Requirements for electronic laboratory reports according to the German guideline Rili-BAEK and ISO 15189

Objectives 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. Methods Laboratory and legal experts analyse the relevant guidelines and provide checklists and practical recommendations for implementation. Results 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. Conclusions 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.

Platelet storage and functional integrity

Platelet transfusion is a topic of common interest for many specialists involved in patient care, from laboratory staff to clinical physicians. Various aspects make this type of transfusion different from those of other blood components. In this review, the challenges in platelet transfusion practice that are relevant for laboratory colleagues will be discussed, highlighting how the biochemical and structural characteristics of these blood elements directly affect their function and consequently the clinical outcome. More than 1,300 platelet concentrates are transfused in Germany every day, and several types are offered by their respective manufacturers. We describe the technological advances in platelet concentrate production, with a focus on how the storage conditions of platelets can be improved. Laboratory quality assessment procedures for a safe transfusion are discussed in detail. For this purpose, we will refer to the Hemotherapy Directives (Richtlinie Hämotherapie) of the German Medical Association.

Determination and verification of reference interval limits in clinical chemistry. Recommendations for laboratories on behalf of the Working Group Guide Limits of the DGKL with respect to ISO Standard 15189 and the Guideline of the German Medical Association on Quality Assurance in Medical Laboratory Examinations (Rili-BAEK)

Laboratory measurement values require interpretative assistance e.g. so-called guide limits (GL), as an interpretative aid. Legal and normative requirements for medical laboratories do not provide specific information for their implementation and verification. A German Society for Clinical Chemistry and Laboratory Medicine (DGKL) Working Group GL (WG-GL) has, therefore, developed recommendations to support medical laboratories in the management of GL. A specific objective was to create a framework that mainly takes into account those aspects that can be realistically implemented by routine laboratories and that should improve the management of GL of frequently requested quantitative measurement procedures in clinical chemistry. Thus, the focus of these recommendations is on the distinction between reference interval limits and clinical decision limits as well as the determination and verification of reference interval limits. Indirect approaches are highlighted, as they enable routine laboratories with a broad analytical spectrum but limited resources to evaluate or to establish reference limits.

Decentralized Rather than Centralized Pediatric Surgery Care in Germany

Introduction Pediatric surgery has emerged from general surgery to take better care of the needs of surgically ill children. The development of pediatric surgery in Germany started in the early 19th century and is still ongoing. This study was performed to investigate how pediatric surgery is organized in Germany. Materials and Methods Data were obtained from the following sources: German Society, Information System of the Federal Health Monitoring, German Medical Association, Joined Federal Committee, Federal Bureau of Statistics, and Perinatal Centers. Results Pediatric surgery in Germany was started in the beginning of the 19th century. In 1962, there were approximately 20 units. The number increased to 98 in 2005 and to 129 in 2017. Presently, there are 769 pediatric surgeons registered in Germany. The current growth of pediatric surgery is attributed to a political decision of implementing centers for the care of preterm babies who need pediatric surgeons. Most work performed by pediatric surgeons in Germany can be categorized as low-risk, high-volume surgery. Currently, there is a trend of spontaneous centralization for some high-risk, low-volume pediatric surgical procedures. Conclusion Pediatric surgery in Germany shows a development toward a nearly complete coverage of the country, thus providing increasing number of children with specialist care. Rare diseases, such as in oncology or newborn surgery, are generally not centralized and rarely performed by small units. New approaches for better quality measurements may lead to centralization even without political action in the future.

Permissible measurement uncertainty in the lower part of measurement intervals

Many laboratories observe that requirements of the Guideline of the German Medical Association RiliBÄK for the internal quality assurance are difficult to fulfill in the lower part of the measurement interval (e.g. thrombocyte count at 50·10