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Die Neuregelung der Qualitätssicherung für Hormone und Pharmaka gemäß den Qualitätssicherungsrichtlinien der Bundesärztekammer (Rili-BÄK) unterliegt einer intensiven Diskussion, besonders in Hinsicht auf die Praktikabilität Für die ärztlichen Laboratorien und die Diagnostikahersteller ergeben sich erhebliche Veränderungen, die aufgezeigt werden.
Die Nukleinsäure-Amplifikations Testung (NAT) von Blutprodukten wurde Mitte der 90er Jahre von europäischen Plasma verarbeitenden Firmen und großen deutschen Blutspendediensten entwickelt. Primäres Ziel war eine verbesserte Sicherheit von Blutprodukten, indem das so genannte diagnostische Fenster nach einer Virusinfektion bis zum ersten Nachweis von Antikörpern so weit wie möglich geschlossen werden sollte. Bei einer qualitätsgerechten PCR kommen bereits der Probenentnahme, dem Probentransport sowie der Probenlagerung große Bedeutung zu, da vermieden werden muß, daß es durch ungeeignete Antikoagulanzien oder Entnahmetechniken zu einem Sensitivitätsverlust kommt oder daß Kontaminationen falsch positive Ergebnisse hervorrufen. Wird ein Pooling von Proben durchgeführt, ergibt sich ein Verdünnungsfaktor, weshalb darauf zu achten ist, dass gegebenenfalls nachfolgende Anreicherungsschritte für Viren, wie z.B. eine Zentrifugation, implementiert werden. Der Gesamtprozeß von Pooling und Virusanreicherung ist ebenso wie die Probenvorbereitung durch geeignete Maßnahmen zu validieren und durch Qualitätssicherungsmaßnahmen zu flankieren. Die in der Extraktion der viralen Nukleinsäuren verwendeten Reagenzien sollten im Laboralltag möglichst einfach zu handhaben sein, keine Gefährdung des Laborpersonals darstellen und die Virus-Nukleinsäure gleichzeitig mit höchster Effizienz freisetzen und in sehr hoher Reinheit für die anschließende Amplifikation bereitstellen. Qualitätssicherungmaßnahmen sollen hier sowohl die geforderte Effizienz des Prozesses sichern als auch verhindern, daß es in dieser kritischen Phase zu Kontaminationen kommt. Zur Amplifikation stehen verschiedene Methoden zur Verfügung, wobei die PCR, insbesondere bei inhouse-Systemen, die weiteste Verbreitung gefunden hat. Der Prozeß der Amplifikation sollte möglichst im geschlossenen System erfolgen, wie dies z.B. in Real-time PCR-Systemen die Regel ist, ohne daß das Reaktionsgefäß während oder nach dem Amplifikationsprozeß geöffnet werden muß. Dies gewährleistet eine hohe Sicherheit vor Kontaminationen durch freigesetzte Amplifikate. Im Blutspendewesen ist es von höchster Bedeutung, daß negative Ergebnisse tatsächlich negative Blutspenden anzeigen. Interne Kontrollen, die eine korrekte Funktionsweise jeder individuellen PCR signalisieren, sollten deshalb in jeder Reaktion mitgeführt werden. Neben internen Kontrollen sind externe Negativ- und Positiv-Kontrollen mitzuführen, um falsch positive Reaktionen nachzuweisen bzw. auch die vor der PCR liegenden Prozesse wie Virusanreicherung und Extraktion zu überwachen. Alle Prozesse sind nach den von den Behörden festgelegten Kriterien durchgängig zu validieren, und es ist routinemäßig an externen Qualitätskontrollmaßnahmen (Ringversuchen) teilzunehmen.
The Compressed Baryonic Matter (CBM) experiment will explore the phase diagram of strongly interacting matter in the region of high net baryonic densities. The matter at these extreme conditions will be produced and studied in heavy-ion collisions with a fixed target set-up.
The present work is dedicated to the main component of the CBM experiment - the Silicon Tracking System (STS). The STS comprises of 8 tracking stations with 1292 double sided silicon microstrip sensors. The STS has to enable the reconstruction of up to 1000 charged particle tracks per nucleus-nucleus interaction at the rate of up to 10 MHz, provide a momentum resolution of Δp/p =1%, and withstand the radiation load of up to 1 x 1014 neq/cm2 (neq — radiation dose of 1 MeV neutron equivalent). Self-triggering read-out electronics will be located on the periphery of the detecting planes, and connected to the sensors with low mass micro-cables.
During the R&D phase, as well as in the pre-series and series production phase, the characterization of the sensors, of the front-end electronics and of the complete detector modules has to be performed. It is evident that characterization of more than 1000 silicon microstrip sensors and later of complete detector modules is very time-consuming, and may even damage the objects if not performed carefully. One of the goals of this work was to develop a systematic procedure for the quality assurance for the double-sided silicon microstrip sensors. This includes static optical inspection and visual tests, passive electrical test (such as leakage current, bulk capacitance, inter-strip capacitance & resistances, bias resistance and coupling capacitance), radiation hardness and long-term stability. A strategy for the quality assurance of these sensors is presented, defining the various tests to be performed and the documentation of the results. The techniques and quality assurance criteria will be applied for the pre-series and series production.
With decreasing feature size and increase in functionality and structures, the classical mechanical probe approach for internal fault detection and functional testing faces increasing challenges. In the field of silicon based chips and sensors there is rarely any analysis on the topic of non-invasive or contact-less probing and characterization, despite the fact that the contact-less probing is becoming more and more important as the fabrication technologies become smaller and more susceptible to the parasitic impact of mechanical probes. The silicon micro-strip double sided sensors used in STS have a complex structure, such as 1024 metal electrodes, 2048 bias resistors, 2048 DC pads and 4098 AC pads for probing, several guard rings, and even more in the 6.2 cm x 6.2 cm prototype sensor. Photo-intrusive technique is the best solution for the characterization and investigation of crucial parameters related to the detector operation and its functionality. A photo-intrusive probing is a method in which a non-invasive pulsed laser of a desired wavelength is used to inject the photon into the bulk and resulting in electron-hole pairs (e-h). In a completely depleted silicon sensor the charge injected (or generated) by the pulsed laser beam could be detected as current and shall be used for characterization.
A non-invasive contact-less Laser Test System (LTS) was developed based on a pulsed laser to investigate properties of the silicon sensors. The set-up is able to inject charge locally and scan sensors(or detector modules) with a pulsed infra-red laser driven by a step motor. The LTS is designed to measure sensor response in an automatized procedure at several thousand positions across the sensor with focused infra-
red laser light (spot size = 12 μm , wavelength = 1060 nm). The duration (10 ns) and power (5 mW) of the laser pulses are selected such that the absorption of the laser light in the 300 μm thick silicon sensors produces a number of about 24000 electrons, which is similar to the charge created by the minimum ionizing particles (MIP) in these sensors. The set-up was used to developed characterization procedures to determine the charge sharing between strips, and to measure a qualitative uniformity of the sensor response over the whole active area. The prototype sensors which are tested with the set-up are small prototype sensors (256 strips, pitch = 50 μm on each side) and full-size detector modules (1024 strips/side and pitch = 58 μm). They are read-out using a self-triggering prototype read-out electronic ASIC called n-XYTER. Laser scans for amplitude response, charge sharing in the inter-strip region, and spot-size determination technique are reported. For the verification of the some design parameters, unique methods of determining coupling capacitance, and inter-strip capacitance have been developed. The modules were also tested with proton beams, and the charge sharing in the inter-strip region has been compared to the laser test results.
In many countries a majority of cancer patients are not treated at Comprehensive Cancer Centers (CCCs). Even for those that are, parts of the treatment or follow‐up may be carried out in local community hospitals or in private practices. How to assure quality in cancer care and create innovation? How to integrate decentralized versus centralized patient care, education, and cancer research? Outlined here is a 360° view of outreach to include all stake holders – most importantly patients and their families, patient advocacy groups, health care providers, health insurers, and policy makers.
Introduction: In 2008, the German Council of Science had advised universities to establish a quality management system (QMS) that conforms to international standards. The system was to be implemented within 5 years, i.e., until 2014 at the latest. The aim of the present study was to determine whether a QMS suitable for electronic learning (eLearning) domain of medical education to be used across Germany has meanwhile been identified.
Methods: We approached all medical universities in Germany (n=35), using an anonymous questionnaire (8 domains, 50 items).
Results: Our results (response rate 46.3%) indicated very reluctant application of QMS in eLearning and a major information deficit at the various institutions.
Conclusions: Authors conclude that under the limitations of this study there seems to be a considerable need to improve the current knowledge on QMS for eLearning, and that clear guidelines and standards for their implementation should be further defined.