Accurate results depend on accurate data
A laboratory information system touches every result the laboratory issues: the request, the sample label, the analyser interface, the report and the record kept afterwards. When it is poorly chosen, configured or validated, errors creep in quietly and workarounds multiply.
ISO 15189:2022 expects laboratory information systems, including their interfaces, to be validated before use and controlled afterwards, with data protected against loss and unauthorised change. We help you meet that requirement while making daily work faster: comparing systems against your needs, validating configuration and interfaces, redesigning workflows around the system and auditing data integrity.
The work applies whether you are choosing a first LIS, replacing an old one or getting more from the system you already have.
How it works
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LIS vendor evaluation
Requirements drawn from your tests, volumes and reporting needs, then a structured comparison of the systems on offer.
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Configuration and interface validation
Test catalogue, reference ranges, calculations, report formats and analyser interfaces checked end to end before go-live.
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Workflow re-engineering
Sample reception, processing and reporting redesigned around the system to cut manual transcription and bottlenecks.
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Data integrity audits
Review of user access, audit trails, backups and change control, and of data passed between systems.
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Reporting and dashboard design
Patient reports that read clearly for clinicians, and quality indicator dashboards for your management review.
What you receive
Requirements and evaluation report
Your documented requirements and a scored comparison of the systems assessed against them.
Validation records
Test scripts and results for the configuration and each interface, with sign-off before go-live.
Workflow maps
Current and redesigned workflows, with the procedure changes they require.
Data integrity findings
Audit results with recommended controls for access, audit trails, backup and change management.
Common questions
Do you recommend a specific LIS?
No single system suits every laboratory. We compare the systems on offer against your requirements, and the final choice stays with you.
Do we need to validate an LIS that is already in use?
If it was never formally validated, or has been changed since, yes. Validation can be done on the live configuration, starting with the highest-risk areas such as analyser interfaces and calculated results.
Can you help after an interface error or data incident?
Yes. A data integrity audit traces how the error happened, identifies other results that may be affected and recommends controls to prevent it happening again.
What can the quality dashboards show?
Turnaround time, specimen rejection rates, amended reports and the other quality indicators you monitor, drawn from LIS data wherever the system allows it.