Implementing Vitek MS: Implementing Vitek MS: The St JamesThe St James’’s Hospital s Hospital

ExperienceExperienceLisa RoseLisa Rose

Senior Medical ScientistSenior Medical ScientistMicrobiology Dept. Microbiology Dept.

St JamesSt James’’s Hospital, Dublin, Irelands Hospital, Dublin, Irelandlrose@stjames.ielrose@stjames.ie

OutlineOutline

Vitek MS & Myla ValidationVitek MS & Myla Validation

VitekVitek--MS WorkflowMS Workflow

Advantages & Challenges Advantages & Challenges

St JamesSt James’’s Hospital, Dublins Hospital, Dublin

1000 bed tertiary care hospital1000 bed tertiary care hospitalLargest laboratory in Rep of IrelandLargest laboratory in Rep of IrelandMicrobiology lab: >300,000 specimens/yrMicrobiology lab: >300,000 specimens/yr

MALDI: What did we want & Why?MALDI: What did we want & Why?Current issues:Current issues:

–– Improved patient care: antibiotic therapy & MDRO & management oImproved patient care: antibiotic therapy & MDRO & management of sepsisf sepsis–– Staffing restrictionsStaffing restrictions–– Stringent budget control Stringent budget control

Faster IDFaster IDCheaperCheaperBetterBetter

Consistent results: all staff & all shiftsConsistent results: all staff & all shiftsAutomated: futureAutomated: future--proof proof -- full lab automationfull lab automationEasy to use: trainingEasy to use: trainingReduce TATsReduce TATsReallocate staff to added value tasksReallocate staff to added value tasks

Improve patient management & antimicrobial therapyImprove patient management & antimicrobial therapy

How did we Implement VitekHow did we Implement Vitek--MS? MS? Selection: performance, existing Selection: performance, existing instrumentation, middlewareinstrumentation, middleware

ISO15189:2012 standardISO15189:2012 standardInstallation qualification (IQ)Installation qualification (IQ)

–– Installation engineerInstallation engineer–– DeliveryDelivery–– UnpackingUnpacking–– Vitek MS Vitek MS –– PC checkPC check–– Prepare slide, fine tuningPrepare slide, fine tuning

Operational Qualification (OQ) Operational Qualification (OQ) –– Medical scientist & application specialistMedical scientist & application specialist–– Creation of user accountsCreation of user accounts–– Barcode validationBarcode validation–– Send analysis request ID & AST from LISSend analysis request ID & AST from LIS

Performance Qualification (PQ)Performance Qualification (PQ)–– equipment consistently performs as intendedequipment consistently performs as intended

Workflow

Training

Validation

Installation

Vitek MS

OQ: InterfaceOQ: InterfaceLocal LIS support essential from start of project Local LIS support essential from start of project

Prepare detailed LIMS validation protocolPrepare detailed LIMS validation protocolAll permutationsAll permutations–– Investigation typesInvestigation types–– MRN/hospital sourceMRN/hospital source–– ID, ID/ASTID, ID/AST

Dedicate resources at time of switch over: staff, time, space Dedicate resources at time of switch over: staff, time, space

Myla uses stem organisms: Multiple codes for different organismsMyla uses stem organisms: Multiple codes for different organisms

Never switch over on a Friday!Never switch over on a Friday!

Vitek MS PQVitek MS PQ

Accuracy of ID:Accuracy of ID:–– 40 ATCC bacterial, 2 ATCC fungal strains40 ATCC bacterial, 2 ATCC fungal strains–– Tested in duplicateTested in duplicate

Repeatability of ID:Repeatability of ID:–– ATCC stains tested, 2 operators, on 3 different occasions ATCC stains tested, 2 operators, on 3 different occasions

Reproducibility/precision of ID:Reproducibility/precision of ID:–– ID 15 ATCC isolates, in triplicate, 2 operators, same slideID 15 ATCC isolates, in triplicate, 2 operators, same slide

Results: 100% accuracy, repeatability, reproducibility Results: 100% accuracy, repeatability, reproducibility

Y. enterocolitica ATCC 27729

Staphylococcus aureusBAA 977

Neiserria gonorrhoeae. ATCC 49226

Haemophilus influenzae ATCC 49247

V. parahaemolyticus ATCC 17802

Staphylococcus aureusBAA 976

Moraxella catarrhalis, WILDEnterococcus faecalisATCC 29212

Stenotrophomonas ATCC 13637

MRSA, ATCC 43300Legionella pneumophila ATCC 33152

Enterococcus faecalisATCC 51299

Streptococcus equisimilis43079

Staphylococcus aureusATCC 29213

Klebsiella pneumoniae ATCC 700603

Escherichia coli ATCC 35218

Strep. pneumoniae ATCC 49619

Staphylococcus aureus,ATCC 25923

Klebsiella oxytoca ATCC 700324

Escherichia coli ATCC 25922

Strep. pyogenes, ATCC 19615

Serratia marcescens ATCC 8100

Klebsiella pneumoniae BAA 2146

Clostridia perfringens ATCC 13124

Streptococcus agalactiae12386

Salmonella typhimurium ATCC 14028

Klebsiella pneumoniae BAA 1706

Candida parapsilosis ATCC 2019

Staph. saprophyticus ATCC 15303

Proteus mirabilis ATCC 12453

Klebsiella pneumoniae BAA 1705

Candida albicansATCC 10231

Staph. epidermidis ATCC 12228

Pseudomonas aeruginosa, ATCC 27853

Haemophilus influenzae NCTC 8468

Campylobacter jejuni ATCC 33291

Staphylococcus aureus BAA1026

Neiserria meningitidis ATCC 13090

Haemophilus influenzae ATCC 49766

Bacteroides fragilis ATCC 25285

PQ: Prospective Clinical StudyPQ: Prospective Clinical Study

100%100%API ID32C, Cornmeal, germ API ID32C, Cornmeal, germ tubetube

1111CandidaCandida

2 isolates ID to genus level2 isolates ID to genus levelVitek MS ID to species Vitek MS ID to species

100%100%APIID32A, API Coryne, gram APIID32A, API Coryne, gram morphology morphology

Coryne & Coryne & ClostridiumClostridium

100%100%API Rapid NH, Phadebact API Rapid NH, Phadebact Monoclonal GCMonoclonal GC

1515NeisseriaNeisseria

2 Lancefield Grp G isolates: 2 Lancefield Grp G isolates: 50%/50% Str dysgalactiae subsp. 50%/50% Str dysgalactiae subsp. equisimilis/ Streptococcus equisimilis/ Streptococcus dysgalactiae subsp. dysgalactiae dysgalactiae subsp. dysgalactiae Species Id sufficientSpecies Id sufficient

100%100%Prolex Streptococcal latex Prolex Streptococcal latex grouping kitgrouping kit

5454BHSBHS

100%100%X&V, optochin, API rapid NH, X&V, optochin, API rapid NH, Tazo sugarsTazo sugars

2121H.influ, S.pn, Str H.influ, S.pn, Str sp, Moraxellasp, Moraxella

100%100%Vitek GN, API 20NE, ChromID Vitek GN, API 20NE, ChromID CPSCPS

5151GNBs: GNBs: E.coli, P.aer, E.coli, P.aer, Kleb, Ent spp, Citro, Kleb, Ent spp, Citro, Ser, Prot, MorgSer, Prot, Morg

100%100%tube coagulasetube coagulasePastorex Staph plus latex Pastorex Staph plus latex

agglutination kitagglutination kit

5252Staph sp.Staph sp.S.aureusS.aureusCNSCNS

CommentsCommentsCorrelateCorrelateID methodID methodNo.No.IsolatesIsolates

PQ Validation of Media TypePQ Validation of Media Type

100%100%BloodBloodMaltMalt

CandidaCandida4 ATCC, 2EQA, 36 4 ATCC, 2EQA, 36 isolatesisolates

100%100%

ChocChocChoc, NYCChoc, NYCChoc, BloodChoc, BloodBlood, NEO, NATBlood, NEO, NAT

Anaerobic & Anaerobic & MicroaerophilicMicroaerophilicH.influ, NeisseriaH.influ, NeisseriaCampCampB.frag & Cl.perB.frag & Cl.per

100%100%ChocolateMacConkeyNeomycin & NATVRE selective agar

Ent/StrepEnt/Strep

100%100%BloodBloodChocolateChocolateMacConkeyChrome, ASAP, DCA, TCBS, CINChrome, ASAP, DCA, TCBS, CIN

GNBGNB

100%ChocolateMannitol SaltMacConkeyMRSA Chrome

StaphStaph

ID CorrelationID CorrelationMedia TypeMedia TypeATCC StrainsATCC Strains

BA: Blood Agar; Choc: Chocolate Agar; ASAP: Salmonella ASAP agar; CIN: Cefsulidin, Irgasin, Novobiocinagar; TCBS: Thiosulfate citrate bile sucrose agar, DCA: Desoxycholate citrate agar

PQ: Effect of Culture Age and PQ: Effect of Culture Age and Storage on IDStorage on ID

16 ATCC strains tested16 ATCC strains tested•• CO2, O2, 35 CO2, O2, 35 °°CC: 24hr, : 24hr,

48hr, 72hr48hr, 72hr•• Room temp: 24hr, 48hRoom temp: 24hr, 48h•• 4 4 °°C: 24hr, 48hrC: 24hr, 48hr

100% correlation at 100% correlation at 24hr, 48hr24hr, 48hr15/16 correlate at 72 hr 15/16 correlate at 72 hr •• N. gonorrhoeaeN. gonorrhoeae ID ID

unreliable after 48hr (low unreliable after 48hr (low ID/fail to ID)ID/fail to ID)

�������Mor. catarrhalis (wild)

����**��Neis. gonorrhoeae 49226

�������H. influenzae 49249

�������Candida albicans 10231

�������Proteus mirabilis 12453

�������Steno. maltophilia 13637

�������Ps aeruginosa 27853

�������Kleb. pneumoniae 700603

�������Ser. marcescens 8100

�������E. coli 25922

�������Strep. pneumoniae 49619

�������Strep. agalactiae 12386

�������Strep. pyogenes 19615

�������Ent. faecalis 29212

�������St epidermidis12228

�������St aureus 25923

4˚C@48

4˚C@24

RT@48

RT@24

72 hr

48

hr

24 hr

Plate ReadingPlate reading:

Significant growth?

CommensalsReport

ReleasedTATsTATs

Review ID/AST

Purity Plates

Centralised ID/ASTCentralised ID/ASTCentralised IDCentralised ID

CentralisedCentralised

Day 1

Day 2

am

Barcode!Barcode!

CentralisedCentralisedCentralised ASTCentralised AST

Inform ClinicianInform Clinician

Check!Check!

Check!Check!

Approx 1min/IDApprox 1min/ID

WorkflowWorkflow

WorkflowWorkflow

CPS Chrom IDCPS Chrom IDCPS Chrom IDCPS Chrom IDE.coli E.coli (Urines)(Urines)

Post MALDIPost MALDIPre MALDIPre MALDIOrganismOrganism

Vitek MSVitek MSPhadebactPhadebact

API NHAPI NHPhadebactPhadebact

N.gonorrhoeaeN.gonorrhoeae

MicroscopyMicroscopyMicroscopyMicroscopyMouldMould

APIAPIGerm tubeGerm tubeCornmeal agarCornmeal agar

CandidaCandida

OptochinOptochinVitek IDVitek IDAPIAPI

StrepStrep

XV, APIXV, APIHaemophilusHaemophilus

Latex group, BacitracinLatex group, BacitracinBHSBHS

Vitek GP ID cardVitek GP ID cardEnt sp.Ent sp.

PastorexPastorexTube coagTube coagVitek IDVitek ID

Staph sp.Staph sp.

Vitek MSVitek MS

Vitek IDVitek IDGNBGNB

MRSA Select & Vitek MSMRSA Select & Vitek MSMRSA SelectMRSA SelectMRSA screenMRSA screen

Bidirectional InterfaceBidirectional Interface

LIS

Acquisition PC

Prep Station PC

Vitek PC

Pros: Pros: ID & AST (S, I, R) results available in MylaID & AST (S, I, R) results available in MylaResults transfer automatically Results transfer automatically –– less transcription errorless transcription errorMultiple users access results in MylaMultiple users access results in Myla

Micro medical staff access resultsMicro medical staff access results

Cons:Cons:Full Vitek functionality not available in MylaFull Vitek functionality not available in Myla

Link to Vitek softwareLink to Vitek softwareCannot change S/I/R in MylaCannot change S/I/R in Myla

MylaMyla

MALDI ID Challenges/Algorithms MALDI ID Challenges/Algorithms Subspecies/species groupSubspecies/species group

–– Ent cloacae asburiae/cloacae Ent cloacae asburiae/cloacae 50%/50%: report as 50%/50%: report as E.cloacae complex.E.cloacae complex.–– Proteus vulgaris/penneri Proteus vulgaris/penneri 50%/50%: report as 50%/50%: report as P.vulgaris/penneriP.vulgaris/penneri–– Strep dysgalactiae sub sp. dysgalactiae/Strep dysgal sub sp equiStrep dysgalactiae sub sp. dysgalactiae/Strep dysgal sub sp equisimilissimilis–– LIS translates both eg Strep. dysgalLIS translates both eg Strep. dysgal

Strep ID:Strep ID: if consistently fail ID: calibration required? if consistently fail ID: calibration required?

N. gonorrhoeaeN. gonorrhoeae: continue to perform Phadebact monoclonal GC test: continue to perform Phadebact monoclonal GC test

Organisms with low ID accuracy:Organisms with low ID accuracy:–– H.pyloriH.pylori–– Haemophilus haemolyticus, Asp. niger, Aerococcus urinae, PeptoniHaemophilus haemolyticus, Asp. niger, Aerococcus urinae, Peptoniphilus asaccharolyticusphilus asaccharolyticus

NLF ?NLF ?E.coliE.coli:: Shigella & E. coli 0157Shigella & E. coli 0157 ID as ID as E. coli E. coli -- perform Vitek IDperform Vitek ID

Brucella sp.Brucella sp. not in databasenot in databaseMoulds:Moulds: more Aspergillus species in databasemore Aspergillus species in databaseCorynebacterium sp:Corynebacterium sp: more species in databasemore species in database

Vitek MS Preliminary Blood Culture Vitek MS Preliminary Blood Culture ID/ASTID/AST

Prelim IDPrelim IDNo of isolates: 115No of isolates: 115Growth at 4Growth at 4--6hr6hrIsolate types: GNB, Isolate types: GNB, Staph, EntStaph, Ent97% correlation 6hr ID & 1897% correlation 6hr ID & 18--24hr ID 24hr ID Discrepancies:Discrepancies:

S. aureusS. aureus: inform clinicians if cefoxitin resistant : inform clinicians if cefoxitin resistant Prelim AST Prelim AST

Growth at 4Growth at 4--6hr6hr8 performed8 performedOnly 1 antibiotic discrepancy: Only 1 antibiotic discrepancy: K.pneumoK.pneumo Cefepime prelim Vitek MIC <=1(3Cefepime prelim Vitek MIC <=1(3rdrd

gen ceph res), at full incubation Vitek MIC=8, gen ceph res), at full incubation Vitek MIC=8, Encourages you to look at ID/AST early! Encourages you to look at ID/AST early!

Pantoea agglomeransPantoea agglomeransPantoea dispersaPantoea dispersa

S.warneriiS.warneriiS. capitisS. capitis

S.epi & S.hominsS.epi & S.hominsS. epidermidisS. epidermidis

Vitek MS IDVitek MS IDPrelim IDPrelim ID

Blood Culture WorkflowBlood Culture WorkflowPositive

Blood Culture

Gram stain

Culture Direct Susceptibility

Vitek MS ID

Preliminary Vitek MS ID@4-6hr growth

Inform Clinician

Prelim Vitek 2 AST @ 4-6hr growth

Inform Clinician

Vitek 2 AST

Inform Clinician

Day 2 am

Day 1

Day 3

Clinical Impact: Case 1Clinical Impact: Case 1

Haematology patientHaematology patientPersistent line related bacteraemiaPersistent line related bacteraemiaTx: Meropenem & VancomycinTx: Meropenem & VancomycinSat pm: blood culture flag posSat pm: blood culture flag posSun am: Vitek MS ID: Steno maltophiliaSun am: Vitek MS ID: Steno maltophiliaChange Tx : Stop Meropenem, Change Tx : Stop Meropenem,

Add Timentin & SeptrinAdd Timentin & Septrin

ID & appropriate treatment 1 day earlier using ID & appropriate treatment 1 day earlier using Vitek MSVitek MS

Clinical Impact: Case 2Clinical Impact: Case 290 yr old lady90 yr old lady

Hospitalised 3 week, cardiac problemsHospitalised 3 week, cardiac problemsHospital acquired pneumonia, pip/tazo & vancHospital acquired pneumonia, pip/tazo & vancBlood culture flag pos, gram=GNDC Blood culture flag pos, gram=GNDC Vitek MS ID 99.9% @ 6hr = Vitek MS ID 99.9% @ 6hr = N.meningitidisN.meningitidisTx Tx changed to Ceftriaxone & isolated changed to Ceftriaxone & isolated droplet precautions and contact tracing starteddroplet precautions and contact tracing startedID confirmed at full incubation by MALDI ID & PCRID confirmed at full incubation by MALDI ID & PCR

Impact of early IDImpact of early IDChoice of appropriate TxChoice of appropriate TxInfection control measures implemented soonerInfection control measures implemented soonerPublic health notification Public health notification

MALDI Impact on Respiratory TATsMALDI Impact on Respiratory TATs

Comparison of Cumulative % Turn around Time (TAT) for Respiratory Cultures Q1 2013 vs Q1 2014

100%100%99%

1%6%

8%

29%

80%

96%

Q1 2013

80%

97%95%

60%

13%

3%

Q1 2014

90%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Day 0 Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Day 8 >8 days

Days to reporting

Cu

mu

lati

ve %

TA

T

Vitek MS & Myla: ProsVitek MS & Myla: ProsTimeTime--saving:saving:

–– Rapid ID: Clinical Impact Rapid ID: Clinical Impact –– Automated: Reduced hands on timeAutomated: Reduced hands on time

Future proof: full laboratory automationFuture proof: full laboratory automation–– Reagent ordering, batch acceptance, IQCReagent ordering, batch acceptance, IQC–– Enhanced TATsEnhanced TATs

Improved Quality: Clinical impactImproved Quality: Clinical impact–– accurate ID reporting, enhanced speciationaccurate ID reporting, enhanced speciation

Blood culture: distinguish contaminants/pathogens Blood culture: distinguish contaminants/pathogens –– Consistent results: all staff & at all timesConsistent results: all staff & at all times

Only 1 colony required for IDOnly 1 colony required for IDFlexibleFlexible

–– Broad applicability: all bacterial types, aerobes, anaerobes, fuBroad applicability: all bacterial types, aerobes, anaerobes, fungingi–– Process small (Process small (��16) or large nos (192 samples/run)16) or large nos (192 samples/run)–– select from variety of media types & incubation conditionsselect from variety of media types & incubation conditions

Myla: Less transcription errorMyla: Less transcription error–– ID/AST transfer automatically, not transcribing API/coag resultsID/AST transfer automatically, not transcribing API/coag results

Traceability: records held indefinitelyTraceability: records held indefinitely–– Reagents & disposables: target slidesReagents & disposables: target slides–– ID/AST results ID/AST results –– User login recordUser login record–– Auditing, qualityAuditing, quality

Change in workflowChange in workflow: rationalise, centralise ID/AST: rationalise, centralise ID/ASTTraining: user friendlyTraining: user friendly, 1 ID method, 1 ID methodCostCost

–– Low consumables cost: Low consumables cost: approx 40 cent/ID (Vitek ID approx 4approx 40 cent/ID (Vitek ID approx 4€€))–– Fewer reagents in use, order, batch accept, IQCFewer reagents in use, order, batch accept, IQC

Environmentally friendlyEnvironmentally friendly: less consumable waste : less consumable waste Small footprintSmall footprint

Lessons Learnt & ChallengesLessons Learnt & Challenges

Remote access to Vitek2 through Remote access to Vitek2 through Myla.Myla.Suggest for next Myla update?Suggest for next Myla update?

Myla lacks full Myla lacks full Vitek2 functionalityVitek2 functionality

Vitek 2Vitek 2AST reviewAST review

Plan: Rearrange working day early/latePlan: Rearrange working day early/lateSLA with lab using same instrumentSLA with lab using same instrumentSmall stock: Vitek ID cardsSmall stock: Vitek ID cards

No access to No access to MALDIMALDI1 ID system1 ID system

Multiple ID Multiple ID methods methods availableavailable

CalibrationCalibrationBiann PMBiann PMBreakdownBreakdown

Interface requiredInterface requiredIssues: Responsibility Myla or LIMS?Issues: Responsibility Myla or LIMS?

Myla: Vitek2/VitekMyla: Vitek2/Vitek--MS/LIMSMS/LIMS

Vitek2 direct Vitek2 direct LIMSLIMS

ID/AST ID/AST MiddlewareMiddleware

Check classification/breakpoint Check classification/breakpoint committee: eg committee: eg Str. pseudopneumoniaeStr. pseudopneumoniae

New ID/no New ID/no breakpointsbreakpoints

Breakpoints Breakpoints availableavailable

ID/ASTID/AST

Check colony morphology & IDCheck colony morphology & IDHuman/numerical errorHuman/numerical error

Algorithms: when to accept ID: 99.9%Algorithms: when to accept ID: 99.9%Skills loss? Ongoing training & edSkills loss? Ongoing training & ed

OverOver--reliance on reliance on MALDI IDMALDI ID--forget to check forget to check gram, morphgram, morph

Use of trad ID Use of trad ID methods: gram methods: gram morphology, morphology, biochem, sero biochem, sero teststests

Automation Automation of IDof ID

Inform of users of changeInform of users of changeInclude comment on report: Include comment on report: ““Strep Strep agalactiae was previously reported by this laboratory agalactiae was previously reported by this laboratory as Beta Haemolytic Strep Group Bas Beta Haemolytic Strep Group B””

New/unfamiliar IDNew/unfamiliar ID--increased increased speciationspeciation

Familiar namesFamiliar namesClinicians/MS Clinicians/MS

IDID

What did we do?What did we do?Post MALDIPost MALDIPre MALDIPre MALDIChallengeChallenge

Has it been worth it?Has it been worth it?

Validation & training required in change overValidation & training required in change overFaster, better, cheaper: rapid, accurate, consistent IDFaster, better, cheaper: rapid, accurate, consistent IDStill learning: unfamiliar IDsStill learning: unfamiliar IDsPrompted change in work practices & workflowPrompted change in work practices & workflowMore time to deal with unusual ID/ASTMore time to deal with unusual ID/ASTFuture: Future: –– preliminary blood culture ID preliminary blood culture ID –– Mycobacteria IDMycobacteria ID–– detection of resistance: CPE detection of resistance: CPE

YES!YES!

lrose@stjames.ielrose@stjames.ie

Thank youThank you