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

www.AlvernoLabs.com

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

www.AlvernoLabs.com

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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THANKYOU!Sam.Terese@franciscanalliance.org

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