Research Determination

Print Date: 4/15/22

Title:

NCEH DLS Laboratory Quality Assurance Programs

Project Id:

0900f3eb81e1b52e

Accession #:

NCEH-DLSPB-9/30/21-dfba9

Project Contact:

Linde J Parcels

Organization:

NCEH/ATSDR/DLS/DLSPB

Status:

Pending Regulatory Clearance

Intended Use:

Project Determination

Estimated Start Date:

10/01/2021

Estimated Completion Date:

10/01/2024

CDC/ATSDR HRPO/IRB Protocol #:
OMB Control #:
2021-0086

Source System #:

Determinations
Determination

Justification

Completed

Entered By & Role

11/16/21

Davis_Stephanie I. (sgd8) CIO HSC

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Quality Assurance / Improvement

PRA:
PRA Applies

11/16/21

Davis_Stephanie I. (sgd8) CIO OMB / PRA

Description & Funding
Description
Priority:

Standard

Date Needed:

11/30/2021

Determination Start Date:

11/16/21

Description:

The CDC DLS QA programs operate out of multiple laboratories within the Division. They establish the baseline measurements and
provide calibration and/or QC samples that laboratories around the world rely on to develop and improve methods with acceptable
levels of accuracy and reliability and, in some cases, meet certain required certifications or accreditation. Laboratories use DLSdeveloped samples to test the quality and accuracy of their methods/assays. Participating laboratories enroll in the DLS QA
program that fits their needs (I.e.: external quality assurance/performance assessment, proficiency testing, accuracy-based
monitoring, or standardization/harmonization). After the laboratories receive DLS QA samples and perform their measurements,
they return test results to DLS. DLS then evaluates the data using statistical methods and reports back to the laboratories on their
analytical performance. Laboratories may receive additional technical assistance (TA)/troubleshooting to improve their method
performance as needed. DLS programs are offered at different frequencies.

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

Accuracy and reliability of laboratory tests is important to identify and to monitor exposures and health biomarkers, which in turn
improves diagnosis and treatment. Laboratories that conduct biomonitoring or test for certain environmental or nutritional chemicals
participate in quality assurance (QA) activities for many reasons: to assess internal test performance, calibrate methods to
standards among other laboratories, receive certification of proficiency to comply with certain regulations, or simply improve quality.
Participation may help a laboratory to verify the accuracy of their methods and results or ensure accurate and consistent test results
across multiple laboratories.
Collectively, these programs improve the quality of laboratory tests that measure environmental exposures and chronic disease

Objective:

biomarkers (including nutritional indicators and hormones) to better inform critical patient care and public health decisions for an
expansive host of health outcomes such as rare heritable disorders in newborns, endocrine disorders, maternal health and risk of
birth defects, bone, kidney and cardiovascular disease, cancers (including breast cancer), diabetes, thyroid and hormone
dysregulation.

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:

All Work Onsite at CDC Facilities

Target Populations to be Included/Represented:

Other - Not Applicable

Tags/Keywords:

DLS 2021-0086

CDC's Role:

CDC is the sole institution conducting activity

Method Categories:

QA/QI

Methods:

There are thirteen (13) DLS QA programs conducted by the following five DLS branches. These programs provide materials and
test result analysis to laboratories for the purpose of improving and/or standardizing test performance. # Clinical Chemistry Branch
(5): Lipid Standardization Program (LSP) for Clinical Biomarkers; Cholesterol Reference Method Laboratory Network (CRMLN);
Accuracy-based Laboratory Monitoring Programs (AMP); Hormone Standardization (HoST) Program; Vitamin D Standardization
Certification Program (VDSCP) # Nutrition Biomarkers Branch (3): Vitamin A Laboratory # External Quality Assurance (VITALEQA); Quality Assurance Method Performance Verification (MPV) for Folate Microbiologic Assay; Quality Assurance Method
Performance Verification (MPV) for Micronutrients # Organic Analytical Toxicology Branch (1): Biomonitoring Quality Assurance
Support Program (BQASP) # Inorganic Radiation and Analytical Toxicology Branch (3): Proficiency in Arsenic Speciation (PAsS)
Program; Ensuring the Quality of Urinary Iodine Procedures (EQUIP); Lead and Multielement Proficiency (LAMP) Testing Program
# Newborn Screening and Molecular Biology Branch (1): Newborn Screening and Quality Assurance Program (NSQAP) All thirteen
(13) CDC quality assurance programs help improve the accuracy and reliability of tests performed by laboratories in patient care,
research, commercial and public health settings. They also help to make measurement results among research studies and among
clinical laboratories more comparable.
Data will be collected electronically via email and online forms; data reporting forms are returned to DLS via Excel templates, PDFs,
or web platforms. Laboratories that participate in the various programs are domestic and international and can include public health

Collection of Info, Data or Biospecimen:

laboratories, research laboratories, commercial laboratories, and diagnostic test manufacturers. They can be associated with
medical schools, hospital systems, state health departments, universities/academic institutions, ministries of health, nonprofit
organizations.

Expected Use of Findings/Results and their impact:

Could Individuals potentially be identified based on
Information Collected?

Collectively, these programs improve the quality of laboratory tests that measure environmental exposures and chronic disease
biomarkers (including nutritional indicators and hormones) to better inform critical patient care and public health decisions for an
expansive host of health outcomes such as rare heritable disorders in newborns, endocrine disorders, maternal health and risk of
birth defects, bone, kidney and cardiovascular disease, cancers (including breast cancer), diabetes, thyroid and hormone
dysregulation.
No

Funding

Funding Type

Funding Title

Funding #

CDC Funding Intramural

Project Funding and Partners

HSC Review

HSC Attributes
Quality Assurance / Improvement

Yes

Regulation and Policy
Do you anticipate this project will be submitted to
the IRB office
Estimated number of study participants

No

Original Budget Yr

# Years Award

Budget Amount
1762845.00

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

Linde
Parcels

09/13/2024

Yan Ding

03/01/2024

CITI Biomedical
Exp. Date

07/02/2024

CITI Social & Behavioral
Exp. Date

CITI Good Clinical Practice
Exp. Date

Staff Role

Email

Phone

Organization

Project
Officer

404-4985892

DLS POLICY BRANCH

Project
Officer

770-4887934

DIVISION OF LABORATORY
SCIENCES

Data
DMP
Proposed Data Collection Start Date:

9/30/21

Proposed Data Collection End Date:

9/30/24

Proposed Public Access Level:

Non-Public

Non-Public Details:
Reason For Not Releasing Data:

Other - QA/QC

Public Access Justification:

QA/QC

How Access Will Be Provided for Data:

Project data is not public health data

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...

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date