Notice2021-18694
Agency Information Collection Activities: Proposed Collection; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 31, 2021
Issuing agencies
Health and Human Services DepartmentAgency for Healthcare Research and Quality
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 166 (Tuesday, August 31, 2021)</title>
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[Federal Register Volume 86, Number 166 (Tuesday, August 31, 2021)]
[Notices]
[Pages 48703-48705]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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
<a href="/cdn-cgi/l/email-protection#bedad1ccd7cd90d2dbd8d5d1c9d7cac4fefff6ecef90d6d6cd90d9d1c8"><span class="__cf_email__" data-cfemail="40242f3229336e2c25262b2f3729343a00010812116e2828336e272f36">[email protected]</span></a>.
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:
<bullet> Raise staff awareness about patient safety;
<bullet> Elucidate and assess the current status of patient safety
culture in their ASC;
<bullet> Identify strengths and areas for patient safety culture
improvement;
<bullet> Examine trends in patient safety culture change over time;
and
<bullet> 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:
<bullet> Eligibility and registration form (completion is estimated
to take about 5 minutes).
<bullet> Data use agreement (completion is estimated to take about
3 minutes).
<bullet> ASC Site Information Form (completion is estimated to take
about 5 minutes).
<bullet> 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
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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
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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 <a href="https://www.bls.gov/oes/current/naics4_621400.htm#11-00000">https://www.bls.gov/oes/current/naics4_621400.htm#11-00000</a>).
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
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