[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
[email protected].
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
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Number of
Form name Number of responses Hours per Total burden
respondents/POCs per POC response hours
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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
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Total........................................ NA NA NA 86
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Exhibit 2--Estimated Annualized Cost Burden
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Total burden Average hourly Total cost
Form name hours wage rate * burden
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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
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Total....................................................... 86 NA 4,386
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* 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]
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