The words lab software vendors use

LISLaboratory Information System

A LIS is the software a clinical laboratory runs its daily work on — registering patients, ordering tests, capturing results from analyzers, and issuing reports. It is the system of record for what was tested, for whom, and what the result was.

The term is used most often for clinical and pathology laboratories doing patient testing, as opposed to research or industrial labs. A LIS typically covers registration, billing, specimen tracking, result entry, instrument interfacing, verification and report delivery. Whether it also covers accounting and inventory varies by product rather than by definition.

In SamLab: SamLab is a LIS with the billing, accounting and reporting a diagnostic centre needs, built to run offline-first on the lab’s own machine.

See also: lims, astm, hl7

LIMSLaboratory Information Management System

A LIMS manages samples, workflows and data in a laboratory — most often a research, environmental, food or industrial lab rather than a clinical one. It is sample-centric where a LIS is patient-centric.

In practice the two words are used interchangeably by buyers and precisely by vendors, which is why search results for them overlap so heavily. The useful distinction is the unit of work: a LIMS tracks a SAMPLE through a workflow and cares about batches, protocols and chain of custody; a LIS tracks a PATIENT and cares about orders, reference ranges and a clinician-readable report.

See also: lis

Analyzer middleware

Software that sits between laboratory instruments and the LIS, usually supplied by the instrument manufacturer. It collects results from one or more analyzers and passes them on, sometimes applying rules or auto-verification first.

Middleware is useful where many instruments share a bench or where the vendor’s own rules engine is wanted. It is not required to connect an analyzer: an instrument that speaks ASTM or HL7 over serial or TCP can be read directly. Buying middleware you do not need adds a licence, a server and another thing to fail.

In SamLab: SamLab connects directly to the instrument, and can also sit downstream of existing vendor middleware where a lab already runs it.

See also: astm, hl7, bidirectional interface

ASTM (E1381 / E1394)also published as CLSI LIS1-A and LIS2-A2

The messaging standard most bench analyzers use to send results to a laboratory system. E1381 defines the low-level transfer over a serial or network link; E1394 defines the record structure carrying patient, order and result.

CLSI later reissued the same work as LIS1-A and LIS2-A2, so an instrument manual saying “LIS2-A2” and one saying “ASTM E1394” are describing the same thing. It has been stable for decades, which is why a fifteen-year-old analyzer is often easier to interface than a new one behind proprietary middleware.

In SamLab: SamLab’s LIS engine is built around ASTM over serial or TCP, with a small parser file per analyzer model carrying that machine’s test-code map.

See also: hl7, bidirectional interface, middleware

HL7 v2Health Level Seven, version 2

The messaging standard used to exchange clinical data between healthcare systems — a laboratory and a hospital information system, or a lab and a referral lab. ORU^R01 is the message type that carries results.

HL7 v2 is pipe-delimited and predates modern APIs, but it remains what most hospital systems actually speak. It matters for system-to-system exchange rather than for the bench: the majority of analyzers speak ASTM, not HL7. Versions differ enough in practice that any integration is confirmed against the counterpart’s real message spec.

In SamLab: HL7 v2 message reconciliation is available on the Enterprise plan — inbound results are matched to an open order before being written, so a reused order number cannot silently attach a result to the wrong patient.

See also: astm, fhir

FHIRFast Healthcare Interoperability Resources

The modern REST/JSON successor to HL7 v2, built around discrete “resources” such as Patient, Observation and DiagnosticReport. It is what most new national health-data programmes specify.

A vendor answering “yes, we support FHIR” without asking which resource types and which implementation guide has not understood the question — conformance is defined by the profile, not by the word. FHIR and HL7 v2 commonly coexist, with v2 carrying day-to-day traffic while FHIR serves newer programme integrations.

In SamLab: Not implemented. FHIR is on the SamLab roadmap and this entry exists so the honest answer is findable.

See also: hl7

Bidirectional interface

An analyzer connection that works both ways: the laboratory system sends the worklist to the instrument, and the instrument sends results back. A unidirectional interface only does the second half.

Bidirectional operation removes the step where someone selects tests on the instrument keypad, which matters most on biochemistry and immunoassay analyzers with a varying menu. Whether it is possible is a property of the INSTRUMENT — many bench analyzers only broadcast results and have no host-query mode, and no laboratory system can add one.

See also: astm, middleware

LOINCLogical Observation Identifiers Names and Codes

A universal coding system for laboratory tests and clinical observations, so that “serum sodium” means the same code in every system exchanging it. Widely required for health-information exchange in the US.

LOINC solves the problem that every lab and every analyzer names tests slightly differently. It matters when results leave the laboratory for a system that did not order them. Within a single lab, a local code map does the same job for less effort, which is why many labs only encounter LOINC when they first integrate externally.

See also: hl7, fhir

ISO 15189

The international standard for quality and competence in medical laboratories. Accreditation against it is granted to a LABORATORY by a national accreditation body — never to software.

It covers the management system, personnel competence, equipment, pre-analytical and post-analytical processes, quality control and reporting. National bodies apply it under their own schemes: UKAS in the UK, KENAS in Kenya, SANAS in South Africa, MLSCN in Nigeria, NABL in India. What software can do is produce and retain the records an assessment examines.

In SamLab: SamLab supplies the record trail — barcoded specimen traceability, IQC with Levey-Jennings, audit logs, and a result revision history where a verified result locks. It cannot make a laboratory accredited, and no software can.

See also: iqc, eqas, clia, nabl

CLIAClinical Laboratory Improvement Amendments

The US federal regulatory standard covering laboratory testing on human specimens. A CLIA certificate is required to report patient results in the United States, and the certificate is held by the laboratory.

CLIA is regulatory and mandatory; CAP accreditation is a separate, voluntary programme that can satisfy CLIA requirements through deemed status. Both examine records: who performed a test, whether quality control was in range, and whether a result was verified before release.

See also: cap, iso 15189, iqc

CAP accreditationCollege of American Pathologists

A voluntary US laboratory accreditation programme with detailed checklists, inspected on a two-year cycle. It is held by the laboratory and can satisfy CLIA requirements through deemed status.

CAP inspections are checklist-driven and document-heavy, which is where a laboratory system either helps or hurts: consistent report formats, retrievable quality-control records and a defensible audit trail are the difference between an inspection that goes smoothly and one that does not.

See also: clia, iso 15189

IQCInternal Quality Control

Running known control material alongside patient samples to check that an analytical run is performing as expected, before results are released. Plotted over time on a Levey-Jennings chart and judged against Westgard rules.

IQC answers “is the instrument right today?”, which is a different question from EQAS’s “is this laboratory right compared with its peers?”. A failed control caught at the point of running costs a repeat; the same failure caught after reports have gone out costs recalls.

In SamLab: IQC with Levey-Jennings charting and Westgard rule monitoring is retained per analyte and per instrument.

See also: eqas, levey jennings, iso 15189

EQAS / PTExternal Quality Assessment Scheme / Proficiency Testing

A scheme where an external provider sends unknown samples that the laboratory tests and reports back, so its results can be compared against other laboratories using the same method.

EQAS is a requirement of most accreditation schemes and is the only routine check on whether a laboratory’s results agree with everyone else’s. It complements IQC rather than replacing it: internal control can be perfectly stable around a value that is systematically wrong.

See also: iqc, iso 15189

Levey-Jennings chart

A control chart plotting quality-control results over time against the mean and standard deviation lines, so drift and shift are visible before they become an out-of-range failure.

Westgard rules are the decision rules applied to that chart — for example, one point beyond 3SD rejects a run, while two consecutive points beyond 2SD on the same side suggests systematic error rather than random noise. The chart is what makes those patterns visible at a glance.

See also: iqc

TATTurnaround Time

The elapsed time from sample collection to report release. Usefully split into three intervals: collection to receipt, receipt to result, and result to report delivered.

In most small and mid-size laboratories the analytical middle interval is the smallest of the three, which is why buying a faster analyzer is usually the most expensive way to address the least of the problem. Referring clinicians value predictability over speed, so a target per test group beats one lab-wide number.

See also: pre analytical

Pre-analytical phase

Everything before the sample is analysed: ordering, patient identification, collection, labelling, transport and accessioning. It is where the majority of laboratory errors originate.

Haemolysis, insufficient volume, wrong tube, and above all mislabelling are pre-analytical failures, and none of them is detectable by the analyzer. Barcoding at registration — labelling the tube before it is filled — removes the step where a human reads a number and types it somewhere else.

See also: tat, accessioning

Accessioning

Receiving a specimen into the laboratory and giving it a unique identifier that ties it to the order and the patient for the rest of its life in the lab.

The accession number is what the analyzer matches on, what the worklist is sorted by, and what a query three years later is answered from. Where labelling happens at registration rather than at the bench, accessioning stops being a queue.

See also: pre analytical

Critical / panic value

A result so far outside the normal range that it may indicate immediate danger to the patient, requiring the laboratory to notify the requesting clinician directly rather than simply issuing a report.

Accreditation schemes expect a defined list of critical values, a defined notification path, and a record that notification actually happened including who was told and when. This is distinct from an ordinary out-of-range flag — treating both the same way means the genuinely urgent result competes for attention with everything else.

In SamLab: Critical high and critical low are handled separately from ordinary out-of-range flagging.

See also: reference range

Reference range

The interval of values expected in a healthy population for a given analyte, printed beside the result so a clinician can interpret it. Frequently qualified by sex, age or pregnancy status.

Ranges are method-dependent and instrument-dependent, so a range copied from a textbook may not apply to the assay actually in use. A single global band per analyte is the commonest reporting shortcut and the commonest source of a misleading flag on a paediatric or antenatal sample.

See also: panic value

Verification / authorisation

The step where a qualified person reviews a result and releases it for reporting. Until it happens the result is provisional; after it happens the value is part of the clinical record.

What accreditation schemes examine is not only that verification occurred but that it is attributable and that any later change is traceable. A system that lets a verified value be edited silently cannot answer the question an assessor actually asks, which is “what did the clinician see, and when did it change?”

In SamLab: A verified result locks, and any amendment is versioned with its reason kept alongside the original value.

See also: amendment, panic value

Amended report

A report reissued after a result has already been released, because the original was wrong or incomplete. The amendment must be visible as an amendment, not a silent replacement.

The record has to show the original value, the corrected value, who changed it, when and why. Overwriting quietly is the failure mode that turns a small analytical error into an unanswerable question during an inspection or a complaint.

See also: verification