Helsetilsynet

In accordance with the Blood Regulations, the Norwegian Board of Health Supervision investigated whether health trusts, through their internal control systems and quality management systems, ensure that there are necessary measures to provide a high level of safety for people who donate and receive blood.

The main focus in 2008 and 2009 is:

  • to ensure correct identity in all stages from blood donor to patient
  • to prevent spread of infection
  • to ensure that the right blood is given to the right patient
  • to ensure that the correct temperature is maintained during the storage and transportation of blood and blood components.

In order to fulfil the above requirements, systematic leadership, organization and management are necessary. Good communication and teamwork between blood banks, other hospital departments and health trusts is important. Other important factors are: management of staff, guidelines, procedures, dealing with adverse events, and internal audits. In addition the leadership is required to monitor and follow up activity in the blood bank.

New Blood Regulations came into force on 1 January 2007, to be in accordance with the EU directive. According to the Blood Regulations, the Norwegian Board of Health Supervision is required to carry out supervision of all blood banks in the country every other year. In order to carry out this supervision, and to do it in the most appropriate way, in 2007 we have had several meetings with professionals who work in this area, and we have reviewed the available literature and other sources of information to find out which activities are most often deficient. We wish to focus our attention on situations where the risks for donors and recipients of blood and blood products are greatest. The rules in the Blood Regulations are detailed, both with regard to clinical matters and quality control. This gives the possibility for different approaches to and methods for supervision.

In 2008, supervision was carried out by studying documents that blood banks are required to have in accordance with the Blood Regulations. Supervision visits and spot checks were made when this was considered necessary. This approach has been continuously evaluated and adjusted as appropriate.

Supervision of blood banks will be carried out in about half of the health trusts in 2008, and in the rest in 2009. When supervision is completed, we will produce a report to summarize the situation for the whole country.