Monitoring Blood Supply in Germany: A Regulatory Perspective

Abstract

Background and objectives: A sufficient supply of safe, high-quality blood components for transfusion is essential to the healthcare system in Germany. The requirements for the current reporting system are laid down in the German Transfusion Act. The present work elaborates on the advantages and limitations of the current reporting system and investigates the feasibility of a pilot project that collects specific data on blood supply based on weekly reports.

Materials and methods: Selected data on blood collection and supply from 2009 to 2021 derived from the §21 German Transfusion Act database were examined. In addition, a pilot study over a period of 12 months was conducted on a voluntary basis. The number of red blood cell (RBC) concentrates was documented and stock availability was calculated weekly.

Results: From 2009 to 2021, the annual number of RBC concentrates decreased from 4.68 to 3.43 million, the per capita distribution decreased from 58 to 41 RBC concentrates per 1,000 inhabitants. These figures did not change significantly during the COVID-19 pandemic. The data of the 1-year pilot project represented 77% of the released RBC concentrates in Germany. Percentage share of O RhD positive RBC concentrates fluctuated between 35% and 22% and for O RhD negative concentrates between 17% and 5%. The availability of O RhD positive RBC concentrate stocks varied between 2.1 and 7.6 days.

Conclusion: The data presented shows a decrease in annual RBC concentrate sales over an 11-year period and no further change over the past 2 years. A weekly monitoring of blood components detects acute problems in RBC provision and supply. Close monitoring seems helpful but should be combined with a nationwide supply strategy.

Keywords: Blood availability; Blood supply; Monitoring; Red blood cell concentrates.

Fig. 1.

Whole-blood donations from 2009 to 2021. Number of whole-blood donations (million) in Germany from 2009 to 2021 reported by blood establishments according to §21 German Transfusion Act. Numbers in parentheses indicate whole-blood donations per 1,000 inhabitants.

Fig. 2.

Distribution and expiry rates of RBC concentrate from 2009 to 2021. Distribution and expiry rates (%) of red blood cell (RBC) concentrates from 2009 to 2021 reported by the blood establishments according to § 21 German Transfusion Act. Numbers in parentheses indicate distributed RBC units per 1,000 inhabitants. Lines show percentage expiry rates at blood establishments (dark blue line) and healthcare establishments (green line).

Fig. 3.

Red blood cell (RBC) concentrates stocks and availability 2021–2022. RBC concentrates O RhD negative and O RhD positive stocks and O RhD negative stock availability reported to on a weekly basis from November 2021 to November 2022. The dark red bars show RBC concentrates with blood group O rhesus negative; the light red bars show RBC concentrates with blood group O rhesus positive; dashed squares indicate school vacation periods; dark blue solid horizontal lines indicate year; dark red horizontal line indicates lockdown period.

Fig. 4.

Stock availability RBC concentrates 0 RhD positive 2021–2022. Weekly reported RBC concentrates O RhD positive stock availability from November 2021 to November 2022 with predefined alert signal at 3 days based on experience by participating blood establishments. The red area marks stock availability of RBC concentrates with blood group O rhesus positive given in days; dashed squares indicate school vacation periods; solid blue dashed line marks the minimum availability for a sufficient blood supply situation; dark blue solid horizontal lines indicate year; dark red horizontal line indicates lockdown period.