Quality Assurance in the IVF Lab

August 19, 2010Carole 4 Comments »

This post probably falls under the “too much information” category for most of my readers but for those of you who like to look under the hood of your IVF lab, these are some of the things you might see in a good IVF lab.

Teamwork and Collegiality: A good IVF team meshes a diverse group of professionals including physicians, nurses and technicians who have a common goal- getting their patients pregnant. Ideally, this team will have more in common with each other than they have disagreements if their primary focus is on making great embryos for you, the patient. It’s a bad sign if you get the vibe that half the team despises the other half or denigrates the professional contribution of other team members. Every member of the team has the potential to screw up an IVF cycle and every member has the potential to make that cycle better.  An IVF team, particularly if they are a small group, will become a sort of work family but you may not want a dysfunctional family making your embryos!

Ovverall team work is extremely important but each professional specialty of the team contributes significantly to the outcome. Nurses and physicians may not have a written quality assurance program in the same way that the lab is required to have one but they generally have their own idea of the critical points in an IVF cycle that make or break a cycle.  You can ask them what they think are the most important factors in achieving a good stimulation, making good embryos, having a smooth transfer and ultimately achieving and keeping a pregnancy. If they are engaged in their profession, they will probably have thought about this and be pleased to talk about what makes them good at what they do.

The devil is in the details. In the IVF lab, it is often the smallest details that make the difference which may explain why “detail oriented” is a ubiquitous adjective found in job descriptions to describe attributes wanted in an embryologist. Here are some of the things embryologists obsess over in the IVF lab.

IVF Supplies including but not limited to: culture medium, freezing medium, plastic dishes, tubes, gloves, pipettes of all kinds, mineral oil, injection needles. Every supply that enters the lab must be embryo tested or sperm tested to confirm that it has no toxic properties. In the old days, embryologists had access to mouse colonies and generated their own mouse embryos for toxicity testing. Thankfully, vendors now perform those tests as part of their production process and provide certificates of quality assurance with toxicity test results. Testing by the vendor tends to provide a more consistent testing program and also reduces costs to the end user- at least in comparison to maintaining a mouse colony!  The first “date of use” for each production lot of a supply is also noted in the lab so that problems in the lab can be correlated with introduction of new lots.

The pH and temperature of the culture medium: These two characteristics are perhaps the most important factors because a problem with either can derail fertilization and embryo development. Although everyone agrees that the pH of the medium is critical, not every lab measures pH directly and if they do, they often disagree on the best method for measuring pH. Part of the problem is that bench pH meters can be finicky, especially if they are used only infrequently when a new lot of medium comes in. pH readings are temperature sensitive and a variety of factors can cause faulty readings such as failure to pre-warm the standards as well as the test medium. Some vendors sell (expensive!)  equipment to  continuously monitor the pH of culture medium in the incubator.

Equipment: The typical embryology and andrology (sperm) lab is humming with equipment including incubators, microscopes of various sizes and functions, micromanipulators for ICSI and biopsy or hatching, refrigerators, freezers, semen and embryo storage tanks, heat blocks and clinical hoods for working with gametes or embryos under sterile or ultra-clean conditions. Each piece of equipment is expected to perform within a specified range. So you will find a log book entry for every working day in the lab and rows and rows of numbers indicating equipment readings such as temperatures or flow rates or incubator gas levels (carbon dioxide, oxygen) etc. Liquid nitrogen levels are recorded daily or monitored continuously to avoid severe liquid nitrogen loss and warming of stored reproductive tissues.

Embryologists record this data and compare it to the acceptable ranges previously determined for the operation of the instrument. If equipment is not functioning within acceptable ranges, it is usually removed from service until it can be repaired or replaced. Electrical safety tests are also performed, usually annually to make sure there are no electrical problems with equipment.

Ongoing data analysis: All equipment data is collected and reviewed on an on-going basis to look for trends or problems.  The equipment data is analyzed to look for declining trends in the data to signal an early warning that an incubator or other piece of equipment is beginning to fail and needs maintenance or replacement. Performance outcomes are also tracked and analyzed for declining trends in outcomes such as  fertilization rates, rates of embryo development, embryo survival after freezing and pregnancy rates.

Avoiding technical drift: The personal stats for each technician can also be reported and tracked. For instance, the percent fertilization rate using ICSI for each tech can be recorded and tracked to identify when someone may need some re-training. The embryo recovery rate after freezing can also be an important endpoint to track because freezing protocols are especially vulnerable to protocol deviations which can cause poor outcomes. Technical drift is a well-known phenomenon among technicians who typically repeat the same task over and over. Over time, there are likely to be subtle deviations in how techs perform procedures that eventually add up to significant deviations from written protocols that can cause problems.

Staff training and education: Every IVF program should have a written training program in place for the newest technicians so that it is clear what the training expectations are for each position, training mileposts and time frame in which training should be completed. Typically, more senior technician train junior technicians. But sometimes a more junior member of the team can have a “knack” for a particular skill and may be the best person to teach the skill. This is where respect for each team member’s skill, regardless of seniority, is a characteristic of the best IVF teams.

Embryology staff should have on-going opportunities to improve their technical skills and keep up with professional advances in the field. This may mean attendance at professional meetings such as the annual American Society for Reproductive Medicine (ASRM) meeting or other regional assisted reproduction technology meetings. In this economy, travel is becoming prohibitively expensive for many programs so relatively inexpensive on-line courses (which are slowly becoming more available for embryologists) are being used more frequently. The American Association of Bioanalysts  website posts a list of continuing education options for lab techs. Some vendors also host free (except for travel) training sessions for clients who use their equipment or supplies.

Troubleshooting: This is where your best IVF teams shine. If there is collegiality and respect in the IVF team, then every member is empowered to speak up and brainstorm about problems. Egos can be set aside for the moment if everyone remembers that the organizing principle is making embryos for the patient. The best programs remember this. Every program encounters problems from time to time. Sometimes the source of problems are never found and results suddenly seem to improve and normal pregnancy rates resume. Although it is a relief when things go right again, not knowing what caused the problems is unsettling and may leave the program vulnerable to another streak of bad outcomes.

Part of the problem in IVF trouble shooting is that even with extensive tracking of everything in the IVF lab, there are too many variables that are not tracked and not accounted for. Few, if any, programs ask patients to track the lot of medications they are using, so a bad lot of ovarian stimulation drugs can cause problems for a streak of patients. Problems with patient education can result in patients who may not be taking the dose they think they are getting which will affect the ovarian response.

Also, unlike genetically similar lab mice, every patient couple has underlying and variable fertility problems. Some labs even go so far as to use two different culture mediums to culture half of the eggs in a single case, convinced that gametes from some couples will perform better in one medium over the other due to individual patient differences. I think the science is still lacking to support this dual culture media approach and I would be concerned that it adds unnecessary complexity which generally increases the potential for mistakes.

The KISS principle. I am a big fan of the KISS or “Keep it Simple, Stupid!” principle. In my experience, every procedure or policy should be scrutinized on a regular basis to see if it still serves the main mission of making healthy embryos. For example, I inherited a lab which was collecting a lot of charting data on each embryo. When I asked what the clinical use was for the data, no one knew. It was part of the work sheet generated for research studies that had been discontinued for years. The physicians didn’t use the data. The lab didn’t use the data but the lab still dutifully continued to record the data. The time out of the incubator to chart the data was prolonged and didn’t promote (and may have been detrimental) to the main mission of creating healthy embryos. So that embryo charting worksheet was redesigned and that data was no longer tracked.

Sometimes things are done because they have always been done that way and no one remembers why it was done in the first place. Of course, compliance documentation for the FDA, CDC and Joint Commission is increasing all the time and is unavoidable, but anything that isn’t required and doesn’t support the creation of healthy embryos probably needs to be reconsidered and possibly discontinued.

© 2010, Carole. All rights reserved.

4 Responses to this entry

  • Ten things about IVF that you must know | Fertility Lab Insider Says:

    […] Quality Assurance in the IVF lab […]

  • Anonymous Says:

    Is there a way, by looking at the SART data, to identify good IVF labs? I really think this is a VERY critical component to IVF.

  • Carole Says:

    Hi Anonymous,
    SART data can certainly be used as an indication of whether the lab is good. Good pregnancy outcomes are only possible if the lab is good. It is a team effort. A consistently bad pregnancy rate can mean that EITHER the lab or the doctor is subpar or BOTH are subpar. To get good pregnancy rates, both parts of the team have to be good enough and one might be excellent. As a rule of thumb, good programs have at least a 50% preganncy rate per transfer in their youngest age group. If you can’t get at least 50% of your youngest patients pregnant, there is probably a systemic issue. The really excellent programs have rates in the 60’s or higher. Youc an see both the national average and data for individual programs at the SART site. http://sart.org/frame/detail.aspx?id=3893 Good Luck! Carole

  • Dr M.S Beebeejaun Says:

    Dear Sir/Madam,

    We are an IVF centre based in Mauritius. We have been practicing IVF for several years and we would like to improve our Quality Control in our Lab aiming to have better success rate.
    We have been through your website and we would appreciate to have your advice for better Quality Control.
    That is for PH meter, Particle count test, Filter Integrity test and Hygiene test.

    Best regards,
    mobile 5-1750555

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