Hematopathology Requisition

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)