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.

Management of complaints in blood establishments: thirteen years of experience at the Croatian Institute of Transfusion Medicine.

BACKGROUND: The aim of the study is to present the results and experience in the management of complaints in a transfusion service in order to draw attention to the importance of this segment of quality management and to stimulate publication of other studies on the topic. MATERIALS AND METHODS: This study is based on data from the Croatian Institute of Transfusion Medicine obtained by analysis of complaints recorded during a 13-year period (1998-2010). The distribution of the types and frequencies of complaints is presented, along with the level of their justifiability and criticality. The dynamics of the complaints is analysed overall and within particular categories. In addition, corrective actions and other factors that may have influenced the trends observed are discussed. RESULTS: During the study period, 817 complaints were received, most of which (40.9%) referred to the positive direct antiglobulin test in red cell concentrates, followed by blood product issuing and distribution (12.9%) and blood product quality (9.4%). Of the 817 complaints, 177 (21.7%) were assessed as serious and 645 (78.9%) as justified based on the testing performed. CONCLUSION: Data collected by systematic recording and analysis of complaints provide a basis for problem identification, implementation of corrective and preventive actions, and improvement of product and service quality, and, thereby, customer satisfaction.

Error management in blood establishments: results of eight years of experience (2003-2010) at the Croatian Institute of Transfusion Medicine.

BACKGROUND: Continuous and efficient error management, including procedures from error detection to their resolution and prevention, is an important part of quality management in blood establishments. At the Croatian Institute of Transfusion Medicine (CITM), error management has been systematically performed since 2003. MATERIALS AND METHODS: Data derived from error management at the CITM during an 8-year period (2003-2010) formed the basis of this study. Throughout the study period, errors were reported to the Department of Quality Assurance. In addition to surveys and the necessary corrective activities, errors were analysed and classified according to the Medical Event Reporting System for Transfusion Medicine (MERS-TM). RESULTS: During the study period, a total of 2,068 errors were recorded, including 1,778 (86.0%) in blood bank activities and 290 (14.0%) in blood transfusion services. As many as 1,744 (84.3%) errors were detected before issue of the product or service. Among the 324 errors identified upon release from the CITM, 163 (50.3%) errors were detected by customers and reported as complaints. In only five cases was an error detected after blood product transfusion however without any harmful consequences for the patients. All errors were, therefore, evaluated as "near miss" and "no harm" events. Fifty-two (2.5%) errors were evaluated as high-risk events. With regards to blood bank activities, the highest proportion of errors occurred in the processes of labelling (27.1%) and blood collection (23.7%). With regards to blood transfusion services, errors related to blood product issuing prevailed (24.5%). CONCLUSION: This study shows that comprehensive management of errors, including near miss errors, can generate data on the functioning of transfusion services, which is a precondition for implementation of efficient corrective and preventive actions that will ensure further improvement of the quality and safety of transfusion treatment.