[Federal Register Volume 89, Number 201 (Thursday, October 17, 2024)]
[Notices]
[Pages 83685-83687]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23931]


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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: Notice.

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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 
<a href="/cdn-cgi/l/email-protection#6f3d2a3f203d3b3c2c232a2e3d2e212c2a202929262c2a3d2f0e071d1e4107071c41080019"><span class="__cf_email__" data-cfemail="5f0d1a0f100d0b0c1c131a1e0d1e111c1a101919161c1a0d1f3e372d2e7137372c71383029">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

Proposed Project

Surveys on Patient Safety Culture[supreg] (SOPS[supreg]) 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[supreg] (SOPS[supreg]) 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

[[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
----------------------------------------------------------------------------------------------------------------
                                                                         Number of
                    Form name                           Number of        responses    Hours per    Total burden
                                                     respondents/POCs     per POC      response        hours
----------------------------------------------------------------------------------------------------------------
1. Eligibility and Registration Form.............                   60            1         3/60               3
2. ASC Site Information..........................                   60            4         5/60              20
3. Data Use Agreement............................                   60            1         3/60               3
4. SOPS ASC Survey Data Files Submission.........                   60            1            1              60
                                                  --------------------------------------------------------------
    Total........................................                   NA           NA           NA              86
----------------------------------------------------------------------------------------------------------------


                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                                   Total burden   Average hourly    Total cost
                            Form name                                  hours        wage rate *       burden
----------------------------------------------------------------------------------------------------------------
1. Eligibility and Registration Form............................               3          $50.99            $153
2. ASC Site Information.........................................              20           50.99           1,020
3. Data Use Agreement...........................................               3           50.99             153

[[Page 83687]]

 
4. SOPS ASC Survey Data Files Submission........................              60           50.99           3,060
                                                                 -----------------------------------------------
    Total.......................................................              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


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