Assisted Reproduction Registries and Reporting
RRM Academy Synopsis
UK fertility clinic non-compliances fell 12% in 2019/20
The UK fertility regulator's 2019/20 annual report found that inspectors recorded 12% fewer non-compliances, 308 across 94 inspections. Patient complaints rose 16% to 87. The regulator, known as the HFEA, drew on inspections, incident reports and patient feedback among the 106 licensed fertility clinics.
Key Findings
- Clinics reported 562 incidents, including near misses, an average of 0.7% per cycle. Two were category A, 280 were category B (down 5%) and 233 were category C (down 12%).
- Inspections yielded 308 non-compliances (16 critical, 166 major, 126 other), 12% fewer than the year before. The average per inspection was 3.3, down from 3.6 in 2018/19.
- Incidents of ovarian hyperstimulation syndrome (OHSS) reported to the HFEA dropped 25% to 115, the fewest since 2015/16. No cases of critical OHSS were reported.
- Of almost 1,500 patients giving feedback, 94% reported being treated with privacy and dignity, with good or excellent team empathy and understanding. Only 64% said they paid about what they expected.
- The HFEA received 87 complaints from patients, 16% more than in 2018/19. Complaints covered communication, missing information about add-ons and their costs, and involvement in decision making.
Interpretation
The report is a regulator's annual descriptive summary. Its sources are inspections, the HFEA Register, incident reports and patient feedback. The HFEA reports absolute counts and averages per inspection and per cycle, with no live birth rates or other treatment outcomes. The authors state that the OHSS decrease may follow a change in what clinics must report. They also state that the patient feedback is not representative of the sector, because nine clinics supplied 50% of responses.
RRM Context
Compliance counts describe how clinics operate. Restorative reproductive medicine asks what is preventing a couple from conceiving, assessed in both partners. IVF bypasses that question. The drugs used in fresh IVF cycles can cause ovarian hyperstimulation syndrome, a potentially serious side effect that the regulator counts among reported incidents.
Abstract
State of the Sector is the annual report of the Human Fertilisation and Embryology Authority (HFEA) on its regulatory work, and this edition covers the financial year 2019/20 (1 April 2019 to 31 March 2020). The report is compiled from HFEA inspections and from its Register of fertility treatments, incident reports and patient feedback, and gives a high-level overview of sector-wide compliance. For 2019/20 the report counts 106 clinics licensed by the HFEA in the UK to provide fertility treatment and 94 inspections. The report also records 562 incidents, including near misses, and describes how General Direction 0014 required all clinics to cease fertility treatments by 15 April 2020 because of COVID-19.
Read the guide
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ART Registries and Codes of Practice: A Reference for Patients and Clinicians
A global reference to national IVF registries (HFEA, RTAC, ANZARD, Q-IVF, CDC, DIR, JSOG, CARTR Plus, REDLARA, ESHRE EIM, ICMART) and the codes of practice that govern fertility clinics. What each measures, and what they miss.
