Attachment N -- Federal Register Notice

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Settlement Agreement include that Dr.
Bois denied that he committed research
misconduct but he agreed not to further
appeal ORI’s findings of research
misconduct set-forth above. Dr. Bois and
HHS further agreed to the following
administrative actions beginning on
March 14, 2013:
(1) To have his research supervised
for a period of three (3) years beginning
on the effective date of the Agreement;
he agreed that prior to the submission
of an application for U.S. Public Health
Service (PHS) support for a research
project on which his participation is
proposed and prior to his participation
in any capacity on PHS-supported
research, he shall ensure that a plan for
supervision of his duties is submitted to
ORI for approval; the supervision plan
must be designed to ensure the
scientific integrity of his research
contribution; he agreed that he shall not
participate in any PHS-supported
research until such a supervision plan is
submitted to and approved by ORI, with
such review and approval to be
conducted promptly by ORI and not
unreasonably withheld; he agreed to
maintain responsibility for compliance
with the agreed upon supervision plan;
(2) that for three (3) years beginning
with the effective date of the Agreement,
any institution employing him shall
submit, in conjunction with each
application for PHS funds, or report,
manuscript, or abstract involving PHSsupported research in which Dr. Bois is
involved, a certification to ORI that the
data provided by him are based on
actual experiments or are otherwise
legitimately derived and that the data,
procedures, and methodology are
accurately reported in the application,
report, manuscript, or abstract; and
(3) to exclude himself voluntarily
from serving in any advisory capacity to
PHS, including, but not limited to,
service on any PHS advisory committee,
board, and/or peer review committee, or
as a consultant for a period of three
years (3) beginning with the effective
date of the Agreement.
Dr. Bois further agreed to dismiss his
lawsuit with prejudice and to withdraw
further proceedings before HHS. Dr.
Bois and HHS both agreed to waive or
abandon all other claims. This notice
supercedes the notice regarding this
matter that was previously published in:
Federal Register 76:111, June 9, 2011.
FOR FURTHER INFORMATION CONTACT:

Director, Division of Investigative
Oversight, Office of Research Integrity,

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1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, (240) 453–8800.
David E. Wright,
Director, Office of Research Integrity.
[FR Doc. 2013–09134 Filed 4–17–13; 8:45 am]
BILLING CODE 4150–31–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities; Proposed Collection;
Comment Request
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: ‘‘Pilot
Test of the Proposed Value and
Efficiency Surveys and Communicating
with Patients Checklist.’’ In accordance
with the Paperwork Reduction Act, 44
U.S.C. 3501–3521, AHRQ invites the
public to comment on this proposed
information collection.
This proposed information collection
was previously published in the Federal
Register on January 7th, 2013 and
allowed 60 days for public comment. No
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment.
DATES: Comments on this notice must be
received by May 20, 2013.
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).
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:
SUMMARY:

Proposed Project
Pilot Test of the Proposed Value and
Efficiency Surveys and Communicating
With Patients Checklist
Maximizing value within the
American health care system is an

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important priority. Value is often
viewed as a combination of high quality,
high efficiency care, and there is general
agreement by consumers, policy makers,
payers, and providers that it is lacking
in the U.S. A recent report by the
Institute of Medicine estimated that 20
to 30 percent ($765 billion a year) of
U.S. healthcare spending was inefficient
and could be reduced without lowering
quality.
Multiple overlapping initiatives are
currently seeking to improve value
using a variety of approaches. Public
reporting efforts led by the Centers for
Medicare and Medicaid Services (CMS),
other payers and consumer groups seek
to enable consumers to make more
informed choices about the quality, and
in some cases, the costs of their care. A
variety of demonstration projects and
payment reforms initiated by CMS and
private insurers are attempting to more
closely link care quality with payments
to create incentives for higher value
care. And national improvement
initiatives led by AHRQ (comprehensive
unit-based safety programs [CUSP] for
central line-associated blood stream
infection [CLABSI], catheter-associated
urinary tract infections [CUTI], and
surgical units [SUSP]) and CMS
(hospital engagement networks, QIO
scopes of work) are seeking to raise care
quality and reduce readmissions.
Results from the CUSP–CLABSI project
have demonstrated that central line
infections can be reduced and
unnecessary costs can be avoided across
the health care system by concerted,
unit-based improvement efforts.
As a systems level example, Denver
Health, with initial funding from AHRQ,
has taken major steps towards
redesigning clinical and administrative
processes so as to reduce staff time,
patient waiting, and unnecessary costs.
These improvements occurred without
harm to quality and in some instances
actually improved quality.
In many cases, improving quality
improves efficiency naturally. Reducing
the number of hospital errors, for
example, will reduce costs associated
with longer length of stay or errortriggered readmissions. It is more costeffective to do things right the first time.
But higher value may be more likely if
organizations doing quality
improvement link efforts to improve
care quality with efforts to reduce
unnecessary costs. AHRQ understands
that many of the root causes of
inefficiencies that drive up costs are
closely linked to root causes of
inefficiencies that lead to poor quality,
uncoordinated care where redundancies
and system failures place patients at
risk. Enhancing value in healthcare

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requires understanding the contribution
that organizational culture makes to
value and working to foster a culture
where high value is a cultural norm.1
AHRQ’s development of the Hospital
Survey on Patient Safety Culture
(HSOPS) has contributed greatly to
efforts to promote the important role
culture plays in providing safe care.
HSOPS is used extensively in national
improvement campaigns and many
hospitals and health systems now
regularly assess their safety cultures and
use culture scores on organizational
dashboards and as parts of variable
compensation programs.
If organizations lack cultures
committed to value then discrete efforts
to raise dimensions of value are likely
to yield limited and unsustainable
results. And if organizational leaders
have no plausible way to know whether
their organizational culture is
committed to value, then their ability to
make value a higher organizational
priority will be very limited. Thus,
developing value and efficiency survey
instruments for hospitals and medical
offices fills an important need for many
ongoing and planned efforts to foster
greater value within American health
care.
Given the widespread impact of cost
and waste in health care, AHRQ will
develop the Value and Efficiency (VE)
Surveys for hospitals and medical
offices. These surveys will measure staff
perceptions about what is important in
their organization and what attitudes
and behaviors related to value and
efficiency are supported, rewarded, and
expected. The surveys will help
hospitals and medical offices to identify
and discuss strengths and weaknesses
within their individual organizations.
They can then use that knowledge to
develop appropriate action plans to
improve their value and efficiency. To
develop these tools AHRQ will recruit
medical staff from 42 hospitals and 96
medical offices to participate in
cognitive testing and pretesting.
In addition to the VE surveys, AHRQ
also intends to develop and test the
feasibility and utility of a Patient
Communication Checklist. Patients are
demanding greater clarity into the costs
of health care and what they can do
about affordability problems. While
there is recent interest in making health
care prices more transparent for
1 (refers to 2nd paragraph in page 3) According to
Pronovost and Sexton (Assessing Safety Culture:
Guidelines and Recommendations, Qual Saf Health
Care 2005; 14:231–23), ‘‘Definitions of culture
commonly refer to values, attitudes, norms, beliefs,
practices, policies, and behaviors of personnel. In
essence, culture is ‘the way we do things around
here’.’’

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consumers (e.g., the Health Care Price
Transparency Promotion Act of 2013
(H.R. 1326)), physician communication
with patients about the cost of care will
be a key component to attaining highvalue, high-quality care from a patient
perspective. To aid physicians, this
proposal will develop a consumer value
(CV) checklist. Physician checklists
have been instrumental in many quality
improvements, such as with AHRQ’s
reduction in central line-associated
blood stream infections [CLABSI] (See
Atul Gawande’s Checklist Manifesto,
Metropolitan Books, 2009). Checklists
have also reduced surgical
complications by preventing
miscommunication during complex
procedures. Similarly, checklists could
potentially facilitate communication
between clinicians and patients in
complex discussions about patient
preferences, quality, value, and out-ofpocket costs. The objective of the CV
checklist is to facilitate shared decisionmaking, and also engage physician and
patients in joint problem solving. For
example, if discussions emanating from
use of a checklist show that the patient
is not likely to fill a critical prescription
for financial reasons, this could trigger
a discussion of generic substitutes or
state or other subsidies available. Since
the proper goal for any health care
delivery system is to improve the
quality and value of care delivered to
patients, such a tool will bring the
patient perspective on value into the
decision-making about their care.
The CV checklist will address three
major topics: who should talk with
patients about preferences and value
issues (e.g., nurses, physicians, etc.),
when should these conversations occur
(e.g., when patients may incur costs,
when they express financial concerns,
etc.), and how can clinicians prepare for
and effectively facilitate such
discussions.
This research has the following goals:
(1) Develop, cognitively test and
modify as necessary the VE surveys (one
for hospitals and one for medical
offices);
(2) Pretest the VE surveys in hospitals
and medical offices and modify as
necessary based on the results;
(3) Develop, cognitively test and
modify as necessary the checklist;
(4) Seek consumer/patient input on
the potential value of the checklist;
(5) Pretest the checklist in hospitals
and medical offices and either drop or
modify as necessary based on patient
and clinician views of the results;
(6) Make the final VE surveys and
checklist available for use by the public.
This study is being conducted by
AHRQ through its contractor, Health

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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 these goals the following
activities and data collections will be
implemented:
(1) Cognitive interviews for the YE
surveys. One round of interviews on the
VE surveys will be conducted by
telephone with 9 respondents from
hospitals and 9 respondents from
medical offices. The purpose of these
interviews is to understand the
cognitive processes the respondent
engages in when answering a question
on the VE survey and to refine the
survey’s items and composites. These
interviews will be conducted with a mix
of senior leaders and clinical staff (i.e.,
unit/department managers,
practitioners, nurses, technicians, and
medical assistants) from hospitals and
medical offices throughout the U.S. with
varying characteristics (e.g., size,
geographic location, type of medical
office practice/hospital, and possibly
extent of experience with wastereduction efforts).
(2) Pretest for the VE surveys. The
surveys will be pretested with senior
leaders and clinical staff from 42
hospitals and 96 medical offices. The
purpose of the pretest is to collect data
for an assessment of the reliability and
construct validity of the surveys’ items
and composites, allowing for their
further refinement. A site-level point-ofcontact (POC) will be recruited in each
medical office and hospital to manage
the data collection at that organization
(compiles sample information,
distribute surveys, promote survey
response, etc.). Exhibit 1 includes a
burden estimate for the POC’s time to
manage the data collection.
(3) Medical office information form.
This form will be completed by the
medical office manager in each of the 96
medical office pretest sites to provide
background characteristics, such as type
of specialty(s) and majority ownership.
A hospital information form will not be
needed because characteristics on
pretest hospitals will be obtained from
the American Hospital Association’s
(AHA) data set based on a hospital’s
AHA ID number.
(4) Survey to identify items for CV
checklist. In order to identify items to

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put on the checklist, a survey will be
developed and sent to 160
representative participants (40
Physicians, 40 Registered Nurses, 20
Social Workers, 20 Health Educators,
and 40 Patients). Once the survey
responses have been collected,
responses will be analyzed to help
inform the development of the CV
checklist. Checklist items will be chosen
based on what is learned. For example,
if clinicians strongly believe that it is
inappropriate to discuss costs and value
with patients, the checklist may require
different items than if clinicians
recognize the importance of such
conversations but believe they lack
required information to facilitate them.
(5) Cognitive Interviews for the CV
checklist. Once checklist items have
been identified, cognitive interviews
will be conducted with 9 respondents in
hospitals and 9 respondents in medical
offices to understand the cognitive
processes the respondent engages in
when using the CV checklist. Cognitive
interviewing will allow checklist
developers to identify and classify
difficulties respondents may have
regarding checklist items. To get
different perspectives, interviews will
be conducted with a mix of physicians,
nurses, social workers, health educators,
and patients in hospitals and medical
offices.
(6) Pretest the CV checklist. The
checklist will then be pretested to solicit
feedback from 50 physicians in
hospitals and 50 physicians in medical
offices. The pilot testing process will
help identify areas where users of the
checklist have trouble understanding,
learning, and using the checklist. It also
provides the opportunity to identify

issues that can prevent successful
deployment of the checklist.
(7) Dissemination activities. The final
VE Surveys and CV checklist will be
made available to the public 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 VE Surveys and CV
checklist.
The final VE instruments will be
made available to the public for use in
hospitals and medical offices to assess
value and efficiency from the
perspectives of their staff. The survey
can be used by hospitals and medical
offices to identify areas for
improvement. Researchers are also
likely to use the surveys to assess the
impact of hospitals’ and medical offices’
value and efficiency improvement
initiatives.
The final CV checklist will be made
available to hospital and medical office
clinicians to aid in having conversations
with patients about value.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents’ time to participate in this
research. Cognitive interviews for the
Hospital VE survey will be conducted
with 9 hospital staff (approximately 3
managers, 3 nurses, and 3 technicians)
and will take about one hour and 30
minutes to complete. Cognitive
interviews for the Medical Office VE
survey will be conducted with 9
medical office staff (approximately 4
physicians and 5 medical assistants)

and will take about one hour and 30
minutes to complete. The Hospital VE
survey will be administered to about
4,032 individuals from 42 hospitals
(about 96 surveys per hospital) and
requires 15 minutes to complete. A sitelevel POC will spend approximately 16
hours administering the Hospital VE
survey. The Medical Office VE survey
will be administered to about 504
individuals from 96 medical offices
(about 5 surveys per medical office) and
requires 15 minutes to complete. A sitelevel POC will spend approximately 6
hours administering the Medical Office
VE survey. The medical office
information form survey will be
completed by a medical office manager
at each of the 96 medical offices
participating in the pretest and takes 10
minutes to complete.
One-hundred and sixty individuals
(40 physicians, 40 nurses, 20 social
workers, 20 health educators, and 40
patients) will participate in the survey
to identify items for the CV checklist
and will take 15 minutes to complete.
Cognitive interviews for the CV
checklist will be conducted with 18
individuals (9 in hospitals and 9 in
medical offices, consisting of
approximately 4 physicians, 4 nurses, 2
social workers, 2 health educators, and
6 patients) and will take about one hour
to complete. One hundred physicians
will participate in the pretest of the CV
checklist (50 in hospitals and 50 in
medical offices). The total burden is
estimated to be 2,534 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 $115,559 annually.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

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Form name

Number of
resonses per
resondent

Hours per
response

Total burden
hours

Cognitive interviews for the Hospital VE survey ...........................................
Cognitive interviews for the Medical Office VE survey .................................
Pretest for the Hospital VE survey ................................................................
Pretest for the Medical Office VE survey ......................................................
POC Administration of the Hospital VE survey .............................................
POC Administration of the Medical Office VE survey ...................................
Medical office information form .....................................................................
Survey to identify items for CV checklist .......................................................
Cognitive interviews for the CV checklist ......................................................
Pretest for the CV checklist ...........................................................................

9
9
4,032
504
42
96
96
160
18
100

1
1
1
1
1
1
1
1
1
1

1.5
1.5
15/60
15/60
16
6
10/60
15/60
1
30/60

14
14
1,008
126
672
576
16
40
18
50

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

5,066

na

na

2,534

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Federal Register / Vol. 78, No. 75 / Thursday, April 18, 2013 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents

Form name

Total burden
hours

Average
hourly wage
rate*

Total cost
burden

Cognitive interviews for the Hospital VE survey .............................................
Cognitive interviews for the Medical Office VE survey ...................................
Pretest for the Hospital VE survey ..................................................................
Pretest for the Medical Office VE survey ........................................................
Administration of the Hospital VE survey ........................................................
Administration of the Medical Office VE survey ..............................................
Medical office information form .......................................................................
Survey to identify items for CV checklist .........................................................
Cognitive interviews for the CV checklist ........................................................
Pretest for the CV checklist .............................................................................

9
9
4,032
504
42
96
96
160
18
100

14
14
1,008
126
672
576
16
40
18
50

a$36.16

i87.98

$506
656
36,308
3,494
37,498
29,364
816
1,801
717
399

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

5,066

2,534

na

115,559

b46.87
c36.02
d27.73
e55.80
f50.98
f50.98
g45.02
h39.84

* National Occupational Employment and Wage Estimates in the United States, May 2011, ‘‘U.S. Department of Labor, Bureau of Labor Statistics’’ (available at http://www.bls.gov/oes/current/naics4_621100.htm [for medical office setting] and http://www.bls.gov/oes/current/
naics4_622100.htm [for hospital setting]).
a Based on the weighted average wages for 3 Registered Nurses (29–1111, $33.56), 3 Medical and Clinical Laboratory Technicians (29–2012,
$19.11), and 3 General and Operational Managers (11–1021, $55.80) in the hospital setting;
b Based on the weighted average wages for 4 Family and General Practitioners (29–1062; $87.18) and 5 Medical Assistants (31–9092, $14.63)
in the medical office setting;
c Based on the weighted average wages for 1,937 Registered Nurses, 1,131 Medical and Clinical Laboratory Technicians, 526 General and
Operational Managers and 446 Physicians (29–1069; $66.23) in the hospital setting;
d Based on the weighted average wages for 91 Family and General Practitioners and 413 Medical Assistants in the medical office setting;
e Based on the average wages for General and Operational Managers in the hospital setting;
f Based on the average wages for General and Operational Managers in the medical office setting;
g Based on the weighted average wages for 40 Physician and Surgeons (29–10692; $88.78), 40 Registered Nurses (29–1111; $33.23), 20 Social Workers (21–1022; $24.28), 20 Health Educators (21–1091, $25.07), and 20 Patients (00–0000; $21.74);
h Based on the weighted average wages for 4 Physician and Surgeons, 4 Registered Nurses, 2 Social Workers, 2 Health Educators, and 6 Patients;
i Based on the weighted average wages for 50 Physician and Surgeons in the hospital setting and 50 Family and General Practitioners in the
medical office setting;

Estimated Annual Costs to the Federal
Government
Exhibit 3 shows the estimated total
and annualized cost to the government

for this data collection. Although data
collection will last for less than one
year, the entire project will take about

2 years. The total cost for the three
surveys is approximately is $1,001,202.

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST
Cost component

Annualized
cost

Project Development ...............................................................................................................................................
Data Collection Activities .........................................................................................................................................
Data Processing and Analysis .................................................................................................................................
Publication of Results ..............................................................................................................................................
Project Management ................................................................................................................................................
Overhead .................................................................................................................................................................

$273,838
153,119
171,764
14,753
10,032
377,696

$136,919
76,560
85,882
7,377
5,016
188,848

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

1,001,202

500,601

Request for Comments

sroberts on DSK5SPTVN1PROD with NOTICES

Total cost

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

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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.

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Dated: April 8, 2013.
Carolyn M. Clancy,
Director.
[FR Doc. 2013–08946 Filed 4–17–13; 8:45 am]
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