Revision of the “Guideline of the German Medical Association on Quality Assurance in Medical Laboratory Examinations – Rili-BAEK” (unauthorized translation)
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In November 2007, the previous version of the Guideline of the German Medical Association on Quality Assurance in Medical Laboratory Examinations -Rili-BAEKwas approved by the Executive Board of the German Medical Association and published in the spring of 2008 in the Deutsches Ärzteblatt -the German Medical Association's official international bilingual science journal.At that time, the Guideline comprised Chapter A, Part B1 and Chapter C, D and E, thus specifying basic requirements for quality assurance in medical laboratory examinations and requirements for conducting external quality assurance programmes.In subsequent years, additions were made to the guideline designated Parts B2, B3, B4 and B5.Also, Expert Groups for these respective parts were installed to supervise and further develop the external quality assurance programmes.In 2013, the Expert Groups instituted according to the Rili-BAEK undertook another revision of the entire guideline and prepared a new, linguistically consolidated version.A few additions were made in Chapter A in the definition of terms, and the tables for Parts B1 and B5 were updated.The Executive Board of the German Medical Association decided to publish the consolidated version in its entirety in order to create a quotable text. Berlin, August 2014The German Medical Association (BAEK) has been informed of this translation of the Rili-BAEK guideline into English, and it is being done with the chamber's approval.The original publication in the Deutsches Ärzteblatt (German Medical Journal) remains the basis for a legally compliant application of the Rili-BAEK guideline in Germany. Guideline of the German Medical Association on Quality Assurance in Medical Laboratory ExaminationsAs per the decision by the Executive Board of the German Medical
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Verification of trueness and precision of both reference measurement procedures was performed during the experimental phase by regular internal and external quality control measurements.
“As required by Rili-BÄK,17 the Guideline of the German Medical Association on Quality Assurance in Medical Laboratory Examinations, verification of trueness and precision of both reference measurement procedures was performed during the experimental phase by regular internal and external quality control measurements.”
From System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015 (2020) · cites this paper as [17]
Section 8, “Internal and external quality assurance” (page not provided), requires internal controls and regular participation in external quality assessment programmes. The guideline also defines trueness and precision, but the cited passages do not require verification of both reference measurement procedures by those controls or document what was done during the citing study’s experimental phase. (LLM, conf=0.86)
Experimental — accuracy not yet measuredThe relevant quality criteria were considered for the creatinine and cystatin C assays.
“The relevant quality criteria were considered (24).”
From A Method to Combine Neurofilament Light Measurements From Blood Serum and Plasma in Clinical and Population-Based Studies (2022) · cites this paper as [24]
Table B1a gives permissible deviations and applicable concentration intervals for creatinine in plasma, serum, or whole blood; Table B1b gives corresponding criteria for urine creatinine. The passages do not identify cystatin C-specific criteria, and this guideline cannot establish whether the citing authors actually considered the criteria in their assays. (LLM, conf=0.82)
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- Venue
- LaboratoriumsMedizin
- Publisher
- Walter de Gruyter GmbH
- Published
- 2015-03-01
- Volume
- 39
- Issue
- 1
- Pages
- 26-69
- ISSN
- 0342-3026 (ISSN-L)
- 1439-0477
- OpenAlex
- W4238974272
- Cited by
- 69
- References
- 0
- Citations by year
- 2026: 2 · 2025: 2 · 2024: 3 · 2023: 3 · 2022: 11 · 2021: 9 · 2020: 10 · 2019: 8 · 2018: 5 · 2017: 6 · 2016: 8 · 2015: 2
- FWCI
- 5.17
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- Journal of Laboratory Medicine (publishedVersion, cc-by)
- Topics
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Health Professions › Health Information Management › Healthcare Quality and Management
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Scientific Measurement and Uncertainty Evaluation
- Keywords
- quality assurance, German Medical Association, laboratory accreditation, guideline revision
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