LIS Software for Belgian Laboratories — INAMI & BELAC
A laboratory information system built for a Belgian laboratoire de biologie clinique approved under the royal decree of 3 December 1999: the quality manual and external quality evaluation it requires, the electronic billing file INAMI reimbursement demands, and no dependence on the connection.
Quel logiciel de laboratoire pour un laboratoire de biologie clinique en Belgique ?
SamLab est un système d’information de laboratoire offline first pour les laboratoires de biologie clinique belges agréés. Il conserve les preuves du manuel qualité, le registre d’évaluation externe, l’identité du biologiste validant et l’historique des modifications, exporte le fichier de facturation électronique INAMI et continue de fonctionner sans internet. L’agrément appartient au laboratoire.
What a Belgian laboratory is approved and reimbursed against
A Belgian clinical biology laboratory is approved by the Minister of Public Health under the royal decree of 3 December 1999, for a period of at most five years: it must document its quality system in a quality manual, appoint a director from the specialists in clinical biology, and take part in external quality evaluation programmes run by Sciensano. Reimbursement by INAMI/RIZIV is available only to approved laboratories, and in third-party payment a claim must be accompanied by an electronic billing file. Since 1 January 2024 a laboratory may charge supplements only with the patient’s express prior agreement. From 2026 business-to-business invoices travel as Peppol e-invoices, with businesses performing only VAT-exempt operations excluded.
Approval of a clinical biology laboratory is granted for a period of at most five years, and each laboratory must document its quality system in a quality manual meeting the decree’s criteria (royal decree of 3 December 1999, articles 9 and 11).
In SamLab: A laboratory profile holding the approval reference and expiry, and process records — QC, verification, amendments, corrective actions — that print as the quality manual’s evidence.
The operator appoints a laboratory director from the specialists in clinical biology, and participation in external quality evaluation programmes is obligatory (articles 13 and 29 of the same decree).
In SamLab: Verifier identity on every result tied to the director’s record, and an external-quality-evaluation register per analyte with organiser, date and result.
Reimbursement is reserved for laboratories approved by Sciensano, and in third-party payment the claim must be accompanied by the delivery of an electronic billing file, according to INAMI.
In SamLab: Per-prescription claim data with nomenclature codes, prescriber and insurer, exported as the electronic billing file the third-party-payment channel requires.
Since 1 January 2024 a laboratory may charge supplements only with the patient’s express prior agreement, the unilateral administrative fee is abolished, and fully conventioned laboratories may charge none, according to INAMI.
In SamLab: Invoices that separate the reimbursable amount, the patient’s share and any agreed supplement, with the agreement recorded per patient.
Source: Arrêté royal du 3 décembre 1999 — agrément des laboratoires de biologie clinique (Moniteur belge) · 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 Belgium laboratories
SamLab est-il agréé ou accrédité en Belgique ?
L’agrément est accordé par le ministre de la Santé publique au laboratoire, et l’accréditation ISO 15189 par BELAC, jamais au logiciel. SamLab fournit les preuves que le manuel qualité et une évaluation exigent : intervalles de référence avec unités, identité du biologiste validant, historique conservé des modifications, registre d’évaluation externe de la qualité et traçabilité du prélèvement au protocole.
SamLab produit-il le fichier de facturation électronique INAMI ?
SamLab tient par prescription les codes de nomenclature, le prescripteur et l’organisme assureur, sépare le montant remboursable, la part du patient et un éventuel supplément convenu, et exporte le fichier de facturation électronique qu’exige le tiers payant. Confirmez la chaîne de transmission lors d’une démonstration.
Que se passe-t-il si internet tombe ?
L’enregistrement, la facturation, la saisie des résultats, l’édition des protocoles et la connexion aux automates continuent de fonctionner. SamLab travaille sur une base de données locale, sur la machine du laboratoire, et se synchronise quand la connexion revient.
Try the whole lab, free for 7 days.
No card. No catch. Run SamLab on your own data — online or offline — and feel the difference before you pay anything.