Joint Committee on Health debate -
Wednesday, 31 May 2017

Issues relating to Medical Scanning Services

Chairman

This is our third session of the afternoon, and we will now meet with Professor Sean Daly, consultant obstetrician in the Coombe Women and Infants University Hospital on the issue of medical scanning. On behalf of the committee, I welcome him and thank him for attending. I wish to draw his attention to the fact that by virtue of section 17(2)(l) of the Defamation Act 2009, witnesses are protected by absolute privilege in respect of their evidence to this committee. However, if he is directed by the committee to cease giving evidence on a particular matter and he continues to do so, he is entitled thereafter only to qualified privilege in respect of his evidence. He is directed that only evidence connected with the subject matter of these proceedings is to be given, and he is asked to respect the parliamentary practice to the effect that where possible he should not criticise or make charges against any person, persons or entity by name or in such a way as to make him or her identifiable. I also wish to advise that any submissions or opening statement that is made to the committee may be published on the committee's website after the meeting.

Members are reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make charges against the person or persons outside the Houses or an official, either by name or in such a way as to make him or her identifiable. I would also remind Members to remember to turn off their mobile phones.

Professor Sean Daly

I submitted a briefing document which I presume people have had a chance to look at. The provision of medical scanning services in Ireland is unregulated. This creates a situation where Irish women may be exploited and even harmed by inadvertently trusting a medical investigation which is performed by individuals who are either unfit or untrained to perform this investigation. There are many aspects to this issue, and I will happily take questions on anything that members wish to discuss with me. There are three broad areas which I would like to briefly comment on.

I believe that the use of ultrasound in the practice of gynaecology is very important. It gives valuable information about the anatomy of the female pelvis. When a woman presents with symptoms suggestive of a gynaecological problem, she may be referred to a gynaecologist. Unfortunately, the waiting times are long for those appointments. More and more general practitioners are looking to investigate and manage these things themselves. That is very worthwhile, but if they are depending upon an ultrasound investigation the people performing that ultrasound should be regulated and there should be defined training. Unfortunately, ultrasound equipment, unlike radiological equipment, has now become very cheap, and any of us can buy an ultrasound machine and set ourselves up as an expert in any form of scanning one wishes to be an expert in. No one oversees that, and the ultimate consequence of that could be harm.

On infertility services, virtually all of them in Ireland are in the private sector. Within the private sector there is not the same regulation as there might be within the public sector. There is a professional body which oversees the practice of infertility treatments. Scanning is part of infertility services. If one is having scans one has to be confident that the person who is performing those investigations is trained to do so. In general, gynaecology scans are provided and supervised by radiologists. These are trained doctors who have gone through formalised training schemes and are competent to sign off on the examinations. That is not to say that they perform all of the examinations, but there are images that one would expect to see. The gynaecology scan is really the only scan in obstetrics and gynaecology which is entirely reviewed and signed off on by a doctor. Outside of that the practice is disparate. There are a growing number of infertility services, and couples who require infertility services are really a very at-risk group. These people desperately want a baby and they will do virtually anything to get one. They will go to anyone who professes to be able to help them achieve that. Unfortunately, there is a wide variety in the quality of infertility services available in the country.

On the issue of pregnancy scanning, I will discuss two categories. Early pregnancy assessment, which is the assessment of pregnancies before 14 weeks, has provoked much discussion since 2010 about the incorrect diagnoses of miscarriages. An independent inquiry was set up which reported on the issue, and as a result of that the HSE made significant amounts of money available for training. Every unit in Ireland got a very good ultrasound machine, and people were identified to oversee that service. In general, that service runs reasonably well.

Obstetric scanning has been discussed here before. Dr. Peter Boylan and Professor Louise Kenny discussed it in some detail on 16 February. The reality is that in Ireland many women do not get a foetal anomaly scan. I believe that is a tragedy and can result in tragic consequences for the baby, if it is born with a significant abnormality and born in the wrong place. There is huge geographical variation in terms of where women attend for care during pregnancy. If one is lucky enough to live in Dublin every woman, irrespective of her income, will have at least one anomaly scan. However, that is not the case throughout the rest of the country.

There is more information in my briefing document, but I am very happy to take questions.

Deputy Louise O'Reilly

I thank the witness for his presentation, which I had an opportunity to read.

I will not be alone in this, but people contact us regularly about infertility services because they are desperate to have a child. They are so desperate that they will reach out to a stranger like me and share intimate details of their lives which are absolutely heartbreaking. It is very concerning that these services are currently unregulated and that we are about to see a plethora of services emerge in that context. While the service itself is not regulated, the individual radiographer, doctor and nurse must be registered with CORU, the Medical Council and the NMBI, respectively. Is that sufficient regulation or is there a need to regulate the practice or industry? Although I hesitate to use that word, that is what it is.

Professor Sean Daly

Internationally, what happens is that certain doctors specialise in reproductive endocrinology and infertility. Those doctors go through a formal training programme over at least two years to become specialised in that area. There are many infertility services where people have not undergone that training. There are certainly very good infertility services available in this country but the Deputy is right that this is a very vulnerable group and people will reach out to whatever service they believe can help them achieve a pregnancy. What most concerns me, or at least the reason I am here, is ultrasound. On the provision of ultrasound in infertility, there is now a nine month training programme within UCD leading to certification of expertise in infertility services. We should seek to ensure that everybody who is scanning within infertility services at least has that certification. That is not to say that clinics need to close all over the country tomorrow. They do not. However, support should at least be given to allow people to go and train and that should be audited.

Deputy Louise O'Reilly

The 20-week anomaly scan is an issue Deputy O'Connell and I have raised many times. We are not alone in that. There is a post-code lottery which Professor Daly rightly alluded to. How far are we from being able to train the personnel we have? Professor Daly said diagnostic equipment was getting cheaper, which it is. In terms of being able to provide a 20-week anomaly scan as a matter of routine in every maternity unit in the country, we have the staff but there is obviously some skill deficit and possibly an equipment deficit, about which the professor might be able to tell us. How far away are we from being able to train the people we have and provide them with the equipment they need?

Professor Sean Daly

To be honest, we are quite a distance away. The Health Service Executive must realise that it needs to put significant finance into this. The equipment is not the real burden, rather it is getting the individuals trained up. There is an MSc programme in UCD which takes 16 months and at the end, one is certainly skilled to realise what is not normal. That is the key thing. The other problem is one which is plaguing the service in the UK. Every woman in the UK is entitled to two ultrasounds. There is an early pregnancy ultrasound where one might diagnose multiple pregnancies and significant abnormalities which can be diagnosed early like anencephaly, and women are offered screening for Down's syndrome. Then one has the anomaly scan. The difficulty is getting people trained and then keeping them within the system. It is a tough job scanning people every 25 minutes for a whole day, day in and day out. That is hard work. If one steps away from being a midwife, for example, one gives up night duty and weekend duty and one's pay suffers significantly. We need to reimburse these people properly to motivate them to stay within the service. Many people are trained and leave the service and that is a huge problem in the UK. That is the main challenge. We need to provide money to train people and then we need to recognise that they are skilled individuals and try to motivate them to stay within the service.

Chairman

When Professor Kenny was here, she said that if she had the capacity, she could release some midwives who had been trained up or who could be trained up to become skilled scanners. However, she could not actually release them from their midwifery duties as they would not be replaced. She said, however, that there was capacity within the system for her to provide people for training but they would not be replaced for their general work.

Professor Sean Daly

One needs to backfill those posts, obviously. The situation in Cork is that they have been unable to provide ultrasound for every woman. They have had to use some kind of metric to decide who gets a scan. That is dreadful. The purpose of the scan is not to diagnose Down's syndrome. If one wants to diagnose Down's syndrome, it is an early screen because only about half of Down's syndrome cases will be diagnosed on the early scan. It is really about structural abnormalities like spina bifida and gastroschisis. They do not increase as a woman gets older. Using a cut-off age of 35 or 40 is not relevant if one is thinking about structural abnormalities. We want to diagnose major congenital heart disease, spina bifida, gastroschisis and anterior abdominal wall defects in order to optimise things for that baby once it is born. One does not want a baby born with no left ventricle in Letterkenny at 3 a.m. on the Sunday morning of a bank holiday weekend. By the time that child gets to Crumlin, it will be significantly compromised. That is the difficulty.

Deputy Kate O'Connell

The first line of the professor's statement read that the provision of medical scanning services in Ireland was unregulated. Does that mean a private company can set up a premises with 3-D scanning equipment and just offer fancy photographs to people who for some reason desire a 3-D image of their child? Is that what is happening?

Professor Sean Daly

That is what is happening.

Deputy Kate O'Connell

Let us say a left ventricle was missing, or something like that which would not be diagnosed at the 12-week scan, and take it to its natural conclusion. In Cork or somewhere where 20-week anomaly scans are not fully rolled out, one could go into a glorified photographer at 25-week gestation and maybe even know oneself from looking at the image that something is wrong. The naked eye can tell if there is gastroschisis. One could walk out of a glorified unregulated photographer with a very serious diagnosis for one's child 13 weeks after one had one's 12-week scan. One is literally walking down the pavement going "God, I do not think that is right". Is that possible the way things are at the minute?

Professor Sean Daly

Yes, it is. The issue of 3-D scans is not one I am particularly exercised about. People go to these places with an expectation that they will get a nice picture and not with the expectation they will have an anomaly scan. It is difficult. The Deputy is absolutely right that anyone can open a shop tomorrow on Grafton Street claiming to be an expert in ultrasound and that is not right. However, if the expectation of the public going in is that they are going to get a pretty picture and that is what they get, they are happy.

If it is their expectation they will have a good scan in which their baby will be looked in detail, they will definitely not have it. Many private institutions make people sign a disclaimer to acknowledge that they realise it is not an anomaly scan. While I do not think it is ideal, it is the lack of anomaly scans in the public service about which I would be more exercised.

Deputy Kate O'Connell

We have mentioned GPs and ultrasound machines. We have a GP present. GPs deal with a lot of patients in the early stages of pregnancy and are often the ones who first diagnose a pregnancy. Many of them now have ultrasound machines. Has the Medical Council told GPs, as their regulatory body, that if they have not completed the proper course, they are in breach of ethics? What is the position in that regard?

Professor Sean Daly

I do not think so. GPs scan early in pregnancy to identify a foetal heart which anybody can see. It is just as the Deputy said. If they do not see it, they need to refer the patient on. I can totally understand primary health care physicians wanting to reassure women that everything is okay. If they use a scanner and see a foetal heart, everybody can see it, but it does not remove the need to refer on. Where GPs will potentially run into trouble is when they come back from a weekend course and think they can scan as well as anybody. That is a problem. If they are using an ultrasound machine just to document a foetal heart, it is probably okay.

Deputy Kate O'Connell

I am not sure whether it was Professor Daly or Deputy Louise O'Reilly who said infertility services involved the most vulnerable persons in the most vulnerable circumstances. I have been dealing with this issue for many years in my role as a community pharmacist. There are often very complex prescriptions and I have often wondered about the regimes of different clinics and the complete difference in approach. Some people leave with ten bags of stuff, while others leave with one. Every case is individual and we are back to ethics again in the medical profession. In his professional opinion and from what he has seen in his role, does Professor Daly think people are being taken advantage of by certain providers in certain circumstances?

Another thing I have seen is a lot of people going abroad. They are referred by clinics in Ireland to undergo various treatments in Greece or Spain with donor eggs and sperm. Is it Professor Daly's view that the system is not fit for purpose and that, in some instances, people are being taken advantage of? How do we solve that problem? IVF is very traumatic for both parties involved and sometimes the wider family. I have heard about it costing €30,000 by the time everything is taken into account. Is it Professor Daly's view that this is a very serious problem? It really only kicked off about ten years ago when IVF became mainstream in Ireland. Will Professor Daly give me his view?

Professor Sean Daly

Assisted reproduction really took off when Professor Harrison started his unit in the Rotunda Hospital. He had started in St. James's Hospital and then moved to the Rotunda Hospital in the early 1990s. A plethora of services have since been made available. For financial reasons, some decide to recommend that women travel to countries outside Ireland. The Czech Republic is the most common. My experience of these services is that they are good. One of the key performance indicators - if that is the correct word to use - in infertility services is the number of multiple pregnancies. Multiple pregnancy rates have dropped significantly as people are being much more careful. Pregnancies end up being complicated with triplets or quads when the ovary is stimulated pharmaceutically and people do not make sure it is not over-stimulated and do not follicle-track the women involved. That has been poor in this country.

Deputy Kate O'Connell

Finally-----

Senator Colm Burke

I am sorry, but as I have to be in the Seanad Chamber at 4.30 p.m., I am conscious of time.

Deputy Kate O'Connell

We spoke about cancer services and I mentioned that the GP was the person on the ground dealing with patients. An earlier delegate spoke about health literacy. It is something that occurred to me in my role. When people attend private fertility clinics, sometimes only the fertility element is focused on. They do not look at anything else such as mental health or something more sinister in the bowel or that area. Does Professor Daly see it as a problem if a fertility clinic focuses on that issue only and washes its hands of everything else outside the area of the ovaries and uterus? Is there anything he can suggest we can do to address the issue? I know that people are signing disclaimers in places where there is 3-D scanning. I am not 100% convinced that service users are aware that it is a less holistic approach and has just one focus. I have seen it happening in the community. What is Professor Daly's experience?

Chairman

I will allow Senator Colm Burke to ask his questions now because he is under a little time pressure.

Senator Colm Burke

I have to speak in the Seanad Chamber at 4.30 p.m.

I thank Professor Daly for his presentation. I asked the committee to invite him because I had heard a number of complaints about people having scans on a Friday evening in services in which there was no medical backup to give advice. Advice has been given on a Friday evening without a medical person being present. That has occurred. There are quite a number of such companies. It is not a major problem in Dublin, but it seems to be happening outside the main population centres. Has Professor Daly received complaints about it? Is there a concern in the profession about these services being offered? That is one issue.

The second issue concerns people, GPs or otherwise, who do not receive training. If GPs have not received training and are providing a service, will there be complications about professional indemnity insurance? I am wondering if they have been made aware of this. I have heard of a GP giving advice, but when the person concerned presented at the hospital traumatised, it turned out that the advice which had been given was incorrect. That leaves the GP quite open to the giving of incorrect advice and a question arises immediately about whether he or she is covered by insurance, especially if he or she has not received training. I am wondering if the issue has been highlighted.

The third issue is anomaly scans. What would it take to reach a stage where the service would be available to everyone? What numbers would need to be trained and what backup services would need to be provided? The equipment is not that expensive; it is, therefore, about personnel. About what shortfall are we talking in real terms?

Professor Sean Daly

I will answer the questions in reverse order. There are 70,000 births in Ireland each year and each scan takes about 30 minutes. That amounts to 35,000 hours of scanning.

Each midwife, sonographer and radiographer will do approximately 35 hours per week. As such, the numbers required will be significant. It is important to have scanning available when people go on holidays, etc. That is the type of personnel numbers that will need to be trained and in place before routine anomaly scans can be rolled out.

To back up these people, foetal medicine consultants are required. If someone scans and sees something, he or she will generally not make a diagnosis. Instead, that person will get someone like me to confirm or refute.

Regarding GP training, everyone should be trained. There are ultrasound training opportunities within UCD. It is the only third level college that offers them and they take approximately six months to do.

Medical indemnity and insurance comprise a significant issue. People who open up ultrasound facilities generally are not properly insured, so there is no comeback for the person who suffers as a result of inappropriate advice or a misdiagnosis. This is an important issue and there should be a regulatory body charged with overseeing all of these services.

As to the first question, it is not necessary to have a doctor always available where there is a trained person doing the ultrasound. In any hospital or clinic, sonographers or midwives function independently. The hope is that they will not inadvertently diagnose or reassure people. That is where the difficulty lies. If someone believes that there is a problem, explains it to a patient and makes a treatment or referral plan, that is probably okay. A situation in which a qualified radiologist or foetal medicine specialist is always available probably does not exist. Even in centres like St. James's, where the radiology service is very good, radiographers function independently and radiologists review images afterwards.

Senator Colm Burke

I was referring to standalone facilities without medical backup. The concern arises in that respect.

Professor Sean Daly

It is probably not necessary as long as the person who is doing the examination is certified and trained to do so. That is where problems can develop.

Chairman

Does Deputy O'Connell have further comments?

Deputy Kate O'Connell

I am going from memory from when Professor Louise Kenny appeared before us. Professor Daly has referred to risk groups. To paraphrase him, my understanding is that there is screening in Cork of people who are over 40 years of age and are X, Y and Z. High-risk people are being taken although, obviously, it has nothing to do with the mother's age, only certain conditions. The committee worked out that approximately one pregnancy per week in the non-risk factor group was being missed, or 50 pregnancies per year that did not go to birth. I am going from memory, so I will have to look back over the record.

How do we give people the best outcomes? Purely from the point of view of assisting the child to survive rather than the opposite, as some people might interpret my question, is it a combination of the GP being the lead person for the patient in the community and maternal blood tests being conducted at eight or nine weeks to identify what might be coming down the tracks? This would be followed on by a 12-week scan and a 20-week proper anomaly scan. Is this what Ireland needs to provide to give the best outcomes to women who are producing the next generation?

Professor Sean Daly

I agree that the GP is central. There are two issues, namely, the provision of a service to diagnose structural abnormalities and the screening and identification of chromosomal abnormalities. In the UK, everyone gets both. In Ireland, people have not traditionally got either. Were we to concentrate on one area, it should be the structural abnormalities. If finance and so forth were no object, of course we would offer screening for chromosomal abnormalities to everyone, but we cannot even offer everyone a structural scan. If we are to focus our attention on priorities, that should be it. We should subsequently roll out screening for chromosomal abnormalities. If more than 20,000 women are not getting a structural scan, it is awful.

Chairman

I have just done a calculation. According to Professor Daly, 70,000 births at half an hour per scan is 35,000 hours or 35 hours per week. Does that mean that we would need 1,000 scanners?

Professor Sean Daly

The figure is 1,000 weeks.

Chairman

Excuse me. It is 1,000 weeks of scanning.

Professor Sean Daly

If each person scanned for 44 weeks in his or her year, we would reach that number.

Deputy Kate O'Connell

I assume that Professor Daly is not taking into account the number of people who have been scanned already. The figure is minus that amount.

Professor Sean Daly

Yes.

Deputy Kate O'Connell

It is a good thing that I am here to do the sums, Chairman.

Chairman

Yes. It is late in the day. I was wondering where the 1,000 scanners would come from.

If 20,000 women are not getting an anomaly scan, how many children are at risk of being born with serious and unidentified problems?

Professor Sean Daly

The most common structural abnormality is cardiac. Dr. Paul Oslizlok, the most senior cardiologist in Our Lady's Children's Hospital, Crumlin, reckons that approximately 50% of major congenital heart disease is unrecognised before birth. That puts those babies at significant risk. The provision of ultrasound to diagnose cardiac defects is problematic worldwide. The UK, which has structural scanning, has set up an anomaly register. There used to be anomaly registers in various places in the UK. Interestingly, there was none in London. Now there is a national register. Every baby identified with a significant anomaly will be registered and followed. Units will be identified that are not diagnosing, for example, heart defects. That is an opportunity to have additional training.

If one element could oversee this situation, it would be an anomaly register. We could then identify areas in the country where more resources and training were required.

Chairman

The report of the Committee on the Future of Healthcare, which was launched yesterday, proposes a ten-year vision for a new health service. We are all optimistic about it. It calls for a guaranteed waiting time for procedures, outpatient appointments and diagnostic tests. How realistic would it be to introduce legislation to guarantee women this right? They would not just be eligible, rather, they would be entitled to a scan by legislation. Is this a realistic proposition, particularly in terms of the maternity strategy, which is another matter on which the Committee on the Future of Healthcare is producing a report? I presume that the maternity strategy refers to the provision of anomaly scanning.

Is it lack of political will that prevents these targets being met?

Professor Sean Daly

There is a relatively small window for anomaly scanning. As people get bigger, scanning becomes more difficult. Between 18 and 22 weeks pregnant is the ideal time to scan. For example, in looking at the heart, as the ribs become more calcified it is more difficult to see the heart. There is a four or five week window when we need to try to ensure that women have anatomy ultrasounds. That is feasible, as long as resources are put in to training people and supporting the service. In the UK, every woman is entitled to two scans whether she is in the centre of London or the outback of Scotland. The service there does manage more or less to deliver on that commitment.

Senator Colm Burke

I would like to thank Professor Daly for giving us a very comprehensive presentation and for the work he and his colleagues are doing in the maternity services.

Chairman

On behalf of the committee, I thank Professor Daly for coming here and giving us his expert opinions. The committee will continue to put pressure on the Government to make funds available because is astounding that women do not receive this essential scan. I thank the Professor for his expert report.

Senator Colm Burke

Could we put the proposal to write to the Department and the issue of regulation of people providing scanning services on the agenda for the next meeting?

Chairman

Certainly, thank you.

The joint committee adjourned at 4.32 p.m. until 1.30 p.m. on Wednesday, 28 June 2017.