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Unrelated cord blood (CB) units, already manufactured, fully tested and stored, are high-quality products for haematopoietic stem cell transplantation and cell therapies, as well as an optimal starting material for cell expansion, cell engineering or cell re-programming technologies. CB banks have been pioneers in the development and implementation of Current Good Manufacturing Practices for cell-therapy products. Sharing their technological and regulatory experience will help advance all cell therapies, CB-derived or not, particularly as they transition from autologous, individually manufactured products to stored, 'off-the shelf' treatments. Such strategies will allow broader patient access and wide product utilisation., (© 2021 British Society for Haematology and John Wiley & Sons Ltd.)

Background: The assessment of suppliers of critical goods and services to European blood establishments is a regulatory requirement proving difficult to resource. This study was to establish whether European Blood Alliance member blood services could collaborate to reduce the cost of auditing suppliers without diminishing standards., Materials and Method: Five blood services took part, each contributing a maximum of one qualified auditor per audit (rather than the usual two). Four audits were completed involving eight auditors in total to a European Blood Alliance agreed policy and process using an audit scope agreed with suppliers., Results: Audits produced a total of 22 observations, the majority relating to good manufacturing practice and highlighted deficiencies in processes, procedures and quality records including complaints' handling, product recall, equipment calibration, management of change, facilities' maintenance and monitoring and business continuity. Auditors reported that audits had been useful to their service and all audits prompted a positive response from suppliers with satisfactory corrective action plans where applicable. Audit costs totalled € 3,438 (average € 860 per audit) which is no more than equivalent traditional audits. The four audit reports have been shared amongst the five participating blood establishments and benefitted 13 recipient departments in total. Previously, 13 separate audits would have been required by the five blood services., Discussion: Collaborative supplier audit has proven an effective and efficient initiative that can reduce the resource requirements of both suppliers and individual blood service's auditing costs. Collaborative supplier audit has since been established within routine European Blood Alliance management practice.

Umbilical cord blood transplantation from HLA-identical siblings provides good results in children. These results support targeted efforts to bank family cord blood units that can be used for a sibling diagnosed with a disease which can be cured by allogeneic hematopoietic stem cell transplantation or for research that investigates the use of allogeneic or autologous cord blood cells. Over 500 patients transplanted with related cord blood units have been reported to the Eurocord registry with a 4-year overall survival of 91% for patients with non-malignant diseases and 56% for patients with malignant diseases. Main hematologic indications in children are leukemia, hemoglobinopathies or inherited hematologic, immunological or metabolic disorders. However, family-directed cord blood banking is not widely promoted; many cord blood units used in sibling transplantation have been obtained from private banks that do not meet the necessary criteria required to store these units. Marketing by private banks who predominantly store autologous cord blood units has created public confusion. There are very few current validated indications for autologous storage but some new indications might appear in the future. Little effort is devoted to provide unbiased information and to educate the public as to the distinction between the different types of banking, economic models and standards involved in such programs. In order to provide a better service for families in need, directed-family cord blood banking activities should be encouraged and closely monitored with common standards, and better information on current and future indications should be made available.

Background: Previous studies have shown that countries with a low or medium Human Development Index (HDI) transfuse far fewer blood products than countries with a high HDI. HDI comprises both economical and non-economical elements. We considered the hypothesis that non-economical, cultural differences may be additional factors in understanding blood donation and blood supply differences., Methods: We quantified the explained variance, r(2), in: the number of donors, the number of whole blood collections and the number of red blood cell units supplied to hospitals for 25 European countries. Candidate predictors were Hofstede's cultural dimensions, the demographic factor Old Age Dependency Ratio and the three components of HDI: Gross National Income, Life Expectancy and the Educational Development Index., Results: The cultural dimension Power Distance was the best sole predictor of whole blood collection (r(2) = 56.8%) and the number of donors (r(2) = 25.1%). The Educational Development Index best predicted the number of red blood cell units (r(2) = 45.0%). Multivariable models including the cultural dimension Power Distance and the Educational Development Index gave the best results in predicting the number of whole blood collections and red blood cell units supplied and, to a lesser extent, the number of donors, with adjusted r(2) values of 63.6%, 51.9% and 28.6%, respectively. In contrast, Gross National Income made no significant predictive contribution to any of the multivariable models. Neither did the other cultural dimensions, Life Expectancy or Old Age Dependency Ratio., Conclusion: The effects of education level and cultural aspects should be taken into account as influencers on donation behaviour. The concept of power distance, in particular, presents a challenge to blood donor managers in cross-cultural and multi-cultural donor management contexts.

Summary: Along with the increasing expenses of the blood system, enhancing efficiency is a necessary task at blood establishments. Labour is the primary expense and is the most likely area for efficiency improvements. The aim of this study was to evaluate and compare the relative efficiency of component production departments from the perspective of labour and cost. The data set was from 13 European blood centres and blood banks for 3 years and was analysed using data envelopment analysis (DEA). Working hours, estimated total costs, produced red blood cells and produced platelets were used in DEA modelling. Comparative analyses included an empirical cost model, in which the costs of working hours were adjusted with purchasing power parities to equalize the costs between countries. Estimated total costs were used to determine the savings potential of production, the unit cost and the economic value of discarded components (waste cost). Results showed a wide variation in labour efficiency (25-100%), in unit cost (fraction of labour costs in component production department) and in cost efficiency (13-100%). Savings potential both in labour and in costs was more than 50% in six departments in all study years. Median waste cost was 9.4% of estimated total costs in the four largest departments and 6.6% in the other departments. Thus, size of department was not a measure of its efficiency. Simple empirical analyses are applicable in efficiency comparisons and can encourage blood establishments to improve their resource management.

Leukoreduction, filtering white blood cells from transfusion blood, effectively avoids leukocyte-related complications of blood transfusion. The technology has proven its relative cost-effectiveness for specific patient populations. With the advent of variant Creutzfeldt-Jakob disease, a transmittable spongiform encephalopathy caused by mad cow disease (bovine spongiform encephalopathy), the hard hit United Kingdom introduced universal leukoreduction for all patients as a precaution for transmission of prions in 1999. This costly policy was followed by many other countries, in the absence of much evidence of an actual health problem or of a more than presumed effectiveness of leukoreduction in preventing prion transmission. The core problem proved to be legal. The blood banks are legally accountable for blood safety. This accountability is absolute, based on avoidance of all possible risks, regardless of costs. This strategy leads to inefficiencies in health care: (i) blood safety management is guided by available rather than cost-effective technology, and (ii) private insurance premiums for civil liability are sharply increasing, while they are in no way related to the expected returns and the high and increasing blood safety. A rational safety policy is to be optimal, taking into account costs and effects of the safety procedures. This issue will need an open discussion with the general public of the real risks and a clear and unambiguous definition of proportionality in the precautionary principle, based on the European law.

Manufacturers of blood products have to maintain the highest possible standards for plasma screening and good manufacturing practices to ensure maximum purity and viral safety. The private sector companies have much experience in implementing and complying with national and international regulations. These requirements involve considerable cost in the areas of (1) plasma collection facilities, (2) research and clinical research, (3) manufacture, and (4) quality control. Total self-sufficiency would mean the loss of many existing resources. An alternative would be a collaboration between the public and private sectors to meet the needs of all patients who require plasma derived products. The current definition of self-sufficiency suggests that it is not financially viable.

The European Association of the Plasma Products Industry represents the private sector member companies that manufacture and provide plasma products throughout Europe. EAPPI believes that the most important aspect of self-sufficiency is a sufficient supply of safe and efficacious product; the question of paid or unpaid donations is of lower importance. To achieve a supply of high quality plasma, EAPPI considers it is necessary to harmonize standards throughout Europe, and suggests a five-point programme towards improving public confidence in the available plasma products.