Electronic witnessing

Human error in Healthcare

6 examples of errors which have happened (from HFEA, UK)

Case A – Wrong sperm used for insemination problem with inadequate transfer of info on samples

after staff handoverCase B – Six eggs injected with wrong sperm

Witnessing of samples when moving from one dish to another must take place at the same time of

procedureCase C – Wrong sperm used in PGD case

Same as aboveCase D – Wrong embryos transferred to the patient

Same as aboveCase E – Wrong embryos thawed and transferred to the patient

Embryologist working aloneCase F – Genetic testing results were wrongly transferred to the lab who then discarded the normal embryos and transferred back to the patient the abnormal ones

Data association error between sample and embryo

Not just the UK: The Reproductive Technology Accreditation Committee (RTAC) Working groups to assess ID checking and errors in IVF:

Nine “major identity errors” reported“Major identity errors” defined as:

- wrong babies born- wrong embryos transferred- wrong sperm inseminated

• 48 relevant responses• 49th response… .. …their clinic was so good they had never had an error

Data courtesy of Kelli Sorby, IVF Partners, Australia

2013 HFEA, UK 182 "incidents" 8 serious

Data courtesy of Kelli Sorby, IVF Partners, Australia

The RTAC working group concluded that:

• Human double witnessing, regardless of how they witness, does not overcome all identity errors

• Staff should never be allowed to work alone

• Witnessing only selected parts of laboratory processes is inherently risky behavior

• Major identity errors occur more often with handwritten labeling rather than printed labels

• Staff rushing, being flustered, or intimidated by people waiting for them is the major root cause in all errors reported

Data courtesy of Kelli Sorby, IVF Partners, Australia

Studies in an IVF laboratory in the UK found that:

“the true human error rate is 1 in

1000…” BUT this is 1 in 1000 STEPS

which equates to 1 in 100 patients’ samples coming

into proximity with another’s.

Implementing an electronic witnessing system into a busy IVF clinic – one clinic’s experience. Roberta Maggiulli, Laura Rienzi and Filippo Ubaldi . Genera Center for Reproductive Medicine, Rome, Italy

Processes are only as good as the people performing them

People and systems under stress will underperform

• Fatigue

• Stress

• Physical environment – low lighting

• High workloads

• “Look alike – Sound alike” errors

ASRM recommended staffing levels

NB. 2008

Increased PGS / PGDA cycles knock-on effects in lab:

2012 2013 2014 2015 2016 20170

10

20

30

40

50

60

70

80

% of ART cycles including PGS in the USA *

* Data from various sources including Dr Dagan Wells, Reprogenetics, UK

Extra work for the lab:

• 2 days extra culture to blastocyst is standard• TE Biopsy – 1-2 hours prep and sample handling• Correct sample & embryo ID• Vitrification of spare blastocysts (fresh transfer)• Vitrification of all blasts (Freeze all)• Hatching vitrified embryos with laser post-warming

for transfer

= Increased workload which is not normally commensurate with increased staffing2008

UK history of witnessing guidelines for IVF:

2002 – HFEA implemented mandatory human double witnessing for specific steps

2005 – independent study analysing risk in IVF found double witnessing to have several disadvantages previously unperceived: distraction, perception, etc (Brian Toft and Hugo Mascie-Taylor. ‘Involuntary automaticity: a work system induced risk to safe health care’. Health Services Management Research 18: 211-216, 2005.)

2006 – IVF WITNESSING AND ELECTRONIC SYSTEMS. FINAL REPORT. Dr Sally Adams and Dr Jane Carthey,

Current - http://www.hfea.gov.uk/docs/Review_witnessing_samples_id_standard_and_guidance.pdf

Current - % cycles now covered in UK by electronic witnessing: 75-80%

From oocyte pick up to insemination through to embryo transfer, biopsy or cryo storage, the dishes containing samples are logged, timed and matched AUTOMATICALLY (without the embryologists needing to ask it to check them*)

* All other forms of witnessing (human single, double, barcoding etc) require the embryologist to ask for a check, and even then only give a tiny snapshot of the whole process

Electronic Witnessing: RI Witness™

RI Witness monitors and records all activity at all workstations where samples are moved from one dish to another, 24/7

RFID tag

Every sample is detected, every procedure is recorded.

User: Sally

Patient : Minnie Mouse

Sample type: Day 3 embryo dish

Time: 15.05.21s

Duration of procedure: 2 minutes 17 secs

Data collected automatically:

Interaction with EMRs

RI Witness hardware –Embryology Heated Reader with test-tube reader attached

UnheatedSelf-tuningSingle Power cable outComes with 12-tube test-tube rack

Andrology (Sperm prep) reader

Admin / card reader

RI Witness Manager Software:

Safety:

FDA Cleared July 2016

Independently tested with mouse embryos at much greater power and constant exposure and no difference found between RI Witness and control group at blastocyst stage

The first systems have been in constant use since 2007

after

Summary: 130 in 25+ countriesOver a million embryos tracked

Over 150,000 babies born

Thank you and quick demonstration