[Federal Register Volume 87, Number 115 (Wednesday, June 15, 2022)]
[Notices]
[Pages 36128-36129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-12828]


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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 ``Measure Dx: A Resource to Identify, Analyze, and Learn from 
Diagnostic Safety Events.''

DATES: Comments on this notice must be received by August 15, 2022.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, by email at 
<a href="/cdn-cgi/l/email-protection#e3878c918a90cd8f8685888c948a9799a3a2abb1b2cd8b8b90cd848c95"><span class="__cf_email__" data-cfemail="bbdfd4c9d2c895d7deddd0d4ccd2cfc1fbfaf3e9ea95d3d3c895dcd4cd">[email protected]</span></a>.
    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 
<a href="/cdn-cgi/l/email-protection#1f7b706d766c31737a79747068766b655f5e574d4e3177776c31787069"><span class="__cf_email__" data-cfemail="cbafa4b9a2b8e5a7aeada0a4bca2bfb18b8a83999ae5a3a3b8e5aca4bd">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: 

Proposed Project

Measure Dx: A Resource To Identify, Analyze, and Learn From Diagnostic 
Safety Events

    The Measure Dx resource (the Resource) is a modular toolkit that 
provides clinicians, quality and safety personnel, and healthcare 
organization leaders with guidance for implementing diagnostic safety 
measurement strategies for the purposes of learning and improvement. 
The Resource was developed and pilot tested (Fast Track OMB control 
number: 0935-0179) during the base year of an AHRQ contract awarded to 
the MedStar Health Research Institute and provides pragmatic 
recommendations for implementing measurement strategies that were 
identified in the AHRQ Issue Brief titled Operational Measurement of 
Diagnostic Safety: State of the Science. In particular, the Resource 
focuses on four broad measurement strategies that were assessed to be 
approaching readiness for implementation in operational settings.
    AHRQ is requesting full OMB approval to conduct a formal evaluation 
of the Resource. AHRQ would like to further develop this resource, 
expanding on the initial pilot test which qualitatively examined 
feasibility of implementing the resource, general receptivity, and 
feedback for improvement.
    This information collection has the following goal:
    1. To evaluate the Resource in order to stimulate measurement 
activities for learning and improvement and quantitatively and 
qualitatively examine:
    a. Feasibility of implementing the Resource with limited to no 
technical assistance;
    b. User experience and satisfaction with the Resource;
    c. Impact of the Resource on diagnostic safety policies or 
activities;
    d. Yield of newly detected diagnostic safety events and associated 
learning resulting from use of the Resource;
    e. Intent to sustain use of the Resource and continue with the 
diagnostic safety process following evaluation efforts.
    This information collection is being conducted by AHRQ through its 
contractor, MedStar Health Research Institute, 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 and with respect to quality measurement 
and improvement. 42 U.S.C. 299a(a)(1) and (2).

Method of Collection

    To achieve the goals of this project the following information 
collection instruments will be completed:
    (1) Organizational Characteristics Survey--designed to 
qualitatively describe the characteristics of the organizations engaged 
in evaluation (e.g., patient characteristics, practice size, and 
staffing).
    (2) Organizational Self-Assessment Survey--designed to 
qualitatively assess the organization's readiness (e.g., leadership 
support, resources, and safety culture/infrastructure) for implementing 
the Resource.
    (3) The Safer Dx Checklist--A synthesis of foundational practices 
that health care organizations can use to advance diagnostic 
excellence. The checklist provides a framework for organizations to 
conduct a self-assessment to understand the current state of diagnostic 
practices, identify areas to improve, and track progress toward 
diagnostic excellence over time.
    (4) Pre-test Evaluation Interview Protocol--designed to 
qualitatively assess the organization's current policies and structures 
related to diagnostic safety, plans for implementing the Resource, and 
initial feedback on resource materials.
    (5) Post-test Evaluation Interview Protocol--designed to 
qualitatively assess the organization's experience with implementing 
the Resource, the impact of the Resource on diagnostic safety policies 
or activities in their organization, contextual information about 
whether and how the Resource facilitated case detection, and intent to 
sustain use of the Resource following evaluation efforts.
    (6) Team Questionnaire--adapted to help organizations self-assess 
diagnostic teamwork in their organization & their diagnostic team's 
commitment to implementing the Resource.
    (7) Case Review Summary Form--designed to quantitatively and 
qualitatively summarize the diagnostic safety intelligence that 
participants have detected, analyzed, and/or learned from while 
implementing one Measure Dx strategy.
    (8) ECHO Calls Protocol--The purpose of virtual ECHO calls is to

[[Page 36129]]

foster bi-directional learning among the participating organizations, 
to check site progress during the implementation period and to 
understand ``real-time'' challenges, successes, and lessons learned. 
Standard questions for each ECHO session will be asked to foster shared 
learning and discussion. AHRQ will use the information collected to 
assess and enhance the feasibility of organizations in adopting the 
Resource to stimulate diagnostic safety measurement activities for 
learning and improvement. AHRQ's ability to publicly share a diagnostic 
measurement resource that has been scientifically validated is expected 
to be of great interest to the health care community and important in 
helping organizations measure diagnostic safety for patient safety and 
quality improvement efforts.

Estimated Annual Respondent Burden

                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
Organizational Characteristics Survey...........              10               1               1              10
Organizational Self-Assessment (from Measure Dx)              10               1              .5               5
Safer Dx Checklist..............................              10               2            0.25               5
Pre-Test Interview Protocol.....................              20               1               1              20
Post-test Evaluation Interview Protocol.........              20               1               1              20
Team Questionnaire..............................              10               2            0.25               5
Case Review Summary Form........................              10               2             .75              15
ECHO Call Protocol..............................              10               6               1              60
                                                 ---------------------------------------------------------------
    Total.......................................             100              NA              NA             140
----------------------------------------------------------------------------------------------------------------


                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                    Form name                        Number of     Total burden     hourly wage     Total cost
                                                    respondents        hours          rate *          burden
----------------------------------------------------------------------------------------------------------------
Organizational Characteristics Survey...........              10              10      \a\ $57.61          $576.1
Organizational Self-Assessment (from Measure Dx)              10               5       \a\ 57.61          288.05
Safer Dx Checklist..............................              10               5       \a\ 57.61          288.05
Pre-Test Interview Protocol.....................              20              20      \b\ 136.37        2,727.40
Post-test Evaluation Interview Protocol.........              20              20      \b\ 136.37        2,727.40
Team Questionnaire..............................              10               5       \a\ 57.61          288.05
Case Review Summary Form........................              10              15      \b\ 136.37        2,045.60
ECHO Call Protocol..............................              10              60       \a\ 57.61        3,456.60
                                                 ---------------------------------------------------------------
    Total.......................................             100             140              NA       12,397.25
----------------------------------------------------------------------------------------------------------------
* National Compensation Survey: Occupational wages in the United States May 2021 ``U.S. Department of Labor,
  Bureau of Labor Statistics.'' (https://www.bls.gov/oes/current/oes_nat.htm#29-0000).
\a\ Based on the mean wages for Medical and Health Services Managers (Code 11-9111).
\b\ Based on the mean wages for Physicians (broad) (Code 29-1210).

Request for Comments

    In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-
3520, 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.

    Dated: June 9, 2022.
Marquita Cullom,
Associate Director.
[FR Doc. 2022-12828 Filed 6-14-22; 8:45 am]
BILLING CODE 4160-90-P


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