How to Submit a Sample - Vectra · (-5˚C) 24 HOURS 2b. FILL 6. ... • Use a Vectra kit box with pre-applied FedEx label • Place 1 frozen ice pack in the bottom of the foam cooler

©2019, Myriad Genetics, Inc. All Rights Reserved / MKT-00440 7-19

How to Submit a Sample

Collection, Processing & Shipping Instructions

©2019, Myriad Genetics, Inc. All Rights Reserved

Submitting a Vectra Sample: Step 1Call Vectra Customer Service to request a customized Test Requisition Form (TRF)


Required Information for the Test Requisition Form (TRF)

• Section 1. Ordering Physician Account Information

- Required: Ordering provider name, NPI number, Clinic Information



• Section 2. Patient Information -Required:Patient’slastname,firstname, address, date of birth, gender, phone number

• Section 3. Billing Information - Required: a copy of both sides of patient’s insurance card or complete insurance information - Note: All group, subscriber, and claims mailing address must be legible

• Patient needs to sign and check for financial information and resources associated with the Vectra test



• Section 4. ICD-10 Code - Required: ICD-10 Code requires all valid codes be derived from M05 or M06 category -Unspecifiedcodesarenot acceptable

Note: Regardless of whether listed herein, you should refer to the ICD-10 Code Book when making your diagnosis and report only the diagnosis code(s) you have independently determined are appropriate based on documentation in your patient medical record.



• Section 6. Statement of Medical Necessity

- Required: Physician’s Signature


Submitting a Vectra Sample: OptionsInOfficeBloodDraworContracted3rdParty Laboratory Services


Phlebotomy Options

• In-Office - Phlebotomist can draw and prepare

specimen for shipping using provided kits (No reimbursement will be made for specimens collected via In-OfficePhlebotomists)

• Contracted 3rd Party Laboratory Services (e.g. LabCorp)


Submitting a Vectra Sample: Step 2 - ForIn-OfficeBloodDraws • Call Vectra Customer Service to request

Vectra Kits with pre-paid return labels


x1Shipping Box Foam Insulated Cooler Ice Pack

Biohazard Zip-Style Bag SST Tube Barcode

x1 x2

x1 x1 x1

Single Kit Contents


Phlebotomist Completes the Following

• Specimen Collection & Processing Date - Specimen collection date and time • Patient Specimen Barcode Label - Large barcode label should include patient’s

nameandDOBandbeaffixedtoSST-AmatchingbarcodeshouldbeaffixedtotheTRF

(theSSTmusthaveatleastTWOmatchingidentifiersthatcorrelatetotheTRF)


Submitting a Vectra Sample: Step 3 - ForIn-OfficeBloodDraws• Instructions on sample processing (detailed slides to follow):

• Draw 4 ML of whole blood in Serum Separating Tube (SST)

• Invert SST 5X

• Let clot upright for 30 minutes to 2 hours

•Centrifuge for 15 minutes


Specimen Processing Instructions Overview

1. FREEZE 2a. LABEL

23˚F (-5˚C)

24HOURS

2b. FILL

6. SHIP

Freeze PolarPack® FoamBricks (-5°C/23°F) for a minimum of 24 hours prior to use.

Specimens must be properly processed, refrigerated andreceived by Crescendo Bioscience, Inc. a Myriad Genetics Lab within 7 days. For specimen pickup call FedEx at 1-800-463-3339*

Write the patient’s DOB, first and last name on the Patient Specimen Barcode Label. Place the Patient Specimen Barcode Label lengthwise onto the Serum Separating Tube (SST). Fill the SST tube with 4 mL of blood.

4 mL

3a. INVERT 3b. CLOT

Gently mix the SST tube by inverting at least 5 times. Allowthe SST tube to clot upright at room temperature (20-25°C) for no less than 30 minutes and no more than 2 hours.

5X

68-77˚F (20-25˚C)

30 MINTO 2 HRS

4. CENTRIFUGE

Centrifuge for 15 minutes (1100-1300 RCF at room temperature) in a swinging bucket or fixed angle centrifuge.

68-77˚F (20-25˚C)

15 MIN

1100 TO 1300

7 DAYS

5. PACKAGE

Insert specimen(s) into protective sleeve then into the biohazard bag. Place and seal a test requisition form(s) into side pocket of bag. Up to 5 specimens may be packaged into a single cooler between frozen Polar Packs.

UP TO 5 SPECIMENS

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Note: Specimens must be received by Crescendo Bioscience Inc., a Myriad Company within 168 hours (7 days) of collection or the order will be canceled due to sample viability



•ShoulduseanyswingingbucketorfixedangleCentrifugethat can spin at 1100 to 1300 RCF at room temperature - Popular/Commonly used: Drucker Horizon

model 614B

• For maintenance and calibration of your centrifuge, refer to the Centrifuge product literature - Also, you can contact Centrifuge vendor for

a list of local technical support available for maintenance and calibration

•Remembertomixthespecimengentlybyinverting5 times, then allowing the specimen to clot at room temperature for 30-120 minutes, BEFORE centrifugation

• Centrifuge for 15 minutes at 1100 to 1300 RCF in a swingingbucketorfixedanglecentrifugeatroomtemperature

4. CENTRIFUGE

Centrifuge for 15 minutes (1100-1300 RCF at room temperature) in a swinging bucket or fixed angle centrifuge.

68-77˚F (20-25˚C)

15 MIN

1100 TO 1300


Submitting a Vectra Sample: Step 4a - InOfficeBloodDraws • Verify you have a useable sample: Hemolyzed Sample


Centrifuging Specimens

• Hemolysis Scale

- It is acceptable to test moderately hemolyzed specimens all the way up to and including the ~550 mg/dL color visual level on the BD Relative Hemolysis Scale chart


Submitting a Vectra Sample: Step 4a -InOfficeBloodDraws • Verify you have a useable sample: Unspun and

Partial Spun vsCompletely Spun –the gel of the SST must completely move to the center of the tube


Centrifuging Specimens: Spinning Scale

Unspun Bad Sample

Partially spun Bad Sample

Completely spun Good Sample


Submitting a Vectra Sample: Step 5 - InOfficeBloodDraws • Packing the sample with frozen ice bricks

•ShippingthesampleovernightviaFedEx


Preparing Specimens for Shipping

•UseaVectrakitboxwithpre-appliedFedExlabel

• Place 1 frozen ice pack in the bottom of the foam cooler

• Place each specimen in its own white absorbent sleeve and biohazard bag -Youmayshipupto5specimensperVectraKitBox

• Place the TRF (with attached demographic sheet if applicable and copy of insurance card) in the side pouch of the biohazard bag

• Place the 2nd ice pack on top of the specimen(s) and close the cooler lid

5. PACKAGE

Insert specimen(s) into protective sleeve then into the biohazard bag. Place and seal a test requisition form(s) into side pocket of bag. Up to 5 specimens may be packaged into a single cooler between frozen Polar Packs.

UP TO 5 SPECIMENS


Vectra Sample Post-Collection Checklist *Requirements for Vectra Samples

VectraBarcodeLabelonSSTTubeandTestRequisitionForm(confirmbarcodematches)

Specimen collection Date & Time (on TRF) completed (phlebotomist and/or lab to complete this at time of draw)

Completed paperwork needs to be placed in Vectra Kit along with wrapped specimen and Ice Packs

Specimen must be received by Crescendo Bioscience Inc., a Myriad Company within 7 days of collection date. If the shipment has not been received within 7 days, the order will be canceled due to sample viability


Shipping Vectra to Crescendo Bioscience Inc., a Myriad Genetic Company

•Forspecimenpickup,simplycallFedExat1-800-463-3339 and say:

“ I would like to schedule a pick-up for a pre-paid return package.”

Note: Specimens must be received by Crescendo Bioscience Inc., a Myriad Company within 7 days of collection or the order will be canceled due to sample viability


VectraIsPerformedinaCLIA-certified Clinical Laboratory

Local Blood Draw Pre-Paid Shipping Bioinformatics

Vectra Report

MultiplexProteinAnalysis

Treating Physician Reviews Results & Integrates with Other Data

Patient Counseling & Patient Management Adjustments


Documents

How to Submit a Sample - Vectra · (-5˚C) 24 HOURS 2b. FILL 6. ... • Use a Vectra kit box with pre-applied FedEx label • Place 1 frozen ice pack in the bottom of the foam cooler