Agency Information Collection Activities: Proposed Collection; Comment Request, 11203-11206 [2018-05067]
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Federal Register / Vol. 83, No. 50 / Wednesday, March 14, 2018 / Notices
by small businesses that have merged
with or been acquired by another
business. This information is used by
the SBA, Congress, Federal agencies and
the general public for various reasons
such as determining if agencies are
meeting statutory goals, set-aside
determinations, and market research.
B. Annual Reporting Burden
C. Public Comments
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Public comments are particularly
invited on: Whether this collection of
information is necessary for the proper
performance of functions of the FAR,
and whether it will have practical
utility; whether our estimate of the
public burden of this collection of
information is accurate, and based on
valid assumptions and methodology;
ways to enhance the quality, utility, and
clarity of the information to be
collected; and ways in which we can
minimize the burden of the collection of
information on those who are to
respond, through the use of appropriate
technological collection techniques or
other forms of information technology.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat Division (MVCB),
1800 F Street NW, Washington, DC
20405, telephone 202–501–4755.
Please cite OMB Control No. 9000–
0163, Small Business Size Rerepresentation, in all correspondence.
Dated: March 7, 2018.
Lorin S. Curit,
Director, Federal Acquisition Policy Division,
Office of Governmentwide Acquisition Policy,
Office of Acquisition Policy, Office of
Governmentwide Policy.
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Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:
An upward adjustment is being made
to the estimated annual reporting
burden since the last notice regarding an
extension for this clearance published
on May 4, 2015 in the Federal Register
at 80 FR 25293. Based on fiscal year
2017 re-representation modification
data from the Federal Procurement Data
System (FPDS), the number of annual
respondents has increased from 1,700 to
2,200.
Respondents: 2,200.
Responses per Respondent: 1.
Total Number of Responses: 2,200.
Hours per Response: 0.5.
Total Burden Hours: 1,100.
[FR Doc. 2018–05066 Filed 3–13–18; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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.’’
DATES: Comments on this notice must be
received by May 14, 2018.
ADDRESSES: Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by
email at doris.lefkowitz@AHRQ.hhs.gov.
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 doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Proposed Project
Ambulatory Surgery Center Survey on
Patient Safety Culture Database
In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3521,
the Agency for Healthcare Research and
Quality (AHRQ) invites the public to
comment on this proposed information
collection. Ambulatory surgery centers
(ASCs) are a fast-growing health care
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 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.
How AHRQ’s Mission and Directives
Relate to ASCs. As described in its 1999
reauthorizing legislation, Congress
directed AHRQ to enhance the quality,
appropriateness, and effectiveness of
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11203
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.’’ 42
U.S.C. 299a(a)(8).
Shortly after Congress enacted this
legislation, the Institute of Medicine
(IOM) published ‘‘To Err is Human,’’ a
seminal report on medical errors that
connected the dots between errors and
workplace culture. In it, the IOM called
for health care organizations to develop
a ‘‘culture of safety’’ such that staffing
and system processes are aligned to
improve the reliability and safety of
patient care. This appeal for safety
culture improvements directly relates to
AHRQ’s legislative directive and
mission (i.e., ‘‘to produce evidence to
make health care safer, higher quality,
more accessible, equitable, and
affordable, and to work within the U.S.
Department of Health and Human
Services and with other partners to
make sure that the evidence is
understood and used’’). Given its
legislatively mandated role, AHRQ is
uniquely positioned to support data
collection and analyses that will help
fuel ASC patient safety culture
improvements.
The expanding volume and scope of
ASC services, the growing attention of
federal regulators on patient safety
within ASCs, and the resultant
implications for public health has
prompted AHRQ to present this
application to the Office of Management
and Budget (OMB). In this request,
AHRQ seeks OMB approval to expand
its Surveys on Patient Safety CultureTM
(SOPSTM) program by creating an ASC
SOPS Database to capture and report on
ASC SOPS data voluntarily submitted
by ASCs that have administered the
ASC SOPS. This is the newest database
for the SOPS program and would be
modeled after four other SOPS
databases developed by AHRQ: Hospital
SOPS [OMB NO. 0935–0162; last
approved 10/18/2016]; Medical Office
SOPS [OMB NO. 0935–0196; last
approved 08/25/15]; Nursing Home
SOPS [OMB NO. 0935–0195; last
approved 09/30/15]; and Community
Pharmacy SOPS [OMB NO. 0935–0218;
last approved 06/26/17].
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Background on ASC SOPS. This
section provides context for this request
to the OMB regarding the need for
AHRQ’s requested database. Factors
include the continued ASC growth
trajectory and increasing public
attention on the quality of ASC care—
particularly as it relates to patient safety
culture.
Rapid ASC Growth. Medicarecertified ASCs have experienced
impressive growth in the last 35 years—
up from 239 facilities in 1983 to 5,316
in 2010. In recent years, Medicare ASCs
have seen continued growth in both
their number and scope, as illustrated
by the annual average growth rate of 1.1
percent between 2010 to 2014. In 2015,
CMS spent $4.1 billion for 3.4 million
fee-for service Medicare beneficiaries to
receive care across 5,500 Medicarecertified ASCs. Research suggests that
transitioning eligible surgical
procedures from inpatient to ASC
settings may yield significant and
sustained Medicare cost savings.
Federal Attention on ASC Care
Quality and Safety Culture. Concern
about the quality of ASC care is not
new. Following a 2008 Hepatitis C
outbreak in Nevada blamed on poor
ASC infection control practices, HHS’s
Office of the Secretary oversaw a $10
million program for state survey
agencies to improve healthcareassociated infection reduction in ASCs.
The Centers for Disease Control’s
National Healthcare Safety Network
subsequently expanded its surgical site
infection (SSI) surveillance efforts to
enable ASC data submission to
accommodate state SSI reporting
mandates. Through the Affordable Care
Act of 2010, Congress also pursued ASC
performance improvement by directing
the HHS Secretary to implement an
ASC-focused Medicare value-based
purchasing program.
The relationship between patient
safety culture and the quality of ASC
care has attracted more recent attention
from policymakers and regulators. On
the national level, the Joint Commission
in early 2017 within its ASC
accreditation manual established a new
chapter on patient safety systems
improvement, which includes strategies
for ‘‘motivating staff to uphold a fair and
just safety culture.’’ CMS, meanwhile,
published in November 2017 its Final
Rule outlining the ASC Quality
Reporting Program, which ties quality
and patient safety performance to
reimbursement.
ASC SOPS Pilot. AHRQ developed
and pilot tested the ASC SOPS with
OMB approval (OMB No. 0935–0216;
approved 10/31/2013). The survey is
designed to enable any ASC, regardless
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of type of procedures it performs, to
assess its staff’s perceptions about
patient safety and quality assurance
issues, including what safety-related
attitudes and behaviors are supported,
rewarded, and expected. It includes 27
items that measure 8 composites of
patient safety culture, as well as five
individual items on near-miss
documentation, overall rating on patient
safety and communication in the
procedure/surgery room. The pilot test
was conducted in early 2014 in ASC
facilities: (1) Where patients have
surgeries, procedures, and treatments
and are not expected to need an
inpatient stay, and (2) that have been
certified and approved to participate in
the CMS ASC program. Twenty-five
percent of the pilot sites were affiliated
with a hospital and 75% were not
hospital-affiliated. Participants included
1,800 staff members from 59 ASCs—or
approximately one percent of the total
number of ASCs at that time.
AHRQ made the survey publicly
available along with a Survey User’s
Guide, the pilot study results, and
related toolkit materials on the AHRQ
Ambulatory Surgery Center Survey on
Patient Safety Culture Web page in
April 2015. The AHRQ ASC SOPS
Database will consist of data from the
AHRQ ASC patient safety culture
survey. ASCs in the U.S. will be asked
to voluntarily submit data from the
survey to AHRQ.
Rationale for the information
collection. AHRQ sponsored the
development of the ASC SOPS as a new
survey in the suite of AHRQ Surveys on
Patient Safety Culture. The database
will support AHRQ’s goals of promoting
improvements in the quality and safety
of health care in ASC settings. Like the
survey and other toolkit materials, the
database results will be 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. Technical assistance will
also be provided to support ASC data
submission.
The goal of this project is to create the
ASC SOPS Database. This database will:
(1) Present results from ASCs that
voluntarily submit their data;
(2) Present trend data for ASCs that have
submitted their data more than once;
(3) Provide data to ASCs to facilitate
internal assessment and learning in the
patient safety improvement process; and
(4) Provide supplemental information to
help ASCs identify their strengths and areas
with potential for improvement in patient
safety culture.
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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 health care
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 pointofcontact (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 level specifications,
completed by the ASC manager, is to
collect background characteristics of the
ASC. This information will be used to
analyze data collected with the ASC
SOPS 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 privacy
assurances.
(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.
With the approval and addition of the
ASC SOPS Database, data from the
database will be used to produce three
types of products:
(1) An ASC SOPS Database Report that will
be made publicly available on the AHRQ
website (see, for example, another project in
the SOPS suite, the Hospital User 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 data to enable researchers to
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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, will then clean and aggregate
the data to produce a PDF-formatted
Database Report displaying averages,
standard deviations, and percentile
scores on the survey’s 33 items and 8
patient safety culture dimensions. In
addition, the report will also display
results by respondent characteristics
(e.g., staff position, tenure, and hours
worked per week).
The Database Report will include 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 submit their data
voluntarily 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. These limitations will be
noted in the database report. We will
recommend that users review the
database results with these caveats in
mind.
Each ASC that submits its data will
receive a customized survey feedback
report that presents their results
alongside the aggregated results from
other participating ASCs. If an ASC
submits data more than once, its survey
feedback report will also present trend
data.
ASC users of the ASCs SOPS Survey,
Database Reports, and Individual ASC
Survey Feedback Reports can use these
documents to:
• Raise staff awareness about patient
safety;
• Diagnose and assess the current
status of patient safety culture in their
own 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
intervention.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents’ time to participate in the
database. Given that this will be the first
call for voluntary data submission,
participation is initially expected to be
modest. 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
$5,472.83.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents/POCs
Form name
Number of
responses
per POC
Hours per
response
Total burden
hours
Eligibility and Registration Form ..............................................................
Data Use Agreement ...............................................................................
ASC Site Information Form .....................................................................
Data Files Submission .............................................................................
100
100
100
100
1
1
1
1
5/60
3/60
5/60
1
8
5
8
100
Total ..................................................................................................
NA
NA
NA
121
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents/POCs
Form name
Total
burden hours
Average
hourly wage
rate *
Total cost
burden
Eligibility and Registration Form ..............................................................
Data Use Agreement ...............................................................................
ASC Site Information ...............................................................................
Data Files Submission .............................................................................
100
100
100
100
8
5
8
100
$45.23
45.23
45.23
45.23
$361.84
226.15
361.84
4,523.00
Total ..................................................................................................
NA
121
45.23
5,472.83
* Based on the mean hourly wage for 100 ASC Administrative Services Managers (11–3011; $45.23) obtained from the May 2016 National Industry-Specific Occupational Employment and Wage Estimates: NAICS 621400—Outpatient Care Centers (located at https://www.bls.gov/oes/current/naics4_621400.htm#11-0000).
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Request for Comments
In accordance with the Paperwork
Reduction Act, 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
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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
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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.
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Karen J. Migdail,
Chief of Staff.
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Direct
written comments and/or suggestions
regarding the items contained in this
notice to the Attention: CDC Desk
Officer, Office of Management and
Budget, 725 17th Street NW,
Washington, DC 20503 or by fax to (202)
395–5806. Provide written comments
within 30 days of notice publication.
[FR Doc. 2018–05067 Filed 3–13–18; 8:45 am]
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Centers for Disease Control and
Prevention
[30Day–18–17AVB]
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Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘Leveraging the
Emerging Field of Disaster Citizen
Science to Enhance Community
Resilience and Improve Disaster
Response’’ to the Office of Management
and Budget (OMB) for review and
approval. CDC previously published a
‘‘Proposed Data Collection Submitted
for Public Comment and
Recommendations’’ notice on
September 19, 2017 to obtain comments
from the public and affected agencies.
CDC did not receive comments related
to the previous notice. This notice
serves to allow an additional 30 days for
public and affected agency comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(a) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) Minimize the burden of the
collection of information on those who
are to respond, including, through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
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Proposed Project
Leveraging the Emerging Field of
Disaster Citizen Science to Enhance
Community Resilience and Improve
Disaster Response—New—Office of
Public Health Preparedness and
Response (OPHPR), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The information collection for which
approval is sought is in accordance with
OPHPR’s mission to safeguard health
and save lives by providing a platform
for public health preparedness and
emergency response. As part of its role,
OPHPR is empowered to fund applied
research to improve the ability of CDC
and its partners, including but not
limited to state and local health
departments, emergency management
organizations, and health care entities,
to effectively prepare for and respond to
public health emergencies and disasters.
Citizen science is defined as research
activities (e.g., data collection, analysis,
and reporting) performed by members of
the general public without any
particular training in science. Citizen
science is growing in popularity, fueled
in part by growing use of smartphones
and other personal devices in the
population. Although citizen collection
and use of data during disasters has
increased exponentially in recent years
and there is great policy interest in the
phenomenon, there has been no robust
research to date on the use of, barriers
to, and impact of citizen science in
disasters. Local health departments
(LHDs) lack tools to respond to and
coordinate with citizen science
activities within communities.
Furthermore, citizen science
organizations lack information on how
to organize their activities for ultimate
impact.
This is an exploratory study and is the
first of its kind to explore the growing
phenomenon of disaster citizen science.
Disaster citizen science is a rapidly
growing field that is the focus of policy
interest, but currently devoid of
research. While interviews will be
hypothesis generating and provide rich
data on the experiences with citizen
science to date across all stakeholders
active in this enterprise, the nationally-
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representative survey data will allow us
to generalize findings to the full
population of LHDs in the U.S.
CDC requests approval of a new
information collection to learn about
how the emerging field of disaster
citizen science can enhance community
resilience for a period of 1 year. This
(mixed methods) information collection
using interviews and a cross-sectional
survey aims to: (1) Explore the potential
of disaster citizen science for increasing
community resilience, enhancing
participation in preparedness and
response activities, and improving
preparedness efforts; and (2) provide
evidence to inform the development of
educational and instructional tools for
communities and health departments to
navigate the emerging field of disaster
citizen science and promote
collaborations. Insights from this
information collection will be used to
inform the development of guidance
and toolkits for LHDs and community
groups so that they can align their
efforts and strengthen the benefits and
positive impacts of citizen science
activities. For interviews, the
information collection will target citizen
scientists and end users of citizen
science data.
This information collection will be
implemented in collaboration with a
contractor and will target citizen
scientists and their partners (e.g.,
academics who work with citizen
scientists on research projects) and
LHDs in a position to use citizen science
data to inform public health decisionmaking. For interviews, researchers will
sample for maximum variation, seeking
to obtain variation on U.S. region, type
and sophistication of citizen science
project, type of disaster encountered,
and previous experience with disaster
citizen science.
The project aims to conduct 35–55
facilitated, semi-structured, individual
and group interviews, each lasting
approximately 60 minutes, to cover
topics including benefits and uses of
citizen science, barriers to and
facilitators of citizen science, and
strengths and limitations of citizen
science activities and resources.
Researchers will identify potential
interview participants through literature
reviews and snowball sampling in a
phased approach starting with citizen
science and LHD organizations.
The project will sample for maximum
variation in order to capture the full
range of citizen scientist and health
department experiences on this topic.
For the survey, the project aims to
obtain a nationally representative
sample of 600 local health officials and
will apply survey weights to ensure that
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]]>Agencies
[Federal Register Volume 83, Number 50 (Wednesday, March 14, 2018)]
[Notices]
[Pages 11203-11206]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05067]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.''
DATES: Comments on this notice must be received by May 14, 2018.
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:
Proposed Project
Ambulatory Surgery Center Survey on Patient Safety Culture Database
In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-
3521, the Agency for Healthcare Research and Quality (AHRQ) invites the
public to comment on this proposed information collection. Ambulatory
surgery centers (ASCs) are a fast-growing health care 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
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.
How AHRQ's Mission and Directives Relate to ASCs. As described in
its 1999 reauthorizing legislation, Congress directed 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.'' 42 U.S.C. 299a(a)(8).
Shortly after Congress enacted this legislation, the Institute of
Medicine (IOM) published ``To Err is Human,'' a seminal report on
medical errors that connected the dots between errors and workplace
culture. In it, the IOM called for health care organizations to develop
a ``culture of safety'' such that staffing and system processes are
aligned to improve the reliability and safety of patient care. This
appeal for safety culture improvements directly relates to AHRQ's
legislative directive and mission (i.e., ``to produce evidence to make
health care safer, higher quality, more accessible, equitable, and
affordable, and to work within the U.S. Department of Health and Human
Services and with other partners to make sure that the evidence is
understood and used''). Given its legislatively mandated role, AHRQ is
uniquely positioned to support data collection and analyses that will
help fuel ASC patient safety culture improvements.
The expanding volume and scope of ASC services, the growing
attention of federal regulators on patient safety within ASCs, and the
resultant implications for public health has prompted AHRQ to present
this application to the Office of Management and Budget (OMB). In this
request, AHRQ seeks OMB approval to expand its Surveys on Patient
Safety CultureTM (SOPSTM) program by creating an
ASC SOPS Database to capture and report on ASC SOPS data voluntarily
submitted by ASCs that have administered the ASC SOPS. This is the
newest database for the SOPS program and would be modeled after four
other SOPS databases developed by AHRQ: Hospital SOPS [OMB NO. 0935-
0162; last approved 10/18/2016]; Medical Office SOPS [OMB NO. 0935-
0196; last approved 08/25/15]; Nursing Home SOPS [OMB NO. 0935-0195;
last approved 09/30/15]; and Community Pharmacy SOPS [OMB NO. 0935-
0218; last approved 06/26/17].
[[Page 11204]]
Background on ASC SOPS. This section provides context for this
request to the OMB regarding the need for AHRQ's requested database.
Factors include the continued ASC growth trajectory and increasing
public attention on the quality of ASC care--particularly as it relates
to patient safety culture.
Rapid ASC Growth. Medicare-certified ASCs have experienced
impressive growth in the last 35 years--up from 239 facilities in 1983
to 5,316 in 2010. In recent years, Medicare ASCs have seen continued
growth in both their number and scope, as illustrated by the annual
average growth rate of 1.1 percent between 2010 to 2014. In 2015, CMS
spent $4.1 billion for 3.4 million fee-for service Medicare
beneficiaries to receive care across 5,500 Medicare-certified ASCs.
Research suggests that transitioning eligible surgical procedures from
inpatient to ASC settings may yield significant and sustained Medicare
cost savings.
Federal Attention on ASC Care Quality and Safety Culture. Concern
about the quality of ASC care is not new. Following a 2008 Hepatitis C
outbreak in Nevada blamed on poor ASC infection control practices,
HHS's Office of the Secretary oversaw a $10 million program for state
survey agencies to improve healthcare-associated infection reduction in
ASCs. The Centers for Disease Control's National Healthcare Safety
Network subsequently expanded its surgical site infection (SSI)
surveillance efforts to enable ASC data submission to accommodate state
SSI reporting mandates. Through the Affordable Care Act of 2010,
Congress also pursued ASC performance improvement by directing the HHS
Secretary to implement an ASC-focused Medicare value-based purchasing
program.
The relationship between patient safety culture and the quality of
ASC care has attracted more recent attention from policymakers and
regulators. On the national level, the Joint Commission in early 2017
within its ASC accreditation manual established a new chapter on
patient safety systems improvement, which includes strategies for
``motivating staff to uphold a fair and just safety culture.'' CMS,
meanwhile, published in November 2017 its Final Rule outlining the ASC
Quality Reporting Program, which ties quality and patient safety
performance to reimbursement.
ASC SOPS Pilot. AHRQ developed and pilot tested the ASC SOPS with
OMB approval (OMB No. 0935-0216; approved 10/31/2013). The survey is
designed to enable any ASC, regardless of type of procedures it
performs, to assess its staff's perceptions about patient safety and
quality assurance issues, including what safety-related attitudes and
behaviors are supported, rewarded, and expected. It includes 27 items
that measure 8 composites of patient safety culture, as well as five
individual items on near-miss documentation, overall rating on patient
safety and communication in the procedure/surgery room. The pilot test
was conducted in early 2014 in ASC facilities: (1) Where patients have
surgeries, procedures, and treatments and are not expected to need an
inpatient stay, and (2) that have been certified and approved to
participate in the CMS ASC program. Twenty-five percent of the pilot
sites were affiliated with a hospital and 75% were not hospital-
affiliated. Participants included 1,800 staff members from 59 ASCs--or
approximately one percent of the total number of ASCs at that time.
AHRQ made the survey publicly available along with a Survey User's
Guide, the pilot study results, and related toolkit materials on the
AHRQ Ambulatory Surgery Center Survey on Patient Safety Culture Web
page in April 2015. The AHRQ ASC SOPS Database will consist of data
from the AHRQ ASC patient safety culture survey. ASCs in the U.S. will
be asked to voluntarily submit data from the survey to AHRQ.
Rationale for the information collection. AHRQ sponsored the
development of the ASC SOPS as a new survey in the suite of AHRQ
Surveys on Patient Safety Culture. The database will support AHRQ's
goals of promoting improvements in the quality and safety of health
care in ASC settings. Like the survey and other toolkit materials, the
database results will be 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. Technical assistance will also be
provided to support ASC data submission.
The goal of this project is to create the ASC SOPS Database. This
database will:
(1) Present results from ASCs that voluntarily submit their
data;
(2) Present trend data for ASCs that have submitted their data
more than once;
(3) Provide data to ASCs to facilitate internal assessment and
learning in the patient safety improvement process; and
(4) 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 health care 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 pointofcontact (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 level
specifications, completed by the ASC manager, is to collect background
characteristics of the ASC. This information will be used to analyze
data collected with the ASC SOPS 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 privacy assurances.
(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.
With the approval and addition of the ASC SOPS Database, data from
the database will be used to produce three types of products:
(1) An ASC SOPS Database Report that will be made publicly
available on the AHRQ website (see, for example, another project in
the SOPS suite, the Hospital User 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 data to
enable researchers to
[[Page 11205]]
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, will then clean and
aggregate the data to produce a PDF-formatted Database Report
displaying averages, standard deviations, and percentile scores on the
survey's 33 items and 8 patient safety culture dimensions. In addition,
the report will also display results by respondent characteristics
(e.g., staff position, tenure, and hours worked per week).
The Database Report will include 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
submit their data voluntarily 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. These limitations will be
noted in the database report. We will recommend that users review the
database results with these caveats in mind.
Each ASC that submits its data will receive a customized survey
feedback report that presents their results alongside the aggregated
results from other participating ASCs. If an ASC submits data more than
once, its survey feedback report will also present trend data.
ASC users of the ASCs SOPS Survey, Database Reports, and Individual
ASC Survey Feedback Reports can use these documents to:
Raise staff awareness about patient safety;
Diagnose and assess the current status of patient safety
culture in their own 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 intervention.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated annualized burden hours for the
respondents' time to participate in the database. Given that this will
be the first call for voluntary data submission, participation is
initially expected to be modest. 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 $5,472.83.
Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of
Form name Number of responses per Hours per Total burden
respondents/POCs POC response hours
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Number of Total burden Average hourly Total cost
Form name respondents/POCs hours wage rate * burden
----------------------------------------------------------------------------------------------------------------
Eligibility and Registration Form........... 100 8 $45.23 $361.84
Data Use Agreement.......................... 100 5 45.23 226.15
ASC Site Information........................ 100 8 45.23 361.84
Data Files Submission....................... 100 100 45.23 4,523.00
-------------------------------------------------------------------
Total................................... NA 121 45.23 5,472.83
----------------------------------------------------------------------------------------------------------------
* Based on the mean hourly wage for 100 ASC Administrative Services Managers (11-3011; $45.23) obtained from the
May 2016 National Industry-Specific Occupational Employment and Wage Estimates: NAICS 621400--Outpatient Care
Centers (located at https://www.bls.gov/oes/current/naics4_621400.htm#11-0000).
Request for Comments
In accordance with the Paperwork Reduction Act, 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.
[[Page 11206]]
Karen J. Migdail,
Chief of Staff.
[FR Doc. 2018-05067 Filed 3-13-18; 8:45 am]
BILLING CODE 4160-90-P
