There are many IVF centers over the globe, but itis time to make criteria, standards and parameters for establishing an IVF center. This talk may help in this
4. How to Establish!
• KnowHow
Available or not
• Budget
(small vs large)
• Team
(one man show vs
group)
• District : central vs
periphary
• Target : Upper class
vs middle class
• Aim : finance /
prestigue / adjuvant
service
5. Site selection
Inside a hospital: UNIT
- To benefit from the infrastructure of :
• Electric generator
• Laundry facilities
• Sterilization facilities
7. Design
- Enough space to allow equipment
installation and free movement of
personnel
- Enough space to allow for expansion
- allow enough time after construction
before installing equipments and use.
8. So How to make ur decision?
• Usually circumstances drive ur decision
• But none of the previous factors will make
it succeeds : they will help u for the setup
• For success: it is all about Personnel
10. Training of personnel
I. Training the IVF laboratory practitioners
• Minimum of one year (hands on) work
II. Training of the IVF clinical team
• Gynecologists working in infertility
• Three months (hands on) work
11. Strict System
• From the start
• Applied to all (no exception)
• Be ready for turn over
• Do not forget training of nurses and
workers (infertility is a special entity)
18. What is Quality Control (QC)?
QC involves all measures undertaken to
control the quality of:
products equipment
protocols environment
to insure that the IVF Laboratory is
functioning correctly
19. What is Quality Assurance (QA)?
QA is a comprehensive program
QC
Measures of :
- Equipment
- Protocols
- Environment
- Products
Results
reporting
Record
keeping
Treatment
auditing
and
incident
reporting
Education
of
laboratory
staff
20. Benefits of Employing
QC & QA
- Maintain the optimal laboratory performance
- Detect problems before they become
significant.
- Evaluating personnel performance and
motivating staff.
21. Micro droplet – Oil Overlay
VOC’s Filtration Oil Issues
Plastic
Ware
MediapH
Temperature
22. QC Program
routine monitoring
1) Equipment
2) Culture media and consumables
3) The environment
4) Protocols
initial validation +
23. Equipment validation
- Installed by the manufacturer
- Switched on and monitored for a
sufficient time to identify
problems before use in clinical
treatment
24. Quality Control Measures
Range ±
accuracy
MethodFrequencyTestEquipment
± 0.5%
-10 to + 50
± 0.5ºC
0.03 EU/mL
-10 to +50
±1 ºC
- 10 to + 50
± 1 ºC
Fyrite
Thermometer
Sperm
survival
assay
Limulus
amoebocyte
test
Thermometer
Thermometer
3 / week
Daily
as required
Weekly
Daily
Monthly
CO2%
Temperature
Environment
Endotoxin
Temperature
Temperature
Incubator
Water System
Refrigerator
Heated stages
25. Company-manufactured media:
- QC testing of all new batches of culture
media is important because of transport,
and incorrect storage conditions.
26. Air pollutants
Volatile organic compounds (VOCs) and
chemical airborne contaminants (CACs)
can significantly affect culture
conditions
27. Prevention of VOCs
- Consideration should be given to the site
and location of the laboratories
- The use of air purification units
- Positive pressure airflow
- Sealants, toxic glues, paint, should be
avoided
28. Cleaning
- Routine cleaning after every procedure
during work.
- Daily cleaning after work (microscopes
– all surfaces – laminar flows)
- Weekly cleaning
Incubators - laminar flows
29. Assessment of Follicular
Stimulation
Length of stimulation
A. E2 level
B. No. of mature oocytes
C. Dosage (Type?) of gonadotrophin
Oocyte response during ICSI
A. post-retrieval
1. Immediate
2. Fertilisation rate
30. What is Quality Assurance (QA)?
QA is a comprehensive program
QC
Measures of :
- Equipment
- Protocols
- Environment
- Products
Results
reporting
Record
keeping
Treatment
auditing
and
incident
reporting
Education
of
laboratory
staff