View
6
Download
0
Category
Preview:
Citation preview
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
Recommended