Implementing new techniques, technologies
and programs into an IVF clinic
Ronny Janssens - Quality Manager
Summary
1.
2.

3.
4.
5.

2

Why new technology?
How to choose?
How to implement into your practice?
Examples @ UZB
Conclus...
Why new technology?




3

Technological innovations are products of a
society’s economy, a force for economic
growth an...
Sources of technological innovation
(external)











4

Patients
Industry
Competitors
Consultants
Universiti...
Sources of technological innovation
(internal)


Own R & D
 ICSI



Unexpected event
 Witness



Change of work proce...
Obstacles to new technology









6

No access
Lack of time (to learn, to plan, ...)
No budget or high costs
Tech...
Summary
1.
2.

3.
4.
5.

7

Why new technology?
How to choose?
How to implement into your practice?
Examples @ UZB
Conclus...
Harper et al. Hum. Reprod. 2012



8

“Every procedure involving application to the
human body should be defined as
exper...
Definition of experimental procedures



9

The practice committe of the American Society for
Reproductive Medicine. Fer...
Ask yourself what is...


Benefit?
 To patient
 To service



Safety?
 Has it been tested?
 Is it safe?




Where ...
What is the right equipment?



Define required performance characteristics
Review functionality
 Does it conform?
 Is...
What is the right equipment/procedure?


Use available information
 Literature
 External experts (universities, researc...
Where is the evidence?


Evidence based medicine:

“Sackett: Integrating individual expertise with the
best available cli...
Assisted reproductive technology: an overview of
Cochrane Reviews Farquhart et al 2013


Effective interventions
 Low ox...
Be objective!



Recombinant vs. Urinary gonadotrophins
 No difference, known since mid 1990s
“It is obvious why 7339 pa...
Take home message


Does new technology increase productivity?



Focus on results, not technology



Be objective
 Is...
Summary
1.
2.

3.

Why new technology?
How to choose?
How to implement into your practice?
 Validation
 Staff training

...
PDCA cycle - Implementation in practice



Plan
Do: Installation




 Installation
qualification
 Test phase
 Real ...
ISO 15189


5.5.1.1 Validation of examination procedures
 The laboratory shall only use examination
procedures that have...
ISO 15189


5.5.1.1 Note 2 The means to be used for the determination of the
performance characteristics of a procedure m...
Validation of ART process

21

30-1-2014
Procedures – documents
SOPs
•
•
•

As primary training resources
To control process details
Standard layout

Forms

•

Dat...
Staff
Who – What – When?

Responsibility
 Functions
 Job descriptions
 Task assignments


23

Training

30-1-2014
Training plan
1.
2.

3.

Observation
Work under supervision
Fully qualified
Objective measurable criteria ! (>70% fertilis...
Summary
1.
2.

3.
4.

Why new technology?
How to choose?
How to implement into your practice?
Examples @ UZB





5.

...
New technologies @ UZ Brussel


Not implemented






Coculture
PGS
Spermatid injection
PICSI
Integrated workstation...
PGD/PGS @ UZB

2/93 3/96 5/98

6/98

11/98

6/99

Decompaction media

First PGD
Aspiration of blastomeres

Sequential medi...
Comparison laser with Acid Tyrode




28

Comparison of the results of human embryo biopsy and outcome of
PGD after zona...
PGS by FISH at cleavage stage is not effective in
improving live birth delivery rate per cycle

“This RCT provides no argu...
IMSI




30

Bartoov et al. 2001
Bartoov et coll, 2002
Bartoov et coll, 2003

N Engl J Med, vol. 345, N°14
J. Andrology...
HOW DOES A GOOD SPERM LOOKS
LIKE?

vacuoles

„Standard Image“ ICSI

31

30-1-2014
Intracytoplasmic Morphologically-selected
Sperm Injection (IMSI)

32

30-1-2014





33

Regular (ICSI) versus ultra-high magnification (IMSI)
sperm selection for assisted reproduction
Teixeira DM, B...
IMSI

“It is noteworthy that more prospective randomized trials
are required to confirm the superiority of IMSI over
conve...
IMSI: conclusion





Complex technology
Learning curve
Risks
 Cooling
 Exposure to ambiant atmosphere





35

Ex...
IMSI @ UZB


Benifit

No

 To patient?
 To service?


Safety?

Yes

 Has it been tested?
 Is it safe?



Where is ...
Time lapse imaging


Evidence?
 Cochran: 0
 RCT: 1


Kirkegaard et al. Hum Reprod 2013

 Pubmed: 14 references form 1...
Time Lapse Systems @ UZB


Embryoscope (2010)
 Validation
 RCT (?)
 Conclusion: research only



Primo Vision (-)
 p...
Witness @t UZ Brussel

39

30-1-2014
IVF = Living in the danger zone!




Two sources of biological material (
Donor/acceptor cycles (X + Y = Z)
Complex pro...
Identification errors




How often do you make mistakes?



41

Experience is the name everyone gives to
their mistake...
ISO15189



Use only validated methods
Risk analysis

R = P x E X C = 1 x 6 x 7 = 42
 P = unlikely but possible
 E = d...
Identification systems in IVF

43

30-1-2014
Barcode identification


HFEA risk assessment
 Light and effect on gametes and embryos
 Errors can occur in the printed...
2011: Integration into Clinical Practice


Hardware: work area readers, PCs, monitors







Ward: 2 admin readers
E...
Witness at UZ Brussels anno 2014


Administration




Diagnostic semen lab




2 x 7 stereomicroscopes

Embro replace...
IVF Witness: employees’ motivation


Before: Anxiety
 Less flexible
 Novel technology
 Changes in working
habits

47

...
Summary
1.
2.

3.
4.
5.

48

Why new technology?
How to choose?
How to implement into your practice?
Examples @ UZB
Conclu...
Conclusions





Do you really need the new technology?
Choose the right equipment
Focus on results, not technology
 B...
For something completely different...

50

30-1-2014
51

30-1-2014
Thank you!
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Implementing New Techniques, Technologies and Programs into an IVF Clinic - Ronny Janssens, Quality Manager, Centre for Reproductive Medicine at UZ, Brussels

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  • Practitioner evaluation of products is an extremely difficult task, in view of the enormous amount of both reliable and questionable product information available, variable interpretation of research projects, support of correct or incorrect information in the literature, the funding for research projects, the money that changes hands for some positive product recommendations, and the half-truths that are often used as "hype" to sell a product. On the positive, the products available today are far better than the products of even a few years ago. Practitioners need to seek information from a variety of trusted sources described in this article to make correct decisions. The sources of information identified in this article have not been prioritized. They vary in usefulness depending on the type of product, the geographic area in which you live, the speakers to whom you listen, your relationships with peers, manufacturers, retailers, and your own ability to sort out information. Use the most unbiased, up-to-date information available from the sources you find most appropriate for your practice, and remember, clinical success is the final test!
  • “Every procedure involving application to the human body should be defined as experimental until adequate scientific evidence is provided regarding its safety and efficacy”
  • “Every procedure involving application to the human body should be defined as experimental until adequate scientific evidence is provided regarding its safety and efficacy”
  • Complex process over several daysMultiple samples presentMultiple techniques (IVF/ICSI)Multiple manipulationsMultiple operatorsMultiple work stationsSize of cells/tissueHigh relative “value”
  • *** PLEASE ADD NOTES ***
  • Implementing New Techniques, Technologies and Programs into an IVF Clinic - Ronny Janssens, Quality Manager, Centre for Reproductive Medicine at UZ, Brussels

    1. 1. Implementing new techniques, technologies and programs into an IVF clinic Ronny Janssens - Quality Manager
    2. 2. Summary 1. 2. 3. 4. 5. 2 Why new technology? How to choose? How to implement into your practice? Examples @ UZB Conclusions 30-1-2014
    3. 3. Why new technology?   3 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? 30-1-2014
    4. 4. Sources of technological innovation (external)          4 Patients Industry Competitors Consultants Universities Publications, internet Exhibitions, fairs, seminars and conferences Certification/accreditation bodies Legislation 30-1-2014
    5. 5. Sources of technological innovation (internal)  Own R & D  ICSI  Unexpected event  Witness  Change of work process  Day of transfer - Single step media 5 30-1-2014
    6. 6. Obstacles to new technology       6 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 30-1-2014
    7. 7. Summary 1. 2. 3. 4. 5. 7 Why new technology? How to choose? How to implement into your practice? Examples @ UZB Conclusions 30-1-2014
    8. 8. Harper et al. Hum. Reprod. 2012  8 “Every procedure involving application to the human body should be defined as experimental until adequate scientific evidence is provided regarding its safety and efficacy” 30-1-2014
    9. 9. Definition of experimental procedures   9 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, peerreviewed, 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. 30-1-2014
    10. 10. 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? 10 30-1-2014
    11. 11. What is the right equipment?   Define required performance characteristics Review functionality  Does it conform?  Is it easy to use?  Extra features?    11 Analyze risks Appropriate support? Employees’ motivation? 30-1-2014
    12. 12. What is the right equipment/procedure?  Use available information  Literature  External experts (universities, research laboratories...)  Discussion boards  Conferences, workshops  12 Analyze with data 30-1-2014
    13. 13. 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 13 30-1-2014
    14. 14. 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 14 30-1-2014
    15. 15. 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” 15 30-1-2014
    16. 16. Take home message  Does new technology increase productivity?  Focus on results, not technology  Be objective  Is there enough evidence?  Be aware of external pressure  16 Do you really need it? 30-1-2014
    17. 17. Summary 1. 2. 3. Why new technology? How to choose? How to implement into your practice?  Validation  Staff training 4. 5. 17 Examples @ UZB Conclusions 30-1-2014
    18. 18. PDCA cycle - Implementation in practice   Plan Do: Installation    Installation qualification  Test phase  Real time monitoring?  Check: Validation  Operational verification  NC?  18 Act Plan Do: Integration in work flow  SOP  QC/QA  Staff training  Check  Equipment failures  complaints  Act 30-1-2014
    19. 19. ISO 15189  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 19 30-1-2014
    20. 20. 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) b) c) d) e) f) g) h) 20 Testing of calibration or reference measurement standards, or using reference measurement procedures; Internal quality control data; Use of patient samples with properties defined for the examinand, stability, and homogeneity; Comparison of results achieved with other methods; Inter laboratory comparisons; Systematic assessment of the factors influencing the results; Presence of carryover of material from a preceding high concentration sample, when applicable, and Presence of interferences or non-specificity that may be caused by, for example, metabolic or endogenous substances in the sample 30-1-2014
    21. 21. Validation of ART process 21 30-1-2014
    22. 22. 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 • • • • 22 30-1-2014
    23. 23. Staff Who – What – When? Responsibility  Functions  Job descriptions  Task assignments  23 Training 30-1-2014
    24. 24. Training plan 1. 2. 3. Observation Work under supervision Fully qualified Objective measurable criteria ! (>70% fertilisation - ICSI) 4. 24 Documented 30-1-2014
    25. 25. Summary 1. 2. 3. 4. Why new technology? How to choose? How to implement into your practice? Examples @ UZB     5. 25 PGD/PGS IMSI Time lapse Witness Conclusions 30-1-2014
    26. 26. New technologies @ UZ Brussel  Not implemented      Coculture PGS Spermatid injection PICSI Integrated workstations   Vitrosafe Ac-tive  Embryoglue  Time lapse incubators   Biostation Embryoscope  IMSI  LAISS 26  Implemented            ICSI Extended culture PGD Oocyte imaging Laser Dry incubators RFID (Witnesss) Desktopincubators (G-185) Blastocyst vitrification Embryo vitrification Oocyte vitrification 30-1-2014
    27. 27. PGD/PGS @ UZB 2/93 3/96 5/98 6/98 11/98 6/99 Decompaction media First PGD Aspiration of blastomeres Sequential media Acid Tyrode Laser zona drilling
    28. 28. Comparison laser with Acid Tyrode   28 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 30-1-2014
    29. 29. 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”   29 Confirmed by Mastenbroeck et al., 2007 Example of introduction into clinical practice without evidence 30-1-2014
    30. 30. IMSI    30 Bartoov et al. 2001 Bartoov et coll, 2002 Bartoov et coll, 2003 N Engl J Med, vol. 345, N°14 J. Andrology 23:1-8 Fertil.steril.80:1413-1419 30-1-2014
    31. 31. HOW DOES A GOOD SPERM LOOKS LIKE? vacuoles „Standard Image“ ICSI 31 30-1-2014
    32. 32. Intracytoplasmic Morphologically-selected Sperm Injection (IMSI) 32 30-1-2014
    33. 33.    33 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“ 30-1-2014
    34. 34. 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.” 34 30-1-2014
    35. 35. IMSI: conclusion    Complex technology Learning curve Risks  Cooling  Exposure to ambiant atmosphere    35 Expensive Bias? No evidence yet 30-1-2014
    36. 36. IMSI @ UZB  Benifit No  To patient?  To service?  Safety? Yes  Has it been tested?  Is it safe?   Where is the evidence? Efficiency No  Does it work in your service?  Cost effective? 36 30-1-2014
    37. 37. 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 37 30-1-2014
    38. 38. Time Lapse Systems @ UZB  Embryoscope (2010)  Validation  RCT (?)  Conclusion: research only  Primo Vision (-)  performance characteristics ?  MIRI TL incubator (2013)  Prototype  Validation in 2014    38 Incubator Culture coin Imaging 30-1-2014
    39. 39. Witness @t UZ Brussel 39 30-1-2014
    40. 40. IVF = Living in the danger zone!    Two sources of biological material ( Donor/acceptor cycles (X + Y = Z) Complex process over several days + = → ) DO NOT MAKE A MISTAKE! 40 30-1-2014
    41. 41. Identification errors   How often do you make mistakes?  41 Experience is the name everyone gives to their mistakes (Oscar Wilde,1854 - 1900) When will it happen in your lab? 30-1-2014
    42. 42. ISO15189   Use only validated methods Risk analysis R = P x E X C = 1 x 6 x 7 = 42  P = unlikely but possible  E = daily  C = severe R ≤ 20 20 < R ≤ 70 70 < R ≤ 200 200 < R ≤ 400 R > 400 42 acceptable very low risk, acceptable needs attention action needed immediate improvement required STOP 30-1-2014
    43. 43. Identification systems in IVF 43 30-1-2014
    44. 44. 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” 44 30-1-2014
    45. 45. 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    45 SOP Training (2 days for administrators + in-house sessions) Validation (20 cases with simultaneous manual witnessing) 30-1-2014
    46. 46. Witness at UZ Brussels anno 2014  Administration   Diagnostic semen lab   2 x 7 stereomicroscopes Embro replacement  46 1 sperm prep workstation 3 stereomicroscopes Embryology lab 1 and 2   2 ID card readers Infectious lab    7 sperm prep workstations Eggcollection   3 admin readers Therapeutic semen lab   2 admin readers Insemination rooms   2 admin readers 2 ID card readers 30-1-2014
    47. 47. IVF Witness: employees’ motivation  Before: Anxiety  Less flexible  Novel technology  Changes in working habits 47  After: Optimism  Safe  Easy to adapt  Increased confidence 30-1-2014
    48. 48. Summary 1. 2. 3. 4. 5. 48 Why new technology? How to choose? How to implement into your practice? Examples @ UZB Conclusions 30-1-2014
    49. 49. 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 49 30-1-2014
    50. 50. For something completely different... 50 30-1-2014
    51. 51. 51 30-1-2014
    52. 52. Thank you!

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