The CRG applies a different ISO standard in its laboratories than in its clinical operation, but both are integrated in one electronic quality management system.

In the laboratory – ISO-15189

Already in 2005 the Assisted Reproductive Treatment laboratory (ART) of the CRG – including the andrology and embryology lab – were awarded an ISO-17025 accreditation. This made it a pioneer in Belgium and in Europe.
Later, this standard was converted to ISO-15189, specifically for medical laboratories.
This is the strictest certificate in medical laboratories and for many years has been the standard at the CRG laboratories.

 

In the clinic – EN-15224

For the clinical part, the CRG opted for the ISO-certificate for healthcare (EN-15224).
This is a translation of the widely known ISO-9001-standard, but specifically for the healthcare sector.
This standard underlines the care process and important aspects for the patient such as:

• clear communication,
• safety of the patient,
• patient satisfaction, and
• risk control.

Throughout the entire fertility treatment process, special attention is paid to the correct identification of our patients and their individual samples. That is why:

• we ask all patients to, every time, identify themselves and/or their samples in the course of the treatment, and
• we double-check every critical action in the process- in the laboratory, in the absence of the patient.

This double-check used to be witnessed by a second staff member, but since 2010 the CRG uses the electronic IVF Witness identification system.
This system is based on RFID technology (Radio Frequency Identity):

• per couple or single patient an IVF-identity card is created;
• RFID-identification labels are put on all receptacles with patient material; and
• the identity of the RFID-sticker is automatically read at every workstation.

Any wrong egg-sperm combination automatically results in an alarm signal.

The strict separation (in time and space) of laboratory actions also contributes to the prevention of errors.

A quality management system comprises different elements:

• a description of the organisational structure, positions and responsibilities on the different levels;
• provision of training schemes, further training and assessment of staff members to safeguard the competence;
• an inventory of all procedures.
  This important component provides a detailed description of the working methods for every treatment and action and which materials and products are required.
  These procedures are continuously updated. Only the latest version is available;
• detailed operation and maintenance instructions of all equipment;
• in the ISO-15189 environment, the (obligatory) preliminary validation of methods and equipment;
• the electronic registration of treatments and actions and observations in an accurately described IT system;
• the guarantee that all treatments and actions take place in areas that meet the defined quality standards and have strict access control.

How is the quality management system translated into laboratory practice?

• Sp Specific lab activities are performed in clean rooms with powerful filters that guarantee a high air quality. The strict day-to-day cleaning with tested non-toxic detergents also contributes to the required environment quality.
• The cultivation of embryos requires strictly controlled conditions. To ensure optimum embryo-development, the following conditions are strictly respected:
  • continuous monitoring of temperature and gas composition in incubators,
  • day-to-day monitoring and regular calibration of critical equipment, and
  • meticulous choice of culture mediums.
• Critical parameters are permanently measured and monitored based on an electronic monitoring system:
  
  • someone is automatically notified in case of changes;
  • the storage cylinders with frozen eggs, sperm and embryos are also connected to this permanent monitoring system.
• All liquids and materials which come into contact with eggs, sperm and embryos are tested on possible toxicity.
• To guarantee the sterility, the laboratory systematically uses material that is only used once.
• Access control and registration of lot numbers and expiry dates of materials/products (traceability) are obligatory.

With the implementation and proper application of all agreements and procedures this is not the end of the quality story.
Because a quality system obviously needs ongoing maintenance and stimulation.
That is why

• we carry out risk analysis and management. The risks need to be mapped and analysed for every process;
• we register ideas, complaints and anomalies;
• we study them and deal with them. This usually results in improvement measures which, in turn, are evaluated at a later date; and
  we conduct patient satisfaction surveys.

In this way we achieve a continuous improvement process.

To measure is to know
To measure the performance of the actions and treatments, we use performance indicators, both for clinical and laboratory actions and treatments.
The systematic follow-up of important parameters which determine the success of the treatment both individually and globally, yields important information which may result in a fine-tuning of the process or extra training.

Internal and external evaluation
And finally each element of the quality system is regularly subject to critical evaluation:

• based on internal audits, conducted by staff members of the department. And as a result of this, if necessary, the procedure is adjusted;
• through regular external audits the supervisory body assesses whether the laboratories and CRG clinic still meet the awarded ISO-standard or certification requirements.