Attachment E - Federal Register Notice

Attachment E - Federal Register Notice.pdf

Pretest of the Ambulatory Surgery/Procedure Survey on Patient Safety Culture

Attachment E - Federal Register Notice

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Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Notices

Virginia; to acquire 100 percent of the
voting shares of Virginia Commerce
Bancorp, Inc, and thereby indirectly
acquire Virginia Commerce Bank, both
of Arlington, Virginia.
B. Federal Reserve Bank of St. Louis
(Yvonne Sparks, Community
Development Officer) P.O. Box 442, St.
Louis, Missouri 63166–2034:
1. Banc Investors, L.L.C., Town and
Country, Missouri; to acquire 33.32
percent of the voting shares of 1st
Advantage Bancshares, Inc., and thereby
indirectly acquire 1st Advantage Bank,
both of St. Peters, Missouri.
Board of Governors of the Federal Reserve
System, July 2, 2013.
Michael J. Lewandowski,
Associate Secretary of the Board.
[FR Doc. 2013–16280 Filed 7–5–13; 8:45 am]
BILLING CODE 6210–01–P

follows an initial meeting, on May 20,
2013, of the GBAC. During the May 20,
2013 meeting the GBAC discussed an
initial Green Book draft. Members of the
public will be provided an opportunity
to address the Council with a brief (fiveminute) comment period on matters
directly related to the proposed update
and revision. Any interested person
who plans to participate in the
teleconference as an observer must
contact Kristen Kociolek, Assistant
Director, 202–512–2989, prior to July
19, 2013. The toll free call-in number is
1–800–369–1927, and the participant
code is 41706.
Authority: 31 U.S.C. 3512 (c), (d).
James Dalkin,
Director, Financial Management and
Assurance, U.S. Government Accountability
Office.
[FR Doc. 2013–16256 Filed 7–5–13; 8:45 am]
BILLING CODE 1610–02–M

GOVERNMENT ACCOUNTABILITY
OFFICE
Advisory Council on the Standards for
Internal Control in the Federal
Government
AGENCY:

Government Accountability

Office.

The US Government
Accountability Office (GAO) is
preparing to revise the Standards for
Internal Control in the Federal
Government, known as the ‘‘Green
Book,’’ under the authority provided in
the Federal Managers’ Financial
Integrity Act. As part of the revision
process, GAO is holding a
teleconference with the Green Book
Advisory Council (GBAC). The
Comptroller General has established the
GBAC to provide input and
recommendations to the Comptroller
General on revisions to the ‘‘Green
Book.’’ The purpose of the meeting is to
discuss proposed revisions to the
‘‘Green Book.’’
DATES: The meeting will be held July 25,
2013 from 10:00 a.m. to 12:00 p.m. EDT.
FOR FURTHER INFORMATION CONTACT: For
information on the Green Book
Advisory Council and the Standards for
Internal Control in the Federal
Government please contact Kristen
Kociolek, Assistant Director, Financial
Management and Assurance telephone
202–512–2989, 441 G Street NW.,
Washington, DC 20548–0001.
SUPPLEMENTARY INFORMATION: The
meeting will be a teleconference held by
the US Government Accountability
Office. This teleconference meeting

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Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request

Notice of teleconference
meeting.

ACTION:

SUMMARY:

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:

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: ‘‘Pretest
of the Ambulatory Surgery/Procedure
Survey on Patient Safety Culture
Questionnaire (Ambulatory Surgery
SOPS).’’ In accordance with the
Paperwork Reduction Act, 44 U.S.C.
3501–3521, AHRQ invites the public to
comment on this proposed information
collection.
DATES: Comments on this notice must be
received by September 6, 2013.
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.
SUMMARY:

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SUPPLEMENTARY INFORMATION:

Proposed Project
Pretest of the Ambulatory Surgery/
Procedure Survey on Patient Safety
Culture Questionnaire (Ambulatory
Surgery SOPS)
One setting which has demonstrated
tremendous growth both in the volume
and complexity of procedures being
performed is ambulatory surgical and
procedure centers (ASCs). ASCs are
defined by the Centers for Medicare &
Medicaid Services (CMS) 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 (42
CFR 416.2). Many of the services
performed in these facilities extend
beyond procedures traditionally thought
of as surgery, including endoscopy, and
injections to treat chronic pain.
Currently, there are over 5,300
Medicare-certified ASCs in the U.S.,
which represents a greater than 54%
increase since 2001. In 2007, Medicare
paid for more than 6 million surgeries
performed in these facilities at a cost of
nearly $3 billion. Recent CMS audits
suggest infection control deficiencies in
these facilities are widespread. For
example, preliminary data from 2011
found that 51 percent of ASCs surveyed
had an infection control deficiency; 11
percent were considered very serious
deficiencies. These findings are only
slightly lower than 2010 audits and a
2008 sample of ASCs in three states.
Given the widespread impact of ASCs
on patient safety, the new Ambulatory
Surgery/Procedure Survey on Patient
Safety Culture (Ambulatory Surgery
SOPS) will measure ASC staff
perceptions about what is important in
their organization and what attitudes
and behaviors related to patient safety
culture are supported, rewarded, and
expected. The survey will help ASCs to
identify and discuss strengths and
weaknesses of patient safety culture
within their individual facilities. They
can then use that knowledge to develop
appropriate action plans to improve
their practices and their culture of
patient safety. This survey is designed
for use in ASCs that practice all types
of surgical procedures including those
that require incisions and less invasive
or non-surgical procedures such as
gastrointestinal procedures or pain
management injections.
This research has the following goals:
(1) Develop, cognitively test and
modify as necessary the Ambulatory
Surgery/Procedure Survey on Patient

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Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Notices
Safety Culture Questionnaire
(Ambulatory Surgery SOPS); and
(2) Pretest and modify the
questionnaire as necessary; and
(3) Make the final questionnaire
publicly available.
This study is being conducted by
AHRQ through its contractor, Health
Research & Educational Trust (HRET),
and subcontractor, Westat, pursuant to
AHRQ’s statutory authority to conduct
and support research on healthcare 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 quality
measurement and improvement. 42
U.S.C. 299a(a)(1) and (2).
Method of Collection
To achieve the projects’ goals the
following activities-and data collections
will be implemented:
(1) Cognitive interviews. One round of
cognitive interviews on the Ambulatory
Surgery SOPS will be conducted by
telephone with 15 respondents from
ASCs. The purpose of these interviews
is to understand the cognitive processes
the respondent engages in when
answering a question on the survey and
to refine the survey’s items and
composites. These interviews will be
conducted with a mix of physicians,
management, nurses, surgical
technicians, and administrative staff
throughout the U.S. from ASCs with
varying characteristics (e.g., size,
geographic location, and type of
ownership).
(2) Pretest for the Ambulatory Surgery
SOPS. The draft questionnaire will be
pretested with physicians and staff from

40 ASCs. The purpose of the pretest is
to collect data for an assessment of the
reliability and construct validity of the
survey items and composites, allowing
for their further refinement. A site-level
point of contact (POC) will be recruited
in each ASC to manage the data
collection at that organization (compile
sample information, distribute surveys,
promote survey response, etc.).
(3) Dissemination activities. The final
questionnaire will be made publicly
available through the AHRQ Web site.
This activity does not impose a burden
on the public and is therefore not
included in the burden estimates in
Exhibit 1.
The information collected will be
used to test and improve the draft
survey items in the Ambulatory Surgery
SOPS. Psychometric analysis will be
conducted on the pretest data to
examine item nonresponse, item
response variability, factor structure,
reliability, and construct validity of the
items included in the survey. Because
the survey items are being developed to
measure specific aspects of patient
safety culture in the ambulatory surgery
setting, the factor structure of the survey
items will be evaluated through
multilevel confirmatory factor analysis.
On the basis of the data analyses, items
or factors may be dropped.
The final survey instrument will be
made available to the public for use in
ASCs to assess their safety culture from
the perspectives of their staff. The
survey can be used by ASCs to identify
areas for patient safety culture
improvement. Researchers are also
likely to use the survey to assess the
impact of ASC’s patient safety culture

improvement initiatives such as the
implementation of a surgical safety
checklist. This survey is an expansion of
AHRQ’s suite of surveys on patient
safety culture, which are available on
the AHRQ Web site at (http://
www.ahrq.gov/professionals/qualitypatient-safety/surveys/index.html).
Those surveys have been used by
thousands of hospitals, nursing homes,
medical offices, and pharmacies across
the U.S. to assess patient safety culture.
The Ambulatory Surgery SOPS contains
new and revised questions and
composites that more accurately apply
to the ambulatory surgery setting.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents’ time to participate in this
research. Cognitive interviews will be
conducted with 15 ASC staff
(approximately three physicians, six
nurses, two medical technicians, two
administrative managers, and two
administrative assistants) and will take
about one hour and 30 minutes to
complete. The Ambulatory Surgery
SOPS will be completed by 529 ASC
staff from 40 facilities (about 13 per
facility). Each survey will require
approximately 15 minutes to complete.
A site-level POC will spend
approximately 6 hours administering
the Ambulatory Surgery SOPS. The total
burden is estimated to be 395 hours
annually.
Exhibit 2 shows the estimated
annualized cost burden associated with
the respondents’ time to participate in
this research. The total cost burden is
estimated to be $16,173 annually.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Form name

Number of
responses per
respondent

Hours per
response

Total burden
hours

Cognitive interviews .........................................................................................
Pretest for the Ambulatory Surgery SOPS ......................................................
POC Administration of the survey ...................................................................

15
529
40

1
1
1

1.5
15/60
6

23
132
240

Total ..........................................................................................................

584

na

na

395

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EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Number of
respondents

Form name
Cognitive interviews .........................................................................................
Pretest for the Ambulatory Surgery SOPS ......................................................
POC Administration of the survey ...................................................................

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Total burden
hours

15
529
40

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23
132
240

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Average
hourly wage
rate*
a $46.52
b 46.04
c 37.61

Total cost
burden
$1,070
6,077
9,026

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Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued
orm name
Number of
respondents

Form name
Total ..........................................................................................................

Total burden
hours

584

395

Average
hourly wage
rate*
na

Total cost
burden
16,173

a Based

on the weighted average wages for 1 Anesthesiologist (29–1061, $108.35), 2 Surgeons (29–1067, $106.48), 2 Administrative Services
Managers (11–3011, $37.61), 6 Registered Nurses (29–1141, $34.23), 2 Medical and Clinical Laboratory Technicians (29–2030, $28.90), 1 Licensed Practical or Licensed Vocational Nurse (29–2061, $21.17), and 1 Office and Administrative Support Workers, All Other (43–9199,
$16.92).
b Based on the weighted average wages for 150 Registered Nurses, 85 Office and Administrative Support Workers, 85 Medical and Clinical
Laboratory Technicians, 70 Surgeons, 50 Licensed Practical/Vocational Nurses, 49 Anesthesiologists, and 40 Administrative Services Managers.
c Based on the on the average wages for 1 Administrative Services Managers.
* National Occupational Employment and Wage Estimates in the United States, May 2012, ‘‘U.S. Department of Labor, Bureau of Labor Statistics’’ (available at http://www.bls.gov/oes/current/naics4_621400.htm [for outpatient care setting]

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 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: June 25, 2013.
Carolyn M. Clancy,
Director.
[FR Doc. 2013–16076 Filed 7–5–13; 8:45 am]
BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
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[30Day–13–13PQ]

Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the

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Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–7570 or send an
email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC 20503 or by fax to (202) 395–5806.
Written comments should be received
within 30 days of this notice.
Proposed Project
DELTA FOCUS Program Evaluation—
New—National Center for Injury
Prevention and Control (NCIPC),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Intimate Partner Violence (IPV) is a
serious, preventable public health
problem that affects millions of
Americans and results in serious
consequences for victims, families, and
communities. IPV occurs between two
people in a close relationship. The term
‘‘intimate partner’’ describes physical,
sexual, or psychological harm by a
current or former partner or spouse. IPV
can impact health in many ways,
including long-term health problems,
emotional impacts, and links to negative
health behaviors. IPV exists along a
continuum from a single episode of
violence to ongoing battering; many
victims do not report IPV to police,
friends, or family.
The purpose of the DELTA FOCUS
(Domestic Violence Prevention
Enhancement and Leadership Through
Alliances, Focusing on Outcomes for
Communities United with States)
program is to promote the prevention of
IPV through the implementation and
evaluation of strategies that create a
foundation for the development of
practice-based evidence. By
emphasizing primary prevention, this
program will support comprehensive
and coordinated approaches to IPV
prevention. Each state domestic
violence coalition is required to identify

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and fund one to two well-organized,
broad-based, active local coalitions
(referred to as coordinated community
responses or CCRs) that are already
engaging in, or are at capacity to engage
in, IPV primary prevention strategies
affecting the structural determinants of
health at the societal and/or community
levels of the social ecological model.
State Domestic Violence Coalitions
(SDVCs) must facilitate and support
local-level implementation and hire
empowerment evaluators to support the
evaluation of IPV prevention strategies
by the CCRs. SDVCs must also
implement and with their
empowerment evaluators, evaluate
state-level IPV prevention strategies.
CDC seeks OMB approval for one year
to collect information electronically
from awardees, their CCRs and their
empowerment evaluators. Data will be
collected in year one and analyzed and
disseminated in years two and three. A
reinstatement request will be made to
collect data in the fourth year of the
program. Information will be collected
using the DELTA FOCUS Program
Evaluation Survey (referred to as DF
Survey). The DF survey will collect
information about SDVCs satisfaction
with CDC efforts to support them;
process, program and strategy
implementation factors that affect their
ability to meet the requirements of the
funding opportunity announcement;
prevention knowledge and use of the
public health approach; and
sustainability of prevention activities
and successes.
The DF Survey will be completed by
10 SDVC executive directors, 10 SDVC
project coordinators, 19 CCR project
coordinators, and 10 SDVC
empowerment evaluators and take a
maximum of 1 hour to complete. The
total estimated annualized burden is 49
hours.
There are no costs to respondents
other than their time.

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