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Troubleshooting in ART Lab
 

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

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 Troubleshooting in ART Lab Presentation Transcript

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