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.