[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)]
[Notices]
[Pages 42497-42499]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17635]


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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.
    This proposed information collection was previously published in 
the Federal Register on March 23rd, 2014 and allowed 60 days for public 
comment. No comments were 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 August 17, 2015.

ADDRESSES: Written comments should be submitted to: AHRQ's OMB Desk 
Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by 
email at [email protected] (attention: AHRQ's desk officer).
    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

Medical Office Survey on Patient Safety Culture Comparative Database

    Background on the Medical Office Survey on Patient Safety Culture 
(Medical Office SOPS). 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 Medical Office SOPS with OMB approval (OMB NO.0935-0131; Approved 
July 5, 2007).
    The survey is designed to enable medical offices to assess provider 
and staff opinions about patient safety issues, medical error, and 
error reporting. The survey includes 38 items that measure 10 
composites of patient safety culture. In addition to the composite 
items, 14 items measure how often medical offices have problems 
exchanging information with other settings and other patient safety and 
quality issues. AHRQ made the survey publicly available 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/professionals/quality-patient-safety/patientsafetyculture/medical-office/index.html). Since 
its release, the survey has been voluntarily used by hundreds of 
medical offices in the U.S.
    The Medical Office SOPS Comparative Database consists of data from 
the AHRQ Medical Office SOPS.

[[Page 42498]]

Medical offices in the U.S. are asked to submit data voluntarily from 
the survey to AHRQ, through its contractor Westat. The Medical Office 
SOPS Database (OMB NO. 0935-0196, last approved on June 12, 2012) was 
developed by AHRQ in 2011 in response to requests from medical offices 
interested in knowing how their patient safety culture survey results 
compare to those of other medical offices in their efforts to improve 
patient safety.
    Rationale for the information collection. The Medical Office SOPS 
and the Comparative Database support AHRQ's goals of promoting 
improvements in the quality and safety of health care in medical office 
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 
medical offices, to facilitate the use of these materials for medical 
office patient safety and quality improvement.
    The goal of this project is to renew 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.
    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 health care services; quality 
measurement and improvement; 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) Eligibility and Registration Form--The medical office point-of-
contact (POC) completes a number of data submission steps and forms, 
beginning with the completion of an online eligibility and registration 
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 Medical Office SOPS data to the Medical Office 
SOPS Comparative Database.
    (2) Data Use Agreement--The purpose of the data use agreement, 
completed by the medical office POC, is to state how data submitted by 
medical offices will be used and provides confidentiality assurances.
    (3) Medical Office Site Information Form--The purpose of the site 
information form is to obtain basic information about the 
characteristics of the medical offices submitting their Medical Office 
SOPS data to the Medical Office SOPS Comparative Database (e.g., number 
of providers and staff, ownership, and type of specialty). The medical 
office POC completes the form.
    (4) Data Files Submission--The number of submissions to the 
database is likely to vary each year because medical offices do not 
administer the survey and submit data every year. Data submission is 
typically handled by one POC who is either an office manager, nurse 
manager, or a survey vendor who contracts with a medical office to 
collect their data. POCs submit data on behalf of 10 medical offices, 
on average, because many medical offices are part of a health system 
that includes many medical office sites, or the POC is a vendor that is 
submitting data for multiple medical offices. After registering, if 
registrants are deemed eligible to submit data, an automated email is 
sent to authenticate the account and update the user password. Next the 
POC enters medical office information and uploads their survey 
questionnaire and submits a data use agreement. POCs then upload their 
data file(s), using the medical office data file specifications, to 
ensure that users submit standardized and consistent data in the way 
variables are named, coded, and formatted.
    Survey data from the AHRQ Medical Office SOPS are used to produce 
three types of products: (1) A Medical Office SOPS Comparative Database 
Report that is produced periodically and made publicly available on the 
AHRQ Web site (see http://www.ahrq.gov/professionals/quality-patient-safety/patientsafetyculture/medical-office/2014/index.html); (2) 
Individual Medical Office Survey Feedback Reports that are 
confidential, customized reports produced for each medical office that 
submits data to the database (the number of reports produced is based 
on the number of medical offices submitting each year); and (3) 
Research data sets of individual-level and medical office-level de-
identified data to enable researchers to conduct analyses.
    Medical offices are asked to voluntarily submit their Medical 
Office 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 38 items that measure 10 composites of patient 
safety culture, and 14 items measuring how often medical offices have 
problems exchanging information with other settings and other patient 
safety and quality issues. The report also displays these results by 
medical office characteristics (size of office, specialty, geographic 
region, etc.) and respondent characteristics (staff position).
    Data submitted by medical offices are used to give each medical 
office its own customized survey feedback report that presents the 
medical office's results compared to the latest comparative database 
results.
    Medical offices use the Medical Office SOPS, Comparative Database 
Reports and Individual Medical Office Survey Feedback Reports for a 
number of purposes, to
     Raise staff awareness about patient safety.
     Diagnose and assess the current status of patient safety 
culture in their medical office.
     Identify strengths and areas for improvement in patient 
safety culture.
     Evaluate the cultural impact of patient safety initiatives 
and interventions.
     Compare patient safety culture survey results with other 
medical offices in their efforts to improve patient safety and health 
care quality.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the 
respondents' time to participate in the database. An estimated 150 
POCs, each representing an average of 10 individual medical offices 
each, will complete the database submission steps and forms annually. 
Completing the registration form will take about 3 minutes. The Medical 
Office Information Form is completed by all POCs for each of their 
medical offices (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 291 hours.
    Exhibit 2 shows the estimated annualized cost burden based on the 
respondents' time to submit their data.

[[Page 42499]]

The cost burden is estimated to be $13,968 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/Registration Form...................             150               1            3/60               8
Data Use Agreement..............................             150               1            3/60               8
Medical Office Information Form.................             150              10            5/60             125
Data Files Submission...........................             150               1               1             150
                                                 ---------------------------------------------------------------
    Total.......................................             600              NA              NA             291
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                                   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
----------------------------------------------------------------------------------------------------------------
Registration Form...............................             150               8          $48.00            $384
Data Use Agreement..............................             150               8           48.00             384
Medical Office Information Form.................             150             125           48.00           6,000
Data Files Submission...........................             150             150           48.00           7,200
                                                 ---------------------------------------------------------------
    Total.......................................             600             816              NA          13,968
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* Mean hourly wage rate of $48.00 for Medical and Health Services Managers (SOC code 11-9111) was obtained from
  the May 2013 National Industry-Specific Occupational Employment and Wage Estimates, NAICS 621100--Offices of
  Physicians located at http://www.bls.gov/oes/2013/may/naics4_621100.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 comments will become a matter of 
public record.

Sharon B. Arnold,
Director.
[FR Doc. 2015-17635 Filed 7-16-15; 8:45 am]
 BILLING CODE 4160-90-P