Research Determination

Print Date: 11/8/23

Title:

OneLab REACH (Rapid Education And Capacity-Building Hub)

Project Id:

0900f3eb82187e98

Accession #:

CLSR-TWDB-6/12/23-87e98

Project Contact:

Breyanna M Mikel

Organization:

CLSR/DLS/TWDB

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

11/11/2023

Estimated Completion Date:

11/10/2026

CDC/ATSDR HRPO/IRB Protocol #:
0920-1154

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

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 REACH is a targeted and customized learning management system specifically for laboratory and testing
professionals. OneLab# REACH offers free public health emergency response relevant education and trainings resources,
Continuing Education Units (including P.A.C.E.#), and downloadable materials. OneLab REACH LMS provides trainings and
workforce development resources to laboratory professionals that work in communities that are underserved, work with people who
are part of minority groups and populations, and work within communities that have very limited access to timely, relevant, and
accurate resources. OneLab REACH has the short-term goal of strengthening interconnections between clinical, public health, and
CDC laboratory education and training professionals to collectively support rapid, large-scale responses (e.g., MPox, COVID-19,
etc.) Further, it has the long-term goal of establishing a sustainable learning community to equip the clinical laboratory workforce
with necessary tools, resources, and networks. The evaluation of OneLab REACH aims to determine how well the LMS system is
performing, how the resources and materials are accessed and used by laboratory and testing professionals, and whether OneLab
REACH is meeting both the short-term and long-term goals.

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
As the Training and Workforce Development Branch (TWDB) continues to expand the OneLab Initiative, it is apparent that with
growth that there is a need to assess and track the progress that each of the elements are making and their respective impact and

Goals/Purpose

Objective:

outcome. OneLab REACH is no different in that it#s imperative to collect, measure, and analyze various data and metrics that help
demonstrate the importance and value of the LMS for clinical laboratories, public health laboratories, and the testing community.
Particularly, in addressing and meeting the needs and demands that the laboratory and testing workforce have. The evaluation of
OneLab REACH has the overarching goal and evaluation question to address how OneLab REACH has increased access to
laboratory trainings. The additional goals and supportive evaluation questions consist of 1) determining the extent to which
laboratory professionals access and use OneLab REACH, 2) determining the features that users have found most helpful on
OneLab REACH when looking for a training course or resource, and 3) determining the extent to which the user#s experience can
be tailored and improved to meet the needs of laboratory professionals.
OneLab REACH as a platform has the ability to increase access to laboratory-focused trainings to members of the laboratory
community. The objective of the evaluation is to gain additional knowledge and insight about learners# knowledge, skills, attitudes,
and behaviors around accessing and using the platform for training and workforce development needs.

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?:

Yes

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

General US Population

Tags/Keywords:

Laboratories ; Laboratory Personnel

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:

Survey

Methods:

Several surveys will be disseminated around learners# user experience with the OneLab REACH platform and evaluation surveys
around the different resources that live on OneLab REACH.
1. LMS Profile #Name, email address, password for LMS access; each learner can only access their own information. PII collected
# i.e., names, email addresses, and the associated passwords are administrative data. 2. Single Sign-Up (SSU) Survey
Demographic section of the SSU is at least 15 questions long; however, the length of the survey may vary based on the skip logic of
questions and how learners respond to the survey. For example, if the learner is a student, performs diagnostic testing, or performs
point-of-care testing, then they will be asked several more questions related to the specific type of work that they do. The purpose of
the SSU Survey is to reduce the number of sign-up surveys that learners must take for each of the elements of OneLab. The SSU
Survey will only be taken once by learners. The anticipated number of new subscribers/respondents is 5,000 for the SSU. The SSU
will take approximately 20 minutes to complete. The estimated burden time for the SSU is 1,667 hours per year. 3.Learning Data #
Pre-/post-test scores and continuing education (CE) certificates linked to individual LMS Profile; each learner can only access their
own information. No behavioral data captured. 4. Anonymous Post-Course Evaluation # Predictors of Effectiveness. The postcourse evaluation survey will capture information about the effectiveness and relevancy of the course to the learner. Answers not

Collection of Info, Data or Biospecimen:

Expected Use of Findings/Results and their impact:

Could Individuals potentially be identified based on
Information Collected?

linked to individual LMS Profiles. The anticipated number of learners that will complete the post-course evaluation will be 2,000.
Learners, on average, take 5 of TWDB#s courses. Each survey will take approximately 3 minutes to complete. The estimated
burden time is 500 hours per year. 5. OneLab REACH User Experience Survey # Optional and anonymous survey where learners
provide feedback about their experience using OneLab REACH. Answers not linked to individual LMS Profiles. This survey will be
administered on a rolling basis once a month. The survey will take approximately 2 minutes to complete. The estimated number of
respondents is about 1,000 in a year. The estimated burden time is 33 hours. 6. OneLab REACH Post-Event Survey # Survey that
is offered for recordings and live webinars that are hosted on OneLab REACH that learners will complete to provide feedback on the
content and speakers of the event. 7. OneLab REACH Mini Lesson and Job Aids Surveys # Survey that is offered and optional for
learners to take after using a mini lesson and/or job aid on the OneLab REACH platform. The survey asks about the mini lesson#s
and/or job aid#s content, its helpfulness, and its usefulness. 8. OneLab REACH Post Event P.A.C.E.# Survey # Required survey
where learners provide feedback about their experience completing a OneLab REACH training for P.A.C.E. # credit. The anticipated
number of learners that will complete the post-course evaluation will be 6,000. Learners, on average, take 5 of TWDB#s P.A.C.E. #
eligible courses. Each survey will take approximately 3 minutes to complete. The estimated burden time is 1,500 hours per year.
Evaluation data will be reported publicly in anonymized, aggregated summary form. Identifying information will not be released to
the public. Post-training survey data and job characteristics survey data will be used to better understand users of OneLab REACH,
their needs, and their feedback on available tools, resources, and trainings.
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

HSC Attributes
Program Evaluation

Yes

Quality Assurance / Improvement

Yes

Budget Amount

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

CITI Good Clinical
Practice Exp. Date

Staff Role

Email

Phone

Organization

09/18
/2026

CoInvestigator

oev8@cdc.
gov

4044985815

TRAINING AND WORKFORCE
DEVELOPMENT BRANCH

Breyanna
Mikel

08/31
/2026

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:

11/11/23

Proposed Data Collection End Date:

11/10/26

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 to address gaps identified in the SSU survey, the course evaluation surveys, the job aid and mini lessons
surveys. 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
except for the distribution list populated from demographic entrance survey data # which will not be linked to any of the other data.
Access to survey data will be limited to authorized users and will be password protected in order to promote data security and
compliance. Supporting documentation will include a data dictionary.

Plans for Archival and Long Term Preservation:

Spatiality

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

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

Current

CDC Staff
Member and
Role

Date Added

Description

Supporting Info Type

Supporting Info

Zirger_Jeffrey
(wtj5)
ICRO Reviewer

08/15/2023

NOA 0920-1154 (2023)

Notice of Action

NOA 0920-1154.pdf

Mikel_Breyanna
(qpq5)
Project Contact

06/12/2023

The business continuity plan for
OneLab REACH.

Other-Enter new type

09_REACH 2021 BCP Waiver_sw.pdf

06/12/2023

Demographic section of the SSU is
at least 15 questions long;
however, the length of the survey
may vary based on the skip logic
of questions and how learners
respond to the survey. For
example, if the learner is a student,
performs diagnostic testing, or
performs point-of-care testing, then
they will be asked several more
questions related to the specific
type of work that they do. The
purpose of the SSU Survey is to
reduce the number of sign-up
surveys that learners must take for
each of the elements of OneLab.
The SSU Survey will only be taken
once by learners.

Other-Survey

FINAL_OneLab SSU Survey Clean_v2.docx

Mikel_Breyanna
(qpq5)
Project Contact

Current

Mikel_Breyanna
(qpq5)
Project Contact

06/12/2023

This attachment is a data
collection instrument that asks
about the mini lesson#s and/or job
aid#s content, its helpfulness, and
its usefulness. # Survey that is
offered and optional for learners to
take after using a mini lesson and
/or job aid on the OneLab REACH
platform.

Current

Mikel_Breyanna
(qpq5)
Project Contact

06/12/2023

This file is the SORN/privacy act
system notice document for
OneLab REACH.

Other-Enter new type

14_REACH 2021 SORN 09-20-0161.pdf

Current

Mikel_Breyanna
(qpq5)
Project Contact

06/12/2023

This file is the privacy impact
assessment (PIA) form for OneLab
REACH.

Other-Enter new type

13_REACH 2021 ERAP PIA.pdf

06/12/2023

This data collection instrument is a
survey required for learners
interested in obtaining P.A.C.E.
credit. Required survey where
learners provide feedback about
their experience completing a
OneLab REACH training for P.A.C.
E. # credit.

Other-Survey

FINAL_OneLab REACH PACE Post-Event Survey.docx

Other-Survey

FINAL OneLab REACH Course Evaluation Survey.docx

Current

Mikel_Breyanna
(qpq5)
Project Contact

Other-Survey

FINAL OneLab Mini Lesson and Job Aid Surveys.docx

Current

Mikel_Breyanna
(qpq5)
Project Contact

06/12/2023

This data collection instrument will
collect information related to
Predictors of Effectiveness. The
post-course evaluation survey will
capture information about the
effectiveness and relevancy of the
course to the learner. Answers not
linked to individual LMS Profiles.

Current

Mikel_Breyanna
(qpq5)
Project Contact

06/12/2023

This file is the authorization to
operate (ATO) form for OneLab
REACH.

Other-Enter new type

15_Centers-for-Disease-Control-and-Prevention-REACH2422-CA-09-22-2022-105.pdf

Current

Mikel_Breyanna
(qpq5)
Project Contact

06/12/2023

This file is the baseline system
information (BSI) documentation
for OneLab REACH.

Other-Enter new type

11_REACH 2021 ERAP BSI_FINAL.docx

Current

Mikel_Breyanna
(qpq5)
Project Contact

06/12/2023

This file is the authorization to test
(ATT) form for OneLab REACH.

Other-Enter new type

10_REACH 2021 ERAP ATT_sw.pdf