Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Das Qualitätsmanagement im Blutspendewesen am Beispiel des Blutspendedienstes der Bundeswehr

Martina Krüger Haberkamp (Abschlußjahr: 2012)

The blood donation service of the German Federal Armed Forces (Bundeswehr) in Koblenz was founded about 50 years ago in 1962 in order to supply military hospitals with regard to red blood cell concentrates (RBC) and plasmatic products. Actually, two mobile donation teams visit barracks and institutions all over Germany and annually collect up to 40.000 whole-blood donations from military and civilian volunteers, which are carried overnight to the centre in Koblenz using special vehicles with climate chambers (4°C for laboratory specimens, and 20°C for whole blood bags, respectively). Next morning the donations are processed into RBC and either fresh frozen plasma (FFP) or industrial plasma finished within 24 hours after blood collection. Simultaneously, the corresponding laboratory samples are investigated concerning blood group (AB0), rhesus system, and Kell antigen and in parallel concerning relevant infectious parameters such as HIV, hepatitis A to C, parvovirus B19, Treponema pallidum, and unspecific irregular erythrocytal antibodies by means of serologic testing and/or nucleic acid amplification. The head of quality control releases the examination and the head of manufacture the production protocol. Products may now be labelled with the concerning protocol being released by the head of quality control. Based upon all these safety mechanisms, the qualified person with respect to the German "Arzneimittelgesetz", in one being senior consultant physician of the blood donation centre, releases the products terminally for the application to patients. FFP needs to be placed in quarantine for at least four months until another specimen from the same donor is found to be negative in laboratory testing for HBV, HCV, and HIV, respectively. RBC are stored at 2-6°C and FFP at ≤= -30°C while plasma for industrial use is stored at ≤= -20°C. Military blood centres distribute their products in part all over the world, especially for supply of field hospitals in the setting of peace-keeping missions. For this reason a conception for quality-assured transportation of RBC and FFP was evaluated and experimentally validated by incubation in a climate chamber at extreme environmental temperature (+40°C and -10°C, each for up to 72 hours).

Products derived from human blood are classified as pharmaceuticals and only may be put into circulation if the appropriate national authority (in this context the "Paul-Ehrlich Institut -Bundesamt für Sera und Impfstoffe") has issued the admission in case of sufficient entrance qualification of the drugs. The licence owner is the pharmaceutical industrialist who is settling within the superior department in Munich ("Sanitätsamt der Bundeswehr"). Moreover, a licence for manufacturing has to be given by the state of Rhineland-Palatinate for civilian institutions and by the supervising authority of the Armed Forces within the Ministry of Defence ("Arzneimittelüberwachungsbeauftragter") for military blood bank. A couple of European and German acts, decrees, and guidelines control all activities of a blood donation service both military or civilian. In order to avoid any violation, each enterprise has introduced a comprehensive quality management. This tool is composed of two chapters the first of which generally describes the quality policy including the quality goals in the nearer future. The second chapter adjusts the concrete working rules within the blood bank offering standard operating procedures (SOP) that standardize every process on a high level of quality, and potentially independent from the acting medical staff. All data concerning the life cycle of a blood component are collected using formalized sheets and the complete documentation permits the identification of each employee who has participated in drug handling. All data relevant for the release of the blood products are additionally managed within a validates EDP-system created by a specialized software manufacturer. Furthermore, the blood bank is audited in regular intervals by representatives of the responsible authorities (third party), of the customer for industrial plasma (second party) and internally by the head of quality assurance within the blood bank (first party).

This masterthesis was focuses on presenting the actual quality mechanisms of a blood donation centre on the basis of the military bloodbank of the German Armed Forces in Koblenz and demonstrates that the management system achieves all requests demanded by national and European authorities. Over the past five decades, no serious deficiencies have been detected indicating that the personnel has control of all processes. Nevertheless, there is need for permanent improvement and all staff starting with the unskilled labourer and leading to the director of the institution are appealed to take part in this evolution, since standstill means retrograde step.

Pages: 47