduction in over 1,000
intensive care units (ICUs), and CUSP
for CAUTI in hospitals, which reduced
CAUTI rates by 30% in more than 700
non-ICUs. These two programs, along
with other AHRQ CUSP programs,
resulted in the following Toolkits:
1. Toolkit for Reducing CLABSI: https://
www.ahrq.gov/hai/clabsi-tools/
index.html
2. Toolkit for Reducing CAUTI in Acute
Care Hospitals: https://
www.ahrq.gov/hai/tools/cautihospitals/
3. Toolkit to Improve Safety for
Mechanically Ventilated Patients:
https://www.ahrq.gov/hai/tools/
mvp/
4. Toolkit for Preventing CLABSI and
CAUTI in ICUs: https://
www.ahrq.gov/hai/tools/clabsicauti-icu/
AHRQ and partners developed many
of the tools in these Toolkits several
years ago, and some over 10 years ago.
Some organizations may not want to use
a tool that is older, or dated, and may
wonder whether the information is still
current. AHRQ is also aware that parts
of some Toolkits have supporting
information that has been updated, but
those updates have not been
incorporated into current tools or
resources on the AHRQ website. The
fifth Toolkit for this program to update,
the CUSP Toolkit that supports
translating the evidence into practice,
also requires modernization and
updating to address the current
healthcare environment and resource
realities to ensure success in HAI
reduction.
The AHRQ Safety Program for HAI
Prevention will assess what components
of the updated Toolkits are routinely
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91753
used and helpful and what components
need additional updating and
refinement. Current AHRQ HAI
Prevention Toolkits provide a wealth of
valuable information but also require
revision to incorporate new evidencebased practices and remove those no
longer supported by scientific evidence.
Revised Toolkits based on lessons
learned from the implementation of this
program will enhance their utility to
healthcare workers and support the
adoption of the AHRQ Safety Program
for HAI Prevention practices.
This project has the following goals:
1. Update the five existing AHRQ HAI
Prevention Toolkits.
2. Finalize the updated Toolkits for
public use, incorporating feedback from
participating units.
The AHRQ Safety Program for HAI
Prevention will consist of three cohorts:
1. CLABSI cohort—comprised of
approximately 100 acute care units
(ICUs and non-ICUs);
2. CAUTI cohort—comprised of
approximately 100 ICUs and non-ICUs;
and
3. VAP/VAE cohort—compromised of
approximately 75 ICUs.
All cohorts will include acute care
hospital units from all 10 Health and
Human Services regions. AHRQ will
utilize a pre-post design, comparing
data collected at baseline and at the end
of the program (endline) within each
cohort.
The AHRQ Safety Program for HAI
Prevention will include the following
data collections:
(1) Semi-structured Interviews:
Conducted at the end of the assessment,
the program will select participants
from each of the three cohorts, focusing
on participants who were active during
the cohort (e.g., attended webinars and
office hours regularly) to participate in
virtual discussions to examine
participants’ experiences during the
AHRQ Safety Program for HAI
Prevention, including use and
perceptions of materials, experiences
with measurement, and feedback about
the program.
(2) Hospital Survey on Patient Safety
(HSOPS): The HSOPS will be completed
by all participating staff to assess patient
safety issues, medical errors, and event
reporting practices. Participants will
complete the HSOPS at baseline and
endline for all three cohorts.
(3) CUSP Device Rounds: The CUSP
Device Rounds will be completed
collaboratively by a CUSP staff member
with an Infection Preventionist at each
participating unit once per month to
assess whether units are following best
practices in HAI for the respective
cohort (i.e., for all three cohorts).
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Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices
(4) Gap Analysis: The Gap Analysis is
a tool used to understand the needs of
participating units, prioritize areas for
improvement, and advocate for
institution-level and unit-level
resources. The Gap Analysis will be
completed collaboratively by a Unit
Lead and an Infection Preventionist at
baseline and endline for all three
cohorts. The endline Gap Analysis will
also include questions for self-report
changes in HAI rates and HAI
prevention processes at endline of each
cohort.
(5) Clinical Outcomes Data: AHRQ
will collect unit-level clinical outcomes
data reported by Infection Prevention
and Control Programs to assess HAI
rates across the program. Participating
units will either extract clinical
outcomes data from their Electronic
Health Records (EHRs) and submit via
the secure program website or confer
National Healthcare Safety Network
(NHSN) data rights to the program group
to eliminate data collection burden. The
program will request participating units
to retrospectively provide 12 months of
pre-implementation clinical outcomes
data, and monthly clinical outcomes
data, reported quarterly, during the
implementation period for all three
cohorts. The data collected monthly
include the number of patients in the
medical unit, number of patients with a
medical device in place (central line,
catheter, or ventilator) and the number
HAIs associated with the medical device
(central line, catheter, or ventilator).
This study is being conducted by
AHRQ through its contractor, NORC at
the University of Chicago (NORC) and
NORC’s subcontractor, the Johns
Hopkins Armstrong Institute of Patient
Safety and Quality (JHAI), pursuant to
AHRQ’s statutory authority to conduct
and support research on health care and
on systems for the delivery of such care,
including activities with respect to the
quality, effectiveness, efficiency,
appropriateness and value of health care
services and with respect to quality
measurement and improvement [42
U.S.C. 299a(a)(1) and (2)].
Method of Collection
This data collection effort will be part
of a comprehensive strategy to assess:
1. Participating units’ experiences
related to the AHRQ Safety Program for
HAI Prevention (i.e., use and
perceptions of revised AHRQ Toolkits
and Technical Assistance (TA),
experiences with measurement, and
feedback about the program);
2. Participating units’ changes in HAI
processes (i.e., self-reported
improvements in CLABSI, CAUTI, or
VAP/VAE prevention processes,
interventions implemented by units,
and units’ capacities to improve HAI
rates); and
3. Participating units’ changes in HAI
rates (i.e., units’ CLABSI, CAUTI, or
VAP/VAE reported rates and selfreported improvements in HAI rates).
To minimize respondent burden and
to permit the electronic submission of
survey responses and data collection
forms, the AHRQ HSOPS, CUSP Device
Rounds, Gap Analyses (including selfreported change in HAI rates and HAI
prevention processes), and the clinical
outcomes data collection form from EHR
extracts will be web-based and deployed
using secure, well-designed, lowburden, and respondent-friendly survey
administration instruments and process.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents’ time to participate in this
information collection. The total annual
burden hours are estimated to be 2,854
hours for the following data collection
tools:
1. Semi-structured Interviews:
Conducted with eight interview
participants from each of the three
cohorts (for a total of 24 interviews) at
endline only. Each interview requires 30
minutes on average to complete. We
anticipate a 100% response rate.
2. HSOPS: To be completed by an
average of 20 staff at each participating
unit at both baseline and endline.
Across the three cohorts, with a
maximum of 400 units, this results in
8,000 respondents. An expected
response rate of 45% should yield 3,600
completed respondents at each time
point (baseline/endline). The survey is
administered at baseline and endline for
each cohort to measure the changes in
patient safety culture resulting from
participation in the program. The survey
takes approximately 15 minutes to
complete.
3. CUSP Device Rounds: Completed
monthly for nine months by two staff
members at each participating unit
throughout implementation and
requires 45 minutes for each staff
member, equaling 90 minutes to
complete in total. Across the three
cohorts, with a maximum of 400 units,
this results in 800 respondents. An
expected response rate of 75% should
yield 600 respondents per time point
(monthly).
4. Gap Analysis: Completed by two
staff members at each participating unit,
once at baseline and again at endline for
each cohort. Across the three cohorts,
with a maximum of 400 units, this
results in 800 respondents. An expected
response rate of 75% should result in
600 respondents per time point
(baseline/endline). This data collection
is expected to require 60 minutes to
complete.
5. Clinical Outcomes Data: Completed
by one staff member at each
participating unit to provide 12 months
of pre-implementation clinical
outcomes data and monthly clinical
outcomes data, reported quarterly,
during the implementation period for all
three cohorts. Across the three cohorts,
with a maximum of 400 units, this
results in 400 respondents. An expected
response rate of 75% should result in
300 respondents per time point
(baseline for retrospective data and
quarterly for monthly data). This data
collection is expected to require 3.5
hours to complete at baseline followed
by 30 minutes to complete quarterly,
averaging 75 minutes across
implementation. We anticipate
approximately 90% of hospitals in the
CLABSI and CAUTI cohorts to confer
NHSN data rights to the AHRQ Safety
Program for HAI Prevention. In the
VAP/VAE cohort, we expect
approximately 40% of hospitals to
confer NHSN data rights to the program.
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EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents *
Form name
1.
2.
3.
4.
5.
Semi-structured Interviews ..........................................................................
HSOPS ........................................................................................................
CUSP Device Rounds .................................................................................
Gap Analysis ...............................................................................................
Clinical Outcomes data ...............................................................................
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Number of
responses per
respondent
8
1,200
100
200
100
E:\FR\FM\20NON1.SGM
1
2
9
2
4
20NON1
Hours per
response
30/60
15/60
90/60
60/60
75/60
Total burden
hours
4
600
1,350
400
500
91755
Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
responses per
respondent
Hours per
response
........................
........................
Number of
respondents *
Form name
Total ..........................................................................................................
1,608
Total burden
hours
2,854
* Annualized number of respondents is based on the maximum number of units recruited, times the estimated response rate and divided by
three to capture an annualized number.
Exhibit 2 shows the estimated annual
cost burden associated with the
respondents’ time to participate in this
information collection. The annual cost
burden is estimated to be $199,201.80.
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
1.
2.
3.
4.
5.
Average
hourly wage
rate *
Total burden
hours
Form name
Total cost burden
Semi-structured Interviews ................................................................................................
HSOPS ..............................................................................................................................
CUSP Device Rounds .......................................................................................................
Gap Analysis .....................................................................................................................
Clinical Outcomes data .....................................................................................................
8
1,200
100
200
100
a $74.20
b 49.07
$296.80
44,520.00
100,170.00
29,680.00
24,535.00
Total ................................................................................................................................
1,608
........................
199,201.80
a 74.20
a 74.20
a 74.20
* National Compensation Survey: Occupational wages in the United States May 2023, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’
May 2023 National Occupational Employment and Wage Estimates (bls.gov).
a Average of the mean hourly wage for physicians (29–1210), registered nurses (29–1141), nurse practitioners (29–1171), and physician’s assistants (29–1071).
b Mean hourly wage for Healthcare Practitioners and Technical Occupations (29–0000).
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Request for Comments
In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3520,
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.
Marquita Cullom,
Associate Director.
[FR Doc. 2024–27108 Filed 11–19–24; 8:45 am]
BILLING CODE 4160–90–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10320]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
SUMMARY:
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the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
January 21, 2025.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number: __, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, please access the CMS PRA
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]]>Agencies
[Federal Register Volume 89, Number 224 (Wednesday, November 20, 2024)]
[Notices]
[Pages 91753-91755]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27108]
[[Page 91753]]
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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: Information collection 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 (new): ``The AHRQ Safety Program for Healthcare Associated
Infection Prevention.''
DATES: Comments on this notice must be received by January 21, 2025.
ADDRESSES: Written comments should be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by email at REPORTSCLEARANCE
[email protected].
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by email at REPORTSCLEARANCE
[email protected].
SUPPLEMENTARY INFORMATION:
Proposed Project
The AHRQ Safety Program for Healthcare Associated Infection Prevention
Healthcare-associated infections (HAIs) are a major cause of
illness in the U.S., affecting one out of every 31 hospital inpatients
(3% of all hospitalized patients) daily and resulting in as many as
700,000 infections per year. Some of the most predominant HAIs include
catheter-associated urinary tract infections (CAUTI), central line-
associated blood stream infections (CLABSI), and ventilator-associated
pneumonia and ventilator-associated events (VAP/VAE). The current
estimated incidence in hospitalized patients is approximately 27,000
CAUTI cases annually and 30,000 CLABSI cases annually. VAE cases affect
between 5-40% of patients requiring mechanical ventilator support for
more than two days. VAE cases are considered the deadliest HAI, with
all-cause mortality rates associated with VAE as high as 50% and a
direct attributable mortality rate of 9%.
To help hospitals reduce HAIs, AHRQ created the Comprehensive Unit-
based Safety Program (CUSP). CUSP is designed to engage clinical teams
to make healthcare safer by combining improved teamwork, clinical best
practices, and the science of safety. The CUSP approach improves safety
culture at the unit level, enables harm prevention, and engages
providers who are on the front lines while integrating technical and
adaptive/cultural approaches to making sustainable change. The Core
CUSP Toolkit provides teams with training resources and tools to apply
the CUSP method and build their capacity to address safety issues. This
publicly available Toolkit is modular and modifiable to meet individual
unit needs (https://www.ahrq.gov/hai/cusp/modules/).
AHRQ has had success across numerous national CUSP implementation
programs, including CUSP for CLABSI, which showed a 41% CLABSI
reduction in over 1,000 intensive care units (ICUs), and CUSP for CAUTI
in hospitals, which reduced CAUTI rates by 30% in more than 700 non-
ICUs. These two programs, along with other AHRQ CUSP programs, resulted
in the following Toolkits:
1. Toolkit for Reducing CLABSI: https://www.ahrq.gov/hai/clabsi-tools/
2. Toolkit for Reducing CAUTI in Acute Care Hospitals: https://www.ahrq.gov/hai/tools/cauti-hospitals/
3. Toolkit to Improve Safety for Mechanically Ventilated Patients:
https://www.ahrq.gov/hai/tools/mvp/
4. Toolkit for Preventing CLABSI and CAUTI in ICUs: https://www.ahrq.gov/hai/tools/clabsi-cauti-icu/
AHRQ and partners developed many of the tools in these Toolkits
several years ago, and some over 10 years ago. Some organizations may
not want to use a tool that is older, or dated, and may wonder whether
the information is still current. AHRQ is also aware that parts of some
Toolkits have supporting information that has been updated, but those
updates have not been incorporated into current tools or resources on
the AHRQ website. The fifth Toolkit for this program to update, the
CUSP Toolkit that supports translating the evidence into practice, also
requires modernization and updating to address the current healthcare
environment and resource realities to ensure success in HAI reduction.
The AHRQ Safety Program for HAI Prevention will assess what
components of the updated Toolkits are routinely used and helpful and
what components need additional updating and refinement. Current AHRQ
HAI Prevention Toolkits provide a wealth of valuable information but
also require revision to incorporate new evidence-based practices and
remove those no longer supported by scientific evidence. Revised
Toolkits based on lessons learned from the implementation of this
program will enhance their utility to healthcare workers and support
the adoption of the AHRQ Safety Program for HAI Prevention practices.
This project has the following goals:
1. Update the five existing AHRQ HAI Prevention Toolkits.
2. Finalize the updated Toolkits for public use, incorporating
feedback from participating units.
The AHRQ Safety Program for HAI Prevention will consist of three
cohorts:
1. CLABSI cohort--comprised of approximately 100 acute care units
(ICUs and non-ICUs);
2. CAUTI cohort--comprised of approximately 100 ICUs and non-ICUs;
and
3. VAP/VAE cohort--compromised of approximately 75 ICUs.
All cohorts will include acute care hospital units from all 10
Health and Human Services regions. AHRQ will utilize a pre-post design,
comparing data collected at baseline and at the end of the program
(endline) within each cohort.
The AHRQ Safety Program for HAI Prevention will include the
following data collections:
(1) Semi-structured Interviews: Conducted at the end of the
assessment, the program will select participants from each of the three
cohorts, focusing on participants who were active during the cohort
(e.g., attended webinars and office hours regularly) to participate in
virtual discussions to examine participants' experiences during the
AHRQ Safety Program for HAI Prevention, including use and perceptions
of materials, experiences with measurement, and feedback about the
program.
(2) Hospital Survey on Patient Safety (HSOPS): The HSOPS will be
completed by all participating staff to assess patient safety issues,
medical errors, and event reporting practices. Participants will
complete the HSOPS at baseline and endline for all three cohorts.
(3) CUSP Device Rounds: The CUSP Device Rounds will be completed
collaboratively by a CUSP staff member with an Infection Preventionist
at each participating unit once per month to assess whether units are
following best practices in HAI for the respective cohort (i.e., for
all three cohorts).
[[Page 91754]]
(4) Gap Analysis: The Gap Analysis is a tool used to understand the
needs of participating units, prioritize areas for improvement, and
advocate for institution-level and unit-level resources. The Gap
Analysis will be completed collaboratively by a Unit Lead and an
Infection Preventionist at baseline and endline for all three cohorts.
The endline Gap Analysis will also include questions for self-report
changes in HAI rates and HAI prevention processes at endline of each
cohort.
(5) Clinical Outcomes Data: AHRQ will collect unit-level clinical
outcomes data reported by Infection Prevention and Control Programs to
assess HAI rates across the program. Participating units will either
extract clinical outcomes data from their Electronic Health Records
(EHRs) and submit via the secure program website or confer National
Healthcare Safety Network (NHSN) data rights to the program group to
eliminate data collection burden. The program will request
participating units to retrospectively provide 12 months of pre-
implementation clinical outcomes data, and monthly clinical outcomes
data, reported quarterly, during the implementation period for all
three cohorts. The data collected monthly include the number of
patients in the medical unit, number of patients with a medical device
in place (central line, catheter, or ventilator) and the number HAIs
associated with the medical device (central line, catheter, or
ventilator).
This study is being conducted by AHRQ through its contractor, NORC
at the University of Chicago (NORC) and NORC's subcontractor, the Johns
Hopkins Armstrong Institute of Patient Safety and Quality (JHAI),
pursuant to AHRQ's statutory authority to conduct and support research
on health care and on systems for the delivery of such care, including
activities with respect to the quality, effectiveness, efficiency,
appropriateness and value of health care services and with respect to
quality measurement and improvement [42 U.S.C. 299a(a)(1) and (2)].
Method of Collection
This data collection effort will be part of a comprehensive
strategy to assess:
1. Participating units' experiences related to the AHRQ Safety
Program for HAI Prevention (i.e., use and perceptions of revised AHRQ
Toolkits and Technical Assistance (TA), experiences with measurement,
and feedback about the program);
2. Participating units' changes in HAI processes (i.e., self-
reported improvements in CLABSI, CAUTI, or VAP/VAE prevention
processes, interventions implemented by units, and units' capacities to
improve HAI rates); and
3. Participating units' changes in HAI rates (i.e., units' CLABSI,
CAUTI, or VAP/VAE reported rates and self-reported improvements in HAI
rates).
To minimize respondent burden and to permit the electronic
submission of survey responses and data collection forms, the AHRQ
HSOPS, CUSP Device Rounds, Gap Analyses (including self-reported change
in HAI rates and HAI prevention processes), and the clinical outcomes
data collection form from EHR extracts will be web-based and deployed
using secure, well-designed, low-burden, and respondent-friendly survey
administration instruments and process.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated annualized burden hours for the
respondents' time to participate in this information collection. The
total annual burden hours are estimated to be 2,854 hours for the
following data collection tools:
1. Semi-structured Interviews: Conducted with eight interview
participants from each of the three cohorts (for a total of 24
interviews) at endline only. Each interview requires 30 minutes on
average to complete. We anticipate a 100% response rate.
2. HSOPS: To be completed by an average of 20 staff at each
participating unit at both baseline and endline. Across the three
cohorts, with a maximum of 400 units, this results in 8,000
respondents. An expected response rate of 45% should yield 3,600
completed respondents at each time point (baseline/endline). The survey
is administered at baseline and endline for each cohort to measure the
changes in patient safety culture resulting from participation in the
program. The survey takes approximately 15 minutes to complete.
3. CUSP Device Rounds: Completed monthly for nine months by two
staff members at each participating unit throughout implementation and
requires 45 minutes for each staff member, equaling 90 minutes to
complete in total. Across the three cohorts, with a maximum of 400
units, this results in 800 respondents. An expected response rate of
75% should yield 600 respondents per time point (monthly).
4. Gap Analysis: Completed by two staff members at each
participating unit, once at baseline and again at endline for each
cohort. Across the three cohorts, with a maximum of 400 units, this
results in 800 respondents. An expected response rate of 75% should
result in 600 respondents per time point (baseline/endline). This data
collection is expected to require 60 minutes to complete.
5. Clinical Outcomes Data: Completed by one staff member at each
participating unit to provide 12 months of pre-implementation clinical
outcomes data and monthly clinical outcomes data, reported quarterly,
during the implementation period for all three cohorts. Across the
three cohorts, with a maximum of 400 units, this results in 400
respondents. An expected response rate of 75% should result in 300
respondents per time point (baseline for retrospective data and
quarterly for monthly data). This data collection is expected to
require 3.5 hours to complete at baseline followed by 30 minutes to
complete quarterly, averaging 75 minutes across implementation. We
anticipate approximately 90% of hospitals in the CLABSI and CAUTI
cohorts to confer NHSN data rights to the AHRQ Safety Program for HAI
Prevention. In the VAP/VAE cohort, we expect approximately 40% of
hospitals to confer NHSN data rights to the program.
Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of
Form name Number of responses per Hours per Total burden
respondents * respondent response hours
----------------------------------------------------------------------------------------------------------------
1. Semi-structured Interviews................... 8 1 30/60 4
2. HSOPS........................................ 1,200 2 15/60 600
3. CUSP Device Rounds........................... 100 9 90/60 1,350
4. Gap Analysis................................. 200 2 60/60 400
5. Clinical Outcomes data....................... 100 4 75/60 500
---------------------------------------------------------------
[[Page 91755]]
Total....................................... 1,608 .............. .............. 2,854
----------------------------------------------------------------------------------------------------------------
* Annualized number of respondents is based on the maximum number of units recruited, times the estimated
response rate and divided by three to capture an annualized number.
Exhibit 2 shows the estimated annual cost burden associated with
the respondents' time to participate in this information collection.
The annual cost burden is estimated to be $199,201.80.
Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Total burden Average hourly
Form name hours wage rate * Total cost burden
----------------------------------------------------------------------------------------------------------------
1. Semi-structured Interviews................................ 8 \a\ $74.20 $296.80
2. HSOPS..................................................... 1,200 \a\ 74.20 44,520.00
3. CUSP Device Rounds........................................ 100 \a\ 74.20 100,170.00
4. Gap Analysis.............................................. 200 \a\ 74.20 29,680.00
5. Clinical Outcomes data.................................... 100 \b\ 49.07 24,535.00
--------------------------------------------------
Total.................................................... 1,608 .............. 199,201.80
----------------------------------------------------------------------------------------------------------------
* National Compensation Survey: Occupational wages in the United States May 2023, ``U.S. Department of Labor,
Bureau of Labor Statistics.'' May 2023 National Occupational Employment and Wage Estimates (bls.gov).
\a\ Average of the mean hourly wage for physicians (29-1210), registered nurses (29-1141), nurse practitioners
(29-1171), and physician's assistants (29-1071).
\b\ Mean hourly wage for Healthcare Practitioners and Technical Occupations (29-0000).
Request for Comments
In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-
3520, 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.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-27108 Filed 11-19-24; 8:45 am]
BILLING CODE 4160-90-P
