IVF laboratories or fertility clinics are subject to technological advancement continuously. Currently, the work inside an IVF laboratory poses a high degree of technological complexity. However, this does not necessarily guarantee the risk of error happening to be lower, instead with more complexity comes an even greater chance of risk. There is always risk of mistake/error to happen in every procedural step during a cycle of IVF. Some errors might be considered to be minor and some might have major impact to both the patient and the clinic involved.
The international organization for standardization, ISO 9001, requires the implementation of a mechanism to identify and keep track of the "product" throughout the process inside IVF laboratories. The products being gametes and the end result of gametes fusion is the embryo. Identifying what could possibly go wrong inside the IVF laboratory during the whole process of an IVF cycle should be a good start. Afterwards, the identified errors should be prevented from happening by facilitating strategies to help detect the error. Aside from that, avoiding any situation that can lead to error can be done. Mitigating any error, if one ever happens, should be done through double-checking and traceability tool function by means of proper documentation.
Different IVF laboratories or fertility clinics would have their own Standard Operational Procedures (SOP) to be followed and double witnessing would always be made as a mandatory act to do as it is the requirement of the ISO 9001 as the best preventative action to avoid any error or mismatch of products throughout a cycle. However, double witnessing can sometimes be difficult to implement, and new human error can happen due to the variation that occurs in different laboratories.
Reproductive societies such as the European Society for Human Reproduction and Embryology (ESHRE), the American Society for Reproductive Medicine (ASRM) and the regulatory bodies like the Human Fertilisation and Embryology Authority (HFEA), have evaluated and produce code of practice to be used throughout an IVF cycle to correctly identify the patients and collect the right specimen and to properly handle the procedures. It is well established that the list of IVF procedures that are required to be double witnessed include:
- Patient specimen labeling
- Oocyte pick-up
- Semen collection and sperm preparation
- Mixing sperm and the eggs for conventional IVF or sperm injection into egg for ICSI
- Transfer of gamete or embryos between dishes
- Embryo transfer
- Insemination using sperm prepared in the laboratory
- Cryopreservation of gametes or embryos
- Thawing of gametes or embryos
- Disposal and/or transport of gametes or embryos
Some of the key steps in IVF process are initial gamete collection, fertilisation through either ICSI or conventional IVF, cryopreservation and thawing of gametes/embryos, and embryo transfer. These key steps are susceptible to human error because gametes and/or embryos are handled by not just one but several embryologists, which can increase the potential of error. Any mistakes in any of the mentioned key steps can result in loss or mismatch/mix-up of samples. The more staff involve in manipulating one sample, the more probability of error to happen, hence why it has to be a requirement for IVF laboratory to conduct double witnessing during the action of these key steps.
Manual double witnessing should always keep proper documentation of the procedure taken, the exact date and time of the procedure, the signature of the person handling the procedure as well as the person double witnessing the procedure. Manual double witnessing is rather a tedious process which can add more complexity to the already complex and busy IVF laboratory. Aside from that, some liabilities have been indicated from conducting manual double witnessing such as independent redundancy, ambiguous accountability, and intentional blindness. A study done by Toft et al. (2005) stated that "factors that are associated with the occurrence of human-made errors include stress, lack of education and training, conscious automaticity, and involuntary automaticity."
These factors can be prevented by the implementation of what's called the electronic witnessing system (EWS). As technology becomes more advanced, other protocols for witnessing systems in an IVF laboratory have started to emerge, such as employing the use of barcode, radiofrequency or even direct tagging on the gametes and embryos, or easily known as EWS. This system does have the potential to standardize the witnessing protocol inside the IVF laboratory, as it will be able to monitor the procedures undertaken in a more accurate way and will minimize the introduction of interruption to other embryologist from their work to perform double witness.
EWS was introduced to the field to focus on reducing the possibility of error and as a traceability tool, with additional benefit through different functions in helping the clinic to comply to the SOP, implementing quality management system and many more. Fertility clinics who implement the use of EWS are assured of having a proper monitoring system throughout each Assisted Reproductive Technology (ART) cycle. The system is applied in every step making all the IVF procedures safer given the fact that EWS will be able to keep track of documentation and record all the procedures that have taken place and future steps to be taken. As a more advanced option, EWS can help maintain the security and integrity of the clinic's SOP by means of the state-of-the-art technology the system is based on. In a busy IVF laboratory or fertility clinic setting, EWS can help lower the risk of human error when samples are transferred from one dish to another. Cross-checking of a step is done automatically by the system which makes sure the sample on hand is correct, therefore preventing the occurrence of human error such as accidental mismatch.
MIRI® Evidence as a part of the Esco Medical family acts as a traceability tool within an IVF laboratory to manage all the procedural steps by helping to eliminate the risk of human errors and preventing system mix-ups. Aside from that, MIRI® Evidence will also help the associated clinic to comply with the current SOP and the existing regulation by providing a quality management system. Implementation of MIRI® Evidence will be placed in every step of an ART cycle, therefore, will provide a chronological record of documentation. Furthermore, here’s how the MIRI® Evidence can assist the workflow within an IVF clinic:
- Retrofit
- Hybrid Labels
- Chain of Custody
- Mismatch Prevention
MIRI® Evidence can be efficiently retrofitted to the IVF clinic without the need to modify the already existing laboratory/clinic equipment. The hardware can be fitted to the workstations that are currently available on the market. User may also opt to have a monitor that’s designated solely to monitor the arrangement of sample placement within an incubator, which practically works with incubators of various brands.
MIRI® Evidence uses an intuitive labeling system for all the labels printed out, making use of all 3 aspects of human-readable font, universal data matrix code, as well as RFID tags. The human-readable content can be customized to fit the need of the IVF clinic meanwhile the matrix code and the RFID tag are incorporated to ensure the identification and traceability of the samples.
As an electronic witnessing system, MIRI® Evidence is capable of visualizing the full-blown chain of custody for a specific gamete or embryo, from the initiation of the cycle until the final act. The chain of custody includes all of the utensils and lot numbers that have been used throughout the cycle, denoting that all of the utensils that have been in contact with the embryo or gametes are documented. The complete chain of custody by MIRI® Evidence is generated through the employment of unique identification number and the implementation of RFID tag within the labels used throughout the IVF cycle.
MIRI® Evidence as an electronic witnessing system proposes the idea to eliminate the need of conducting double witnessing. The advanced usage of hybrid labeling in MIRI® Evidence plays a big part in the prevention of any error or possible mismatch from happening. Each label has a unique identifier and RFID tag which ensure the accuracy of the sample at hand. User will be clearly notified if by mistake they have taken the wrong dish. Upon such mistake, clarification by the current user shall be documented in the system to make sure the error has been thoroughly ruled out.
Click here and learn how MIRI® Evidence can help you improve your IVF Laboratory/Clinic procedures.
