On Wednesday, March 30, the Norwegian Health Authority visited Medicus for an inspection related to the "Regulations on the handling of cells and tissues intended for assisted fertilization".
We are very satisfied with both the way the audit was conducted and the audit's assessment of the clinic's quality and management system and the managers' and employees' awareness of quality and safety.
Two non-conformities were reported following the inspection, one related to consistent, unambiguous labeling, the other related to the lack of a checklist documenting that all relevant requirements in the regulations have been checked before release.
That all relevant requirements have been checked is evident in the couple's medical record, at the stage in the treatment process where it is natural to check the requirement. We nevertheless see that it is useful, and have prepared and implemented a checklist that collectively documents that all requirements have been met.
It was pointed out that bowls marked with full name and date of birth did not meet the requirement in the regulation for unique marking. The clinic has therefore changed its procedure so that bowls are marked with full name and social security number, in the same way as we have done with cryo vials.
The Norwegian Health Authority points out that the discrepancies are due to their stricter interpretation of the regulations than the company has done.
We think supervision is good as it gives us the opportunity for further improvement.
