Cordstat 19

Test Code
14306


CPT Codes
80307 (x19)

Includes
Presumptive positive initial tests are reflexed to a Mass Spectrometric Confirmation assay.


Preferred Specimen
6-inch segment of umbilical cord


Instructions
*Informed consent: No*

Important: Prevent the umbilical cord and specimen from coming in contact with ethanol-based liquids or vapors previous to and during the collection process. This includes ethanol-based hand sanitizer and alcohol prep pads.

1.) Pinch the specimen between the finger and thumb, then run your fingers down the specimen 3-4 times to drain excess blood. Discard any excess blood.
2.) Rinse the exterior/outside of the specimen with normal saline or an equivalent rinsing solution.
3.) Pat the specimen dry and place in the specimen container.
4.) Place newborn's id number on the specimen container (newborn name is optional). The ID number may be the medical record number, hospital laboratory accession number, or any other unique identifying number of the collection facility's choosing. The hospital patient ID label/sticker may be utilized to satisfy this step.

5.) Fill out the chain-of-custody and control form. Please verify that the pre-printed company information is correct in the client section of the form.
a) Place the newborn's ID number on the chain-of-custody and control form in the patient/donor section. A hospital patient ID label/sticker may be utilized to satisfy this step.
b) Mark the specimen type box for Cordstat®.
c) Mark the test(s) requested to be performed in the test(s) requested section. Check all that apply.

6.) The specimen container must be sealed with a tamper-evident seal. Match/verify the newborn's information on the chain-of-custody and control form with the newborn's information on the specimen container. Peel off one of the bar-coded, tamper-evident seals located at the bottom of the chain-of-custody and control form. Place the bar-coded, tamper-evident seal over the cap. Failure to place a tamper-evident seal over the cap will result in a rejected specimen.
7.) Initial and date the tamper-evident specimen seal(s).
8.) Print, sign and date in the collector/processor certification section of the chain-of-custody and control form.
9.) Place the original, white copy (copy 1 lab copy) of the chain-of-custody and control form in the large pouch of the plastic specimen bag provided.
10.) Place the sealed specimen container in the small pouch of the specimen bag and seal the specimen bag.
11.) Place the sealed specimen bag in the transport box provided. Close the box.
12.) Place the specimen box in an appropriate courier transport overwrap.
13.) Contact your courier for pick-up. Specimens should be kept refrigerated in a secure area until they are ready to be shipped.


Transport Container
See instructions


Transport Temperature
Room temperature


Specimen Stability
Room temperature: 7 days
Refrigerated: 21 days
Frozen: 1 year


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Mismatched id's • No identification • Profile not indicated • Improper collection • Damaged/leaked • Broken security seal • Quantity not sufficient • No requisition form • Missing collection date • Failure to place tamper-evident seal over the cap


Methodology
Immunoassay • LDTD-MS/MS • Liquid Chromatography/Tandem Mass Spectrometry • Gas Chromatography Mass Spectrometry

FDA Status
Test developed and characteristics determined by United States Drug Testing Laboratories, Inc. See Compliance Statement on our website http://www.usdtl.com/compliance_statement

Setup Schedule
Set up: Daily; Report available: 1 day of receipt of specimen in lab; (Further confirmation requires: 1-2 days)


Reference Range
Negative




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.