[Federal Register Volume 76, Number 228 (Monday, November 28, 2011)]
[Notices]
[Pages 72929-72931]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-30269]
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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: ``Medical Office 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 27, 2012.
ADDRESSES: Written comments should be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by email at
doris.lefkowitz@AHRQ.hhs.gov.
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
doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
Proposed Project
Medical Office 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 collection of information for the AHRQ
Medical Office Survey on Patient Safety Culture (Medical Office SOPS)
Comparative Database. The Medical Office SOPS Comparative Database
consists of data from the AHRQ Medical Office Survey on Patient Safety
Culture. Medical offices in the U.S. are asked to voluntarily submit
data from the survey to AHRQ, through its contractor, Westat. The
Medical Office 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 outpatient ambulatory health care, AHRQ developed and
pilot tested the Medical Office Survey on Patient Safety Culture with
OMB approval (OMB NO.0935-0131; Approved July 5, 2007).
[[Page 72930]]
The survey is designed to enable medical offices to assess provider
and staff opinions about patient safety issues, medical error, and
error reporting and includes 52 items that measure 12 dimensions of
patient safety culture. AHRQ released the survey to the public along
with a Survey User's Guide and other toolkit materials in December 2008
on the AHRQ Web site (located at http://www.ahrq.gov/qual/patientsafetyculture/mosurvindex.htm). Since its release, the survey
has been voluntarily used by hundreds of medical offices in the U.S.
The Medical Office 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 medical office settings. The survey, toolkit
materials, and preliminary comparative database results are all made
available to the public along with technical assistance provided by
AHRQ through its contractor at no charge to medical offices, to
facilitate the use of these materials for medical office patient safety
and quality improvement.
The goal of this project is to create the Medical Office SOPS
Comparative Database. This database will (1) Allow medical offices to
compare their patient safety culture survey results with those of other
medical offices; (2) provide data to medical offices to facilitate
internal assessment and learning in the patient safety improvement
process; and (3) provide supplemental information to help medical
offices 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 data
analysis. The database will include 52 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; quality
measurement and improvement; and database development. 42 U.S.C.
299a(a)(1), (2), and (a)(8).
Method of Collection
To achieve the goal of this project the following activities and
data collections will be implemented:
(1) Eligibility Form--The purpose of this form is to determine the
eligibility status and initiate the registration process for medical
offices seeking to voluntarily submit their MO SOPS data to the MO SOPS
Comparative Database. The medical office point of contact (POC) will
complete the form. The POC is either an office manager, nurse manager,
or a survey vendor who contracts with a medical office to collect their
data. The POC may submit data on behalf of multiple medical offices
because many medical offices are part of a larger practice with
multiple sites or part of a larger health system that includes many
medical office sites.
(2) Data Use Agreement--The purpose of this form is to obtain
authorization from medical offices to use their voluntarily submitted
MO SOPS data for analysis and reporting according to the terms
specified in the Data Use Agreement (DUA). The medical office POC will
complete the form.
(3) Medical Office Information Form--The purpose of this form is to
obtain basic information about the characteristics of the medical
offices submitting their MO SOPS data to the MO SOPS Comparative
Database (e.g., number of providers and staff, ownership, and type of
specialty). The medical office POC will complete the form.
(4) Data Submission--After the medical office POC has completed the
Medical Office Eligibility Form, the Data Use Agreement and the Medical
Office Information Form, they will submit their data from the MO SOPS
to the MO SOPS Comparative Database.
Data from the AHRQ Medical Office Survey on Patient Safety Culture
are used to produce three types of products: 1) A Medical Office SOPS
Comparative Database Report that is produced periodically and made
available to the public on the AHRQ Web site (see http://www.ahrq.gov/qual/mosurvey10/moresults10.htm); 2) Medical Office Survey Feedback
Reports that are confidential, customized reports produced for each
medical office that submits data to the database; and 3) Research data
sets of staff-level and medical office-level de-identified data that
enable researchers to conduct additional analyses.
Medical offices are asked to voluntarily submit their Medical
Office SOPS data to the comparative database. The data are then edited
to detect and correct errors and aggregated and used to produce a
Comparative Database Report that displays averages, standard
deviations, and percentile scores on the survey's 52 items and 12
patient safety culture dimensions, as well as displaying these results
by medical office characteristics (size of office, specialty,
geographic region, etc.) and staff characteristics (staff position).
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated annualized burden hours for the
medical office to participate in the Medical Office SOPS Comparative
Database. The POC completes a number of data submission steps and
forms, beginning with completion of the online Medical Office SOPS
Database Eligibility Form and Data Use Agreement, which will be
completed for 150 medical offices annually. The Medical Office
Information Form will be completed for each medical office; since each
POC represents an average of 10 medical offices, a total of 1,500
Information Forms will be completed annually, each requiring about 5
minutes to complete. The POC will submit data for all of the medical
offices they represent which will take about 4 and \1/2\ hours,
including the amount of time POCs typically spend deciding whether to
participate in the database, preparing their materials and data set for
submission to the database, and performing the submission. The total
annual burden hours are estimated to be 816.
Medical offices administer the AHRQ Medical Office 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 medical office submissions
to the database is likely to vary each year because medical offices do
not administer the survey and submit data every year. The 150
respondents/POCs shown in Exhibit 1 are based on an estimate.
Exhibit 1--Estimated Annualized Burden Hours
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Number of
Form name Number of responses per Hours per Total burden
respondents/POCs POC response hours
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Eligibility Form........................ 150 1 3/60 8
[[Page 72931]]
Data Use Agreement...................... 150 1 3/60 8
Medical Office Information Form......... 150 10 5/60 125
Data Submission......................... 150 1 4.5 675
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Total............................... 600 NA NA 816
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Exhibit 2 shows the estimated annualized cost burden based on the
respondents' time to submit their data. The cost burden is estimated to
be $34,779 annually.
Exhibit 2--Estimated Annualized Cost Burden
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Number of Total burden Average hourly Total cost
Form name respondents/POCs hours wage rate * burden
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Eligibility Form........................ 150 8 $42.62 $341
Data Use Agreement...................... 150 8 42.62 341
Medical Office Information Form......... 150 125 42.62 5,328
Data Submission......................... 150 675 42.62 28,769
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Total............................... 600 816 NA 34,779
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* Mean hourly wage rate of $42.62 for Medical and Health Services Managers (SOC code 19111) was obtained from
the May 2009 National Industry-Specific Occupational Employment and Wage Estimates, NAICS 621100--Offices of
Physicians located at http://www.bls.gov/oes/2009/may/naics4_621100.htm.
Estimated Annual Cost to the 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 for 3 years. The total cost is estimated to be $930,000.
Exhibit 3--Estimated Annualized Cost
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Cost component Total cost Annualized cost
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Project Development............... $59,715 $19,905
Data Collection Activities........ 82,107 27,369
Data Processing and Analysis...... 111,963 37,321
Publication of Results............ 111,966 37,322
Project Management................ 7,464 2,488
Overhead.......................... 556,785 185,595
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Total......................... 930,000 310,000
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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.
Dated: November 7, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011-30269 Filed 11-25-11; 8:45 am]
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