Troubleshooting in ART Lab


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A presentation done by Dilip Patil, Biomedical Engineer, CEO of Trivector at Fertivision-Six conference in Nagpur on 19th November 2010

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Troubleshooting in ART Lab

  1. 1. TROUBLE SHOOTING IN ART LAB (BEATING MURPHY’S LAW)   Dilip Patil , Biomedical Engineer, CEO, Trivector Scientific International, dilip@
  2. 2. MURPHY’S LAW <ul><li>If anything can go wrong, </li></ul><ul><li>It will go wrong </li></ul>
  3. 3. PRIMARY GOAL OF AN IVF CLINIC <ul><li>Gift Infertile couples with….. </li></ul><ul><li>The Live birth of healthy child(ren) </li></ul>
  4. 4. ALL IS WELL ….. TILL DISASTER STRIKES YOU! <ul><li>Why bother about trouble shooting? We never had any problem in our clinic </li></ul><ul><li>We are getting one of the best success rates in our clinic, so what is this talk about quality control and improvement? </li></ul><ul><li>If everything is working fine Why bother spending on maintenance contract and routine calibration (Let’s handle it when problem occurs!) </li></ul><ul><li>Fear of exposure/ridicule if admitted that there is a ‘problem’ in your clinic </li></ul>REMEMBER : Experienced captain Smith hadn’t hit any iceberg before Titanic’s maiden voyage
  5. 5. IVF CLINIC DILEMMA <ul><li>Gradual Reduction in success rates </li></ul><ul><li>Sudden Reduction in Success rates </li></ul><ul><li>In consistency in success rates (60% success in one batch while drawing blank in next batch or vice versa!) </li></ul><ul><li>No single factor can be attributed for a failure or improvement in results (making trouble shooting even worse!) </li></ul>
  6. 6. WHAT ARE THE TROUBLE AREAS? <ul><li>Empty follicles (Stimulation Protocols) </li></ul><ul><li>Person to person variations </li></ul><ul><li>pH and temperature fluctuations </li></ul><ul><li>Plastic ware / Disposable Toxicity </li></ul><ul><li>Equipment failures / calibration </li></ul><ul><li>Accidents / Mix-ups </li></ul><ul><li>Air Quality / Contamination / Vibrations </li></ul><ul><li>Power failure </li></ul><ul><li>Material logistic issues, </li></ul><ul><li>Human Resources -Staff </li></ul>
  7. 7. HORMONE STIMULATION <ul><li>Patients variation (age, drug response etc.) </li></ul><ul><li>Use of substandard (un-proven) drugs </li></ul><ul><li>Sub-optimal stimulation protocols </li></ul><ul><li>Batch to batch variation in drugs </li></ul><ul><li>Patient errors : Confusion between HCG and HMG (in case of self administrations) </li></ul>
  8. 8. PERSON-TO-PERSON VARIATION <ul><li>For bigger clinics where one task is performed by multiple people: </li></ul><ul><li>There may be inconsistency in follicle measurements </li></ul><ul><li>Possibility of inter- and intra-operator variation in ultrasound monitoring </li></ul><ul><li>Variation in skills for ovum-pick-up / Embryo Transfer and ICSI </li></ul>
  9. 9. <ul><li>Important parameters </li></ul>Basic conditions for culturing human cells : Temperature Control pH Control Osmolarity Control Sterility Control
  10. 10. CULTURE MEDIA <ul><li>Normally the ‘soft target’ for IVF failures </li></ul><ul><li>Transportation and handling Problems (Break in Cold chain, Integrity of packages) </li></ul><ul><li>Home-cooked media (No quality control) </li></ul><ul><li>Exposure to sun-light </li></ul><ul><li>pH /Osmolarity changes </li></ul><ul><li>Batch-to batch variation </li></ul><ul><li>Overuse of media from opened bottle / Use of Expired media </li></ul><ul><li>Fungus/ contamination in media (Faulty aliquots) </li></ul><ul><li>Non-compliance with manufacturer’s instructions for use (equilibration, bench time, centrifugation time etc) </li></ul>
  11. 11. DISPOSABLES <ul><li>Embryo Toxicity </li></ul><ul><li>Material used (PP, PS, Rubber) </li></ul><ul><li>Packaging size (individually pkd vs pack of many) </li></ul><ul><li>No proper off-gassing of ETO sterilized material </li></ul><ul><li>Breakages / particles in the dishes/tubes </li></ul>
  12. 12. CO2 INCUBATORS <ul><li>Inadequate number of Incubators </li></ul><ul><li>Lack of Individual doors/compartment </li></ul><ul><li>Frequent opening, loss of temperature, gases, humidity </li></ul><ul><li>Out of sync display and actual parameters </li></ul><ul><li>Condensation on glass door /side walls </li></ul><ul><li>Inadequate humidification / water contamination </li></ul><ul><li>Lack of calibration and preventive maintenance contract </li></ul>
  13. 13. WORKSTATIONS (LAF BENCHES) <ul><li>Absence of heat control / Temperature gradients </li></ul><ul><li>Noisy operations / Vibrations </li></ul><ul><li>Use of Non-medical grade monitors (radiation) </li></ul><ul><li>Wooden parts </li></ul><ul><li>Switching on/off as per convenience </li></ul><ul><li>Blocked filters, No preventive maintenance </li></ul>
  14. 14. ICSI EQUIPMENT <ul><li>Vibrations </li></ul><ul><li>Incorrect temperature control of sample </li></ul><ul><li>Oil leakages, air-bubbles and lag in movement </li></ul><ul><li>Inadequate pipette alignment skills </li></ul><ul><li>Normally inadequate/ incorrect optical configuration </li></ul><ul><li>Lack of regular servicing results in gradual reduction in performance </li></ul>
  15. 15. CRYOPRESERVATION / VITRIFICATION <ul><li>Shortage of Liquid Nitrogen (LN2) </li></ul><ul><li>Lower Levels of LN2 in tank (No alarm) </li></ul><ul><li>Spillage, Cold shocks and sudden burst of vials </li></ul><ul><li>Depleted Oxygen level in cryo-storage room </li></ul><ul><li>Losing samples due to improper handling / Lack of labeling and tracking (inventory) </li></ul><ul><li>Accidental thawing of samples </li></ul><ul><li>Wrong freezing techniques </li></ul>
  16. 16. ACCIDENTS AND MIX-UPS <ul><li>Embryology lab is like air traffic control room (ATC)- Zero tolerance for errors </li></ul><ul><li>Accidental bump-up of embryo-dish (in busy and crowded lab) </li></ul><ul><li>Spillage of (possibly contaminated) fluid on work benches, centrifuge and incubators </li></ul><ul><li>Improper labeling of utensils and absence of witnessing </li></ul><ul><li>Processing of more than one patients’ gametes at a time leading to accidental mix-ups </li></ul>
  17. 17. LAB ENVIRONMENT <ul><li>Dust particles, bacteria and other particulate matters </li></ul><ul><li>No proper air-differentials in different rooms </li></ul><ul><li>Excess or lower humidity </li></ul><ul><li>Chemical Air Contaminants (CACs) and Volatile Organic Compounds (VOCs) generated from : </li></ul><ul><li>Car fumes and neighborhood Industrial emissions </li></ul><ul><li>Building materials, flooring adhesives, Plastic casings of equipment, like TV monitors, microscopes </li></ul><ul><li>Compressed (impure) CO2 gases, de-gassing emissions from plastic ware (petri-dishes, tubes) </li></ul><ul><li>Anesthetic gases, refrigerants, cleaning agents (isopropyl alcohol) </li></ul><ul><li>Aromatic agents like after-shave lotion, perfumes, lipsticks </li></ul><ul><li>Effects of above CACs and VOCs result in fertilization failure and delayed embryonic development to a reduction in viability and pregnancy rates </li></ul>
  18. 19. ELECTRICITY <ul><li>Power failures and unclean power is the common occurrence in most part of India </li></ul><ul><li>Absence of on-line UPS with spike guards (inverter and generators are not appropriate) </li></ul><ul><li>Improper wiring and earthing (leakage current damages equipment, electrical shocks) </li></ul><ul><li>Inconvenient location of power points </li></ul><ul><li>Too many appliances running from single power point </li></ul>
  19. 20. LOGISTICS ISSUES <ul><li>Non-availability or Delayed delivery of material when it is needed most </li></ul><ul><li>Suppliers keeping you in dark about the transportation/delivery of material till the last moment </li></ul><ul><li>Receipt of products in sub-optimal condition </li></ul><ul><li>Unexpected shortage of last minute requirements, expired stock (No Inventory) </li></ul><ul><li>No planning of requirement, underestimating the requirements </li></ul>
  20. 21. HUMAN RESOURCES (STAFF) <ul><li>Shortage of skilled man-power </li></ul><ul><li>Lack of expertise and continual training of technical staff </li></ul><ul><li>Attitudes, Egos, jealousy and conflicts between staff members (lack of team-work) </li></ul><ul><li>Unreported absence of key staff member(Back-up) </li></ul><ul><li>Attrition ( Poaching of staff by rival clinics) </li></ul><ul><li>Sick and over-stressed staff member may not be able to concentrate on the work (Back-up) </li></ul>
  21. 22. BEATING MURPHY’S LAW: SUMMARY <ul><li>Appropriately educated and trained personnel </li></ul><ul><li>Team work aimed at producing healthy baby </li></ul><ul><li>Attention to details </li></ul><ul><li>Documental control and detailed written standard procedures (SOPs, Log Books) </li></ul><ul><li>Proper air quality, HEPA filtration, VOC Filters, Positive Air Pressure, 15-20 Air changes per hour </li></ul><ul><li>Correct operation and calibration of all laboratory instruments on regular basis </li></ul><ul><li>Advance Planning and Control of logistics and vital parameters of disposables and culture media </li></ul><ul><li>Definite method for Identification and tracking of patients and their biological material </li></ul><ul><li>Identification and correction of deviations from laboratory procedures </li></ul><ul><li>TROUBLE SHOOTS BACK </li></ul>
  22. 23. ROOT CAUSE ANALYSIS - CHART <ul><li>Understand the problem (Impartial-No Blame game) </li></ul><ul><li>Identify all possible contributing factors (Why? How? When) </li></ul><ul><li>Collect data about problem by observation or experimentation </li></ul><ul><li>Generate an Action Plan by including corrective action(s) </li></ul><ul><li>Implement the Action Plan by taking corrective action and monitoring the process </li></ul><ul><li>Follow-up – Assessment of the corrective actions via the monitoring process </li></ul>