Tech-only, Plasma Cell Neoplasia Follow-up Panel

Test Code
91349


CPT Codes
88184, 88185 (x6)* <br><strong>This test code is for non-New York patient testing. For New York patient testing, use test code 38191.</strong><br><strong>Client Restricted Code</strong>

Includes
Includes antibodies directed against CD20, CD38, CD45, CD56, CD138 and cytoplasmic kappa and lambda light chains.

Additional markers may be performed based on the pathologist review. These markers will be performed at an additional charge (CPT code(s): 88185 for each additional marker)


Preferred Specimen
Peripheral blood: 5 mL collected in a sodium heparin (green- top) tube, ACD-A (yellow-top) tube, or EDTA (lavender-top) tube or

Bone marrow: 4 mL collected in a sodium heparin (green-top) tube, ACD-A (yellow-top) tube, or EDTA (lavender-top) tube or

Tissue or body fluids: Any type is acceptable


Minimum Volume
3 mL peripheral blood • 1 mL bone marrow


Other Acceptable Specimens
Bone marrow: Pediatric heparin tube


Instructions
Peripheral 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. (The tissue is disaggregated into single cells so that a minimum of 50,000 cells of interest are harvested.) 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. (A minimum of 50,000 cells of interest in total volume of fluid). Place fluid in sterile plastic container. Absolutely no fixative should be added. Refrigerate and ship immediately.

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.

Do not freeze. Send specimen to testing lab for viability determination. All orders for this code from clients that do not meet the above criteria will be converted to the interpretive version of this panel.
Note: Any request for additional marker(s) must be communicated to laboratory within 48 hours of submitting sample and will delay results. Contact Oncology Services (866-677-0742) for further information on the qualification process described above.

A clinical indication and specimen source are required with each specimen. If possible, submit CBC results with differential or an EDTA tube of peripheral blood. Because of the critical nature of these specimens, the laboratory will attempt to process all specimens received, regardless of age of specimen.


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


Specimen Stability
Peripheral blood and bone marrow
Room temperature: 72 hours (May extend to 5 days depending on cell viability)
Refrigerated: Not established
Frozen: Not established

Tissue and body fluid

Room temperature: Not established
Refrigerated: 72 hours
Frozen: Unacceptable


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
See instructions


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. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Set up: Mon-Sat; Report available: 1 day


Reference Range
See Laboratory Report


Clinical Significance
Technical-only flow cytometry services utilizing a 7-marker panel for evaluation of tissues, fluids, blood or bone marrow to evaluate for the presence of a known plasma cell neoplasm. If lymphoma, leukemia, MDS or other myeloid disorders are in the diagnostic differential, please use test code 91346- Tech-only, Leukemia/Lymphoma Evaluation instead.




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.