Embryo Certification Meeting Radisson SAS Royal Hotel, Brussels, Belgium 17 September 2007

1° Presentation of the participants

• Almeida, V. (the Portuguese Society of Reproductive Medicine)
• Argyriou, A. (PEKE, Greece)
• Baukloh, V. (AGRBM, Germany)
• Curfs, M. (KLEM, The Netherlands)
• Ebner, Th. (Alpha, Austria)
• Figueiredo, H. (the Portuguese Society of Reproductive Medicine)
• Grossmann, M. (ASEBIR, Spain)
• Hardarson, T. (The Nordic IVF Laboratory Society)
• Hughes, C. (ICE, Ireland)
• Lundin, K. (Sweden)
• Magli, C. (Italy)
• Nolan, A. (ICE, Ireland)
• Pelekanos, M. (PEKE, Greece)
• Raick, D. (ABEF, Belgium)
• Royère D. (BLEFCO, France)
• Sunde, A. (Norway)
• Thonon, F. (ABEF, Belgium)
• Van den Abbeel E. (Dutch-speaking Embryologists and SIG Coordinator, Belgium)
• Van den Bergh M. (Alpha)
• Van den Eede, B. (ESHRE Central Office, Belgium)
• Vidal, F. (Spain)
• Würth, Y.(KLEM, The Netherlands)
• Ziebe, S. (Denmark)

2° Status report

• K. Lundin, who chaired the meeting, explained that she would to go through the following items:
• Background and tasks 
• Timing
• Senior Embryologists – Fast track
• Senior Embryologists – Regular track
• Clinical Embryologists - Regular track
• Who is eligible?
• Exams, curriculum, logbook
• Website

K. Lundin explained that in most European countries clinical embryologists did not have a system for formal recognition. As far as clinicians was concerned, there was a well established system of a sub-speciality in reproductive medicine through the EBCOG-ESHRE collaboration. However, clinical embryologists have a large and increasing responsibility in the IVF laboratory/clinic. Also the EU Tissue Directive further enhanced the need for recognition. Therefore, the Executive Committee (EC) of ESHRE was working towards implementing a certification system for clinical embryologists. The aim of this undertaking was to develop and run an ESHRE certification system for clinical embryologists active within human assisted reproduction laboratories in order to increase quality and to be recognised.

K. Lundin continued to report that there had been several meetings to discuss how the system could be started up. Invitations had been sent out to a number of established National Societies (i.e. for the UK, Spain, Germany, The Nordic Countries) including Alpha and the SIG Embryology Coordinator to join efforts. The curriculum, time lines, criteria for applicants etc. were established, and A. Sunde gave a presentation at the “Members’ Information Session” during the Annual Meeting held in Lyon. Finally more National Societies were invited to the information and discussion meeting on 17 September 2007.

At the meetings, held in July and September 2007, of the Executive Committee of ESHRE it was decided that an ”Embryologists Certification Group” should be established in relation with the Special Interest Group “Embryology” and to report to the Executive Committee. The Executive Committee also decided that K. Lundin should chair the Certification Group. Although all ESHRE members had to be eligible, it was agreed - for practical reasons - to start with members working in Europe.

It was further decided by the Executive Committee, that people applying for an Embryologist certificate should be ESHRE members. As far as the “Fast- tracks” were concerned, unless they were already member of ESHRE, they will be asked to become member of the Society. In case they are not yet member, the “Regular tracks” would have to pay 80 Euro for each year that they are in the ”program”. This 80 Euro automatically included the membership. “Regular tracks” would not have to pay if they are already member (i.e. it is advisable to join ESHRE before applying!)

K. Lundin further explained the application schedule. First of all, applications for the Fast Tracks (10 years in a clinical IVF lab, currently lab head, at least M.SC/PhD) were called for and the deadline for these was set by 31 October 2007. These applications will then be reviewed and a decision will be made by January 2008. Secondly, application for the Regular Senior Clinical Embryologists (6 years in clinical IVF lab, M.Sc/PhD, log book), will be receivable by February 2008 and the first exams will then be held during the Annual Meeting in Barcelona 2008. Finally, the Regular Clinical Embryologists (3 years in clinical IVF lab, B.Sc,log book) applications will be receivable by February 2009. The first exams will be arranged during the Annual Meeting in Amsterdam 2009.

K. Lundin further clarified that “strict” criteria would have to be applied, because the certificate should be worth something. The applicants should have had a certain number of years experience working in the lab, because it was intended that lab-people with practical hands-on experience should be running the lab. In other words the lab director should be a lab-person with management skills to run the lab. One could perhaps argue that for some countries that already had a certification system running (e.g. UK and The Netherlands), the ESHRE certification could be offered automatically. However, ESHRE cannot certify something that is beyond its control. In addition, the ESHRE certification would be theoretically based to a large extent. It was certainly not intended to compete with existing (national) systems.

As regards the log book, K. Lundin explained that for the first two years it might be retrospective, but thereafter it would have to be prospective, and preferably signed by a “senior-senior”. The exams would consist of multiple choice questions. The idea was to create a data bank of questions and also to develop test exams that would appear on the website. J. Harper had volunteered to work on this and K. Lundin asked everyone to send in questions before 31 October 2007. The questions should be grouped under the correct subject categories, and for each question one correct answer, and three incorrect answers should be given.

K. Lundin concluded her presentation by saying that there were still many things to do, such as: setting up of a website, curriculum, question bank and “model exams”; translations of question data bank, training materials, exam preparations etc.

3° Discussion / Comments / Suggestions
 
There was some doubt as to who would have to be considered the head of the lab. K. Lundin replied that this would be the person who is responsible for the tasks in the lab. Apparently in Greece, there were two persons: someone responsible for the day to day running and an other one who is also responsible, but who is not there all the time. It was concluded that in this case it would most likely be the person in charge of the day to day running of the lab. So normally one person should be identified as the lab head. However, if this was a large lab there may be two persons. S. Ziebe added that one should also be looking into what type of responsibility and skills this person had. For instance, a person who had the responsibility for the Andrology lab only would not have the full overview. The bottom line was that detailed knowledge would be required form each person who applied.

It was remarked that some people did not have 10 years experience, but was nevertheless the lab head and whereas someone else had the detailed knowledge, but was officially not the lab head. K. Lundin explained that in reviewing the applications, some flexibility would be needed. The proposed certification scheme had to be looked upon as a way to get people into the system. S. Ziebe further clarified the reason for the fast track: 1) ambassadors were needed to assist in implementing the system; 2) senior people, who did not need to pass an exam, were needed. K. Lundin agreed and said that the purpose was to get rather more people in than too few.

It was remarked that it was probably a bit harsh on them to ask senior embryologists to do the exam. K. Lundin replied that the level would be very theoretical. Normally someone with 6 years experience should be able to pass it easily. S. Ziebe added that one of the aims was also to achieve “political” recognition and therefore there was a need to show that people’s skills were documented. M. Van den Bergh said that the applicants could have different backgrounds and that the exams were intended to certify that they had the minimal requirements.

The question was raised as to when will the information about the exams would be available. S. Ziebe explained that by December it should be possible to release what type of exams this would be. It was remarked that in the Netherlands there was already a system of education with exams and so there were some questions as to how this would relate to the ESHRE scheme. K. Lundin replied that this question had been raised before and explained that the ESHRE scheme was an overall system to cover several countries. So the Dutch, provided they wanted ESHRE certification would have to go through the same system. There were some doubts as to whether the Dutch could be motivated to do this (this was also the case of the UK). It was said that ESHRE recognised the fact that some countries already had a system, and so the ESHRE scheme could be regarded as a “supplement” and voluntary system.

A remark was made about the exams that would be held during the ESHRE Annual Meeting. What if the colleagues could not attend the ESHRE meetings? K. Lundin said that for the time being the exams would only be taken at the Annual Meeting, and later on other possibilities would be offered (i.e. local exams).

Some questions were raised about the log book.  K. Lundin explained that applicants should have done 50 cases of various procedures. S. Ziebe added that one should not mix up “accreditation” and “certification”. After 50 times it was presumed that the person knew how to do it. Also no clinic would allow anyone to do the procedures, when after this times the person was not able to do it. It was noted that in the Netherlands no log book was required. S. Ziebe agreed that in the beginning one needed to make compromises, and so perhaps one would have to have some adaptations in order to find the best system.

S. Ziebe said that in some countries the clinician was also the lab head, and it was thought that needed to change. In Greece many centres were private and so some colleagues working there would be afraid to stand up against this. K. Lundin said that she was convinced that they would follow when they see the system spread across Europe. S. Ziebe insisted that it was a voluntary system and, in addition, labs would have a comply to the EU Directive. ESHRE was now offering a system to document “quality” regarding the persons working in the lab.

It was noted that perhaps ESHRE should be the body would have the authority from the EU to give accreditation. If this was to be the case, it would be more important. S. Ziebe agreed that this was true. M. Van den Bergh explained that for now, ESHRE would certify a minimal requirements, but could not offer accreditation which was a far more complex matter. A. Sunde confirmed this, but added that this should be a long term goal.

There were some questions about the number of applications that could be accepted. Currently around 80 applications had been received for the fast track. K. Lundin said that around 50 to 100 applications were expected for the Barcelona exams. A. Sunde added that in the long term, ESHRE would try to work together with local organizations to translate the exam questions, to check exams etc., and to set-up educational programs.

The question was raised as to who would set up the exams. K. Lundin replied that a question databank would be created. The exam questions will be multiple choice questions, and J. Harper had agreed to start it up and all the Group members present were asked to submit questions (including one correct answer and two wrong answers). K. Lundin said that she would send out the curriculum so that questions can be prepared. She further explained that there would be test exams on the web. There would be a more difficult level for senior embryologists and a not so difficult level for clinical embryologists.

Someone wanted to know whether the group of people who were invited to attend the meeting, would meet again on regular occasions. K. Lundin replied that there would be no regular meetings, but contacts would be maintained and perhaps an open meeting could be arranged at the ESHRE congress.

It was further suggested to organise exams in various European countries, because some people would not be able attend the congress. All agreed that this would be a good idea, but for the first time it will be at ESHRE annual meetings. S. Ziebe added that it would be good to have the exams within the framework of the National Societies. They were considered to play a vital role in spreading the information and in participating in the system. So collaboration would be needed to achieve the goals.

Someone wanted to know whether there had been any discussions or feedback from the medical colleagues. A. Sunde said that most clinicians seemed to think it was a good idea, but some also expressed concerns.

The delegate from Ireland explained that in his country they were trying to set up a system.  He noted that text books were important, perhaps it would be good if ESHRE could come up with the information to do this. K. Lundin replied that there is a lot of competence within ESHRE, and so maybe it would be good to collaborate to bring the information together. S. Ziebe added that in the initial stage ESHRE would not provide the education, but A. Sunde suggested that ESHRE could produce syllabi for the courses. E. Van den Abbeel (Coordinator of the Special Interest Group “Embryology”) agreed that it should be a future task of the SIG Embryology to establish courses and create syllabi correlating to the certification demands.

There were some questions about the timing of the exams. This had not yet been established except that the first exams would be held during the Annual Meeting in Barcelona. It was noted that Senior Embryologists who did not apply before 31 October, would need to pass exams afterwards.

There were some discussions about the Masters degree and it was noted that there were variations from country to country, and so this had to be borne in mind and one had to show some flexibility

The question was raised what should be done with people who had experience but did not have the degree. K. Lundin replied that if there were exceptional cases these should be looked at more carefully.

It was also noted that for the time being, the certification would be restricted to European countries. Afterwards, when the system was running it would be open for other countries.

There were some further questions about the validity of the system and what would be the value if it was not recognised by the national governments. K. Lundin replied that this was a first step towards actual recognition. A. Sunde referred to the EU Directory, which was an important driver in this matter. Perhaps national regulators would adopt the ESHRE system, so they would not have to work it out themselves. This would be especially true for countries that did not have a system whereby embryologists were recognized. It could also be important for countries that had a licensing or certification system in place. K. Lundin said that sooner or later this would be required on an EU level and then all countries would have to comply. Therefore it was good to be in advance and to show that ESHRE could do this. A. Sunde added that the idea of the system was also to avoid a new Directive imposed upon us and therefore one had to be pro-active.

It was also thought important to guarantee the quality of professionalism throughout and so there would be a need for an on-going education including evaluation like clinicians have it.

Some of the participants asked for the list of names who had already applied for the Fast Track, but it was finally agreed not to circulate it, before it had been reviewed. Applications could be revoked if the information provided in the application was not correct.

Finally the participants in the meeting were asked to send in the name of one national representative/spokesperson to maintain future contacts with ESHRE and the Chair of the Group.