Project Determination_2024 Spring Clinical Laboratory Partners Forum Meeting (24EN)

Project Determination

2024 Spring Clinical Laboratory Partners Forum Meeting

Project ID:	0900f3eb82344243
Accession #:	CLSR-DLS-3/22/24-44243
Project Contact:	Latesha Whisby
Organization:	CLSR/DLS
Status:	Pending Clearance
Intended Use:	Project Determination
Estimated Start Date:	03/22/24
Estimated Completion Date:	04/05/24
CDC/ATSDR HRPO/IRB Protocol#:
OMB Control#:	0920-1050

Description

Priority

Standard

Date Needed

04/05/24

Determination Start Date

03/22/24

Description

This information collection is being conducted to examine the effectiveness of the May 22, 2024, Meeting for the Clinical Laboratory Partners Forum (CLPF), a group of laboratory professional, standard-setting, and accreditation organizations that meets periodically to share information and focus on clinical and public health laboratory partnerships, particularly as related to preparedness and response, laboratory workforce, biosafety, and patient safety and diagnostic excellence. The Division of Laboratory Systems at the Centers for Disease Control and Prevention, who periodically convenes this group or organizations, is seeking feedback from participants to assess the effectiveness and relevance of the May 22, 2024, meeting, in an effort to ensure that meetings of this group are managed effectively and focused on issues of current importance to clinical and public health laboratories.

IMS/CIO/Epi-Aid/Lab-Aid/Chemical Exposure Submission

No

IMS Activation Name

Not selected

Select the primary priority of the project

Not selected

Select the secondary priority(s) of the project

Not selected

Select the task force associated with the response

Not selected

CIO Emergency Response Name

Not selected

Epi-Aid Name

Not selected

Lab-Aid Name

Not selected

Assessment of Chemical Exposure Name

Not selected

Goals/Purpose

DLS is seeking feedback from participants to assess the effectiveness and relevance of the May 22, 2024, meeting in an effort to ensure that the meetings of this group are managed effectively and focused on issues of current importance to clinical and public health laboratories.

Objective

This survey will collect participant feedback to assess 1) How useful CLPF is to participants, 2) the effectiveness of the topics and format, and 3) the planning and organization of future meetings.

Does your project measure health disparities among populations/groups experiencing social, economic, geographic, and/or environmental disadvantages?

No

Does your project investigate underlying contributors to health inequities among populations/groups experiencing social, economic, geographic, and/or environmental disadvantages?

No

Does your project propose, implement, or evaluate an action to move towards eliminating health inequities?

Yes

Activities or Tasks

New Collection of Information, Data, or Biospecimens

Target Population to be Included/Represented

Other-Clinical laboratory professionals

Tags/Keywords

Clinical Laboratory Services

CDC's Role

Activity originated and designed by CDC staff, or conducted at the specific request of CDC, or CDC staff will approve study design and data collection as a condition of any funding provided

Method Categories

Survey

Methods

Quantitative and qualitative data collection using an online survey will be conducted with clinical and public health laboratory professionals. Thematic analysis will be performed for the data collected to inform the effectiveness and relevance of the 2024 Clinical Laboratory Partners Forum. No biospecimens will be collected.

Collection of Info, Data, or Bio specimens

Quantitative and qualitative data will be collected using an online survey. No personally identifiable information will be collected. Descriptive and thematic analysis will be conducted. All results will be in aggregate form, without attribution to any person, to preserve the anonymity of respondents.

Expected Use of Findings/Results and their impact

The end results will be a comprehensive report that summarizes survey data findings and key takeaways. DLS will conduct quantitative and qualitative analysis to describe findings and generate themes based on collected data. DLS staff will receive briefings on the report, which will be used to inform future planning and organization strategies for CLPF.

Could Individuals potentially be identified based on Information Collected?

No

Funding
Funding Type	Funding Title	Funding #	Original Fiscal Year	# of Years of Award	Budget Amount

HSC Review

HSC Attributes

Program Evaluation

Yes

Additional Ethical Considerations

The division plans to do an anonymous survey of the participants of the May 22, 2024 Clinical Laboratory Partners Forum (CLPF) to examine the usefulness and effectiveness of this CDC organized activity. No PII will be collected. This information collection project is not intended to develop or contribute to generalizable knowledge so does not meet the definition of research as defined under 45 CFR 46.102(l).

Regulation and Policy

Do you anticipate this project will need IRB review by the CDC IRB, NIOSH IRB, or through reliance on an external IRB?

No

Will you be working with an outside Organization or Institution? No

Institutions
Institution	FWA #	FWA Exp. Date	Funding	Funding Restriction Amount

Institution	Funding Restriction Percentage	Funding Restriction Reason	Funding Restriction has been lifted

Institution	Institution Role(s)	Institution Project Title	Institution Project Tracking #	Prime Institution

Institution	Regulatory Coverage	IRB Review Status

Institution	Registered IRB	IRB Registration Exp. Date	IRB Approval Status

Institution	IRB Approval Date	IRB Approval Exp. Date	Relying Institution IRB

Staff
Staff Member	SIQT Exp. Date	Citi Biomedical Exp. Date	Citi Social and Behavioral Exp. Date	Citi Good Clinical Exp. Date	Staff Role	Email	Phone #	Organization/ Institution
QiZheng	08/30/2026				Project Coordinator	[email protected]	404-498-6258	DIVISION OF LABORATORY SYSTEMS

DMP
Proposed Data Collection Start Date	05/22/24
Proposed Data Collection End Date	06/14/24
Proposed Public Access Level	Non-Public
Reason for not Releasing the Data	Other- Data will be for CDC and DLS internal use to inform the meeting's effectiveness.
Public Access justification	Information will be used by CDC and DLS internally and will not be released publicly.
How Access Will Be Provided for Data	The anonymous, deidentified data will be retained on DLS internal SharePoint site so that only authorized staff are permitted access. The data will be stored with adequate security measures in compliance with CDC requirements and adherence with federal records requirements.
Plans for archival and long-term preservation of the data	Plans for Archival and Long-term Preservation of the Data

Spatiality (Geographic Location)
Country	State/Province	County/Region

Determinations
Determination	Justification	Completed	Entered By & Role
HSC: Does NOT Require HRPO Review	Not Research / Other 45 CFR 46.102(l) Program Evaluation	03/29/24	Leaumont_Collette (chf3) CIO HSC
PRA: PRA Applies		03/29/24	Leaumont_Collette (chf3) OMB/PRA