Software LIS per laboratori analisi in Italia
A laboratory information system built for an Italian laboratorio di analisi: the records regional authorisation and accreditamento istituzionale examine, the ISO 15189 evidence an ACCREDIA assessment asks for, and the patient-invoice data the Sistema Tessera Sanitaria collects.
Quale software LIS per un laboratorio di analisi cliniche in Italia?
SamLab è un sistema informativo di laboratorio offline-first per laboratori di analisi cliniche italiani. Conserva intervalli di riferimento con unità, identità di chi valida ogni risultato, storico delle modifiche e tracciabilità del campione per l’autorizzazione regionale e una valutazione ACCREDIA ISO 15189, esporta le fatture per il Sistema Tessera Sanitaria e continua a funzionare senza internet. L’accreditamento appartiene al laboratorio.
What an Italian laboratory is authorised and accredited against
Under article 8-ter of Decreto legislativo 502/1992, building a health structure and exercising health activity, explicitly including structures dedicated only to diagnostics, require authorisation, with the regions setting the procedure. To work for the national health service a laboratory also needs accreditamento istituzionale from the region under article 8-quater, granted only on further quality requirements and a positive verification of activity. Accreditation to UNI EN ISO 15189 is granted by ACCREDIA and is voluntary nationally. Every structure delivering health services sends its patient invoices to the Sistema Tessera Sanitaria, health services to consumers must never be e-invoiced through the Sistema di Interscambio, and diagnostic services are exempt from VAT under article 10 of DPR 633/1972.
Building a health structure and exercising health activity, including structures dedicated exclusively to diagnostic activity, are subject to authorisation, with the regions setting procedures and deadlines (D.Lgs 502/1992, article 8-ter).
In SamLab: A laboratory profile that prints the regional authorisation reference and the responsible director on every report, and staff and equipment registers for the authorisation inspection.
Accreditamento istituzionale, required to bill the national health service, is granted by the region only to authorised structures that meet further quality requirements and pass a positive verification of the activity performed (article 8-quater).
In SamLab: Verifier identity on every result, a retained amendment history, internal QC per analyzer and specimen traceability, exportable as the evidence a regional verification reads.
Every structure or professional delivering health services must send its patient invoices to the Sistema Tessera Sanitaria, authorised non-accredited structures included since 1 January 2016, by 31 January of the following year.
In SamLab: Patient invoices carrying the codice fiscale and the classification the Sistema TS needs, exported for the annual transmission.
No electronic invoice may ever be issued through the Sistema di Interscambio for a health service delivered to a final consumer, according to the Agenzia delle Entrate.
In SamLab: Consumer invoices kept outside the SdI flow by design, while business invoices carry the fields an SdI e-invoice requires.
Source: D.Lgs 502/1992, articles 8-ter and 8-quater (Normattiva) · 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 Italy laboratories
SamLab è accreditato ACCREDIA?
L’accreditamento è rilasciato da ACCREDIA al laboratorio, mai al software. SamLab fornisce le evidenze che una valutazione secondo la UNI EN ISO 15189 esamina: intervalli di riferimento con unità, identità di chi valida ogni risultato, storico conservato delle modifiche e tracciabilità del campione dal prelievo al referto.
SamLab invia le spese al Sistema Tessera Sanitaria?
SamLab produce le fatture ai pazienti con il codice fiscale e la classificazione che il Sistema TS richiede e le esporta per la trasmissione annuale entro il 31 gennaio; le fatture ai consumatori restano fuori dal flusso SdI, come impone l’Agenzia delle Entrate.
Cosa succede se cade la connessione internet?
Accettazione, fatturazione, inserimento risultati, stampa referti e collegamento agli analizzatori continuano a funzionare. SamLab lavora su un database locale, sulla macchina del laboratorio, e si sincronizza quando la connessione torna.
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