Clarient Diagnostic Services 31 Columbia, Aliso Viejo, CA 92656 888 443 3311 / Fax 888 443 3345 Hematopathology Requisition Client Information Specimen Information □ Tissue Block/Specimen included in shipment □ Tissue Block/Specimen located at third party location [information attached] Phone Location Name Specimen & Block ID* Fixative/Preservative Ordering Physician Collection Date Retrieved Date NPI # Phone Fax Treating Physician Phone Patient Information Name (Last, First) Date of Birth: mm /dd □ Male □ Female /yy Medical Record # Client represents it has obtained informed consent from patient to perform the services described herein. Billing Information □ See Attached for Patient Address and Billing Information (Required) Bill: □ Insurance □ Medicare – Part B □ Patient □ Hospital/Institution Patient Status: □ Inpatient □ Outpatient □ Non-Hospital Patient □□Comprehensive Consultation [Based upon their judgment, Clarient hematopathologists will select clinically indicated tests] Hodgkin Lymphoma Profile by MultiOmyx™ □ □□Bone Marrow Morphology Flow Cytometry Global Flow Panels □□Comprehensive Leukemia/Lymphoma □□Lymphoma/Lymphocytosis (B- & T-cell) □□Plasma Cell □□PNH, High Sensitivity, FLAER [EDTA peripheral blood preferred] Technical-Only Flow Panels □□Comprehensive Leukemia/Lymphoma □□Routine Acute Leukemia† □□Monocyte Maturation† □□B-ALL □T-ALL □□Erythroid Cells □□Megakaryocytes □□Hematogone □□Lymphoma/Lymphocytosis (B- & T-cell) □□Cytoplasmic Light Chain‡ □□Hairy Cell Leukemia‡ □□T-cell Receptor‡ □□Plasma Cell □□ZAP70 □□PNH, High Sensitivity, FLAER [EDTA peripheral blood preferred] †Clarient will only perform these panels as a part of Comprehensive Leukemia/Lymphoma panel and do not perform the panels individually. ‡Clarient will only perform these panels as a part of Lymphoma/Lymphocytosis (B- & T-cell) panel and not individually. □ Primary □ Metastasis If Metastasis, list Primary □ Bone Marrow [must provide CBC and Path Report]: Green Top(s) Purple Top(s) Core Biopsy Clot Purple Top(s) Other □ Peripheral Blood: Green Top(s) □ Fresh Tissue (Media Type required) Pleural Other □ Fluid: CSF □ FNA cell block Fixed Stained (type of stain) □ Smears: Air Dried Unstained Stained □ Slides # □ H&E □ No H&E □ Paraffin Block(s) # □ Choose best blocks □ Perform tests on all blocks If you do NOT wish to have the specimen exhausted, please check here. Date Note: Cell selection (if required) for all the molecular and FISH assays will be performed by a Clarient pathologist. FISH - Panels and Individual Probes G - Global □ New Diagnosis □ Relapse □ In Remission □ MRD □ Monitoring Bone Marrow Transplant Type: □ Autologous □ Allogeneic □ Sex Mismatch Gender of Donor (required): □ Male □ Female □ Attach all relevant clinical history, pathology/cytology report(s) and other applicable test report(s) □ Diagnosis Code/ICD-9 or 10 Code (Required) T - Technical [FISH probes on panels may be ordered individually by checking the box beside test name] GT □□ APL Panel§ • PML/RARA, t(15;17) •RARA Rearrangement (17q21) □□ AML Panel □ □ MYH11/CBFB; inv(16), t(16;16) □ □ MLL Rearrangement (11q23) □ □ RUNX1/RUNX1T1 (AML/ETO) t(8;21) □ □ PML/RARA t(15;17) □□ MDS Panel □ □Deletion 5q/Monosomy 5 □ □ Deletion 7q/Monosomy 7 □ □ Trisomy 8 □ □ Deletion 20q □N/A Eosinophilia Panel □N/AFIP1L1/PDGFRA (CHIC2, Deletion 4q12) □N/APDGFRB Rearrangement (5q33) □N/AFGFR1 Rearrangement (8q21) □□ CML Panel □ □ BCR/ABL1/ASS, t(9;22) □□ ALL Panel (Adult) □ □ BCR/ABL1/ASS, t(9;22) □ □ MLL Rearrangement (11q23) □N/A ALL Panel (Pediatric) □ □ BCR/ABL1/ASS, t(9;22) □ □ MLL Rearrangement (11q23) □N/A ETV6/RUNX1 (TEL/AML1) t(12;21) □ N/A Trisomy 4, 10, 17 □□ CLL/SLL Panel □ □ Deletion 6q □ □Deletion 11q (ATM) □ □ Deletion 13q/Monosomy 13 □ □Deletion 17p (TP53) □ □ Trisomy 12 □ □ IGH/CCND1, t(11;14) §Only Global service is performed STAT For a complete list of our test menu, please visit clarient.com Molecular (PCR) Assays Acute Myeloid Leukemia [AML] □□CBFB/MYH11 inv(16) □□CEBPA Mutation analysis □□FLT3 [ITD/D835] Mutation analysis □□IDH1 and IDH2 Mutation analysis □□KIT [exon 8 and 17] Mutation analysis □□NPM1 Mutation analysis □□PML/RARA t(15;17), quantitative □□RUNX1/RUNX1T1 (AML1/ETO) translocation t(8;21), quantitative □□WT1 Mutation analysis GT □□ Plasma Cell Myeloma Panel □ □ Deletion 13q/Monosomy 13 □ □ Deletion 17p (TP53) □ □Deletion 1p/1q Gain □ □ Trisomy 5, 9, 15 □ □ IGH/CCND1, t(11;14) □ □ IGH/FGFR3, t(4;14) □ □ IGH/MAF, t(14,16) □□ NHL Panel □ □ IGH/CCND1, t(11;14) □ □ MYC Rearrangement Myeloproliferative Neoplasms (8q24) (MPN) and Precursor Lymphoid □ □ BCL2 Rearrangement Neoplasms (B- and T- ALL) (18q21) □ □ BCL6 Rearrangement □□ABL1 Kinase domain [exon 4 to 9] Mutation analysis [TKI resistance] (3q27) □ □ IGH Rearrangement □□ABL1 T315I Mutation analysis (14q32) [TKI resistance] □ □ MALT1 Rearrangement □□BCR/ABL1, Major [p210], (18q21) Quantitative [International Scale] □□ Burkitt Panel □□BCR/ABL1, Minor [p190], •IGH/MYC, t(8;14) •MYC Rearrangement (8q24) □□ Aggressive B Cell Panel □ □ IGH/BCL2, t(14;18) □ □ BCL2 Rearrangement (18q21) □ □ BCL6 Rearrangement (3q27) □ □ IGH/MYC, t(8;14) •MYC Rearrangement (8q24) Supplemental FISH Tests N/AALK Rearrangement (2p23) for ALCL N/A API2/MALT1 t(11;18) CCND1 Rearrangement (11q13) N/AETV6 Rearrangement (12p13) N/A E2A/PBX1 (TCF3/PBX1) t(1;19) N/A EVI1 t(3;3); inv(3) (3q26) N/A X/Y for bone marrow transplant □ □ □□ □ □ □ □ □ AM □ PM Collection Time Body Site Clinical Information Hospital Discharge Date Individual Test Analysis [Testing will be performed only on the individual test components selected below. An interpretation report is not a component of “Technical only” testing] / / □*Clarient may need to exhaust/use entire specimen in order to perform the test/services ordered. The undersigned certifies that he/she is licensed to order the test(s) listed below and that such test(s) are medically necessary for the care or treatment of the above-referenced patient. Authorized Signature / / Quantitative □□CALR (Calreticulin) Mutation analysis □□JAK2 V617F Mutation analysis □□Reflex to CALR □□JAK2 exon 12 Mutation analysis □□KIT [D816V] Mutation analysis [Systemic Mastocytosis] □□MPL Mutation analysis □□MPN Reflex Panel [JAK2V617F: if negative reflex to, CALR: if negative reflex to, MPL: if negative reflex to, JAK2 exon 12 Mutation analysis] Non-Hodgkin Lymphoma □□B-cell clonality panel (IGH) □□BRAF V600E Mutation analysis □□CLL/SLL IGHV (immunoglobulin heavychain variable region) Mutation status □□MYD88 Mutation analysis □□IGH/CCND1 translocation t(11;14)* □□IGH/BCL2 translocation t(14;18) □□TP53 Mutation analysis □□T-cell clonality panel (TCRG, TCRB) Infectious Disease □□Mycobacterium, qualitative PCR Therapy □□Cytochrome P450 2D6 (CYP2D6), PCR □□UGT1A1 promoter genotyping *NCCN Guidelines recommended for initial diagnosis of MCL. Cytogenetics □□Classical Cytogenetics [Chromosome Analysis] □□180K CGH/SNP array (clinical indication required) Other (Specify) Clarient Use Only: Date □ Insurance □ N/A □ Path Rep □ Containers □ Tubes □ Slides □ Smears □ Blocks November 2014 JB20017US(2) Test Descriptions and Notations Flow Cytometry Panels Comprehensive Leukemia/Lymphoma panel (26 markers): CD2, CD3, CD4, CD5, CD7, CD8, CD10, CD13, CD14, CD16, CD19, CD20, CD23, CD33, CD34, CD38, CD43, CD45, CD56, CD57, CD64, CD117, FMC7, Kappa, Lambda, HLADR Lymphoma and Lymphocytosis (B-& T-cell) panel (18 markers): CD2, CD3, CD4, CD5, CD7, CD8, CD10, CD19, CD20, CD23, CD38, CD43, CD45, CD56, CD57, FMC7, Kappa, Lambda Plasma cell panel (9 markers): CD19, CD20, CD38, CD45, CD56, CD117, CD138, cKappa, cLambda PNH, high sensitivity panel (8 markers): CD14, CD15, CD24, CD33, CD45, CD59, CD235a (Glycophorin A), FLAER Routine Acute Myeloid Leukemia (AML) panel (6 markers; can only be ordered with Comprehensive panel): MPO, cytoplasmic CD3, cCD22, CD45, cCD79a, CD123 Monocyte maturation panel (10 markers; can only be ordered with Comprehensive panel): CD11b, CD11c, CD13, CD14, CD15, CD36, CD45, CD64, CD163, HLADR B-ALL Add-On panel: cTDT, CD10, CD19, CD34, CD45 T-ALL Add-On panel: TDT, CD1a, cCD3, CD45 Erythroid cells Add-On panel: Glycophorin A, CD45, CD71 Megakaryocytes Add-On panel: CD41, CD45, CD61 Cytoplasmic Light Chain panel: cKappa, cLambda, CD19, CD20, CD45 Hairy Cell Leukemia Add-On panel: CD11c, CD19, CD25, CD45, CD103 T-cell Receptor Add-On panel: TCR-GammaDelta, TCR-AlphaBeta, CD3, CD5, CD45 CLL/SLL ZAP70 Add-On panel: ZAP70, CD3, CD5, CD19, CD45 Hematogone Add-On panel (9 markers): TdT, CD10, CD19, CD20, CD22, CD34, CD38, CD43, CD45 Specimen Requirements Molecular [PCR and Sequencing] Assays Clarient Diagnostic Services requires 10% Neutral Buffered Formalin as tissue fixative for tumor testing. Please do not use zinc fixatives. Decalcified specimen is not acceptable for FISH and PCR assays. Use cold pack during transport of fresh tissue biopsy, peripheral blood, bone marrow [core/clot/aspirate], malignant fluids, FNA, CSF and Urine specimens. Cold pack should not be placed in direct contact with the specimen during shipping (cold packs are not required for tissue fixed in formalin). •Please include the address where the blocks and/or slides should be returned. Clarient accepts the following specimen types: •A formalin-fixed, paraffin-embedded (FFPE) tissue block Or •One (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and Per test, at least four (4) unbaked, unstained, 7 micron sections on regular slides (if the circled area is >5mm or the tumor percentage is >10%) or per test, eight (8) unstained slides cut at 7 microns (if the circled area is < 5mm or the tumor percentage is <10%) •Sequencing based assays (mutation analysis; translocations): at least five (5) unbaked, unstained, 10 micron sections [with > 40% tumor] on regular slides are required along with an H&E •Please do not oven dry unstained tissue sections – AIR DRY ONLY •Please do not use coverslips •More slides may be required if tumor tissue is too small. If you have concerns regarding the specimen please contact a Clarient pathologist before submission. •Fresh Tissue Biopsy in transport media [minimum of 2mm3] – acceptable only for B & T cell Gene Rearrangement studies; Storage/Transport Temperature: Refrigerated, 48 hours •Peripheral Blood in EDTA [Lavender/Purple top tube] – 5-10mL; Storage/Transport Temperature: Refrigerated, 48 hours •Bone marrow aspirate in EDTA [Lavender/Purple top tube] – 3-5mL; Storage/ Transport Temperature: Refrigerated, 48 hours •Bone Marrow Core in transport media; Storage/Transport Temperature: Refrigerated, 48 hours [Bone Marrow Core – FFPE is NOT acceptable] •Malignant Fluid: 50-100mL depending on dellularity; Storage/Transport Temperature: Refrigerated, 24 hours Flow Cytometry Immunophenotyping Clarient accepts the following specimen types. For optimal cell viability, we request that the specimen be analyzed within 24 hours of collection if ambient, or within 48 hours of collection, if refrigerated. •Fresh tissue Biopsy in transport media [minimum of 2mm3] •FNA tissue in transport media •Peripheral Blood [Green and/or Lavender/Purple top tube] – 5-10mL •Bone marrow aspirate [Green and/or Lavender/Purple top tube] – 1-2mL •Malignant Fluid: 50-100mL depending on cellularity •Cerebral Spinal Fluid (CSF): In sterile tube [with equal volume of transport media] FISH Assays Clarient accepts the following specimen types: •A formalin-fixed, paraffin-embedded (FFPE) tissue block – If block not available then: One (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and 2-3 positively charged unstained slides cut at 3-4 microns for each marker ordered •Fresh Tissue Biopsy in transport media [minimum of 2mm3]; Storage/Transport Temperature: Refrigerated, 48 hours or Ambient, 24 hours [Acceptable specimen for Tech (Virtual) HemeFISH] •Peripheral Blood in Sodium Heparin [Green top tube] – 5-10mL; Storage/Transport Temperature: Refrigerated, 48 hours or Ambient, 24 hours [Acceptable specimen for Tech (Virtual) HemeFISH] •Bone Marrow Clot – FFPE is acceptable •Bone Marrow Core in transport media; Storage/Transport Temperature: Refrigerated, 48 hours or Ambient, 24 hours [Bone Marrow Core – FFPE is NOT acceptable] [Acceptable specimen for Tech (Virtual) HemeFISH] •Bone Marrow Aspirate in Sodium Heparin [Green top tube] – 1-2mL; Storage/ Transport Temperature: Refrigerated, 48 hours or Ambient, 24 hours [Acceptable specimen for Tech (Virtual) HemeFISH] •Malignant Fluid: 50-100mL depending on cellularity; Storage/Transport Temperature: Refrigerated, 48 hours or Ambient, 24 hours •Cerebral Spinal Fluid (CSF): In sterile tube [with equal volume of transport media]; Storage/Transport Temperature: Refrigerated, 48 hours or Ambient, 24 hours Cytogenetics Clarient accepts the following specimen types: •Fresh Tissue Biopsy in transport media [minimum of 2mm3] •Peripheral Blood in Sodium Heparin [Green top tube] – 5-10mL •Bone Marrow Core in transport media •Bone Marrow Aspirate in Sodium Heparin [Green top tube] – 1-2mL •Malignant Fluid: 50-100mL depending on cellularity •Storage/Transport Temperature: Refrigerated, 48 hours or Ambient, 24 hours CGH/SNP Array Hematopathology FISH: Aggressive B-cell Lymphoma, Non-Hodgkin Lymphoma (NHL) and Burkitt Lymphoma panel testing may be performed on FFPE or fresh tissue specimen. All other Hematopathology FISH panel testing may be performed on fresh tissue only. Clarient accepts the following specimen types: •Peripheral Blood in EDTA tube [purple top] – 2-5mL [1-2 million cells]; Storage/Transport Temperature: Refrigerated, 48 hours •Bone marrow aspirate in EDTA tube [purple top] – 1-2mL [1-2 million cells]; Storage/Transport Temperature: Refrigerated, 48 hours •Fresh tissue in transport media – minimum two pieces tissue 0.2cm3 [1-2 million cells]; Storage/Transport Temperature: Refrigerated, 48 hours •Formalin-fixed, paraffin-embedded (FFPE) tissue block •Nine to nineteen (9-19) unbaked, unstained slides cut at 10 microns and an H&E •Please do not oven dry unstained tissue sections – AIR DRY ONLY •Please do not use coverslips •More slides may be required if tumor tissue is too small. If you have concerns regarding the specimen please contact a Clarient pathologist before submission. For more details please refer to “Diagnostic Services Specimen Requirements and Handling Procedures” form. © 2014 General Electric Company — All rights reserved. GE and the GE Monogram are trademarks of General Electric Company. Please call Clarient Client Services (888 443 3311) with any questions regarding specimen requirements or shipping instructions. Clarient Diagnostic Services, Inc. is a CLIA licensed laboratory and a division of General Electric Company. MultiOmyx is a trademark of General Electric Company or one of its subsidiaries. November 2014 JB20017US(2)
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