[Federal Register Volume 81, Number 223 (Friday, November 18, 2016)]
[Notices]
[Pages 81770-81772]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27705]


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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, 44 U.S.C. 
3501-3521, AHRQ invites the public to comment on this proposed 
information collection.

DATES: Comments on this notice must be received by January 17, 2017.

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 issuesand 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.
    Request for information collection approval. The Agency for 
Healthcare Research and Quality (AHRQ) requests that the Office of 
Management and Budget (OMB) reapprove, under the Paperwork Reduction 
Act of 1995, AHRQ's collection of information for the AHRQ Pharmacy 
Survey on Patient Safety Culture (Pharmacy SOPS) Comparative Database; 
OMB NO. 0935-0218, last approved on June 12, 2014.
    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 health care and on systems for the delivery of such care, 
including activities with respect to the quality, effectiveness, 
efficiency, appropriateness and value of health care services; quality 
measure and development, and database development. 42 U.S.C. 
299a(a)(1), (2), and 8.

Method of Collection

    To achieve the goal of this project the following activities and 
data collections will be implemented:
    (1) Pharmacy Eligibility and Registration Form--The point of 
contact (POC), often the pharmacy manager of a participating 
organization, completes a number of data submission steps and forms, 
beginning with completion of an online Eligibility and Registration 
Form. The purpose of this form is to collect basic demographic 
information about the pharmacy and initiate the registration process.
    (2) Data Use Agreement--The purpose of the data use agreement, 
completed by the pharmacy POC, is to state how data submitted by 
pharmacies will be used and provides confidentiality assurances.
    (3) Pharmacy Site Information Form--The purpose of this form, 
completed by the pharmacy POC, is to collect background characteristics 
of the pharmacy. This information will be used to analyze data 
collected with the Pharmacy SOPS survey.
    (4) Data Files Submission--POCs upload their data file(s), using 
the community pharmacy or hospital 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

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the survey and submit data every year. Data submission is typically 
handled by one POC who is either a pharmacy manager or a survey vendor 
who contracts with a pharmacy to collect and submit its data. POCs 
submit data on behalf of 3 pharmacies, on average, because many 
pharmacies are part of a multi-pharmacy system, or the POC is a vendor 
that is submitting data for multiple pharmacies.
    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 (see http://www.ahrq.gov/professionals/quality-patient-safety/patientsafetyculture/pharmacy/pharm-reports.html), (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. Pharmacies are asked to voluntarily submit their Pharmacy 
SOPS survey data to the comparative database. The data are then cleaned 
and aggregated and used to produce a Comparative Database Report that 
displays averages, standard deviations, and percentile scores on the 
survey's 36 items and 11 patient safety culture dimensions, as well as 
displaying these results by pharmacy characteristics (pharmacy type, 
number of locations, average number of prescriptions dispensed per 
week, etc.) and respondent characteristics (staff position, tenure, and 
hours worked per week).
    Data submitted by pharmacies are also used to give each pharmacy 
its own customized survey feedback report that presents the pharmacy's 
results compared to the latest comparative database results. If a 
pharmacy submits data more than once, its survey feedback report also 
presents trend data, comparing its previous and most recent data.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the 
respondents' time to participate in the database. An estimated 100 POCs 
from community pharmacies and 50 POCs from hospital pharmacies, each 
representing an average of 3 individual pharmacies, will complete the 
database submission steps and forms. Completing the eligibility and 
registration form will take about 5 minutes. The Pharmacy Site 
Information Form is completed by all POCs for each of their pharmacies 
(150 x 3 = 450 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 209 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 $11,222 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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Eligibility and Registration Form...............             150               1            5/60              13
Data Use Agreement..............................             150               1            3/60               8
Pharmacy Site Information Form..................             150               3            5/60              38
Data Files Submission...........................             150               1               1             150
                                                 ---------------------------------------------------------------
    Total.......................................              NA              NA              NA             209
----------------------------------------------------------------------------------------------------------------


                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                     Number of
                    Form name                      respondents/    Total burden   Average hourly    Total cost
                                                       POCs            hours        wage rate *       burden
----------------------------------------------------------------------------------------------------------------
Eligibility and Registration Form...............             150              13          $53.69            $698
Data Use Agreement..............................             150               8           53.69             430
Pharmacy Site Information Form..................             150              38           53.69           2,040
Data Files Submission...........................             150             150           53.69           8,054
                                                 ---------------------------------------------------------------
    Total.......................................              NA             209              NA          11,222
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* Based on the weighted average hourly wage in community pharmacies for 100 General and Operations Managers (11-
  1021; $49.26) and 50 General and Operations Managers (11-1021; $62.56) obtained from the May 2015 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) and NAICS 622000--Hospitals (located at http://www.bls.gov/oes/current/naics3_622000.htm).

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

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comments will become a matter of public record.

Sharon B. Arnold,
Deputy Director.
[FR Doc. 2016-27705 Filed 11-17-16; 8:45 am]
 BILLING CODE 4160-90-P