Monitoring Blood Supply in Germany: A Regulatory Perspective

Blood components for transfusion are essential medicinal products. An adequate and enduring nationwide stock is of critical importance to the healthcare system in Germany. Therefore, a well-functioning blood supply recording system appears necessary to initiate appropriate measures, for the maintenance a safe and adequate supply of blood and blood products. Specifications for quality assurance and the supply of blood components have been laid down in the German Transfusion Act (TFG) [1], as well as in the quality and medical standards of the Hemotherapy Guidelines of the German Medical Association [2]. Blood establishments (BEs) in Germany are required by law to report annually (§21 TFG) on the collection, manufacturing, distribution, and use of blood components.

During the SARS epidemic from 2002 to 2003 cities severely affected by the virus experienced a dramatic decrease in blood donations by 90%. Multiple countermeasures had to be pursued to sustain blood supply. Hospitals around the world had to postpone elective surgeries to decrease the demand for blood units. However, fluctuations and limitations in the availability of blood components do not only occur in crisis situations, such as the recent COVID-19 pandemic, but are also observed every year regionally, and seasonally, e.g., during the summer months and holidays. Therefore, additional regulatory measures are needed to manage future supply shortages in blood supply. This work examines the benefits and limitations of the current reporting system and explores, based on a pilot project, the feasibility of a weekly reporting system to obtain real-time data on the current blood supply situation.

BEs are required to submit annual data to the Paul-Ehrlich-Institute (PEI) on the blood and blood components supply situation in accordance with §21 of the TFG [1]. BEs report on the number of blood units and components collected, as well as the number of blood units and components produced, expired, marketed, imported, and exported cellular blood and plasma units. In this analysis, we examined the number of donations as well as the production and expiry of red blood cell (RBC) concentrates over the last 13 years. Per capita production was defined by the number of blood donations per 1,000 inhabitants and per capita distribution was defined by the number of blood components distributed per 1,000 inhabitants.

From November 2021 to November 2022, we collected data weekly via an online database on manufactured blood components as well as RBC concentrate stock. During this observation period, BEs reported their RBC concentrate stocks of all blood groups as well as the predicted reach of their blood components stock with respect to clinical supply in days. For the evaluation, the percentage of O Rhesus negative RBC concentrate (RBC O RhD negative) and O Rhesus positive (RBC O RhD positive) in the total RBC concentrate stock was calculated. The stock availability data are given in relation to O RhD positive RBC concentrates. A sufficient supply situation was defined as a reserve of RBC concentrates for three or more days. The three-day-supply was calculated from the number of RBCs based on the documented consumption from the previous year.

Around 60% of blood donations in Germany are whole-blood donations. In addition, RBC concentrates account for the largest share of blood components for transfusion, with a share of about 73%. Whole-blood donations and the number of available RBC concentrates are thus a suitable estimate of the overall blood supply situation.

Figure 1 shows the number of whole-blood donations over the past 13 years. With a total of 4,927,122 donations, BEs reported the largest number of whole-blood donations in the entire survey period in 2011. Since then, the number of whole-blood donations has decreased by 25% to 3,702,715 in 2021. Whole-blood donations fell from 61 in 2011 to 44 per 1,000 inhabitants in 2021. In 2021, for the first time in 11 years, the number of whole-blood donations actually increased slightly by around 31,000 donations compared to the previous year (Fig. 1).

In Germany, RBC concentrates are almost completely manufactured from whole-blood donations. Thus, the development of produced and distributed RBC concentrates corresponds to the number of whole-blood donations. The number of RBC concentrates distributed per year decreased from 4.68 million in 2011 to 3.42 million in 2021. As with whole-blood donations, RBC concentrates production declined by 26.3% between 2011 and 2020. In the last 2 years of the COVID-19 pandemic, 2020 and 2021, the number of produced and distributed RBC concentrates remained constant. The number of distributed RBC concentrates decreased from 58 in 2011 to 41 per 1,000 inhabitants in 2021 (Fig. 2).

Each year, an average of 2.7% of the produced RBC concentrates expires at BEs, corresponding to around 111,000 units (2009–2021). Between 2009 and 2019, expiration increased from 1.4 to 3.6 per 100 RBC concentrates manufactured. Over the last 2 years of the COVID-19 pandemic, the expiry rate fell to 2.8% in 2020 and 2.4% in 2021 (Fig. 2). The same trend was observed in the discard at healthcare establishments. The expiry rate increased from 3.3% in 2009 to 4.2% in 2019 and then declined to 3.7% in 2021. However, due to incomplete or missing reports, an underreporting must be assumed.

In this project, participating BEs represent approximately 77% of blood donation and blood supply in Germany. During the observed 1-year period from November 2011 to November 2022, relevant variations appeared in the proportion of RBC concentrates of different blood groups. Relative to the total of all RBC concentrates, the percentage share of O RhD positive RBC concentrates fluctuated between 35% and 22% and for O RhD negative RBC concentrates between 17% and 5% (Fig. 3). The availability of O RhD positive RBC concentrates was highest in December 2021 at 7.5 days, while it was at a low of 2.1 days in May 2022 (Fig. 4).

The mean stock availability of RBC concentrates blood group 0 RhD positive below the limit of 3 days were documented in the calendar weeks 45–49 (December 2021) and calendar weeks 21–25 (May 2022). During this period, stock availability at individual BEs was even less than 2 days, leading to short-term corrective measures such as increasing blood donations and postponing elective surgical procedures at affected hospitals.

The promotion of a self-sufficient in blood and plasma stock enabling the secure and safe supply of blood products based on voluntary and non-remunerated blood donation is a goal that has been legally outlined in both Germany §1 TFG [1] and the European Union according to Directive 2002/98/EC [3]. Monitoring the supply situation with blood and blood components is essential to counteract any impending supply bottlenecks. In order to investigate the challenges posed by the pandemic regarding the blood supply situation in Germany in particular, a specific assessment of data derived from the annual database was performed.

Since 2000, the PEI has received reliable data from an annual survey conducted in accordance with §21 TFG. These data provide a good basis for assessing the performance of the German blood donation system and for identifying long-term trends in the supply of blood and blood components.

Within the past 10 years, a steady decline in whole-blood donations and thus in the number of produced RBC concentrates have been observed (Fig. 1, 1, 2). One important reason for the decline could be a reduced demand for RBC concentrates in healthcare facilities as result of the introduction of patient blood management (PBM) interventions. Although controversial [4], the stabilization of production and consumption figures may indicate that the PBM’s resource-saving measures have been largely exhausted.

During an 11-year period (2009–2019), the expiry rate of RBC concentrates increased and then decreased significantly the last 2 years (Fig. 2). Whether the loss rate could be reduced further cannot be answered on the basis of these data. This would require the implementation of a data collection system that records the exact consumption of blood components in healthcare facilities. Since, to date, the manufacturing and distribution data of BEs are only collected on an annual basis, a pilot project has been established to generate an overview of the current status quo of the blood supply situation, focusing on the availability of RBC concentrates.

Regularly occurring seasonal blood shortages led to the consideration of establishing a monitoring system with short-term notification intervals, as in other countries, to support BEs in managing current blood supply [5, 6]. The necessity to have an up-to-date overview has intensified during the pandemic. Consequently, the PEI, together with BE partners, established a pilot database in 2021 to collect data on RBC concentrates stock and availability on a weekly basis. O RhD positive RBC concentrates were chosen as a key indicator for the supply situation, as this blood group is considered most critical in clinical practice. This pilot monitoring was conducted over a 1-year period and allows first conclusions on the actual blood supply situation including seasonal fluctuations in Germany. For example, in May 2022, participating BEs reported a significant RBC concentrate supply shortage, as demonstrated in Figure 4. The reason for this shortage was probably several holidays in May and the 2 weeks of school vacation around the Pentecost. In contrast, no shortages were noted during the 2021 Christmas vacation, due in part to a decrease in elective surgical procedures at several hospitals.

At that time, the availability at O RhD positive RBC concentrates dropped below an alert signal, which was predefined as 3 days based on the experience of participating BEs. These data also demonstrated that this situation could be resolved.

However, it can be assumed that in the future these temporary measures will not be sufficient to ensure a comprehensive supply of blood components. The expected influence of demographic change on the development of regional blood donations has already been studied. Schönborn et al. [7] investigated the characteristics of transfusion recipients in all hospitals in the state of Mecklenburg-Vorpommern in a 10-year longitudinal study. Eichler et al. [8] analyzed retrospective data on the current and future supply of RBC concentrates in the federal state of Saarland in order to assess the current and future RBC requirements in the hospitals concerned. Both studies conclude that due to the major demographic changes an increased risk of blood shortages has to be expected. Therefore, among other measures, a nationwide monitoring system of RBC transfusions should be established to obtain realistic data for planning of the future blood supply.

The data from our pilot study support this requirement. Long-term as well as short-term blood supply monitoring systems both produces valuable information. It becomes clear that, especially in seasonal and emergency situations, a current overview of blood availability is essential to introduce any appropriate measures. However, in order to be able to use these data in a meaningful way, a national supply strategy must also be developed.

The need for a blood contingency and preparedness plan including an early warning system is being proposed on European level. In the blood contingency and preparedness plan, it is recommended that member states monitor the blood supply and regularly evaluate it on a national level by introduction of appropriate mechanisms [9].

Until now, there has only been a regional approach established to adequately respond to seasonal shortages and emergencies in Germany. Compared to the reporting system prescribed by law in Germany, which requires reporting once a year, it was demonstrated that the weekly monitoring of blood components allows the early detection of acute problems in their provision and supply.

However, in order to balance expenditure and outcome, automated reporting systems and further resources based on legal provisions would be needed. A collaboration of all concerned parties is necessary to introduce an efficient blood contingency and emergency plan for Germany.

We would like to thank all participating BEs for their professional cooperation. We are grateful to Mrs Lucinda Pike for her active support.

All applicable data protection rules were respected. No patient samples were used. This study complies with the principles of the Declaration of Helsinki.

The authors have no conflicts of interest to declare.

None.

Sarah Anna Fiedler, Olaf Henseler, Marcus Hoffelner, Manfred Doll, Gabriele Hutschenreuter, Jochen Hoch, Franz Weinauer, Andreas Humpe, Anneliese Hilger, and Markus Funk developed the concept, collected and analyzed the data; all authors wrote the manuscript and have approved the final version of the manuscript. All authors have reviewed and approved the submitted version of the manuscript, the manuscript has neither been published nor is it under consideration for publication elsewhere.

All data generated or analyzed during this study are included in this article. Further inquiries can be directed to the corresponding author.