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 Department of Health and Human Services Agency for Healthcare Research and Quality
 AGENCY: Agency for Healthcare Research and Quality, HHS.
 ACTION: 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 extension without change of the currently approved information collection “Surveys on Patient Safety Culture (SOPS) Ambulatory Surgery Center (ASC) Survey Database,” OMB No. 0935-0242. This proposed information collection was previously published in the 
                        **Federal Register**
                         on August 13, 2024 and allowed 60 days for public comment. AHRQ received no substantive 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 November 18, 2024.
 ADDRESSES: Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to 
                        *www.reginfo.gov/​public/​do/​PRAMain.*
                         Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
 FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email 
                        *REPORTSCLEARANCEOFFICER@ahrq.hhs.gov.*


SUPPLEMENTARY INFORMATION: Proposed Project Surveys on Patient Safety Culture® (SOPS®) Ambulatory Surgery Center (ASC) Survey Database In 1999, the Institute of Medicine called for healthcare organizations to develop a “culture of safety” such that their workforce and processes focus on improving the reliability and safety of care for patients (IOM, 1999; “To Err is Human: Building a Safer Health System”). To respond to the need for tools to assess patient safety culture in healthcare, AHRQ developed and pilot tested the Surveys on Patient Safety Culture® (SOPS®) Ambulatory Surgery Centers (ASC) Survey with OMB approval (OMB No. 0935-0216; approved October 31, 2013). The SOPS-ASC is designed to enable ASCs to assess provider and staff perspectives about patient safety issues, medical error, and error reporting. The survey includes 27 items that measure 8 composites of patient safety culture. In addition to the composite items, the survey includes one item measuring how often ASCs document near-misses; one item asking whether the respondent is in the room during surgeries, procedures, or treatments; and three items about communication before and after surgeries, procedures, or treatments. The survey also includes an overall rating item on patient safety, two items about respondent characteristics, and a section for open-ended comments. AHRQ made the survey publicly available along with a Survey User's Guide and other toolkit materials in May 2015 on the AHRQ website. The AHRQ SOPS-ASC Database consists of data from the AHRQ ASC Survey on Patient Safety Culture. Ambulatory surgery centers in the U.S. can voluntarily submit data from the 
                    ( print page 83686)
                    survey to AHRQ, through its contractor, Westat. The SOPS ASC Database (OMB No. 0935-0242; last approved on October 7, 2021; expiration date October 31, 2024) was developed by AHRQ in 2019 in response to requests from ASCs 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 ASCs submitting data. These reports are used to assist ASC staff in their efforts to improve patient safety culture in their organizations. The SOPS ASC Survey and the SOPS ASC Database support AHRQ's goals of promoting improvements in the quality and safety of healthcare in ASCs. The survey, toolkit materials, and database results are all made publicly available on AHRQ's website. Technical assistance is provided by AHRQ through its contractor at no charge to ASCs, to facilitate the use of these materials for ASC patient safety and quality improvement. The goals of the SOPS-ASC database are: (1) Presents results from ASCs that voluntarily submit their data; (2) Provides data to ASCs to facilitate internal assessment and learning in the patient safety improvement process; and (3) Provides supplemental information to help ASCs identify their strengths and areas with potential for improvement in patient safety culture. To achieve these goals, the following activities and data collections will be implemented: (1) Eligibility and Registration Form—The point-of-contact (POC), often the manager of the ASC, completes a number of data submission steps and forms, beginning with completion of an online Eligibility and Registration Form. The purpose of this form is to collect basic demographic information about the ASC and initiate the registration process. (2) ASC Site Information—The purpose of the site information form, completed by the ASC POC, is to collect background characteristics of the ASC. This information will be used to analyze data collected with the SOPS ASC Survey. (3) Data Use Agreement—The purpose of the data use agreement, completed by the ASC manager, is to state how data submitted by ASCs will be used and provides confidentiality assurances. (4) SOPS ASC Survey Data File(s) Submission—POCs upload their data file(s), using the SOPS ASC Survey data file specifications, to ensure that users submit their data in a standardized way (
                    *e.g.,*
                     variable names, order, coding, formatting). The number of submissions to the database is likely to vary from submission period to submission period because ASCs do not administer the survey and submit data every year. Data submission is typically handled by one POC who is either an ASC administrative manager or a survey vendor who contracts with an ASC to collect and submit its data. This study is being conducted by AHRQ through its contractor, Westat, pursuant to AHRQ's statutory authority to conduct and support research on healthcare and on systems for the delivery of such care, including activities with respect to: the quality, effectiveness, efficiency, appropriateness and value of healthcare services; quality measurement and improvement; and database development. 42 U.S.C. 299a(a)(1), (2), and (8). Method of Collection All information collection for the SOPS ASC Database is done electronically, except the Data Use Agreement (DUA), which ASCs will print, sign, and return (either via fax, by scanning and emailing or uploading to a secure website, or by mailing back). Registration, submission of ASC information, and data upload is handled online through a secure website. Customized feedback reports will be delivered electronically (the person submitting the data will enter a username and password and will have access to a secure website from which to download their reports). Estimated Annual Respondent Burden Exhibit 1 shows the estimated annualized burden hours for the respondents' time to participate in the database. The total burden is estimated to be 86 hours. (1) 
                    *Eligibility and Registration Form*
                    —Completed once by 60 ASC POCs. The form takes about 3 minutes to complete. (2) 
                    *ASC Site Information*
                    —Completed an average of 4 times by the 60 ASC POCs. The form takes 5 minutes to complete. (3) 
                    *Data Use Agreement*
                    —Completed once by 60 ASC POCs. The form takes about 3 minutes to complete. (4) 
                    *SOPS ASC Survey Data File(s) Submission*
                    —Each of the 60 POCs will submit their SOPS ASC Survey data. The data submission requires an hour on average to complete. Exhibit 2 shows the estimated annualized cost burden based on the respondents' time to submit their data. The cost burden is estimated to be $4,386 annually. Exhibit 1—Estimated Annualized Burden Hours
Form name
Number of
                             respondents/POCs
Number of
                             responses 
                             per POC
Hours per
                             response
Total burden
                             hours1. Eligibility and Registration Form
60
1
3/60
32. ASC Site Information
60
4
5/60
203. Data Use Agreement
60
1
3/60
34. SOPS ASC Survey Data Files Submission
60
1
1
60Total
NA
NA
NA
86
 Exhibit 2—Estimated Annualized Cost Burden
Form name
Total burden
                             hours
Average
                             hourly 
                             wage rate *
Total cost
                             burden1. Eligibility and Registration Form
3
$50.99
$1532. ASC Site Information
20
50.99
1,0203. Data Use Agreement
3
50.99
153( print page 83687)4. SOPS ASC Survey Data Files Submission
60
50.99
3,060Total
86
NA
4,386* Based on the mean hourly wage for 60 ASC Administrative Services Managers (11-3010; $50.99) obtained from the May 2023 National Industry-Specific Occupational Employment and Wage Estimates: NAICS 621400—Outpatient Care Centers (located at 
                        *https://www.bls.gov/​oes/​current/​naics4_​621400.htm#11-00000*).
 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: October 11, 2024. Marquita Cullom, Associate Director.


[FR Doc. 2024-23931 Filed 10-16-24; 8:45 am] BILLING CODE 4160-90-P