Agency Information Collection Activities: Proposed Collection; Comment Request

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Agency for Healthcare Research and Quality</SUBAGY> <SUBJECT>Agency Information Collection Activities: Proposed Collection; Comment Request</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Agency for Healthcare Research and Quality, HHS. <HD SOURCE="HED">ACTION:</HD> Information collection notice. <SUM> <HD SOURCE="HED">SUMMARY:</HD> 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 <E T="04">Federal Register</E> 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. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Comments on this notice must be received by June 18, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to <E T="03">www.reginfo.gov/public/do/PRAMain.</E> 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. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at <E T="03">REPORTSCLEARANCE OFFICER@ahrq.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">Proposed Project</HD> <HD SOURCE="HD2">The AHRQ Safety Program for Healthcare Associated Infection Prevention</HD> 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 ( <E T="03">https://www.ahrq.gov/hai/cusp/modules/index.html</E> ). 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: <FP SOURCE="FP-2"> 1. Toolkit for Reducing CLABSI: <E T="03">https://www.ahrq.gov/hai/clabsi-tools/index.html</E> </FP> <FP SOURCE="FP-2"> 2. Toolkit for Reducing CAUTI in Acute Care Hospitals: <E T="03">https://www.ahrq.gov/hai/tools/cauti-hospitals/index.html</E> </FP> <FP SOURCE="FP-2"> 3. Toolkit to Improve Safety for Mechanically Ventilated Patients: <E T="03">https://www.ahrq.gov/hai/tools/mvp/index.html</E> </FP> <FP SOURCE="FP-2"> 4. Toolkit for Preventing CLABSI and CAUTI in ICUs: <E T="03">https://www.ahrq.gov/hai/tools/clabsi-cauti-icu/index.html</E> </FP> 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. <E T="03">This project has the following goals:</E> 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) <E T="03">Semi-structured Interviews:</E> 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 T="03">e.g.,</E> 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) <E T="03">Hospital Survey on Patient Safety (HSOPS):</E> 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) <E T="03">CUSP Device Rounds:</E> 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 ( <E T="03">i.e.,</E> for all three cohorts). (4) <E T="03">Gap Analysis:</E> 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) <E T="03">Clinical Outcomes Data:</E> 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 ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 18k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━