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Stage 03 · Care

Full traceability, from the sample to the result.

LIS manages the clinical laboratory process from the order and sample collection through to professional validation and secure delivery of the result. It is aligned with ISO 15189 and gives the laboratory the tools to achieve and maintain its accreditation.

01 Who it is for

Connecting analysers and knowing the state of every sample

Clinical laboratories that need to replace scattered records, connect analysers, know the state of every sample and deliver results with professional control and traceability. Laboratories that are accredited, or working towards ISO 15189 accreditation, and need their system to hold the evidence the audit asks for. And laboratory networks with several branches that want to work from a single catalogue.

02 How it works

From the order to releasing the result

  1. The order identifies the tests requested, the preparation conditions and the authorisation to start the process. It can arrive from the institution’s HIS or electronic medical record.
  2. At collection, labels are printed and the system records who took the sample, when, and which containers were used.
  3. Reception confirms the integrity, identification and condition of the sample; any incidents are documented.
  4. Results are entered manually or received from multiple analysers integrated via ASTM, within the scope of the project.
  5. Reference ranges, configured rules and critical value alerts support the technical review.
  6. The authorised professional validates, signs and releases the result, leaving a record of states, owners and times.
  7. The result is published in a controlled way on the Portal for the patient and the referring physician, and becomes available to Clinic or to the institution’s HIS/EMR via HL7 or FHIR.
03 Key capabilities

What it includes

  • Orders, appointments, patient preparation and labelling with barcodes or QR codes.
  • Reception, chain of custody and sample traceability.
  • Integration with multiple analysers, with support for the ASTM protocol, as well as manual entry.
  • Configurable reference ranges, critical values, rules and alerts.
  • Technical and professional validation, electronic signature and controlled release.
  • TAT by stage: sample collection, result entry, validation and release.
  • HL7 and FHIR interoperability for orders and results.
  • Integration with the institution’s HIS and EMR.
  • Portal for referring physicians: they check their patients’ results without calling the laboratory.
  • Multiple branches with centralised catalogues: tests, panels and reference ranges are managed once and apply at every site.
04 Quality

Aligned with ISO 15189

LIS is designed around what ISO 15189 asks of a clinical laboratory: every sample identified and traceable, every result validated by someone with the authority to do so, and every correction recorded. The accreditation belongs to your laboratory; LIS gives you the evidence to achieve and maintain it.

What the audit reviews and how LIS supports it
What the audit reviews How LIS supports it
Sample identification and traceability Barcode or QR labelling and a chain of custody with the person responsible and the time at every step.
Reception and rejection conditions Record of integrity, conditions and incidents at reception.
Staff authorisation Separation of duties: reception, technologist, supervisor and validating professional.
Validation and release of results Technical and professional validation, electronic signature and controlled release.
Critical values Configurable alerts and a record of how each one was handled.
Report corrections Result versions with a history of changes.
Turnaround times Total TAT and TAT by stage.
05 Integrations

It connects with what your laboratory already has

Analysers, institutional systems and referring physicians, through open standards.

What LIS integrates with and how
With what How
Laboratory analysers Integration with multiple analysers, with support for the ASTM protocol.
HIS, EMR and clinical records HL7 and FHIR.
Other institutional systems REST APIs.
Referring physicians Web portal with access to their patients’ results.
The rest of the ecosystem Q-Flow, Q-Pay and Clinic, within the same ecosystem.
06 Data ownership

Your data is yours

The platform is ours; the data belongs to your institution. You can request a complete handover of your information at any time.

07 Value for the organisation

What changes in the operation

Accuracy

Less duplication and less manual transcription.

Traceability

A complete history of the sample and the result.

Performance

Actionable TAT for fixing bottlenecks.

Compliance

The evidence accreditation asks for, generated by day-to-day operation.

08 Connection with the ecosystem

How it connects with the rest

It receives the patient and the authorisation from Q-Flow and Q-Pay; it publishes results through the authorised channels and shares them with Clinic, so the physician finds them in the record without looking for them separately. If the institution already has an HIS or EMR, LIS connects to it via HL7 or FHIR.

09 Management and indicators

What can be administered and what can be measured

Management and control

  • Catalogues of tests, panels, samples, containers and reference ranges, centralised for every branch.
  • Chain of custody and traceability from collection through to release.
  • Separation of duties for reception, technologist, supervisor and validating professional.
  • Management of critical values, corrections, incidents and result versions.

Indicators it can provide

  • Total TAT and TAT by stage: collection, entry, validation and release.
  • Results pending, in progress, validated and released.
  • Productivity by test, technologist, shift or analyser.
  • Critical values, repeats and sample incidents.

These are the indicators the module calculates from your institution’s own operation.

10 Frequently asked questions

What people usually ask about LIS

Is IRRAD’s LIS aligned with ISO 15189?

Yes. LIS covers sample traceability and chain of custody, separation of duties, validation and electronic signature, critical value management, versions of corrected results and TAT by stage. Accreditation is granted to the laboratory by the accreditation body; LIS provides the tools and the evidence to achieve and maintain it.

Does it work for a laboratory with ISO 9001 or ISO 27001?

Yes. TAT, productivity and incident indicators support ISO 9001 continual improvement, and role-based access, the activity record and controlled delivery support ISO 27001 information security.

Which analysers does it integrate with?

With multiple analysers from different manufacturers, with support for the ASTM protocol. The list of instruments is confirmed for each project.

Does it integrate with our HIS or electronic medical record?

Yes, via HL7 and FHIR, as well as REST APIs for other institutional systems.

Can referring physicians see the results?

Yes. The referring physician portal gives them access to their patients’ results once released.

Who owns the data?

Your institution. The platform belongs to GT-IT Medical; the data belongs to the client and is handed over in full whenever it is requested.

Does it work for a laboratory with several branches?

Yes. LIS works with multiple branches and centralised catalogues: tests, panels and reference ranges are managed once and apply at every site.

Is it available in the cloud and on premises?

Yes. LIS is part of IRRAD Cloud, for clinics and medical centres, and of TGMed Enterprise, for complex institutions, with the capabilities described on this page.

LIS makes every stage of the laboratory visible; measuring TAT stage by stage lets you find the bottleneck instead of blaming the whole clock.
Available in both editions

The process is the same. How it is implemented is different.

This module is part of the ecosystem and is available in both IRRAD Cloud and TGMed Enterprise. What changes is the implementation model, not what it covers.