Understanding of quality
Laboratory analysis at the highest level

The quality management of Labor Berlin
Optimum quality in findings and processes is one of the cornerstones of Labor Berlin: this is why all specialist areas are already accredited in accordance with the currently valid DIN EN ISO 15189 standard and the specialist areas of Forensic Toxicology and Forensic Genetics are accredited in accordance with DIN EN ISO/IEC 17025.
The centralised quality management system that has been introduced ensures that each department is supported by qualified QM officers on site. Comprehensive audit, complaint and error management ensures that the quality of laboratory analyses is always carried out at the best possible level.
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The entire analysis of all specialised areas is continuously checked by internal and external quality controls:
- The most recent guidelines of the German Medical Association (RILIBÄK) are the benchmark for this. In addition, all parameters not subject to certification are checked in accordance with the guidelines.
- Participation in external quality controls (interlaboratory tests) takes place at national interlaboratory test organisations such as INSTAND and DGKL.
- The departments are headed by highly qualified scientists, some of whom work closely with reference institutes or carry out target value analyses for the Reference Institute for Bioanalysis. Other departments act as reference laboratories themselves.
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Campus Virchow Clinic
Laboratory medicine Central laboratory
Reference laboratory for haemoglobinopathiesCampus Mitte
Virology
National consiliary laboratory for hantavirusesLocation Klinikum im Friedrichshain
Laboratory medicine presence laboratory
Urinary stone analysesCampus Virchow Clinic
Immunology- Standardisation of cytokine measurements at the DGKL (Deutsche Vereinigte Gesellschaft für Klinische Chemie und Laboratoriumsmedizin e.V.)
- Standardised immunodiagnostics after transplantation as part of the EU networks “RISET” and “The one Study”
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Accreditations
Labor Berlin – Charité Vivantes GmbH, process number D-ML-13440-03-00 | attachment | flexible accreditation area
Labor Berlin – Charité Vivantes GmbH, process number D-PL-13440-03-00 | attachment
Labor Berlin – Charité Vivantes GmbH, process number D-PL-13440-04-00 | attachment | flexible accreditation area
Labor Berlin – Charité Vivantes GmbH, process number D-PL-13440-05-00 | attachment | flexible accreditation area
Labor Berlin – Charité Vivantes Services GmbH, process number D-ML-19677-01-00 | attachment | flexible accreditation area
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Every measurement result is subject to a certain degree of uncertainty. Knowing this measurement uncertainty can be very helpful when it comes to assessing the significance of medical laboratory findings.
In other words: How does the parameter relate to the reference range? Does the current value deviate significantly from a previous value (follow-up)?
According to ISO/DIN 3534-1, the measurement uncertainty is defined as an estimated value that specifies the range in which the true value can be expected. A number of the points that determine the “overall measurement uncertainty” are strongly dependent on the individual circumstances of the patient.
The doctors in the laboratory are always available to discuss the significance of a finding. They bring current data on analytical measurement uncertainty and considerations on pre-analysis into the discussion of individual findings.
Information on measurement uncertainty is provided by the individual departments in writing or by telephone on request.
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In accordance with § 6 of the Medical Devices Operator Ordinance (MPBetreibV), a Medical Device Safety Officer is available to you at Labor Berlin.
Its tasks include, among others:
· Contact person for authorities, manufacturers and distributors in connection with reports on the risks of medical devices and the implementation of safety corrective measures at our company and other necessary corrective measures,
· Coordination of internal processes to fulfil the reporting and cooperation obligations of users and operators,
· Coordination of the implementation of corrective measures and safety corrective measures at our company.
You can reach our Medical Device Safety Officer at the following e-mail address: Medizinproduktesicherheit@laborberlin.com
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Declaration pursuant to Art. 5 para. 5 lit. f of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) on the in-house manufacture of devices in the healthcare establishment
The healthcare institution “Labor Berlin – Charité Vivantes GmbH”, Sylter Straße 2, 13353 Berlin, hereby declares that the devices listed in Annexes 1-7 are manufactured and used exclusively in the healthcare institution and meet the essential safety and performance requirements in accordance with Annex I of Regulation (EU) 2017/746 (IVDR), insofar as these are applicable to the devices. The products are manufactured in-house on a non-industrial scale.
- Appendix 1 to the declaration – Laboratory medicine
- Appendix 2 to the declaration – Immunology
- Appendix 3 to the declaration – Hematology & Oncology
- Appendix 4 to the declaration – Toxicology
- Appendix 5 to the declaration – Endocrinology & Metabolism
- Appendix 6 to the declaration – Human genetics
- Appendix 7 to the declaration – Virology & Microbiology
23.05.2024
Labor Berlin – Charité Vivantes GmbH
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The healthcare institution “Labor Berlin – Charité Vivantes Services GmbH”, Sylter Straße 2, 13353 Berlin, hereby declares that the devices listed in the annex are manufactured and used exclusively in the healthcare institution and meet the essential safety and performance requirements in accordance with Annex I of Regulation (EU) 2017/746 (IVDR), insofar as these are applicable to the devices. The products are manufactured in-house on a non-industrial scale.
26.05.2024
Labor Berlin – Charité Vivantes Services GmbH