Agency Information Collection Activities: Proposed Collection; Comment Request, 27778-27781 [2018-12767]
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Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Notices
not intended to constitute an official
interpretation of the proposed Consent
Agreement or to modify its terms in any
way.
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proprietary, competitively sensitive
information of a rival SRM supplier
supporting Northrop’s missile system
business could be transferred to
Northrop’s vertically integrated SRM
business.
VI. The Consent Agreement
The Consent Agreement remedies the
acquisition’s likely anticompetitive
effects by requiring, whenever Northrop
competes for a missile system prime
contract, that Northrop must make its
SRM products and related services
available on a non-discriminatory basis
to all other third-party competing prime
contractors that wish to purchase them.
The non-discrimination prohibitions of
the Consent Agreement are
comprehensive and apply to any
potential discriminatory conduct
affecting price, schedule, quality, data,
personnel, investment, technology,
innovation, design, or risk.
The Consent Agreement requires
Northrop to establish firewalls to ensure
that Northrop does not transfer or use
any proprietary information that it
receives from competing missile prime
contractors or SRM suppliers in a
manner that harms competition. These
firewall provisions require that
Northrop maintain separate firewalled
teams to support offers of SRMs to
different third-party missile prime
contractors and to maintain these
firewalled teams separate from the team
supporting Northrop’s missile prime
contractor activities. The firewall
provisions also prohibit Northrop’s
missile business from sharing
proprietary information it may receive
from third-party SRM suppliers with
Northrop’s SRM business.
The Consent Agreement also provides
that the DOD’s Under Secretary of
Defense for Acquisition and
Sustainment shall appoint a compliance
officer to oversee Northrop’s compliance
with the Order. The compliance officer
will have all the necessary investigative
powers to perform his or her duties,
including the right to interview
respondent’s personnel, inspect
respondent’s facilities, and require
respondents to provide documents,
data, and other information. The
compliance officer has the authority to
retain third-party advisors, at the
expense of Northrop, as appropriate to
perform his or her duties. Access to
these extensive resources will ensure
that the compliance officer is fully
capable of overseeing the
implementation of, and compliance
with, the Order.
The purpose of this analysis is to
facilitate public comment on the
proposed Consent Agreement, and it is
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By direction of the Commission.
Janice Frankle,
Acting Secretary.
[FR Doc. 2018–12750 Filed 6–13–18; 8:45 am]
BILLING CODE 6750–01–P
Government Accountability
Office (GAO).
AGENCY:
Request for letters of
nomination and resumes.
ACTION:
The Medicare Access and
CHIP Reauthorization Act of 2015
established the Physician-Focused
Payment Model Technical Advisory
Committee to provide comments and
recommendations to the Secretary of
Health and Human Services on
physician payment models, and gave
the Comptroller General responsibility
for appointing its members. GAO is now
accepting nominations of individuals
for this committee.
SUMMARY:
Letters of nomination and
resumes should be submitted no later
than July 20, 2018, to ensure adequate
opportunity for review and
consideration of nominees prior to
appointment. Appointments will be
made in October 2018.
DATES:
Submit letters of
nomination and resumes by either of the
following methods: Email:
PTACcommittee@gao.gov. Include
PTAC Nominations in the subject line of
the message, or Mail: U.S. GAO, Attn:
PTAC Nominations, 441 G Street NW,
Washington, DC 20548.
ADDRESSES:
Greg
Giusto at (202) 512–8268 or giustog@
gao.gov if you do not receive an
acknowledgement within a week of
submission or if you need additional
information. For general information,
contact GAO’s Office of Public Affairs,
(202) 512–4800.
FOR FURTHER INFORMATION CONTACT:
Authority: Pub. L. 114–10, Sec. 101(e), 129
Stat. 87, 115 (2015).
Gene L. Dodaro,
Comptroller General of the United States.
[FR Doc. 2018–12736 Filed 6–13–18; 8:45 am]
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Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
Request for Nominations for the
Physician-Focused Payment Model
Technical Advisory Committee (PTAC)
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Agency for Healthcare Research and
Quality
AGENCY:
GOVERNMENT ACCOUNTABILITY
OFFICE
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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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 March 14th, 2018 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 July 16, 2018.
ADDRESSES: Written comments should
be submitted to: AHRQ’s OMB Desk
Officer by fax at (202) 395–6974
(attention: AHRQ’s desk officer) or by
email at OIRA_submission@
omb.eop.gov (attention: AHRQ’s desk
officer).
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at doris.lefkowitz@AHRQ.hhs.gov.
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,
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.
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Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Notices
How AHRQ’s Mission and Directives
Relate to ASCs. 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.’’ 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
connects 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. The ASC SOPS Database is
the newest database for the SOPS
program and would be modeled after
AHRQ’s existing SOPS Databases for
Hospitals, Medical Offices, Nursing
Homes, and Community Pharmacies,
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which have all undergone OMB review
and approval.
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 (CDC)
National Healthcare Safety Network
(NHSN) 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 (VBP) 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 established within its ASC
accreditation manual 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 (ASCQR) Program, which ties
quality and patient safety performance
to reimbursement.
ASC SOPS Pilot. AHRQ developed
and pilot tested the Ambulatory Surgery
Center Survey on Patient Safety Culture
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(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 their 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 nearmiss 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.
The ASC SOPS Database will 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].
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.
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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 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) 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 individuallevel and ASC-level data to enable
researchers to conduct analyses. All
data released in a data set are deidentified 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 voluntarily submit their
data into the database and therefore are
not a random or national sample of
ASCs, estimates based on this selfselected 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
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EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents/
POCs
Form name
Eligibility and Registration Form ......................................................................
Data Use Agreement .......................................................................................
ASC Site Information Form .............................................................................
Data Files Submission .....................................................................................
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Number of
responses per
POC
100
100
100
100
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1
1
1
1
14JNN1
Hours per
response
5/60
3/60
5/60
1
Total burden
hours
8
5
8
100
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Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Notices
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents/
POCs
Form name
Total ..........................................................................................................
Number of
responses per
POC
NA
NA
Hours per
response
NA
Total burden
hours
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).
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.
Francis D. Chesley, Jr.,
Acting Deputy Director.
[FR Doc. 2018–12767 Filed 6–13–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2018–0057]
Notice of Intent To Prepare an
Environmental Impact Statement,
Public Scoping Meeting, and Request
for Comments; Acquisition of Site for
Development of a Replacement
Underground Safety Research
Program Facility for the Centers for
Disease Control and Prevention/
National Institute for Occupational
Safety and Health (CDC/NIOSH) in
Mace, West Virginia
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS)
ACTION: Notice of intent; announcement
of public meeting; and request for
comments.
AGENCY:
The Centers for Disease
Control and Prevention (CDC) within
the Department of Health and Human
Services (HHS), in cooperation with the
General Services Administration (GSA),
announces its intent to prepare an
Environmental Impact Statement (EIS)
to analyze and assess the environmental
impacts of the proposed acquisition of
a site in Mace, West Virginia, and the
development of this site into a
replacement of the National Institute for
Occupational Safety and Health
(NIOSH) Underground Safety Research
Program facility (Proposed Action). The
current acquisition and development
would replace the former Lake Lynn
Experimental Mine in Fayette County,
Pennsylvania and would support
SUMMARY:
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research programs focused on miner
health and safety issues. The site being
considered for acquisition and
development includes 461.35 acres
located off of U.S. Route 219 in
Randolph and Pocahontas Counties near
Mace, West Virginia.
This notice is pursuant to the
requirements of the National
Environmental Policy Act of 1969
(NEPA) as implemented by the Council
on Environmental Quality (CEQ)
Regulations (40 CFR parts 1500–1508).
CDC, in cooperation with GSA, also
intends to initiate consultation, as
required by Section 106 of the National
Historic Preservation Act (NHPA), to
evaluate the potential effects, if any, of
the Proposed Action on historic
properties. Following the scoping
meeting, a Draft EIS will be prepared
and circulated for public comment. CDC
is the lead federal agency for this
Proposed Action.
DATES:
Public Scoping Meeting: A public
scoping meeting in open house format
will be held on June 26, 2018 in
Slatyfork, West Virginia. The meeting
will begin at 5:30 p.m. and end no later
than 8:30 p.m.
Written comments: Written scoping
comments must be submitted by 11:59
p.m. on July 14, 2018.
Deadline for Requests for Special
Accommodations: Persons wishing to
participate in the public scoping
meeting who need special
accommodations should contact Sam
Tarr at 770–488–8170 by 5:00 p.m.
Eastern Time, June 19, 2018.
ADDRESSES: The public scoping meeting
will be held at the Linwood Community
Library, 72 Snowshoe Drive, Slatyfork,
West Virginia 26291.
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]]>Agencies
[Federal Register Volume 83, Number 115 (Thursday, June 14, 2018)]
[Notices]
[Pages 27778-27781]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12767]
=======================================================================
-----------------------------------------------------------------------
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.''
This proposed information collection was previously published in
the Federal Register on March 14th, 2018 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 July 16, 2018.
ADDRESSES: Written comments should be submitted to: AHRQ's OMB Desk
Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by
email at [email protected] (attention: AHRQ's desk 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, 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.
[[Page 27779]]
How AHRQ's Mission and Directives Relate to ASCs. 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.'' 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 connects 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. The ASC SOPS Database is the newest database
for the SOPS program and would be modeled after AHRQ's existing SOPS
Databases for Hospitals, Medical Offices, Nursing Homes, and Community
Pharmacies, which have all undergone OMB review and approval.
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 (CDC) National Healthcare
Safety Network (NHSN) 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
(VBP) 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
established within its ASC accreditation manual 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 (ASCQR) Program, which ties quality and patient
safety performance to reimbursement.
ASC SOPS Pilot. AHRQ developed and pilot tested the Ambulatory
Surgery Center Survey on Patient Safety Culture (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 their 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. The ASC SOPS Database
will 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].
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.
[[Page 27780]]
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 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) 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 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
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. 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 Number of
Form name respondents/ responses per Hours per Total burden
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
---------------------------------------------------------------
[[Page 27781]]
Total....................................... NA NA NA 121
----------------------------------------------------------------------------------------------------------------
Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Number of
Form name respondents/ Total burden Average hourly Total cost
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.
Francis D. Chesley, Jr.,
Acting Deputy Director.
[FR Doc. 2018-12767 Filed 6-13-18; 8:45 am]
BILLING CODE 4160-90-P
