Attachment F -- Federal Register Notice

Attachment F -- Federal Register Notice.pdf

Pilot Test of the Proposed Pharmacy Survey on Patient Safety Culture

Attachment F -- Federal Register Notice

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30172

Federal Register / Vol. 76, No. 100 / Tuesday, May 24, 2011 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued
Maximum
number of
respondents

Interview type
Total ..........................................................................................................

Total burden
hours

120

Average
hourly
wage rate*

147

NA

Total cost
burden
7,454

* The hourly wage for the participants across the four data collections (screening questionnaire, needs assessment interview, usability testing
interviews, and discussion group interviews) is based upon the mean of the average hourly wages for Social science research assistants (19–
4061; $19.39 per hour); Postsecondary Health Specialties Teachers (25–1071; $53.88 per hour);Management analysts (13–1111; $40.70 per
hour); Computer and Information Systems Managers (11–3021; $58.00 per hour); Family and General Practitioners Teachers (29–1060; $81.03
per hour);Pharmacists (29–1051; $51.27 per hour). May 2009 National Occupational Employment and Wage Estimates, United States, U.S. Bureau of Labor Statistics Division of Occupational Employment Statistics http://www.bls.gov/oes/current/oes_nat.htm#29–0000.

Estimated Annual Costs to the Federal
Government
The estimated total cost to the Federal
Government for this project is

$411,641.00 over a two-year period from
September 8, 2010 to September 7,
2012. The estimated average annual cost
is $205,821.

Exhibit 3 provides a breakdown of the
estimated total and average annual costs
by category.

EXHIBIT 3—ESTIMATED TOTAL AND ANNUAL COST * TO THE FEDERAL GOVERNMENT
Cost component

Total cost

Annualized
cost

Project Management and Coordination Activities ...................................................................................................
Evaluation Plan and Protocol Development ............................................................................................................
OMB Submission Package ......................................................................................................................................
Conduct Evaluation ** ..............................................................................................................................................
Data Analysis, Report and Briefing .........................................................................................................................
Documentation and 508 Compliance ......................................................................................................................

$58,140
44,908
12,362
159,991
118,081
18,159

$29,070
22,454
6,181
79,996
59,041
9,080

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

411,641

205,821

* Costs are fully loaded including overhead, G&A and fees.
** These activities include the data collections described in this submission.

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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 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: May 10, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011–12506 Filed 5–23–11; 8:45 am]
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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 Pharmacy Survey
on Patient Safety Culture.’’ 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 March 11th, 2011 and
allowed 60 days for public comment.
One comment was 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 June 23, 2011.
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
e-mail at doris.lefkowitz@
AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
Proposed Project
Pilot Test of the Proposed Pharmacy
Survey on Patient Safety Culture
As the baby boomer population ages,
the general U.S. population continues to
grow, and as drug therapies for the
treatment of chronic diseases become
more efficacious, the expected increase

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30173

Federal Register / Vol. 76, No. 100 / Tuesday, May 24, 2011 / Notices
in the number of prescriptions and
demand for pharmaceutical products is
likely to increase the potential for
medication errors in community/retail
pharmacies. In 2007, there were about
56,000 community/retail pharmacies,
including about 22,000 traditional chain
pharmacy companies, nearly 17,000
independent drug stores, about 9,300
supermarket pharmacies, and about
7,700 mass merchant pharmacies.
Numerous reports substantiate the
presence of medication errors in
pharmacies. For example, one national
observational study of prescription
dispensing accuracy and safety in 50
pharmacies in the U.S. found a rate of
about 4 errors per day in a pharmacy
filling 250 prescriptions daily. This
error rate translates to an estimated 51.5
million errors occurring during the
filling of 3 billion prescriptions each
year.
Given the widespread impact of
pharmacies on patient safety, the new
Pharmacy Survey on Patient Safety
Culture (Pharmacy SOPS) will measure
pharmacy staff perceptions about what
is important in their organization and
what attitudes and behaviors related to
patient safety are supported, rewarded,
and expected. The survey will help
community/retail pharmacies to identify
and discuss strengths and weaknesses of
patient safety culture within their
individual pharmacies. 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 community/retail pharmacies,
which includes chain drugstores (e.g.,
Walgreens and CVS), supermarket
pharmacies, independently owned
pharmacies, and mass merchant
pharmacies (e.g., Wal-Mart, Costco,
Target), not for use in hospital
pharmacies.
This research has the following goals:
(1) Cognitively test and modify as
necessary the Pharmacy Survey on
Patient Safety Culture Questionnaire;

(2) Pretest and modify the
questionnaire as necessary;
(3) Make the final questionnaire
available to the public.
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.
42 U.S.C. 299a(a)(1) and (2).
Method of Collection
To achieve the goals of this study the
following activities and data collections
will be implemented:
(1) Cognitive interviews—Two rounds
of interviews will be conducted by
telephone with 10 respondents each.
The purpose of these interviews is to
refine the questionnaire’s items and
composites. Each round will be
conducted with a mix of pharmacists
and non-pharmacist staff working in
community/retail pharmacies
throughout the U.S. The same interview
guide will be used for each round.
(2) Pretest—The draft questionnaire
will be pretested with all pharmacy staff
in approximately 60 community/retail
pharmacies. The purpose of the pretest
is to collect data for an assessment of
the reliability and construct validity of
the survey’s items and composites,
allowing for their further refinement.
(3) Pharmacy background
questionnaire—This questionnaire will
be completed by the pharmacy manager
in each of the 60 pretest sites to provide
background characteristics of the
pharmacy, such as pharmacy type
(independently owned or chain), type of
chain (traditional drugstore,
supermarkets, mass merchant), average
number of prescriptions filled weekly,
average number of hours the pharmacy
is open on weekdays, etc.

(4) Dissemination activities—The
final questionnaire will be made
available to the public through the
AHRQ website. 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 Pharmacy Survey on
Patient Safety Culture Questionnaire.
Psychometric analysis will be
conducted on the pilot 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 pharmacy 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.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
pharmacies’ time to participate in this
research. Cognitive interviews will be
conducted with staff at 20 pharmacies
(approximately 10 pharmacists and 10
nonpharmacist staff) and will take about
one hour and 30 minutes to complete.
627 staff from 60 pharmacies will
participate in the pretest (an average of
10.45 staff from each pharmacy). The
pretest questionnaire (the Pharmacy
Survey on Patient Safety Culture)
requires 15 minutes to complete. The
pharmacy background questionnaire
will be completed by the manager at
each of the 60 pharmacies participating
in the pretest and takes 10 minutes to
complete. The total annualized burden
is estimated to be 197 hours.
Exhibit 2 shows the estimated
annualized cost burden associated with
the pharmacies’ time to participate in
this research. The total cost burden is
estimated to be $4,948 annually.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
pharmacies

jlentini on DSK4TPTVN1PROD with NOTICES

Form Name/activity

Number of
responses
per pharmacy

Hours per
response

Total burden
hours

Cognitive interviews .........................................................................................
Pretest ..............................................................................................................
Pharmacy background questionnaire ..............................................................

20
60
60

1
10.45
1

1.5
15/60
10/60

30
157
10

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

140

na

na

197

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30174

Federal Register / Vol. 76, No. 100 / Tuesday, May 24, 2011 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
pharmacies

Form Name/activity

Total burden
hours

Average
hourly wage
rate *

Total cost
burden

Cognitive interviews .........................................................................................
Pretest ..............................................................................................................
Pharmacy background questionnaire ..............................................................

20
60
60

30
157
10

$32.28
22.08
51.27

$968
3,467
513

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

140

197

na

$4,948

* Based upon the mean of the average hourly wages for Pharmacists (29–1051; $51.27), Pharmacy Technicians (29–2052; $13.92), and Pharmacy Aides (31–9095; $10.74), National Compensation Survey: Occupational wages in the United States May 2009, ‘‘U.S. Department of Labor,
Bureau of Labor Statistics.’’ The hourly wage for the cognitive interviews is a weighted average for 10 pharmacists, 8 pharmacy technicians and
2 pharmacy aides; the hourly wage for the pretest is a weighted average for 157 pharmacists, 235 pharmacy technicians and 235 pharmacy
aides.

Estimated Annual Costs to the Federal
Government
Exhibit 3 shows the estimated total
and annualized cost for this project.

Although data collection will last for
less than one year, the entire project
will take about 3 years. The total cost for
this project is approximately $320,818.

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 .................................................................................................................................................................

$65,340
62,831
11,004
15,767
7,496
158,380

$21,780
20,944
3,368
5,256
2,498
5,293

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

320,818

106,939

Request for Comments

jlentini on DSK4TPTVN1PROD 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: 0(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.

VerDate Mar<15>2010

16:47 May 23, 2011

Jkt 223001

Dated: May 10, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011–12505 Filed 5–23–11; 8:45 am]
BILLING CODE 4160–90–M

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M/S K–50, Atlanta, Georgia 30333,
telephone 770/488–5709 or fax 770/
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