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[Federal Register Volume 89, Number 191 (Wednesday, October 2, 2024)]
[Notices]
[Pages 80247-80249]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22578]

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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 of the currently approved 
information collection project: Medical Office Survey on Patient Safety 
Culture Database. This proposed information collection was previously 
published in the Federal Register on July 31, 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 1, 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. 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: Doris Lefkowitz, AHRQ Reports 
Clearance Officer, (301) 427-1477, or by email 
[email protected].

SUPPLEMENTARY INFORMATION:

Proposed Project

Medical Office Survey on Patient Safety Culture Database

    In 1999, the Institute of Medicine called for health care 
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 
Surveys on Patient Safety Culture[supreg] (SOPS[supreg]) Medical Office 
Survey with OMB approval (OMB NO. 0935-0131; Approved July 5, 2007).
    The survey is designed to enable medical offices to assess provider 
and staff perspectives about patient safety issues, medical error, and 
error reporting. The survey includes 38 items that measure 10 
composites of patient safety culture. In addition to the composite 
items, 14 items measure staff perceptions of how often medical offices 
have problems exchanging information with other settings as well as 
other patient safety and quality issues. AHRQ made the survey publicly 
available along with a Survey User's Guide and other toolkit materials 
in January 2009, on the AHRQ website.
    The AHRQ SOPS Medical Office Database consists of data from the 
AHRQ Medical Office Survey on Patient Safety Culture and may include 
reportable, non-required supplemental items. Medical offices in the 
U.S. can voluntarily submit data from the survey to AHRQ, through its 
contractor, Westat. The SOPS Medical Office Database (OMB NO. 0935-
0196, last approved on September 24, 2021) was developed by AHRQ in 
2011 in response to requests

[[Page 80248]]

from medical offices interested in tracking their own survey results. 
Those organizations submitting data receive a feedback report, as well 
as a report of the aggregated, de-identified findings of the other 
medical offices submitting data. These reports are used to assist 
medical office staff in their efforts to improve patient safety culture 
in their organizations.
    The goal of the Medical Office Survey on Patient Safety Culture 
Database is to promote improvements in the quality and safety of 
healthcare in medical office settings. 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 medical offices, to facilitate the use of these materials for 
medical office patient safety and quality improvement.
    This database:
    (1) Presents results from medical offices that voluntarily submit 
their data,
    (2) Provides data to medical offices to facilitate internal 
assessment and learning in the patient safety improvement process, and
    (3) Provides supplemental information to help medical offices 
identify their strengths and areas with potential for improvement in 
patient safety culture.
    To achieve the goal of this project, the following activities and 
data collections will be implemented:
    (1) Eligibility and Registration Form--The medical office point-of-
contact (POC) completes several data submission steps and 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 medical office and initiate the registration 
process.
    (2) Medical Office Site Information Form--The purpose of the site 
information form, also completed by the medical office POC, is to 
collect background characteristics of the medical office. This 
information will be used to analyze data collected with SOPS Medical 
Office Survey.
    (3) Data Use Agreement--The purpose of the data use agreement, 
completed by the medical office POC, is to state how data submitted by 
medical offices will be used and provides privacy assurances.
    (4) Data File(s) Submission--POCs upload their data file(s), using 
the medical office 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 
medical offices do not administer the survey and submit data every 
year. Data submission is typically handled by one POC who is either an 
office manager or a survey vendor who contracts with a medical office 
to collect their data. POCs submit data on behalf of 30 medical 
offices, on average, because many medical offices are part of a health 
system that includes many medical office sites, or the POC is a vendor 
that is submitting data for multiple medical offices.
    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 Medical Office Database is 
done electronically, except the Data Use Agreement (DUA) that medical 
offices print, sign and return (either via fax, by scanning and 
emailing or uploading to a secure website, or by mailing back). 
Registration, submission of medical office information, and data upload 
is handled online through a secure website. Customized feedback reports 
are delivered electronically (the person submitting the data will enter 
a username and password for 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. An estimated 85 POCs, 
each representing an average of 30 individual medical offices each, 
will complete the database submission steps and forms. Each POC will 
submit the following:
    1. Eligibility and Registration Form--Estimated to take 3 minutes 
to complete.
    2. Medical Office Site Information Form--Estimated to take 5 
minutes to complete.
    3. Data Use Agreement--Estimated to take 3 minutes to complete.
    4. Survey Data File(s) Submission--Estimated to take 1 hour to 
complete.
    The total burden is estimated to be 308 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 $19,891 annually.

                                  Exhibit 1--Estimated Annualized Burden Hours
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                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                    respondents         POC          response          hours
----------------------------------------------------------------------------------------------------------------
1. Eligibility/Registration Form................              85               1            3/60               5
2. Medical Office Site Information Form.........              85              30            5/60             213
3. Data Use Agreement...........................              85               1            3/60               5
4. Data File(s) Submission......................              85               1               1              85
                                                 ---------------------------------------------------------------
    Total.......................................              NA              NA              NA             308
----------------------------------------------------------------------------------------------------------------

                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                                 Total burden    Average hourly     Total cost
                           Form name                                 hours         wage rate *        burden
----------------------------------------------------------------------------------------------------------------
1. Eligibility/Registration Form..............................               5            $64.58            $323
2. Medical Office Site Information Form.......................             213             64.58          13,756
3. Data Use Agreement.........................................               5             64.58             323

[[Page 80249]]

 
4. Data File(s) Submission....................................              85             64.58           5,489
                                                               -------------------------------------------------
    Total.....................................................             308                NA          19,891
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* Mean hourly wage rate of $64.58 for Medical and Health Services Managers (SOC code 11-9111) was obtained from
  the May 2023 National Industry-Specific Occupational Employment and Wage Estimates, NAICS 621100--Offices of
  Physicians located at https://www.bls.gov/oes/current/naics4_621100.htm.

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 26, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-22578 Filed 10-1-24; 8:45 am]
BILLING CODE 4160-90-P
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