Project Determination

Print Date: 8/25/23

Title:

CDC OneLab Summit Evaluation

Project Id:

0900f3eb82188492

Accession #:

CLSR-TWDB-6/12/23-88492

Project Contact:

Amber S Broughton

Organization:

CLSR/DLS/TWDB

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

10/26/2023

Estimated Completion Date:

10/25/2025

CDC/ATSDR HRPO/IRB Protocol #:
0920-1050

OMB Control #:

Determinations
Determination

Justification

Completed

Entered By & Role

6/15/23

Hummel_Kimberly B. (kbh2) CIO HSC

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Program Evaluation
Quality Assurance / Improvement

PRA:
PRA Applies

ICRO:
PRA Applies

OMB Approval date: 6/28/22
OMB Expiration date: 6/30/25

6/15/23

Hummel_Kimberly B. (kbh2) OMB/PRA

8/15/23

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Standard

Date Needed:

06/27/2023

Determination Start Date:

06/15/23

Description:

CDC OneLab# Summit is an annual free, three-day virtual summit that connects laboratory professionals in real time to support a
unified response to laboratory training needs. OneLab Summit helps attendees improve their skills through training in technologies,
learning and development tools, and practices. The collaborative environment connects peers in laboratory education and training
to each other and to CDC. The OneLab Summit evaluation post survey will allow DLS to better understand how the OneLab Summit
cultivates and fosters learning, development, and collaboration among peers in the laboratory and testing community.

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

No

IMS Activation Name:

Not selected

Primary Priority of the Project:

Not selected

Secondary Priority(s) of the Project:

Not selected

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

The goal of CDC OneLab Summit evaluation is to better understand how the OneLab Summit cultivates and fosters learning,
development, and collaboration among peers in the laboratory and testing community.

Objective:

The objective of the OneLab Summit evaluation: 1) is to understand how the OneLab Summit improved awareness of the CDC
OneLab initiative 2) engagement among OneLab Summit attendees, 3) Sustainability of the overall OneLab Summit and 4) how
sessions and resources highlighted in the Summit were relevant, useful, and timely.

Does your project measure health disparities among No
populations/groups experiencing social, economic,

geographic, and/or environmental disadvantages?:
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?:

No

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

General US Population

Tags/Keywords:

Program Evaluation ; Laboratory Personnel

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:

Respondents to the OneLab Summit post survey will consist of testing, clinical and public health professionals as well as
representatives with responsibility for education and training within major laboratory organizations (e.g., clinical and public health
laboratories, large commercial laboratories, and manufacturers). All participants who attend the OneLab Summit will be recruited to
take the OneLab Summit post survey following the event. In 2022, we had 854 participants who attended the OneLab Summit and
we expect to have 854 participants or greater for future OneLab Summits.

Collection of Info, Data or Biospecimen:

OneLab Summit will occur annually. Following the conclusion of the OneLab Summit, attendees will complete the post survey. Each
attendee will receive an email that will include a link to a voluntary and anonymous post survey. The estimated burden time for the
OneLab Summit post survey is 142 burden hours.

Expected Use of Findings/Results and their impact:

The information collected from the OneLab Summit post survey will be used to improve future OneLab Summits. Additionally, over
time collecting this information will allow DLS to better understand the impact of OneLab Summit and how it cultivates and fosters
learning, development, and collaboration among peers in the laboratory and testing community.

Could Individuals potentially be identified based on
Information Collected?

No

Funding

Funding Type

Funding Title

Funding #

Original Budget Yr

# Years Award

Other Federal Funding

OneLab Laboratory Capacity- Building Community

BAC C6M1161101

2021

5

Budget Amount

HSC Review

HSC Attributes
Program Evaluation

Yes

Quality Assurance / Improvement

Yes

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

Estimated number of study participants

Population - Children

Protocol Page #:

Population - Minors

Protocol Page #:

Population - Prisoners

Protocol Page #:

Population - Pregnant Women

Protocol Page #:

Population - Emancipated Minors

Protocol Page #:

Suggested level of risk to subjects
Do you anticipate this project will be exempt
research or non-exempt research

Requested consent process waviers
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Alteration of authorization under HIPPA Privacy
Rule

No Selection

Requested Waivers of Documentation of Informed Consent
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Consent process shown in an understandable language
Reading level has been estimated

No Selection

Comprehension tool is provided

No Selection

Short form is provided

No Selection

Translation planned or performed

No Selection

Certified translation / translator

No Selection

Translation and back-translation to/from target
language(s)

No Selection

Other method

No Selection

Clinical Trial
Involves human participants

No Selection

Assigned to an intervention

No Selection

Evaluate the effect of the intervention

No Selection

Evaluation of a health related biomedical or
behavioral outcome

No Selection

Registerable clinical trial

No Selection

Other Considerations
Exception is requested to PHS informing those
bested about HIV serostatus

No Selection

Human genetic testing is planned now or in the
future

No Selection

Involves long-term storage of identfiable biological
specimens

No Selection

Involves a drug, biologic, or device

No Selection

Conducted under an Investigational New Drug
exemption or Investigational Device Exemption

No Selection

Institutions & Staff
Institutions
Institutions yet to be added .....

Staff
Staff
Member

SIQT
Exp. Date

Amber
Broughton

CITI Biomedical
Exp. Date

CITI Social &
Behavioral Exp. Date

Staff Role

Email

Phone

Organization

09/14
/2023

Principal
Investigator

oev8@cdc.
gov

4044985815

TRAINING AND WORKFORCE
DEVELOPMENT BRANCH

Breyanna
Mikel

05/23
/2025

CoInvestigator

qpq5@cdc.
gov

4044984095

TRAINING AND WORKFORCE
DEVELOPMENT BRANCH

Meron
Asfaha

03/02
/2026

CoInvestigator

oyi3@cdc.
gov

--

DIVISION OF LABORATORY
SYSTEMS

Data
DMP
Proposed Data Collection Start Date:

10/6/23

Proposed Data Collection End Date:

10/5/26

Proposed Public Access Level:

Public

CITI Good Clinical
Practice Exp. Date

Public Access Justification:

Project results will be reported publicly in anonymized, aggregated summary form to inform CDC and other public health and clinical
laboratory partners. Identifying information for responding laboratories and organizations will not be released to the public.

How Access Will Be Provided for Data:

Data collected and generated by this project will be transferred and stored to CDC internal servers. All data will be deidentified.
Access to survey data will be limited to authorized users and will be password protected in order to promote data security and
compliance.

Plans for Archival and Long Term Preservation:

OneLab Summit post survey will be initially retained on DLS/TWDB#s password protected SurveyMonkey account. The data will be
downloaded onto CDC internal servers and deleted from SurveyMonkey 6 months after each OneLab Summit. The data will be
stored with adequate security measures in adherence to federal records requirements.

Spatiality

Spatiality (Geographic Locations) yet to be added .....

Dataset
Dataset
Title

Dataset
Description

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date

Dataset yet to be added...

Supporting Info
Current

Current

CDC Staff
Member and Role

Date Added

Description

Supporting Info Type

Supporting Info

Zirger_Jeffrey
(wtj5)
ICRO Reviewer

08/15/2023

NOA 0920-1050 (2022)

Notice of Action

NOA 0920-1050_2022.pdf

Broughton_Amber
(oev8)
Project Contact

06/12/2023

This document is the email
communication that will be used to
disseminate the post survey link.

Other-email communication

Email_OneLab Summit Post Survey.docx

Broughton_Amber

This document is the post survey

Current

(oev8)
Project Contact

06/12/2023

that will be disseminated following
the OneLab Summit.

Other-data collection tool

FINAL_OneLab Summit Post-Event Survey.docx