Presentation on theme: "OUR EXPERIENCES WITH THE PHOENIX"— Presentation transcript:
1OUR EXPERIENCES WITH THE PHOENIX BSAC13TH May 2010J. HancockCwmTaf Microbiology and Infectious Diseases ( MID ) Service Lead
2Experiences with the PHOENIX Why we have the PhoenixImplementationProcessingIssues--- ID---AST---Practical experiences---Company support
3The Royal Glamorgan Hospital Set the scene – back in 2005 , the laboratory at RGH ‘s standard susceptibility testing was the VITEK one and E tests for fastidious organisms using as was NCCLS break points .The laboratory was fully funded for the consumable cost for automated sensitivities and had realigned its skill mix to support the cost Howeverthis methodology was out of kilter with most labs across Wales who were using disc testing and BSAC 2004 methodology
4Welsh Procurement led by the NPHS( PHW ) end of year capital 2005 WHY did we have Phoenix???RGH Changed from Vitek 1 to Phoenix in 2005/2006‘Free’ from WAG !!!!Welsh Procurement led by the NPHS( PHW ) end of year capital 2005AimStandardise susceptibility testing across WalesComparable data across WalesEarly in 2005 we were approached by the NPHS to see if we would be prepared to take part in an all Wales tender for a new/er automated instument .When discussed with staff , everyone agreed that they would rather have an updated version of the VITEK but they were prepared to work with any validated automated system . The outcome of the initial tendering process yielded two companies . Both were invited to present their and the procurement team followed the process and finally the contact was awarded to BD and the phoenix rose from the ashes so to speak !!! .
5HOW? it was achieved across Wales Wide Consultation with clinical and laboratory scientific staff from all laboratoriesAgreement to :-to use British Society for Antimicrobial Chemotherapy systemic breakpointsdesign bespoke Welsh panelsto implement according to a testing algorithm( except RGH )Standardise expert interpretation rules within the systemThere were a number of meetings where we agreed across Wales ( exception of one lab )
6IMPLEMENTATION at RGH (first lab in Wales) Instrument location/ Bench/BD standSite surveyWell ventilated /air conditioned roomSpace for EpicentrePower( red socket )LIS connectionTraining -Two fully trained BMS staffLocal training --- half dayOther staff as required---BMS, MLA, Medical Staff---basic trainingWe had to do the same as always we decided we would have it sited on a bench . Had to decide if the bench would be stong enough so our substantilaly built estates manager sat on the bench and siad – YES no probs ( he did do it proberly as well later on )
7IMPLEMENTATION cont’d Phoenix Sited in the Main labBoxes of Panels stored – everywhere !!!3 work areas :–CL3 ( storage of boxes)Urines/faecesMain labWe decided NOT to centralise susceptibity testing but we agreed to have three main areas for put up – 3 nephelometers - £900 2 gave us 2 buy 3rdStorage of boxes was an issue . The CL3 lab was the biggest area for storage but we couln’t put them in there – John Daniels – fumigationIt would be an issue if we ever had to fumigate the lab .
8Instrument OverviewAutomated system for the identification and susceptibility testing of clinically relevant bacteriaState-of-the-art instrumentationDirect LIS ConnectionOptional EpiCenter data managementA maximum of 100 identification and antimicrobial susceptibility tests can be performed in the Phoenix instrument at a time using Phoenix combination panels the id panels are modifications of the classical methods – fermentation , oxidation , degredatiuon and hydrolysis of various substnces . Also uses chromogenic and fluorogenic substnces .Both microdilution – exposing the nbacteria to decreasing concentrtimns of antimicrobial agents in liquiid media by 2 fold diltion the lowest conc of the antibiotic that in which no visible growth occurs is the mic – the poenix is a miniaturised version of the micro-broth double diluting technique . – it is the determination of bacterial growth in the presence of various concentrations on the antimicrobial agent tested with the aid of the AST indicator in continuously incubated and read micro-wells in the panels .LIS and Epi interfaces are bi-directional and unsolicited, if the user configures the interface that way.
9Phoenix Instrument Random Panel Entry Only 1 moving part : rotor No pipetting of liquids or transfer of samplesInstrument Self-checkNo Calibration RequiredMinimal Maintenance“Pared down” free standing design for customers who do not want added data management.Maintenance required:changed 3 filters approx... 6 monthstest LED’s weeklytemp check daily or as required by local regulating agency
10Simple daily and weekly checks Daily instrument reportTemperaturePanel statusLED LightsDaily back up CDCalibrate the Nephelometers weeklyIf any checks fail – phone BDDidn’t stop us having a normaliser failureSimple daily checks – print a sheet off the computer which gives confirmation that the instument is ok – nornlise passedDaily – record the temp on the main screen and the panel temp printer suppy .Daily check the LED lights and the alert indicator and the audible alarm
11Phoenix Instrument Soft-keys Simple to operate Barcode-reader Fast and easy scanning of panel number BUTStill type in specimen number- transcription errorsSoftwareEasy adding of information? BUTNo training on EpicentrePANEL nos – code for the GP pos /negInsufficient space on panel design for bar code labels – All Panels need to labelled BEFORE working on them -
12Phoenix Instrument 100(99) panel capacity (200 tests) Incubates panels and reads every 20 minutesIdentification databaseBDXpert system4 tiers are stacked vertically. Each tier hold 26 panels. (One panel in each tier is a normalizer panel.) 99 ACTUAL – TEMPERATURE PANELReadings are on the hour, 20 minutes after the hour and 40 minutes after the hour.BDXpert system consists of standards breakpoints (NCCLS, SFM or DIN) AND the expert rules to determine resistance markers, intrinsic resistance, etc.
13Software Use of up to date Standards Customized adjustment possible EUCASTCLSISFMCustomized adjustment possibleUpgrades are fairlyt simple and usually by the lab staff via a CD and a verbal talk through
14Phoenix Panels Identification & Susceptibility Susceptibility Leak Resistant51 ID wells (45 substrates)85 AST wells (doubling dilutions)Room temp storage–(AST INDICATOR -- 4◦C)One type for:GN (Enterobacteriaceae/Nonfermenters)GP(Staphylococci/Enterococci/Streptocci)Streptocci ID/AST)ONLY Gram-stain necessary!Many different AST formats available–agreed Welsh FormatA sealed and self-inoculating molded polystyrene tray, with 136 micro-wells containing dried reagents, serves as the Phoenix disposable.The combination panel includes an ID side with dried substrates for bacterial identification and an AST side with varying concentrations of antimicrobial agents, growth and fluorescent controls at appropriate well locations.The Phoenix system utilizes an optimized colorimetric redox indicator for AST, and a variety of colorimetric and fluorometric indicators for ID.The Phoenix Panel is comprised of a 51 well ID side and an 85 well AST side.The ID side contains 45 wells with dried biochemical substrates and 2 fluorescent control wells.The AST side potentially contains up to 84 wells with dried antimicrobial agents and 1 growth control well.Panels are available as ID only, AST only, or ID/AST combination. Unused wells are reserved for future use.Panel has one format; ID only will have only the ID side filled, AST only will have only AST side filled.The only refrigerated component is the AST Indicator.
15PHOENIX Panel Issues Identification only Susceptibility only 10,000 a year usageyear to change panelsAgreed Welsh FormatStorage -- HUGE BOXES – room tempEnsure the caps are on properly( caught in the instrument )CAPS HAVE CHANGED – Removel of outer edge which was the bit that got caughtAlthough they state that they have id and ast panels it has since transpired that if you have bespoke panels , you have to guarentee 10,000 usuage per year and if ypu want to change the format of your panel it can take a year before the new panels are available .From our lab perspective as we have agreed to use the welsh format it prohibits us using the ast panels that are used by Europe – hopefully this will be adddressd soon .Storage of the panels is an issue because of the size but it would be even worse if they had to be fridrged .In the early days , we had some issues with staff not pushing the caps down firmly enough and the edges of the caps caught in the instument .The company appear to have solved this issue by changing the style of the cops and the edges do not over lap now .
16Not suitable for fastidious organisms ORGANISM SELECTIONGram negative panelEnterobacteriacaeBurkholderia cepaciaPseudomonas sppProblems with :-Mucoid organismsGram positive panelStaphylococciEnterococciListeriaCorynebacteriaNot suitable for fastidious organismsCan have id but no AST
17Validated Media Cannot use media containing esculin Chromagar Orientation may cause false susceptibility results when testing erythromicin with Gram+
18RGH Organism selection Organisms picked from -- non antibiotic containing medium HBA /heated HBA ( CHOC )CLEDMacConkeyUrine Chrom agar ( not the MRSA chrom)
19Workflow Safety with a closed panel design The test organism is inoculated in to the broth – 0.5/0.6 McFarland as measured by the nephelometer . Select appropriate panelOpen foil and place in inoculating rackPlace ID and AST broths in rackAdd one drop of indicator to AST brothPrepare organism suspension in ID brothTake 25µl of ID broth into AST brothPour broths into wells of panelFit closures to panelTransfer to vertical holding racksLoad on PHOENIX
20Phoenix Issues Sensitivity – 2005 EQA Sensitivity - Present IdentificationInstrumentInitially when we statred using the instrument Dr White had a feeling there were some issues so the lab performed a number of e tests to investigate .
22Initial testing issues 2005 phoenix v Etest Trimethoprim - Staphylococci BP was 0.5Changed to 2 in 2007Choramphenicol - Staphyloccocci BP issue ( 8 -16)Not on panel any moreMeropenem - P.mirabilis all SensitiveGentamicin – P mirabilis I eTest always SensitiveErtapenem – lots of I/R ?? Why ? Inoculum dependent * carbapenem resistance markerRifampicin – Phoenix gave - XChange of BP and issue resolvedMupirocin - Staphylococci flagged as high level resistance with an MIC < 1ESBLs (1505) need to check the Cephalosporins and confirm with E test any new isolateMost of the initial work was requested by Dr White as she wished to ensure that the reults that the phx was generated were accurate .This work resulted in the lab perfoming a lot of E tests to confirm or not as the case might be if the phx resluts were accurataeTHE RESISTANCE TO TRIM ON STAPHS ESPECIALLY MRSA was very high . Due to the inappropriate BP set at 0.5 changed to 1 and then 2 this was reviewed in O7Prot mirabilis Mero all sensitive even though the organism has low level resistance to IMP .Often have a flag forACINS AND PSEUDO RESISTANT
23Summary EQA sensitivities 2005-06 In this year we recieved -4 x E.coli3 x Ps.aeruginosa2 x E.faecalis1 x E.faecium6 x S.aureus - ISSUEIssueFor 2 of the S.aureus isolates we scored only 1 as the Phoenix reported Erythromycin as I and it should have been R.We missed the Clindamycin dissociated resistance
25Summary EQA sensitivities 2008-09 OrganismAntibiotic/TestReportedActualNEQASResultExtraE.coliESBLPositiveNegativeNot ScoredRpt stillE.faecalisVancomycinRSEtest = RRpt= SensitiveA.haemolyticusCeftazidimeIPip/TazoEtest on BP
26Summary EQA Antimicrobial sensitivities 2009-10 Two sensitivity failures :-Phx ID = Enterobacter cloacae –Expert rules changed sensitivitiesActual ID = Klebsiella oxytocaConfidence limits 93% ( 99%)Human and Phoenix Error!!2. S.aureusPenicillin R >0.25 BUT rpt organism was SENS?? No idea ? Duff panel !!! Score = 0Not clinically relevant!! But NEQAS relevant
28Current Sensitivity Issues Staphylococcus aureus –- Phx result = Mupirocin High level Resistant when Low Level = Sensitive- Phx changes Low level to Resistant- Etest always confirms they are sensitive - COST!- Clinical Relevance – Affects treatment of colonised patients if it is not picked up !!Psuedomonas aeruginosa –Phx reports Ciprofloxacin as ResistantEtest confimation = Sensitive- Clinical Relevance – Reported in some Respiratory Samples and is often the only oral drug available for treatmentEscherichia.coli & Klebsiella spp –Phx reports Ertapenem as Resistant- All Etest results = Sensitive, ? NO CONFIRMED TRUE CARBAPENAMASE RESISTANCE !We still have currrent issues that are the same as the itial issues that we found !!!
30Summary of General EQA ID YearMeanPoints lost for Phx id1.9541.971.921.75 (ano2 orgs)– Phx could not correctly identify Aeromonas hydrophilia or Vibrio parahaemoliyticus to species level and points were lost.
31General Bacteriology EQA 2009-10 One failureB/C isolatePhx Id of culture -S.hominis ( confidence limits 99%)Actual (NEQAS) – S.epidermidis and rpt S.epidermidis“Double Whammy”Not noted it was a B/C isolate and Reported as No Significant GrowthBUT STILL ID WAS WRONG, WOULD HAVE SCORED ZERO!!!
32Current Identification Issues 1) Suspected S.aureusPhx Id’s them as a variety of Coag Neg StaphylococciRepeat Phx, Staphaurex and DNAse plate = COSTRepeat always confirms S.aureusProblem since new EUCAST panels were introducedClinical Relevance – Delay in reporting2) Coag Neg StaphylococcusRarely get the same organism to ID the same twiceVariety of confidence limitsClinical Relevance – ICU patients with ? Line associated Infections3) E.Coli & ShigellaPhx has difficulty distinguishing between themRepeat Phx and antiserum – Cost and Time4) Speciation of rarely isolated organisms e.g. Yersinia, Vibrio etc
33Instrument Issues Error Codes 1) E18 & E23 – Normaliser Alert - Normaliser panal ‘died’ leading to loss of panels- Some tiers e.g. A & C stopped working overnight- All work in these tiers aborted – LOSS OF 50 PANELS!!!- Manual states – ‘the system will alert before expiration to allow replacement’- No Instrument warning- Unable to supply engineer ( WEEK END )- Daily checks report showed all normalisers were working!2) E13 – Power Supply FailureBack up box failed and had to be replacedWe had a few months where we had this E18 – normaliser alert
34Instrument issues cont’d Epicenter front screen too “busy”Still waiting for epicentre training !!Resulted in –- Collation of information difficult- Difficult to resolve transcription error of specimen number entry
35Staff Views Easy to use Fits in to the routine working practises Address staff skill mixExcellent ID to genus level not speciationExcellent AST for routine organismsEarly ID of e.g Listeria spp / Salmonella sppMechanically robust
36Thanks Kelly Ward - Senior BMS @ RGH Robert Powell - Chief BMS @ RGH Alison King - Chief PCHDr Ali Omrani – Consultant MicrobiologistBecton Dickenson