[Federal Register Volume 78, Number 235 (Friday, December 6, 2013)]
[Notices]
[Pages 73540-73541]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-29071]


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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.

DATES: Comments on this notice must be received by February 4, 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 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.

[[Page 73541]]

    (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
----------------------------------------------------------------------------------------------------------------
                                                     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
                                                 ---------------------------------------------------------------
    Total.......................................             600              NA              NA             296
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                                  Exhibit 2--Estimated Annualized Burden Hours
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                                                     Number of
                    Form Name                      respondents/    Total burden   Average hourly    Total cost
                                                       POCs            hours        wage rate*        burden
----------------------------------------------------------------------------------------------------------------
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
                                                 ---------------------------------------------------------------
    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.

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: November 22, 2013.
Richard Kronick,
AHRQ Director.
[FR Doc. 2013-29071 Filed 12-5-13; 8:45 am]
BILLING CODE 4160-90-M