[Federal Register Volume 83, Number 142 (Tuesday, July 24, 2018)]
[Notices]
[Pages 35002-35004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15751]


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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 Database.''
    This proposed information collection was previously published in 
the Federal Register on May 10th, 2018 and allowed 60 days for public 
comment. AHRQ did not receive substantive comments. 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 23, 2018.

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 <a href="/cdn-cgi/l/email-protection#a4ebedf6e5fbd7d1c6c9cdd7d7cdcbcae4cbc9c68ac1cbd48ac3cbd2"><span class="__cf_email__" data-cfemail="67282e3526381412050a0e14140e080927080a054902081749000811">[email protected]</span></a> (attention: AHRQ's desk officer).

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports 
Clearance Officer, (301) 427-1477, or by email at 
<a href="/cdn-cgi/l/email-protection#1b7f7469726835777e7d70746c726f615b5a53494a35737368357c746d"><span class="__cf_email__" data-cfemail="3c58534e554f1250595a57534b5548467c7d746e6d1254544f125b534a">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

Proposed Project

Medical Office Survey on Patient Safety Culture 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. 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 Survey on Patient Safety Culture with OMB approval (OMB 
No. 0935-0131; Approved July 5, 2007).
    The survey is designed to enable medical offices to assess provider 
and staff perspectives 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 staff perceptions of how often medical offices 
have problems exchanging information with other settings as well as 
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 website (located at https://www.ahrq.gov/sops/quality-patient-safety/patientsafetyculture/medical-office/index.html).
    The AHRQ Medical Office SOPS Database consists of data from the 
AHRQ Medical Office Survey on Patient Safety Culture and may include 
reportable, non-required supplemental items. Medical offices in the 
U.S. can voluntarily submit data from the survey to AHRQ, through its 
contractor, Westat. The Medical Office SOPS Database (OMB No. 0935-
0196, last approved on August 25, 2015) was developed by AHRQ in 2011 
in response to requests from medical offices interested in tracking 
their own survey results. Those organizations submitting data receive a 
feedback report, as well as a report of the aggregated, de-identified 
findings of the other medical offices submitting data. These reports 
are used to assist medical office staff in their efforts to improve 
patient safety culture in their organizations.
    Rationale for the information collection. The Medical Office SOPS 
and the Medical Office SOPS Database support AHRQ's goals of promoting 
improvements in the quality and safety of health care in medical office 
settings.

[[Page 35003]]

The survey, toolkit materials, and database results are all made 
publicly available on AHRQ's website. 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.
    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 Medical 
Office SOPS Database; OMB No. 0935-0196, last approved on August, 25, 
2015.
    This database will:
    (1) Present results from medical offices that voluntarily submit 
their data,
    (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 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 
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 collect basic demographic 
information about the medical office and initiate the registration 
process.
    (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 provide privacy assurances.
    (3) Medical Office Site Information Form--The purpose of the site 
information form, also completed by the medical office POC, is to 
collect background characteristics of the medical office. This 
information will be used to analyze data collected with the Medical 
Office SOPS survey.
    (4) Data Files Submission--POCs 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. 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 or a survey vendor who 
contracts with a medical office to collect their data. POCs submit data 
on behalf of 35 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.
    Survey data from the AHRQ Medical Office Survey on Patient Safety 
Culture are used to produce three types of products:
    (1) A Medical Office SOPS Database Report that is made publicly 
available on the AHRQ website (see Medical Office User Database 
Report);
    (2) Individual Medical Office Survey Feedback Reports that are 
customized for each medical office that submits data to the database; 
and
    (3) Research data sets of individual-level and medical office-level 
de-identified data to enable researchers to conduct analyses. All data 
released in a data set are de-identified at the individual-level and 
the medical office-level.
    Medical offices will be invited to voluntarily submit their Medical 
Office SOPS survey data to the database. AHRQ's contractor, Westat, 
then cleans and aggregates the data to produce a PDF-formatted Database 
Report displaying averages, standard deviations, and percentile scores 
on the survey's 38 items and 10 patient safety culture 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).
    The Database Report includes a section on data limitations, 
emphasizing that the report does not reflect a representative sampling 
of the U.S. medical office population. Because participating medical 
offices will choose to voluntarily submit their data into the database 
and therefore are not a random or national sample of medical offices, 
estimates based on this self-selected group might be biased estimates. 
We recommend that users review the database results with these caveats 
in mind.
    Each medical office that submits its data receives a customized 
survey feedback report that presents their results alongside the 
aggregated results from other participating medical offices.
    Medical offices use the Medical Office SOPS, Database Reports, and 
Individual Medical Office Survey Feedback Reports for a number of 
purposes, to:
    <bullet> Raise staff awareness about patient safety;
    <bullet> Elucidate and assess the current status of patient safety 
culture in their medical office;
    <bullet> Identify strengths and areas for patient safety culture 
improvement;
    <bullet> Evaluate trends in patient safety culture change over 
time; and
    <bullet> Evaluate the cultural impact of patient safety initiatives 
and interventions.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the 
respondents' time to participate in the database. An estimated 70 POCs, 
each representing an average of 35 individual medical offices each, 
will complete the database submission steps and forms. Each POC will 
submit the following:
    <bullet> Eligibility and registration form (completion is estimated 
to take about 3 minutes).
    <bullet> Data Use Agreement (completion is estimated to take about 
3 minutes).
    <bullet> Medical Office Information Form (completion is estimated 
to take about 5 minutes).
    <bullet> Survey data submission will take an average of one hour.
    The total burden is estimated to be 283 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 $14,880 annually.

[[Page 35004]]



                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                     Number of       Number of
                    Form name                      respondents/    responses per     Hours per     Total burden
                                                       POCs             POC          response          hours
----------------------------------------------------------------------------------------------------------------
Eligibility/Registration Form...................              70               1            3/60               4
Data Use Agreement..............................              70               1            3/60               4
Medical Office Information Form.................              70              35            5/60             205
Data Files Submission...........................              70               1               1              70
                                                 ---------------------------------------------------------------
    Total.......................................              NA              NA              NA             283
----------------------------------------------------------------------------------------------------------------


                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of
                    Form name                      respondents/    Total burden   Average hourly    Total cost
                                                       POCs            hours        wage rate *       burden
----------------------------------------------------------------------------------------------------------------
Registration Form...............................              70               4          $52.58            $210
Data Use Agreement..............................              70               4           52.58             210
Medical Office Information Form.................              70             205           52.58          10,779
Data Files Submission...........................              70              70           52.58           3,680
                                                 ---------------------------------------------------------------
    Total.......................................              NA             213              NA          14,880
----------------------------------------------------------------------------------------------------------------
* Mean hourly wage rate of $52.58 for Medical and Health Services Managers (SOC code 11-9111) was obtained from
  the May 2016 National Industry-Specific Occupational Employment and Wage Estimates, NAICS 621100--Offices of
  Physicians located at https://www.bls.gov/oes/current/oes119111.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's 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.

Francis D. Chesley, Jr.,
Acting Deputy Director.
[FR Doc. 2018-15751 Filed 7-23-18; 8:45 am]
BILLING CODE 4160-90-P


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