Quality assurance in the IVF Lab
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The IVF laboratory |
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The ICSI lab |
The IVF Lab fullfills an important role. High demands and expectations are placed upon our standards of work - and quite rightly too, because we would have to account for the consequences of any mistakes we might make. Although countless couples become pregnant and give birth to healthy children, the number of unsuccessful treatments still outweigh the successful ones. IVF labs are therefore under constant pressure to improve the quality of their services and increase the percentage of successful treatment cycles.
A quality control system is the tool with which this expectation is met. It is a concept adapted from the industry sector. Worldwide, laboratories and pharmaceutical companies are obliged to integrate a quality control management concept into their production process, which complies to international standards (ISO-EN). The aim of this is to establish procedures (standard work methods), which ensure that these established levels of quality are reached and maintained. Furthermore, the result must be visible, in order to prove that standards are being adhered to and met.
Many IVF labs are currently working to develop and establish a Quality control system specific to their particular work methods. The are guided by the international standards (EN45001 - ISO 25) and the specifications of scientific associations such as
ESHRE (European Society for Human Reproduction and Embryology).
The Embryology and Andrology labs at UZ Brussel are therefore especially proud that they were awarded the
ISO-accreditation 15189 in April 2005. This is the strictest set of standards in the laboratory world.
What is a quality system?
The principles of the quality system are straightforward enough:
- say what you do;
- do what you say;
- do it better.
in other words:
- we standardize our procedures to the finest detail;
- we apply them consequently;
- we continuously evaluate our standards and remain ever alert for improvements.
The application of these principles however, is rather more complex. In order to reach the standards set, an organization must undertake a number of steps:
- define and state the aim of their work: what do we hope to achieve?
- bring the organization and its management systems into play: how can we reach our goal and make it reality?
- establish standard procedure protocols: who is responsible for what, when and in what order?
- establish work standards: how must we work?
the whole set of priciples is then written into a handbook, which not only sets out how the quality system works in principle, but also how it managed and evaluated.
The quality handbook
The quality handbook describes the organizatory structure, the responsibilities, procedures, processes and measures required in order to meet quality controllable standards. It sets out the rules and highlights the precautions which the laboratory must adhere to. The handbook contains various sections.
1. the organization
Who are the people concerned, what is their function and responsibility and to what measure are they involved with other disciplines? But also: what structure of thought is there and how does it function?
2. the procedures and work standards
The IVF-lab at the CRG contains more than 300 pieces of equipment. There are complicated operating instructions for every piece. Similarly, every technique used is standardized in work protocols and there are established logistic procedures for all supporting activities (cleaning, ordering etc...) which guarantee the safety of patients and staff alike.
3. conclusions and observations
This section describes how conclusions and observations are to be recorded and registered. It contains a complete description of the information system used.
4. maintenance procedures regarding work areas and equipment
The IVF lab was designed in such a way as to facilitate cleaning and maintenance. It is equipped with air conditioning and air filtering systems and a permanent electricity supply in the event of a power failure. Lighting is kept to restricted levels and the walls are coated with a non evaporative, non toxic and easy to clean coating. Cleaning procedures are carried out according to a strict protocol and with non toxic detergents. the levels of air born particles which could be detrimental to embryo culture are kept to a minimum.
5. control of delivered material and resources
Tissue culture - more specifically embryo culture demands strictly controlled conditions to ensure optimal development. Control of the most important physical conditions (pH, temperature, osmolality), composition of culture medium and the absence of embryo-toxic material can make the difference between a pregnancy or not in IVF. Inconsistencies in the production of embryo culture or sub-optimal culture conditions are brought to light by the use of mouse bio-assessments. There are entry controls on all delivered products and reactants; lot numbers and expirary dates are recorded.
6. The treatment of samples in every phase of the laboratory process
The importance of correct handling of samples seems obvious. The risk of a switching of gametes or embryos must be completely eliminated. Therefore patients undergoing treatment are continuously asked to identify themselves.
Mistakes during the laboratory process and the embryo transfer must of course be rendered impossible as well. This is done by means of a double identification process and by the fact that every step of the treatment process is implemented and checked by two people. One performs the actual procedure, whilst the other performs identification checks. The identities of these members of staff are registered.
Furthermore, there is strict segregation of work areas (sperm, egg cells etc...) and there may never me more than one specimen at a time in any one work area.
Systematic use of disposable material is implemented. Every laboratory procedure is performed under sterile conditions and optimal environmental parameters (temperature, pH etc...). Strict criteria determine and govern the use of culture medium. Critical process parameters such as CO2 levels in incubators are permanently monitored.
Finally, the pregnancy percentages of the culture system and personnel performing it are recorded every week and month, i.e. the pregnancy statistics of each embryologist and gynaecologist involved.
7. management of measurement and examination apparatus
The result of a treatment must not be allowed to be compromised because of a technical problem in a piece of equipment. There are back-up pieces of equipment for all the apparatus in the lab (incubators, storage tanks for embryos and sperm etc...). Furthermore, critical equipment is attached to an alarm system, which monitors the function of the lab. As soon as an abnormality is detected - day or night, it is brought to a responsible persons' attention, so that immediate steps can be taken to rectify the situation.
All lab equipment is included in an inventory, wherein the type and frequency of maintenance is recorded. Before a new piece of equipment is taken into service, it undergoes a validation procedure to ensure that is functions as it should do. Every apparatus is regularly calibrated and measurements of temperature, volume and weight are adjusted to the certified references.
8. Document management
The introduction and application of a Quality system results in an influx of documents, procedures, check lists etc. They all form part of the standard application methods and authorizations. Various updated versions of documents are stored and when no longer applicable, archived. An electronic management system make the need for paperwork largely unnecessary.
9. evaluation of the quality system
Every aspect of the treatment and care provided is regularly evaluated though internal auditing.
10. Dealing with complaints and deviations
Problems and faults can occur during any human procedure. Therefore how these problems are handled is important for a well functioning quality system. Complaints from patients or members of staff are registered, examined and followed up. If applicable, they lead to a revision of an existing procedure, or the introduction of a new one. In this way, improvements can always be made.
External audits
After the introduction of a quality system, it will be judged, certified and accredited by an independent and impartial external auditor. This procedure will decide whether the activities and result correspond to the quality system and what it aims to achieve.
In Belgium, the audit is performed by Belac (formerly know as Beltest). An accreditation may be considered proof of competence. The andrology and IVF labs at the CRG are particularly proud of their
ISO-accreditation 15189 which was awarded in April 2005 and is the strictest laboratory accreditation available. For our patients, this official label of quality means that the strictest guidelines will be adhered to in their treatment and the handling of their genetic material.