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

Author:

Bietenbeck Andreas1ORCID,Cadamuro Janne2ORCID,Holdenrieder Stefan3,Leichtle Alexander Benedikt4ORCID,Ludwig Amei5,von Meyer Alexander1,Nauck Matthias6,Orth Matthias7,Özçürümez Mustafa8,Ponader Alexander9,Streichert Thomas10ORCID,Strobl Dominik9,Tolios Alexander11,Wiegel Bernhard12,Gassner Ulrich9

Affiliation:

1. Institut für Laboratoriumsmedizin, Medizinische Mikrobiologie und Technische Hygiene, München Klinik , Munich , Germany

2. Department of Laboratory Medicine , Paracelsus Medical University Salzburg , Salzburg , Austria

3. Institut für Laboratoriumsmedizin, Deutsches Herzzentrum München , Munich , Germany

4. University Institute of Clinical Chemistry , Inselspital - Bern University Hospital and Center for Artificial Intelligence in Medicine , University of Bern , Bern , Switzerland

5. Central Institute for Clinical Chemistry and Laboratory Diagnostics, Heinrich Heine University Düsseldorf , Düsseldorf , Germany

6. Institut für Klinische Chemie und Laboratoriumsmedizin, Universitätsmedizin Greifswald , Greifswald , Germany

7. Institut für Laboratoriumsmedizin, Marienhospital , Stuttgart , Germany

8. Medizinische Klinik, Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH, Ruhr-Universität Bochum , Bochum , Germany

9. Juristische Fakultät, Universität Augsburg , Augsburg , Germany

10. Institute for Clinical Chemistry, University of Cologne, Faculty of Medicine and University Hospital Cologne , Cologne , Germany

11. Medical University of Vienna , Vienna , Austria

12. MVZ Labor Passau GbR , Passau , Germany

Abstract

Abstract 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.

Publisher

Walter de Gruyter GmbH

Subject

Biochemistry (medical),Clinical Biochemistry,Discrete Mathematics and Combinatorics

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