[Federal Register Volume 90, Number 176 (Monday, September 15, 2025)]
[Notices]
[Pages 44377-44379]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-17713]


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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.

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SUMMARY: This notice announces the intention of the Agency for 
Healthcare

[[Page 44378]]

Research and Quality (AHRQ) to request that the Office of Management 
and Budget (OMB) approve the extension, without change, of the 
currently approved information collection project ``Surveys on Patient 
Safety Culture Hospital Database'' (OMB No. 0935-0162).

DATES: Comments on this notice must be received by November 14, 2025

ADDRESSES: Written comments should be submitted to: AHRQ by email at 
[email protected].
    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.

FOR FURTHER INFORMATION CONTACT: Margie Shofer, AHRQ Reports Clearance 
Officer, 301-427-1696 or by email at 
[email protected].

SUPPLEMENTARY INFORMATION:

Proposed Project

Surveys on Patient Safety Culture Hospital Database

Project Overview
    The Surveys on Patient Safety Culture[supreg] (SOPS[supreg]) 
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.
    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:
    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)].
Method of Collection
    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.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.

Estimated Annual Respondent Burden

    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:
    1. Hospital Eligibility and Registration Form--Completed once by 
165 hospital POCs. The form takes about 3 minutes to complete.
    2. Hospital Site Information--Completed an average of three times 
by the 165 hospital POCs. The form takes 5 minutes to complete.
    3. Data Use Agreement--Completed once by 165 hospital POCs. The 
form takes about 3 minutes to complete.
    4. 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 $31,880 annually.

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                                  Exhibit 1--Estimated Annualized Burden Hours
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                                                     Number of       Number of
                    Form name                      respondents/    responses per     Hours per     Total burden
                                                       POCs             POC          response          hours
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1. Hospital Eligibility/Registration Form.......             165               1            3/60               8
2. Hospital Site Information....................             165               3            5/60              41
3. Data Use Agreement...........................             165               1            3/60               8
4. SOPS Hospital Survey Data File(s) Submission.             165               1               1             165
                                                 ---------------------------------------------------------------
    Total.......................................             N/A             N/A             N/A             222
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                                   Exhibit 2--Estimated Annualized Cost Burden
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                                     Number of
            Form name              respondents/    Total burden   Average hourly     Adjusted       Total cost
                                       POCs            hours        wage rate *   hourly rate **      burden
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1. Hospital Eligibility/                     165               8          $71.80         $143.60          $1,149
 Registration Form..............
2. Hospital Site Information....             165              41           71.80          143.60           5,888
3. Data Use Agreement...........             165               8           71.80          143.60           1,149
4. SOPS Hospital Survey Data                 165             165           71.80          143.60          23,694
 File(s) Submission.............
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    Total.......................             N/A             N/A             N/A             N/A          31,880
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* 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.

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: September 10, 2025.
Mamatha Pancholi,
Deputy Director.
[FR Doc. 2025-17713 Filed 9-12-25; 8:45 am]
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