Attachment F -- Federal Register Notice

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Federal Register / Vol. 77, No. 17 / Thursday, January 26, 2012 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED TOTAL COST BURDEN
Type of data
collection

Number of
respondents

Average
hourly wage
rate *

Total
burden hours

Total
cost burden

Focus Groups with Clinicians ..........................................................
Focus Groups with Support Staff ....................................................
Patient Interviews ............................................................................
Feedback Questionnaire for Patients Requesting Mailed Guides ..
Feedback Questionnaire for Patients Visiting Mobile Web site ......

30
36
300
200
200

23
27
75
33
33

$83.59
14.31
21.35
21.35
21.35

$1,923
386
1,601
705
705

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

766

191

na

5,320

* Based upon the mean wages for clinicians (29–1062 family and general practitioners), clinical team members (31–9092 medical assistants)
and consumers (00–0000 all occupations), National Compensation Survey: Occupational wages in the United States May 2010, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’

Estimated Annual Costs to the Federal
Government
The maximum cost to the Federal
Government is estimated to be $203,531

annually. Exhibit 3 shows the total and
annualized cost by the major cost
components.

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST
Cost component

Annualized cost

Project Development .......................................................................................................................................
Data Collection Activities .................................................................................................................................
Data Processing and Analysis .........................................................................................................................
Project Management ........................................................................................................................................
Overhead .........................................................................................................................................................

$146,175
85,425
65,375
47,588
62,500

$73,088
42,713
32,688
23,794
31,250

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

407,063

203,531

Request for Comments

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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 healthcare
research and healthcare 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.

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Dated: January 17, 2012.
Carolyn M. Clancy,
Director.
[FR Doc. 2012–1402 Filed 1–25–12; 8:45 am]
BILLING CODE 4160–90–M

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: ‘‘Nursing
Home Survey on Patient Safety Culture
Comparative 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.
This proposed information collection
was previously published in the Federal

SUMMARY:

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Register on November 2nd, 2011 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 February 27, 2012.
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:
Proposed Project
Nursing Home Survey on Patient Safety
Culture Comparative Database
The Agency for Healthcare Research
and Quality (AHRQ) requests that the
Office of Management and Budget
(OMB) approve, under the Paperwork
Reduction Act of 1995, AHRQ’s

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Federal Register / Vol. 77, No. 17 / Thursday, January 26, 2012 / Notices
collection of information for the AHRQ
Nursing Home Survey on Patient Safety
Culture (Nursing Home SOPS)
Comparative Database. The Nursing
Home SOPS Comparative Database
consists of data from the AHRQ Nursing
Home Survey on Patient Safety Culture.
Nursing homes in the U.S. are asked to
voluntarily submit data from the survey
to AHRQ through its contractor, Westat.
The Nursing Home SOPS Database is
modeled after the Hospital SOPS
Database [OMB NO. 0935–0162,
approved 05/04/2010] that was
originally developed by AHRQ in 2006
in response to requests from hospitals
interested in knowing how their patient
safety culture survey results compare to
those of other hospitals. In 1999, the
Institute of Medicine called for health
care organizations to develop a ‘‘culture
of safety’’ such that their workforce and
processes focus on improving the
reliability and safety of care for patients
(IOM, 1999; To Err is Human: Building
a Safer Health System). To respond to
the need for tools to assess patient safety
culture in nursing homes, AHRQ
developed and pilot tested the Nursing
Home Survey on Patient Safety Culture
with OMB approval (OMB NO.0935–
0132; Approved July 5, 2007). The
survey is designed to enable nursing
homes to assess provider and staff
opinions about patient safety issues,
medical error, and error reporting and
includes 42 items that measure 12
dimensions of patient safety culture.
AHRQ released the survey into the
public domain along with a Survey
User’s Guide and other toolkit materials
in November 2008 on the AHRQ Web
site (located at http://www.ahrq.gov/
qual/patientsafetyculture/
nhsurvindex.htm). Since its release, the
survey has been voluntarily used by
hundreds of nursing homes in the U.S.
The Nursing Home SOPS and the
Comparative Database are supported by
AHRQ to meet its goals of promoting
improvements in the quality and safety
of health care in nursing home settings.
The survey, toolkit materials, and
preliminary comparative database
results are all made available in the
public domain along with technical
assistance provided by AHRQ through
its contractor at no charge to nursing
homes, to facilitate the use of these
materials for nursing home patient
safety and quality improvement.
The goal of this project is to create the
Nursing Home SOPS Comparative
Database. This database will (1) allow
nursing homes to compare their patient
safety culture survey results with those
of other nursing homes; (2) provide data
to nursing homes to facilitate internal
assessment and learning in the patient

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safety improvement process; and (3)
provide supplemental information to
help nursing homes identify their
strengths and areas with potential for
improvement in patient safety culture.
De-identified data files will also be
available to researchers conducting
patient safety analysis. The database
will include 42 items that measure 12
areas, or composites, of 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
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, and
database development. 42 U.S.C.
299a(a)(1) and (2), and (a)(8).
Method of Collection
To achieve the goal of this project the
following activities and data collections
will be implemented:
(1) Nursing Home Eligibility and
Registration Form—The purpose of this
form is to determine the eligibility
status and initiate the registration
process for nursing homes seeking to
voluntarily submit their NH SOPS data
to the NH SOPS Comparative Database.
The nursing home (or parent
organization) point of contact (POC) will
complete the form. The POC is either a
corporate level health care manager for
a Quality Improvement Organization
(QIO), a survey vendor who contracts
with a nursing home to collect their
data, or a nursing home Director of
Nursing or nurse manager. Many
nursing homes are part of a QIO or
larger nursing home or health system
that includes many nursing home sites
(2) Data Use Agreement—The purpose
of this form is to obtain authorization
from nursing homes to use their
voluntarily submitted NH SOPS data for
analysis and reporting according to the
terms specified in the Data Use
Agreement (DUA). The nursing home
POC will complete the form.
(3) Nursing Home Site Information
Form—The purpose of this form is to
obtain basic information about the
characteristics of the nursing homes
submitting their NH SOPS data to the
NH SOPS Comparative Database (e.g.,
bed size, urbanicity, ownership, and
geographic region). The nursing home
POC will complete the form.
(4) Data Submission—After the
nursing home POC has completed the
Nursing Home Eligibility and
Registration Form, the Data Use

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Agreement and the Nursing Home Site
Information Form they will submit their
data from the NH SOPS to the NH SOPS
Comparative Database.
Data from the AHRQ Nursing Home
Survey on Patient Safety Culture are
used to produce three types of products:
(1) A Nursing Home SOPS Comparative
Database Report that is produced
periodically and made available in the
public domain on the AHRQ Web site
(see http://www.ahrq.gov/qual/
nhsurvey11/nhsurv111.pdf for the 2011
report); (2) Nursing Home Survey
Feedback Reports that are confidential,
customized reports produced for each
nursing home that submits data to the
database; and (3) Research data sets of
staff-level and nursing home-level deidentified data that enable researchers to
conduct additional analyses.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the nursing
home to participate in the Nursing
Home SOPS Comparative Database. The
POC completes a number of data
submission steps and forms, beginning
with completion of the online Nursing
Home SOPS Database Eligibility and
Registration form and Data Use
Agreement, which will be completed for
85 nursing homes or groups of affiliated
nursing homes annually. The Nursing
Home Site Information Form will be
completed for each individual nursing
home; since each POC represents an
average of 5 nursing homes a total of
425 Information Forms will be
completed annually and requires about
5 minutes to complete. The POC will
submit data for all of the nursing homes
they represent which will take about 5
and 1⁄2 hours, including the amount of
time POCs typically spend deciding
whether to participate in the database
and preparing their materials and data
set for submission to the database, and
performing the submission. The total
annual burden hours are estimated to be
511.
Nursing homes administer the AHRQ
Nursing Home Survey on Patient Safety
Culture on a periodic basis. Hospitals
submitting to the Hospital SOPS
Comparative Database administer the
survey every 16 months on average.
Similarly, the number of nursing home
submissions to the database is likely to
vary each year because nursing homes
do not administer the survey and submit
data every year. The 85 respondents/
POCs shown in Exhibit 1 are based on
an estimate of nursing homes submitting
data in the coming years, with the
following assumptions:
• 30 POCs for QIOs submitting on
behalf of 10 nursing homes each.

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Federal Register / Vol. 77, No. 17 / Thursday, January 26, 2012 / Notices

• 5 POCs for vendors outside of QIOs
submitting on behalf of 10 nursing
homes each.

• 50 independent nursing homes
submitting on their own behalf.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents/
POCs

Form name

Number of
responses per
POC

Hours per
response

Total burden
hours

Eligibility/Registration Forms ...........................................................
Data Use Agreement .......................................................................
Nursing Home Site Information Form ..............................................
Data Submission ..............................................................................

85
85
85
85

1
1
5
1

3/60
3/60
5/60
5.5

4
4
35
468

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

340

NA

NA

511

Exhibit 2 shows the estimated
annualized cost burden based on the
respondents’ time to submit their data.

The cost burden is estimated to be
$21,152 annually.

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents/
POCs

Form name

Total burden
hours

Average hourly
wage rate *

Total cost burden

Eligibility/Registration Forms ...........................................................
Data Use Agreement .......................................................................
Nursing Home Site Information Form ..............................................
Data Submission ..............................................................................

85
85
85
85

4
4
35
468

$41.39
41.39
41.39
41.39

$166
166
1,449
19,371

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

340

511

NA

21,152

* The wage rate in Exhibit 2 is based on May 2009 National Industry-Specific Occupational Employment and Wage Estimates, Bureau of Labor
Statistics, U.S. Dept of Labor. Mean hourly wages for nursing home POCs are located at http://www.bls.gov/oes/2009/may/naics4_623100.htm
and http://www.bls.gov/oes/2009/may/naics2_62.htm. The hourly wage of $41.39 is the weighted mean of $41.94 (General and Operations Managers; N = 25), $37.29 (Medical and Health Services Managers; N = 25), $42.89 (General and Operations Managers; N = 30) and $50.00 (Computer and Information Systems Managers; N = 5).

Estimated Annual Costs to the Federal
Government
The estimated annualized cost to the
government for developing,

maintaining, and managing the database
and analyzing the data and producing
reports is shown below. The cost is
estimated to be $310,000 annually. The

total cost over the three years of this
information collection request is
$930,000.

EXHIBIT 3—ESTIMATED ANNUALIZED COST
Cost component

Annualized cost

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

$59,715
82,107
111,963
111,966
7,464
556,785

$19,905
27,369
37,321
37,322
2,488
185,595

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

930,000

310,000

Request for Comments

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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 healthcare
research and healthcare information
dissemination functions, including
whether the information will have

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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.

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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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Federal Register / Vol. 77, No. 17 / Thursday, January 26, 2012 / Notices
Dated: January 17, 2012.
Carolyn M. Clancy,
Director.

Proposed Project

[FR Doc. 2012–1400 Filed 1–25–12; 8:45 am]
BILLING CODE 4160–90–M

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.

AGENCY:
ACTION:

Notice.

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:
‘‘Assessing the Feasibility of
Disseminating Effective Health Care
Products through a Shared Electronic
Medical Record Serving Member
Organization of a Health Information
Exchange.’’ 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 November 15th, 2011 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.

SUMMARY:

Comments on this notice must be
received by February 27, 2012.

DATES:

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.

mstockstill on DSK4VPTVN1PROD with NOTICES

ADDRESSES:

FOR FURTHER INFORMATION CONTACT:

Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at [email protected].
SUPPLEMENTARY INFORMATION:

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Assessing the Feasibility of
Disseminating Effective Health Care
Products through a Shared Electronic
Medical Record Serving Member
Organization of a Health Information
Exchange
The Agency for Healthcare Research
and Quality (AHRQ) requests that the
Office of Management and Budget
(OMB) approve under the Paperwork
Reduction Act of 1995 this collection of
information from users of work products
and services initiated by the John M.
Eisenberg Clinical Decisions and
Communications Science Center
(Eisenberg Center).
AHRQ is the lead agency charged
with supporting research designed to
improve the quality of healthcare,
reduce its cost, improve patient safety,
decrease medical errors, and broaden
access to essential services. AHRQ’s
Eisenberg Center’s mission is improving
communication of findings to a variety
of audiences (‘‘customers’’), including
consumers, clinicians, and health care
policy makers. The Eisenberg Center
compiles research results into useful
formats for customer stakeholders. The
Eisenberg Center also conducts
investigations into effective
communication of research findings in
order to improve the usability and rapid
incorporation of findings into medical
practice. The Eisenberg Center is one of
three components of AHRQ’s Effective
Health Care (EHC) Program. The
collections proposed under this
clearance include activities to assess the
feasibility of disseminating materials
developed by the Eisenberg Center
through the use of an electronic medical
record (EMR) shared by a network of
clinical care providers that are part of a
Health Information Exchange (HIE)
operating in multiple sites in several
states. Our Community Health
Information Network (OCHIN) members
include 30 clinical care organizations
operating more than 230 primary care
clinics in six states. Data will be
gathered from three different OCHINmember organizations representing a
total of 10 primary care clinics. The
information generated will be provided
to AHRQ to guide decision making and
planning for additional efforts to foster
EHC Program product distribution via
EMR prompting and product linkages.
This research has the following goals:
(1) Identify facilitators and barriers to
successful efforts to implement
processes that: (a) Support use of EHC
Program products by clinicians in
practice, and (b) place relevant clinical
information in the hands of patients and
family members in languages and

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4041

formats that are appropriate to patients’
information needs;
(2) Examine ways in which EHC
Program products can be used in
concert with other support programs
and products (e.g., healthwise®
resources available through the EMR;
brief patient instructions and letters,
including those designed for use with
persons having very low literacy skills);
(3) Assess the extent to which EHC
Program products are used (e.g.,
accessed by clinicians, provided to
patients in relevant formats) in settings
where use is supported by automated
EMR features, such as on-screen
prompts and reminders; and
(4) Document the perceived value of
integrating EHC Program products into
systems of care supported by an EMR
system as self-reported by clinicians
involved in direct care of patients and
clinic support personnel who interact
with patients.
This study is being conducted by
AHRQ through its contractor, the
Eisenberg Center—Baylor College of
Medicine, pursuant to AHRQ’s statutory
authority to conduct and support
research, and disseminate information,
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 clinical practice. 42 U.S.C.
299a(a)(1) and (4).
Method of Collection
To achieve the goals of this project the
following data collections will be
implemented:
(1) Automated Data Capture from
EMR Usage Logs. Electronic usage data
will be collected to determine the extent
to which EHC Program guides for
clinicians and patients were accessed to
support shared decision making and
patient education. The data will be
retrieved from the existing EMR-linked
database operated by the Kaiser
Permanente staff in their coordination of
activities related to the OCHIN HIE.
Data will include: (a) Number and
frequency of retrieval of EHC resource
materials; (b) specific types of materials
retrieved; and (c) health topic or
condition targeted in the EHC materials.
These data will inform the development
of follow-up questions to be
administered to clinicians and patients
in the interviews and surveys described
below. Because the data will be
obtained using automated systems
already in place, no special effort will
be needed to generate these data, and
thus this task is not included in the
burden estimates in Exhibits 1 and 2.

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