2022-12828. 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 “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 [e-mail].

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, [phone], or by email at [e-mail].

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 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

Form name	Number of respondents	Number of responses per respondent	Hours per response	Total burden 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

Form name	Number of respondents	Total burden hours	Average hourly wage rate *	Total cost 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.