[Federal Register Volume 86, Number 166 (Tuesday, August 31, 2021)]
[Notices]
[Pages 48703-48705]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18694]


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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 (AHRQ), 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 the proposed information collection 
project ``Ambulatory Surgery Center Survey on Patient Safety Culture 
Database.'' This proposed information collection was previously 
published in the Federal Register on May 25, 2021 and allowed 60 days 
for public comment. AHRQ did not receive substantive comments. The 
purpose of this notice is to allow an additional 30 days for public 
comment.

DATES: Comments on this notice must be received by September 30, 2021.

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 at 
[email protected].

SUPPLEMENTARY INFORMATION:

Proposed Project

Ambulatory Surgery Center Survey on Patient Safety Culture Database

    Ambulatory surgery centers (ASCs) are a fast-growing healthcare 
setting, demonstrating tremendous growth both in the volume and 
complexity of procedures being performed. ASCs provide surgical 
services to patients who are not expected to need an inpatient stay 
following surgery. The

[[Page 48704]]

Centers for Medicare and Medicaid Services (CMS) defines ASCs as 
distinct entities that operate exclusively to provide surgical services 
to patients who do not require hospitalization and are not expected to 
need to stay in a surgical facility longer than 24 hours.
    AHRQ's mission. As described in its 1999 reauthorizing legislation, 
Congress directed the Agency for Healthcare Research and Quality (AHRQ) 
to enhance the quality, appropriateness, and effectiveness of health 
services, as well as access to such services, by establishing a broad 
base of scientific research and promoting clinical and health systems 
practice improvements. The legislation also directed AHRQ to ``conduct 
and support research, evaluations, and training, support demonstration 
projects, research networks, and multidisciplinary centers, provide 
technical assistance, and disseminate information on health care and on 
systems for the delivery of such care, including activities with 
respect to health statistics, surveys, database development, and 
epidemiology.''
    Furthermore, AHRQ shall conduct and support research ``to provide 
objective clinical information to health care practitioners and other 
providers of health care goods or services; identify the causes of 
preventable health care errors and patient injury in health care 
delivery; develop, demonstrate, and evaluate strategies for reducing 
errors and improving patient safety; and disseminate such effective 
strategies throughout the health care industry''.
    Background on the Ambulatory Surgery Center Survey on Patient 
Safety Culture (ASC SOPS). 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 with OMB approval (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 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.
    Rationale for the information collection. The ASC SOPS and the ASC 
SOPS Database support AHRQ's goals of promoting improvements in the 
quality and safety of health care 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.
    Rationale for information collection approval. 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 ASC SOPS 
Database; OMB NO. 0935-0242; Approved September 10, 2018.
    This database will:
    1. Present results from ASCs that voluntarily submit their data;
    2. Provide data to ASCs to facilitate internal assessment and 
learning in the patient safety improvement process; and
    3. Provide 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.
    Survey data from the AHRQ Ambulatory Surgery Center Survey on 
Patient Safety Culture are used to produce three types of products:
    (1) An ASC SOPS Database Report that will be made publicly 
available on the AHRQ website (see ASC Database Report);
    (2) Individual ASC Survey Feedback Reports that are customized for 
each ASC that submits data to the database; and
    (3) Research data sets of individual-level and ASC-level de-
identified data to enable researchers to conduct analyses. All data 
released in a data set are de-identified at the individual-level and 
the ASC-level.
    ASCs will be invited to voluntarily submit their ASC SOPS survey 
data into the database. AHRQ's contractor, Westat, then cleans and 
aggregates the data to produce a PDF-formatted

[[Page 48705]]

Database Report displaying averages, standard deviations, and 
percentile scores on the survey's items and patient safety culture 
composite measures. The report also displays these results by ASC 
characteristics (e.g., number of operating/procedure rooms and 
geographic region) and respondent characteristics (e.g., staff position 
and hours worked per week).
    The Database Report includes a section on data limitations, 
emphasizing that the report does not reflect a representative sampling 
of the U.S. ASC population. Because participating ASCs will choose to 
voluntarily submit their data into the database and therefore are not a 
random or national sample of ASCs, estimates based on this self-
selected group might be biased estimates. We recommend that users 
review the database results with these caveats in mind.
    Each ASC that submits its data receives a customized survey 
feedback report that presents their results alongside the aggregated 
results from other participating ASCs.
    ASCs use the ASC SOPS Survey, Database Reports, and Individual ASC 
Survey Feedback Reports for a number of purposes, to:
     Raise staff awareness about patient safety;
     Elucidate and assess the current status of patient safety 
culture in their ASC;
     Identify strengths and areas for patient safety culture 
improvement;
     Examine trends in patient safety culture change over time; 
and
     Evaluate the cultural impact of patient safety initiatives 
and interventions.

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.

                                  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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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
                                                 ---------------------------------------------------------------
    Total.......................................              NA              NA              NA             121
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                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                     Number of
                    Form name                      respondents/    Total burden   Average hourly    Total cost
                                                       POCs            hours        wage 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
                                                 ---------------------------------------------------------------
    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: August 25, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021-18694 Filed 8-30-21; 8:45 am]
BILLING CODE 4160-90-P