State of the fertility sector 2019/2020
Annual publication on our regulatory work
Published: November 2020
About this report
We are the independent regulator of fertility treatment and human embryo research in the United Kingdom (UK). We aim to ensure that everyone who steps into a fertility clinic, and everyone born as a result of treatment, receives high quality care. We do this by licensing, monitoring and inspecting fertility clinics and providing free, clear and impartial information about fertility treatment, clinics, and egg, sperm and embryo donation.
State of the Sector is our annual report, which summarises what we have seen through our regulatory work during the year. The report is compiled from information gathered from our inspections throughout the year and uses other sources of information including our Register of fertility treatments, incident reports and patient feedback mechanisms.
In 2019/20, we introduced a Clinical Governance Quarterly Update which provides clinics with detailed insight into non-compliances in a more timely manner to help clinics improve compliance and prepare for inspections. As a result, the State of the Sector report this year provides a high-level overview of sector-wide compliance, reporting on the absolute number of inspections, non-compliances, incidents and complaints.
Impact of COVID-19 on the fertility sector
This report looks at the financial year 2019/20 (1 April 2019 – 31 March 2020), predominantly covering the period before any COVID-19 restrictions were put in place. As COVID-19 caused unprecedented demand on the NHS during the initial wave of the pandemic, the Human Fertilisation and Embryology Authority (HFEA) made the difficult decision to publish General Direction 0014 on 23 March 2020. This required all clinics to cease fertility treatments by 15 April 2020, reflecting both professional body advice and Government guidance.
During the time of treatment cessation, only fertility preservation treatments were undertaken (for example for patients about to start chemotherapy). Many clinics during this time had staff redeployed or furloughed and maintained a skeleton staff to ensure patients were looked after appropriately and their stored gametes and embryos were kept safe.
As the initial peak subsided, we gave clinics permission to apply to reopen from 11 May by submitting a Treatment Commencement Strategy which demonstrated how their services could be provided in a safe COVID-19 secure manner. Many clinics were well prepared and were able to recommence treatments quickly, adapting and introducing new ways of delivering their services safely. Whilst some patients may have been disadvantaged during this short lockdown, the vast majority of clinics have now reopened to patients and treatment numbers have steadily increased in both the NHS and private sector.
During the national lockdown, HFEA inspections of clinics were suspended but with the safety of patients and their gametes and embryos being our priority, we also adapted and introduced new ways of working to ensure continued compliance. Clinics who were due an inspection have been assessed using a risk-based approach and a desk-based assessment process was used to allow continued close oversight of the fertility sector as the pandemic continued. The Authority approved onsite inspections to recommence from November 2020, however, as the pandemic continues and tighter Government restrictions are put in place, a risk-based approach will continue to be used alongside virtual technologies to minimise the amount of time an inspector spends in a clinic.
In 2019/20, 106 clinics were licensed by the HFEA to provide fertility treatment
In 2019/20, there were 106 fertility clinics licensed by the HFEA in the UK to provide fertility treatment. In addition, 16 clinics were licensed to undertake research involving human embryos and 14 clinics were licensed to provide storage only. As in previous years, two-thirds of clinics were standalone, and the rest were owned by 10 private clinic groups. Of the 106 licensed clinics that offered fertility treatment, 62 clinics (58%) are privately owned. Just over a quarter of clinics offering fertility treatment were based in London (30 clinics), followed by the South East (11 clinics).
Figure 1. The vast majority of HFEA licensed clinics provide treatment with storage
Number of licensed fertility clinics by type, 2019/20
Figure 2. London is the region with the highest number of fertility clinics
Number of clinics licensed to provide fertility treatment by geographical area, 2019/20 (excluding storage and research only)
In 2019/20, 94 inspections were carried out by HFEA inspectors
The Human Fertilisation and Embryology Act 1990 sets out our powers to inspect clinics to ensure compliance with the law. We typically inspect clinics to renew licences every four years, with an interim inspection after two years, so the number of renewal and interim inspections varies from year to year. There were 94 inspections carried out in 2019/20. All inspections were suspended on 23 March, due to COVID-19, and a total of seven inspections (two interim, two renewal and three additional inspections) were cancelled as a result at the end of 2019/20.
Figure 3. Just under half of all inspections in 2019/20 were interim inspections
Number of inspections by type, 2015/16 – 2019/20
The total number of non-compliances has declined for the third year in a row
Following each clinic inspection, a report identifying areas of good practice and those which are non-compliant and require improvement is published. In 2019/20, 308 non-compliances were identified, a 12% decline in the number of non-compliances identified the previous year. This represents a decline in the total number of non-compliances for the third year in a row.
The average number of non-compliances per inspection has also declined – in 2019/20 there were an average of 3.3 non-compliances per inspection, compared to 3.6 in 2018/19. As in previous years, the areas in which most non-compliances were identified were medicines management and the quality management system.
Figure 4. The number of non-compliances continues to decline
Number of non-compliances by severity, 2015/16 – 2019/20
The average number of incidents per cycle remains stable
More than 80,000 treatment and storage cycles are carried out each year and the vast majority of those cycles are carried out without any problems occurring. All incidents that occur in licensed fertility clinics must be reported to the HFEA in a timely manner. Proactive reporting allows clinics to learn from incidents and ensure changes can be made to prevent reoccurrence. We monitor incidents in clinics to make sure that everything is done to understand what went wrong and, crucially, to take steps to ensure it does not happen again. We also share learning and notify other clinics of potential issues to ensure all clinics learn from this.
In 2019/20, 562 incidents (including near misses) were reported to the HFEA. The average number of incidents per cycle has remained low at 0.7%. The number of category C incidents have been in steady decline for the past few years. This trend has continued in 2019/20 with a 12% decline as 233 incidents were recorded compared with the previous year. Similarly, there has been a decline in category B incidents with 280 recorded in 2019/20 representing a 5% decline from 2018/19. The number of category A incidents has remained extremely small: two such incidents were recorded in 2019/20. We have summarised details of the two category A cases below.
Figure 5. Grade B incidents remain the most common but have decreased since last year
Number of incidents by grade, 2015/16 – 2019/20
All grade A incidents are reviewed to understand what went wrong and what steps are taken to ensure that it does not happen again
Following a positive pregnancy test after a second treatment cycle, an alert was issued by the clinic management software to prescribe a patient with medication due to their case history. The alert was missed as the alert system was also used for other non-critical information and the patient had to be admitted to hospital. While a medical review was not mandatory after the first failed cycle, a consultation is always strongly advised and was a missed opportunity to spot the prescribing error. The clinic subsequently carried out a root cause analysis investigation which led to several actions being implemented:
- Introduction of a new process for identifying and managing complex patients to ensure there is a clear care plan in place, which is shared with the staff involved in the patient’s care and the patient so that they are proactively involved in their own care.
- Complex patients are to have a medical review following each treatment cycle.
- Guidance for staff has been developed to reduce the number of non-essential alerts on the system and to ensure that the alert function is correctly and consistently used by all staff.
- On the alert system, there is a new positive test result ‘progress note’ that confirms the reading of and acting on alerts.
The second category A incident involved a couple attending a clinic for treatment using donor sperm. Following a number of unsuccessful IVF and DI cycles using donor sperm, the incorrect donor sperm was allocated during the couples’ consent appointment for their final cycle. The couple’s treatment using this incorrect donor achieved a live birth. Following an investigation, the person responsible carried out a review of the entire donor sperm process including all associated documentation. Based on this review several actions have been carried out:
- A new SOP ‘matching donors to recipients’ was developed and put into practice.
- Nursing and laboratory staff have received training on the new process. Regular audits of this SOP will be performed to assess ongoing compliance.
- An audit of current patients using donor sperm has been carried out to ensure that the correct donor has been allocated, there are no other discrepancies.
In both cases, a HFEA inspector visited the clinics to review the root cause analysis and to ensure the identified actions had been integrated into clinical practice.
The number of incidents of OHSS reported declined in 2019/20
Ovarian Hyperstimulation Syndrome (OHSS) is a potentially serious side effect which some patients develop due to the drug treatment necessary for fresh cycles of IVF. The number of OHSS incidents reported has decreased by 25% on the previous year to 115 in 2019/20. This is the lowest number of OHSS incidents since 2015/16, which may come as a result of change in the way clinics report incidents of OHSS to us (we no longer require clinics to report mild and moderate cases). No cases of critical OHSS were reported.
Figure 6. OHSS incidents have decreased from the previous year
Number of mild, moderate and severe OHSS incidents reported, 2015/16 - 2019/20
A total of 87 patient complaints were received about licensed clinics in 2019/20
Patients can raise a complaint with us if they are unhappy with how a clinic has handled their original complaint. There has been an increase in the number of complaints we received with a total of 87 in 2019/20 which represents a 16% increase from 2018/19. Complaints received are multifaceted and the complexity of patient complaints has increased. Complaints were received relating to communication, lack of information about add-ons and the associated costs and involvement in the process of decision making. We actively monitor and interrogate the information we receive regarding patient complaints and feed this into the inspection process.
Where a complaint is received, we discuss it with the clinic and encourage them to further engage with the complainant to try to locally resolve the issues raised. Complaints are discussed at regular clinical governance meetings to ensure clinics are actively engaging with patient complaints and providing thorough and well considered responses. We expect clinics to provide a sincere acknowledgement of the complainant’s experience; to explain what, if anything, went wrong; what measures the clinic has put in place to minimise the risk of this happening again and what the clinic can offer the complainant by way of support.
Further advice to clinics on thoroughly engaging and resolving patient complaints was in last year’s State of the Sector report and we would urge clinics to incorporate this into their complaint handling processes.
Figure 7. Complaints received have increased since last year
Number of complaints received, 2015/16-2019/20
Patients are asked to rate and provide feedback on their clinic experience through the HFEA’s website Choose a Fertility Clinic (CaFC). We looked at patient feedback collected between August 2019 and March 2020. Feedback from almost 1,500 patients was received; however 50% of these responses came from nine clinics and the findings are not therefore representative of the sector as a whole. We continue to work with all clinics in the sector to improve both the quantity and quality of patient feedback so we can take collective action to improve the services and care all patients receive.
In 2019-20, 94% of the patients who gave feedback said they felt they had been treated with privacy and dignity and that the level of empathy and understanding shown by the clinic team had been good or excellent. Most patients (93%) said that they mostly or always understood what was happening through their treatment. In total, 84% of patients providing feedback said they would recommend the clinic to friends and family if they needed similar care. When asked about costs, only 64% of responding patients said they paid about what they expected. An additional 16% reported that the care was slightly or much cheaper than expected – many of these were NHS funded patients.
From the feedback, patients wanted the information that was provided throughout treatment to be reliable and accurate. They also placed value on shared decision-making and being given enough time to absorb new information. Many patients said their clinicians were empathetic and explained their medical treatments fully. Patients also expressed satisfaction with clinics that felt clean and professional but simultaneously made them feel at ease and almost ‘at home’. However, some patients expressed displeasure when they felt they were treated as ‘just as a number’ and it was evident that a personal touch was greatly appreciated.
About our data
The information that we publish in this report is compiled from information gathered from our inspections throughout the year and also uses other sources of information including our Register of fertility treatments, incident reports and patient feedback mechanisms. A full list of definitions of classification of incidents and complaints are available in the underlying dataset (.xlsx 47KB).
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Review date: 18 May 2023