How to Setup IUI and IVF Services

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How to Setup IUI and IVF Services

  1. 1. SETTING UP IUI AND IVF SERVICES Dr. Priya Bhave Chittawar MD,DNB,Fellowship In Reproductive Medicine, Head,Reproductive Medicine Mohak Hitech Speciality Hospital Laparoscopy and Infertility Center
  2. 2. Thanks!  IOGS  MP chapter ISAR  Dr. Asha Baxi  Dr. Shilpa and all teammates @Mohak
  3. 3. SCOPE OF THE PRESENTATION  Components of setting up ART services  Good lab design  Good service provision From How? to Wow!
  4. 4. Points to Ponder  What type of service are you thinking of?  Which is your target population?  When do you want to start/expand?  Who are your teammates?  Why do you want to start an ART service?  How much can you invest?
  5. 5. The ART Regulation draft bill:  Primary (Level 1)  Secondary (Level 2)  Tertiary (Level 3)
  6. 6. The TRY Angle INFRASTRUCTURE EQUIPMENT PERSONNEL
  7. 7. IUI services  Use the existing clinical area for consulting, scan, pathology and injection rooms.  The collection room : Separate exit, connection to the lab, privacy, aids  Andrology lab: Sterility , connected to IUI room and collection rooms.  Separate time/area for infertility patients.
  8. 8. Clean Room Concept derived from the pharma industry. How clean is your room? Particles Chemically active compounds Volatile organic compounds Microbes
  9. 9. Embryo does not have liver/kidney /lungs or a nose either!
  10. 10. AT REST (B) IN OPERATION Grade Maximum permitted number of particles/m3 equal to or above 0.5 Um 5 Um 0.5 Um 5 Um A 3500 0 3500 0 B (a) 3500 0 350 000 2000 C (a) 350 000 2000 3 500 000 20000 D (a) 3 500 000 20 000 not defined (c) not defined (c)
  11. 11.  EU directive 2004/22/EC stipulates quality requirements when human tissues and cells are handled  Where tissues or cells are exposed to environmant during processing, air quality with particle counts and microbial quality counts equivalent to those of Grade A as defined in GMP guidelines is essential.
  12. 12. “I use a laminar air flow. It provides me a Grade A environment!” Laminar air flow can achieve a Grade A environment only if incoming air is of grade B or at least C!
  13. 13.  The key to setting up a good lab is to think like the embryo  The quality of air in your lab makes the difference between good and exceptional results  You can buy better equipments or replace them anytime  Can you change your building as easily?
  14. 14. What We Did?  Choice between a centrally located hospital with excellent visibility , patient input and accessibility and building from a scratch in a pollution free area far off from the city.  We chose to build from ground up so that we are embryo friendly all the way.
  15. 15. What is ideal ?1 What is feasible ?2 What is viable?3
  16. 16. The Building  Ideally the second floor.  Area: depends on workload expected  Basic air sampling and VOC determination  Is any modification/renovation planned  30 to 40 square meters  Ducts , pipes placed outside
  17. 17.  Know thy neighbour  Love thy neighbour  Make sure your neighbour loves you back  Renovation/modification in neighbouring areas will influence your results.  Changing vinyl flooring caused dramatic fall in PR  Painting in the building: esp if oil based.
  18. 18. Walls Ceiling Lights Floor Storage IVF LAB Doors AHU
  19. 19. Kwality Walls! Solid surface GI SS Epoxy Tiles Ease of Maintenance +++ + + - - Antimicrobial +++ + + + - Durable +++ + + + - Sustainable +++ + + + - No offgassing +++ + ++ ++ + Seamless +++ - - + - Resilient ++++ ++ +++ + - Non Reflective ++++ + - +++ ++ Installation and assembly + ++ ++ +++ ++ COST +++++ ++ +++ ++ +
  20. 20. Air Handling Unit  Heating, Ventilation and Air Conditioning  Provides air changes and pressure differential  HEPA filters : Particles  Charcoal : VOC  UV light : Microbes  Maintenance and monitoring  Smaller mobile units also available
  21. 21.  Over pressured (0.10 – 0.20 inches of water ) + 7-15 air changes per hour.  100% outside air  Lab temperature 26 to 28 degrees  Humidity <40%  Layout of equipment  Space air outlets to avoid drafts
  22. 22.  Transient cooling to room temperature can cause irreversible of meiotic spindle in human oocyte. Pickering et al.(FertilSteril 54,102-108)  Limited recovery of meiotic spindles in live human oocytes after cooling rewarming observed using polarized microscope. Wang et al (HumRep 16,2374-2378)
  23. 23. Evidence around Air Quality  Paucity of evidence  Urgent need to generate good quality evidence to develop norms for IVF labs  Effect of VOC on ART outcome, Cohen et al (Hum Rep 12,1997)
  24. 24. Electricity  Critical (zero tolerance to interruption)  Critical (interruption allowed but needs backup within seconds)  Non critical with backup  Non critical without backup
  25. 25. Gas supply  TVOR theatre: Oxygen and suction  IVF lab: CO2 and trigas supply.  Dirty corridor for cylinders  Number and position of incubators, today and tomorrow.  Piped supply is ideal- flowmeter within the lab.  Copper pipes leach Cu ions in the gas supply.
  26. 26. The TRY Angle INFRASTRUCTURE EQUIPMENT PERSONNEL
  27. 27. Instruments and Equipments  Bewildering  Beware and be wary!  Three types: Essential, Desirable and Experimental  Look at track record and service commitment  Pick and choose  Frills can be expensive
  28. 28. IUI LAB 1. Equipments:  Essential : Centrifuge, Laminar air flow hood, Microscopes (Light), Incubator, Test tube warmer  Desirable: Phase contrast microscope, Mackler chamber, CO2 incubator  Experimental: CASA 2. Disposables
  29. 29. IVF Lab 1. Essential : Suction pump, tube heaters, Cryopreservation equipment, Incubators, Bio safety cabinet , micromanipulator. 2. Desirable: IVF Chamber, LASER, Low O2 incubators, CO2 analyzer, TC thermometer 3. Experimental : IMSI, Polscope, metabolomics
  30. 30. The TRY Angle INFRASTRUCTURE EQUIPMENT PERSONNEL
  31. 31. PERSONNEL Unlike Obstetrics and Gynecology where individual skill and talent brings credit and recognition. Essentially a ‘TEAM’ One weak link in the chain can spell disaster for the entire team and reflect on results. Training, motivation and spirit. Collection of brilliant minds or brilliant collection of minds?
  32. 32. The Clinicians: Infertility specialist, Sonologist, Pathologist, Andrologist The Embryology Team: Lab Director, Junior Embryologists The IVF Nurse Counselor Cleaning staff Geneticist
  33. 33. Non medical members are as important. Good IVF nurse can be the backbone of the unit. Embryologist is the soul of your programme. Don’t forget the cleaner! Attrition is inevitable Keeping updated is important for all the members, not only the lead clinician.
  34. 34. FINANCE The average cost of essential equipment for an IUI setup is 1.0 to 1.5 lakhs The cost of equipments for an IVF ICSI setup is around 40 lakhs. The cost of equipments in an ideal setup is close to 100K Infrastruture cost is about 40 to 50 lakhs. Clinical services like ultrasound, pathology, consulting chambers.
  35. 35. Think of Economics but don’t think Economically !
  36. 36. Effective service provision Patient centered services. Safety Timely Effective Efficient You cannot always be successful, but you can still succeed.
  37. 37. Elements of Good Lab Design The five elements : Prithvi = Building Agni = Incubators Jal = Water Vayu =Lab air Aakash= Culture system
  38. 38. Take Home Message The five questions: why, when, what, where, who and how much The five elements of good lab design The five elements of service provision The five fingers coming together to form a fist: Team approach.
  39. 39. Dr Shilpa Bhandari Mr.Charudutt Joshi Dipthi Repalle Dr.Vandana Kumawat Gitanjali Joshi Pawan Kumar Mr.Jitendra Sunita,Savita,Hemlata Deptt Of Obst and Gynecology,SAIMS

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