Notice2025-08863
Agency Information Collection Activities: Proposed Collection; Comment Request
Primary source
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Published
May 19, 2025
Issuing agencies
Health and Human Services DepartmentAgency for Healthcare Research and Quality
Abstract
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." This proposed information collection was previously published in the Federal Register on November 20, 2024 and allowed 60 days for public comment. AHRQ received comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.
Full Text
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<title>Federal Register, Volume 90 Issue 95 (Monday, May 19, 2025)</title>
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[Federal Register Volume 90, Number 95 (Monday, May 19, 2025)]
[Notices]
[Pages 21305-21308]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-08863]
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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.
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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 (new): ``The AHRQ Safety Program for Healthcare Associated
Infection Prevention.'' This proposed information collection was
previously published in the Federal Register on November 20, 2024 and
allowed 60 days for public comment. AHRQ received comments from members
of the public. The purpose of this notice is to allow an additional 30
days for public comment.
DATES: Comments on this notice must be received by June 18, 2025.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
Copies of the proposed collection plans, data collection
instruments, and specific details on the estimated burden can be
obtained from the AHRQ Reports Clearance Officer.
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by email at REPORTSCLEARANCE
<a href="/cdn-cgi/l/email-protection#0a454c4c43494f584a6b62787b24626279246d657c"><span class="__cf_email__" data-cfemail="38777e7e717b7d6a7859504a491650504b165f574e">[email protected]</span></a>.
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
[[Page 21306]]
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 (<a href="https://www.ahrq.gov/hai/cusp/modules/index.html">https://www.ahrq.gov/hai/cusp/modules/index.html</a>).
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: <a href="https://www.ahrq.gov/hai/clabsi-tools/index.html">https://www.ahrq.gov/hai/clabsi-tools/index.html</a>
2. Toolkit for Reducing CAUTI in Acute Care Hospitals: <a href="https://www.ahrq.gov/hai/tools/cauti-hospitals/index.html">https://www.ahrq.gov/hai/tools/cauti-hospitals/index.html</a>
3. Toolkit to Improve Safety for Mechanically Ventilated Patients:
<a href="https://www.ahrq.gov/hai/tools/mvp/index.html">https://www.ahrq.gov/hai/tools/mvp/index.html</a>
4. Toolkit for Preventing CLABSI and CAUTI in ICUs: <a href="https://www.ahrq.gov/hai/tools/clabsi-cauti-icu/index.html">https://www.ahrq.gov/hai/tools/clabsi-cauti-icu/index.html</a>
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).
(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,
[[Page 21307]]
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
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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. 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
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Total....................................... 1,608 .............. .............. 2,854
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* 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
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Total burden Average hourly Total cost
Form name hours wage rate * burden
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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
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Total....................................................... 1,608 .............. 199,201.80
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* 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 (<a href="http://bls.gov">bls.gov</a>).
[[Page 21308]]
\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.
Dated: April 24, 2025.
Jeffrey P. Toven,
Executive Officer.
[FR Doc. 2025-08863 Filed 5-16-25; 8:45 am]
BILLING CODE 4160-90-P
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