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Embryology I.D. systems - Steve Fleming - Sydney

Date post: 01-Jun-2015
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A review of human witnessing and electronic witnessing by Steve Fleming in Sydney. Looks at the true error rate in clinics and the ability to monitor what is (and what is not) happening.
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Embryology ID Systems SIRT 2013, Sydney August 2013 Embryology ID Systems
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Page 1: Embryology I.D. systems - Steve Fleming -  Sydney

Embryology ID Systems

SIRT 2013, Sydney

August 2013 Embryology ID Systems

Page 2: Embryology I.D. systems - Steve Fleming -  Sydney

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

Page 3: Embryology I.D. systems - Steve Fleming -  Sydney

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

Page 4: Embryology I.D. systems - Steve Fleming -  Sydney

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

Page 5: Embryology I.D. systems - Steve Fleming -  Sydney

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

Page 6: Embryology I.D. systems - Steve Fleming -  Sydney

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

Page 7: Embryology I.D. systems - Steve Fleming -  Sydney

Errors reported to us

August 2013 Embryology ID Systems

Page 8: Embryology I.D. systems - Steve Fleming -  Sydney

Causes of ID errors

August 2013 Embryology ID Systems

Page 9: Embryology I.D. systems - Steve Fleming -  Sydney

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

Page 10: Embryology I.D. systems - Steve Fleming -  Sydney

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

Page 11: Embryology I.D. systems - Steve Fleming -  Sydney

Witnessing learning curve

August 2013 Embryology ID Systems

Page 12: Embryology I.D. systems - Steve Fleming -  Sydney

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

Page 13: Embryology I.D. systems - Steve Fleming -  Sydney

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

Page 14: Embryology I.D. systems - Steve Fleming -  Sydney

Embryology ID SystemsHuman witnessingPhotographic witnessingBarcode checking

FertiProof™Matcher™Trusty™

Silicon-based barcode checkingRFID tag checking

RI Witness™

August 2013 Embryology ID Systems

Page 15: Embryology I.D. systems - Steve Fleming -  Sydney

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

Page 16: Embryology I.D. systems - Steve Fleming -  Sydney

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

Page 17: Embryology I.D. systems - Steve Fleming -  Sydney

System learning curve

August 2013 Embryology ID Systems

Page 18: Embryology I.D. systems - Steve Fleming -  Sydney

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

Page 19: Embryology I.D. systems - Steve Fleming -  Sydney

FertiProof™

Developed by MTGPassive system but used activelyControls workflowHas to be customised

August 2013 Embryology ID Systems

Page 20: Embryology I.D. systems - Steve Fleming -  Sydney

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

Page 21: Embryology I.D. systems - Steve Fleming -  Sydney

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

Page 22: Embryology I.D. systems - Steve Fleming -  Sydney

RI WitnessTM

Page 23: Embryology I.D. systems - Steve Fleming -  Sydney

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

Page 24: Embryology I.D. systems - Steve Fleming -  Sydney

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

Page 25: Embryology I.D. systems - Steve Fleming -  Sydney

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

Page 26: Embryology I.D. systems - Steve Fleming -  Sydney

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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