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Notice

Agency Information Collection Activities: Proposed Collection; Comment Request

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Document Details

Document Number2025-22531
TypeNotice
PublishedDec 11, 2025
Effective Date-
RIN-
Docket ID-
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Full Document Text (1,446 words · ~8 min read)

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<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> 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 reinstatement without change of the previously approved information collection project “Surveys on Patient Safety Culture Hospital Database” (OMB No. 0935-0162). This information collection was previously published in the <E T="04">Federal Register</E> on September 15, 2025, and allowed 60 days for public comment. AHRQ received one comment from the public that was not responsive. 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 January 12, 2026. </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> Margie Shofer, AHRQ Reports Clearance Officer, 301-427-1696 or by email at <E T="03">REPORTSCLEARANCEOFFICER@ahrq.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">Proposed Project</HD> <HD SOURCE="HD2">Surveys on Patient Safety Culture Hospital Database</HD> <HD SOURCE="HD1">Project Overview</HD> The Surveys on Patient Safety Culture® (SOPS®) Hospital Survey is designed to enable hospitals to assess provider and staff perspectives about patient safety issues, medical error, and error reporting. In 2004, Version 1.0 of the survey, which includes 42 items that measure 12 composites of patient safety culture, was released on the AHRQ website. AHRQ made the survey publicly available along with a Survey User's Guide and other toolkit materials. In 2019, an updated version of the survey, Version 2.0, was released on the AHRQ website. This version includes a total of 40 items: 32 items across 10 composite measures, 2 single-item measures, and 6 background questions. The AHRQ SOPS Hospital Database consists of data from the AHRQ SOPS Hospital Survey 2.0 and may include reportable, non-required supplemental items. Hospitals in the U.S. can voluntarily submit data from the survey to AHRQ, through its contractor, Westat. The SOPS Hospital Database (OMB NO. 0935-0162, last approved on October 18, 2022) was developed by AHRQ in 2006 in response to requests from hospitals interested in tracking their own survey results. Organizations submitting data receive a feedback report, as well as a report of the aggregated, de-identified findings of the other hospitals submitting data. These reports are used to assist hospital staff in their efforts to improve patient safety culture in their organizations. AHRQ requests that OMB approve the extension, without change, of AHRQ's collection of information for the AHRQ SOPS Hospital Database; OMB NO. 0935-0162, last approved on October 18, 2022. The SOPS Hospital Database seeks to answer the following research questions: 1. What is the current state of patient safety culture in hospitals? 2. Has there been a change in patient safety culture scores since the previous database? 3. Are there differences in scores based on staff position and unit/work area? This research has the following goals: 1. Produce aggregated results from hospitals that voluntarily submit their data; and 2. Provide feedback reports to hospitals that voluntarily submit their data to help them identify their strengths and areas for improvement in patient safety culture. This study is being conducted by AHRQ through its contractor, Westat, 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 healthcare services and with respect to surveys and database development [42 U.S.C 299a(a)(1) and (8)]. <HD SOURCE="HD1">Method of Collection</HD> 1. Hospital Eligibility and Registration Form—The hospital point-of-contact (POC) completes several data submission forms, beginning with the completion of an online Eligibility and Registration Form. The purpose of this form is to collect basic demographic information about the hospital and initiate the registration process. 2. Hospital Site Information—The purpose of the site information form, also completed by the hospital POC, is to collect background characteristics of the hospital. This information will be used to analyze data collected with the SOPS Hospital Survey. 3. Data Use Agreement—The purpose of the data use agreement, submitted by the hospital POC, is to state how data submitted by hospitals will be used and to provide privacy assurances. 4. SOPS Hospital Data File(s) Submission—The hospital POC uploads their data file(s), using the SOPS Hospital Survey data file specifications to ensure that users submit their data in a standardized way ( <E T="03">e.g.,</E> variable names, order, coding, formatting). The number of submissions to the database is likely to vary from submission period to submission period because hospitals do not administer the survey and submit data every year. Data submission is typically handled by one POC who is either a patient safety manager in the hospital or a survey vendor who contracts with a hospital to collect and submit their data. On average, hospital POCs submit data on behalf of 3 hospitals because many hospitals are part of a health system that includes many hospitals, or the POC is a vendor that is submitting data for multiple hospitals. <HD SOURCE="HD1">Estimated Annual Respondent Burden</HD> Exhibit 1 shows the estimated annualized burden hours for the respondents' time to participate in the database. An estimated 165 POCs, each representing an average of 3 individual hospitals, will complete the database submission steps and forms annually. Each POC will submit the following: <EXTRACT> 1. <E T="03">Hospital Eligibility and Registration Form</E> —Completed once by 165 hospital POCs. The form takes about 3 minutes to complete. 2. <E T="03">Hospital Site Information</E> —Completed an average of three times by the 165 hospital POCs. The form takes 5 minutes to complete. 3. <E T="03">Data Use Agreement</E> —Completed once by 165 hospital POCs. The form takes about 3 minutes to complete. 4. <E T="03">SOPS Hospital Survey Data File(s) Submission</E> —Each of the 165 POCs will submit their SOPS Hospital Survey Data. The data submission requires an hour on average to complete. </EXTRACT> The total annual burden hours are estimated to be 222 hours. Exhibit 2 shows the estimated annualized cost burden based on the respondents' time to submit their data. The cost burden is estimated to be $31,880 annually. <GPOTABLE COLS="5" OPTS="L2,nj,i1" CDEF="s100,12,12,12,12"> <TTITLE>Exhibit 1—Estimated Annualized Burden Hours</TTITLE> <CHED H="1">Form name</CHED> <CHED H="1"> Number of respondents/POCs <ENT I="01">1. Hospital Eligibility/Registration Form</ENT> <ENT>165</ENT> <ENT>1</ENT> <ENT>3/60</ENT> <ENT I="01">2. Hospital Site Information</ENT> <ENT>165</ENT> <ENT>3</ENT> <ENT>5/60</ENT> <ENT I="01">3. Data Use Agreement</ENT> <ENT>165</ENT> <ENT>1</ENT> <ENT>3/60</ENT> <ENT>8</ENT> </ROW> <ROW RUL="n,s"> <ENT I="01">4. SOPS Hospital Survey Data File(s) Submission</ENT> <GPOTABLE COLS="6" OPTS="L2,nj,i1" CDEF="s100,12,12,12,12,12"> <TTITLE>Exhibit 2—Estimated Annualized Cost Burden</TTITLE> <CHED H="1">Form name</CHED> <CHED H="1"> Number of respondents/POCs </CHED> <CHED H="1">Total burden hours</CHED> <ENT I="01">1. Hospital Eligibility/Registration Form</ENT> <ENT>165</ENT> <ENT>8</ENT> <ENT>$71.80</ENT> <ENT>$143.60</ENT> <ENT>$1,149</ENT> </ROW> <ROW> <ENT I="01">2. Hospital Site Information</ENT> <ENT>165</ENT> <ENT>41</ENT> <ENT>71.80</ENT> <ENT>143.60</ENT> <ENT>5,888</ENT> </ROW> <ROW> <ENT I="01">3. Data Use Agreement</ENT> <ENT>165</ENT> <ENT>8</ENT> <ENT>71.80</ENT> <ENT>143.60</ENT> <ENT>1,149</ENT> </ROW> <ROW RUL="n,s"> <ENT I="01">4. SOPS Hospital Survey Data File(s) Submission</ENT> <ENT>165</ENT> <ENT>165</ENT> <ENT>71.80</ENT> <ENT>143.60</ENT> <ENT>23,694</ENT> </ROW> <ROW> <ENT I="03">Total</ENT> * Mean hourly wage of $71.80 for Medical and Health Services Managers (SOC code 11-9111) was obtained from the May 2024 National Industry-Specific Occupational Employment and Wage Estimates NAICS 622000—Hospitals, located at <E T="03">https://data.bls.gov/oes/#/industry/622000.</E> </TNOTE> <TNOTE>** The Adjusted Hourly Rate was estimated at 200% of the hourly wage.</TNOTE> </GPOTABLE> <HD SOURCE="HD1">Request for Comments</HD> 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 prac ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 11k characters. 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