Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices 91753 

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 

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: 

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 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 

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/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/clabsicauti-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 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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91754 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. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents * 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

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 


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Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices 91755 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Form name Number of 

respondents * 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

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

Form name Total burden 

hours 

Average 

hourly 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). aAverage 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10320] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: 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, 

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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