Friday, June 11, 2010

Quality Control in the IVF Laboratory

This is a guest post by Dr Sai, Chief Embryologist at Malpani Infertility Clinic.

Quality Control (QC) and Quality Assurance (QA) in the IVF laboratory plays an important role in the success of any IVF program.

The role of QC procedures in the IVF laboratory is to fine tune existing protocols in order to more effectively help infertile patients in their quest to have a healthy baby. The three most important physical conditions in the IVF laboratory that can be controlled are the temperature, pH and osmolality of the IVF culture medium. Laboratories are required to document and monitor these physical conditions regularly as part of their ongoing QC/QA programs. Monitoring and documentation of temperatures inside incubators, refrigerators and freezers is an integral part of routine day to day QC in the IVF laboratory.

Quality Control of Laboratory Equipments :

CO2 Incubators :
Variation in pH and temperature affects the embryo quality and thereby pregnancy rate. Therefore proper maintenance of CO2 incubator is very critical.

  • We measure the CO2 percentage and temperature of incubator daily to ensure stability of pH and temperature.
  • A Log book is maintained for proper documentation.
  • Regular Cleaning and decontamination of incubator is done.
  • Water in incubator pan ( to maintain humidity) is changed regularly
  • A Sperm survival test is done before every batch to ensure proper functioning of incubator.
  • We have an Annual maintenance contract with the supplier for regular servicing.
  • Back up Power supply is mandatory.

Laminar Flow workstation :

  • Daily cleaning of surface.
  • Regular servicing, cleaning of HEPA filter.
  • Ensuring the HEPA filter is working properly by testing the density of the particulate matter in the air

Micromanipulator and Stereozoom Microscope :

  • Regular cleaning.
  • Daily measurement of temperature of stage warmer.

Pressure Modules (Air purifier) :

  • Regular servicing.
  • Regular cleaning of HEPA filter.

Quality control of Culture medium and disposables :

  • Documentation of shelf life and batch number is maintained.
  • Stock keeping with reorder level is maintained to avoid shortage.
  • Proper maintenance of refrigerator i.e. cleaning and regular temperature measurement for storage of culture medium.

Sterile Culture Conditions :

To ensure that your embryos are happy in the IVF lab, we need to ensure optimal culture conditions .

These include :

  • IVF Lab cleanliness :

    = Daily Cleaning of IVF lab with proper disinfectant is mandatory.
    = The disinfectant should be non-toxic and odourless. We use diluted H2O2 to do so. Alcohol-based solutions can be embryo toxic and should not be used.

  • CO2 Incubator Cleanliness :

Regular Cleaning and disinfection of CO2 Incubator should be performed.

  • Aseptic precautions while handling Gametes and embryos :

    = One should wash his hands properly before handling the dishes containing embryos.
    = Gloves should be worn, while preparing dishes and handling culture medium

Correct handling and identification of patients and their gametes and embryos

Written procedures should be present describing the various phases of IVF techniques. Rules concerning the correct handling and identification of gametes and embryo samples should be established by a system of checks and, where needed, double-checks.

  1. All material obtained from the patients, i.e. tubes with follicular fluid containing eggs and containers containing sperm, should bear the names of the treated couple.
    • At our centre, when the husband collects a semen sample for an IVF procedure, Semen Freeze or Semen Analysis, the nurse charge will ask the patient to write his full name on a piece of paper, to avoid any spelling mistakes and the same name will be written on semen collection jar. The Jar is labeled with husband's name and cap of jar is labeled with his wife's name.

    • Once the sample is collected and it arrives in the lab along with your file, the name on the jar is cross checked with one on the file. We analyse the sample and transfer the sample to sterile centrifuge tube, which is labeled with his name. The cap is also labeled.

    • The sperms will be processed while they are in this tube and will remain in this tube till we use them for IVF procedure.
    • The culture dishes required for your IVF Procedure are prepared in advance. All the dishes are labeled with your name. The shelf of the incubator in which your dishes are kept is also labeled.

    culture_medium3 Incubator_shelves

  2. Verification of patients' identity should be performed at critical steps: before egg collection, at semen recovery and embryo transfer procedures.
    • At our centre, the nurse and OT staff cross check your file before taking you inside the OT for procedure.
    • The nurse informs Dr. Anjali and me about your being taken into the OT.
    • For embryo transfer, the nurse stands as witness, while I load you embryos into the catheter.
    • I confirm your name audibly with Dr. Malpani, before handing over the catheter loaded with your embryos to her.
  3. Double checks need to be considered at critical procedures such as : insemination of oocytes, replacement of embryos, embryo freezing and thawing.

Handling of oocytes and spermatozoa
The laboratory procedures regarding the handling of gametes for assisted should be easy, simple and effective and must be performed in a laminar flow hood equipped with stages and heating blocks pre-warmed at 37°C. Disposable items used in the laboratory procedures for culturing eggs and embryos should be of tissue culture grade.

  • Aseptic technique should be used at all times.
  • Appropriate measures should be taken to ensure that oocytes and embryos are maintained at 37°C during handling/observation using stage warmers or other systems.
  • Tissue culture grade disposables should be used for handling gametes.
  • Pipetting devices (pasteurs, drawn pipettes, tips etc.) used for procedures should be disposed of immediately after use.
  • Simultaneous treatment of more than one patient should never be done in the same working place.

Protective measures
The purpose of the protective measures is also to ensure aseptic conditions for gamete and embryos :

  • Use of non-toxic (non-powdered) gloves and masks.
  • Use of vertical laminar-flow benches.
  • Use of mechanical pipetting devices.
  • Use of disposable material; after usage, it must be discarded immediately in the proper waste containers. Potential infectious materials must be disposed of in a manner that protects laboratory workers and maintenance, service, and housekeeping staff from exposure to infectious materials in the course of their work.
  • Needles and other sharps should be handled with extreme caution and discarded in special containers. The Pasteur pipettes and broken glassware should be discarded in special containers.

Quality Control using evaluation of results :

At our centre, we evaluate results on a regular basis. The following factors are regularly evaluated:

  • Fertilization rates
  • Embryo Quality
  • Pregnancy rates
  • Multiple pregnancy rates
  • Implantation rates
  • Survival rate for frozen embryos
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