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[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]

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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.''

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/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/cauti-hospitals/index.html
3. Toolkit to Improve Safety for Mechanically Ventilated Patients: 
https://www.ahrq.gov/hai/tools/mvp/index.html
4. Toolkit for Preventing CLABSI and CAUTI in ICUs: https://www.ahrq.gov/hai/tools/clabsi-cauti-icu/index.html

    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).

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    (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
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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
                          Form name                                 hours        wage rate *   Total cost 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
                                                              --------------------------------------------------
    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 (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
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