Determination

Print Date: 1/7/25

Title:

CDC OneLab Formative Evaluation.

Project Id:

0900f3eb8244d66f

Accession #:

CLSR-TWDB-9/24/24-4d66f

Project Contact:

Amber S Broughton

Organization:

CLSR/DLS/TWDB

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

11/26/2024

Estimated Completion Date:

11/25/2026

CDC/ATSDR HRPO/IRB Protocol #:
OMB Control #:

Determinations

0920-1154

Determination

Justification

Completed

Entered By & Role

10/4/24

Leaumont_Collette (chf3) CIO HSC

10/4/24

Leaumont_Collette (chf3) OMB/PRA

10/8/24

Zirger_Jeffrey (wtj5) ICRO Reviewer

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Program Evaluation

PRA:
PRA Applies

ICRO:
PRA Applies

OMB Approval date: 3/3/23
OMB Expiration date: 3/31/26

Description & Funding
Description
Priority:

Standard

Date Needed:

10/18/2024

Priority Justification:
CDC Priority Area for this Project:

Not selected

Determination Start Date:

09/26/24

Description:

In 2021, CDC OneLab was developed to bridge, train, and sustain a capacity-building community among laboratory professionals
and testers to collectively support rapid, large-scale responses to public health emergencies. CDC OneLab includes the following
elements: OneLab REACH, OneLab Network, OneLab TEST, OneLab VR, OneLab Summit, OneLab Resources, and OneLab
Assessments. The seven elements together address the goal of building capacity and establishing a sustainable learning
community that equips the laboratory workforce and testing community with essential tools and resources to improve public health
and patient outcomes.

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

No

IMS Activation Name:

Not selected

Submitted through IMS Clearance Matrix:

Not selected

Primary Scientific Priority:

Not selected

Secondary Scientific Priority (s):

Not selected

Task Force Responsible:

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

It is imperative for our program to understand OneLab#s overall user experience and training and educational needs to support the
planning and creation of future OneLab resources, trainings, and events. Information gleaned from this evaluation will provide rich
insights to better understand the effectiveness of the overall OneLab and five out of seven elements (i.e., OneLab REACH, OneLab
Network, OneLab TEST,OneLab VR, and OneLab Summit).

Objective:

The objectives of this formative evaluation are to: Understand the overall OneLab user experience and users# experience of each
OneLab element to better serve the training and development needs of the laboratory testing community. Identify opportunities to
improve OneLab#s development and dissemination of relevant and timely education and training resources. Determine the extent to
which each OneLab element and OneLab as a whole contribute to the strengthening of partnerships and connections between
clinical laboratories, public health laboratories, testing communities, and CDC. Identify opportunities for real-time program
improvements for each OneLab element and OneLab as a whole. Determine the extent to which each OneLab element and the
OneLab as a whole sustain learning communities that facilitate the exchange of necessary tools, resources, and networks in order
to eventually improve public health and patient outcomes.

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?:

Yes

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:

Laboratories ; Laboratory Personnel ; Program Evaluation

CDC's Role:

CDC employees or agents will obtain data by intervening or interacting with participants ; CDC employees or agents will obtain or
use anonymous or unlinked data or biological specimens

Method Categories:

Focus Group; Individual Interviews (Qualitative)

Methods:

Qualitative data will be collected via focus group interviews and key informant interviews. Focus groups and key informant
interviews will be hosted on a virtual video conferencing platform (e.g., Zoom or Microsoft Teams). OneLab focus group interview
and key informant interview participants will include varying levels of laboratory working professionals across the US. The maximum
anticipated number of participants is 25 for the key informant interviews and 25 for the focus group interviews. The evaluation team
will identify participants based on their level of involvement of OneLab elements. Only eligible participants will be invited for either a
key informant interview or a focus group interview, which will take participants approximately 97 minutes or 107 minutes,

respectively, to complete. Both key informant interview and focus group interview questions were reviewed by evaluation experts
and pilot-tested to collect the minimum information necessary for the purposes of this formative evaluation. Participation in all key
informant interviews and focus group interviews will be voluntary. Interview data will be recorded, aggregated and deidentified.

Collection of Info, Data or Biospecimen:

The OneLab qualitative evaluation will collect data from users of the CDC OneLab Initiative, which are US laboratory professionals
and individuals who perform testing in non-laboratory settings such as point-of-care sites. All the recruited OneLab users will be
interviewed only once either in a focus group or a key Informant interview setting. For the CDC OneLab qualitative data collection,
the project team will recruit participants based on their level of involvement in five of the seven OneLab elements (i.e., OneLab
REACH, OneLab Network, OneLab TEST, OneLab VR, and OneLab Summit). The inclusion and exclusion criteria will vary based
on the group of interest. All participants will be asked about their overall experience as it relates to the initiative as a whole. For
OneLab REACH and OneLab VR, the project team will utilize the OneLab REACH course completion list to identify participants.
Furthermore, the following inclusion criteria will be used to select participants for OneLab REACH and OneLab VR. OneLab REACH
and VR inclusion criteria OneLab REACH: # Must be a laboratory professional or #tester# # an individual who performs testing in
non-laboratory settings such as point-of-care sites # Must have completed at least three courses on OneLab REACH in the past six
months OneLab VR: # Must be a laboratory professional # Must have completed at least one OneLab VR practice scenario/microlearning course or explored the OneLab VR #open play# environment for at least 30 minutes in the past six months. For OneLab
Network, OneLab Test and OneLab Summit, the project team will utilize registration and attendance lists from the most recent
OneLab event to identify the participants. The following inclusion criteria will be used to select participants for OneLab Network,
OneLab Test or OneLab Summit. One Network and Test inclusion criteria # Must be a laboratory professional or #tester# # an
individual who performs testing in non-laboratory settings such as point-of-care sites # Must have attended at least one event in the
past three months OneLab Summit inclusion criteria # Must be a laboratory professional or #tester# # an individual who performs
testing in non-laboratory settings such as point-of-care sites # Must have attended the most recent OneLab Summit

Expected Use of Findings/Results and their impact:

Explore how the overall OneLab increases access to laboratory trainings, resources, materials, and communities of practice among
laboratory professionals and the testing community in order to better meet their needs. In addition, the collected data will drive
insights to support the planning and creation of future OneLab resources, trainings, and events as well as opportunities to improve
OneLab as a whole.

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

HSC Review

Budget Amount

HSC Attributes
Program Evaluation

Yes

Regulation and Policy
Do you anticipate this project will require review by
a CDC IRB or HRPO?

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 HIPAA 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

Will you be working with an outside Organization or Institution? No
Institutions yet to be added .....

Staff
Staff
Member

SIQT
Exp.
Date

Amber
Broughton

Breyanna
Mikel

CITI
Biomedical
Exp. Date

CITI Social &
Behavioral Exp.
Date

CITI Good Clinical
Practice Exp. Date

CITI Good Laboratory
Practice Exp. Date

Staff Role

Email

Phone

Organization

09/18
/2026

Principal
Investigator

oev8@cdc.
gov

4044985815

TRAINING AND WORKFORCE
DEVELOPMENT BRANCH

08/31
/2026

CoInvestigator

qpq5@cdc.
gov

4044984095

TRAINING AND WORKFORCE
DEVELOPMENT BRANCH

Data
DMP
Proposed Data Collection Start Date:

2/3/25

Proposed Data Collection End Date:

2/3/26

Proposed Public Access Level:

Public

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 qualitative 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:

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

Dataset yet to be added...

Supporting Info

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date

Current

CDC Staff
Member and Role

Date Added

Description

Supporting Info Type

Supporting Info

Zirger_Jeffrey
(wtj5)
ICRO Reviewer

10/08/2024

NOA 0920-1154 (2023)

Notice of Action

NOA 0920-1154_2023.pdf

Current

Broughton_Amber
(oev8)
Project Contact

09/26/2024

Email template that will be used for
participant recruitment

Other-Email Template

Email Template_InterviewInvitation_IntakeFrom.docx

Current

Broughton_Amber
(oev8)
Project Contact

09/26/2024

This is the consent form that will
be administered to all participants

Consent Form

Focus Groups Consent Form .docx

Current

Broughton_Amber
(oev8)
Project Contact

09/26/2024

This document is the current draft
for the GenIC request for this
project.

Other-GenIC Request

CDC OneLab Qual Evaluation _GenIC Request_final
draft.docx

Current

Broughton_Amber
(oev8)
Project Contact

09/26/2024

This form will be used for
participant recruitment

Other-Participant Intake Form

Participant Intake Form.docx

Current

Broughton_Amber
(oev8)
Project Contact

09/26/2024

This document consists of the key
informant interview guide for this
project

Data Collection Form

Current

Broughton_Amber
(oev8)
Project Contact

09/26/2024

This document consists of the
focus group interview guide for this
project

Data Collection Form

CleanVersion_OneLab_Qual Evaluation_ Focus Group
Discussion Guide.docx

Current

Broughton_Amber
(oev8)
Project Contact

09/26/2024

This document is the supporting
statement for the GenIC request

Other-Supporting Statement B

OneLab Qual Evaluation_Supporting Statement B_Final.
docx

Current

Broughton_Amber
(oev8)
Project Contact

09/26/2024

This document is the supporting
statement for the GenIC request

Other-Supporting Statement A

OneLab Qual Evaluation_Supporting Statement A_Final.
docx

CleanVersion_OneLab_Qual Evaluation_ KII Guide.
docx