[Evaluation of adherence to the regulations for declaration of notification of transfusion reactions with fever and chills. A study of the Association Inter-Régionale du Sud-Est d'Hémovigilance (AIRSEH)].
Febrile non-hemolytic transfusion reactions (FNHTR) are the most frequently reported acute adverse effects of blood products, and should be notified within 48 h according to the hemovigilance regulation. In order to study the conformity of these notifications and to search for factors associated with non-conformity, we retrospectively studied all FNHTR notified by voluntary centers of the AIRSEH group from 1st September 1994 to 31st December 1999. Seven hundred and sixty-one FNHTR were registered by 10 centers, most of them were benign (grade 1); 67.8% were non-conform. The non-conformity was associated with the number of biological investigations performed (median number, respectively, 4.24 and 2.94--P = 0.038--in non-conform and conform notifications--P = 0.038) in univariate analysis. Using a logistic regression model, center and severity were the only two factors significantly associated with non-conformity. Different center practices, and in particular the interface between the hospital and the blood bank, may be responsible for the effect center. Moreover, the non-conformity concerns first of all benign FNHTR. A stronger separation between alert and epidemiological surveillance is proposed in order to improve the notifications' conformity.
Renaudier
P
P
Unité d'hémovigilance, hôpital de Lyon-Croix-Rousse, 103, grande rue de la Croix-Rousse, 69317 Lyon 04, France.
Brunie
J
J
Vial
J
J
Campergue
L
L
Augey
L
L
Arnuti
B
B
Gay
V
V
Garin
L
L
Pleyber
M
M
Guinard
S
S
Benetaieb
B
B
Adeleine
P
P
Sasco
A J
AJ
D000328:Adult; D000368:Aged; D001771:Blood Banks / Q000458:organization & administration / Q000706:statistics & numerical data; D023341:Chills / Q000453:epidemiology / Q000209:etiology*; D018563:Disease Notification / Q000331:legislation & jurisprudence; D005260:Female; D005334:Fever / Q000453:epidemiology / Q000209:etiology*; D005602:France / Q000453:epidemiology; D019983:Guideline Adherence / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D065227:Transfusion Reaction