[The MDK as an Institution for Quality Assurance in the German Health System: A Practice Report on Quality Audits Based on the Guideline on Minimally Invasive Heart Valve Interventions of the G-BA]. / Der MDK als Institution der Qualitätssicherung im deutschen Gesundheitssystem: Qualitätsprüfungen auf Basis der Richtlinie zu minimalinvasiven Herzklappeninterventionen des G-BA ­ ein Praxisbericht.

INTRODUCTION: In 2015, the Federal Joint Committee (G-BA) adopted a guideline on minimally invasive heart valve interventions (MHI-RL). Every year, hospitals have to declare compliance with the quality requirements of the guideline in the form of checklists vis-à-vis the social service providers, who can have the data checked by the medical service of the health insurance (MDK) on site. Here we report on the experience with these tests in Hessian hospitals. METHODS: At the MDK Hessen, after being commissioned by the social service providers and announcement to this effect, examinations are carried out by two specialist medical assessors as part of on-site inspections in the hospitals. RESULTS: Since the MHI-RL took effect, a total of 33 quality audits for transcatheter aortic valve implantations (TAVI) and/or transcatheter mitral valve repairs (TMVR/"MitraClip®") have been performed in 12 Hessian hospitals. As part of a first review, 87.5% of hospitals performing TAVI and TMVR and 50.0% of TMVR-only hospitals confirmed compliance with the checklists. Following the initial assessment, all hospitals that had not yet complied fulfilled the requirement within the period agreed upon with the social service providers. By the deadline of 21.03.2017, 11 of the 12 hospitals examined fulfilled the requirements of the MHI-RL and since March 2018, all 12 hospitals did so. CONCLUSION: Since the MHI-RL took effect, the MDK Hessen has been commissioned as an independent and impartial socio-medical expert institution within the statutory health insurance system. With the quality checks, it makes an important contribution to the quality assurance of specialized inpatient care in Hesse. This has led to fulfillment of the quality requirements of the MHI-RL throughout Hessen. Based on these experiences, the MDK Hessen is well prepared for the challenges of the future MDK quality control guideline/MDK-QK-RL.

Soft X-ray nanoscale imaging using a sub-pixel resolution charge coupled device (CCD) camera.

A sub-pixel 16 bit charge coupled device camera featuring superresolution for the soft X-ray regime is presented. Superresolution images (SRIs) are reconstructed from a set of 4 × 4 individual low-resolution images that are recorded for different sub-pixel shifts of the detector. SRIs have a 1.3 times higher resolution than individual low-resolution images which is close to the maximum achievable enhancement factor of about 1.5 in the X-ray regime under ideal conditions. To characterize this camera and demonstrate its potential, an X-ray microscope setup is used to image different objects at different photon energies.

Detection of monohydroxylated polycyclic aromatic hydrocarbons in urine and particulate matter using LC separations coupled with integrated SPE and fluorescence detection or coupled with high-resolution time-of-flight mass spectrometry.

A high-performance liquid chromatographic (HPLC) method with integrated solid-phase extraction for the determination of 1-hydroxypyrene and 1-, 2-, 3-, 4- and 9-hydroxyphenanthrene in urine was developed and validated. After enzymatic treatment and centrifugation of 500 µL urine, 100 µL of the sample was directly injected into the HPLC system. Integrated solid-phase extraction was performed on a selective, copper phthalocyanine modified packing material. Subsequent chromatographic separation was achieved on a pentafluorophenyl core-shell column using a methanol gradient. For quantification, time-programmed fluorescence detection was used. Matrix-dependent recoveries were between 94.8 and 102.4%, repeatability and reproducibility ranged from 2.2 to 17.9% and detection limits lay between 2.6 and 13.6 ng/L urine. A set of 16 samples from normally exposed adults was analyzed using this HPLC-fluorescence detection method. Results were comparable with those reported in other studies. The chromatographic separation of the method was transferred to an ultra-high-performance liquid chromatography pentafluorophenyl core-shell column and coupled to a high-resolution time-of-flight mass spectrometer (HR-TOF-MS). The resulting method was used to demonstrate the applicability of LC-HR-TOF-MS for simultaneous target and suspect screening of monohydroxylated polycyclic aromatic hydrocarbons in extracts of urine and particulate matter.

[Quality Controls in Hospitals by MDK Hessen: A Practice Report of Experiences and Outlook]. / Qualitätsprüfungen in Krankenhäusern durch den MDK Hessen: Erfahrungen und Ausblick - ein Praxisbericht.

INTRODUCTION: The Hospital Structure Act introduced § 275a SGB V into the German Social Code. It specifies and expands the legal requirements for future quality controls in hospitals performed by the Medical Review Board of the Statutory Health Insurance Funds (MDK). These controls are intended to ensure high-quality, patient-centered and needs-based medical care of the population. Based on 10 years of experience of the Hessian MDK, the practicability of the quality controls is to be demonstrated. METHODS: The hospital quality controls carried out so far concern either the examination of the structural quality according to the regulations of the Federal Joint Committee (G-BA) for the quality assurance of special care complexes/procedures or the specifications of the German Institute of Medical Documentation and Information (DIMDI) for complex procedures. All quality controls in the Hessian hospitals are performed as on-site inspections by a specialized MDK-team of 2 medical examiners. The quality controls involve the responsible medical staff as well as members of the hospital management. RESULTS: From 2006-2016 a total of 357 quality controls were carried out according to the regulations of the G-BA for 10 different special care complexes/procedures. In about 20% of cases, the requirements were not fulfilled. During the same period, 1624 quality controls were carried out according to the specifications of the DIMDI for 33 different complex procedures. In about 40% of cases the required standards were not fulfilled. CONCLUSION: The deficits revealed demonstrate the need for quality control by an independent and qualified body. The quality controls contribute to quality assurance and thus to the quality of structures, processes and outcomes in hospitals. The quality control practice established by the Hessian MDK is transferable to nationwide quality controls to be performed in future.

Determination of air pollution-related biomarkers of exposure in urine of travellers between Germany and China using liquid chromatographic and liquid chromatographic-mass spectrometric methods: a pilot study.

OBJECTIVE: The influence of different exposures to PM2.5 (particulate matter with an aerodynamic diameter below 2.5 µm) on the concentrations of biomarkers of exposure and oxidative stress should be investigated. For this purpose, urine samples from individuals travelling from Germany to China were collected and analysed. MATERIALS: Robust LC and LC-MS/MS methods were established for the determination of biomarkers including 8-hydroxy-2'-deoxyguanosine, malondialdehyde, F2α-isoprostanes and hydroxylated polycyclic aromatic hydrocarbons. As a pilot study, nine volunteers travelled from Germany (mean daily concentration of PM2.5: 21 µg/m3) to China (mean daily concentration of PM2.5: 108 µg/m3). Urine samples were collected before and after the trip. RESULTS: In samples collected after return to Germany, the median concentrations of oxidative stress biomarkers were observed to be higher than in samples collected before leaving Germany. Decreasing trends were observed in the sequences of samples collected after return in the following weeks. Correlations were found between exposure and oxidative stress biomarkers. CONCLUSION: Travellers are ideal models for PM pollution-induced acute health effects study. Exposure to PM pollution can cause oxidative stress and damage.

The generation challenge programme platform: semantic standards and workbench for crop science.

The Generation Challenge programme (GCP) is a global crop research consortium directed toward crop improvement through the application of comparative biology and genetic resources characterization to plant breeding. A key consortium research activity is the development of a GCP crop bioinformatics platform to support GCP research. This platform includes the following: (i) shared, public platform-independent domain models, ontology, and data formats to enable interoperability of data and analysis flows within the platform; (ii) web service and registry technologies to identify, share, and integrate information across diverse, globally dispersed data sources, as well as to access high-performance computational (HPC) facilities for computationally intensive, high-throughput analyses of project data; (iii) platform-specific middleware reference implementations of the domain model integrating a suite of public (largely open-access/-source) databases and software tools into a workbench to facilitate biodiversity analysis, comparative analysis of crop genomic data, and plant breeding decision making.