[Federal Register Volume 76, Number 228 (Monday, November 28, 2011)]
[Pages 72929-72931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-30269]



Agency for Healthcare Research and Quality

Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Agency for Healthcare Research and Quality, HHS.

ACTION: Notice.


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 
    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.

Clearance Officer, (301) 427-1477, or by email at 


Proposed Project

    Medical Office Survey on Patient Safety Culture Comparative 
    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
                                                                Number of
                Form name                     Number of       responses per       Hours per       Total burden
                                          respondents/POCs         POC            response            hours
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
    Total...............................               600                NA                NA               816

    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
                                              Number of       Total burden     Average hourly      Total cost
                Form name                 respondents/POCs        hours          wage rate *         burden
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
    Total...............................               600               816                NA            34,779
* 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
          Cost component                Total cost      Annualized cost
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
    Total.........................            930,000            310,000

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,
[FR Doc. 2011-30269 Filed 11-25-11; 8:45 am]