Chapter 16 – The Role of Regulation in Reproductive Medicine




Abstract




The Human Fertilisation and Embryology Authority (HFEA) started work on 1 August 1991. However, its formation was the result of a long process of discussion and development of in vitro fertilization (IVF) regulation in the United Kingdom in summary.





Chapter 16 The Role of Regulation in Reproductive Medicine


Nick Jones and Debra Bloor



1 Background


The Human Fertilisation and Embryology Authority (HFEA) started work on 1 August 1991. However, its formation was the result of a long process of discussion and development of in vitro fertilization (IVF) regulation in the United Kingdom in summary:




  • 1982 – Warnock Committee Inquiry starts. The Warnock Committee was established in July 1982 ‘to consider recent and potential developments in medicine and science related to human fertilisation and embryology; to consider what policies and safeguards should be applied, including consideration of the social, ethical, and legal implications of these developments; and to make recommendations’.



  • 1984 – Warnock Report published 18 July. It highlighted the ‘special status’ of the embryo and proposed the establishment of a regulator.



  • 1987 – Human Fertilisation and Embryology: A framework for legislation (Cm 259). White paper picking up the recommendations of the Warnock Report.



  • 1990 – Human Fertilisation and Embryology Act



  • 1991 – Human Fertilisation and Embryology Act 1990 comes into force



  • The HFEA officially starts work on the 1st of August 1991.



  • 2007 – Human Fertilisation and Embryology Bill: Major review of fertility legislation, updating and amending the 1990 Act.



  • 2009 – Human Fertilisation and Embryology Act 20081 comes into force. New provisions come into force in April and October 2009, additional changes in April 2010.


The HFEA licenses all clinics and establishments in the United Kingdom undertaking assisted reproduction and human embryo research. It issues types of licences, depending on which activities are carried out. For example, a clinic carrying out IVF or associated treatments will need to obtain a ‘Treatment and Storage’ licence. If it wishes to extend or change the range of activities carried out, it would need to apply to vary its licence.


The main types of licences are as follows:




  • Storage



  • Treatment – for clinics offering intrauterine insemination (IUI) and other basic fertility treatments which do not involve the creation of embryos



  • Treatment and storage – for clinics offering IVF, intracytoplasmic sperm injection (ICSI) and gamete and embryo storage



  • Treatment (including embryo testing) and storage – for clinics offering IVF, ICSI, gamete and embryo storage and embryo testing



  • Research – for laboratories carrying out research on human embryos


The HFEA monitors clinics’ performance, expects clinics to report adverse incidents and checks compliance with standards at inspection. Most clinics are granted a four-year licence, and are usually inspected every two years. If there are concerns about a clinic, inspections may be more frequent – particularly if it is considered the safety of patients, embryos and gametes are at risk. The purpose of an inspection is to assess a clinic’s compliance with the Human Fertilisation and Embryology Act 1990 (as amended), licence conditions, General Directions and the provisions of the Code of Practice [2]. Inspection is intended to




  • provide an independent and professional perspective on the running of the clinic



  • promote good practice so that clinics can improve the quality of service they provide to patients and donors



  • provide clinics with a positive learning experience



  • provide clinics with the opportunity to feed back on their experience of the inspection process, to assist the HFEA improve its procedures



  • give patients reliable information about a clinic’s compliance with statutory and other obligations, and about the quality and safety of licensed activities undertaken at that centre



  • be evidence-based, consistent, proportionate and focused on risk – to add value for clinics and people using services.


The clinic is provided an opportunity by the inspector to prepare for the inspection to minimise potential disruption to activities being carried out on the day. Some inspections are unannounced or, where relevant, with short notice (where clinics have low activity levels) providing an opportunity to see things as they are. The onus is on clinics to demonstrate compliance, not on inspectors to find fault. There is a focus on quality and safety of patient care and the protection of the embryo. Most of the time is spent on direct observation of practice, with some sampling of documentation and records.


The inspection team usually consists of two to four inspectors, depending on the size of the clinic and the services it offers. The inspectors are HFEA staff members, supplemented by external advisors (doctor, nurse, embryologist, counsellor working in licensed centres) who occasionally form part of the inspection team.


During the inspection of new clinics or clinics applying to renew their licence, the inspection team evaluates compliance with all relevant standard licence conditions. A focused interim inspection takes place midway through the four-year inspection cycle and is usually unannounced. During the interim inspection the inspection team gathers information without spending too much time talking to clinic staff or reviewing documentation. Instead, practice is observed and patients are asked about their experiences of care. The inspection team also evaluates




  • the actions taken by the clinic to address any areas of non-compliance identified either at the previous inspection, or through continuous monitoring;



  • compliance with the following inspection areas:




    • quality of service (including outcomes and multiple pregnancy rates);



    • patient experience;



    • effectiveness of witnessing;



    • staffing levels;



    • management of stored gametes and embryos;



    • the suitability of the premises and facilities for surgical procedures;



    • medicines’ management practices;



    • infection prevention and control practices;



    • compliance with requirements to use CE marked medical devices (particularly culture medium and reagents);



    • effectiveness of the quality management system and review of the centre’s website;



  • The inspection report will also comment on information from on-going monitoring of clinics’ performance and on information in self assessment questionnaires.


Feedback is provided to the Person Responsible (PR) on the day of inspection. After the inspection, the HFEA inspector writes a report, which includes areas of good practice and those areas of practice which require improvement. The inspection report comments on the actions taken by the clinic to address areas of non-compliance identified. Areas of practice that require improvement are divided into the following categories:




  • A critical area of non-compliance – a critical area of non-compliance is an area of practice which poses a significant risk of causing harm to a patient, donor, embryo or to a child who may be born as a result of treatment services.



  • A major area of non-compliance – a major area of non-compliance is an area of practice which




    • poses an indirect risk of causing harm to a patient, donor, embryo or to a child who may be born as a result of treatment services;



    • indicates a major shortcoming from the statutory requirements;



    • indicates a failure of the Person Responsible to carry out his/her legal duties;



    • is a combination of several ‘other’ areas of non-compliance, none of which on their own may be major but which together may represent a major area of non-compliance.



  • An ‘other’ area of non-compliance – a departure from non-major statutory requirements or good practice.


The Person Responsible is given two weeks to share the report with the team and to comment on the report. A final report is presented to a HFEA licensing committee, which decides whether the licence should be renewed or continued (depending on the type of inspection) and if there are any conditions that must be fulfilled. The final report and minutes from the licensing committee meeting are published on the HFEA website Choose a Fertility Clinic section. The inspection team continues to monitor the actions taken by the clinic, to ensure that all actions are addressed.



2 Analysis


The HFEA adopts a high-trust model – a model in which trust is earned through disclosure of problems (incidents and material events), implementation of recommendations for improvements from inspections and a belief that clinics strive for and are motivated by quality and improvement.


The regulatory landscape in which the HFEA operates changes continually and in response it must expect to adapt and change.


For example, a raft of new requirements was transposed into the Act in 2007. Notably at this time, it became a mandatory requirement for clinics to have documented and validated processes and procedures and to establish a quality management system (QMS) to support continuous improvement. In response, the HFEA’s inspection regime had a greater focus on clinics’ documentation. Moreover, further changes to the Act in 2009 significantly updated the consent regime and introduced complex new consent requirements which in turn resulted in a continued focus on clinics’ consent procedures and documentation of consent. And in 2012 the HFEA extended its remit to inspect a number of additional clinical activities (safeguarding, infection control, medicines management and the pre-, peri- and post-operative pathway) so that clinics in England that only carry out HFEA licensable activity could be exempted from the requirement to be registered with the Care Quality Commission (the health and social care regulator in England).


It was (and remains) straightforward to inspect documentation. It is harder to assess the quality of processes themselves and to evaluate the quality of services provided and experienced by patients.


The HFEA seeks to learn from its clinical governance and inspection activities and its assessment is that while clinics ‘tick the box’ in carrying out audits and in conducting root cause analysis to identify the causes of incidents, complaints and/or poor performance, in common with the healthcare sector in general, these activities may not always be effective in identifying opportunities for improvement.


In consideration of this, since 2014 the HFEA has phrased recommendations for improvement to encourage clinics to consider why a non-compliance has evaded their QMS; why an incident has occurred; or why a patient has experienced poor service. Having identified the root cause, clinics are encouraged to identify corrective actions specific to their own circumstances and then to assess the effectiveness of the corrective actions. Additionally, the HFEA is working closely with clinics that see recurrence of C grade incidents (Box 16.1) or whose root cause analysis is deficient. This approach aims to support the continued development of a ‘learning culture’ that is intended to be more effective in driving improvement. Since early 2015, the HFEA has also focused on whether clinics have learned from incidents (both their own and those documented in the HFEA annual review), complaints and guidance in the course of interim inspections.


Box 16.1

Grade A: involves severe harm to one person (such as a death, being implanted with the wrong embryo or birth of an affected child following genetic testing) or major harm to many (such as the failure of a frozen storage unit containing the embryos of many patients).


Grade B: involves serious harm to one person (such as the loss or damage of embryos for one patient) or moderate harm to many (such as sensitive personal data about more than one patient being sent to the wrong recipient).


Grade C: involves minor harm, such as one of many eggs being rendered unusable in the laboratory.

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Oct 26, 2020 | Posted by in GYNECOLOGY | Comments Off on Chapter 16 – The Role of Regulation in Reproductive Medicine
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