Rev A May 2012 Professional Development 2012

Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 1

Objectives ¬ Flags ¬ Codes ¬ Messages ¬ CBC Parameters ¬Cellular Interference ¬ Differential Parameters ¬ NRBC Parameters ¬ Retic Parameters Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 2

Flags Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 3

Codes Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 4

Messages – Results related: • Suspect: messages are generated by internal algorithms to convey that a clinical condition may exist with a specimen based on an abnormal cell population or distribution. • System: messages indicate an event that may affect the operation of a system, requires operator notification and or entry into a History Log. – Most accompanied by an R (review) flag – Some are accompanied by N or P flags • Definitive: defined by the Operator Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 5

Messages Exception or System Status Messages – Exception: anything with an exception won’t be released, for example – default test order – System Status: an event that may affect system operation. Accompanied by operator notification and entry into log. Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 6

Examples Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 7

CBC Parameters Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 8

Data Fusion Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 9

Cellular Interference • System message Cellular Inter • WBC & associated parameters, or TNC, flagged with R • The results are only flagged if we are uncertain of the correction, or can’t correct (not just because a correction occurred). Rev. A (May 2012) • Suspect message Cellular Inter • WBC & associated parameters, or TNC, flagged with R • For CBC/Retic panels only, when NRBC are detected but not reported. Professional Development © 2012 Beckman Coulter, Inc. 10

Red Cell Messages • Suspect message Dimorphic Reds • Data pattern consistent with the presence of multiple red cell populations Rev. A (May 2012) • Suspect message Red Cell Agglut • Data pattern consistent with the presence of agglutinated red cells Professional Development © 2012 Beckman Coulter, Inc. 11

RBC Fragments/Microcytes • Suspect message RBC Frag/Micro • Pattern observed consistent with the presence of RBC fragments and/or microcytic red cells. Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 12

Giant Platelets • Suspect message Giant Platelet • May be accompanied by System message specific to platelet results • Giant Platelet data pattern observed Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 13

Platelet Clumps • System message Platelet Clumps • PLT & associated parameters flagged with R • Clumped platelet data pattern observed Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 14

Platelet Messages • System message PLT Inter: Debris • PLT & associated parameters flagged with R • PLT requires review due to the possible presence of an interference with small platelets Rev. A (May 2012) • System message RBC-PLT Overlap • PLT & associated parameters flagged with R • PLT histogram shows a possible interference with larger platelets Professional Development © 2012 Beckman Coulter, Inc. 15

WBC Interference from HGB • System message WBC Inter: HGB • HGB & associated parameters flagged with R • HGB may not be adequately corrected for WBC interference Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 16

Differential Parameters Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 17

One Cell at a Time. . . WBCs are hydrodynamically focused Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 18

Flow Cytometric Digital Morphology Multiple angles of light scatter, captures 10 X more data than previously possible – – – AL 2 (axial light loss) LALS (lower angle LS) LMALS (lower med angle LS) UMALS (upper med angle LS) MALS (median angle LS) Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 19

Flow Cytometric Digital Morphology Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 20

Differential Parameters MONO NEUTS LYMPH Rev. A (May 2012) EOS BASO Professional Development © 2012 Beckman Coulter, Inc. 21

Abnormal Cell Distribution 2 1 3 4 5 6 7 1 2 3 4 5 6 7 8 MO Blasts NE Blasts Immature Granulocytes Band Neutrophils LY Blasts Variant Lymphocytes Small Lymps / Low Opacity Non-White Cells 8 Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 22

LY Blast 5 PD 1 5 PD 2 Normal 5 PD 1 • Suspect message LY Blast • Blasts suspected in the LY area of the dataplot • Data pattern consistent with possible presence of very immature cells Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 23

MO Blast 5 PD 1 5 PD 2 Normal 5 PD 1 • Suspect message MO Blast • Blasts suspected in the MO area of the dataplot • Data pattern consistent with possible presence of very immature cells Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 24

NE Blast 5 PD 1 5 PD 2 Normal 5 PD 1 • Suspect message NE Blast • Blasts suspected in the NE area of the dataplot • Data pattern consistent with possible presence of very immature cells Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 25

Immature Granulocytes 5 PD 1 5 PD 2 Normal 5 PD 1 • Suspect message Imm Grans • [Metamyelocytes, myelocytes &/or promyelocytes] or [myelocytes & promyelocytes] • Variable sensitivity with default set at high Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 26

Left Shift 5 PD 1 5 PD 2 Normal 5 PD 1 • Suspect message Left Shift • Metamyelocytes, without more immature granulocytes • Variable sensitivity with default at high • Can be disabled Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 27

Variant LY 5 PD 1 5 PD 2 Normal 5 PD 1 • Suspect message Variant LY • Variant (viral), atypical or abnormal LY suspected • Variable sensitivity with default at high Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 28

Abnormal Diff Pattern 5 PD 1 5 PD 2 Normal 5 PD 1 • System message Abn Diff Pattern • Results do not match any known template • All Diff results accompanied by R flag Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 29

NRBC 5 PD 1 5 PD 2 Normal 5 PD 1 • Suspect message NRBC • NRBC suspected in the signature position of the dataplot • Only in condition where the NRBC module is disabled and the panel includes a Diff Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 30

Aged Sample 5 PD 1 5 PD 2 Normal 5 PD 1 • System message Aged Sample • All Diff results accompanied by R flag • The results are only flagged if we are unable to give a correct differential, not just because aging is present. Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 31

Excessive Debris 5 PD 1 5 PD 2 • System message Excessive Debris: D • All Diff results accompanied by R flag Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 32

NE-EO Overlap 5 PD 2 5 PD 1 • System message NE-EO Overlap • All Diff results flagged with R • Population shift observed (NE and EO not in correct spatial location) Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 33

MO-NE Overlap 5 PD 1 5 PD 2 • System message MO-NE Overlap • All Diff results flagged with R • Population shift observed (MO and NE not in correct spatial location) Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 34

Low Events: D 5 PD 1 5 PD 2 • System message Low Events: D • Not enough events available for differential Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 35

High Opacity Events 5 PD 1 5 PD 2 • System message High OP Events • All Diff results accompanied by R flag • Interference in Opacity that has been observed with bone marrow samples or specimens with platelet clumps. Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 36

Low RMALS Events 5 PD 1 5 PD 2 • System message Low RMALS Events • All Diff results flagged with R • RMALS mode value is too low Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 37

NRBC Parameters PLT/DEBRIS WBC NRBC Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 38

Abnormal NRBC Pattern NRBC 1 NRBC 2 • System message Abn NRBC Pattern • NRBC & associated parameters flagged with R • Fits no known pattern Normal n. RBC Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 39

NRBC-LY Overlap NRBC 1 NRBC 2 • System message NRBC-LY Overlap • NRBC & associated parameters flagged with R • Couldn’t separate NRBC from small LY during analysis Normal n. RBC Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 40

NRBC Interference NRBC 1 NRBC 2 • System message NRBC Inter • NRBC & associated parameters flagged with R • Significant amount of interference in NRBC regions that are not NRBC Normal n. RBC Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 41

Miscellaneous NRBC Messages • Detected by Hardware, not algorithm • Flow Cell Clog: N • System Event: N Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 42

Reticulocyte Parameters WBC’S MATURE RBC’S RETICS PLT/DEBRIS Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 43

Abnormal Hemoglobin • Suspect message Abn Hemoglobin • ‘Others’ category = green (~ platelets) & orange (not cleared) particles. • Indicates a possible clearing problem in the presence of abnormal hemoglobin Normal Retic Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 44

Sickled Cells • Suspect message Sickled Cells • Data pattern consistent with sickled cells Normal Retic Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 45

Retic System Messages • System message RET-RBC Overlap • RET & associated parameters flagged with R. • Unclear separation of retics & mature red cells. • System message RET Inter: PLT • RET & associated parameters flagged with R. • The platelet population may have interfered with the RET. Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 46

Nucleated Cells • System message Nucleated Cells • RET & associated parameters flagged with R • NRBC or small WBC (especially small LY as in CLL) are visible in the dataplot (blue) and may have interfered with RET measurement Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 47

Flow Cell Clog • System message Flow Cell Clog: R • RET and associated parameters flagged with R • Hardware detected a flow cell clog during analysis • It is possible to have a flow cell clog that is severe enough to inhibit data [: : : ]. Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 48

System Event During Retic Examples include (but are not limited to): • Laser Offset Voltage failure • Temperature Out of Range Rev. A (May 2012) • System message System Event: R • RET & associated parameters flagged with R • Hardware parameters were out of limit for an item that could affect RET analysis (e. g. voltage, temperature, pressure). Professional Development © 2012 Beckman Coulter, Inc. 49

Rev. A (May 2012) Professional Development © 2012 Beckman Coulter, Inc. 50