[Why it is necessary to improve data quality and data validity by implementing a timely and integrated controlling system for BQS-compliant quality assurance]. / Notwendigkeit der Verbesserung von Datenqualität und -validität durch Einführung eines zeitnahen und ganzheitlichen Controllings im Bereich der Qualitätssicherung nach BQS.

Since 2007, all German hospitals are obliged to publish 27 quality indicators in their biannual "structured quality reports" as defined by the BQS (= Federal Office for Quality Assurance). Thus, hospitals are required to establish a timely controlling system for process and outcome quality that goes beyond the mere control of documentation rates. The University Medical Center Ulm has implemented an IT solution that allows for the continuous and timely evaluation of the quality assurance reports of the different modules. By developing an internal dialogue with colleagues of all specialties it was possible to optimise adherence to documentation and process standards, and to react promptly to deviations in outcome quality. This improved the quality of documentation and therefore the validity of quality assurance data. It even led to the identification of a programme error in the export file of one of the external modules. By cross-checking quality assurance data and accounting data according to Sect. 21 KHEntG (= regulation for DRG case invoicing), it was possible to detect down-coding in several cases and therefore increase revenue by correcting the accounting record. In current times it should be mandatory for hospitals to establish an internal IT supported medical/quantitative control system of BQS data records for external quality assurance. Quality and quantity of documentation forms the basis for the so-called internal dialogue (standardised review process of substandard quality assurance results), and they allow to identify the potentials for improvement in the quality of care for our patients.

Evaluation of the Merlin MICRONAUT system for rapid direct susceptibility testing of gram-positive cocci and gram-negative bacilli from positive blood cultures.

Bloodstream infections are life-threatening conditions which require the timely initiation of appropriate antimicrobial therapy. We evaluated the automated Merlin MICRONAUT system for rapid direct microtiter broth antimicrobial susceptibility testing (AST) of gram-positive cocci and gram-negative bacilli from BACTEC 9240 bottles with positive blood cultures in comparison to the standard method for the Merlin MICRONAUT system. This prospective study was conducted under routine working conditions during a 9-month period. Altogether, 504 isolates from 409 patients and 11,819 organism-antibiotic combinations were evaluated for comparison of direct and standard AST methods. For gram-negative bacilli, direct and standard AST of 110 isolates was evaluated and MIC agreement was found for 98.1% of 2,637 organism-antibiotic combinations. Category (susceptible, intermediate susceptible, resistant [SIR]) agreement was found for 99.0%, with results for 0.04% of combinations showing very major errors, those for 0.2% showing major errors, and those for 0.8% showing minor errors. For gram-positive cocci, 373 isolates were evaluated and MIC agreement was found for 95.6% of 8,951 organism-antibiotic combinations. SIR agreement was found for 98.8%, with results for 0.3% of combinations showing very major errors, those for 0.4% showing major errors, and those for 0.5% showing minor errors. Although the number of tested isolates was limited (n = 33), direct AST of streptococci was performed for the first time, yielding promising results with SIR agreement for 98.6% of 363 organism-antibiotic combinations. In conclusion, direct AST of gram-negative bacilli and gram-positive cocci from positive blood cultures with the MICRONAUT system is a reliable technique that allows for the omission of repeat testing of subcultured isolates. Thereby, it reduces the time to results of blood culture testing and may have a positive impact on patient care.

Comparison of direct disk diffusion and standard microtitre broth dilution susceptibility testing of blood culture isolates.

Bloodstream infections are life-threatening conditions which require timely initiation of appropriate antimicrobial therapy. The accuracy of direct disk diffusion susceptibility testing of positive blood cultures was investigated, including for the first time beta-lactam/beta-lactam-inhibitor combination antibiotics. Results of direct testing, following the guidelines of the Clinical and Laboratory Standards Institute, were compared to standard microtitre broth dilution susceptibility testing of the subcultured isolate on the Merlin MICRONAUT system. Altogether, 758 isolates and 4930 organism/antibiotic combinations from 590 patients were evaluated. With regard to Gram-positive cocci (n=532), agreement between both methods was found in 93.9% of cases, with 1.6% very major, 1.1% major and 2.6% minor errors. For Gram-negative rods (n=226), agreement was found in 91.9% of cases, with 1.2% very major, 0.7% major and 6.3% minor errors. When applying the breakpoints of the Deutsches Institut für Normung for interpretation of MICRONAUT tests, agreement of direct disk diffusion with standard testing decreased to 82.4% in Gram-negative rods, with 3.6% very major, 0.5% major and 13.4% minor errors. A high rate of disagreement was observed with oxacillin and gentamicin in Gram-positive cocci, and with cefuroxime, amoxycillin/clavulanate and piperacillin/tazobactam in Gram-negative rods. In conclusion, the limitations of direct disk diffusion testing of positive blood cultures must be kept in mind by the clinical microbiologist and should, where necessary, be communicated to the clinician to ensure adequate treatment of severely ill patients.

Expanded spectrum of Nocardia species causing clinical nocardiosis detected by molecular methods.

Nocardia species isolated from seven patients with clinical infection were investigated by conventional biochemical methods and 16S rRNA gene sequencing. Three isolates were identified as recently described species (i.e., N. paucivorans, N. abscessus and N. veterana). We provide data on the epidemiology, clinical significance and antimicrobial susceptibility of these newly described Nocardia species.