Helsetilsynet

The internal control systems/quality management systems of the health trusts do not meet the requirements of the regulations relating to blood and blood components. This reduces patient safety.

In 2008, the Norwegian Board of Health Supervisions carried out supervision of blood banks in 14 health trusts. This section of the health service is regulated in detail by the regulations relating to blood and blood components , because it is a vulnerable area in which errors can have serious consequences for patients. Thus, according to the regulations, supervision of blood banks shall be carried out at least once every two years.

Errors in which patients are given the wrong type of blood, or in which patients get a disease which is transmitted through blood, must never occur. Thus, every stage must be carefully supervised and controlled. Each component of the quality management system should function as a safety barrier to prevent errors occurring when patients are given a blood transfusion.

The supervision reports show that there is reason to conclude that the blood banks are not organized and managed in line with the regulations. The deficiencies that were identified in the health trusts’ internal control systems, that is to say, in their quality managements systems, result in reduced safety for patients. This means that the probability for errors occurring when blood transfusion are given is too high. We identified inadequate management and follow up both of activities in the blood banks and of cooperation between the blood banks and other departments.

The Norwegian Board of Health Supervision points out that critical areas in the activity of blood banks must be organized adequately and followed up by the leadership of the health trusts. The nonconformities (departures from the regulations) that were identified must therefore be regarded as serious deficiencies in the quality management systems of the health trusts. These conditions must be dealt with in order to ensure that patient safety is adequate.

Report from the Norwegian Board of Health Supervision 6/2009 (Pdf in Norwegian)

Summary in Norwegian