I-10: QA in The ART Laboratory

The establishment of a high quality ART program requires a multi-disciplinary effort, involvement and commitment of all staff members - team work. It is of vital importance that all aspects of the treatments are taken into consideration and that you already from the start use international guidelines, standards and indicators to initiate the construction of a well-organised ART program that meets the highest international standards andrequirements. In order to obtain and maintain an optimal level of patient care and success rates, a total formal quality management (TQM) system must be implemented. Professional international and domestic guidelines, accreditation bodies and quality management models can be used. Implementation of a TQM system is associated with a huge workload and requires investments. However, due to increased standardization and efficiency of all processes and procedures, improved transparency and traceability of all actions performed, the quality of service improves substantially, which is of benefit for both the customer and the staff. The TQM system covers all aspects of the clinic and the procedures, from facility parameters, initial evaluation of a patient, stimulation protocols, culture and embryo transfer techniques, gestational period, to parameters in connection with the delivery of the baby. TQM is not only designed to detect and eliminate problems, but also to constantly improve the clinic’s performance by incorporate latest know-how and techniques, as well as to make all procedures and processes more effective and reproducible. It is important to produce an organizational chart, which clearly shows the hierarchy, the line of communication, authority and responsibility. This avoids many unnecessary misunderstandings, conflicts and leads to a more effective communication and interaction between different staff categories (Job descriptions). Standardization is obtained by the introduction of standard operational procedures (SOPs) that can be of technical (equipment’s) or clinical type. The SOPs are upgraded yearly and the latest international technologies and bench mark processes and procedures are incorporated in a never-ending project. International defined key performance indicators (KPI) are used to evaluate the program, which reduces misinterpretations and facilitates communication and auditing. Unfortunately, many clinics only focus on the ultimate outcome - pregnancy rates, which do not assess the overall quality of the ART program. A couple that undertakes a treatment in a “controlled” environment will be given an optimal and safe treatment in a safe environment by highly educated, skilled and professional staff members. One should also remember that the procedures are performed within facilities especially designed for ART, equipped with calibrated certified ART-equipment’s, using embryo-tested disposables and media products, proven to give high reproducible and consistent pregnancy rates. The couples are therefore given high value for money, but it also simultaneously reduces the time spent for auditing and increases the inflow of patients to the clinic.