Summary of supervision of organizations with authorization for dealing with human tissues and cells for medically assisted reproduction

The Norwegian Board of Health Supervision has carried out supervision of organizations with authorization from the Norwegian Directorate of Health for dealing with human tissues and cells for medically assisted reproduction. Medically assisted reproduction is medical treatment for fertilization of the woman’s ova with sperm, either within the woman’s body or externally.

At eight of the ten organizations, nonconformities (breaches of laws or regulations) were detected. At five of the organizations, human material was not adequately labelled, and at six of the organizations, final control of embryos for implantation was inadequate. The Norwegian Board of Health Supervision has a stricter interpretation of the statutory requirements than the organizations. Awareness of the leaders about quality and safety is such that we believe that the probability for mistakes occurring is low.

At four of the organizations, we pointed out that use and control of critical equipment was inadequate. At one of the organizations, we pointed out that the premises did not meet the statutory requirements. When equipment and premises are inadequate, there is an increased risk that human material can be damaged or lost.