57. Jahrestagung der Deutschen Gesellschaft für Transfusionsmedizin und Immunhämatologie

Univ.-Prof. Dr. med.

Objective Structured Clinical Examination (OSCE) to Assess Student Learning in Transfusion Medicine

Quality Management and Regulatory Aspects

Die objektiv strukturierte klinische Prüfung (OSCE) zur Beurteilung des studentischen Lernens in der Transfusionsmedizin

According to the National Competency-Based Catalog of Learning Objectives for Medicine (NKLM), medical students should know how to perform a transfusion including bedside test and what to do in cases of a transfusion related emergency. The objective of this teaching project was to assess the effectiveness of different teaching formats in preparing students for the state board exams.Our institute teaches transfusion medicine as part of the surgery course to students in the 9th semester of medical school. The current teaching format involves a seminar about basic skills in transfusion medicine and a visit to the donation center and blood bank (Control group). To assess critical skills in transfusion medicine, we developed four objective structured clinical examination stations (OSCEs) that simulated the transfusion process from identifying patients for red blood cell transfusion through interpreting results from the blood bank to preforming a transfusion and monitoring the patient (OSCE group). Students were evaluated based on their performance during the OSCEs and completion of a multiple choice questionnaire (MCQ).To gauge how well students performed overall on the OSCE stations, we looked at their average performance over the entire OSCEs as a whole and found that all 10 students passed the threshold of 60%. Only one student demonstrated a strong performance in all four OSCEs while three students performed at or below the 60% cutoff in single OSCEs indicating that we were able to distinguish low performing students from high performing students. As a group, the students performed well in OSCEs that dealt with indications for a transfusion and patient interactions, and comparatively weaker in OSCEs that focused on lab results and the actual transfusion. The hands on tasks during the OSCEs seemed to improve student performance on the MCQ where the control group in turn underperformed in blood group and compatibility testing.Considerable insight was gained using the four OSCE stations to assess student performance across the many different tasks required for an red blood cell transfusion. Most notable was the lack of student knowledge on red blood cell allo- and autoantibodies and how these are tested during the pretransfusion screening.None

Poster

Prof. Dr.

Thrombopoietin external quality assessment – laboratory results and method precision

Externe Qualitätskontrolle von Thrombopoietinmessungen – Vergleich der Laborergebnisse und Untersuchung der Methodengenauigkeit

The aim of the study was to investigate the measurement quality of medical laboratories with regard to thrombopoietin (TPO) determinations within the framework of an external quality assessment (EQA) scheme. Since the results of the past EQA runs since the introduction of the TPO EQA in 2017 were not entirely conclusive, due to the consistently low number of participants, a much more detailed investigation was carried out in this study design with a higher number of samples.A total of six laboratories took part in the EQA and were asked to generate two pooled serum samples. The total of 12 different samples were then distributed to the participating laboratories and measured using enzyme-linked immunosorbent assay (ELISA) at least in duplicates.At the time of submission, data collection and analysis are still ongoing. Preliminary results indicate variability in the measurements between participating laboratories. The average deviation from the mean value of the calculated TPO concentrations in the samples so far is 31.0 ± 11.2 % (n = 4). The average intra-assay variation based on the previous results of the multiple measurements of the optical density values is 6.1 ± 5.0 %. Final results and detailed analysis will be available at the time of the congress presentation.This study emphasizes the importance of EQA, especially in the context of TPO determinations. The observed variations emphasize the need for continuous objective evaluation of measurement quality to ensure reliable TPO test results and patient safety. Further investigations into the causes of the variations and the implementation of corrective interventions are currently ongoing and will be presented at the congress.There is no conflict of interest.

Dr.-Dr.

DKMS Stem Cell Bank as Contract Development and Manufacturing Organization (CDMO)

DKMS Stem Cell Bank als Vertragshersteller und -entwickler

Advanced therapy medicinal products (ATMPs) are often developed via academic facilities. For clinical studies, ATMPs have to be processed under conditions of good manufacturing practice (GMP). Furthermore, upscaling is necessary to reach requested quantities. However, research laboratories and clinical facilities often do not have the capacity to fully comply with all GMP requirements. There is therefore a need for CDMOs that offer the required equipment, a quality management, expertise in regulatory affairs, personnel, specific know-how and experience in ATMP processing and testing.DKMS Stem Cell Bank (DKMS SCB) already evolved from a pure cord blood bank to a stem cell bank by acquiring the manufacturing license and approval for the world's first allogeneic undirected cryopreserved PBSC product. This forms the basis for further development into a CDMO. DKMS SCB is well experienced in manufacturing cellular products for more than 25 years and offers a clean room equipped with isolators to realize aseptic conditions. Moreover, standard processes in cryo-storage, transport, quality management and a set of quality control methods are established and can be expanded for new ATMP. Last but not least, the DKMS SCB has well trained, experienced and responsible persons in terms of the German Medicines Law.As a first pilot project, a cellular product based on mesenchymal stroma cells isolated from the umbilical cord was chosen. The manufacturing and quality control procedures were developed in university research and transferred to the DKMS SCB. The process is currently being established and validated at the DKMS SCB in accordance with GMP standards for the manufacture and quality control of investigational medicinal products. Finally, we will extend our existing manufacturing license for the new stem cell product.The DKMS SCB is a CDMO for cell therapeutics including quality control methods. Important factors for a successful process transfer are the definition of requirements by client and CDMO in an early stage as well as a close exchange between all involved people in all project phases. The DKMS SCB offers know-how, state-of-the-art technical equipment and experienced staff to clients with the aim of processing and testing of cellular products.The authors have no conflict of interest to disclose.

Posterausstellung 12

Wintergartenrestaurant + Foyer

Posterausstellung

Posterausstellung 12
Quality Management and Regulatory Aspects

Termin

Programm

Posterausstellung 12Quality Management and Regulatory Aspects

Termin

Programm

Posterausstellung 12
Quality Management and Regulatory Aspects