embryology i.d. systems - steve fleming - sydney
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Embryology ID Systems
SIRT 2013, Sydney
August 2013 Embryology ID Systems
How often do you make mistakes in the lab?
We never make any mistakesOur last mistake was in the 1980sMistakes are very rare in our labWe think it is low, but we don’t
know…Who wants to have to tell a patient
that there has been a mix-up?
August 2013 Embryology ID Systems
Why should we worry?Arguments for not bothering:
I work in a small lab or segregate my work, so I only deal with one thing at a time…
Not solely responsible if risk is sharedArguments for bothering:
Patient assuranceProtection from litigationAccreditation and licensing
August 2013 Embryology ID Systems
Errors reported to HFEA
The wrong sperm used for ICSIEmbryos unusable following PGDAffected embryos transferred‘Weaker’ embryo transferredWrong embryos were thawedEmbryos implanted in wrong
patient
August 2013 Embryology ID Systems
Evolution of ID checking2002: Errors reported in the UK2002: HFEA mandates
witnessing2004: Contemporaneous records
of witnessing mandated by HFEA2005: HFEA considers introducing
electronic tags or barcode labelling2006: HFEA permits electronic
witnessingAugust 2013 Embryology ID Systems
RTAC sample ID projectInitiated in 2011 to help develop a
framework for introduction of a national standard for ID checking
Five working groups:Review of existing ART guidelinesReview of retentive checking issuesReview of ID errors in medicineReview of known ID errors in ARTID error incidence in Australia & NZ
August 2013 Embryology ID Systems
Errors reported to us
August 2013 Embryology ID Systems
Causes of ID errors
August 2013 Embryology ID Systems
Types of witnessingWitnessing of an intentWitnessing of an eventWitnessing following an eventRecording of witnessing includes:
The procedure undertakenThe date and time of the procedureStaff name, status and signatureWitness name, status and signature
August 2013 Embryology ID Systems
Where is the weakest link?(absolute, should, maybe)Oocyte retrievalSemen receiptSperm preparationInsemination (IVF or ICSI ±donor)Fertilisation checkEmbryo transferCryopreservation and thawing
August 2013 Embryology ID Systems
Witnessing learning curve
August 2013 Embryology ID Systems
Witnessing dish disposalOocyte collection dishesOocyte denudation dishesPre-insemination/injection dishesIVF/ICSI dishesPost-insemination/injection dishesCulture dishesVitrification and warming dishesET and FET dishes
August 2013 Embryology ID Systems
ID system evaluation
Which is the ‘best’?Number of additional interventionsMismatch distribution and durationTrue mismatch rateFlexibility of witnessing system
IVF unit specific requirementsIVF case specific requirementsWitnessing requirements evolve
August 2013 Embryology ID Systems
Embryology ID SystemsHuman witnessingPhotographic witnessingBarcode checking
FertiProof™Matcher™Trusty™
Silicon-based barcode checkingRFID tag checking
RI Witness™
August 2013 Embryology ID Systems
Self double-checking
RTAC COP isn’t prescriptive AS YETHuman error rate = 1-3%Automated error rate = 0.001%Self double-checking method must
be risk assessed and documentedVarious mechanismsHelps if you talk to yourself!
August 2013 Embryology ID Systems
Double manual witnessing
Problematic outside working hoursWorkload required is doubledDistraction from other proceduresSignage paperwork requiredVariable reliability in techniqueInvoluntary automaticity
(Toft & Mascie-Taylor, 2005; Toft & Gooderman, 2009)
August 2013 Embryology ID Systems
System learning curve
August 2013 Embryology ID Systems
Barcode checking>20 years usage in retail industryComputers don’t ‘see’ like humansBarcode error rate = 1 in >15,000Last digit of barcode = check digitBarcode damage miscalculationRequires non-toxic barcode labelsCommercial barcode systems
FertiProof™, Matcher™, Trusty™
August 2013 Embryology ID Systems
FertiProof™
Developed by MTGPassive system but used activelyControls workflowHas to be customised
August 2013 Embryology ID Systems
Matcher™
Developed in 2008 at Liverpool Women’s Hospital, UK
Cycle specific unique barcodesAll consumables barcode labelledMatcher™ confirms and records
every procedure
August 2013 Embryology ID Systems
Trusty™ (Optimal IVF)
August 2013 Embryology ID Systems
Standalone application on PCCycle specific barcodes generatedLabels attached to all consumablesStaff-specific scanning of barcodesAny mismatch error has to be reconciledReports of all scans can be generated
RI WitnessTM
Additional interventions required with RI Witness
Inconvenience rateAdministrative assignments (0.8%)Mismatches (0.25%)
Breakage of RFID tags24,473 RFID tags used24,456 RFID tags valid (99.03%)17 RFID tags broken (0.07%)
Alan Thornhill, ACU, Guy’s Hospital, UK
August 2013 Embryology ID Systems
Conclusions
Electronic witnessing provides the safest risk management if used to augment human witnessing
Electronic witnessing does not take over control IVF processes
August 2013 Embryology ID Systems
References
http://www.slideshare.net/Research_Instruments
Toft B, Mascie-Taylor H. (2005) Involuntary automaticity: a work-system induced risk to safe health care. Health Serv Manage Res. 2005 18:211-6.
Toft B, Gooderham P. (2009) Involuntary automaticity: a potential legal defence against an allegation of clinical negligence? Qual Saf Health Care.18:69-73.
August 2013 Embryology ID Systems
Acknowledgements
Dr Jim CattOptimal IVF, AustraliaCurrently up the Khyber Pass!
Dr Alan ThornhillAssisted Conception UnitGuy’s Hospital, UK
August 2013 Embryology ID Systems
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