Implementing Vitek MS: The St James’s Hospital Experience Lisa Rose Senior Medical Scientist Microbiology Dept. St James’s Hospital, Dublin, Ireland [email protected] Outline Vitek MS & Myla Validation Vitek-MS Workflow Advantages & Challenges St James’s Hospital, Dublin 1000 bed tertiary care hospital Largest laboratory in Rep of Ireland Microbiology lab: >300,000 specimens/yr MALDI: What did we want & Why? Current issues: – Improved patient care: antibiotic therapy & MDRO & management of sepsis – Staffing restrictions – Stringent budget control Faster ID Cheaper Better Consistent results: all staff & all shifts Automated: future-proof - full lab automation Easy to use: training Reduce TATs Reallocate staff to added value tasks Improve patient management & antimicrobial therapy How did we Implement Vitek-MS? Selection: performance, existing instrumentation, middleware ISO15189:2012 standard Installation qualification (IQ) – Installation engineer – – – – Delivery Unpacking Vitek MS – PC check Prepare slide, fine tuning Installation Operational Qualification (OQ) – Medical scientist & application specialist – – – Creation of user accounts Barcode validation Send analysis request ID & AST from LIS Workflow Vitek MS Performance Qualification (PQ) – equipment consistently performs as intended Training Validation OQ: Interface Local LIS support essential from start of project Prepare detailed LIMS validation protocol All permutations – Investigation types – MRN/hospital source – ID, ID/AST Dedicate resources at time of switch over: staff, time, space Myla uses stem organisms: Multiple codes for different organisms Never switch over on a Friday! Vitek MS PQ Accuracy of ID: – 40 ATCC bacterial, 2 ATCC fungal strains – Tested in duplicate Repeatability of ID: – ATCC stains tested, 2 operators, on 3 different occasions Reproducibility/precision of ID: – ID 15 ATCC isolates, in triplicate, 2 operators, same slide Results: 100% accuracy, repeatability, reproducibility Bacteroides fragilis ATCC 25285 Haemophilus influenzae ATCC 49766 Neiserria meningitidis ATCC 13090 Staphylococcus aureus BAA1026 Campylobacter jejuni ATCC 33291 Haemophilus influenzae NCTC 8468 Pseudomonas aeruginosa, ATCC 27853 Staph. epidermidis ATCC 12228 Candida albicans ATCC 10231 Klebsiella pneumoniae BAA 1705 Proteus mirabilis ATCC 12453 Staph. saprophyticus ATCC 15303 Candida parapsilosis ATCC 2019 Klebsiella pneumoniae BAA 1706 Salmonella typhimurium ATCC 14028 Streptococcus agalactiae 12386 Clostridia perfringens ATCC 13124 Klebsiella pneumoniae BAA 2146 Serratia marcescens ATCC 8100 Strep. pyogenes, ATCC 19615 Escherichia coli ATCC 25922 Klebsiella oxytoca ATCC 700324 Staphylococcus aureus, ATCC 25923 Strep. pneumoniae ATCC 49619 Escherichia coli ATCC 35218 Klebsiella pneumoniae ATCC 700603 Staphylococcus aureus ATCC 29213 Streptococcus equisimilis43079 Enterococcus faecalis ATCC 51299 Legionella pneumophila ATCC 33152 MRSA, ATCC 43300 Stenotrophomonas ATCC 13637 Enterococcus faecalis ATCC 29212 Moraxella catarrhalis, WILD Staphylococcus aureus BAA 976 V. parahaemolyticus ATCC 17802 Haemophilus influenzae ATCC 49247 Neiserria gonorrhoeae. ATCC 49226 Staphylococcus aureus BAA 977 Y. enterocolitica ATCC 27729 PQ: Prospective Clinical Study Isolates No. ID method Correlate Staph sp. 52 tube coagulase Pastorex Staph plus latex agglutination kit 100% GNBs: E.coli, P.aer, 51 Vitek GN, API 20NE, ChromID CPS 100% H.influ, S.pn, Str sp, Moraxella 21 X&V, optochin, API rapid NH, Tazo sugars 100% BHS 54 Prolex Streptococcal latex grouping kit 100% Neisseria 15 API Rapid NH, Phadebact Monoclonal GC 100% Candida 11 API ID32C, Cornmeal, germ tube 100% APIID32A, API Coryne, gram morphology 100% S.aureus CNS Kleb, Ent spp, Citro, Ser, Prot, Morg Coryne & Clostridium Comments 2 Lancefield Grp G isolates: 50%/50% Str dysgalactiae subsp. equisimilis/ Streptococcus dysgalactiae subsp. dysgalactiae Species Id sufficient 2 isolates ID to genus level Vitek MS ID to species PQ Validation of Media Type ATCC Strains Media Type ID Correlation Staph Chocolate Mannitol Salt MacConkey MRSA Chrome 100% GNB Blood Chocolate MacConkey Chrome, ASAP, DCA, TCBS, CIN 100% Ent/Strep Chocolate MacConkey Neomycin & NAT VRE selective agar 100% Anaerobic & Microaerophilic H.influ, Neisseria Camp B.frag & Cl.per Candida 4 ATCC, 2EQA, 36 isolates 100% Choc Choc, NYC Choc, Blood Blood, NEO, NAT Blood Malt 100% BA: Blood Agar; Choc: Chocolate Agar; ASAP: Salmonella ASAP agar; CIN: Cefsulidin, Irgasin, Novobiocin agar; TCBS: Thiosulfate citrate bile sucrose agar, DCA: Desoxycholate citrate agar PQ: Effect of Culture Age and Storage on ID 16 ATCC strains tested • CO2, O2, 35 °C: 24hr, 48hr, 72hr • Room temp: 24hr, 48h • 4 °C: 24hr, 48hr 100% correlation at 24hr, 48hr 15/16 correlate at 72 hr • N. gonorrhoeae ID unreliable after 48hr (low ID/fail to ID) 24 hr 4 8 72 hr h r St aureus 25923 St epidermidis12228 Ent. faecalis 29212 Strep. pyogenes 19615 Strep. agalactiae 12386 Strep. pneumoniae 49619 E. coli 25922 Ser. marcescens 8100 Kleb. pneumoniae 700603 Ps aeruginosa 27853 Steno. maltophilia 13637 Proteus mirabilis 12453 Candida albicans 10231 H. influenzae 49249 Neis. gonorrhoeae 49226 Mor. catarrhalis (wild) ** RT @24 RT @48 4˚C @24 4˚C @48 Workflow Plate Platereading: Reading Significant growth? Centralised Centralised ID/AST Centralised ID Barcode! Day 1 Approx 1min/ID Check! TATs Commensals Report Released Purity Plates Centralised AST Inform Clinician Check! Centralised Review ID/AST Day 2 am Workflow Organism Pre MALDI Post MALDI E.coli (Urines) CPS Chrom ID CPS Chrom ID MRSA screen MRSA Select MRSA Select & Vitek MS GNB Vitek ID Staph sp. Pastorex Tube coag Vitek ID Ent sp. Vitek GP ID card BHS Latex group, Bacitracin Haemophilus XV, API Strep Optochin Vitek ID API Candida API Germ tube Cornmeal agar N.gonorrhoeae API NH Phadebact Vitek MS Phadebact Mould Microscopy Microscopy Vitek MS Bidirectional Interface LIS Vitek PC Acquisition PC Prep Station PC Myla Pros: ID & AST (S, I, R) results available in Myla Results transfer automatically – less transcription error Multiple users access results in Myla Micro medical staff access results Cons: Full Vitek functionality not available in Myla Link to Vitek software Cannot change S/I/R in Myla MALDI ID Challenges/Algorithms Subspecies/species group – – – – Ent cloacae asburiae/cloacae 50%/50%: report as E.cloacae complex. Proteus vulgaris/penneri 50%/50%: report as P.vulgaris/penneri Strep dysgalactiae sub sp. dysgalactiae/Strep dysgal sub sp equisimilis equisimilis LIS translates both eg Strep. dysgal Strep ID: if consistently fail ID: calibration required? N. gonorrhoeae: continue to perform Phadebact monoclonal GC test Organisms with low ID accuracy: – – H.pylori Haemophilus haemolyticus, Asp. niger, Aerococcus urinae, Peptoniphilus Peptoniphilus asaccharolyticus NLF ?E.coli: Shigella & E. coli 0157 ID as E. coli - perform Vitek ID Brucella sp. not in database Moulds: more Aspergillus species in database Corynebacterium sp: more species in database Vitek MS Preliminary Blood Culture ID/AST Prelim ID No of isolates: 115 Growth at 4-6hr Isolate types: GNB, Staph, Ent 97% correlation 6hr ID & 18-24hr ID Discrepancies: Prelim ID Vitek MS ID Pantoea dispersa Pantoea agglomerans S. epidermidis S.epi & S.homins S. capitis S.warnerii S. aureus: inform clinicians if cefoxitin resistant Prelim AST Growth at 4-6hr 8 performed Only 1 antibiotic discrepancy: K.pneumo Cefepime prelim Vitek MIC <=1(3rd gen ceph res), at full incubation Vitek MIC=8, Encourages you to look at ID/AST early! Blood Culture Workflow Positive Blood Culture Gram stain Culture Day 1 Preliminary Vitek MS ID @4-6hr growth Direct Susceptibility Prelim Vitek 2 AST @ 4-6hr growth Inform Clinician Vitek MS ID Day 2 am Day 3 Inform Clinician Vitek 2 AST Inform Clinician Clinical Impact: Case 1 Haematology patient Persistent line related bacteraemia Tx: Meropenem & Vancomycin Sat pm: blood culture flag pos Sun am: Vitek MS ID: Steno maltophilia Change Tx : Stop Meropenem, Add Timentin & Septrin ID & appropriate treatment 1 day earlier using Vitek MS Clinical Impact: Case 2 90 yr old lady Hospitalised 3 week, cardiac problems Hospital acquired pneumonia, pip/tazo & vanc Blood culture flag pos, gram=GNDC Vitek MS ID 99.9% @ 6hr = N.meningitidis Tx changed to Ceftriaxone & isolated droplet precautions and contact tracing started ID confirmed at full incubation by MALDI ID & PCR Impact of early ID Choice of appropriate Tx Infection control measures implemented sooner Public health notification MALDI Impact on Respiratory TATs Comparison of Cumulative % Turn around Time (TAT) for Respiratory Cultures Q1 2013 vs Q1 2014 95% 100% 96% 99% 90% 90% 80% 80% Cumulative % TAT 97% 100% 80% Q1 2014 70% 60% 60% Q1 2013 50% 40% 29% 30% 20% 10% 13% 3% 1% 6% 8% 0% Day 0 Day 1 Day 2 Day 3 Day 4 Day 5 Days to reporting Day 6 Day 7 Day 8 >8 days TimeTime-saving: Vitek MS & Myla: Pros – – Rapid ID: Clinical Impact Automated: Reduced hands on time – – Reagent ordering, batch acceptance, IQC Enhanced TATs Future proof: full laboratory automation Improved Quality: Clinical impact – accurate ID reporting, enhanced speciation – Consistent results: all staff & at all times – – – Broad applicability: all bacterial types, aerobes, anaerobes, fungi fungi Process small ( 16) or large nos (192 samples/run) select from variety of media types & incubation conditions – ID/AST transfer automatically, not transcribing API/coag results – – – – Reagents & disposables: target slides ID/AST results User login record Auditing, quality – – Low consumables cost: approx 40 cent/ID (Vitek ID approx 4€ 4€) Fewer reagents in use, order, batch accept, IQC Blood culture: distinguish contaminants/pathogens Only 1 colony required for ID Flexible Myla: Less transcription error Traceability: records held indefinitely Change in workflow: workflow: rationalise, centralise ID/AST Training: user friendly, friendly, 1 ID method Cost Environmentally friendly: friendly: less consumable waste Small footprint Lessons Learnt & Challenges Challenge Pre MALDI Post MALDI What did we do? ID Familiar names Clinicians/MS New/unfamiliar ID -increased speciation Inform of users of change Include comment on report: “Strep agalactiae was previously reported by this laboratory as Beta Haemolytic Strep Group B” B” Automation of ID Use of trad ID methods: gram morphology, biochem, sero tests Over-reliance on MALDI ID -forget to check gram, morph Check colony morphology & ID Human/numerical error Algorithms: when to accept ID: 99.9% Skills loss? Ongoing training & ed ID/AST Breakpoints available New ID/no breakpoints Check classification/breakpoint committee: eg Str. pseudopneumoniae ID/AST Middleware Vitek2 direct LIMS Myla: Vitek2/VitekMS/LIMS Interface required Issues: Responsibility Myla or LIMS? AST review Vitek 2 Myla lacks full Vitek2 functionality Remote access to Vitek2 through Myla. Suggest for next Myla update? Calibration Biann PM Breakdown Multiple ID methods available No access to MALDI 1 ID system Plan: Rearrange working day early/late SLA with lab using same instrument Small stock: Vitek ID cards Has it been worth it? Validation & training required in change over Faster, better, cheaper: rapid, accurate, consistent ID Still learning: unfamiliar IDs Prompted change in work practices & workflow More time to deal with unusual ID/AST Future: – – – preliminary blood culture ID Mycobacteria ID detection of resistance: CPE YES! Thank you [email protected]
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