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GenIC Clearance for CDC/ATSDR
Formative Research and Tool Development
OMB Control No. 0920-1154
Expiration Date: 03/31/2026

CDC OneLab Formative Evaluation


March 25, 2025





Supporting Statement B









Contact: Amber Eberhardt 
Health Scientist/Program Evaluator, TWDB 
Division of Laboratory Systems
Centers for Disease Control and Prevention 
1600 Clifton Road, NE 
Atlanta, Georgia 30333 
Phone: (571) 484-8131
Email: [email protected] 
Table of Contents
B. Collections of Information Employing Statistical Methods	2
B.1. Respondent Universe and Sampling Methods	2
B.2. Procedures for the Collection of Information	3
B.3. Methods to maximize Response Rates and Deal with No Response	3
B.4. Tests of Procedures or Methods to be undertaken	4
B.5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data	4
List of Attachments	4
	Attachment 1: OneLab Key Informant Semi-Structured Interview	4
	Attachment 2: OneLab Focus Group Discussion	4
	Attachment 3: Emails for OneLab Qualitative Evaluation participants	4
	Attachment 4: Participant Intake Form	4
	Attachment 5: Focus Group Consent Form	4
	Attachment 6: Human Subjects Research Determination	4



B. Collections of Information Employing Statistical Methods
The collection does not involve statistical methods and the purpose of the collection is not to make statistical generalizations beyond the particular respondents.
B.1. Respondent Universe and Sampling Methods

For the CDC OneLab Qualitative data collection, the Data and Evaluation project team will be recruiting participants based on their level of involvement in CDC OneLab and the five out of 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. Specifically, 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. At least 25% of participants will be recruited from resource-limited areas. Additional inclusion criteria to select participants for all of the elements can be found in their respective sections below: 

OneLab REACH and VR inclusion criteria 
    • OneLab REACH 
        ◦ All participants have to complete at least three courses for the past six months. 
        ◦ Participants need to be identified as active user of OneLab REACH for the past six months.  
        ◦ Must be a laboratory or testing working professional.  

    • OneLab VR 
        ◦ All recruited participants need to complete at least one or two OneLab VR scenarios/micro-learning courses.  
        ◦ Or Participants need to engage at least 30 minutes in OneLab VR open play for the past six months.  
        ◦ Must be a laboratory or testing working professional.  


OneLab Network and TEST inclusion criteria  
    • All participants must attend at least one event in the last three months.  
    • Must be a laboratory or testing working professional.  

OneLab Summit inclusion criteria 
    • All participants must have attended the most recent OneLab Summit.
    • Must be a laboratory or testing working professional.
 

B.2. Procedures for the Collection of Information

The Data and Evaluation team will select 25 key informant interview and another 25 focus group participants from the OneLab user lists who meet the study eligible criteria. Upon identified participants, the project team will send them an initial study invitation email to explain the purpose of the study and ask for their willingness and availability to join the study. Confirmed participants will also receive 2-3 follow-up email reminders to join the scheduled focus group or key informant interviews. 


Project results from this survey will be reported publicly in anonymized, aggregated summary form (i.e. summary report) 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. Data collected and generated by this evaluation 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.

B.3. Methods to maximize Response Rates and Deal with No Response

The Data and Evaluation team will first conduct research on participants’ available and preferred meeting time. The project team will then send 2-3 follow-up emails and meeting reminders to encourage participants to join the key informant interviews and focus group interviews. 
B.4. Tests of Procedures or Methods to be undertaken

Both the key informant interview guide and focus group interview guide will be pilot-tested among staff in the Data and Evaluation team. 
B.5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data
No individuals were consulted on statistical aspects of the design. The individuals collecting and/or analyzing data include: 
Lead Investigator: Amber Eberhardt, Health Scientist/ Program Evaluator, Center for Laboratory Systems and Response, Division of Laboratory Systems (DLS), Centers for Disease Control and Prevention (CDC)

Co-Investigators: 
    • Breyanna Mikel, Health Scientist/ Program Evaluator, Center for Laboratory Systems and Response Division of Laboratory Systems (DLS), Centers for Disease Control and Prevention (CDC)

List of Attachments
    • Attachment 1: OneLab Key Informant Semi-Structured Interview  
    • Attachment 2: OneLab Focus Group Discussion 
    • Attachment 3: Emails for OneLab Qualitative Evaluation participants  
    • Attachment 4: Participant Intake Form  
    • Attachment 5: Focus Group Consent Form  
    • Attachment 6: Human Subjects Research Determination