[Federal Register Volume 86, Number 99 (Tuesday, May 25, 2021)]
[Notices]
[Pages 28111-28112]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10938]



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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, Health and Human 
Services (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) reapprove the proposed information 
collection project ``Ambulatory Surgery Center Survey on Patient Safety 
Culture Database.''

DATES: Comments on this notice must be received by July 26, 2021.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, 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: Doris Lefkowitz, AHRQ Reports 
Clearance Officer, (301) 427-1477, or by email at 
[email protected].

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality (AHRQ) requests that the Office of Management and Budget (OMB) 
reapprove, under the Paperwork Reduction Act of 1995, AHRQ's collection 
of information for the AHRQ Ambulatory Surgery Center (ASC) Survey on 
Patient Safety (SOPS) Database; OMB NO. 0935-0242; Approved September 
10, 2018.
    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 ASC 
Survey on Patient Safety Culture (OMB NO. 0935-0216; approved October 
31, 2013).
    The survey 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 ASC SOPS 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 survey to AHRQ, through its 
contractor, Westat. The ASC SOPS Database (OMB NO. 0935-0242; Approved 
September 10, 2018) was developed by AHRQ 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.
    This database:
    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.
    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 health statistics, surveys, and database development. 42 
U.S.C. 299a(a)(1) and (8).

Method of Collection

    To achieve the goal of this project 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. 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 privacy assurances.
    3. ASC Site Information--The purpose of the site level 
specifications, completed by the ASC POC, is to collect background 
characteristics of the ASC. This information will be used to analyze 
data collected with the ASC SOPS survey.
    4. Data Files Submission--POCs upload their data file(s), using ASC 
survey data file specifications, to ensure that users submit 
standardized and consistent data in the way variables are named, coded, 
and formatted. The number of submissions to the database is likely to 
vary each year 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.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the 
respondents' time to participate in the database. An estimated 100 ASC 
managers (i.e., POCs from ASCs) will complete the database submission 
steps and forms. Each POC will submit the following:
     Eligibility and registration form (completion is estimated 
to take about 5 minutes).
     Data use agreement (completion is estimated to take about 
3 minutes).
     ASC Site Information Form (completion is estimated to take 
about 5 minutes).
     Survey data submission will take an average of one hour.
    The total burden is estimated to be 121 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 $5,804.37

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                                  Exhibit 1--Estimated Annualized Burden Hours
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                                                                     Number of
                  Form name                        Number of       responses per     Hours per     Total burden
                                               respondents/POCs         POC          response          hours
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Eligibility and Registration Form...........                 100               1            5/60               8
Data Use Agreement..........................                 100               1            3/60               5
ASC Site Information Form...................                 100               1            5/60               8
Data Files Submission.......................                 100               1               1             100
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    Total...................................                  NA              NA              NA             121
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                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                                                      Average
                  Form name                        Number of       Total  burden    hourly wage     Total cost
                                               respondents/POCs        hours          rate *          burden
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Eligibility and Registration Form...........                 100               8          $47.97         $383.76
Data Use Agreement..........................                 100               5           47.97          239.85
ASC Site Information........................                 100               8           47.97          383.76
Data Files Submission.......................                 100             100           47.97        4,797.00
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    Total...................................                  NA             121              NA        5,804.37
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* Based on the mean hourly wage for 100 ASC Administrative Services Managers (11-3010; $47.97) obtained from the
  May 2019 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: May 19, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021-10938 Filed 5-24-21; 8:45 am]
BILLING CODE 4160-90-P