23256 Federal Register / Vol. 78, No. 75 / Thursday, April 18, 2013 / Notices 

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, 

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: 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: ‘‘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 

OIRA_submission@omb.eop.gov 

(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 doris.lefkowitz@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

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 

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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Federal Register / Vol. 78, No. 75 / Thursday, April 18, 2013 / Notices 23257 

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’.’’ 

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 

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 

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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23258 Federal Register / Vol. 78, No. 75 / Thursday, April 18, 2013 / Notices 

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

Form name Number of 

respondents 

Number of 

resonses per 

resondent 

Hours per 

response 

Total burden 

hours 

Cognitive interviews for the Hospital VE survey ........................................... 9 1 1 .5 14 

Cognitive interviews for the Medical Office VE survey ................................. 9 1 1 .5 14 

Pretest for the Hospital VE survey ................................................................ 4,032 1 15/60 1,008 

Pretest for the Medical Office VE survey ...................................................... 504 1 15/60 126 

POC Administration of the Hospital VE survey ............................................. 42 1 16 672 

POC Administration of the Medical Office VE survey ................................... 96 1 6 576 

Medical office information form ..................................................................... 96 1 10/60 16 

Survey to identify items for CV checklist ....................................................... 160 1 15/60 40 

Cognitive interviews for the CV checklist ...................................................... 18 1 1 18 

Pretest for the CV checklist ........................................................................... 100 1 30/60 50 

Total ........................................................................................................ 5,066 na na 2,534 


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Federal Register / Vol. 78, No. 75 / Thursday, April 18, 2013 / Notices 23259 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number of 

respondents 

Total burden 

hours 

Average 

hourly wage 

rate* 

Total cost 

burden 

Cognitive interviews for the Hospital VE survey ............................................. 9 14 a$36.16 $506 

Cognitive interviews for the Medical Office VE survey ................................... 9 14 b46.87 656 

Pretest for the Hospital VE survey .................................................................. 4,032 1,008 c36.02 36,308 

Pretest for the Medical Office VE survey ........................................................ 504 126 d27.73 3,494 

Administration of the Hospital VE survey ........................................................ 42 672 e55.80 37,498 

Administration of the Medical Office VE survey .............................................. 96 576 f50.98 29,364 

Medical office information form ....................................................................... 96 16 f50.98 816 

Survey to identify items for CV checklist ......................................................... 160 40 g45.02 1,801 

Cognitive interviews for the CV checklist ........................................................ 18 18 h39.84 717 

Pretest for the CV checklist ............................................................................. 100 50 i87.98 399 

Total .......................................................................................................... 5,066 2,534 na 115,559 

* 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]). aBased 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; bBased 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; cBased 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; dBased on the weighted average wages for 91 Family and General Practitioners and 413 Medical Assistants in the medical office setting; eBased on the average wages for General and Operational Managers in the hospital setting; 

fBased on the average wages for General and Operational Managers in the medical office setting; 

gBased 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); hBased on the weighted average wages for 4 Physician and Surgeons, 4 Registered Nurses, 2 Social Workers, 2 Health Educators, and 6 Patients; iBased 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 Total cost Annualized 

cost 

Project Development ............................................................................................................................................... $273,838 $136,919 

Data Collection Activities ......................................................................................................................................... 153,119 76,560 

Data Processing and Analysis ................................................................................................................................. 171,764 85,882 

Publication of Results .............................................................................................................................................. 14,753 7,377 

Project Management ................................................................................................................................................ 10,032 5,016 

Overhead ................................................................................................................................................................. 377,696 188,848 

Total .................................................................................................................................................................. 1,001,202 500,601 

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: April 8, 2013. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2013–08946 Filed 4–17–13; 8:45 am] 

BILLING CODE 4160–90–M 


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