Now 34 How One Health Network Lab Hospitals! Supports ... · IgD Inhibin p120 P504s PAX-8 PHH3 PIN4...
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www.AlvernoLabs.com How One Health Network Lab Supports Precision Medicine in 27 Hospitals Across Three States Vision Molecular – powered by Alverno Laboratories 1 Now 34 Hospitals!
Transcript of Now 34 How One Health Network Lab Hospitals! Supports ... · IgD Inhibin p120 P504s PAX-8 PHH3 PIN4...
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HowOneHealthNetworkLabSupportsPrecisionMedicinein27HospitalsAcrossThreeStatesVisionMolecular–poweredbyAlvernoLaboratories
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Now34Hospitals!
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Disclaimerandacknowledgement
• Early stages • The team at Alverno Laboratories deserves the credit
• Dr. Beth Shearon, Medical Director • Dr. Judy Lyzak, Vice President of Medical Affairs • Mr. Dale Kahn, Vice President of Operations • Ms. Nadine Ali, Director. Central Laboratory Operations
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Agenda
• Introductions- Background and History of Alverno
• Current and State of Alverno’s Precision Medicine Program- the Now
• What’s Next- Near and Far
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DevelopmentofAlverno
2005 2008 2011 2012 2018 2018 1999
AlvernobeganasanintegratedlaboratoryownedbySSFHS
MergewithMedCentreLab,ProvenaandSSFHShospitals
ProvenaHealthandResurrectionHealthmergetoformPresenceHealth
AdditionalhospitalpurchasedbyFranciscanAlliance
3rdownerjoins–ResurrectionHealthCare
TwohospitalsoldbyPresenceHealth
PresenceHealthpurchasedbyAMITA(AscensionandAdventHealth)Healthcare
6Hospitals 18Hospitals 26Hospitals 24Hospitals
23Hospitals 32Hospitals37withcontracted39withcontractpending
25Hospitals
Managevariouscomponentsoffivenon-systemhospitals
Outreach-235%increase2006to2016or21.4%peryear PrecisionMedicineCriticalMass
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AlvernoToday
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AlvernoLaboratoriesToday
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• AlvernoLaboratoriesisoneofthelargestintegratedlaboratorynetworksintheUnitedStatesandownsandoperatesover30hospitallaboratoriesandacentrallaboratoryperformingbothclinicalandanatomicpathology.Alverno'sinnovative,state-of-the-artlaboratoryofferscosteffectivetestingandpersonalizedcustomerservice,withadvancedtechnologyandtestinginPrecisionMedicine/Next-GenSequencing,toxicologyandotherspecialtytesting.
• 2,100+dedicatedassociates
• AlvernoLaboratoriesCentralFacility-ISO15189Accredited(oneofapprox.65USlabs)
• Stakeholders/ownersareFranciscanHealthandAMITAHealth.
• Inadditiontoourhospitallaboratories(34owned/5contracted)-Multipleurgentcare/freestandingED/Microhospitalslabsinplaceorunderdevelopment45,000sq.ft.centrallaboratory-Hammond,IN
• 3,000+physicianclients,staffinmultiplephysicianoffices• 32patientservicecentersacrossIllinoisandIndiana.Alllocations,approximately120• Interfacingcapabilitiesapproximately200EMR/EHRinterfacesandfourdifferentLISs
withmultipledatabases• CentralLaboratory–LLC• HospitalLaboratories501esharedservice,managedbyAlverno• OperatetwoschoolsofMedicalTechnologyandoneschoolofHistotechnology.Multiple
schoolpartnerships
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AlvernoLaboratories
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• Standardizedequipment-allsitesonsameChemistry,ImmunoChem,Coagulation,Hematology,BloodBank,Urinalysis,SedRatesetc.Analyzer
• StandardizedHomogenousQualityManagement-AlvernoBusinessSystems
• Standardizedandcentralizedpoliciesandprocedures-PolicyStat• Standardizedcompetencyreviewandreporting-MaplewoodStaffReady
• Standardizedscheduling-MaplewoodScheduleReady
• StandardizedHRfunctions-performancereviews,etc.
• Standardizedreferenceranges• StandardizationofPOCTtestingthroughoutthesystemhospitalsandphysicianoffices-stillaworkinprogress
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StrategicPlanning–theShortVersionBreakthroughInitiatives-Firstdevelopedin2018
PrecisionMedicine/NextGenerationSequencing
DigitalPathology
LCMSPainManagementandHeavyMetals
DirectAccessTesting
TeachItForward
MarketingandRebranding
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Warning-PrecisionMedicine
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NotNecessarilyastraightpath
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EarlyWork-GuidancetotheMedicalStaff
SoftLabCode TestName PerformingLab EPICEAPCode CPTCodeILYCH Lynch
Syndrome19genePanel
Invitae EAP6010286 81435,81436
MLYCH LynchSyndrome6genePanel
Myriad EAP6010287 81292,81294,81295,811297,8129881300,81317,81319
AMLH1 LynchSyndrome(MLH1)
ARUP EAP6010288 81292,81294
AMLH2 LynchSyndrome(MLH2)
ARUP EAP6010289 81295,81297
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LynchSyndrome
SoftLabCode TestName PerformingLab EPICEAPCode CPTCodeIBR12 BRAC1&2(9
genepanel)Invitae EAP6010291 81211
MBR12 BRAC1&2(2genepanel)
Myriad EAP6010292 81211,81213
BRCAS BRCASeq,Del/Dup(HBOC)
ARUP EAP6020041 81162
BRCA1&2
SoftLabCode TestName PerformingLab EPICEAPCode CPTCodeIHBCA Hereditary
BreastCancer(47genepanel)
Invitae EAP6010294 81211mostofthetime.81162forUHC
MHBCA HereditaryBreastCancer(35genepanel)
Myriad EAP6010295 81162
AHBCA HereditaryBreastCancer(20genepanel)
ARUP EAP6010296 81432,81433
Expandedhereditarybreastpanels
SoftLabCode TestName PerformingLab EPICEAPCode CPTCodeCPBCS PrenatalBasic
CarrierScnMyriadHealth EAP6010297 81407,81405,
81400,81401,81406,81479,81220,81221,81222,81223,81224,81408,81403,81404
IPBCS PrenatalBasicCarrierScn
Invitae EAP6010298 81220,81243,81400
NPBCS PrenatalBasicCarrierScn
Natera EAP6010299 81420or81422(w/microdeletions)
PPBCS PrenatalBasicCarrierScn
Progenity EAP6010300 81220,8120981200,8125181260,8124281290,8133081255,8308081250,8140081401,8124381257,81205
CFBR3 CysticFibrosisCarrierScreen
Alverno EAP600849 81220
SICKL SickleCellScrn Alverno EAP715100 85660SMACN Spinal
MuscularAtrophyCopyNo.Analysis
Alverno EAP6010265 81401
FMR1 FragileX(FMR1)
ARUP EAP724300 81243
AGDDP A.Globin(HBA1&2)Del/Dup
ARUP EAP6010301 81269
BGDDP B.Globin(HBB)Del/Dup
ARUP EAP6010302 81363,81364
BLM1V BloomSyndrome,1Variant
ARUP EAP6010303 81209
CND4V CanavanDisease,4Variants
ARUP EAP6010304 81200
FAC2V FanconiAnemiaGrpC,2Variants
ARUP EAP6010305 81242
GBA8V GaucherDisease(GBA)8Variants
ARUP EAP6010306 81251
MCO2V MucolipidosisTypeIV,2variants
ARUP EAP6010307 81290
NNA4V NiemannPickTypeA,4Variants
ARUP EAP6010308 81330
TAYSC HexosaminidaseA%&TotalEAP
ARUP EAP6010309 83080
BasicCarrierScreen
SoftLabCode TestName PerformingLab EPICEAPCode CPTCodeCNIPN Noninvasive
PrenatalTestMyriadHealth EAP6010310 81420,81422
PNIPN NoninvasivePrenatalTest
Progenity EAP6010311 81420,8147981422
NNIPN NoninvasivePrenatalTest
Natera EAP6010312 81220,81243,81400,81404,81408,81161
FETAN NIPTforFetalAneuploidy
ARUP EAP6020037
Noninvasiveprenataltest
SoftLabCode TestName PerformingLab EPICEAPCode CPTCodeIPDCP Productsof
ConceptionInvitae EAP6010313 88291,88230
88262NPDCP Productsof
ConceptionNatera EAP6010314 81229
ASNPP GenomicSNPMicroarrayPC
ARUP EAP6010315 81229
ProductsofConception
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OrderingProcessMap
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Prerequisites - Foundation to Build
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Alverno–WhereWeareToday
• Flow Cytometry • Navios 10 color laser • Leukemia/Lymphoma panels
• Aquios • Lymphocyte subsets
Navios
Aquios
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Alverno–WhereWeareToday• FISH Panels
• Heme FISH: • MDS/AML • CLL • Plasma cell neoplasia • NHL • CML • ALL
• HER2 FISH: • Breast • Gastric Cancer
• Solid Tumor FISH: • ALK, ROS1
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Alverno–WhereWeareToday
ACTHActinMuscleAE1/AE3AFPALK-1b-cateninbcl-2bcl-6BerEp4BOB.1CA19-9CA-125CAIXCalcitoninCaldesmonCalponinCalretininCAM5.2(CK8/18)CD1ACD3CD3-CD20
CD4CD5CD7CD8CD10CD15CD20CD21CD23CD30CD31CD34CD43CD45CD45ROCD56CD57CD61CD68CD79aCD99
CD138CD163CDX2CEA(monoclonal)CEA(polyclonal)ChromograninCK5/6CK5/14CK7CK19CK20c-Kit(CD117)CKOscarCMVCyclinD1DesminDOG-1E-cadherinEMAERERG
FascinFactorVIII(8)FactorXIIIa(13a)FSHGata3GCDFP-15GFAPGlycophorinAGrowthHormoneHBME-1HCGHelicobacterpyloriHepPar1HER2HHV-8HMB-45HMWK34BE12HSV-1HSV-2IgDInhibin
FascinFactorVIII(8)FactorXIIIa(13a)FSHGata3GCDFP-15GFAPGlycophorinAGrowthHormoneHBME-1HCGHelicobacterpyloriHepPar1HER2HHV-8HMB-45HMWK34BE12HSV-1HSV-2IgDInhibin
p120P504sPAX-5PAX-8PHH3PIN4(p63/P504s/34BE12)PLAPPMS2Podoplanin(D2-40)PRProlactinPSAPSAPRCCS-100SentinelLNprotocol(AE1/AE3)SMASmoothelinSOX10SquamousCocktailSynaptophysin
Syphilis(Tpallidum)TdTThyroglobulinTryptaseTSHTTF-1TTF-1/NapsinAUroplakinVillinVimentinWideSpectrumKeratinWT-1EBERKappaLambda
TissueDiagnosticsIHCandISHStains
Ultra
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Alverno–WhereWeareToday
• Breast Prognostic Marker Panel • ER • PR • HER2
• Image Acquisition and Analysis • Digital Pathology
• Iscan Coreo • Virtuoso
Ultra
IscanCoreo15
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Alverno–WhereWeareToday
• Cystic Fibrosis Genotyping Test • Panel includes 23 recommended mutations
• Single Gene PCR Assays • EGFR • BRAF
Genmark
CobasZ480
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Vision Molecular – powered by Alverno Laboratories
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PrecisionMedicineContinuum
COMMUNITYBASED ACUTECAREBASED POSTACUTE
ü DirecttoConsumerü Preventive(ScreenDNAforRisk)ü PrimaryCare-FamiliarRiskü DNSDruginteractionand
effectivenessü RapidInfectiousDxü Geneticriskfactorstochange
frequencyfortestsuchasColonoscopyorMammogram
ü Integrativediagnostics-rapidNICUscreening
ü IoMTmonitoring,ICUtriage,sepsis
ü RareGeneticDx
ü PrecisionMedicine-targettherapy
ü TumorSequencingü Geneticdxtesting,
Immunotherapy,Chemotherapy
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CHALLENGINGREIMBURSEMENT
CHALLENGINGREIMBURSEMENT
BESTCHANCE–ESPECIALLYSTAGE3/4
AdaptedfromSg2
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CriticalEnablers
• CMS National Coverage Decision • FoundationFocusTM CDxBRCA • F1CDx (Foundation Medicine) • OncomineTM Target Test(ThermoFisher) • PraxisTM Extended RAS Panel
• Is this the beginning?
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WhatgoesintotheROI
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CapitalinvestmentNewVolumesRequisitions-HospitalReqOutreach3rdpartyReqOutreachClientbillBillabletests-HospitalBillabletests-OutreachBillabletests-ClientRVU's-HospitalRVU's-OutreachRVU'sClient
NetrevenueHospital($.75perRVU)NetrevenueOutreachNetrevenueClientRev/RequisitionTotalNetrevenueExpensesSalariesBenefitsCostoftestingCollectionsuppliesCourierITProfessionalComponentDepreciationofcapital
FTETech/HourlyRateFTEBioInformatics/HourlyRateExp/RequisitionCurrentSendoutExpenseTechnicalproductivityRevenueperrequisitionHospital/Outpatient/ClientAverageExpperRVURevenueperRVU
MedicareOutpatientfeeschedulePayormixCharitycareDenialsSelfpayMedicareAnthem,United,BlueCross
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Proforma-EstimatesforAlverno
2020 2021 2022 2023 2024 Total
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TotalNetRevenueTotalExpensesMarginMargin%
Ifnotpositiveandnotacertain%-Discussionisover
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Wherewewanttogo
• Join the fight against cancer at the molecular level • Unlock the mystery of drug sensitivity • Prepare for tomorrow by knowing your genes and risk
factors
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Alverno–WhereWeareToday/Justdoitmodel
• Next Generation Sequencing • Testing up to 52 Gene Solid Tumor Panel • Myeloid Panel in validation phase
• Oncomine Knowledge Reporter • Treatment Labels and Global Clinical Trials
IonChef S5 IonChef S5 IonChef S5
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Implementation-3to4months
• NGS Implementation • Vendor/Platform selection • Space evaluation/Instrument placement/ environmental and electrical
considerations • Prep area, detection area, computer area
• Personnel/staffing decision • Other equipment needed?
• Thermocycler, Server, Freezer, refrigerator • Data Storage Considerations • Panel selection/ menu determination
• Reagents • Specimens
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Implementation-3to4months
• Instruments installed • Validation plan/Execution
• Reference lab guidance • Regulatory considerations • Specimen procurement • Nucleic acid extraction • Library prep • Data analysis • Accuracy/reproducibility • SOP/QC
• Training of Technical Staff • Competency setup in StaffReady
• Training of Pathologists
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Implementation-3to4months
• LIS Build • Software for clinical trials • Data storage
• Billing/reimbursement • Supplies set up in material management • Physician/client education • CAP activity menu and proficiency surveys • Announcement • Go-live
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ProjectStatusPrecisionMedicine
Q12019 Q22019 Q32019 Q42019
NextGenSequencing SolidTumorPanel X
LaunchMyeloidPanel X
StartGeneticPanelDevelopment X
LaunchGenetic X
DigitalPathology Implementfirst4scannerX
Firstsitestransitiontodigital X
Purchaseadditional4scanners X
Syapse-NonDisclosureagreementsignanddiscussionsaremovingforwardandITdiscussionsmovingforwardTechnologyinvestmentplannedandfunded
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Syapse–PrecisionMedicineInitiative Linking NGS Data with Clinical Data.
Syapse Oncology is a point-of-care solution that: Empowers care
teams and service line leaders with insights that inform clinical and business decisions.
Integrates clinical, molecular, treatment, and outcomes data to create a structured, foundational database for the precision medicine program.
Enables the sharing of real-world evidence and clinical best practices with a trusted network of leading health systems.
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Vision Molecular What’s Next
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PathForwardfromCurrentStateTeamsandLaboratoryMedicalStaff
ABS-ContinuousImprovement
SystemwideQuality
QualityCommitteeoftheBoard
CentrallabQualityCommittee&HospitalQuality–agendaSiteLeadersmeeting
ABS-SafetySystemwide
Safety
ABS-EngagementCustomerExperience
SystemwideCustomerandEmployee
Engagement
ABS-UtilizationManagement SystemwideUM-
IncludesVPMA
ABS-Innovation
ABS-Stewardship
ABS-Medicine(PathCouncilSubcommittee-Micro)
PathologyCouncil
Compliance
PathologyStandardizationCommittee
ABSOperationsCommittee
NewTeamsneededtosupportthePrecisionMedicineProgram:AmitaHealth–currentteamAlvernoLaboratories–defined–initialmeetingApril10thFA-nocurrentteamdefine30
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Alverno–Governance
• Precision Medicine Advisory Committee • Composed of: Pathologists, Oncologists, PharmDx, Genetic Counselor and CMOs
• To understand clinical needs and guide the laboratory in the direction of patient-centered laboratory testing.
Pathologists:VenAduanaMD-AMITABethShearonMD-AlvernoPCINathanAardsmaMDAlvernoPCILaurieEisengartMDHeadofAmitaLeadershipTeamonPrecisionMedicineJimUrbanMDAMITA
Oncologists:AMITAGaryGradMDABMCIraOliffMDAMITASt.FrancisRechaHartingMDAMITAHinsdaleJayDalalMDAMITAHinsdaleAssaadSemaanMDAMITAABMCandSAMCJasonSuhMDAMITAStJosephJoliet
Oncologists:FranciscanAllianceMasoodGhouse,MDFHOFMohamedFarhat,MDFHCOPeterTothy,MDMethodistandFAYameedRashid,MDFHMU/DY/HATaylorOrtiz,MDFALafayette
GeneticCounselorTinaMarieBaumannSAMCandABMC
PharmDwithspecialinterestinOncologyChunchuHsuAMITAABMCandSAMDebSproatAMITAHinsdale
CMOStewardMarcusMD,CMOofAMITAHealthAlTomchaneyMD,CMOofFranciscanHealth
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RoleofCommittee• Develop guidelines to standardize test ordering practices • Identify and make recommendation on test development initiatives • Provide education and guidance for ordering practices to ensure
appropriateness of testing • Provide education and guidance to ordering physicians regarding test
choice and result interpretation • Design digital collaborative tumor boards • Reduction in the total cost of treatment. • Fewer side effects and avoidance of unnecessary treatment.
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FutureGoals
GuidethedevelopmentofaCenterforPersonalizedMedicineatmemberorganizations
○ Expandevidence-basedtestingtoincludepopulationhealthandotherspecialties
○ Geneticcounselortodiscussramificationsoftestingaswellastheresultswiththepatient(overthephoneversusin-person)
■ PrivacyConcerns■ Costsoftesting■ Life/DisabilityInsuranceConcerns■ Follow-up/Testingoffamilymembers
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What’sNext-PrecisionMedicine
• Living the definition- form of medicine that uses the information about a persons’ genes, proteins and environment to prevent, diagnosis and treat disease
• Application in Primary Care
• Application in Pharma – i.e. related to depression and others
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NotJustOncology
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PrecisionMedicineFutureValueProposition
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Alverno–WhereWeareToday
• Companion Diagnostics Testing • PD-L1 IHC 22C3 PharmDX
• Non Small Cell Lung Cancer • Gastric Carcinoma
• Lynch Syndrome IHC Panel Agilent
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Alverno–RelatedProjects
• Digital Pathology • Acquiring 12 IntelliSite Scanners
• Microbiology • Genmark Eplex
• Blood Culture Identification Panels • Organism ID leading to sepsis • Resistance genes
• Blood Bank • Immucor PreciseType
IntelliSiteScanner
Eplex
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QuestionstobeAnswered
• Marketing Plan/Product Detail • Features and benefits
• Ordering protocol and appropriateness
• Report template
• Applicable conditions to help identify treatment
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QuestionstobeAnswered
• Benefit to System • Additional non-ancillary volume • Reputation for expertise in diagnostic and treatment
increase
• Revenue flow and opportunity-we still have gaps • Billing process • Pre-certification and coding
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Attheendofday
Now. Be successful in the now and simultaneously make the critical pivot to
the far.
Near Place bets on the future and pivot resources to support those bets.
Far
Envision a future state and future role, knowing that any prediction is uncertain and subject to change.
40 2019KaufmanHallandAssociatesFordMotorCompany
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WETOUCHLIVES...ASPECIMENISAPARTOFAHUMANBEING,SOMEONEWHOISLOVED,WEDONOTKNOWTHESTORY…WEDONOTPROCESSSPECIMENS,WECAREFORPEOPLE,PATIENTS,HUMANS,ANDWESHOULDNEVERFORGET...NEVERSETACULTURE,TUBE,ASLIDEORTESTASIDEBECAUSEITISDIFFICULTORWILLTAKETOOMUCHTIME…WETOUCHLIVESANDTHATSHOULDBEMORETHANWORDS…
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