56. Jahrestagung der Deutschen Gesellschaft für Transfusionsmedizin und Immunhämatologie

Prof. Dr.

Vorsitz

Dipl.-Ing.

State of Automation and Data Processing at the 56th annual meeting of the DGTI in Berlin 2023

Background The state of automation and data processing for transfusion medical facilities in connection with patient care clinics will be presented at the 56th Annual Congress of the DGTI in Berlin. New practical solutions are used to show examples of GAMP5 validations and GMP Guide Annex 15 for routine qualification for hospitals, transfusion facilities and medical facilities on the new Internet website in the DGTI members' area.addition. Methods The state of automation and data processing techniques will be discussed for selected topics. With the involvement of external speakers, institutions, authorities, solution examples for the implementation of GAMP5 and GMP Guide in the routine for hospitals, transfusion facilities, and medical facilities are to be recorded, taking into account legally binding guidelines. In order to implement the specifications for the validation of methods, the qualification of devices according to GMP Guide Annex 15, and for risk-assessing decisions according to GAMP, the following topics should be presented in the automation and data processing session. Results These sample qualifications and validations are to be published from last year on the previous DGTI platform. The results are to be made available on the new DGTI website with results for sample qualifications and validations. Both the main topics presented in the meeting of the Automation and Data Processing section at the digital DGTI Congress in Vienna in 2021 and the topics presented in Berlin 2023 should be made available on the digital platform in the members' area. The following topics were presented at the digital DGTI Congress in Mannheim in 2022. Status of digital patient file, electronic entry of organ donation in the register Critical IT infrastructure for blood donation services (KRITIS) - Environment of digitization IT sector Conclusion For the automation and data processing meeting at the 56th annual meeting of the DGTI in Berlin, stipulations on the setting of qualification and validation solutions on the DGTI website are to be adopted for rapid implementation. For this purpose, the new DGTI website should be approved by the board for the section work.Offenlegung Interessenkonflikt: keine

AI, Automation and Digitalization

ePoster

ReMeDi:Blut - A future registry for medical data and antigenic properties of blood products

Background Currently, packed red blood cells are allocated according to relatively few patient-specific criteria - the AB0 blood group, rhesus type, and, in some instances, the Kell blood group system. Effective hemotherapeutic treatment with few side effects requires the selection of the most suitable blood product for each recipient. To date, there is no registry in Germany that systematically compiles clinical data on administered blood transfusions.Methods ReMeDi:Blut ("Registry for medical data and antigenic properties of blood products") aims to initiate a national registry for the centralized collection of data on transfusions performed in Germany. Using an evidence-based approach and artificial intelligence (AI)-driven assessment, the properties of blood products and clinical data of recipients will be accessed and connected to the central register via local bridgeheads at each participating treatment site.Results ReMeDi:Blut is intended to be a research registry with freely accessible interfaces for various hospitals to participate in. In the future, the acquired data may be used to gain important insights through AI-driven operations. This process could make more specific properties of blood products available, avoid incompatibilities and identify rare donors through big data. A more precise characterization of blood products, including molecular genetic blood typing, e.g. based on real-time PCR or next-generation sequencing (NGS), may allow for significantly more blood group antigens to be considered in the selection process of blood products. Overall, ReMeDi:Blut may help prevent the overuse, underuse and misapplication of blood products.Conclusion By implementing a national registry for the collection of data on transfusions performed in Germany, ReMeDi:Blut could make healthcare provision more efficient by distributing transfusions in a more targeted fashion. This could avoid the unnecessary administration of blood products and enable a comprehensive, AI-driven analysis of the factors that influence clinical outcomes.Offenlegung Interessenkonflikt: The authors declare no conflict of interest. Funding: This project is funded by the German Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung, BMBF) as part of the funding initiative 'Medical Technology Solutions for Digital Healthcare' ('Medizintechnische Lösungen für eine digitale Gesundheitsversorgung'), field of action 'Gesundheitswirtschaft im Rahmenprogramm Gesundheitsforschung' (reference number/ Förderkennzeichen 13GW0620A). Figure 1: Diagram showing the general ReMeDi:Blut project design. Detailed information regarding each blood transfusion will be transmitted from local sites to a central registry, where they will undergo an AI-based assessment to analyze antigenic properties and clinical data, improving the selection of the most suitable blood product for each recipient.

Introducing the AutoPiLoT Monitor 2.0: A real-time dashboard for efficient blood bank inventory management

Background In times of declining blood donation numbers, blood banks must manage labile blood products like red blood cell concentrates (RBC), platelet concentrates (PC), and fresh frozen plasma (FFP) efficiently to strike a balance between wastage and product shortages. Current software solutions, however, mostly offer manual inventory queries.Methods The AutoPiLoT Monitor is a web-based tool that provides historical and real-time data on blood product inventory. It uses a RESTful FHIR API interface to communicate with a FHIR-server which integrates various hospital information systems. The previous version served primarily as a reference point for physicians to gauge blood product inventory, but was constrained by computer-only accessibility. The AutoPiLoT Monitor 2.0 has undergone significant improvements, including the development of a new overview page. This page is continuously displayed on a large screen in the distribution area of the Institute for Transfusion Medicine at the University Hospital Essen, ensuring round-the-clock availability to all blood bank staff.Results The new overview page shows the number of RBCs in stock, segregated by crossmatch status and further subdivided by AB0 and Rhesus groups. Additionally, the explicit display of RBCs that will expire within the next three days facilitates timely utilization. Stock levels of pooled and apheresis PCs and the number of units approaching their expiration dates are visualized. Moreover, the dashboard displays PC consumption during the past week and integrates a machine-learning model to forecast PC consumption for the next seven days. Current FFP in stock and past FFP consumption, both itemized by AB0 type, are also pictured. Lastly, the dashboard refreshes every minute, ensuring that the displayed information remains up-to-date and reliable.Conclusion The updated AutoPiLoT Monitor 2.0 provides a comprehensive and user-friendly overview of blood product inventory. It delivers real-time updates and insights into past consumption, current and future stock levels as well as predicted platelet demand. Consequently, the AutoPiLoT Monitor 2.0 enables proactive decision-making to promote optimal resource utilization and waste reduction, ensuring the availability of vital blood products.Offenlegung Interessenkonflikt: The authors declare no conflict of interest. Funding: The AutoPiLoT (Automatisierte leitlinienkonforme Patientenindividuelle Blutproduktezuordnung und smartes Logistikmanagement in der Transfusionsmedizin) project was funded by the Federal Ministry of Health (Bundesministerium für Gesundheit, BMG; Förderkennzeichen: 2519DAT713). Figure 1: The AutoPiLoT Monitor 2.0 overview page displayed at the Institute for Transfusion Medicine of the University Hospital Essen, providing real-time updates and comprehensive oversight of blood product inventory.

Analyzing the protein content in human milk for the effects of different pasteurization methods

Background In the setup of human milk banking, donated human milk (HM) is frequently pasteurized to reduce potential pathogens and to ensure the safety of premature infants. However, it is known that heat treatment can affect the protein composition of HM. In this work, alterations of selected whey proteins were investigated after the application of three different pasteurization approaches.Methods Breast milk samples (n = 15) were Holder-pasteurized (62.5 ± 0.5 °C for 30 min) using either water bath (WB-HoP) or dry temperature (DT-HoP) treatment or were sujected to High Temperature Short Time Treatment (HTST; 62 °C for 5 sec). To enable protein analysis, samples were pretreated by filtration and centrifugation. In the resulting whey, secretory immunoglobulin A (sIgA) and lactoferrin (LF) concentrations were determined by commercially available enzyme-linked immunosorbent assays before and after heat treatment. Alkaline phosphatase activity (ALP) was measured via enzyme activity assay (BioVision, Milpitas, CA, USA).Results Both HoP methods resulted in almost a complete decrease of ALP activity (WB-HoP = 0.3 ± 0.4 %, DT-HoP = 0.5 ± 0.4 %), whereas after HTST 52.8 ± 12.2 % was retained (all p &lt; 0.001). The sIgA retention was significantly higher after WB-HoP (73.2 ± 13.5%) and after HTST (80.4 ± 22.7 %) than after DT-HoP (57.0 ± 14.4%, all p &lt; 0.01). In terms of retention of LF, the two HoP methods did not differ significantly (WB-HoP = 47.0 ± 40.0 % vs. DT-HoP = 25.0 ± 9.7 %). Compared to both HoP methods, HTST showed significantly higher retentions of LF (69.9 ± 41.8 %, all p &lt; 0.01).Conclusion Holder pasteurization by dry tempering (DT-HoP) seems to have a stronger impact on the quality of human milk than the other two approaches (WB-HoP, HTST). In terms of the protein retention, HTST seems to be a good alternative to the current gold standard HoP.Offenlegung Interessenkonflikt: No conflicts of interests.

Biobanking and Tissue Banking

Application of Far-UVC for disinfection of corneal tissue

Background The two main criteria limiting the use of cornea as a transplant are the endothelial cell density, and the requirement for the absence of microorganisms. Resistance to the antibiotics within culturing media limit the microbiological safety of corneal transplants. We aimed to test a new disinfection method using Far-UVC radiation showing a low penetration depth into the cell resulting in killing bacteria (given their small size) while leaving human cells intact.Methods Porcine and human corneas were irradiated with far UVC for bacterial decontamination using a krypton-chloride excimer lamp emitting 222 nm. Corneas were irradiated half-sided for 15 and 60 seconds at 1 mW/cm² , in order to adjust for an irradiation intensity not influencing the integrity of corneal endothelial cells. ANOVA was used for statistical analysis.Results Application of up to 60 mJ/cm² did not influence the integrity of corneal endothelial cells. Conclusion In the next step we are objecting corneal tissue to microbial contamination followed by irradiation at 222nm for 60 seconds aiming at decontaminating the corneas.Offenlegung Interessenkonflikt: No conflicts of interest

Prim. Univ.-Doz. Dr.

Provision of allogeneic bone grafts for orthopaedic surgery: A post pandemic update

Background Bone allografts have been used for surgical treatment of large bone defects, especially in endoprothesis replacement and spinal surgery. From patients undergoing primary total hip arthroplasty (THA), their femoral heads and necks were collected in the operation theatre. They were stored fresh frozen unchanged or converted into bone chips aseptically by the Bone Bank. In order to meet the demand for bone allografts we analysed the entire procedure for potential of improvement.Methods We analysed key data from the bone bank´s registry and the hospital administration between January 2019 and December 2022 with regard to the harvest of fresh frozen allogenic femoral heads and necks, the manufacture of bone chips and their discard rates and reasons over time: donor history, microbial growth, histology, IDM testing, others. Criteria for donor eligibility and product release were assessed in accordance with EU and national legislation.Results 890 femoral heads and necks were harvested during 1,664 THA surgeries. Thanks to the relaxation of Covid-19 restrictions, equal amounts of bone donations were recovered in 2022 and in 2019, 41% of these yielded the bulk material for bone chips. The discard rate for bone chips remained below 1.5%, but increased from 14.7% to 16% for bone donations. Analysis of the reasons for discard revealed donor history as the major cause over time. The increase from 5.6% in 2021 to 8.4% in 2022 had occured despite some improvement measures e.g. clarification of inconclusive diagnoses and a revised donor questionnaire. Thus, other factors may also contribute, such as the inclusion of increasingly older bone donors and staff turnover.Conclusion Providing allogeneic bone grafts of high quality and in sufficient quantity is a challenge. Therefore, it is of utmost importance to regularly review the registry data in order to adjust the procedures if necessary and possible. In this complex task other factors, such as donor characteristics and structural changes should also be considered.Offenlegung Interessenkonflikt: No conflicts of interest to declare

Mag. Dr.

Correlation of storage conditions and DNA degradation

Background Molecular analyses, including RBC typing, epigenetic studies and screening for disease-associated gene alterations, are widely used in blood banks and hospital laboratories. Human genomic DNA (gDNA) isolated from blood samples is the primary material used for these analyses. Improper storage conditions can result in DNA degradation, which can lead to diminished amplification efficiency and even false-negative results, thus compromising the accuracy and reliability of subsequent genotyping.Methods For middle-term storage, a total of 100 gDNA samples derived from 5 blood donors were stored at different temperatures (RT, 4°C, -20°C, -20°C with a single thawing process, and -20°C with thawing every month) for eight months. The level of DNA degradation was assessed by agarose gel electrophoresis, medium-range PCR (1,650 bp), and Agilent Bioanalyzer System. For long-term storage, each 5 EDTA blood and gDNA samples were stored at -20°C for 3, 5, 10, and 15 years. DNA integrity was compared by agarose gel electrophoresis, medium-range PCR (1,650 bp) and RBC genotyping. All extractions and purifications were done by magenetic bead-based technology.Results gDNA samples stored at 4°C exhibited degradation and decreased amplification efficiencies after eight months. Contrary, high DNA integrity was identified in samples stored at RT and -20°C. Additionally, both EDTA blood and gDNA samples stored at -20°C for 3, 5, 10, and 15 years revealed good DNA recovery and prevented DNA degradation.Conclusion In summary, we recommend short and middle-term storage of gDNA samples at RT or -20°C instead of 4°C, as the latter can result in decreased DNA integrity and compromised amplification efficiency. For long-term storage, a temperature of -20°C is suggested to prevent DNA degradation in EDTA blood and gDNA samples for up to 15 years. These results may have implications for molecular diagnostic laboratories, where DNA integrity is crucial for additional typing requests and retrospective studies.Offenlegung Interessenkonflikt: Im Namen aller Autoren erkläre ich, dass zu den Inhalten der Veranstaltung kein Interessenskonflikt vorliegt.

Quality Management

BloodTrain: Results of the first phase of regulatory systems strengthening in Sub-Saharan Africa

Background The GHPP BloodTrain project at PEI seeks to ensure availability, safety and quality of blood products in Africa through regulatory systems strengthening, focusing on haemovigilance, licensing and inspection of blood establishments, and IVDs in five partner countries (Ghana, Nigeria, Tanzania, Zambia, Zimbabwe). The first phase of the project started 2018 and ended in December 2022. Here, we present the achievments from the first phase and give an outlook to the recently started second phase.Methods The BloodTrain Project works to strengthen the regulatory capacity in sub-Sahara Africa with the focus on Blood and Blood products. Based on the results of a benchmarking using the Global Benchmarking Tool of the WHO, we have been pursuing a three-tiered approach to provide specialized technical support to build regulatory structures; perform capacity-building activities like workshops; support continental technical working groups to foster the harmonization of regulatory requirements in Africa. During the first phase of the project, the activities were maintained during the Covid-19 Pandemic by using a self-developed eLearning platform to perform virtual workshops, and online meetings to advance regulatory documents.Results We progressed on all three tiers and achieved important milestones, which will enable our further progress in the currently ongoing second phase of the program: Our technical support activities lead to the development of numerous regulatory documents, including a unified haemovigilance framework and guidelines in Ghana, launched in October 2022. For capacity building we performed numerous workshops including participants from our five partner countries and as well as from other interested countries. This was especially possible during the online courses (see Table in Abb.1). Concerning the effort to harmonise regulation we supported the development of three Guidance documents by the African Blood Regulators Form. Conclusion Together with NRA and NBTS of our partner countries, we supported the strengthening of the regulatory systems, measured by the number of performed workshops and trained participants and the number of developed regulatory system documents. These results are the basis for the continuing work in the second phase to further strengthen the capacities of our partner countries' NRAs so that they can perform trainings of regulators from neighboring countries in the regulation of Blood Products.Offenlegung Interessenkonflikt: Die Autoren haben keinen Interessenkonflikt.

Implementation report: ISO 15189 accreditation of a blood bank

Background Since the new EU-regulation (2017/746) for in-vitro-diagnostics came into effect, many healthcare institutions especially laboratories challenge to make their workflows ISO 15189 conform. Blood banks often use &quot;in house-tests&quot; for donor or product testing, therefore they have to follow this special standard for medical laboratories to fulfill aspects of the EU-regulation. We aimed to implement the requirements and passed accreditation by national authority in 2023.Methods The implementation project of the ISO 15189:2012 standard started in August 2020. The project-members were all in-house employees of the laboratory, without external support. The identified key-milestones of the project were: 1) kick-off 2) gap-analysis and implementation of appropriate measures 3) application for accreditation 4) inspection by national authority 5) resolve nonconformities 6) receipt of accreditation confirmation. Employees of the laboratory were included in all phases of project work to internalize the relevant requirements for their units. The project leader was responsible for planning the project, conducting the application and was the contact person to the authority during the whole project.Results Net project time to implement the ISO 15189 was 30 months. 4 laboratory units and over 80 procedures where successfully accredited. Employees of the laboratory internalized new ISO 15189 requirements by continuously taking part in project work and they could transfer this knowledge instantly into routine. The advantages of an internal project leader are the increase of acceptance of the project and the minimization of external costs. Additionally, the expertise of the accreditation procedure itself remains in the organization. Most important aspects are to take enough time to do the gap-analysis and to examine all documents recommended by national authority before starting implementation of the standard.Conclusion One successful way to implement the ISO 15189 in blood banks is through project work. Expected duration of such a project is medium term. The key to success is to involve internal staff from the beginning to use and retain know-how. Blood banks have high quality standards, as they are obliged to implement the requirements of e.g. parts of the good practice guidelines of the EDQM guide or national law. This could be an advantage in the implementation of the ISO 15189.Offenlegung Interessenkonflikt: The authors have no conflicts of interest to declare.

Traceability beyond borders: Development of a global standard for the labeling of tissue-engineered products

Background ICCBBA develops ISBT 128 as an international code for substances of human origin, and brings together clinical, scientific, technical, and informatics experts, professional societies and observers from regulatory authorities and industry. Several Technical Advisory Groups (TAGs) contribute to the global implementation of ISBT 128. The Regenerative Medicine TAG (RMTAG) developed a terminology for tissue-engineered products (TEPs) and is now pursuing the development of a global labeling standard.Methods With the aim to develop an ISBT 128 standard for the labeling of TEPs with the involvement of facilities experienced in TEP manufacture, a survey was conducted among RMTAG members from September 19 to October 20, 2022. Acknowledging that TEPs can be regulated as Advanced Therapy Medicinal Products (ATMPs), biologics or medical devices, the survey included information on two labeling options: a labeling standard compatible with biologics regulations, and a labeling standard compatible with medical device regulations. Participants were asked to provide background information on their facilities (products manufactured/received and applicable regulations) and which of the two proposed standards they would recommend for the labeling of TEPs.Results A total of 10 survey responses were obtained. Although participants affirmed that TEPs can be regulated as biologics, medical devices, or drugs, the majority (9 out of 10) representing TEPs manufacturers, blood, cellular therapy, and tissue facilities recommended developing a labeling standard compatible with biologics regulations.Conclusion Initial input from stakeholders indicates strong support for developing a labeling standard compatible with ATMP and biologics regulations rather than a labeling standard compatible with medical device regulations. The RMTAG is actively reaching out to stakeholders from academia, industry and across geographical regions to ensure that the resulting standard truly meets users&quot; expectations and effectively enables the traceability of TEPs worldwide.Offenlegung Interessenkonflikt: The authors declare that they do not have any conflicts of interest.

Postersession 1
AI, Automation and Digitalization | Biobanking and Tissue Banking | Quality Management

Appointment

Vorsitz

Topics

Programme

Postersession 1AI, Automation and Digitalization | Biobanking and Tissue Banking | Quality Management

Appointment

Vorsitz

Topics

Programme

Postersession 1
AI, Automation and Digitalization | Biobanking and Tissue Banking | Quality Management