VITEK MS Implementation of Mass Spectrometry

Transcription

1 VITEK MS Implementation of Mass Spectrometry Willson Jang, Technical Leader Microbiology & Virology Laboratory Providence Health Care St. Paul s Hospital October 23, 2013

2 Presentation Outline Procurement Physical Logistics Validation and Training Implemenation Future

3 Procurement Business Case in 2012 Based on a 2011 LMC (Lower Mainland Consolidated) Lab evaluation of Vitek MS and Bruker microflex 5 laboratories (4 hospital, 1 reference) Over 3000 organisms tested

4 Procurement Business Case No significant economic differences between the 2 systems $1.59 (Vitek MS ) vs. $1.57 (Bruker) Clinical sites to choose the platform that fits best with their existing equipment set-up and work processes Based on 80,000 annual samples ROI 8.7 months TAT reduction average 36 hours to 5-10 minutes per identification

5 Procurement BC Health Care Reality 2013 Capital $$ Achieve savings ( Deep Dive ) in operational budgets Funding from: Health Authority Capital $$ process (difficult for net new technology) group together with replacement of ID/AST analyzer (ie. system ) Lease operational budget Foundation $$ from donors

6 Physical Logistics Placement of Vitek MS Size: No larger than a 70 o C upright freezer or incubator IT connections MYLA remote access (IMITS Security and Privacy) and requires IE8 or higher LEAN Principles 28 W x 76 H 33 W x 78 H 39 W x 77 H

7 Physical Logistics PHC Microbiology Lab is old (1983) and floor space not open concept WASH UP SETUP OFFICE OFFICE MEDIA MAKING OFFICES WIF MEDIA MAKING MYCOLOGY WIF Blood Cultures RESIDENT ROOM B E N C H E S OFFICE TB TB VITEK 2 STUDENT AREA

8 Physical Logistics IT Connections IT Closet (port to port connection) including remote access (MYLA) WASH UP SETUP OFFICE OFFICE MEDIA MAKING WIF MEDIA MAKING WIF Blood Cultures B E N C H E S OFFICES MYCOLOGY RESIDENT ROOM OFFICE TB TB VITEK 2 STUDENT AREA

9 Physical Logistics MYLA SERVER

10 Validation and Training Validation Based on our organisms tested (2011 evaluation and onwards) >1000 organisms For our purchased Vitek MS, we ran a panel of 16 organisms (included our 12 training organisms) daily over a period of 1 week

11 Validation and Training Training Staff during spare time were encouraged to ask a Supervisor to train them (SOP theory and methodology) Staff were given a panel of 12 clinical isolates Upon getting all 12 isolates correctly ID d allowed to use Vitek MS for clinical specimens Spotting technique is critical

12 Validation and Training 12 organism panel consisted of: Aeromonas hydrophila Haemophilus influenzae Candida guillermondii Staph. lugdunensis Strep. equi ssp. zooepidemicus Rothia mucilaginosa Cryptococcus neoformans Strep. gallolyticus ssp. pasteurianus Citrobacter amalonaticus Strep. dysgalactiae ssp. equisimilis Campylobacter jejuni Candida krusei

13 Validation and Training Importance of spotting of isolates onto target plate not too much less is better Bacterial isolate placed on each circle Apply 1.0 μl of Matrix For yeasts, apply 0.5 μl formic acid before 1μL Matrix

14 Implementation Workload Units CIHI (Canadian Institute for Health Information) 2013 lacking Microbiology MALDI-TOF workload codes/units Sought help from CMUG and BC Labs (VGH and BC Children s) to standardize our workload units Was MALDI-TOF an upgradable (Tech 2) work procedure? BC HSA MoU Additional Procedures Gas Chromatography (GC) or GC/Mass Sepctrophotometry [Chemistry] Medical Tech 1 procedure

15 Implementation General Vitek MS Process Direct (1 spot) No ID Reaquire No ID Extraction (0.5 μl formic acid) No ID SARAMIS/Vitek MS Plus (batch once per day) and conventional ID protocol

16 Implementation Organism Groups phased in Enterobacteriaceae Cystic Fibrosis NLF s (P. aeruginosa, B. cepacia complex, S. maltophilia) Top 5 yeasts (C. albicans, C. dubliniensis, C. glabrata, C. parapsilosis, C. tropicalis) and Rhodotorula E. faecalis / E. faecium Next H. influenzae, Strep. pneumoniae and other Streps, Staphylococci

17 Implementation For ALL benches except Stool IF Vitek MS And Then LF GNR E. faecalis / E. faecium C. albicans, C. dubliniensis, C. glabrata, C. parapsilosis, C. tropicalis Rhodotorula 1 >99% Correlate with colony Accept and report 1 colony must be pink 95-99% Correlate with colony and susceptibility pattern Review history. If previous history, accept and report. If no PHIST, wait for susceptibility. <95% Do not accept. Perform conventional ID. NLF GNR >99% P. aeruginosa Correlates with colony Accept Enterobacteriaceae 2 2 Exception E. coli. B. cepacia complex S. maltophilia Further testing by Vitek2 ID to R/O Shigella 95-99% Correlate with colony and susceptibility pattern Review history, if PHIST accept and report. If no PHIST, wait for AST. <95% Do not accept. Perform conventional ID Other NLF ID Conventional ID

18 Implementation Stool Bench IF Vitek MS And Then Isolate requires screen circle and number the colony >99% Non-pathogen Correlates with colony Accept <95% Non-pathogen or no ID Go back to plate and set up stool screen sugars on circled isolate E. coli Set up LIM, BAP, MAC If Shigella is suspected then set up stool screen sugars (and Vitek2 if enough colonies) Salmonella, Yersinia, Aeromonas >99% Campylobacter jejuni Gram stain gull wing gram negative rods, oxidase positive Do not report, inform Med Micro. Set up BAP, MAC and Vitek/API (and AST as required) if enough colonies Report

19 Implementation Quality Assurance Calibration organism (E. coli ATCC 8739) for every acquisition group of 16 spots Daily QC: E. aerogenes ATCC E. faecalis ATCC C. glabrata ATCC MYA-2950 Negative control (matrix) EQA Programs CAP, CMPT, NMG-NML

20 Implementation Direct Blood Culture ID Direct Vitek MS ID of + ve Blood Cultures Use non-charcoal bottles (Plus) Lysis-Filtration Protocol

21 Implementation Direct Blood Culture ID Direct Vitek MS ID of + ve Blood Cultures Blood Culture bottles signalled + ve are removed

22 Implementation Direct Blood Culture ID Direct Vitek MS ID of + ve Blood Cultures 2 ml aliquot of positive blood culture Add lysis buffer Vacuum Filtration

23 Implementation Direct Blood Culture ID Direct Vitek MS ID of + ve Blood Cultures Wash Buffer and Water Rinse Scrape filtrate off and apply to target slide Wash Buffer and Water Rinse Scrape Filtrate off and apply to target slide

24 Implementation Direct Blood Culture ID Direct Vitek MS ID of + ve Blood Cultures Add matrix (or formic acid and matrix for yeast)

25 Implementation Direct Blood Culture ID Results (2012 Study 23 rd ECCMID ep758) 207 positive bottles (95 patients) Overall 79% correct identification (90% for Gram negative organisms and 75% for Gram positive organisms) 17 bottles (6 patients) grew multiple organisms Correctly ID d Gram negative isolate in 8 of 10 mixed cultures with a Gram negative organism and Gram positive organism No correct ID with 2 Gram positive organisms (7 mixed cultures)

26 Implementation Direct Blood Culture ID Results Overall average time to ID was 13 hours compared to 33 hours for conventional ID (included bottles detected positive outside of laboratory operating hours) For bottles detected positive during standard lab operating hours, the average time to ID was 4 hours compared to 24 hours for conventional ID

27 Implementation Direct Blood Culture ID Table 1: Gram negative organisms recovered Organism # recovered # correct ID Enterobacteriaceae (40) E. coli K. pneumoniae 3 3 Enterobacter aerogenes 2 2 K. oxytoca 1 1 S. marcescens 1 1 Salmonella spp. 1 0 Morganella morganii 1 0 Fastidious aerobic Gram negative bacilli N. elongata 2 2 [GNB] (4) H. aphrophilus 1 0 Moraxella Gram negative organisms recovered - 44 (90%) concordant identifications when compared to conventional methods Non fermenter GNB (2) P. aeruginosa 1 1 A. baumanii 1 1 Anaerobic GNB (1) B. fragilis 1 1 Other (2) Asaia species 2 0 TOTAL (90% correct ID) 49 44

28 Implementation Direct Blood Culture ID Table 2: Gram positive organisms recovered Organism # recovered # correct ID Staphylococci (85) S. aureus Coag-negative Staphylococcus 16 8 Streptococcus S. pneumoniae 15 8 (33) S. mitis/oralis or S. sanguinis 8 8 S. dysgalactiae 4 2 S. pyogenes 2 2 S. mutans 2 1 S. salivarius 2 2 Enterococci (15) E. faecalis 8 8 E. faecium Gram positive organisms recovered (75%) concordant identifications when compared to conventional methods Yeast (5) C. neoformans or C. glabrata 3 3 C. albicans 2 1 Gram positive bacilli (3) Corynebacterium spp. or Propionibacterium spp. 2 0 Bacillus spp. 1 1 TOTAL (75% correct ID)

29 Future Continue adding organism groups MYLA interface with our LIS Mycobacteria and Mycology SARAMIS spectra with our sequenced organisms CIHI 2014 Workload Units (include MALDI-TOF?)

30 Let s Vitek MS the organism!!