By fertility experts from Spain.
How to be sure that the IVF clinic you have chosen has high-quality standards? Is it possible to check it before you go for the fertility treatment abroad?
All these issues were discussed by Dr Claudia Mika, the Founder and CEO of Temos International, a German-based international accreditation body. With her team of experts in clinical and non-clinical services, Dr. Mika has created accreditation programmes for hospitals and clinics that cater for domestic and international patients across a wide spectrum of healthcare disciplines.
Infertility shapes and affects our life in many ways. Dr Claudia Mika starts her presentation by recalling her own story. She was diagnosed with endometriosis at the age of 26, which resulted in 12 years of hormone replacement therapies and surgeries. At that time, she was told that her only chance to have a child was to get pregnant early. However, the plan of natural conception did not work out and at the age of 35, she, together with her partner, decided on IVF treatment. She underwent 2 IVF cycles, none of which turned out to be successful, unfortunately. But although her infertility struggle developed differently than she expected, it influenced her future life in many important ways. One of them was the professional decision to develop her accreditation company Temos further to have quality standards for medical units, including reproductive care centres. Obviously, that plan worked out very well.
Temos is the first international healthcare accreditation organisation that serves international patients. It was founded in 2010 with headquarters in Germany. It is a spin-off of a European research project with partners from Aachen University Hospital, quality experts, German governmental research organisation, international insurances and many others.
Together with her team, Dr. Claudia Mika checks the quality of hospitals and clinics worldwide to help them achieve better clinical and non-clinical outcomes. For them, every single woman who can get pregnant because of a well implemented quality management system is a success. Temos aims at improving overall patient experience and helps them receive treatment in a safe, secure, trustworthy and – what turns out to be very important – the third-party accredited environment. Basing on her own personal experience, Dr. Mika perfectly realises that assuring high standards and the continuity of care from the first contact to the follow-up meeting is necessary from the patient’s perspective.
Temos stands for Trust, Effective Medicine and Optimized Services. Those words summarise the company’s mission in a great way. It is obvious for them that all fertility patients need to trust their service provider (the clinic), the doctors and the nurses in the first place. Effective medical solutions and services, on the other hand, give assurance that patients will get the best treatment outcome possible.
Before a clinic can get the Temos quality seal in international reproductive care, they must fulfil around 350 standards. These, among others, include communication and cultural sensitivity, organisation management and administration, outcome, ethics, sustainability, safety, facilities, infrastructure and support. It is important to mention that Temos standards fulfil the highest international quality requirements. Therefore, the company got the accreditation of the International Society for Quality in Health Care External Evaluation Association (IEEA) themselves. And this is exactly what they want to transfer to all their accredited partners.
According to Dr Mika, open communication on the part of a clinic is the most important aspect patients should pay attention to. Obviously, the first thing they do is to check the clinic’s website – and as we all know, first impressions are not to be underrated. Therefore, the website should be constructed in a user-friendly way. Transparent information is what counts the most! Patients should have no problems with finding the data on the services offered, costs (including extra costs), available packages or waiting times. It is always helpful to have access to other patients’ testimonials – although you have to realise that it may not be possible in all countries for legal reasons. Another useful way of checking how the clinic communicates its offer and services is via social media.
Dr Mika also advises us to look for what we personally regard as the indication of high-quality standards. These might be all the small things that give us a good impression of the clinic, such as smiling staff with a positive attitude or the fact they communicate in other foreign languages apart from English.
In Dr Mika’s opinion, the clinic’s mission should be clearly stated on the website and in information brochures, leaflets, etc. What patients should look for in such statements are the elements of ‘humanity’, such as the emphasis on compassionate care and respect – before, during and after treatment. But reading about the mission and ‘feeling it’ are two different things. Dr Mika says we should only trust those units that appeal to us with what they are communicating. Hence, the so-called ‘gut feeling’ is of the highest importance here. You should always take a moment and think if the information provided (as well as the way it is presented!) makes you feel well-informed and ‘in good hands’. Trust your instinct – that is what will help you make good choices in this matter!
Another aspect we should pay attention to while looking for our IVF clinic abroad is the ‘reaction’ time. This is how Dr Claudia Mika calls the time that passes from the first contact to the follow-up meeting. Additionally, you should check how much time it takes a clinic to respond to your enquiry, and if you get a contact person for communication and organisation of your treatment plan. How are you being informed about cost estimation and pre- or post-travel services (travel, transport, accommodation, etc.)? Is it personally or via email only? How long does it take them to get your questions answered? These are all questions each patient should ask themselves when assessing their potential clinic. According to Dr Mika, only if you feel 100% prepared and ready to travel, you may believe that the choice you are making is a good one.
You should have trust in the clinic’s services but even more importantly, you should have trust in their doctors’ training and experience. However, it is crucial to always assess it from your individual perspective. As each case is different and treatment must be personalised to achieve the best outcome, make sure that doctors have the right qualifications for your needs and your specific medical history. Dr Mika says that the information on the clinic’s specialists should be available on the clinic’s website – if it is not, do not hesitate to ask for it.
While qualifications and experience are one thing, teamwork is another. All the clinic’s specialists must work together because they have different expertise and knowledge and this all has to come together to serve patients as good as possible. The so-called ‘extra points’ are also earned by the clinic when the information on doctors’ qualifications is coupled with their personal statements in which they present their goals for their patients’ treatment. As always, mentioning all scientific publications or participation in research work may present a doctor in even more positive and professional light – as well as memberships in professional associations, such as e.g. ESHRE (European Society of Human Reproduction and Embryology).
There are also requirements referring to the clinic’s laboratory – if there is one, of course. Depending on the size of the clinic, there should be the head of the laboratory with respective academic degrees (MD, MSc, PhD) and clinical embryologists which should have at least a BSc in biomedical sciences. Dr Mika advises us to pay attention not only to the laboratory itself but also to the embryologists’ qualifications. In the end of the day, this is not high-tech equipment that decides about the outcome of our treatment – but the people that are behind all these sophisticated devices.
Although technology is not decisive for the outcome of the treatment, it offers us a lot of modern solutions to significantly improve it. When choosing a clinic with own laboratory, we should check not only if there is high-tech equipment in place but also if there are any critical (meaning ‘back-up’) devices defined. In case of emergency, they may be of the highest importance for the continuity of your treatment. Apart from that, Dr Mika also recommends making sure if laboratory access is restricted, clean room standards are checked and air quality control is assured. And if you can find no information on these aspects anywhere, just ask the clinic about that. Such data should not be kept secret and you as a patient (and the clinic’s future client!) have full right to demand it.
In comparison to technical aspects, the information about treatment results is generally much easier to find. And in fact, it is what interests potential patients most when researching IVF clinics. According to Dr Claudia Mika, the most important question is if the clinic explains its success rates in an understandable way. Patients should always get transparent and traceable information on this matter – it means that the clinic has to state clearly how its success rates are measured (per embryo transfer/frozen embryo transfer/multiple embryo transfer, etc.) and if they relate to biochemical pregnancies, clinical pregnancies or live births. Only with such data, you can compare a clinic in question with its competitors.
Finally – there is an external evaluation of clinics. It is good to inquire if the clinic you have chosen has any certification or accreditation of a neutral and renowned third party. These may include ISO certification (or CAP accreditation) for the laboratory, ESHRE certification or Temos “Excellence and quality in reproductive care” seals. However, not all quality seals clinics that clinics have should be trusted unreflectively. It is always recommended to check who and what is behind them.
That is why Dr. Mika shares with us a few aspects we should always take into account when looking for serious accreditation bodies. Firstly, such organisations must be experienced and well-respected in the market. Secondly, they should use transparent standards developed and regularly viewed by experts. Thirdly, they must have trained medical and quality assessors who pay visits to clinics and do consultative and balanced onsite inspections. And finally, all accreditation bodies should be authorised by a third party, e.g. the International Society for Quality in Health Care (ISQua), EEA or national authorities.
Summing up, Dr Claudia Mika says that every patient should ask themselves two questions before deciding upon an IVF clinic abroad. The first one is “Does the clinic offer professional medicine and excellent laboratory services?” and the second: “Does it combine high-tech equipment and (clinical and non-clinical) services tailored to your individual needs?”. If both questions are answered positively, you should not hesitate and proceed with your treatment. However, if the answers are ‘NO’, give yourself more time and continue with your research process. Surely, there is a better solution out there for you!
The answer is definitely: no. If it is less expensive, it doesn’t mean that the quality is necessarily lower. You’re absolutely right that it’s because the cost of living, as well as the cost of services and employees, is simply less expensive there than in other countries. In the end, that could lead to the fact that the treatment itself is less expensive, but without violating the quality. In expensive countries, you can also have poor quality of service, so there’s no correlation between the two. It’s always to be determined individually. We should focus on the clinic, its reputation, on what is published about the quality and the experience of other patients. It can also be the fact that the prices there are quite competitive as compared to other countries.
That’s what I tried to explain a bit. For sure, you can ask but you have to do a bit of your own homework, too. If you see a reliable and reputable quality seal somewhere, together with the explanation what was checked by an external accredited certification body, then this might help. I totally agree that from the patient’s perspective, it is difficult to differentiate between what is a good seal and what is only for marketing purposes and nothing more. So the only thing to do is to look for those organisations which have a good reputation in the market and ask the clinic especially for those ones.
Their accreditation is our accreditation, I assume. We have our website (https://www.temos-worldwide.com/) and if you go to the Accredited Partners site, you’ll find all the information there. You can also find me on LinkedIN.
This is a really difficult issue. I’m not an expert in success rates so I cannot tell you exactly what you should ask about. As you said, you see something published and you can’t compare it because you don’t know what the underlying data is. And we don’t have a worldwide standardised way of publishing success rates. So the only thing you can do is to ask what is behind the publication of the clinic’s success rates. And you have to do that for every single clinic – otherwise, you won’t get that information. But even then, unfortunately, some of these so-called success rates are fake data. When we go to the clinics and do our accreditation, we go through the data with our experts. We always ask them what is behind it. But for you as a patient, it’s very difficult. So the only thing I can recommend you to do is to ask them and to insist on getting the explanation of what is behind these so-called success rates – is it given per age group, per transfer, etc.
I have so many questions but if I had to reduce them to three questions, I would put the differentiation of the success rates in the first question, then I would ask for the qualifications of doctors and embryologists and how many embryologists there are. These are the three questions I would have in the first place.
I would be warned if I was offered the cheapest treatment with the best outcome in the shortest time. As we said in the first question, quality does not necessarily mean that the clinic needs to be very expensive because it often depends on where the clinic is located. But if it is the best and number one clinic in everything and the costs – compared to the competitors – are very low, then I would ask myself where the tricky point is. And I would be warned. Quality has its price and it should be somehow indicated when compared to the competitors in the same region or the same country. So it could be a warning sign. Of course, ‘cheap’ doesn’t necessarily mean low quality but this has to be found out. I would be very careful if I was offered the cheapest price and promised the best outcome ever. This can’t work. Quality means that you have to invest in qualifications of doctors and embryologists, in nurses, assistants, midwives and that you need to have back-up devices. It means that you need to have an embryologist in the clinic, perhaps even for seven days a week. This means resources and this is money – therefore how can it work, if it is so cheap?
If the clinic is brand new, the technical infrastructure is new, the team has a very good reputation and they know what they are doing – this all sounds good to me. I would be interested in why you are hesitant regarding this doctor and the team in the new clinic. Because from what you described, all of it makes a lot of sense.
If we have an experienced team with doctors and embryologists, who know from the past how the job is done and how the treatment has to be offered, then the young clinic can be also good. The problem with every new clinic is that it takes time to get into the daily routine – as new staff comes in and there is a new environment, new infrastructure and equipment. That’s one of the points where I would be a bit careful. But otherwise – why not? They can have good quality standards if they transfer what they learned and the protocols they used to have to the new clinic. On the other hand, you can even have a long-established clinic that has no protocols at all and no good quality standards. So ‘old and experienced’ does not necessarily mean the best outcome you can get. It’s the implementation of quality standards, following protocols, international state of the art technology combined with experience and qualifications – that is all that makes a good clinic.
I think this is a question of individual taste. I had this experience myself – I had to call coordinators and I was informed about the test results on the phone. And I didn’t like it. There might be patients who are okay with it, while others might be more sensitive and want the results from the doctors themselves. In my personal opinion, this should be forwarded, delivered and explained by the doctor. If the result is negative, then you as a patient have many questions, like e.g. ‘why?’ and ‘what could be improved?’ The coordinator might not be the person to give you the answers to these questions. Therefore my opinion is that it should be a doctor or a fertility expert who gives you the test result personally – whenever it’s possible.
We have standards for that. I would need to go into the details, describing what it exactly means to have a clean room and good air quality, which is very important in the laboratory. But again, I do not want to give you any wrong information now so I would have to check it in our standards and discuss it with our experts. So please forward your question to me and I’ll be happy to get back to you.
Yes, you will find them on our website. Since we only started last year with this new program, you will find two clinics in Greece and one in Russia and others are in the application phase. Depending on when we can travel again and continue visiting clinics worldwide, we will hopefully add more and more clinics. You will find them on our website definitely, together with the information on the services they offer, etc.
It depends a bit on what is already available. It depends on how much time the clinic can invest, how many protocols there are already implemented, etc. This differs from country to country but the average time would be from 6 to 12 months to get the final approval – meaning that the standards are fulfilled
I’m not sure if I understood the question correctly but it’s the same everywhere in the world. There shouldn’t be a compromise regarding the quality standards and they are valid worldwide.
ISO 9001 is a system that is not specific for IVF centres, not even for medical organisations. ISO 9001 is a quality management system so every gym, every supermarket, every company and every clinic can apply for this certification. Then it’s just checked for its quality management. It can be trustworthy and if it is applied and implemented correctly, it is definitely a tool to implement a quality management system. As I said, it’s not specific for medicine and not even for IVF, so you cannot expect that the quality of the laboratory is inspected in the way it should be inspected from our perspective. The other problem is that, unfortunately, in many countries, ISO 9001 certificates are just purchased or – from the other side – sold, and this gives this certification a bad reputation in some parts of the world. Especially in Eastern European countries, we hear very often that no on-set visit took place or documents were not checked correctly. From this perspective, unfortunately, I can’t give it a 100% yes – although it’s a good underlying system which is helpful. But due to the fact that it is abused by some organisations in the world, my answer cannot be positive.
When it comes to IVF clinics worldwide, there are not many accreditations combining the services for patients and the services of the laboratory. Temos is the only accreditation system worldwide which offers this holistic approach. There is a special certification from ISO which is only for labs – ISO 15189. However, this is only assuring that the laboratory is working well but it’s not including patient services. Therefore, I cannot answer which accreditations are useless and which ones are useful – there are none which we could compare to one another.
I definitely think that there are clinics that are cleaner than others. But I wouldn’t say they are more common in Europe than in the US. The protocols which are implemented are an individual thing. Even if you are in Germany – as I am from Germany – where there is very strict legislation and protocols, the way the procedures are realised in the individual clinic is a different story. So I would never compare continents, countries or even cities. You have to check the individual clinic – how the hygiene plans, protocols and infection prevention are realised on the individual level within each clinic. This is an important thing. And of course, this definitely affects embryo transfers.