Lavender Top Management Alfonso Ziccardi Lab.Operation Manager for AP/CP/Safety Officer New York Hospital Medical Center of Queens SUCCESS BEYOND FINANCES Mission/ Vision. VISION To successfully develop and implement continuous innovative laboratory technologies, and consistently provide the highest quality patient care experience. 1
Hematology Testing Breakdown NYHQ Descrete testing CBCD 42% CBC 45% PLT 0% HGB A1C Retic 5% 1% ESR HGB 3% 2% HH 0% HCT 2% Sysmex XE vs. XN Technology RBC, PLT, Hgb WBC / BASO NRBC DIFF RET / PLT-O RBC, PLT, Hgb WNR WDF RET PLT-F NEW NEW NEW Sysmex XE vs. XN Technology RBC, PLT, Hgb WNR WDF RET PLT-F NEW NEW NEW 2
Sysmex Foundational Technology RBC & Platelet DC Detection / Hydrodynamic Focusing Hemoglobin Absorbance / Sulfolyser Unique Clinical Utility Basic Channels RBC & PLT Impedance HGB Channel WNR Channel (WBC / BASO / NRBC) WDF Channel (6-part DIFF including IG) Body Fluid Channel (Including 2-part DIFF) Advanced Channels Platelet (PLT-F / IPF) Complete Reticulocyte Analysis (Retic / IRF / RET-He) Clinical Utility Basic Channels NRBC Standard With Every XN-CBC IG Standard With Every XN-Diff Body Fluids With Diff Advanced Channels (Advanced Clinical Parameters- ACPs) Thrombopoiesis (IPF) Erythropoiesis (RET-He) 3
Fluorescent Flow Cytometry WNR channel WDF channel PLT-F channel RET channel WNR Channel NRBC BASO Granulocyte MONO LYMPH Fluorescent NRBC with every CBC No sample preparation Accurate WBC counts Virtually eliminates interference from: Lyse resistant RBCs Lipids Reports: WBC, BASO#, BASO%, NRBC#, NRBC% RBC Debris WDF Channel Atypical LYMPH LYMPH MONO NEUT Immature WBC EO Enhanced Flagging Improved separation between lymphs and monos (SAFLAS) Auto- correction of lymphs when NRBC are present 6-part differential with reportable including IG% / # Improved efficiencies Rapid TAT Decreased technical intervention Reportable: NEUT#/%,LYMPH#/%,MONO#/ %,EO#/%,IG#/% 4
Low WBC Analysis Mode WB (Whole Blood) mode LW (Low WBC) mode Dilution Rate : x 61.1 Analysis Volume : 58.2µL Whole Counts *2 : 9,530 Dilution Rate : x 61.1 Analysis Volume : 174.6µL Whole Counts *2 : 28,600 Analysis Time extended to 3 times the Whole Blood WBC count time Low WBC Analysis Mode Analysis time extended to 3 times WB WBC count time Better accuracy and precision on counts < 0.50 x 10 3 No Vote Outs Differential results on all counts Increased reportable differentials PLT-F Channel PLT performance Impedance platelet analysis (size) has limitations in the identification and discrimination of platelets from interfering particles with the same size. Possible interferences RBC fragments counted as platelets: falsely high Microcytic RBCs counted as platelets: falsely high Large platelets counted as RBC: falsely low 5
Binding sites of Fluorocell PLT Fluorocell PLT stains nucleic acid rich organelle Rough-surfaced endoplasmic reticulum (ribosomal RNA) Mitochondria (MtDNA) open tubule mitochondria α granule microtubule RBC RBC roughsurfaced endoplasmic reticulum deep dyeing granule glycogen granule PLT-F separates platelets from RBC fragment by the differences in staining Platelet RBC Fragment Transmitted light CD41/CD61 positive = Platelets Staining by PLT-F dedicated reagent Platelets - Strong, especially within the cell RBC fragments - Weak, only cell membrane CD61/PLT-F Transmitted light PLT-F Channel RBC PLT IPF Second, reportable, method of platelet Extended count time for accuracy, especially in low platelet counts Fluorescent Dye specific for platelet organella Good comparison with CD41/CD61 Minimizes interference from RBC fragments, microcytic RBC s and WBC fragments Automated Action message and reflex action (XN rules) Generates reportable: PLT-F & IPF (Immature platelet fraction) 6
RET Channel RBC RET LFR MFR PLT IRF HFR Improved operational efficiency Reduced Interference From: WBC WBCs Howell Jolley Bodies Parasites Sickle cells Monitor RBC development at the cellular level IRF for Retic production RET-He for iron incorporation in hemoglobin of the erythron Clinically relevant information for: Improved anemia screening and monitoring of iron therapy. Reportable parameters: Ret# / %, IRF, RET-He Reticulocyte Channel Operational Efficiency Reduced Interference From: WBCs Howell Jolley Bodies Parasites Sickle cells Quick and automatic Monitor RBC development at the cellular level IRF for Retic production RET-He for iron incorporation in hemoglobin of the erythron Clinically relevant information for the management of anemia in conjunction with other available clinical information. Body Fluid Analysis HF-BF LY-BF MN MO-BF NE-BF WDF Scattergram Cerebrospinal fluid (CSF) Pleural fluid Peritoneal fluid Synovial fluid PMN EO-BF Efficient process: No pre-analytical sample preparation Rapid Automatic background count Cost effective: No additional reagents Time savings testing Quality results: Fluorescent flow cytometry technology Reports cell count and 2 part differential Generates reportable: WBC & RBC count PMN & MN % / # TC# 7
Lavender Top Management with A1c Testing More Walk-Away Time Reduced maintenance: Once / daily Hands-free maintenance and QC Single aspiration pathway Unique Concentrated Reagent System Inventory space saving Concentrated reagent system (standard with XN-9000) Decrease hands-on 100 changes to 1 change Positive identification: RFID technology Color coding from spout to software Concentrated Cellpack 8
Enhanced Workflow Comprehensive Data Review / Management All-in-One Testing Data Review- A1c 9
So What Have We Learned? Low WBC Better accuracy and precision on counts < 0.50 x 10 3 No Vote Outs Differential results on all counts Increased Reportable differentials PLT-F Fluorescent Dye specific for platelet organelle Extended count time (6 times) for accurate low platelet enumeration Good comparison with CD41/CD61 Automated Action message and reflex with on board rules So What Have We Learned? Low WBC Better accuracy and precision on counts < 0.50 x 10 3 No Vote Outs Differential results on all counts Increased Reportable differentials PLT-F Fluorescent Dye specific for platelet organelle Extended count time (6 times) for accurate low platelet enumeration Good comparison with CD41/CD61 Automated Action message and reflex with on board rules XN Technology Hematology Technology of the Future Today ACP IG, RET He, IPF 10
Rules Set for Hematology and A1c Comprehensive Hematology Rules Database- Examples Test Rule Action Operator Instruction Sample Handling Critical WBC If dimorphic population? ISLH Reflex Smear and Review smear Value cutoffs Criteria Hold ADIFF (Instrument suspect FLAG) RBC HGB If WBC >20 and LOC = PEDs and age < 2 years (Instrument value, location & age) Laboratory Specific Criteria If HGB > 16.0 and Requestor = Smith and no previous result (Instrument value, doctor, previous result) Reflex smear and Re-run and call ward hold ADIFF Reflex Smear and HOLD all tests Delta rules Review smear and call Dr. Smith PLT If PLT ABN distribution and retic ordered and PLT < 80 Instrument (Instrument flag, sample order and instrument Flags value) Hold PLT Review smear and verify PLT count Rules based on previous results Impacts we Have Realized Auto-verification (hematology and A1c) Paperless environment Capacity and opportunity to add new tests Reduce opportunities for error Standardized sample and data workflow Staff cross-training TAT improvements HBA1c on demand Compare rerun/reflex Use: Compare rerun/reflex & STAT rates Review auto / manual validation rates Benefits: Measure laboratory performance & efficiency Compare user productivity 11
Turnaround Statistics Report Counts Statistic Report 12
On-Demand Management Reports Enhanced Workflow Complete Critical Alert Documentation Step 1 Step 2 Step 3 Result Review Enter Call to info in WAM Save and transmit to LIS 13
All-in-One Data Station Multi-application Sysmex WAM workstation: Review of exception results: CBC and A1c Smear review /diff station LIS access Our Lavender Top Management Configuration Bio-Rad VARIANT II TURBO Link- A1c SP 10 Smear prep TS-500- Automated sorting, re-routing and archiving 3 XN Hematology testing Efficiencies Gained with Sysmex WAM Decrease data TAT: Typical heme and A1c Auto-validation rates of ~85% + Automatic identification of STAT exception samples Reduce non-productive tech time: Advanced hematology technology and comprehensive smear rules Standardize review and process across techs, shifts and lab Reduce waste and cost: Paperless environment = decreases costs around paper, printing, storage and destruction of printouts 2 years data storage for easy access 14
LEAN Achievements Workflow improvements: One tube for CBC and A1c Single piece flow Data Review auto-verification Over 85% of CBC s Achieved >90% of A1c Reduction Testing and result TAT: CBC A1c Labor Savings/Resource Reallocation for new testing Our Automated LEAN Work Cell before Our New Automated LEAN Work Cell 15
NEW LINE WITH DI-60 DI-60 /TERMINAL 16
MY SYSMEX QUESTIONS 17