Abstract
The most important purpose of embryo culture in the IVF lab is to make sure that the embryo can develop to its full potential in a safe and secure environment, and to prevent any errors that can lead to cancellation of the IVF cycle, or risk of other adverse outcomes. In a study by Sakkas et al. (2018),1 including data from over 10 years and more than 35,000 fresh and frozen IVF cycles from more than 180,000 individual laboratory procedures, it was shown that the rate of moderate nonconformances was 0.23%. These failures are described as problems that negatively affect a cycle but not to the extent that the cycle is lost or severely compromised. Although the data from this study is reassuring and shows a very low rate of nonconformance during treatment, the most undesirable and catastrophic event that can occur in an IVF laboratory is a misidentification and mix-up of sperm, egg, or embryo. Embryo culture is a lengthy process that can last up to 6 or even 7 days in which the culture dish is manipulated regularly, sometimes on a daily basis, for purposes such as fertilization, embryo quality assessment, transfer, and cryopreservation. During these manipulations stringent procedures and protocols have to be in place in order to track and trace each and every embryo throughout the embryo culture. The ESHRE guideline for good practice in IVF laboratories includes a section on identification of patients and traceability of their reproductive cells.2 Although traceability is part of the quality management systems in IVF laboratories today, there is not one system that is fail-safe.
7.1 Introduction
The most important purpose of embryo culture in the IVF lab is to make sure that the embryo can develop to its full potential in a safe and secure environment, and to prevent any errors that can lead to cancellation of the IVF cycle, or risk of other adverse outcomes. In a study by Sakkas et al. (2018),1 including data from over 10 years and more than 35,000 fresh and frozen IVF cycles from more than 180,000 individual laboratory procedures, it was shown that the rate of moderate nonconformances was 0.23%. These failures are described as problems that negatively affect a cycle but not to the extent that the cycle is lost or severely compromised. Although the data from this study is reassuring and shows a very low rate of nonconformance during treatment, the most undesirable and catastrophic event that can occur in an IVF laboratory is a misidentification and mix-up of sperm, egg, or embryo. Embryo culture is a lengthy process that can last up to 6 or even 7 days in which the culture dish is manipulated regularly, sometimes on a daily basis, for purposes such as fertilization, embryo quality assessment, transfer, and cryopreservation. During these manipulations stringent procedures and protocols have to be in place in order to track and trace each and every embryo throughout the embryo culture. The ESHRE guideline for good practice in IVF laboratories includes a section on identification of patients and traceability of their reproductive cells.2 Although traceability is part of the quality management systems in IVF laboratories today, there is not one system that is fail-safe.
7.2 Towards Effective Traceability
Traceability is key during embryo culture; however, when it does break down, it is important to have a system in place to be able to detect and find the root cause of the error or failure. Most of the time, many more factors than first identified are involved in a traceability failure. One problem-solving strategy that can be applied is the Ishikawa approach. This is illustrated in the fishbone diagram – a cause and effect diagram – created by Kaoru Ishikawa3 (Figure 7.1); use of this makes clear how many factors can potentially be involved in a mix-up during embryo culture. The fishbone diagram can also be used for risk-analysis assessment, i.e., to identify the effects needed to obtain a desired result. Unlike trying to find the root cause to a problem or failure, the latter will show the identified factors that need to be controlled or in place in order to obtain the required outcome. As summarized in Figure 7.1, in order to obtain a traceability system during embryo culture, many factors need to be accounted for.
7.2.1 Method –Witnessing Procedure
Aside from a written protocol explaining the aim of traceability in your IVF laboratory, a specific method for identification and for tracing should be chosen. In most IVF laboratories, the 4-eye principle is still used. This manual double-witnessing procedure entails a double check by another staff member not performing the manipulation. A second person will double check the identification and labelling before the embryologist starts the manipulation or processing of the samples.4 Aside from a double check before or during the procedure, a final check can also be performed at the end of a procedure. This final check is used to intercept adverse events that can be reversible upon detection, or that are not possible to detect until a procedure is complete.5
A traceability method entails more than verifying the identification label on the embryo culture dish to the patient protocol. Additional checking of the material through the microscope might be necessary in certain embryo culture process steps. The difference between the witnessing of the identification label on the dish (= dish check) and the witnessing of the embryo in the culture (= droplet check) should be clearly described in the traceability protocol. When sequential media are used and certain embryos need to be transferred from the cleavage medium dish to the blastocyst culture dish, both a dish check and a droplet check is needed before the cleavage medium culture dish is removed. This droplet check verifies, for instance, that the right embryos are transferred to the blastocyst culture dish before any dish is discarded.
The double-checking approach does not only include the checking itself, but also the registration of the manual witnessing: staff members performing the first check and the double check must register this on a form or in the laboratory system. Preferably, the date and time should be recorded.4, 5
A good traceability method describes:
Why to check: although it seems logical that double-checking is necessary in an IVF laboratory, still the rationale for the traceability needs to be described.
Who is checking: every staff member will check on their own that they have taken the correct culture dish in relation to the patient file they are working on. A double check will be performed by a second staff member (in the case of manual witnessing), before any manipulation to the embryo culture is done.
When to check: which process steps are vulnerable and pose a risk of misidentification and need double checking and witnessing.
What to check: For each check needed, a description of what to check is required:
dish check: the identification label on the dish in comparison to the file of the patient prior to any intervention
droplet check: verification of the embryo in the dish in cases of transferring embryos to other dishes
final check: this is a go/no go check: the next process step can be interrupted at this stage so that a mix-up is prevented. It is a double check that is executed at the end of a process step and before the next process step is started. It can include both dish check, patient file check, and/or droplet check.
Where to check: witnessing and control checks are registered in the patient file. A detailed description of the registration of the checks needs to be documented.
How to check: a description of the way checks are performed (manually or electronically).
How much to check: it is important to find a balance in the amount of witnessing checks that are performed. A group FMEA (failure mode and effect analysis) exercise to pinpoint the risks in the embryo culture will highlight the process steps where witnessing checks are necessary.5–7
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