project-summary

Print Date: 8/2/23

Title:

Clinical Laboratory Partners Forum Meeting Evaluation Survey 2023

Project Id:

0900f3eb821c4c1a

Accession #:

CLSR-DLS-7/25/23-c4c1a

Project Contact:

Kunthea Nhim

Organization:

CLSR/DLS

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

09/25/2023

Estimated Completion Date:

11/30/2023

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

OMB Control #:

Determinations
Determination

Justification

Completed

Entered By & Role

7/26/23

Hummel_Kimberly B. (kbh2) CIO HSC

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

7/26/23

Hummel_Kimberly B. (kbh2) OMB/PRA

7/28/23

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Standard

Determination Start Date:

07/25/23

Description:

This information collection is being conducted to examine the effectiveness of the September 25, 2023 Meeting for the Clinical
Laboratory Partners Forum (CLPF), a group of laboratory professional, standard-setting, and accreditation organizations that meets
periodically to share information and focus on clinical and public health laboratory partnerships, particularly as related to
preparedness and response, laboratory workforce, biosafety, and patient safety and diagnostic excellence. The Division of
Laboratory Systems at the Centers for Disease Control and Prevention, who periodically convenes this group or organizations, is
seeking feedback from participants to assess the effectiveness and relevance of the September 25, 2023, meeting, in an effort to
ensure that meetings of this group are managed effectively and focused on issues of current importance to clinical and public health
laboratories.

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

DLS is seeking feedback from participants to assess the effectiveness and relevance of the September 25, 2023 meeting in an
effort to ensure that the meetings of this group are managed effectively and focused on issues of current importance to clinical and
public health laboratories.

Objective:

This survey will collect participant feedback to assess 1) How useful CLPF is to participants, 2) the effectiveness of the topics and
format, and 3) the planning and organization of future meetings.

Does this project include interventions, services, or

No

policy change work aimed at improving the health of
groups who have been excluded or marginalized and
/or decreasing disparities?:
Project does not incorporate elements of health
equity science:

Yes

Measuring Disparities:

Not Selected

Studying Social Determinants of Health (SDOH):

Not Selected

Assessing Impact:

Not Selected

Methods to Improve Health Equity Research and
Practice:

Not Selected

Other:

Not Selected

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

Other - Clinical laboratory professionals

Tags/Keywords:

Clinical Laboratory Services

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:

Quantitative and qualitative data collection using an online survey will be conducted with clinical and public health laboratory
professionals. Thematic analysis will be performed for the data collected to inform the effectiveness and relevance of the 2023
Clinical Laboratory Partners Forum. No biospecimens will be collected.

Collection of Info, Data or Biospecimen:

Quantitative and qualitative data will be collected using an online survey. No personally identifiable information will be collected.
Descriptive and thematic analysis will be conducted. All results will be in aggregate form, without attribution to any person, to
preserve the anonymity of respondents.

Expected Use of Findings/Results and their impact:

The end results will be a comprehensive report that summarizes survey data findings and key takeaways. DLS will conduct
quantitative and qualitative analysis to describe findings and generate themes based on collected data. DLS staff will receive
briefings on the report, which will be used to inform future planning and organization strategies for CLPF.

Could Individuals potentially be identified based on
Information Collected?

Funding

No

Funding yet to be added .....

HSC Review

HSC Attributes
Program Evaluation

Yes

Regulation and Policy
Do you anticipate this project will be submitted to
the IRB office

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

Kunthea
Nhim

02/15/2024

CITI Biomedical
Exp. Date

CITI Social & Behavioral
Exp. Date

CITI Good Clinical Practice
Exp. Date

Staff Role

Email

Phone

Organization

Program
Lead

xmh8@cdc.
gov

404-5021139

DIVISION OF LABORATORY
SYSTEMS

Data
DMP
Proposed Data Collection Start Date:

9/26/23

Proposed Data Collection End Date:

11/30/23

Proposed Public Access Level:

Non-Public

Non-Public Details:
Reason For Not Releasing Data:

Other - Data will be for CDC and DLS internal use to inform the meeting's effectiveness.

Public Access Justification:

Information will be used by CDC and DLS internally and will not be released publicly.

How Access Will Be Provided for Data:

The anonymous, deidentified data will be retained on DLS internal SharePoint site so that only authorized staff are permitted
access. The data will be stored with adequate security measures in compliance with CDC requirements and adherence with federal
records requirements.

Plans for Archival and Long Term Preservation:

Plans for Archival and Long-term Preservation of the Data.

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

CDC Staff
Member and
Role

Date Added

Description

Supporting Info Type

Supporting Info

Zirger_Jeffrey
(wtj5)
ICRO Reviewer

07/28/2023

NOA 0920-1050 (2022)

Notice of Action

NOA 0920-1050_2022.pdf

Nhim_Kunthea
(xmh8)
Project Contact

07/26/2023

This is the PRA worksheet for the
GenIC we used in the previous
year with updates on number of
respondents for this year.

Paperwork Reduction Act Form

04_Part 2 Worksheet 2022 CLPF Meeting Survey_09-252023.pdf

Nhim_Kunthea
(xmh8)
Project Contact

07/26/2023

This is email communications that
will be used to reach out to the
respondents.

Other

03_Invitation to participate September 25 2023 CLPF
meeting evaluation survey_Final.docx

Nhim_Kunthea
(xmh8)
Project Contact

07/26/2023

This is the Fast Track GenIC form
that we have used in the previous
year.

Paperwork Reduction Act Form

01_Fast_Track_GenIC_Request_2023.9.25 CLPF Meeting
Survey_Clean Final.docx

Nhim_Kunthea

Current

(xmh8)
Project Contact

07/25/2023

Screenshots of online survey
instruments.

Data Collection Form

02_CLPF Meeting Evaluation Survey_2023.09.25 in
Qualtrics.docx