LIS Software for German Laboratories — Rili-BÄK Ready
A laboratory information system built for the records Rili-BÄK and a DAkkS assessment actually ask for, with the quality-control discipline the guideline sets out and billing that keeps running when the connection does not.
Welche Laborsoftware passt zu einem Labor unter Rili-BÄK?
SamLab ist ein Offline-First-Laborinformationssystem für deutsche Labore, die nach Rili-BÄK arbeiten oder eine DAkkS-Akkreditierung nach ISO 15189 anstreben. Es führt die interne Qualitätskontrolle je Gerät, Ringversuchs- und Änderungshistorie, Referenzbereiche mit Einheiten und die Identität der freigebenden Person, und arbeitet ohne Internetverbindung weiter. Akkreditiert wird das Labor, nie die Software.
What a German laboratory is inspected against
Anyone performing laboratory-medicine examinations in Germany must set up a quality assurance system before starting, under § 10 of the Medizinprodukte-Betreiberverordnung, and compliance is presumed when the Bundesärztekammer guideline Rili-BÄK is followed. Rili-BÄK is therefore the binding standard for every laboratory, accredited or not. Accreditation to DIN EN ISO 15189 is granted by DAkkS and is voluntary unless a law requires it, on a cycle of at most five years with regular surveillance. Statutory-insurance work is billed under the EBM and private work under the GOÄ.
Rili-BÄK requires participation in a ring trial every quarter, at every site, for each measurand listed in its tables B1 a to d, and a failed ring trial must be investigated, its cause removed and the whole process documented.
In SamLab: Per-analyzer QC records and a retained history of every corrective action, so the quarterly ring-trial evidence and the follow-up on a failure are on file rather than reconstructed.
On any day patient samples are measured, Rili-BÄK requires a control sample to be measured at least twice within 24 hours and no more than 16 hours apart, and again after every intervention in the measuring system.
In SamLab: Internal QC with Levey-Jennings tracking per analyzer, with the acceptance rule applied and the run recorded, so the twice-daily control measurements are visible per instrument and per day.
Ring-trial certificates and the quality-assurance documentation under § 10 MPBetreibV must be retained for five years.
In SamLab: Local plus encrypted off-site backup and an export of QC and result history by date range, so five years of records survive a machine failure and can be produced on request.
DAkkS accredits medical laboratories to DIN EN ISO 15189 on a cycle of at most five years with regular surveillance, and its rule R-15189 treats Rili-BÄK as the state of the art within the Betreiberverordnung for accredited laboratories.
In SamLab: Reference ranges with units per test, verifier identity on every result, a retained amendment history and specimen traceability from receipt to report, the ISO 15189 evidence an assessor examines.
Since 1 January 2025 every German business must be able to receive electronic invoices, while invoices for VAT-exempt medical services under § 4 Nr. 14 UStG are excluded from the duty to issue them; statutory-insurance laboratory work is billed under EBM chapter 32 and private work under GOÄ section M.
In SamLab: Invoices with the VAT treatment set per service, separate ledgers for statutory, private and referring-practice work, and exports for the practice-management or billing software that submits to the KV.
Source: Bundesärztekammer — Rili-BÄK, Richtlinie zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen · checked 2026-09-03. Accreditation is granted to the laboratory, not to its software — what SamLab provides is the records an assessor asks to see.
Runs when the internet doesn’t
Registration, billing, result entry and reports work with the connection down and sync when it returns. Prices are shown in your own currency.
Questions from Germany laboratories
Is SamLab Rili-BÄK compliant?
Rili-BÄK binds the laboratory, not its software: § 10 MPBetreibV requires the laboratory to run a quality-assurance system, and following the guideline is how compliance is presumed. SamLab produces the records that system consists of, including internal QC per analyzer measured and recorded as the guideline requires, ring-trial and corrective-action history, and five-year retention through backup and export.
Does SamLab support a DAkkS accreditation to ISO 15189?
DAkkS grants accreditation to the laboratory on a cycle of at most five years with surveillance in between. SamLab keeps reference ranges with units, the identity and time of every verification, every amendment with its earlier value, and specimen traceability from receipt to report, and exports them as evidence. The software itself cannot be accredited.
Can SamLab bill under EBM and GOÄ?
SamLab records each service with its tariff reference and VAT treatment, keeps statutory, private and referring-practice work in separate ledgers, and exports for the practice-management software that submits to the Kassenärztliche Vereinigung. Confirm your specific KV submission format in a demo before you commit.
What happens when the internet drops?
Registration, billing, result entry, reporting and analyzer capture keep working. SamLab runs from a local database on your own machine and synchronises when the connection returns.
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