Regulation and Quality Matters
Welcome to our first blog post – Regulation and Quality Matters.
When you read the title, you might read it in two ways; this depends on whether you read the word, “matter” as a noun or a verb.
If it is a noun - a subject or situation under consideration then I am just going to talk about what quality and regulation are.
If it is a verb - be important or significant then I am going to talk about why these things are important.
And I plan to cover both. This is a huge topic and I suspect I will visit it often.
I started in the field of Embryology in 1990. I was incredibly lucky to be in the right place at the right time. There were very few ‘IVF units’ in the UK at the time, and I was applying for jobs as they came up, in different cities.
Regulation was in its very early days. There had been a Voluntary Licensing Authority, the VLA, and some units had agreed to align to this. By 1990, we had the Interim Licensing Authority, ILA and that same year the Human Fertilisation and Embryology Act was passed. I can remember this being explained to me by the Consultant who had employed me; I can recall the gravity in his voice when he said, “These laws, this degree of regulation, will mean that IVF in the UK is the safest in the world”. As someone who likes rules and regulations, I found this comforting. And I believe he was right.
The Act lays out the need for an authority, the Human Fertilisation and Embryology Authority, or HFEA and they remain the regulators of Assisted Conception in the UK. The ‘rules’ of the Act are laid out in a Code of Practice, for Assisted Conception Units to follow. Units have cycles of inspection and must be able to demonstrate that they are working in line with the Code of Practice and must have a licence in order to be able to operate. The Current version, 9.4, came into effect on 26th October 2023 and is available for anyone to read on the HFEA Website.
The original Act was, and the current Act still is, very concerned about confidentiality. The Act covered the use and the storage of gametes (eggs and sperm) and embryos.
There was great emphasis on the need for written consent from a patient or couple.
The Act laid out the need for a “Person Responsible”, (PR) to the HFEA.
At the outset, the PR was nearly always the doctor leading the unit; today in more than 50% of Units it is the Lead Scientist who is the PR. The role of the PR is enshrined in law; if they do not adhere to the Code of Practice sufficiently, they could be imprisoned. They hold ultimate responsibility for all the activities in a Unit, although much of this responsibility is usually delegated to other members of a senior management team.
There have been many amendments to the Act, and to the Code of Practice, since 1990. Some of the biggest changes came after the EU Tissues and Cells Directive, (EUTCD (Directive 2004/23/EC on tissues and cells)) was passed and became enshrined in UK law.
The EUTCD was a piece of legislation passed, in order to make the donation of tissues, cells and blood products more safe. It covers:
- Donation and Procurement
- Testing and Processing
- Preservation and Storage
- Distribution and Import/export
It is aligned with many processes from Pharmaceutical Manufacturing. This legislation covers all tissues and cells used for transplant, such as bone, tendons and heart valves, as well as reproductive cells; eggs, sperm and embryos. It covers tissues and cells for donation AND cells being used by a patient or couple in their own treatment.
This piece of legislation meant enormous changes for Units within the UK and the rest of the EU. In the UK, the responsibility for making sure that Units adhere to this Directive was passed to the HFEA. They decided how much of the parent directive (and its two technical annexes) must be complied with within the UK. These were then written in to the HFE Act, and into the Code of Practice.
It is quite complex trying to apply these principles to reproductive cells, as they are living and need to be protected – they can’t be dried, powdered and sterilised like bone for grafting.
Major changes resulting from this legislation:
· The requirement for air quality within the procedure rooms that is regularly tested and has to achieve certain standards of cleanliness
· The introduction of a Quality Management System.
From the Code of Practice, Current edition (9.4) ;
T32 The centre must put in place a quality management system and implement this system to continually improve the quality and effectiveness of the service provided in accordance with the conditions of this licence and the guidance on good practice as set out in the HFEA’s Code of Practice.
T33 The following documentation must form part of the quality management system:
a. a quality manual
b. standard operating procedures (SOPs) for all activities authorised by this licence and other activities carried out in the course of providing treatment services that do not require a licence
c. guidelines
d. training and reference manuals, and
e. reporting forms.
What exactly IS a quality management system?
A quality management system (QMS) is a collection of processes and procedures which aims to ensure that the quality of service meets - or exceeds - the expectations of the patient. A QMS should be repeatable, measurable, and rely on continuous improvement
This is all very interesting; but how does it apply to a courier company?
In Guidance note 24, from the current edition of the Code of Practice;
24.1 A licensed centre should establish a third party agreement where a third party is carrying out the following two categories of activity:
a. procuring, testing or processing gametes and embryos, or both, for example:
(i) laboratories preparing sperm
(ii) centres where patients are assessed, given fertility-stimulating drugs and monitored, and eggs are retrieved (transport centres)
(iii) centres where sperm is procured
b. supplying goods or services (including distribution services) that may affect the quality and safety of gametes and embryos, for example:
(i) companies supplying equipment and materials, eg, suppliers of culture media
(ii) companies monitoring air quality in laboratories
(iii) clinical or laboratory premises leased from a hospital or other institution, eg, using theatres for collecting eggs under general anaesthetic
(iv) courier companies.
So, there it is – in the HFEA Code of Practice Licence Condition 24, 24.1.b.iv – a licensed centre should establish a third party agreement with courier companies.
What is a third party agreement, or TPA?
A TPA is a written agreement with a third party, which is someone ‘outside of’ an organisation or a usual agreement. When using a courier company, the ‘contract’ is usually with the patient, as it is usually (but not always) a patient and not a clinic requesting and paying for a service. However, the Code of Practice specifies that a TPA should be in place; and it does not specify whether this is for samples being transferred to, or from, that centre.
Are courier companies covered by the HFEA Code of Practice?
Couriers are only covered in this licence Condition above; it is up to the Clinics to satisfy themselves with the standard of service that any courier company can provide. They can choose to set up, or not set up, a TPA with a particular courier company. We will have further information on this in a future blog post, which will be called “ Let’s talk TPAs”.
What other licence conditions are in the HFEA Code of Practice, that apply to couriers?
In Guidance note 10, we have the following mandatory requirements
T105 All gametes and embryos must be packaged and transported in a manner that minimises the risk of contamination and preserves the required characteristics and biological functions of the gametes or embryos. The packaging must also prevent contamination of those responsible for packaging and transportation.
T106 The packaged gametes/embryos must be shipped in a container that is designed for the transport of biological materials and that maintains the safety and quality of the gametes or embryos.
T108 The container/package must be secure and ensure that the gametes or embryos are maintained in the specified conditions. All containers and packages need to be validated as fit for purpose.
What does Life on Ice do, regarding Quality?
Quality is of prime importance to us, in all the senses of the word. Our company was set up out of frustration with the level of service being provided to patients by some couriers. We have aligned ourselves with the standards required by a licensed centre.
We have
· a full quality management system, with a Quality Manual and Quality policy.
· a suite of standard operating procedures (SOPs)
· a documented schedule for training and competency assessments, and written records of all training and assessment
· a schedule of internal audits of all our processes
· Quality Indicators and Key Performance Indicators
· an annual Quality Review
We have been externally audited by the Hewitt Fertility Centre, Liverpool, in 2022. The Hewitt is one of the largest clinics in the UK, if not the largest.
They examined our quality processes, using an external questionnaire. Any of the clinics with whom we hold a TPA may request that they audit us, either in person or via a questionnaire.
As Technical Director and Quality Manager, I set up all of our processes and our quality Management system; I am helped in this by our Quality Assurance Officer, Sam Muir. Sam holds a BSc Hons in Pharmacology, and works in Quality Control in Pharmaceutical manufacturing. This makes him extremely valuable when we are looking at our processes, our validation techniques, our SOPs and the like.
We hope this look at Quality and Regulation has been useful. We plan a blog every month or so; please get in touch if there are any topics you would like to see covered!