[Federal Register Volume 79, Number 32 (Tuesday, February 18, 2014)]
[Notices]
[Pages 9209-9211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-03484]
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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: Agency for Healthcare Research and Quality, HHS.
ACTION: Notice.
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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: ``Pharmacy Survey on Patient Safety Culture Comparative
Database.'' In accordance with the Paperwork Reduction Act of 1995, 44
U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this
proposed information collection.
This proposed information collection was previously published in
the Federal Register on December 6th, 2013 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 March 20, 2014.
ADDRESSES: Written comments should be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by email at
[email protected].
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
Pharmacy Survey on Patient Safety Culture Comparative Database.
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 health care, AHRQ developed and pilot tested the
Pharmacy Survey on Patient Safety Culture with OMB approval (OMB NO.
0935-0183; Approved 08/12/2011). The survey is designed to enable
pharmacies to assess staff opinions about patient and medication safety
and quality-assurance issues, and includes 36 items that measure 11
dimensions of patient safety culture. AHRQ made the survey publicly
available along with a Survey User's Guide and other toolkit materials
in October 2012 on the AHRQ Web site.
The AHRQ Pharmacy Survey on Patient Safety Culture (Pharmacy SOPS)
Comparative Database consists of data from the AHRQ Pharmacy Survey on
Patient Safety Culture. Pharmacies in the U.S. are asked to voluntarily
submit data from the survey to AHRQ, through its contractor, Westat.
The Pharmacy SOPS Database is modeled after three other SOPS databases:
Hospital SOPS [OMB NO. 0935-0162; Approved 05/04/2010]; Medical Office
SOPS [OMB NO. 0935-0196; Approved 06/12/12]; and Nursing Home SOPS [OMB
NO. 0935-0195; Approved 06/12/12] that were originally developed by
AHRQ in response to requests from hospitals, medical offices, and
nursing homes interested in knowing how their patient safety culture
survey results compare to those of other similar health care
organizations.
Rationale for the information collection. The Pharmacy SOPS survey
and the Pharmacy SOPS Comparative Database will support AHRQ's goals of
promoting improvements in the quality and safety of health care in
pharmacy
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settings. The survey, toolkit materials, and comparative database
results are all made publicly available on AHRQ's Web site. Technical
assistance is provided by AHRQ through its contractor at no charge to
pharmacies, to facilitate the use of these materials for pharmacy
patient safety and quality improvement.
The goal of this project is to create the Pharmacy SOPS Comparative
Database. This database will:
(1) Allow pharmacies to compare their patient safety culture survey
results with those of other pharmacies,
(2) provide data to pharmacies to facilitate internal assessment
and learning in the patient safety improvement process, and
(3) provide supplemental information to help pharmacies identify
their strengths and areas with potential for improvement in 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. 42 U.S.C. 299a(a)(1)
and (2).
Method of Collection
To achieve these goals the following data collections will be
implemented:
(1) Registration Form--The point-of-contact (POC), the pharmacy
manager or a survey participating organization, completes a number of
data submission steps and forms, beginning with completion of an online
Registration Form. The purpose of this form is to collect basic
demographic information about the pharmacy and initiate the
registration process.
(2) Pharmacy Background Characteristics Form--The purpose of this
form, completed by the pharmacy manager or a participating
organization, is to collect background characteristics of the pharmacy.
This information will be used to analyze data collected with the
Pharmacy SOPS survey.
3) Data Use Agreement--The purpose of the data use agreement,
completed by the pharmacy manager or participating organization is to
state how data submitted by pharmacies will be used and provide
confidentiality assurances.
(4) Data Files Submission -POCs upload their data file(s), using
the pharmacy data file specifications, to ensure that users submit
standardized and consistent data in the way variables are named, coded,
and formatted. The number of submissions to the database is likely to
vary each year because pharmacies do not administer the survey and
submit data every year.
Survey data from the AHRQ Pharmacy Survey on Patient Safety Culture
are used to produce three types of products: (1) A Pharmacy SOPS
Comparative Database Report that is made publicly available on the AHRQ
Web site, (2) Individual Pharmacy Survey Feedback Reports that are
confidential, customized reports produced for each pharmacy that
submits data to the database (the number of reports produced is based
on the number of pharmacies submitting each year); and (3) Research
data sets of individual-level and pharmacy-level de-identified data to
enable researchers to conduct analyses.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated annualized burden hours for the
respondent's time to participate in the database. An estimated 150
POCs, each representing an average of 10 individual pharmacies each,
will complete the database submission steps and forms annually.
Completing the registration form will take about 5 minutes. The
Pharmacy Background Characteristics Form is completed by all POCs for
each of their pharmacies (150 x 10 = 1,500 forms in total) and is
estimated to take 5 minutes to complete. Each POC will complete a data
use agreement which takes 3 minutes to complete and submitting the data
will take an hour on average. The total burden is estimated to be 296
hours.
Exhibit 2 shows the estimated annualized cost burden based on the
respondents' time to submit their data. The cost burden is estimated to
be $14,392 annually.
Exhibit 1--Estimated Annualized Burden Hours
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Number of Number of
Form name respondents/ responses per Hours per Total burden
POCs POC response hours
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Registration Form............................... 150 1 5/60 13
Pharmacy Background Characteristics Form........ 150 10 5/60 125
Data Use Agreement.............................. 150 1 3/60 8
Data Files Submission........................... 150 1 1 150
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Total....................................... 600 NA NA 296
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Exhibit 2--Estimated annualized cost burden
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Number of Average
Form name respondents/ Total burden hourly wage Total cost
POCs hours rate* burden
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Registration Form............................... 150 13 $48.62 $632
Pharmacy Background Characteristics Form........ 150 125 48.62 6,078
Data Use Agreement.............................. 150 8 48.62 389
Data Files Submission........................... 150 150 48.62 7,293
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Total....................................... 600 296 NA 14,392
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Mean hourly wage rate of $48.62 for General and Operations
Managers (SOC code 11-1021) was obtained from the May 2012 National
Industry-Specific Occupational Employment and Wage Estimates, NAICS
446110--Pharmacies and Drug Stores located at http://www.bls.gov/oes/current/naics5_446110.htm.
[[Page 9211]]
Request for Comments
In accordance with the above-cited Paperwork Reduction Act
legislation, 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, quality improvement and 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: February 6, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014-03484 Filed 2-14-14; 8:45 am]
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