Qualitätsmanagementsystem nach EN ISO 9001

Immer mehr Pflegeeinrichtungen folgen dem Trend in Richtung von Qualitätsmanagementsystemen nach EN ISO 9001, die einen prozessorientierten Ansatz fordern. Die vorliegende Arbeit geht der Frage nach, wie Prozessdiagramme im beruflichen Alltag angewendet und verstanden werden. Der Pflegeprozess als professionelle Handlungsanleitung ist ebenso Thema der Arbeit. Es wurden sechs diplomierte Gesundheits- und Krankenpflegepersonen in einer Langzeitpflegeeinrichtung zur Anwendung und Verständnis von Prozessdarstellungen mittels eines halbstandardisierten Interviewleitfadens befragt. Die Ergebnisse zeigen, dass Pflegepersonen Prozessdiagramme – mit Ausnahme des Pflegeprozesses – im Pflegealltag kaum anwenden. Als Gründe für eine Nichtanwendung wurden folgende zentrale Aussagen genannt: Prozessdiagramme bieten keine präzise Handlungsanleitung, Dokumente sind einfacher und verständlicher sowie die „Gewohnheit“. Der Pflegeprozess als Kernprozess der Pflege bildet eine Ausnahme und wird als struktureller Rahmen und Handlungsvorgabe für eine professionelle Pflege verstanden und angewendet.An increasing number of care facilities follow the trend towards quality management systems based on EN ISO 9001, demanding a process oriented approach. This research paper explores how process diagrams are applied and interpreted in care practice. The nursing process as a professional guide to daily practice is also documented and part of this research paper. Based on a partially open and structured questionnaire, six registered nurses had been interviewed in a long-term care facility to explore how process maps are applied and interpreted in daily practice. The results show that except for the nursing process, nurses do seldom use process diagrams in everyday care, mostly based on the fact that process diagrams provide no precise guide to daily work and documents in written format are much easier to understand and interpret. Furthermore, habits also drive the lack of acceptance of process diagrams. The nursing process as the most important process at the heart of caring is perceived as an exception and is applied and understood as a structural framework and policy for professional care

Urine tests for Down's syndrome screening

Background Down's syndrome occurs when a person has three copies of chromosome 21, or the specific area of chromosome 21 implicated in causing Down's syndrome, rather than two. It is the commonest congenital cause of mental disability and also leads to numerous metabolic and structural problems. It can be life-threatening, or lead to considerable ill health, although some individuals have only mild problems and can lead relatively normal lives. Having a baby with Down's syndrome is likely to have a significant impact on family life. The risk of a Down's syndrome affected pregnancy increases with advancing maternal age. Noninvasive screening based on biochemical analysis of maternal serum or urine, or fetal ultrasound measurements, allows estimates of the risk of a pregnancy being affected and provides information to guide decisions about definitive testing. Before agreeing to screening tests, parents need to be fully informed about the risks, benefits and possible consequences of such a test. This includes subsequent choices for further tests they may face, and the implications of both false positive and false negative screening tests (i.e. invasive diagnostic testing, and the possibility that a miscarried fetus may be chromosomally normal). The decisions that may be faced by expectant parents inevitably engender a high level of anxiety at all stages of the screening process, and the outcomes of screening can be associated with considerable physical and psychological morbidity. No screening test can predict the severity of problems a person with Down's syndrome will have. Objectives To estimate and compare the accuracy of first and second trimester urine markers for the detection of Down's syndrome. Search methods We carried out a sensitive and comprehensive literature search of MEDLINE (1980 to 25 August 2011), EMBASE (1980 to 25 August 2011), BIOSIS via EDINA (1985 to 25 August 2011), CINAHL via OVID (1982 to 25 August 2011), The Database of Abstracts of Reviews of Effectiveness (The Cochrane Library 2011, Issue 7), MEDION (25 August 2011), The Database of Systematic Reviews and Meta-Analyses in Laboratory Medicine (25 August 2011), The National Research Register (archived 2007), Health Services Research Projects in Progress database (25 August 2011). We studied reference lists and published review articles. Selection criteria Studies evaluating tests of maternal urine in women up to 24 weeks of gestation for Down's syndrome, compared with a reference standard, either chromosomal verification or macroscopic postnatal inspection. Data collection and analysis We extracted data as test positive or test negative results for Down's and non-Down's pregnancies allowing estimation of detection rates (sensitivity) and false positive rates (1-specificity). We performed quality assessment according to QUADAS (Quality Assessment of Diagnostic Accuracy Studies) criteria. We used hierarchical summary ROC (receiver operating characteristic) meta-analytical methods to analyse test performance and compare test accuracy. We performed analysis of studies allowing direct comparison between tests. We investigated the impact of maternal age on test performance in subgroup analyses. Main results We included 19 studies involving 18,013 pregnancies (including 527 with Down's syndrome). Studies were generally of high quality, although differential verification was common with invasive testing of only high-risk pregnancies. Twenty-four test combinations were evaluated formed from combinations of the following seven different markers with and without maternal age: AFP (alpha-fetoprotein), ITA (invasive trophoblast antigen), ß-core fragment, free ßhCG (beta human chorionic gonadotrophin), total hCG, oestriol, gonadotropin peptide and various marker ratios. The strategies evaluated included three double tests and seven single tests in combination with maternal age, and one triple test, two double tests and 11 single tests without maternal age. Twelve of the 19 studies only evaluated the performance of a single test strategy while the remaining seven evaluated at least two test strategies. Two marker combinations were evaluated in more than four studies; second trimester ß-core fragment (six studies), and second trimester ß-core fragment with maternal age (five studies). In direct test comparisons, for a 5% false positive rate (FPR), the diagnostic accuracy of the double marker second trimester ß-core fragment and oestriol with maternal age test combination was significantly better (ratio of diagnostic odds ratio (RDOR): 2.2 (95% confidence interval (CI) 1.1 to 4.5), P = 0.02) (summary sensitivity of 73% (CI 57 to 85) at a cut-point of 5% FPR) than that of the single marker test strategy of second trimester ß-core fragment and maternal age (summary sensitivity of 56% (CI 45 to 66) at a cut-point of 5% FPR), but was not significantly better (RDOR: 1.5 (0.8 to 2.8), P = 0.21) than that of the second trimester ß-core fragment to oestriol ratio and maternal age test strategy (summary sensitivity of 71% (CI 51 to 86) at a cut-point of 5% FPR). Authors' conclusions Tests involving second trimester ß-core fragment and oestriol with maternal age are significantly more sensitive than the single marker second trimester ß-core fragment and maternal age, however, there were few studies. There is a paucity of evidence available to support the use of urine testing for Down's syndrome screening in clinical practice where alternatives are available

Specification of a software package format and verified installation procedure including implementation for agile and reproducible rollout in a validated pharmaceutical sector

Installing software into a validated system can be a challenge, especially so for optional software packages. The need to adhere to the closed loop of verification and validation provides an additional hurdle in the installation process. Even more so for software or software packages used only by a part of the users. To help with the problems presented, a software installer is developed in this thesis, which installs optional software packages for the improve® workbench. Based on the reporting module for the improve workbench and based on previously developed software in the improve ecosystem a modular package installer in the programming language R is developed. The resulting installation process is to be configured by the user. Then it is to be verified via automated tests, which return test reports, reviewed and approved. Further a validation step is to be executed and reviewed in the installation procedure, to create a software installation and deployment process fit for a verified and validated system. A software installation process that cannot be altered by the user has been created. It opens the possibility of total reproducibility regardless of user and system, as long as the installation parameters are known. Such a concept of traceability can be an important help in obtaining the approval of notified bodies and in general with adherence to quality assurance standards.Die Installation von Software in validierten System kann eine Herausforderung darstellen, speziell bei optionalen Softwarepaketen. Die Richtlinien, welche in einem verifizierten und validierten System einzuhalten sind, stellen eine besondere Hürde im Installationsprozess dar. Dies gilt im Besonderen, wenn diese Software nur von einem Teil der Nutzer benötigt und verwendet wird. Um diesen Problemen zu begegnen wird in dieser Arbeit ein Software-Installer entwickelt, welcher optionale Softwarepakete für die improve® workbench installiert. Basierend auf dem improve reporting-Modul und auf bereits anderer im improve Ökosystem entwickelter Software wird ein modularer Installationsprozess für optionale Softwarepakete in der Programmiersprache R entwickelt. Die Parameter für diesen Installationsprozess werden von Benutzer konfiguriert und anschließend anhand von automatisierten Tests, welche Testberichte liefern, überprüft und freigegeben. Außerdem beinhaltet das Installationsverfahren einen Validierungsschritt, um einen Installations- und Bereitstellungsprozess zu gewährleisten, welcher für ein verifiziertes und validiertes System geeignet ist. Das Konzept eines Softwareinstallationsprozesses, welcher nicht von einem Nutzer beeinflusst und verändert werden kann wurde umgesetzt. Dieser Prozess gewährleistet einen standardisierten und reproduzierbaren Vorgang, unabhängig von Benutzer und System. Ein solches Konzept der Rückverfolgbarkeit kann eine wichtige Hilfe bei der Erlangung der Zulassung bei benannten Stellen sein, sowie dabei helfen diverse Qualitätssicherungsnormen einzuhalten.Masterarbeit Wien, FH Technikum Wien 202