Free guide · ISO 15189
Pre-analytical phase · EN ISO 15189:2022

Get ready for accreditation ISO 15189

Up to 68,2% of laboratory errors occur in the pre-analytical phase. Our practical guide shows you how to meet the requirements of the standard EN ISO 15189 — sample collection, transport and traceability — without disrupting your lab's processes.

68,2%of errors in the pre-analytical phase
< 2 weeksup and running in the lab
100%sample traceability
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SynlabRocheBeckman CoulterLabor BerlinKBC RijekaHaemalab FreisingHospital de Olot

68.2% of errors start before the lab

Problems start at order entry, in sample non-conformities, in transport delays and in the lack of cold-chain control. Most are discovered only after analysis — too late to avoid repeats, clinical delays and extra costs.

The standard ISO 15189:2022 requires traceability, control and recording across the whole pre-analytical phase. S4DX covers them end-to-end, from collection to receipt.
68,2%Pre-analytical phase
collection, transport, order entry
23%Post-analytical phase
reporting
9%Analytical phase
analyzer, reagents

From collection to receipt, a single tracked flow

Every sample has a digital fingerprint: S4DX follows it end-to-end, generating the data ISO 15189 requires at every step.

01

Pre-collection

Unambiguous patient/sample identification and pre-analytical guidance, right from the request.

02

Collection

Record operator, date and time; the SmartTube starts monitoring temperature and shocks.

03

Transport

Temperature and times monitored in transit; alerts if integrity is compromised.

04

Receipt

Automatic receipt, acceptance/rejection flags and end-to-end traceability through to the report.

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Pre-analytical compliance, without the complexity

End-to-end traceability

From collection to delivery in the lab, every sample is recorded, monitored and verified in real time. Full chain of custody.

ISO 15189 requirements covered

A complete, auditable trail for every sample, ready for inspection and accreditation to EN ISO 15189:2022.

More predictable TAT

Fewer repeats and fewer hours spent chasing samples. A measurable, defensible turnaround time, backed by data.

Patient safety

Every clinical decision rests on a sample whose quality is verifiable from the first second. No ghost samples.

The ISO 15189:2022 requirements S4DX covers

For every pre-analytical phase, S4DX generates the data and traceability the standard requires — audit-ready.

7.2.4.2

Pre-collection activities

Patient preparation, sample type and container, timing and relevant clinical information.

S4DX: pre-analytical guidance and an unambiguous patient/sample link right from the request.
7.2.4.4

Sample collection

Verification of patient identity, collection order, recording of operator, date and time.

S4DX: records who, when and how, with condition tracking (temperature, shocks) from the very first moment.
7.2.5

Sample transport

Time between collection and receipt, specified temperature range, sample integrity.

S4DX: monitors temperature and times in transit and flags if integrity is compromised.
7.2.6

Sample receipt

Unambiguous traceability, acceptance and rejection criteria, date/time recording, handling of urgent samples.

S4DX: automatic receipt, acceptance/rejection flags and end-to-end traceability through to the report.

Certified quality and security

Made in Germany & Made in Europe
Made in Germany & Europe — hardware and software built and supported in the EU
DIN EN ISO 9001:2015 — quality management system
DIN ISO/IEC 27001:2022 — information security
Data encrypted on EU servers — compliant with ISO 15189 and GDPR requirements
“

With the S4DX sample tracking system we save up to 6 hours a day of administrative work in our laboratory.

Jürgen Weghofer
COO, Synlab Austria