Tech-only, Leukemia/Lymphoma Evaluation

Test Code
91346


CPT Codes
88184, 88185 (x21)<br>*** Restricted Use *** This code is available to Client 58719 ONLY. **<br>** This test is not available for New York patient testing **

Includes
Test may reflex to: Tech-only, 1 Additional Marker; Tech-only, 2 Additional Markers or Tech-only, 3 Additional Markers
Use of this code requires:
(1) Prequalification of the signout pathologist(s) for use of Quest Diagnostics flow cytometry tech-only testing services.
(2) A Query Tool login for the signout pathologist(s) through their client account.
(3) Access to the web data portal on the signout pathologist's computer system and ability to view flow cytometry data in the FCS Express file format.

If an order is received and the client does not meet the above criteria, the client will be contacted to clarify their order.
Contact Oncology Services (866-677-0742) for further information on the qualification process described above.


Preferred Specimen

4 mL whole blood collected in an EDTA (lavender-top), sodium heparin (green-top) tube or ACD-A (yellow-top) tube or

3 mL bone marrow collected in an EDTA (lavender-top), sodium heparin (green-top) tube or ACD-A (yellow-top) tube or

>0.3 cm of fresh tissue in a sterile plastic container with RPMI 1640 enriched with FBS (10%FBS RPMI)



Minimum Volume
3 mL whole blood • 1 mL bone marrow


Other Acceptable Specimens
Bone marrow: Pediatric heparin tube • Any tissue or body fluid


Instructions
Whole blood and bone marrow:
The tube must be kept at room temperature and shipped to the lab immediately.

Tissue:
Any tissue type is acceptable. Tissue size is dependent upon leukocyte cellularity. Ship tissue in a sterile plastic container with RPMI 1640 enriched with FBS (10% FBS RPMI). Absolutely no fixative should be added. Refrigerate and ship immediately.

Body fluids:
Any body fluid is acceptable. Sample size is dependent upon cellularity of the sample. Place fluid in sterile plastic container. Absolutely no fixative should be added. Refrigerate and ship immediately.

Do not freeze. Send specimen to testing lab for viability determination. Do not reject.

Note: Additional markers may be performed based on the pathologist review. These markers will be performed at an additional charge. Any request for additional marker (s) must be communicated to laboratory within 48 hours of submitting sample and will delay results. A clinical indication and specimen source are required with each specimen. If possible, submit CBC results with differential. Because of the critical nature of these specimens, the laboratory will attempt to process all specimens received, regardless of age of specimen. Specimens received frozen or in fixative will be rejected.


Transport Temperature
Whole blood and bone marrow: Room temperature
Tissue and body fluids: Refrigerated (cold packs)


Specimen Stability

Whole blood or bone marrow:
Room temperature: 72 hours
Refrigerated: Unacceptable
Frozen: Unacceptable

Tissue or body fluid:
Room temperature: 72 hours
Refrigerated: 72 hours
Frozen: Unacceptable



Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Specimens received frozen or in fixative


Methodology
Flow Cytometry (FC)

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
A.M.; P.M. Sets up 7 days a week.


Clinical Significance
Technical-only flow cytometry services utilizing a 22-marker panel for evaluation of blood, bone marrow, tissue or body fluids for lymphoid or myeloid disorders. Includes antibodies directed against CD2, CD3, CD4, CD5, CD7, CD8, CD10, CD11c, CD13, CD19, CD20, CD23, CD33, CD34, CD38, CD45, CD56, CD64, CD117, HLA-DR, kappa, and lambda.




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.