Project summary

Print Date: 11/6/24

Title:

Development of Biosafety Community of a Biosafety Community of Practice Based on the ECHO Methodology

Project Id:

0900f3eb8246906f

Accession #:

CLSR-QSSB-10/11/24-6906f

Project Contact:

Aufraconselia C Araujo

Organization:

CLSR/DLS/QSSB

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

10/11/2024

Estimated Completion Date:

12/31/2026

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

Determinations

0920-1050

Determination

Justification

Completed

Entered By & Role

10/22/24

Leaumont_Collette (chf3) CIO HSC

10/22/24

Leaumont_Collette (chf3) OMB/PRA

10/23/24

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

Description & Funding
Description
Priority:

Standard

Priority Justification:
CDC Priority Area for this Project:

Not selected

Determination Start Date:

10/11/24

Description:

Clinical and public health laboratories play an essential role to protect the health of individuals and their communities. Laboratory
quality and safety standards and procedures are required to conduct accurate and timely testing without jeopardizing the health of
laboratory employees, staff, the environment, or the public. Lessons learned from past outbreaks and discussions with the
Association of Public Health Laboratories# Biosafety and Biosecurity Committee highlighted opportunities for improvement in
biosafety areas including risk assessment and management; specimen collection, processing, and storage; equipment and
instrumentation safety; personal protective equipment; waste management; and employee burnout. In 2024, the focus is on
implementation of biorisk Management in laboratories (ISO 35001) and in 2025 the focus will be on other general biosafety topics
such as Best Practices in Biosafety and Biosecurity for Bioterrorism Response and The role of Artificial Intelligence in Biosafety.

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

The purpose of this project is to develop a biosafety community of practice (CoP) based on the Extension for Community Healthcare
Outcomes (ECHO) methodology to address biosafety challenges in clinical and public health laboratories.

Objective:

# Discuss biosafety challenges among clinical laboratory professionals # Decrease professional isolation by fostering collaborations
and sharing of laboratory safety expertise # Promote application of best safety practices and advance culture and practice of
laboratory safety

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:

No Human Population ; Other - Laboratory Professionals

Tags/Keywords:

Biosafety ; Risk Assessment ; Laboratories ; Project ECHO

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:

This project#s objectives include bringing together clinical and public health laboratory professionals, biosafety officers, quality
managers, laboratory directors, scientists, and technicians in order to 1) discuss biosafety challenges among clinical laboratory
professionals, 2) decrease professional isolation by fostering collaborations and sharing of laboratory safety expertise, and 3)
promote application of best safety practices and advance culture and practice of laboratory safety. CDC/DLS will accomplish the
project#s goals through development of Biosafety Community of Practice based on ECHO Methodology. This community of practice
will bring together the above personnel from multiple locations and facilities to meet at regularly schedule times to present deidentified cases, experiences, and/or lessons learned in regard to the application of biosafety across various laboratory settings.
Case-based discussion are supplemented with a short didactic presentation to provide context, increase knowledge, and share
evidence-based practices. Following each group discussion, surveys will be used to evaluate the current session and improve future
ones. ECHO participants will be identified through collaboration with the Association for Public Health Laboratories (APHL) and
invited via email. Participants in ECHO session engage a community of peers to present cases for discussion and
recommendations. Through sharing, the community offers support, guidance, and feedback. As a result, participants increase
knowledge and competency, reduce professional isolation, and increase the application of best safety practices.

Collection of Info, Data or Biospecimen:

The OLSR/DLS Biosafety ECHO project lead will facilitate ECHO sessions with non-federal stakeholders: subject matter experts
(SMEs), low-resource (e.g., rural) laboratories, state/local public health laboratory professionals, commercial laboratories, and
laboratory professional organizations (e.g., American Biological Safety Association). We will conduct a total of eleven sessions and
will invite no more than 100 participants per session. The participants will be invited by OLSR/DLS based on laboratory safety
experience in clinical and public health laboratories and willingness to discuss the challenges encountered. During ECHO sessions,
a laboratory SME will deliver a brief didactic presentation followed by a case study on the topic and participants will discuss the
laboratory safety challenges, share their experience and propose solutions. Participants will be informed that ECHO sessions will be
recorded. Audio and transcript of each session will be available at the DLS ECHO webpage. Data collection will occur through three
surveys (during ECHO session registration, immediately after each session, and six-month after sessions one and six) for session
evaluation and to assess participants# potential application of knowledge acquired post ECHO sessions. Personally identifiable
information (PII) or protected health information (PHI) is not collected in any form during ECHO sessions or the three surveys.

Expected Use of Findings/Results and their impact:

Findings will demonstrate participation and engagement of state/local public health laboratory professionals to discuss biosafety
challenges, increase professional networking, improve use of best safety practices and advance culture and practice of laboratory
safety. Audio and a transcript of each session will have PII removed and be made available at the DLS ECHO webpage. Summary
of feedback obtained post-sessions will be compiled in aggregated report without any identifiable information about the participants
or their organizations. Lessons learned and key findings from session evaluation will be used to inform the development of
presentations internal to CDC programs, and potentially be presented, at professional conferences or disseminated as s a peerreviewed manuscript.

Could Individuals potentially be identified based on
Information Collected?

No

Funding

Funding yet to be added .....

HSC Review

HSC Attributes
Program Evaluation

Regulation and Policy

Yes

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? Yes
Institution
University of Niew Mexico Health Sciences Project ECHO

FWA #

FWA Exp Date

Funding
Non-Financial Support

Funding Restriction Amount

Institution

Funding Restriction Percentage

Funding Restriction Reason

Funding Restriction has been Lifted

University of Niew Mexico Health Sciences Project ECHO

Institution

Institution Role(s)

Institution Project Title

University of Niew Mexico Health Sciences Project
ECHO

Providing Technical
Assistance

Project ECHO Biosafety Laboratory
Challenges

Institution

Regulatory Coverage

University of Niew Mexico Health Sciences Project ECHO

IRB Review is Not Required

Institution

Registered IRB

Institution Project Tracking
#

Prime
Institution

IRB Review Status

IRB Registration Exp. Date

IRB Approval Status

IRB Approval Exp. Date

Relying Institution IRB

University of Niew Mexico Health Sciences Project ECHO

Institution
University of Niew Mexico Health Sciences Project ECHO

IRB Approval Date

Staff
Staff
Member

SIQT
Exp.
Date

Alicia
Violette

07/17
/2026

Ashley
Marshall

07/10
/2026

George
Xiang

Sabrina
DeBose

CITI
Biomedical
Exp. Date

CITI Social &
Behavioral Exp. Date

Staff Role

Email

Phone

Organization

CoInvestigator

sho6@cdc.
gov

4044980080

DIVISION OF
LABORATORY
SYSTEMS

CoInvestigator

isg6@cdc.
gov

4046397202

DIVISION OF
LABORATORY
SYSTEMS

10/04
/2026

CoInvestigator

obn1@cdc.
gov

4044985423

DIVISION OF
LABORATORY
SYSTEMS

08/23
/2026

Project
Coordinator

sof7@cdc.
gov

4047182062

QUALITY AND SAFETY
SYSTEMS BRANCH

02/25/2022

CITI Good Clinical
Practice Exp. Date

CITI Good Laboratory
Practice Exp. Date

Data
DMP
Proposed Data Collection Start Date:

10/11/24

Proposed Data Collection End Date:

12/31/26

Proposed Public Access Level:

Non-Public

Non-Public Details:
Reason For Not Releasing Data:

Other - The demographics information and session evaluation feedback will not be released to protect participants privacy and
confidentiality. Answers will be anonymized and reported only in aggregate form.

Public Access Justification:

Reason for Restricting the Data: The demographics information and session evaluation feedback from the participants will not be
released for public to protect their privacy and confidentiality. Respondents# individual answers will be anonymized and reported
publicly only in aggregate form.

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 and
will not be linked to any of the other identifiable data. Access to questionnaire data will be limited to authorized users and will be
password protected in order to promote data security and privacy. Supporting resources will include a data dictionary.

The anonymous, deidentified survey data will be initially retained on DLS#s password protected Qualtrics account. The data will be
downloaded onto CDC internal servers and deleted from Qualtrics at least every two months throughout the network#s existence.
The data will be stored with adequate security measures in adherence to federal records requirements.

Plans for Archival and Long Term Preservation:

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

Current

CDC Staff Member
and Role

Date Added

Description

Supporting Info Type

Supporting Info

Zirger_Jeffrey (wtj5)
ICRO Reviewer

10/23/2024

NOA 0920-1050 (2022)

Notice of Action

NOA 0920-1050_2022.pdf

Araujo_Aufraconselia
A. (aka8)
Project Contact

10/21/2024

Survey Instruments

Other

02_Biosafety_2025
ECHO_Survey_Screenshots_Compiled_AUG2024.
docx

Araujo_Aufraconselia
A. (aka8)
Project Contact

10/21/2024

Request for Approval Form

Other

01_Fast_Track_GenIC_Request Template for 2025
ECHO Biosafety_AUG2024.docx

Araujo_Aufraconselia
A. (aka8)
Project Contact

10/21/2024

Survey Invitation Email Messages

Other

03_Biosafety_2025 ECHO
Biosafety_Emails_AUG2024.docx

Araujo_Aufraconselia
A. (aka8)
Project Contact

10/11/2024

PAPERWORK REDUCTION ACT
SUBMISSION WORKSHEET

Data Collection Form

01497 Form_Fast Track GenIC Part 2
Worksheet_2025 Project ECHO Biosafety
Community of Practice.pdf