implementing new techniques, technologies and programs into an ivf clinic - ronny janssens, quality...
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Ronny Janssens, Quality Manager at UZB presented on implementing new techniques, technologies and programs into an IVF clinicTRANSCRIPT
Implementing new techniques, technologies and programs into an IVF clinic
Ronny Janssens - Quality Manager
2 09-04-2023
Summary
1. Why new technology?
2. How to choose?
3. How to implement into your practice?
4. Examples @ UZB
5. Conclusions
Why new technology?
Technological innovations are products of a society’s economy, a force for economic growth and are affected by a society's cultural traditions.
How do science concepts, engineering skills, and applications of technology improve the results?
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Sources of technological innovation (external)
Patients Industry Competitors Consultants Universities Publications, internet Exhibitions, fairs, seminars and conferences Certification/accreditation bodies Legislation
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Sources of technological innovation (internal)
Own R & D ICSI
Unexpected event Witness
Change of work process Day of transfer - Single step media
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Obstacles to new technology
No access Lack of time (to learn, to plan, ...) No budget or high costs Technical/IT problems Intimidating – non expert status Too many strategies to try now – one more
thing
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Summary
1. Why new technology?
2. How to choose?
3. How to implement into your practice?
4. Examples @ UZB
5. Conclusions
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Harper et al. Hum. Reprod. 2012
“Every procedure involving application to the human body should be defined as experimental until adequate scientific evidence is provided regarding its safety and efficacy”
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Definition of experimental procedures
The practice committe of the American Society for Reproductive Medicine. Fertil Steril, vol 99, 2013.
Procedures ...will be considered experimental or investigational until the published medical evicence regarding their risks, benefits, and overall safety and efficacy is sufficient to regard them as established medical practice. Relevant medical evidence can derive only from appropriately designed, peer-reviewed, published studies performed by several independent investigators, including a description of materials and methods sufficient to assess their scientific validity and to allow independent verification.
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Ask yourself what is...
Benefit? To patient To service
Safety? Has it been tested? Is it safe?
Where is the evidence? Efficiency?
Does it work in your service? Cost effective?
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What is the right equipment?
Define required performance characteristics Review functionality
Does it conform? Is it easy to use? Extra features?
Analyze risks Appropriate support? Employees’ motivation?
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What is the right equipment/procedure?
Use available information Literature External experts (universities, research
laboratories...) Discussion boards Conferences, workshops
Analyze with data
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Where is the evidence?
Evidence based medicine:“Sackett: Integrating individual expertise with the best available clinical evidence from systematic research.” Archie Cochrane
Founded in 1993 in the United Kingdom
Cochrane Database of Systematic Reviews
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Assisted reproductive technology: an overview of Cochrane Reviews Farquhart et al 2013
Effective interventions Low oxygen concentration for embryo culture SET US guided ET
Promising (more evidence needed) AH Brief co-incubation of sperm for IVF
Possibly ineffective IMSI
Ineffective PGS
No conclusion possible ICSI vs IVF for non-male infertility
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Be objective!
Recombinant vs. Urinary gonadotrophins No difference, known since mid 1990s
“It is obvious why 7339 patients were included in redundant trials: industry funding”
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Take home message
Does new technology increase productivity?
Focus on results, not technology
Be objective Is there enough evidence? Be aware of external pressure
Do you really need it?
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Summary
1. Why new technology?
2. How to choose?
3. How to implement into your practice? Validation Staff training
4. Examples @ UZB
5. Conclusions
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PDCA cycle - Implementation in practice
Plan Do: Installation
Installation qualification
Test phase Real time monitoring?
Check: Validation Operational
verification NC?
Act
Plan Do: Integration in
work flow SOP QC/QA Staff training
Check Equipment failures complaints
Act
5.5.1.1 Validation of examination procedures The laboratory shall only use examination
procedures that have been validated as suitable for their intended use.
The validation shall be as extensive as is necessary and confirm, through the provision of objective evidence (in the form of performance characteristics), that the specific requirements (in the form of performance specifications ) for the intented use of the examination have been fulfilled
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ISO 15189
ISO 15189
5.5.1.1 Note 2 The means to be used for the determination of the performance characteristics of a procedure may be one of or a combination of the following:a) Testing of calibration or reference measurement standards, or using
reference measurement procedures;
b) Internal quality control data;
c) Use of patient samples with properties defined for the examinand, stability, and homogeneity;
d) Comparison of results achieved with other methods;
e) Inter laboratory comparisons;
f) Systematic assessment of the factors influencing the results;
g) Presence of carryover of material from a preceding high concentration sample, when applicable, and
h) Presence of interferences or non-specificity that may be caused by, for example, metabolic or endogenous substances in the sample
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Validation of ART process
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Procedures – documents
SOPs• As primary training resources• To control process details• Standard layout
Forms• Data collection• Process control• Patienten ID verification• Operator ID & witnessing• Materials logging
• Mentality change: from oral to written culture
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Staff
Who – What – When?
Responsibility Functions Job descriptions Task assignments
Training
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Training plan
1. Observation
2. Work under supervision
3. Fully qualifiedObjective measurable criteria ! (>70%
fertilisation - ICSI)
4. Documented
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Summary
1. Why new technology?
2. How to choose?
3. How to implement into your practice?
4. Examples @ UZB PGD/PGS IMSI Time lapse Witness
5. Conclusions
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Not implemented Coculture PGS Spermatid injection PICSI Integrated workstations
Vitrosafe Ac-tive
Embryoglue Time lapse incubators
Biostation Embryoscope
IMSI LAISS
Implemented ICSI Extended culture PGD Oocyte imaging Laser Dry incubators RFID (Witnesss) Desktopincubators (G-
185) Blastocyst vitrification Embryo vitrification Oocyte vitrification
New technologies @ UZ Brussel
PGD/PGS @ UZB
2/93
Laser zona drilling
3/96 11/98 6/99
First PGD
Aspiration of blastomeres
Decompaction media
5/98 6/98
Acid Tyrode
Sequential media
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Comparison laser with Acid Tyrode
Comparison of the results of human embryo biopsy and outcome of PGD after zona drilling using acid Tyrode medium or a laser. Joris, H., De Vos, A., Janssens, R., Devroey, P., Liebaers, I., and Van Steirteghem, A. Hum. Reprod. 2003. The use of laser in cases of PGD is an easier procedure and
results more intact blastomers in comparison with using acid Tyrode medium.Since similar pregnancy rates are obtained ,it is adventageous to use laser for zona drilling
Laser confers less embryo exposure than acid tyrode for embryo biopsy in preimplantation genetic diagnosis cycles: a randomized study. Geber et al. Reprod Biol Endocrinol. 2011
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PGS by FISH at cleavage stage is not effective in improving live birth delivery rate per cycle
“This RCT provides no arguments in favour of PGD-AS for improving clinical outcome per initiated cycle in patients with AMA when there are no restrictions in the number of embryos to be transferred” Confirmed by Mastenbroeck et al., 2007 Example of introduction into clinical practice without
evidence
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IMSI
Bartoov et al. 2001 N Engl J Med, vol. 345, N°14 Bartoov et coll, 2002 J. Andrology 23:1-8 Bartoov et coll, 2003 Fertil.steril.80:1413-1419
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„Standard Image“ ICSI
vacuoles
HOW DOES A GOOD SPERM LOOKS LIKE?
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Intracytoplasmic Morphologically-selected Sperm Injection (IMSI)
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Regular (ICSI) versus ultra-high magnification (IMSI) sperm selection for assisted reproduction
Teixeira DM, Barbosa MAP, Ferriani RA, Navarro PA, Raine-Fenning N, Nastri CO, Martins WP, July 25, 2013
“We concluded that the current evidence does not support using IMSI: there is no evidence of benefit for live birth and miscarriage, we are very uncertain of the beneficial effect of IMSI in clinical pregnancy, and there is no evidence of the effect of this intervention on congenital abnormalities“
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IMSI
“It is noteworthy that more prospective randomized trials are required to confirm the superiority of IMSI over conventional ICSI and to identify the causes of infertility that could benefit from the IMSI procedure.”
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IMSI: conclusion
Complex technology Learning curve Risks
Cooling Exposure to ambiant atmosphere
Expensive Bias? No evidence yet
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IMSI @ UZB
Benifit To patient? To service?
Safety? Has it been tested? Is it safe?
Where is the evidence? Efficiency
Does it work in your service? Cost effective?
Yes
No
No
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Time lapse imaging
Evidence? Cochran: 0 RCT: 1
Kirkegaard et al. Hum Reprod 2013 Pubmed: 14 references form 1 group
External pressure? “Further randomized prospective studies are being developed
at the moment to evaluate and confirm the power of embryo selection by time-lapse systems
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Time Lapse Systems @ UZB
Embryoscope (2010) Validation RCT (?) Conclusion: research only
Primo Vision (-) performance characteristics ?
MIRI TL incubator (2013) Prototype Validation in 2014
Incubator Culture coin Imaging
Witness @t UZ Brussel
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Two sources of biological material ( + = → ) Donor/acceptor cycles (X + Y = Z) Complex process over several days
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IVF = Living in the danger zone!
DO NOT MAKE A MISTAKE!
Identification errors
Experience is the name everyone gives to their mistakes (Oscar Wilde,1854 - 1900)
How often do you make mistakes?
When will it happen in your lab?
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ISO15189
Use only validated methods Risk analysisR = P x E X C = 1 x 6 x 7 = 42
P = unlikely but possible E = daily C = severe
R ≤ 20 acceptable very low risk, acceptable
20 < R ≤ 70 needs attention
70 < R ≤ 200 action needed
200 < R ≤ 400 immediate improvement required
R > 400 STOP
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Identification systems in IVF
Barcode identification
HFEA risk assessment Light and effect on gametes and embryos Errors can occur in the printed barcode label Barcode scanning can interrupt workflow
processes Possibility of circumvention
Novo et al., HR Vol 29, 2014 “it only allows the identification and traceability of
oocytes destined for ICSI and embryos. Thus, the traceability of all reproductive samples (oocytes destined for IVF and sperm) is not yet ensured”
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2011: Integration into Clinical Practice
Hardware: work area readers, PCs, monitors Ward: 2 admin readers Egg collection and transfer: 2 ID card readers Embryolab: 7 stereomicroscopes Semen lab: 3 semen prep antennas
Software Define witness flow chart Interface with hospital system
SOP Training (2 days for administrators + in-house sessions) Validation (20 cases with simultaneous manual
witnessing)
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Witness at UZ Brussels anno 2014
Administration 2 admin readers
Diagnostic semen lab 2 admin readers
Insemination rooms 3 admin readers
Therapeutic semen lab 7 sperm prep workstations
Eggcollection 2 ID card readers
Infectious lab 1 sperm prep workstation 3 stereomicroscopes
Embryology lab 1 and 2 2 x 7 stereomicroscopes
Embro replacement 2 ID card readers
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IVF Witness: employees’ motivation
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Before: Anxiety Less flexible Novel technology Changes in working
habits
After: Optimism Safe Easy to adapt Increased confidence
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Summary
1. Why new technology?
2. How to choose?
3. How to implement into your practice?
4. Examples @ UZB
5. Conclusions
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Conclusions
Do you really need the new technology? Choose the right equipment Focus on results, not technology
Be objective, look for evidence Does it work in your lab? Validate
Documentation Staff training
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For something completely different...
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Thank you!