VDSCP Data Submission Form

NCEH DLS Laboratory Quality Assurance Programs

Att 3e. VDSCPEnroll&DataReturn

VDSCP Data Submission Form (Assay Manufacturer)

OMB: 0920-1389

Document [pdf]
Download: pdf | pdf
Form Approved
OMB No. 0920-xxxx
Exp. Date xx/xx/20xx

CDC Standardization Programs 
Participant Contact Form 

Enrollment in (mark with a “X”) 
____Hormone Standardization (HoSt) – Testosterone   (Reportable Range in ng / dL: ____________________) 
____Hormone Standardization (HoSt) – Estradiol           (Reportable Range in pg/mL: ____________________) 
____Vitamin D Standardization Certification Program (VDSCP) 
____Other (please add description)________________________________ 
       

A. DIRECTOR AND LABORATORY:
Director’s Title: 
First Name: 
Last Name: 
E‐mail: 
Phone: 
Fax: 

     

Lab Name:
Department:
Address 1:
Address 2:
City:
Zip Code:
Country: 

State:

B. PRIMARY LABORATORY CONTACT (send correspondence to):
Title: 
Lab Name:
First Name: 
Department:
Last Name: 
Address 1:
E‐mail: 
Address 2:
Phone: 
City:
Fax: 
Zip Code:
C. SHIP SAMPLES TO (if different from primary laboratory contact):
Title: 
Lab Name:
First Name: 
Department:
Last Name: 
Address 1:
E‐mail: 
Address 2:
Phone: 
City:
Fax: 
Zip Code:
D. BILLING INFORMATION
Lab Name: 
Lab ID*: 
Phone: 
Fax: 

Address 1:
Address 2:
City:
Zip Code:

E. SHIPPING INFORMATION
FedEx Account No.: 

State: 

 

State: 

 

State: 

 

VAT/Tax ID 

Laboratory Director’s Signature: 

Date: 
SUBMIT ELECTRONIC COPIES TO 

Centers for Disease Control and Prevention 
Division of Laboratory Sciences 
4770 Buford Highway, NE  F25 
Atlanta, Georgia  30341‐3724 
Phone (770) 488‐7391;  
Email: [email protected] 

*Lab ID:

(assigned by CDC)
CDC HOST document 10.13.2011 

CDC estimates the average public reporting burden for this collection of information as 30 minutes for enrollment and 60 minutes per response to
submit data, including the time for reviewing instructions, searching existing data/information sources, gathering and maintaining the data/
information needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a currently valid OMB Control Number. Send comments regarding this burden estimate or
any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Information Collection Review Office,
1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-xxxx).
Version 2.0.0

Assay Characteristics
Fill all applicable white fields in sections 1 ‐ 7
Analyte:
Matrix:

1. Instrument/Assay Description

Total Estradiol (E2)
Serum

Description
Laboratory's Assay Identifier (CLIA code etc.)
Choose Methodology Category:
if other:

2. Participant Information

‐‐‐‐‐ Please Select ‐‐‐‐‐

Primary Contact (First and Last):
Company/Institution:
Location:
Telephone Number:
Email:
CDC Lab ID (provided by CDC):

‐‐‐‐‐ Please Select ‐‐‐‐‐
‐‐‐‐‐ Please Select ‐‐‐‐‐
‐‐‐‐‐ Please Select ‐‐‐‐‐

E007

3. Phase Information
Volume of Serum Used Per Analysis (uL):
Analysis Time Per Sample (min):
Units used to report results:
Limit of Detection (pg/mL):
Reportable Range Min (pg/mL):
Reportable Range Max (pg/mL):
Single or Multi‐Analyte Method:
if Multi‐Analyte Method, list other analytes included:

Phase/Quarter:
Cycle/Year:
pg/mL

4. Notes/Comments
‐‐‐‐‐ Please Select ‐‐‐‐‐

5. Bench Quality Controls (one level per row)
Manufacturer

Level
1
2
3
4
5
6
7
8
9
10

Lot Number

Assigned Concentration Range (pg/mL)
Lower limit
Upper limit

6. Calibrators (one level per row)
Manufacturer:
if other:
Level
1
2
3
4
5
6
7
8
9
10
11
12

‐‐‐‐‐ Please Select ‐‐‐‐‐

Manufacturer
‐‐‐‐‐ Please Select ‐‐‐‐‐
‐‐‐‐‐ Please Select ‐‐‐‐‐
‐‐‐‐‐ Please Select ‐‐‐‐‐
‐‐‐‐‐ Please Select ‐‐‐‐‐
‐‐‐‐‐ Please Select ‐‐‐‐‐
‐‐‐‐‐ Please Select ‐‐‐‐‐
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‐‐‐‐‐ Please Select ‐‐‐‐‐
‐‐‐‐‐ Please Select ‐‐‐‐‐
‐‐‐‐‐ Please Select ‐‐‐‐‐

Name

Lot Number

Manufacturer
‐‐‐‐‐ Please Select ‐‐‐‐‐
‐‐‐‐‐ Please Select ‐‐‐‐‐
‐‐‐‐‐ Please Select ‐‐‐‐‐
‐‐‐‐‐ Please Select ‐‐‐‐‐
‐‐‐‐‐ Please Select ‐‐‐‐‐
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‐‐‐‐‐ Please Select ‐‐‐‐‐

Name

Lot Number

7. Reagents

**If Manufacturer Not Listed, Please Specify Below**

Concentration (pg/mL)

2C
5

DAY 1 ‐ Extra Volume
Fill all applicable white fields in sections 1 ‐ 3
Date of Analysis: mm
Lab ID:

dd
E007

yyyy

1. Sample Results (in pg/mL)
Replicate 1

Results (pg/mL)
NR
Replicate 2

NR

Replicate 1

Results (pg/mL)
NR
Replicate 2

NR

 Vial ID
Sample #

Replicate 1

Replicate 2

1/11
2/12
3/13
4/14
5/15
6/16
7/17
8/18
9/19
10/20

162901242SA
160125749SA
162050781SA
160001259SA
165297934SA
867613811SA
160877439SA
163631532SA
163940410SA
161009480SA

162901270SA
160515749SA
162020281SA
160147237SA
165265989SA
867609153SA
161700417SA
163630300SA
163938612SA
161009344SA

*Comments/Error Message & Explanation

2. Bench Quality Controls
Level

Lot Number

*Comments/Error Message & Explanation

1
2
3
4
5
6
7
8
9
10

3. Comments

Not Reported (NR) Legend
Code

Description

QNS
File Typeapplication/pdf
AuthorGXE7
File Modified2022-08-19
File Created2019-04-17

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