Blood collection failures from a blood establishment perspective.

OBJECTIVES: The objective of this study was to show experience of the Croatian Institute of Transfusion Medicine in monitoring and analysing collection failures caused by the venepuncture technique or occurred as a result of adverse reactions and complications experienced by donors during donation. BACKGROUND: Collection failures represent one of the leading nonconformities in blood establishments. Apart from being a negative motivating factor for blood donors, they also affect the blood components supply and have a negative financial impact. METHODS: Nonconformity records referring to collection failures were analysed retrospectively over a 6-year period (2013-2018) with regard to their frequency, causes, donor characteristics (age, gender, number of donations), place of occurrence (blood establishment, mobile sessions) and trends during the analysed period. RESULTS: A total of 5166 collection failures out of 618 251 donations (0.84%) were recorded during the analysed period. The leading cause was haematoma at puncture site (1676, i.e., 32.4%). Collection failures which are primarily attributed to the venepuncture technique or vein selection accounted for 91% of all cases, whereas collection failures which occurred as a result of discontinued punctures due to adverse reactions in donors accounted for 9% of all cases. A much higher frequency of all collection failure types was recorded in female donors, whereas younger donors experienced adverse reactions more frequently (median age of 24). CONCLUSION: The analysis and monitoring frequency of collection failures play an important role in planning of staff training activities, work organisation and timely implementation of corrective actions.

Product recall: a Croatian experience (2000-2010).

BACKGROUND: Timely and efficient recall of products known or suspected to be non-conforming is an important measure in the prevention of adverse events and in patients' safety. Product recall in the transfusion service is regulated by professional standards and legal acts, but publications presenting results related to the implementation of these procedures are quite rare. MATERIALS AND METHODS: Data from the Croatian Institute of Transfusion Medicine (CITM) on the procedures of product recall during an 11-year period (2000-2010) were retrospectively analyzed. Reasons for product recall, their frequency, level of severity and efficiency of the procedures are presented and discussed. RESULTS: During the study period, there were 245 procedures of product recall, for an average of 22 (18-29) procedures/year, all of low extent (1-25 products). Recall was required for 1/3,571 blood products issued, while the frequency of laboratory test report recalls was 1/5,447 patients. The leading reasons for product recall were suspected bacterial contamination of blood products (30.2%) and suspected or demonstrated non-conformity of laboratory test reports (28.6%). In total, 99 (40.4%) product recalls were categorized as class I, 30 (12.2%) as class II and 116 (47.3%) as class III. DISCUSSION: According to the available literature data, the product recall procedures were performed quite infrequently by the CITM and were of low extent. There was a remarkable decreasing trend in the rate of product recall due to non-conformities or errors made at the CITM, along with a constant or increasing rate of recalls because of biological variability of blood products.