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Legal regulations and guidelines such as the Guidelines of the German Medical Association for the Quality Assurance of Laboratory Medical Examinations (Rili-BAEK) and ISO 15189 apply to electronic laboratory reports. However, many laboratories struggle with practical implementation of these regulations and guidelines. Laboratory and legal experts analyse the relevant guidelines and provide checklists and practical recommendations for implementation. Laboratories have less control over the display of electronic laboratory reports than over paper documents. However, an electronic report alone is legally sufficient and need not be accompanied by a paper copy. Rili-BAEK and ISO 15189 stipulate a set of minimum information in every report. The laboratory must verify that reports are transmitted and displayed correctly. To help laboratories do so, agreements between laboratories and the report recipients can clarify responsibilities. Electronic laboratory reports can improve patient care, but laboratories need to verify their quality. Towards this end, Rili-BAEK and ISO 15189 set out helpful provisions. [ABSTRACT FROM AUTHOR]

In recent years, there has been renewed interest in the "old" average of normals concept, now generally referred to as moving average quality control (MA QC) or patient-based real-time quality control (PBRTQC). However, there are some controversies regarding PBRTQC which this review aims to address while also indicating the current status of PBRTQC. This review gives the background of certain newly described optimization and validation methods. It also indicates how QC plans incorporating PBRTQC can be designed for greater effectiveness and/or (cost) efficiency. Furthermore, it discusses controversies regarding the complexity of obtaining PBRTQC settings, the replacement of iQC, and software functionality requirements. Finally, it presents evidence of the added value and practicability of PBRTQC. Recent developments in, and availability of, simulation methods to optimize and validate laboratory-specific PBRTQC procedures have enabled medical laboratories to implement PBRTQC in their daily practice. Furthermore, these methods have made it possible to demonstrate the practicability and added value of PBRTQC by means of two prospective "clinical" studies and other investigations. Although internal QC will remain an essential part of any QC plan, applying PBRTQC can now significantly improve its performance and (cost) efficiency. [ABSTRACT FROM AUTHOR]

The quest to use patient results as quality control for routine clinical chemistry testing has long been driven by issues of the unavailability and cost of suitable quality control material and the matrix effects of synthetic material. Hematology laboratories were early adopters of average of normals techniques, primarily because of the difficulty in acquiring appropriate, stable quality control material, while in the chemistry laboratories, the perceived advantages and availability of synthetic material outweighed the disadvantages. However, the increasing volume of testing in clinical chemistry plus the capability of computer systems to deal with large and complex calculations has now made the use of patient-based quality control algorithms feasible. The desire to use patient-based quality control is also driven by increasing awareness that common quality control rules and frequency of analysis may fail to detect clinically significant assay biases. The non-commutability of quality control material has also become a problem as laboratories seek to harmonize results across regions and indeed globally. This review describes the history of patient-based quality control in clinical chemistry, summarizes the various approaches that can be implemented by laboratory professionals, and discusses how patient-based quality control can be integrated with traditional quality control techniques. [ABSTRACT FROM AUTHOR]

The article offers information on The point-of-care testing (POCT) working group POCT of the German Society for Clinical Chemistry and Laboratory Medicine (DGKL) organized the 4th Munich POCT Symposium on the subject of "POCT at the Interface of Emerging Technologies and New Clinical Applications".

Background: Point-of-care tests (POCT) measure analytes close to the patients and are a complementary supplement to the test menu of medical laboratories. However, the involvement of many different stakeholders makes it challenging to ensure reliable results. Methods: In a survey, we asked experienced POCT users how they control their total POCT process and what factors they consider essential for success. Results were verified in four in-depth interviews. Results: Overall, 73 German participants from various medical disciplines completed the survey. All but one participant regarded operator training as important but only half of the participants' institutions conducted operator training on a regular basis. Participants often requested e-learning, but face-to-face teaching is still preferred. Twenty-one percent of participants already used e-learning and reported mixed satisfaction. Fifty-five percent of the participants never refer to the quality management manual. Instead, 94% stated that if a POCT error arises a contact person for POCT is always available at their workplace. The majority of participants think that external and, in particular, internal quality controls are important for POCT. Only a few difficulties for performing quality control such as "temporal expenditure" and "lack of information about the importance of internal quality control" were commonly mentioned. For future developments, participants expect evolution and improvements especially with regard to "measurement quality and reliability". The answers of the experts in the in-depth interviews largely corresponded with the participants of the survey. Conclusions: The importance of operator training is well established and confirmed in this work. How to conduct this training is less certain, but the answers in this survey suggest some form of blended learning with e-learning and practical elements. The discrepancy between the high importance that guidelines and other normative documents place on written information and their low practical usage was striking. [ABSTRACT FROM AUTHOR]

An introduction to articles in the issue is presented on topics including a set of ICT tools that is used in Switzerland to render laboratory data interoperable, the process of implementing the Australian electronic health record, and some of the challenges of new diagnostic tests that produce so much data.

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The article discusses guideline of the German Medical Association for quality assurance of medical laboratory examinations in the form of the "Peer Review" in addition to the classic audits. It mentions focus on collegial exchange and ultimately improve quality; and also mentions need for quality assurance in laboratory medicine.