Sectors · Laboratories

Medical laboratories with fewer manual steps from sample to result.

Blood, urine, microbiology cultures and tissue samples. We connect your LIS (laboratory information system) with referring doctors, collection points, analysers and patients, and build the software that is still missing. Orders arrive electronically. Every tube can be traced from the collection point to the analyser. Results reach the doctor and the patient when they are validated, and your quality manager gets the documents the quality system needs.

Systems
LIS · middleware · analysers
Standards
HL7 v2 · ASTM · FHIR · LOINC · EN ISO 15189
First step
Free call with our management
The sample path

A sample's path from the order to the result.

01

Order

The referring doctor's order arrives on paper or by phone, and reception types it into the LIS.

ImprovementOrders arrive electronically with the patient identified, so nobody retypes them.

02

Collection

Staff take the sample at a collection point, label it and register it.

ImprovementThe label prints at the collection point from the electronic order, with one sample identifier.

03

Transport

Couriers bring samples from several sites to the laboratory, and nobody can say where a tube is on the way.

ImprovementEvery hand over is scanned, so staff see where each tube is and which one is overdue.

04

Analysis

The analyser runs the sample, and the result travels through the middleware to the LIS. Each new analyser means a new interface project.

ImprovementA new analyser is connected from its interface manual, tested and documented for the quality system.

05

Validation

Staff check the result against reference ranges and flag critical values.

ImprovementCritical values reach the ordering doctor, with a record of who was told and when.

06

Result delivery

Staff email the validated report as a PDF, and nobody can see whether it arrived.

ImprovementResults go out automatically to the doctor's system and the patient portal, and every delivery is logged.

The goal

Results out on time, from a laboratory whose software is documented.

For the laboratory

  • Turnaround and capacity visible across sites and analysers
  • A new analyser connected as a defined work package, with its documents for the quality system

For staff and the quality manager

  • No retyping of orders at reception
  • The last scan of every tube known, with overdue tubes flagged
  • Interface specifications, test records and a change log ready for the quality system

For patients and referring doctors

  • The right tests for the right patient
  • Results in the portal once they are validated and released
  • Reference ranges and earlier values next to each result
Problems and solutions

What we hear, and what we do about it.

Orders arrive on paper and are typed into the LIS at reception.

We build an order entry form, or an interface from the doctor's system, that creates the order in the LIS with the patient identified. The label prints at the collection point.

Digitalisation and workflow automation
Between the collection point and the analyser we cannot say where a tube is.

Every station reads and writes one sample identifier. Hand over, arrival and loading are scanned with a time and a name, and an overdue tube raises an alert before anyone asks for its result. In a laboratory chain we also plan courier routes, collection point hours and the run plan of each analyser.

Digitalisation and workflow automation
Each new analyser is an interface project, and the LIS supplier sets the price.

We build the connection from the analyser's interface manual, over ASTM or HL7 v2, with LOINC codes on the results. We test it message by message against a simulator, then on site with the analyser and control samples, and hand over the specification and the test records.

Interoperability
Results go out as PDFs by email, and nobody can see whether they arrived.

Released results go to the doctor's system, to a patient portal with reference ranges and earlier values, and to the national record. Results that a doctor should explain first can be held back by a rule.

Interoperability
Under ISO 15189 we have to validate and document our software, and supplier papers arrive late or not at all.

The laboratory validates and documents how it uses software. We deliver the documents the quality manager files, which are the interface specification, the test records and a change log for every release, written for your quality system. Accreditation stays with the laboratory and the accreditation body.

QA and regulatory compliance
We want AI in digital pathology and cannot compare the vendors' claims.

We compare CE marked or FDA authorized IVD algorithms for whole slide images against your criteria and test them on your own slides before you decide. We then connect the chosen one to the scanner, the image store and the LIS.

Clinical AI selection and integration
Systems

The laboratory systems, and the interfaces between them.

SystemWhat it holdsInterfaceOur work
LISOrders, samples, results, audit trailHL7 v2 ORM, OML, ORU · FHIR ServiceRequestElectronic orders with the patient identified, one sample identifier, and alerts for overdue tubes.
Analysers and middlewareInstrument messages, reference rangesCLSI LIS1-A and LIS2-A2 (formerly ASTM E1381, E1394) · HL7 v2 OUL, ORU · POCT1-AWe build the interface from the analyser manual, test it against a simulator, then on site with the analyser and control samples, and hand the test records to the quality manager.
Doctor's systemOrders and released resultsHL7 v2 ORU · FHIR DiagnosticReport, Observation · LOINCResults go to the ordering doctor, and critical values are sent with a record of who was reached and when.
Patient portalReports, reference ranges, earlier valuesFHIR DiagnosticReport · PDFThe patient signs in to see results, and results a doctor should explain first are held back by a rule.
Digital pathologyWhole slide imagesDICOM WSI (Supplement 145) · DICOMwebScanner integration, an image store sized for whole slide images, a web viewer, and the link from the slide to the case in the LIS.
National recordResults shared with other providersTelematikinfrastruktur and ePA (DE) · ELGA (AT) · EPD (CH) · EESZT (HU)When a system is replaced, we test that the connection to the national record still works through the certified components already in place.
Fit

When we are the right partner.

Call us when

  • You want orders and results to move between the LIS and the doctors without retyping
  • You want to know where every sample is between the collection point and the analyser
  • You want a new analyser connected as a defined work package, with its documents for the quality system
  • You want your quality manager to have the software documents ISO 15189 asks for
Talk to us

Tell us what you would like to improve.

An order flow, sample tracking or an analyser connection. Write a few lines, or book a free call with our management.

Book a call with our management
We reply within one working day.
FAQ

Frequently asked questions.

01

Can you connect a new analyser to our LIS?

Yes, where the analyser has a documented interface. We specify the messages from its interface manual, build the connection to the LIS or the middleware, test it against a simulator and then on site, and hand over the interface specification and the test records.

02

Do you sell a LIS?

No. We build around the LIS you run. When you replace a LIS, we write the requirements and a scoring matrix for the tender, and compare the vendors without favouring any of them, since we resell no product.

03

What do you give our quality manager under ISO 15189?

Under EN ISO 15189 the laboratory validates and documents how it uses software. We deliver the interface specification, the test records and a change log for each release, so the quality manager can file them. The validation and any accreditation stay with the laboratory.

04

Can you help us introduce AI in digital pathology?

Yes. We compare CE marked or FDA authorized IVD algorithms against your criteria, test them on your own slides before a decision, and integrate the chosen one with the scanner, the image store and the LIS.

05

How do you handle patient data under the GDPR?

Laboratory results are health data under Article 9 of the GDPR. Patient data stays in your systems and we work on it there. Test data is pseudonymised and stays in the EU, under a data processing agreement with Silurus Software as processor. In the US, the same work runs under HIPAA and a business associate agreement.

06

How does a first project start?

With a free call with our management about one process or one interface. The next step is a written scope with effort, duration and price, agreed before any work starts.