Administration Safety of Blood Products - Lessons Learned from a National Registry for Transfusion and Hemotherapy Practice.

BACKGROUND: Compared to blood component safety, the administration of blood may not be as safe as intended. The German Interdisciplinary Task Force for Clinical Hemotherapy (IAKH) specialized registry for administration errors of blood products was chosen for a detailed analysis of reports. METHODS: Voluntarily submitted critical incident reports (n = 138) from 2009 to 2013 were analyzed. RESULTS: Incidents occurred in the operation room (34.1%), in the ICU (25.2%), and in the peripheral ward (18.5%). Procedural steps with errors were administration to the patient (27.2%), indication and blood order (17.1%), patient identification (17.1%), and blood sample withdrawal and tube labeling (18.0%). Bedside testing (BST) of blood groups avoided errors in only 2.6%. Associated factors were routine work conditions (66%), communication error (36%), emergency case (26%), night or weekend team (39%), untrained personnel (19%). Recommendations addressed process and quality (n = 479) as well as structure quality (n = 314). In 189 instances, an IT solution would have helped to avoid the error. CONCLUSIONS: The administration process is prone to errors at the patient assessment for the need to transfuse and the application of blood products to patients. BST is only detecting a minority of handling errors. According to the expert recommendations for practice improvement, the potential to improve transfusion safety by a technical solution is considerable.

Coding of Tissue and Cell Preparations Using Eurocode.

Traceability of products requires their unique identification. In Germany blood products have been encoded by Eurocode since 1998. EU Directives 2004/23/EC, 2006/86/EC and 2015/565/EC demanded unique identification and safe traceability procedure also for tissues and cells. Eurocode IBLS e.V. and the German Society of Transfusion Medicine and Immunohematology (DGTI) working parties '!' within the Single European Code (SEC). Several data elements of Eurocode can be used to create the complete SEC data structure, except the tissue establishment number. This can be found on the EU Coding Platform in the internet. Consequently, existing software and labeling solutions in Eurocode format could be easily upgraded with SEC.

Coding of tissue preparations with eurocode in Germany.

SUMMARY: A safe look back of products requires their unique identification. Blood products are encoded in Germany with Eurocode since 1987. EU Directives 2004/23/EC und 2006/86/EC demanded unique identification and safe look back procedure also for tissues and cells. Eurocode IBLS e.V. and the DGTI working parties 'Tissue Preparations' and 'Automation and Data Processing' supplemented the already available Eurocode nomenclature for blood products with further data structures for tissue preparations and deliberated the federal authorities during the EU hearings. In result all EU member states can administer the coding system oneself, but have to take care about the 'key code' structure as defined and the common part at the begin of the ID number of the preparations. Eurocode today offers an EU-conform coding system considering various aspects of blood, tissue and cell preparations in an ISO-standardized form.

"Eurocode International Blood Labeling System" enables unique identification of all biological products from human origin in accordance with the European Directive 2004/23/EC.

Due to their limited availability and compatibility, biological products must be exchanged between medical institutions. In addition to a number of national systems and agreements which strive to implement a unique identification and classification of blood products, the ISBT 128 was developed in 1994, followed by the Eurocode in 1998. In contrast to other coding systems, these both make use of primary identifiers as stipulated by the document ISO/IEC 15418 of the International Organization for Standardization (ISO), and thus provide a unique international code. Due to their flexible data structures, which make use of secondary identifiers, both systems are able to integrate additional biological products and their producers. Tissue and cells also constitute a comparable risk to the recipient as that of blood products in terms of false labeling and the danger of infection. However, in contrast to blood products, the exchange of tissue and cells is much more intensively pursued at the international level. This fact is recognised by Directives 2004/23/EC and 2006/86/EC of the European Union (EU), which demand a standardized coding system for cells and tissue throughout the EU. The 2008 workshop agreement of the European Committee for Standardization (CEN) was unique identification by means of a Key Code consisting of country code corresponding to ISO 3166-1, as well as competent authority and tissue establishment. As agreed at the meeting of the Working Group on the European Coding System for Human Tissues and Cells of the Health and Consumers Directorate-General of the European Commission (DG SANCO) held on 19 May 2010 in Brussels, this Key Code could also be used with existing coding systems to provide unique identification and allow EU traceability of all materials from one donation event. Today Eurocode already uses country codes according to ISO 3166-1, and thus the proposed Key Code can be integrated into the current Eurocode data structure and does not need to be introduced separately. The Eurocode product classification for all products is based on its own unique coding system, which can be accessed over the internet by all users who are not themselves members of Eurocode. In summary, it can be said that the standardized single coding system for tissues and cells requires only unique sections in the data structure such the Key Code to fulfil the requirements of the EU Directive. Thus, various systems currently in place in different EU member states can continue to operate if the Key Code as suggested by the EU is integrated into them. The classification and description of each product characteristic is currently being discussed by the DG SANCO Working Group on the European Coding System for Human Tissues and Cells. Following intensive scrutiny in light of the stipulations laid out in EU Directives 2004/23/EC and 2006/86/EC as well as the CEN/ISSS workshop agreements, the Germany Federal Ministry for Health and organisations representing German tissue establishments under the responsibility of the German Society of Transfusion Medicine and Immunohematology, Working Party "Tissue preparations" proposed in 2009 that Eurocode be adopted for the donor identification and product coding of tissue and cells in Germany. The technical details for implementation have already been completed and are presented in the current article.

Increased arterial oxygen content by artificial haemoglobin induces a decrease in regional cerebral blood flow and decreased regional cerebral oxygen delivery.

BACKGROUND AND OBJECTIVE: Under physiological conditions, cerebral oxygen delivery is kept constant by adaptation of the regional cerebral blood flow (CBF) in relation to the oxygen content. So far, decreases of the regional CBF induced by a higher arterial oxygen content have been produced under hyperbaric or hyperviscous conditions. We tested whether local CBF is also reduced by a high haemoglobin (Hb) concentration at a normal haematocrit (Hct). METHODS: Compared with controls (n=8), Hb content was increased to 19 g dl(-1) in conscious rats by isovolaemic replacement of the plasma fraction with an artificially high Hb solution (Hb-based oxygen carriers; HH group, n=8). In another group (n=8), Hct was decreased by isovolaemic exchange with an Hb-based oxygen carrier resulting in a normal Hb content (NH group). Mean and regional CBF was measured by iodo-[(14)C]-antipyrine autoradiography. Oxygen delivery was calculated from arterial oxygen content and CBF. RESULTS: Compared with the controls (Hb 15.3 g dl(-1), Hct 0.44), mean CBF was lower in the HH (Hb 20.3 g dl(-1), Hct 0.44) group by 23% (P < or = 0.05), but remained unchanged in the NH group (Hb 15.0 g dl(-1), Hct 0.29). On a local level, hyperoxygenation reduced CBF in 22 out of 39 brain regions. In the NH group mean CBF was unchanged, whereas local CBF was higher in 10 areas. In both groups, overall cerebral oxygen delivery was unchanged compared with the control group. Locally though, high arterial Hb content decreased oxygen delivery in one-third of the brain structures. CONCLUSION: Whereas the overall cerebral oxygen delivery in the brain is maintained during hyperoxygenation and haemodilution, local oxygen delivery is decreased by high arterial Hb content in some brain regions.

Prognostic significance of tumour size in patients after tumour nephrectomy for localised renal cell carcinoma.

OBJECTIVES: Staging of the primary tumour is accepted as the most important prognostic factor in organ confined renal cell carcinoma. METHODS: The outcome of 286 patients with non-metastatic RCC treated by radical nephrectomy at our institution between 1968 and 1992 was evaluated retrospectively. The median follow-up was 114 +/- 62.6 months. In T1/T2 tumours, the validity of tumour size cut-off points for predicting survival outcome was tested. RESULTS: According to the 1997 TNM classification, 168 patients (59%) showed pathological stage T1 (72 stage T1a, 96 stage T1b), 30 (10%) showed stage T2, 84 patients (29%) demonstrated T3 tumours (53 stage T3a, 31 stage T3b), and 4 patients (2%) presented with T4 tumours. The median survival estimated by Kaplan-Meier analysis for T1a, T1b, T2, T3a, T3b and T4 tumours was over 300 months, 187.0 +/- 32.76; 177.0 +/- 1.21; 121.0 +/- 2.57; 124.0 +/- 11.82 and 52.0 +/- 18.38 months, respectively. Regarding survival in T1/T2 tumours Cox regression analysis yielded the highest significance level for a tumour size cut-off point at 4 cm (p = 0.003; 95%CI 1.511-6.991), but no prognostic value for a cut-off point at 7 cm (T1 vs. T2) (p = 0.375; 95%CI 0.655-3.071). CONCLUSIONS: Tumour size is an important prognostic factor in patients with organ confined RCC. The recently specified new cut-off point of 4 cm for T1a/T1b tumours is feasible for separating groups with different survival after tumour nephrectomy and should be considered as the new boundary between T1 and T2 stages. Hence, a more accurate prediction of prognostic differences between these groups should be possible.