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Concept: Quality assurance


As a component of the practice-based core competency of the Accreditation Council for Graduate Medical Education, all residents must receive training to be able to evaluate and improve their patient care practices. To further enhance our overall resident quality improvement (QI) educational experience, and to ensure resident involvement in the many aspects of a quality assurance program, we have established a resident educational leadership role and have appointed a resident as resident QI director.

Concepts: Better, Improve, Quality control, Physician, Management, Quality assurance, Medical school, Teacher


Since several years risk-based monitoring is the new “magic bullet” for improvement in clinical research. Lots of authors in clinical research ranging from industry and academia to authorities are keen on demonstrating better monitoring-efficiency by reducing monitoring visits, monitoring time on site, monitoring costs and so on, always arguing with the use of risk-based monitoring principles. Mostly forgotten is the fact, that the use of risk-based monitoring is only adequate if all mandatory prerequisites at site and for the monitor and the sponsor are fulfilled.Based on the relevant chapter in ICH GCP (International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use - Good Clinical Practice) this publication takes a holistic approach by identifying and describing the requirements for future monitoring and the use of risk-based monitoring. As the authors are operational managers as well as QA (Quality Assurance) experts, both aspects are represented to come up with efficient and qualitative ways of future monitoring according to ICH GCP.

Concepts: Time, Clinical trial, Management, Quality assurance, Clinical research, Good clinical practice, GxP


Correlation of intraoperative frozen section diagnosis with final diagnosis can be an important component of an institution’s quality assurance process.

Concepts: Management, Quality assurance, Frozen section procedure


In the United States, hospitals receive accreditation through unannounced on-site inspections (ie, surveys) by The Joint Commission (TJC), which are high-pressure periods to demonstrate compliance with best practices. No research has addressed whether the potential changes in behavior and heightened vigilance during a TJC survey are associated with changes in patient outcomes.

Concepts: Patient, Hospital, United States, Quality assurance, Hospital accreditation, Accreditation, Joint Commission, Trent Accreditation Scheme


Assessment of the quality of included studies is an essential component of any systematic review. A formal quality assessment is facilitated by using a structured tool. There are currently no guidelines available for researchers wanting to develop a new quality assessment tool.

Concepts: Evaluation, Quality, Quality control, Quality assurance, Object-oriented programming, Tool


Cerebrospinal fluid (CSF) leaks are one of the most common complications of endoscopic sinus and skull base surgery, and are associated with significant morbidity and cost. A quality improvement program can be designed for individual surgeons or groups of surgeons to monitor outcomes and implement changes to decrease the risk of a postoperative CSF leak. Analytic tools include a root cause analysis, statistical analysis of risk factors, and predictive modeling. Monitoring of outcomes is accomplished with a time series plot or run chart. A circular action loop for assessing and implementing changes facilitates incremental progress and creates a learning culture for the institution.

Concepts: Scientific method, Statistics, Quality, Quality assurance, Cerebrospinal fluid, Time series, Root cause analysis, Spontaneous cerebrospinal fluid leak


The transition to a fully digital breast screening programme, utilising three different full-field digital mammography (FFDM) systems has presented many challenges to the implementation of the European guidelines for physico-technical quality assurance (QA) testing. An analysis of the QA results collected from the FFDM systems in the screening programme over a 2-y period indicates that the three different systems have similar QA performances. Generally, the same tests were failed by all systems and failure rates were low. The findings provide some assurance that the QA guidelines are being correctly implemented. They also suggest that there is more scope for the development of the relevance of the guidelines with respect to modern FFDM systems. This study has also shown that a summary review of the QA data can be achieved by simple organisation of the QA data storage and by automation of data query and retrieval using commonly available software.

Concepts: Breast cancer, Type I and type II errors, Quality assurance, Breast, Mammography, Digital Mammography and PACS, Failure rate, The Europeans


: Quality management systems are, as a rule, tightly defined systems that conserve existing processes and therefore guarantee compliance with quality standards. But maintaining quality also includes introducing new enhanced production methods and making use of the latest findings of bioscience. The advances in biotechnology and single-use manufacturing methods for producing new drugs especially impose new challenges on quality management, as quality standards have not yet been set. New methods to ensure patient safety have to be established, as it is insufficient to rely only on current rules. A concept of qualification, validation, and manufacturing procedures based on risk management needs to be established and realized in pharmaceutical production. The chapter starts with an introduction to the regulatory background of the manufacture of medicinal products. It then continues with key methods of risk management. Hazards associated with the production of medicinal products with single-use equipment are described with a focus on bioreactors, storage containers, and connecting devices. The hazards are subsequently evaluated and criteria for risk evaluation are presented. This chapter concludes with aspects of industrial application of quality risk management.

Concepts: Risk, Biotechnology, Quality control, Management, Risk management, Quality assurance, Production and manufacturing, Quality management system


Quality assurance (QA) of volumetric modulated arc therapy (VMAT) increases the workload significantly. We compared the results from 4 verification methods to establish an efficient VMAT QA. Planning for VMAT treatments was carried out for 40 consecutive patients. Pretreatment verifications were carried out with ion chamber array Physikalish-Technische Werkstätten (PTW729), electronic portal dosimetry (EPID), ion chamber measurements, and independent dose calculation with Diamond program. 2D analyses were made using the gamma analysis (3mm distance to agreement and 3% dose difference relative to maximum, 10% dose threshold). Average point dose difference calculated by Eclipse relative to ion chamber measurements and Diamond were 0.1%±0.9% and 0.6%±2.2%, respectively. Average pass rate for PTW729 was 99.2%±1.9% and 98.3%±1.3% for EPID. The total required time (linac occupancy time given in parentheses) for each QA method was: PTW729 43.5 minutes (26.5 minutes), EPID 14.5 minutes (2.5 minutes), ion chamber 34.5 minutes (26.5 minutes), and Diamond 12.0 minutes (0 minute). The results were consistent and allowed us to establish an optimized protocol, considering safety and accuracy as well as workload, consisting of 2 verification methods: EPID 2D analysis and independent dose calculation.

Concepts: Mathematical analysis, Quality assurance, Analysis, Formal verification, Verification


Purpose: The purpose of the present study was to investigate the ability of commercial patient quality assurance (QA) systems to detect linear accelerator-related errors.Methods: Four measuring systems (Delta4®, OCTAVIUS®, COMPASS, and Epiqa™) designed for patient specific quality assurance for rotational radiation therapy were compared by measuring four clinical rotational intensity modulated radiation therapy plans as well as plans with introduced intentional errors. The intentional errors included increasing the number of monitor units, widening of the MLC banks, and rotation of the collimator. The measurements were analyzed using the inherent gamma evaluation with 2% and 2 mm criteria and 3% and 3 mm criteria. When applicable, the plans with intentional errors were compared with the original plans both by 3D gamma evaluation and by inspecting the dose volume histograms produced by the systems.Results: There was considerable variation in the type of errors that the various systems detected; the failure rate for the plans with errors varied between 0% and 72%. When using 2% and 2 mm criteria and 95% as a pass rate the Delta4® detected 15 of 20 errors, OCTAVIUS® detected 8 of 20 errors, COMPASS detected 8 of 20 errors, and Epiqa™ detected 20 of 20 errors. It was also found that the calibration and measuring procedure could benefit from improvements for some of the patient QA systems.Conclusions: The various systems can detect various errors and the sensitivity to the introduced errors depends on the plan. There was poor correlation between the gamma evaluation pass rates of the QA procedures and the deviations observed in the dose volume histograms.

Concepts: Medicine, Ionizing radiation, Measurement, Quality, Management, Quality assurance, Systems of measurement, Intention