Supporting Statement Part A -- HSOPS DB Renewal_1 5 26

The mission of the Agency for Healthcare Research and Quality (AHRQ) set out in its authorizing legislation, The Healthcare Research and Quality Act of 1999 (see https://www.ahrq.gov/policymakers/hrqa99a.html), is to enhance the quality, appropriateness, and effectiveness of health services, and access to such services, through the establishment of a broad base of scientific research and promoting clinical and health systems practice improvements, including the prevention of diseases and other health conditions. AHRQ shall promote healthcare quality improvement by conducting and supporting:

research that develops and presents scientific evidence regarding all aspects of health care; and

the synthesis and dissemination of available scientific evidence for use by patients, consumers, practitioners, providers, purchasers, policy makers, and educators; and

initiatives to advance private and public efforts to improve health care quality.

Summary of this Information Collection Request (ICR):

This ICR is for an extension without change for the Surveys on Patient Safety Culture^® (SOPS^®) Hospital Survey Database. AHRQ requests that the Office of Management and Budget (OMB) approve the extension, under the Paperwork Reduction Act of 1995, AHRQ’s collection of information for the AHRQ SOPS Hospital Database; OMB NO. 0935-0162, last approved on October 18, 2022.

Project Overview:

Background on the Surveys on Patient Safety Culture Hospital Survey (SOPS Hospital Survey).

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 health care, AHRQ developed and pilot tested the Hospital Survey on Patient Safety Culture with OMB approval (OMB NO. 0935-0115; Approved 2/4/2003).

The 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 (OMB 0935-0230, approved 01/21/2016). This version includes a total of 40 items: 32 items across 10 composite measures, 2 single-item measures, and 6 background questions¹.

The AHRQ SOPS Hospital Database consists of data from the AHRQ SOPS Hospital Survey 2.0 and may include reportable, non-required supplemental items². 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.

Rationale for the information collection. The SOPS Hospital Survey and the SOPS Hospital Database support AHRQ’s goals of promoting improvements in the quality and safety of healthcare in hospitals. 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 hospitals, to facilitate the use of these materials for hospital patient safety and quality improvement.

The SOPS Hospital Database seeks to answer the following research questions:

What is the current state of patient safety culture in hospitals?
Has there been a change in patient safety culture scores since the previous database?
Are there differences in scores based on staff position and unit/work area?

The goals of the SOPS Hospital Database are:

Produce aggregated results from hospitals that voluntarily submit their data; and
Provide feedback reports to hospitals that voluntarily submit their data to help them identify their strengths and areas for improvement in patient safety culture.

To achieve these goals, the following activities and data collections will be implemented:

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 (see Attachment A). The purpose of this form is to collect basic demographic information about the hospital and initiate the registration process.

Hospital Site Information – The purpose of the site information form (see Attachment B), 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.

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 provides privacy assurances (see Attachment C).

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.g., 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 (see Attachments D, E, and G).

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) and (2).

2. Purpose and Use of Information

Survey data from the AHRQ SOPS Hospital Survey 2.0 are used to produce three types of products:

A SOPS Hospital Database Report that is made publicly available on the AHRQ website (see Hospital User Database Report)³;
Individual Feedback Reports that are customized for each hospital that submits data to the database; and
Research data sets of individual-level and hospital-level de-identified data to enable researchers to conduct analyses. All data released in a data set are de-identified at the individual-level and the hospital-level.

Hospitals will be invited to voluntarily submit their SOPS Hospital Survey Version 2.0 data to the database. AHRQ’s contractor, Westat, will then clean and aggregate the data to produce a PDF-formatted Database Report displaying averages, standard deviations, and percentile scores on the survey’s 32 items and 10 composites of patient safety culture and two single item measures. The report will also display these results by hospital characteristics (e.g., bed size and geographic region) and respondent characteristics (e.g., hospital work area/unit, and tenure in work area/unit).

The Database Report includes a section on data limitations, emphasizing that the report does not reflect a representative sampling of the U.S. hospital population. Because participating hospitals will choose to voluntarily submit their data into the database and therefore are not a random or national sample of hospitals, estimates based on this self-selected group might be biased estimates. We recommend that users review the database results with these caveats in mind.

Each hospital that submits data receives a customized survey feedback report that presents their results alongside the aggregated results from other participating hospitals.

Hospitals use the SOPS Hospital Survey, Database Reports, and Individual Feedback Reports to:

Raise staff awareness about patient safety;
Elucidate and assess the current status of patient safety culture in their hospital;
Identify strengths and areas for improvement in patient safety culture;
Examine trends in patient safety culture change over time; and
Evaluate the cultural impact of patient safety initiatives and interventions.

3. Use of Improved Information Technology

All information collection for the SOPS Hospital Database is done electronically, except the Data Use Agreement (DUA), which hospitals 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 hospital 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).

4. Efforts to Identify Duplication

While survey vendors and hospital systems that administer the AHRQ SOPS Hospital Survey may maintain a database of survey responses for their particular clients (survey vendors) or their individual facility (hospitals), AHRQ is the only entity that serves as a central U.S. repository for data on the SOPS Hospital Survey and houses the largest known database of the survey’s results.

5. Involvement of Small Entities

AHRQ designed the data collection instruments and procedures to minimize burden on individual hospital respondents. The data requested of hospitals represents the absolute minimum information required for the intended uses and the data submission process does not unduly burden small hospitals or other businesses.

6. Consequences if Information Collected Less Frequently

Because hospitals administer the survey voluntarily, on their own schedule, most hospitals would only submit their data once every two years (depending on their survey administration schedule), and greater frequency may not be immediately feasible. Less frequent data collection would inhibit timely response to developing interventions designed to enhance patient safety culture. Hospital data submission will be available in June 2026 and June 2028.

7. Special Circumstances

This request is consistent with the general information collection guidelines of 5 CFR 1320.5(d)(2).

8. Federal Register Notice and Outside Consultations

8.a. Federal Register Notice

As required by 5 CFR 1320.8(d), notice was published in the Federal Register on September 15, 2025, for 60 days. AHRQ received one comment which was not responsive.

8.b. Outside Consultations

AHRQ periodically convenes an external Technical Expert Panel (TEP) to provide expertise and guidance to the development, functioning, and expansion of the SOPS Databases. The most recent TEP was comprised of 16 members from various parts of the health sector covered by the patient safety culture surveys (see Attachment F), including hospital representatives. The TEP will provide guidance as needed on the administration of the SOPS Hospital Database.

9. Payments/Gifts to Respondents

No payment or remuneration is provided to hospitals for submitting data to the database.

10. Assurance of Confidentiality

Data will be kept private to the extent allowed by law. Individuals and organizations are assured limitation on use of certain information under Section 944(c) of the Public Health Service Act, 42 USC 299c-3(c). That law requires that information collected for research conducted or supported by AHRQ that identifies individuals or establishments be used only for the purpose for which it was supplied.

Privacy of the Point-of-Contact for a Hospital. The hospital point-of-contact, who submits data on behalf of a hospital, is asked to provide his/her name, phone number, and email address during the data submission process to ensure that the hospital’s individual feedback report is delivered to that person. Such contact information is critical if any clarifications or corrections of the submitted data set are necessary. However, the name of the hospital point-of-contact and name of the hospital is kept private and not reported. Only aggregated, de-identified results are displayed in any reports.

Privacy of the Survey Data Submitted by a Hospital. Hospitals are assured of the privacy of their SOPS Hospital Survey data responses under the Data Use Agreement (DUA; see Attachment B). All hospital points-of-contact or representatives must sign the DUA. Reviewed by HHS’s general counsel, the DUA states that all submitted data will be handled in a secure manner using necessary administrative, technical, and physical safeguards to limit access to it and maintain its privacy. In addition, the DUA outlines that survey response data will be used for the purposes of the database, that only aggregated results will be reported, and that the hospital will not be identified by name.

11. Questions of a Sensitive Nature

There are no questions of a sensitive nature.

12. Estimates of Annualized Burden Hours and Costs

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 each, will complete the database submission steps and forms annually. Each POC will submit the following:

Hospital Eligibility and Registration Form – Completed once by 165 hospital POCs. The form takes about 3 minutes to complete.
Hospital Site Information – Completed an average of three times by the 165 hospital POCs. The form takes 5 minutes to complete.
Data Use Agreement – Completed once by 165 hospital POCs. The form takes about 3 minutes to complete.
SOPS Hospital Survey Data File(s) Submission – Each of the 165 POCs will submit their SOPS Hospital Survey Data. The data submission requires an hour on average to complete.

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 $30,867 annually.

Exhibit 1. Estimated annualized burden hours

Form Name	Number of respondents/ POCs	Number of responses per POC	Hours per response	Total burden hours
Hospital Eligibility/Registration Form	165	1	3/60	8
Hospital Site Information	165	3	5/60	41
Data Use Agreement	165	1	3/60	8
SOPS Hospital Survey Data File(s) Submission	165	1	1	165
Total	N/A	N/A	N/A	222

Exhibit 2. Estimated annualized cost burden

Form Name	Number of respondents/ POCs	Total burden hours	Average hourly wage rate*	Adjusted Hourly Rate**	Total cost burden
Hospital Eligibility/Registration Form	165	8	$71.80	$143.60	$1,149
Hospital Site Information	165	41	$71.80	$143.60	$5,888
Data Use Agreement	165	8	$71.80	$143.60	$1,149
SOPS Hospital Survey Data File(s) Submission	165	165	$71.80	$143.60	$23,694
Total	N/A	N/A	N/A	N/A	$31,880

*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 https://data.bls.gov/oes/#/industry/622000.

**The Adjusted Hourly Rate was estimated at 200% of the hourly wage.

13. Estimates of Annualized Respondent Capital and Maintenance Costs

There are no direct costs to respondents other than their time to participate in the study.

14. Estimates of Annualized Cost to the Government

Exhibit 3 shows the estimated annualized cost to the government for the contract that develops, maintains, and manages the database and analyzes the data and produces reports for each year in which data are collected. The cost is estimated to be $275,000 each data submission year. Exhibit 3b shows the cost for government staff to oversee the project. That cost is $21,016.32. The total cost to the government is $296,016.32.

Exhibit 3. Estimated Annualized Cost

Cost Component	Annualized Cost
Project Development	$16,000
Data Collection Activities	$110,000
Data Processing and Analysis	$68,000
Publication of Results	$64,000
Project Management	$17,000
Overhead	--
Total	$275,000

Exhibit 3b: Annual cost to AHRQ for project oversight

AHRQ Position	% Time (hrs)	Hourly Rate*	Adjusted Hourly Rate**	Annualized Cost
GS15/5	3% (62.4 hrs)	$91.02	$182.04	$11,359.30
GS14/5	3% (62.4 hrs)	$77.38	$154.76	$9,657.02

* Salary 2025 for the locality pay area of Washington-Baltimore-Arlington, DC-MD-VA-WV-PA https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/25Tables/html/DCB_h.aspx

** The Adjusted Hourly Rate was estimated at 200% of the hourly wage.

15. Changes in Hour Burden

The estimated number of POCs decreased from 340 in the previous information collection request (ICR) to 165 in this ICR. This updated estimate is based on the actual number of POCs from the 2024 SOPS Hospital data submission. As a result of fewer POCs submitting data, the total burden hours have decreased from 459 to 222.75.

16. Time Schedule, Publication and Analysis Plans

Information for the SOPS Hospital Database is collected by AHRQ through its contractor, Westat. Hospitals will be asked to voluntarily submit their SOPS Hospital Survey data to the database approximately every other year in June. The data are then cleaned and aggregated and used to produce a Database Report that is posted on the AHRQ website. Hospitals are also automatically provided with their own customized feedback report.

17. Exemption for Display of Expiration Date

AHRQ does not seek this exemption.

List of Attachments:

Attachment A: Hospital Eligibility and Registration Form

Attachment B: Hospital Site Information

Attachment C: Data Use Agreement

Attachment D: Data Submission Emails

Attachment E: Survey Data File Specifications

Attachment F: Databases TEP List

Attachment G: Example Screen Shots of Hospital SOPS Data Submission Website Information Collection

1 Hospital Survey on Patient Safety Culture. Content last reviewed July 2024. Agency for Healthcare Research and Quality, Rockville, MD. https://www.ahrq.gov/sops/quality-patient-safety/patientsafetyculture/hospital/index.html Last accessed 2/25/2025.

2 Hospital Survey on Patient Safety Culture. Content last reviewed July 2024. Agency for Healthcare Research and Quality, Rockville, MD. https://www.ahrq.gov/sops/quality-patient-safety/patientsafetyculture/hospital/index.html Last accessed 2/25/2025.

3 SOPS Hospital Database. Content last reviewed September 2021. Agency for Healthcare Research and Quality, Rockville, MD. Available at https://www.ahrq.gov/sops/databases/hospital/index.html Last accessed 2/25/2025.

File Type	application/vnd.openxmlformats-officedocument.wordprocessingml.document
File Title	OMB Clearance Application
Author	hamlin-ben
File Modified	0000-00-00
File Created	2026-01-07

Supporting Statement Part A -- HSOPS DB Renewal_1 5 26