This document discusses key factors to consider when designing an in vitro fertilization (IVF) program and laboratory. It emphasizes that the program should be patient-centered and focus on quality of care, safety, effectiveness, and timeliness. Technical aspects like equipment, layout, air handling and electrical systems are reviewed. Costs for a mid-size 250-cycle per year program are estimated at 50-70 lakhs. The real key to success is positive patient experience and satisfaction.

1. SawadThotathil Designing a Best in class IVF program Essentials – Components/Equipment/Infrastructure

3. Institute of Healthcare Improvement

4. Department of Health, South Australia

6. Reasons and ongoing pregnancy numbers for couples (n = 319) that discontinued fertility workup and/or fertility treatment before conceiving an ongoing pregnancy, divided according to the initiator (the couple or the fertility specialist). Brandes M et al. Hum. Reprod. 2009;24:3127-3135 © The Author 2009. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

7. Factors incorporated in design Evidence-Based Design is the process of basing decisions about the built environment on credible research to achieve the best possible outcomes. Service offerings – Treatment offerings Quality of the service – Various dimensions of service quality Type of patient – Values, choices, affordability

8. EBD factors impact the following Layout and interiors Technology and equipment choices Systems and protocols– Functioning of the entire clinical unit including the people, their roles, protocols for activities and information technology Cost of establishment, running costs, pricing of services Elaboration of this approach in the following slides……

9. Service offerings Standard - standard (IVF/ICSI) Biological plausible yet unproven (low oxygen culture, IMSI, metabolic screening of embryos) Experimental (Pre-implantation screening PGS of gene expression for embryo selection, in-culture video monitoring) IMPACT Additional space , equipment and scientific staff Cost of project can double the cost of a standard IVF/ICSI lab ex: PGS IMSI can result in 15 to 20 % cost increase Example: Low oxygen culture is likely to be beneficial for embryo culture but you have to buy different type of incubators (some more costly), running costs are slightly higher for the gas

10. Dimensions of service quality Patient centeredness – concerns and desires of the patient are the chief determinant of decision making by the treatment provider Timely – Care when it is needed Safety of patients and staff Effective – Service or treatment procedure has been proven in a clinical environment Efficient – avoiding wastage in materials, time etc because the costs are ultimately passed onto the patient

11. Interiors Effect of construction materials on embryo growth Impact of interiors on patient experience – air quality, privacy, space etc

16. Clinic layout and impact on patient experience Patient perception of quality of care is affected by the ambience Space and layout should take into account the workflow ,expected workload and patient experience 1.Ex: Moving stretchers should go over a smooth surface without too many acute turns 2.Ex: Privacy between beds 3.Ex: Comfortable seating for partner besides bed

17. Safety of embryos, patients and staff Embryos -Monitoring of equipment (data logging equipment that continuously monitor incubator parameters, liquid nitrogen levels in the cryotanks) Staff -Safety gloves and mask when handling liquid nitrogen Patients – Falls prevention especially in the post anesthetic period

18. Effectiveness of service/treatment Technology choices as mentioned before More important dimension - How do providers use the technology as individuals and teams? Do you have standard operating procedures in place for quality control, embryo/patient safety? – Documentation is necessary for guidance, training Do you have performance measurement in place? – database and patient management software is necessary for patient reports, data analysis

19. Timely care This can mean different things in different care settings Timely alerts, advises to patients Reminders also to staff to execute scheduled activities Timely care can be provided only if there is a team approach and technology (ex: Concepta) can be used as an enhancer

21. Technical choices during construction Air conditioning or Air handling Electrical system design Gas supplies

22. Air handling Particle filtration VOC removal Air changes per hour Temperature control Considerations in design -Noise levels, room size, external temperature, heat load in the room

23. Electrical system design Categorize equipment and other needs Critical (zero tolerance to interruption) Critical (interruption allowed but needs back up within minutes) Non critical with back up. Non critical without back up Calculate the loads and allot for backup with UPS/Inverters/Generators as appropriate

24. Gas supplies Quality of gas, adequacy of pressure at incubator end Number of incubators now and in the future Location of cylinders Back up cylinders? Length of piping – cost and drop in pressure Type of piping – copper pipes of numerous types available Filters

25. How do you go about it? Project consultant – Expert with project management skills and good knowledge/experience establishing multiple IVF units. Onsite Project lead – usually the architect Structure Interiors -General Electrical design Electrical execution contractor Lab/OT floor/wall Lab/OT ceiling Air handling unit for Lab/OT Gas piping for Labs Gas piping for OT and Recovery Lab Equipment Lab furniture Data logger LAN and telephone points General furniture Theatre equipment Start to finish – 12 weeks provided budget is approved, determination on the part of the doctor and the space is constraint free for work

26. Role of the Project consultant Understanding requirements Communicating with all stakeholders Give design inputs as in next slide (example: lighting requirements) Planning Monitoring Closing

28. Costs for mid size program (250 cycles per year) Lab equipment – roughly about 50 lakhs Other furnishing/civil/interiors/electrical/theatre equipment – another 20 lakhs Cost reduction possible but not recommended if you wish to create a good IVF program Key factors for success – contracting or hiring the right people from architect to nurse to embryologist Training and supervision for ovarian stimulation, oocyte retrieval and embryo transfer procedures Standard operating procedures, good protocols set by experts

29. Real key to success Patient experience Satisfaction of patient needs

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