Haemovigilance in Norway. TROLL. Norwegian Blood Transfusion Service. Method and discussion
Report
|Updated
This 2010 report is divided into sub reports. This sub report is about background, method and discussion.
Summary
The Norwegian Knowledge Centre for the Health Services runs the Norwegian Haemovigilance System on behalf of the Norwegian Directorate of Health. One of our tasks is to publish an annual report. The purpose of this report is to form the knowledge basis for the continuous improvement of the transfusion services. This 2010 report is divided into sub reports. This sub report is about background, method and discussion.
The Norwegian Haemovigilance System was voluntary and anonymous from 2004 until 2007, when new legislation made it compulsory. The transition from voluntary to compulsory system was smooth. In 2007 reports of near misses were included in the system.
Materials and methods
Transfusion reactions are reported to the blood bank by the clinical staff. The blood bank has a haemovigilance contact person who reports to the Haemovigilance system electronically on www.hemovigilans.no. Adverse events in donors and near misses are similarly reported by the blood bank. Predefined criteria determine whether reports are flagged as serious. The flagged reports are read by the haemovigilance staff before the end of the next working day. Additional information is collected if required and advice given if needed. The other reports are followed up within a day or two.
The haemovigilance contact persons are an important factor in the Haemovigilance System. They are employed by the blood banks and their haemovigilance responsibilities are just a small part of their day to day duties. Their function is, however, very important, as they are a link between the blood bank and the Norwegian Haemovigilance System. The contact persons have a good knowledge of the Haemovigilance System, what should be reported, definitions used etc. They follow up reports locally and teach Haemovigilance in their local blood bank and hospital.
Results
All Norwegian blood banks and hospitals take part in the Norwegian Haemovigilance System. Many blood banks are small, and may not send all three types of reports every year. However, the rate of reporting per 100 000 transfusions or per 100 000 donations vary a lot between the blood banks. ISO certified (ISO 2001:2009) or Accredited (ISO 15189 or ISO 17025) blood banks have lower reporting rates than the others.
For details on transfusion reactions, donor reactions and near misses please see the relevant sub reports.
Discussion
It is safe both to donate blood and to receive transfusions in Norway. Complications do occur, but serious complications are rare.
In the different sub reports we present the statistics.We also present a number of cases to better illustrate what has happened, because we think it is easier to relate to and to learn from actual case histories.
We use data from the Haemovigilance System in lectures, and make presentations available on www.hemovigilans.no for others to use. Our impression is that this is useful, e.g. for our contact persons, but also for others who are teaching transfusion medicine.
From the haemovigilance reports we receive, and comparing with haemovigilance reports from other countries, we have been able to show that Octaplas® gives few transfusion reactions compared to fresh frozen plasma from single donors. From the reports we receive on donor reactions, we have shown that syncope after leaving the blood bank occur almost exclusively in female donors, and we suspect that this is related a relatively larger reduction in blood volume in females. This has led to recommendations concerning female donors, especially if they are young and have low body weight.
In establishing the Norwegian Haemovigilance System we looked to SHOT in the UK and DART in Denmark. This has proved useful, because it makes comparisons between countries easier. Common definitions are also important and taking part in the work done by IHN and the ISBT-WP on haemovigilance has been helpful.
The Norwegian Haemovigilance System has shown that establishing a national reporting and learning system can be a success and be well accepted if reports are anonymous in the sense that no donor or patient identification is reported and no identification of staff involved in events is reported. The reports are used only for understanding and learning and there is no blame.
Has the Norwegian Haemovigilance System improved safety for blood donors and blood recipients as the intention is? We cannot answer that question, but we have learned more, and we understand more, about risk factors. That in itself is important for improving safety.