do you have chemistry? - microbicide trials network
TRANSCRIPT
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MTN REGIONAL MEETING
LABORATORY BREAKAWAY
DO YOU HAVE CHEMISTRY?
RASHIKA MAHARAJ LABORATORY MANAGER
MEDICAL RESEARCH COUNCIL OF SA
HIV PREVENTION RESEARCH UNIT
MTN REGIONAL MEETING
12 OCTOBER 2011
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IN A NORMAL WORLD-DEFINITION OF CHEMISTRY
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NETWORK LAB PEOPLE WHO HAVE CHEMISTRY
LORNA TED WAYNE URVI
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THE ABCs OF CHEMISTRY SET-UP
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•Supplier challenges – Calibration Disc – every new generation reagent requires a Supported cal disc to be loaded onto analyser – Cal disc was not sent on time by supplier - Resolution – Bench med techs trained to review all new stock received note new lot nos , check if new generation sent , Lab Co-ord – regularly checks Vitros ortho website for distribution of new discs and ensures that supplier sends disc to central lab. Supplier not very knowledgeable on instrument - noted during training and when experiencing troubleshooting issues – Resolution staff have read user manuals , Co-ordinator reviews troubleshooting log to ensure that corrective action or schedules for calibration etc are put in place , experience on machine has capacity developed staff to be more vigilant with maintenance , calibration frequency , control review LJ graphs. Troubleshooting log – also assists as a tool to identify areas for training and review competency of bench staff. Reagent availability challenges – Supplier does not have any other Vitros350 in KZN – hence stock ordered from manufacturer when ordered placed by Central lab – Resolved – 2 months stock kept on hand. •Controls – initially supplier recommended Verifier 1 and 2 ( Vitros controls ) for use , however noted stability issues as controls had to made up , Resolution : Network lab recommended Biorad Unassayed Liquicheck 1 and 2 Controls – available as frozen ready to use controls – minimizes errors with reconstituting , noted that this control is more stable . Biorad Controls in use presently. •Validation : - initially did a wet vs dry chem. Validation - correlation was poor for most analytes – then proceeded after negotiation with another customer in PE using the Vitrs350 - to set up a validation – challenges here where limited analytes run by ref lab , time delay in receiving samples from PE – however correlation was much better. Also discussed these challenges with SMILE – approved validation based on the no of CAPS Surveys run. •Staff Competency - Staff competency initially poor , poor understanding of review of LJ graphs , handling of reagents and controls. Resolution : trained staff on observing for bubbles in CAP , bench organization , instituted trouble shooting , calibration log , control review log - this has assisted greatly with understanding instrument and staff being more aware of Westgard Rules and reviewing of LJ graphs , staff aware of thawing out times etc..
Problem What Happened? Resolution
Supplier challenges
Calibration Disc – every new generation reagent requires a Supported cal disc to be loaded onto analyser – Cal disc was not sent on time by supplier -
Resolution – Bench med techs trained to review all new stock received note new lot nos , check if new generation sent , Lab Co-ord – regularly checks Vitros ortho website for distribution of new discs and ensures that supplier sends disc to central lab.
CHALLENGES WHEN YOU JUST DON’T HAVE ‘CHEMISTRY’
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Problem What Happened? Resolution
Supplier challenges
Supplier not very knowledgeable on instrument - noted during training and when experiencing troubleshooting issues – of bench staff.
Resolution staff have read user manuals , Co-ordinator reviews troubleshooting log to ensure that corrective action or schedules for calibration etc are put in place , experience on machine has capacity developed staff to be more vigilant with maintenance , calibration frequency , control review LJ graphs. Troubleshooting log – also assists as a tool to identify areas for training and review competency
CHALLENGES WHEN YOU JUST DON’T HAVE ‘CHEMISTRY’
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Problem What Happened? Resolution
Supplier challenges
Reagent availability challenges – Supplier does not have any other Vitros350 in KZN – hence stock ordered from manufacturer when ordered placed by Central lab –
Resolved – 2 months stock kept on hand.
CHALLENGES WHEN YOU JUST DON’T HAVE ‘CHEMISTRY’
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1. VOICE protocol meeting - Clinic Workflow: the uniqueness of clinic flow was very evident
amongst all sites, nurses doing testing, storage and microscopy- HPCSA update-this is not correct for all aspects!
- V2.0 of protocol- PBMCs is added on , in addition the current plasma archive would include testing for HSV-2 at study end - Seroconvertors- sample 2 operational reminder which included
the following aspects:
Problem What Happened? Resolution
Controls
– initially supplier recommended Verifier 1 and 2 ( Vitros controls ) for use , however noted stability issues as controls had to made up ,
Resolution : Network lab recommended Biorad Unassayed Liquichek 1 and 2 Controls – available as frozen ready to use controls – minimizes errors with reconstituting , noted that this control is more stable . Biorad Controls in use presently.
CHALLENGES WHEN YOU JUST DON’T HAVE ‘CHEMISTRY’
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Problem What Happened? Resolution
Validation
Initially did a wet v.s .dry chem. Validation - correlation was poor for most analytes e.g. creatinine– then proceeded after negotiation with another customer in PE using the Vitros350 - to set up a validation – challenges here where limited analytes run by ref lab , time delay in receiving samples from PE
PE correlation was much better with our lab Also discussed these challenges with SMILE – Approved validation based on the no of CAPS Surveys run-which was 100% from 2010 to 2011
CHALLENGES WHEN YOU JUST DON’T HAVE ‘CHEMISTRY’
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Problem What Happened? Resolution
Staff Competency Staff competency initially poor , poor understanding of review of LJ graphs , handling of reagents and controls.
Resolution : trained staff on observing for bubbles in CAP , bench organization , instituted trouble shooting , calibration log , control review log - this has assisted greatly with understanding instrument and staff being more aware of Westgard Rules and reviewing of LJ graphs , staff aware of thawing out times etc..
CHALLENGES WHEN YOU JUST DON’T HAVE ‘CHEMISTRY’
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Problem What Happened? Resolution
Interphase with LIMS Supplier not knowledgeable on interphasing- problems with LIMS and supplier differences on how to implement
Currently communication could not be established – 3 days arranged with supplier
CHALLENGES WHEN YOU JUST DON’T HAVE ‘CHEMISTRY’
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MY LAB FAMILY
Visited: Ms. Estelle M. Piwowar-Manning, MT (ASCP) SI Deputy Director HPTN Laboratory
Department of Pathology, Johns Hopkins University
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THANK YOU ANY QUESTIONS?