0–9
- 21 CFR Part 11
- The US FDA regulation governing electronic records and electronic signatures — requiring controls such as audit trails, system validation and signature integrity when records are kept electronically.
A
- Accession number
- A unique identifier assigned to a specimen or test request, used to track it through the workflow and match results back to the original order.
- ACK (acknowledgement)
- An HL7 v2 acknowledgement message. The receiving system returns an ACK to confirm that a message arrived and was accepted — or to signal that it was rejected.
- Accreditation
- Formal recognition by an authorised body that a laboratory or testing service meets the requirements of a defined standard, such as ISO 15189.
- Analyte
- The substance or component a test measures — glucose, haemoglobin and sodium are all analytes.
- ASTM E1381 / E1394
- A pair of older laboratory-instrument communication standards: E1381 defines the low-level framing and E1394 the message content, classically over a serial connection. E1394’s successor is CLSI LIS2-A2.
- Audit trail
- A chronological record of who did what, when and on which system — kept so that actions on data can be reconstructed and verified later.
B
- Bidirectional connectivity
- An interface in which data flows both ways — the host system can send information such as worklists, operator lists or time-syncs to the device, not just receive results from it.
D
- Data manager
- In the POCT1-A architecture, the central system that communicates with point-of-care devices and access points — collecting observations and managing device, operator and reagent information.
- Demographics
- The identifying details of a patient — name, date of birth, identifiers — carried with an order or result so it can be matched to the correct record.
E
- Edge gateway
- A small software agent installed near the instruments, typically on a clinic PC, that connects local analysers to a central platform and buffers data when the network is briefly unavailable.
- EHR / EMR
- Electronic Health Record / Electronic Medical Record — the patient’s electronic clinical record, into which diagnostic results typically need to flow.
- EQA (external quality assessment)
- Periodic blind testing of samples distributed by an external scheme, used to compare a service’s results against other participants. Closely related to proficiency testing.
F
- FHIR
- Fast Healthcare Interoperability Resources — HL7’s modern interoperability standard, which exchanges healthcare data as discrete resources over web APIs.
H
- HL7 v2
- The widely used healthcare messaging standard. For diagnostics, ORU messages carry results out and ORM messages carry orders in, usually framed with MLLP over TCP.
I
- Interface
- In laboratory informatics, the connection that lets an instrument and an information system — or two systems — exchange data automatically.
- IQC (internal quality control)
- Quality control performed by the testing site itself — running control materials and monitoring the results statistically to confirm a method is performing as expected.
- ISO 15189
- The international standard specifying quality and competence requirements for medical laboratories — the standard most medical-laboratory accreditation schemes assess against.
- ISO 22870
- The international standard that set quality and competence requirements specifically for point-of-care testing, used alongside ISO 15189. Its requirements were folded into ISO 15189:2022.
L
- Levey-Jennings chart
- A control chart plotting QC results against the mean and standard-deviation bands over time — a statistical view that makes drift, shifts and outliers visible.
- LIMS
- Laboratory Information Management System — software for managing samples, tests and workflows, most common in research and industrial laboratories. In clinical settings the equivalent role is usually played by a LIS.
- LIS
- Laboratory Information System — the software that manages orders, results and reporting in a clinical laboratory.
- LIS2-A2
- The CLSI standard, successor to ASTM E1394, that specifies the content and structure of messages exchanged between laboratory instruments and information systems.
- Lockout
- A device or data-manager setting that prevents testing until defined conditions are met — for example, valid QC or a certified operator.
- LOINC
- Logical Observation Identifiers Names and Codes — a universal coding system for identifying laboratory tests and clinical observations, so different systems can recognise the same test by the same code.
M
- Middleware
- The software layer that sits between analysers and systems such as a LIS or EHR — translating device protocols, normalising data and managing the flow of results.
- MLLP
- Minimal Lower Layer Protocol — the thin framing convention used to send HL7 v2 messages over a TCP connection.
O
- Operator competency
- The documented training and assessment confirming that an individual is qualified to perform a given test. Connectivity systems typically record operator identity and certification status alongside results.
- ORM
- The HL7 v2 order message — it carries a test request from an ordering system towards the system or device performing the test.
- ORU
- The HL7 v2 observation result message — it carries results and their associated details from the producing system outward.
P
- POCT (point-of-care testing)
- Diagnostic testing performed near the patient, outside the central laboratory.
- POCT-1A / POCT1-A2
- The connectivity standard built specifically for point-of-care devices, defining how instruments, access points and data managers exchange observations and directives. POCT1-A2 is the current revision.
- Proficiency testing
- A formal programme in which testing sites analyse blind samples and their results are compared across participants. In many regions the term is used interchangeably with EQA.
Q
- QC (quality control)
- Running known control materials to confirm an analyser is performing within expected statistical limits. In connected systems, QC status travels with the data it governs.
R
- Reference range
- The interval of values for an analyte established for a defined reference population. Laboratories and manufacturers publish reference ranges, and reporting systems display them alongside results.
- Result validation
- The step in which an authorised person reviews a result and releases it according to the organisation’s procedures, before it is reported onward.
T
- Tamper-evidence
- A property of records or audit trails that makes any later alteration detectable — for example, by chaining entries cryptographically.
- Turnaround time (TAT)
- The elapsed time from sample collection or receipt to the availability of a result — one of the standard operational measures of a testing service.
U
- UCUM
- The Unified Code for Units of Measure — a coding system that expresses units (mmol/L, g/dL and so on) in a single, unambiguous, machine-readable form.
W
- Westgard rules
- A set of multi-rule statistical criteria applied to control results to decide whether an analytical run should be accepted or rejected.
Two terms you'll meet constantly are unpacked properly in their own guides: What is POCT middleware? and HL7 vs POCT-1A vs ASTM.