Quality
External programmes
External Quality Management Programme (EQMP)
To ensure compliance with UNE179007 and ISO 9001 regulations, as well as the quality and safety standards established in Royal Decrees 9/2014 and 112/1998 and the European SOHO regulation, it is essential that every assisted reproduction laboratory has a robust quality control program.
In this context, Gametia Biobank, in collaboration with external associations such as ASEBIR (Association for the Study of Reproductive Biology) or SEMEDLAB, offers its clients an external quality management program (PEGC) for embryonic analysis and semen analysis. This service allows registered laboratories to compare and evaluate their performance in blind analyses alongside other participants, thus ensuring objective and reliable monitoring of their results. The statistical comparison of values between laboratories helps to identify the precision and reliability of the analyses performed, while maintaining the confidentiality of all results. In addition, laboratories will receive their respective results reports and notifications via email and a secure web platform.SEMEDLAB / SEQC-ML
Embryo classification based on morphology presents challenges to homogeneity due to the inherent subjectivity between different observers, as well as the same observer on different occasions. For this reason, external quality controls have emerged, aiming to unify classification criteria and help embryologists categorize embryos in a more homogeneous and precise manner. The embryology quality control program offered by Gametia Biobank is the only one endorsed by ASEBIR.
What does the external quality management program endorsed by ASEBIR consist of?
The quality control program establishes a systematic methodology that allows the laboratory to evaluate its performance through collaboration with other laboratories that perform, in a blind manner, the analysis of the same control sample. The consensus value obtained by those using the same method is used to carry out the appropriate comparisons, providing each laboratory with knowledge of its performance in relation to the rest of the laboratories. In addition to the consensus value, for embryonic categorization, there is a consensus assessment carried out by a group of experts formed by members of the ASEBIR Quality and Embryology Interest groups and a senior embryologist from Gametia Biobank.
What material is sent?
Participants will receive an annual shipment that will include the necessary material, as well as the information required to access the web platform for data collection and embryo visualization. The program includes:
- Assessment of embryonic quality (ASEBIR classification)
- Clinical decision assigned to each embryo
- Embryonic cytomorphology
- Cryopreservation assessment
- Cytotoxicity test for:
- Laboratory material
- HEPES-buffered media for SMA assay.
All participants will have access to 57 embryo development videos through a web platform. The cases to be analyzed will be as follows:
- 2 short culture cases up to day 3: These will be 5 embryos, each with day +2 and day +3 videos (Total: 20 videos)
- 2 long culture cases, up to day 5-6: These will be 5 embryos each with day +5 and day +6 videos (Total: 20 videos)
- 1 long culture case with 5 embryos: A single timelapse video for each embryo of the entire morphokinetic development. Following the recommendations DOI:10.1016/J.RBMO.2023.103570. (Total: 5 videos)
- A Fertilization section: 10 different zygotes, one video per zygote, where it will be evaluated whether the fertilization is correct or abnormal. (Total: 10 videos)
- Cryopreservation. Videos of blastocysts thawed and cultured 2-3 hours prior to transfer. (Total: 2 videos)
- The evaluation of embryos on D+1, D+2, D+3, D+4, D+5, and D+6: This will be done following ASEBIR criteria: Cytomorphological characteristics of the embryos.
- Verification of toxicity of material and culture media.
WHAT DOES THE INTERNAL QUALITY PROGRAM (IQP) FOR AN ASSISTED REPRODUCTION LABORATORY CONSIST OF?
The Internal Quality Program (IQP) for the reproduction laboratory is a system that allows for the objective evaluation of laboratory staff performance. It provides the laboratory manager with a detailed view of the team’s performance through the blind analysis of various control samples.
The consensus value obtained by all professionals using the same methodology serves as a reference for making precise comparisons. This allows each embryologist to determine their level of concordance with their colleagues within the same laboratory.
In addition to the consensus value, in the case of embryo classification, there is an assessment based on the consensus of a group of experts with over 10 years of experience, who are members of the NEXT CLINICS Spain Group.
ORGANIZATION OF THE IQP IN THE REPRODUCTION LABORATORY
Since 2011, CEIFER has developed external and internal quality management programs in collaboration with external entities. In 2025, following its rebranding to GAMETIA BIOBANK, it will continue to offer its clients the Internal Quality Program with a renewed version, just like the rest of its quality programs.
MANDATORY PARTICIPATION IN AN ASSISTED REPRODUCTION LABORATORY IQP
All assisted human reproduction centers must mandatorily have an internal quality management system. Furthermore, it is highly recommended to implement a program that allows for the evaluation and comparison of best practices among embryologists through objective and measurable control systems. This will ensure continuous evaluation of the embryology team and facilitate the implementation of improvements in the results obtained.
The implementation of the IQP will optimize oversight by laboratory managers, ensuring compliance with a methodology aligned with an internal quality management system. Additionally, it will allow for the detection of potential differences in criteria during embryo evaluation, promoting the standardization and improvement of procedures.
IQP MATERIAL FOR THE ASSISTED REPRODUCTION LABORATORY
The IQP will consist of 57 videos intended for assessing embryonic quality and the clinical decision assigned to each embryo. This material is the same as that used in the 2025 Embryo Analysis EQMP.
The videos to be analyzed are as follows:
- 2 short culture cases up to day 3: 5 embryos, each with videos for day +2 and day +3 (Total: 20 videos)
- 2 long culture cases, up to day 5-6: 5 embryos, each with videos for day +5 and/or day +6 (Total: 20 videos)
- 1 long culture case with 5 embryos: A single timelapse video of the entire morphokinetic development for each embryo. (Total: 5 videos)
- A fertilization section: 10 different zygotes, one video per zygote, where it will be evaluated whether the fertilization is correct or abnormal. (Total: 10 videos)
- Cryopreservation. Videos of blastocysts thawed and cultured for 3 hours prior to transfer. (Total: 2 videos)
Each user will receive an individual report with their results compared to the average of the participants within the same laboratory. Likewise, the team leader will receive a control report that will include the results of all laboratory participants, as well as the average obtained by the team. These data can be compared with the assessment conducted by the expert group from NEXT CLINICS Spain.
FAQs
How can I register?
Through this same website https://www.gametia.com/quality/ or by sending a request via email to the Customer Service Gametia Biobank department.
Until when can I register, and when does the program start?
- EQMP – Embryo analysis: Participants can register from the 1st week of May 2025 until July 15th. The material will be sent to participants during the 2nd week of September, and the report for the centers will be available in the 2nd half of December. It will not be possible to register for the program once the registration period has closed.
- IQP – Assisted Reproduction Laboratory: Participants can register from the 1st week of May 2025 until July 15th. The material will be sent to participants during the 2nd week of September, and the report for the centers will be available in the 2nd half of December.
It will not be possible to register for the program once the registration period has closed.
What is the cost of the program?
EQMP – Embryo Analisis
How will I know when to execute the control?
- EQMP – Embryo analysis: Gametia Biobank will send the instructions to be followed along with the receipt of the material, in addition to reminders of the deadlines for reporting results by the centers.
- IQP – Assisted reproduction laboratory: Gametia Biobank will send the instructions to be followed along with the receipt of the material, in addition to reminders of the deadlines for reporting results by the centers.
- Participation:
- Anonymous
- Confidential results
- Execution frequency:
- Andrology laboratory will be quarterly
- Embryology laboratory will be annual
- Duration: one calendar year
- Certificate of registration and participation
- Comparative results report against your own center and against the rest of the participants.
- Electronic registration
