Israel | The State Comptroller’s report reveals: serious failures in the supervision of fertility treatments

“The State of Israel is in first place in the world in fertility treatments. The report points to the lack of preparation at the national level for the significant increase in the scope of IVF treatments in Israel. Also, about deficiencies and discrepancies that arose in the Ministry of Health’s inspections of the IVF units approximately three years before the unusual event in September 2022 and the lack of follow-up on the correction of the deficiencies,” warns the State Comptroller Matanyahu Engelman In a special audit report on IVF in Israel.

“The deficiencies amount to a fundamental failure. The Ministry of Health is obligated to correct the deficiencies in order to ensure that critical mistakes do not happen again,” states Engelman in the poignant audit report. The health department announced that as part of an examination of a fetus after in vitro fertilization treatment performed in one of the units, it was found that the fetus that was returned to the womb of the woman carrying it was not her biological child, and that another fetus was mistakenly returned to her.

Following this, the Commissioner of Public Acceptance for Medical Professions at the Ministry of Health ordered the establishment of an inspection committee on behalf of the Ministry of Health, to examine the circumstances of the case. In March 2023, the committee submitted its conclusions to the commissioner. In May 2023, the Ministry of Health announced the occurrence of additional unusual events in another unit – an event in which it became clear that there was no genetic compatibility between a child born after IVF treatments and his father; as well as two events in which fertilized eggs dried up.

“As of May 2024, the inspection committee established by the Ministry of Health to examine these additional incidents has not yet completed its work. These incidents caused a public uproar and raised among couples and women who had previously undergone in vitro fertilization treatments the fear that their child was not their biological child, and that their biological child was being raised by their parents Others,” warns Engelman.

The poignant audit report also states that in September 2023, the biological parents of the baby born after the incident of the mistake in returning the embryos were located. Engelman – “The Ministry of Health stated that the overloads in the units where the unusual events occurred were among the reasons for their occurrence.”

The data shows that Israel is at the top of the list of countries, in terms of treatment cycles per thousand women of childbearing age – 27 cycles, compared to only six in Great Britain. The total expenses for IVF treatments in 2023 were approximately NIS 323 million, paid by the four health insurance funds from the health fund.
The data also shows that private units performed 60% of the operations in the field of in vitro fertilization in 2021, while only 40% were performed in public units.

The report shows that the public funding policy in Israel is unusual relative to that of the countries examined – both in terms of the maximum age of the woman eligible for funding – her 45th birthday, which is one of the main parameters that affect the chances of treatment success, and in terms of the number of treatment cycles to which she is entitled – in Israel almost In recent years, there has been a significant increase in the number of IVF cycles performed each year in Israel, and as of 2021, approximately 61,000 cycles of treatment have been performed in the decade since 2011.

“Until the unusual events occurred in the two units, the Ministry of Health did not take steps to deal with the consequences of the significant increase in the scope of in vitro fertilization treatments and to ensure the quality of treatment in parallel with this increase,” the report further claims. are significant, since an increase in such volumes may lead to a burden and damage to the quality of treatments if it is not accompanied by preparation in terms of personnel and infrastructure and appropriate control and supervision mechanisms”, states the State Comptroller.

“The fact that among the serious deficiencies that were not re-checked to make sure that they do not reoccur were deficiencies related to patient identification and deficiencies in the medical record is particularly serious. These are deficiencies related to an event that happened in 2022,” the audit report further claimed. The audit revealed that some of the gaps – including the lack of manpower – which were raised in the controls from the years 2018 – 2019, were also changed in the controls from the years 2022 – 2023 carried out in the private units.

“The lack of correction of the serious defects exposed the patients to risks,” states the State Comptroller. “This result and the events that have occurred in this area in recent years emphasize the fundamental responsibility of the hospitals, where the units are located, to correct deficiencies that arose in the controls of the Ministry of Health, and the responsibility of the ministry to ensure that the answer is given to serious deficiencies raised in the controls it carried out,” the audit report further states.

An inspection carried out by the State Comptroller’s Office regarding the reports received by the Ministry of Health from all IVF units regarding special events in the field of IVF beginning in 2017 revealed that during the six-year period, from 2017 until the publication in the media of the incident of the mistake in the return of the embryos in September 2022, were transferred to the Ministry of Health A total of four reports on special events in the field of in vitro fertilization, an average report of less than one event each year.

In contrast, in the following year and eight months (October 2022 – May 2024), 17 reports were submitted, an average of about ten reports per year.
“The sharp increase in the rate of reports on special events in the field of in vitro fertilization in the period after September 2022 – ten times compared to the period before it – raises a real concern that special events in this field had also occurred before, but these were not reported to the Ministry of Health as required,” it was further claimed in Dou. H. The review.

The audit report also stated that the embryologists are part of the professional backbone for managing the professional processes that take place in the IVF units. The embryologists are entrusted with carrying out sensitive processes in the IVF unit laboratory, which concern all stages of fertilization, including the identification of eggs and embryos at all the required stages “As of 2018-2019, the units had a significant shortage of 111 embryologists (45%) relative to what was required according to the draft standards (244 embryologists),” state the authors of the report.

Although it is a draft of standards, the draft was intended to set the appropriate standard in this area, and the units were instructed to adapt their activities to what is stated in it,” the authors of the report further state – in ten of the 25 units that were examined, the rate of missing embryologists was 50% or more than required according to the draft standards; In 13 units, the rate of missing embryologists was about 30% – 49% of what was required; In another unit, the rate of missing embryologists was about 20% of what was required; And only in one unit did the number of embryologists meet the standard required by the draft standards.

“A severe shortage in the number of embryologists, as is found in most units, inevitably affects the burden placed on their shoulders and jeopardizes the ability to ensure optimal and high-quality care in the various IVF units,” warn the authors of the audit report. The audit also shows that in 2022 it was reported to the ministry Health received a donation from 547 egg donors from abroad, but the ministry did not have data on the number of women to whom each donor contributed.

This is because from each pumping cycle of a donor, eggs can be allocated to several donors, and each donor can donate eggs several times. “It therefore follows that the Ministry of Health does not have information on the number of those who actually helped Israel by donating eggs from abroad. Moreover, the national database also does not include complete information on the subject. At the end of the audit, in March 2024, the Ministry of Health and the Israel Police issued a statement according to which a suspicion was investigated that fertilized eggs with a genetic disease were imported from abroad for the purpose of performing IVF treatments on Israeli women. Their women contributed every egg donor,” the report further states.

The State Comptroller states that there is a need to strengthen the supervision and control mechanisms of the Ministry of Health in the field of in vitro fertilization. “The Ministry of Health must complete without delay the determination of the procedures for operating the units for in vitro fertilization; make sure that the units correct the deficiencies that it raises in the controls and make sure that it has all the reports about special events that happened in this area,” recommends Engelman in the summary of the poignant audit report.

“In addition to all of this, it was brought up that the national database is not complete and reliable, and that the ability to achieve all the goals that were the basis of its establishment, including the promotion of the safety and quality of treatment and the possibility of making decisions and setting policies based on it – is missing and limited. The improvement of the database will help the Ministry of Health in setting policies in this area in general and in evaluating the existing policy in particular.” The State Comptroller further recommends that the Ministry of Health ensure that the scope of treatments in each and every unit corresponds to the manpower and infrastructure therein, in a way that provides an adequate response to the quality and safety of treatment in this sensitive area.