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About this publication
This is the fourth annual haemovigilance report from Norway. Since 2007 Haemovigilance Norway has been run by the Norwegian Knowledge Center for the Health Services on behalf of the Norwegian Directorate of Health.
The Norwegian Haemovigilance system collects reports on adverse events in blood donors, adverse transfusion reactions and incorrect blood component transfused
(IBCT), as well as near misses. Reporting is done electronically on www.hemovigilans.no and participation in the haemovigilance scheme is about 95%.
Since January 2007, reporting of serious adverse events related to blood donation and blood transfusion has been mandatory. According to the EU directive only serious reactions in patients and blood donors, and serious near misses should be reported. However, blood banks in Norway are encouraged to report all transfusion reactions, but only the serious blood donor reactions. All episodes of incorrect blood transfused are reported regardless of consequences. Near misses have been reported since 2007.
The Norwegian haemovigilance scheme is anonymous as neither the blood donors nor the patients are identified. For practical reasons the reporting person is identified to make it possible to obtain additional information about a reported case if necessary.
The haemovigilance task group has arranged annual haemovigilance seminars for blood bank staff and other health personnel involved in transfusions, given lectures and in other ways participated in teaching. Some of our recommendations are now included in the national guidelines in transfusion medicine.
We hereby present an English summary of the Norwegian Haemovigilance report for 2007.
In 2007 Norway was self sufficient in blood components for transfusion. A total of 191 000 units of red cell concentrates, 19 000 adult doses of platelets and 40 000 units of Octaplas were transfused. There were 200 000 whole blood donations and 15 000 aphaeresis donations.
460 adverse events related to blood transfusions were reported (184 per 100 000 transfusions). This is a 27 % increase in the number of reports compared to 2006. The incidence of serious transfusion reactions, i.e. life threatening reactions, reactions with long time morbidity (more than one month) or deaths caused by blood transfusion is 4.8 per 100 000 transfusions.
Febrile non haemolytic transfusion reactions (FNHTR) are the most frequently reported reactions, 44 % of all reports (81 per 100 000 transfusions). Allergic reactions are the second most frequently reported reactions, 20 % of all reports (38 per 100 000 transfusions). Patients receiving platelet concentrates have the highest risk for FNHTR and allergic reactions.
Incorrect blood component transfused (IBCT)
IBCT is defined as blood components transfused to the wrong patient or blood components transfused even if they did not fulfill expected requirements. A total of 17 reports were received, 6.4 per 100 000 transfusions. In ten cases the blood component did not fulfill the expected requirements, while in six cases the blood component was transfused to the wrong patient. In one case a patient was transfused based on another patient’s haemoglobin value. In three cases the transfused blood unit was ABO incompatible. In one of these cases the patient had a serious haemolytic transfusion reaction, but fortunately recovered.
Five patients received non-irradiated blood, despite indication for irradiation.
Transfusion transmitted infections
Three cases of transfusion transmitted infections (TTI) were reported, one possible bacterial transmission, one possible case of CMV transmission and one confirmed case of chickenpox transmission.
Other serious transfusion reactions
Thirteen cases not mentioned above were reported as serious reactions. There were three cases of anaphylactic reaction, one case of serious FNHTR, three cases of TACO, three cases of lung edema, one case of serious vasovagal reaction related to plasma exchange, and two cases of transfusion related dyspnoea.
Recommendations on transfusion reactions
The most important recommendations given are:
1. Implementation of electronic systems for bedside patient identification.
2. Two blood samples from the patients, taken at different times, are required before an ABO identical blood transfusion can be given. Otherwise the patients should be transfused with group O blood.
3. Improve training of the staff involved in blood transfusions, with particular focus on the bedside control routines before transfusion.
4. Avoid satellite blood fridges at the hospital departments.
5. Implementation of automated ABO and RhD typing and screening for blood group antibodies, with on-line transfer of data to the blood bank software system.
ADVERSE EVENTS IN BLOOD DONORS
The Norwegian haemovigilance system received a total of 195 reports on serious adverse events related to blood donation (90.6 per 100 000 blood donations). Women seem to have about three times higher risk for serious complications than men. Vasovagal reactions are the commonest serious complication of blood donation. Complications are more frequent among younger donors and first time donors.
In 2007 we received 65 reports on syncope without an injury (32 per 100 000 blood donations) and nine reports on syncope followed by injury of the blood donor, who in all the nine cases were females. Based on our haemovigilance data, female donors have a 2.3 times higher risk for fainting than male donors. This may be due to lower blood volume in women compared to men. First time donors have almost eight times higher risk of fainting than regular blood donors. In 14 % of the reported cases of syncope the episode occurred after the blood donor had left the blood bank, in many cases several hours after blood donation. The haemovigilance working group has developed an additional form to look at possible risk factors for fainting outside the blood bank.
In 2007 only serious citrate reactions were reported. Seven reports were received
(47 per 100 000 donations), all of them occurring during platelet aphaeresis.
Serious adverse reactions in blood donors
A total of 42 reports on serious reactions in blood donors were received. (19.5 per 100 000 donations). Serious reactions are defined as: Fatal reactions, life threatening reactions, reactions which lead to disability, sick leave or hospitalization, long time morbidity (more than one week), syncopal or serious vasovagal reactions or reactions which lead to consultation of another medical doctor than the blood bank doctor.
Recommendations on blood donor adverse reactions
1. Adequate compression of the venipuncture site after blood donation.
2. Stop the donation immediately if the insertion of the needle is painful.
3. The donors should be recommended not to perform hard physical activities and avoiding situations where syncope may lead to dangerous consequences for the blood donor or others.
4. Blood donors with history of two moderate or serious vasovagal episodes should be permanently deferred.
5. Give extra attention to first time donors.
6. Ask donors to report all adverse reactions to their blood bank.
7. Vasovagal reactions may be reduced by simple measures such as resting after donation for at least ten minutes and drinking water before or during donation.
In 2007 near misses were reported to the haemovigilance system for the first time. We only got 57 reports. The low number of reports is possibly due to inexperience in reporting near misses. The complexity of the classification in the form we used may also be of importance. Approximately 50 % of the blood banks did not report any near miss.
In summary, the reported near misses were classified as: Positive infection test at time of donation (2 reports), important information from the donor history not elicited during the donor interview (15 reports), the blood donor was accepted after incorrect decision by the interviewer, (4 cases), the donor revealed information after the donation session which led to recall of the blood products from that donation (3 reports), technical errors (9 reports), errors in the laboratory results (12 reports), incorrect transport of the blood products (3 reports), wrong labelling of blood samples or blood products (5 reports) and “other”(4 reports).