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Updated: Feb 2, 2026

Quality-Controlled Sputum Analysis by Flow Cytometry
Published on: August 9, 2021
[Analysis of individual quality categories from quality management systems and their influence on the overall system]
Marcus Gumpert1, Jens-Peter Reese2
1Abteilung Qualitätssicherung und Qualitätsmanagement, Kassenärztliche Vereinigung Sachsen, Dresden, Deutschland.
Introduction:
According to Sect. 135a (2) of the Fifth Book of the German Social Code (SGB V), all physicians, psychotherapists and medical care centers are obliged to introduce an intra-institutional quality management system (QM system). The legislator instructed the Federal Joint Committee (G-BA) to develop basic requirements in a quality management guideline (QM-RL). Factor analysis was used to examine whether individual quality categories had a significant influence on the scores of QM systems.
Methods:
The random sample was collected in Saxony and included a total of 24 medical practices because these practices were made available for analysis by the Saxon Association of Statutory Health Insurance Physicians. First, two primary units (family physicians/specialists) were established from the population. In the following step, one sample per QM system was drawn for each primary unit. In total, there were twelve family physicians and twelve specialists, or eight practices per QM system. The analysis was performed using three self-constructed questionnaires (physician, employee and patient). The individual items were developed independently of a QM system (26 quality categories with 40 questions per survey group). For the analysis, the arithmetic mean was calculated in the individual groups of questions. Factor analysis was used to investigate which quality categories per QM system had a significant influence on the evaluations. The Kaiser-Meyer test was used to measure the data's suitability for factor analysis, also Bartlett's test relating to significance and the cumulative percentage of total of variance were applied.
Results:
In the first step, the quality categories having a significant influence on the overall evaluation of the QM system are presented. Regarding the DIN EN ISO 9001, 18 quality categories have a significant influence on the overall result; in QEP and QisA, 17 quality categories each have a significant influence on the overall result. The quality categories 'continuous professional development and qualification', 'hygiene and cleaning', 'quality management system', 'quality objectives', and 'procurement and storage' do not define an influence on the overall rating in any of the QM systems. Finally, eleven relevant quality categories were discovered which have an influence on all the QM systems.
Conclusion:
17 quality categories have a significant influence on the overall rating based on sample documents, flow charts, process flows, interview guidelines, maintenance protocols, or job advertisements. There are also eleven categories with a significant and pronounced effect on all three QM systems.
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