A point-of-care testing device earns its place in a GP surgery the moment it shortens a diagnostic decision from days to minutes. What is less visible to the clinician reading the result is who is responsible for proving that number is trustworthy in the first place. Point-of-care testing quality assurance is not a one-off validation at installation — it is an ongoing governance function, and in most well-run services it has a named owner: the POCT Coordinator.
Why point-of-care testing needs its own governance layer
A sample sent to a hospital pathology laboratory passes through trained biomedical scientists, calibrated analysers, and a quality management system that has been accredited for decades. A point-of-care device, by contrast, is typically operated by a receptionist, healthcare assistant, or nurse who has other jobs to do that day. The test itself may take two minutes; the infrastructure needed to trust its output does not shrink to match. Moving the analyser closer to the patient does not remove the need for quality control — it just relocates who has to run it.
This is the gap that point-of-care testing quality assurance exists to close: making sure a device sitting on a consulting-room shelf is held to a standard comparable to the laboratory it is replacing, even though it is operated by non-laboratory staff, often without a scientist in the building.
The standards a compliant service is built on
Near-patient testing in the NHS is not governed by a single document, but by a small stack of standards that fit together. The core reference point is ISO 15189, the international standard for the quality and competence of medical laboratories, which was updated in its 2022 revision to explicitly incorporate point-of-care testing requirements — the previous separate standard for POCT, ISO 22870:2016, is being withdrawn as a result. In practice, this means a GP practice's POCT service is expected to meet essentially the same competence bar as a hospital laboratory, just applied to a device the size of a printer.
Underneath that international standard sit two UK-specific mechanisms. UKAS, the United Kingdom Accreditation Service, is the body that accredits POCT services against ISO 15189 and provides the independent assurance that a practice's quality claims hold up to scrutiny. Alongside accreditation, the MHRA (Medicines and Healthcare products Regulatory Agency) issues guidance on the safe management and use of the in vitro diagnostic devices themselves — the physical analysers and test cartridges — covering everything from procurement to incident reporting.
Internal quality control and external quality assessment
Meeting a standard on paper and meeting it in daily use are different things, which is why point-of-care testing quality assurance runs on two parallel checks. Internal Quality Control (IQC) is the routine, in-house testing of known control samples on the device itself, done regularly to confirm the instrument is performing consistently between patient tests. External Quality Assessment (EQA) is the independent check on top of that: a scheme such as UK NEQAS periodically sends practices "blind" samples with an unknown-to-the-tester result, which are tested exactly like a patient sample and the results compared against a national benchmark. A device can pass every internal check and still drift silently out of true — EQA is the mechanism that catches that drift before it reaches a clinical decision.
What the POCT Coordinator role actually covers
Because this governance spans procurement, training, IT, and ongoing monitoring, it is rarely something a GP or practice manager can absorb alongside their existing workload. The POCT Coordinator role exists to own it end-to-end. The responsibilities typically bundled into this role include:
- Governance framework. Developing and maintaining the practice's written POCT policy, and ensuring it aligns with national statutory requirements including UKAS accreditation and MHRA guidance.
- Training and competency. Running structured training for every member of staff who operates a device, assessing their competency, and maintaining a register of who is currently authorised to use it — testing is restricted to trained users wherever the device allows.
- Quality control programme. Scheduling and reviewing IQC results, keeping the associated records, and coordinating participation in an accredited EQA scheme such as UK NEQAS.
- Troubleshooting and escalation. Acting as the first point of contact when a device flags an error or a result looks clinically implausible, and knowing when that becomes an incident report rather than a one-off fault.
- Connectivity and records. Working with IT to ensure results flow automatically into the patient record rather than being transcribed by hand, which is itself a common source of error.
- Audit. Periodically checking that the policy is actually being followed in practice, not just documented.
Central laboratory versus point-of-care: who is accountable
| Quality function | Central laboratory pathway | Point-of-care pathway |
|---|---|---|
| Who operates the test | Trained biomedical scientist | Clinical or administrative staff, non-specialist |
| Calibration & internal QC | Built into laboratory workflow | Must be scheduled and logged by the POCT Coordinator |
| External quality assessment | Standard laboratory EQA membership | Separate EQA enrolment (e.g. UK NEQAS) per device type |
| Accreditation standard | ISO 15189 | ISO 15189 (POCT-specific provisions since the 2022 revision) |
| Result entry to records | Automated via laboratory information system | Depends on device connectivity — manual entry is a known risk point |
Conclusion
A near-patient testing device changes a care pathway the moment it is switched on, but the value it delivers depends entirely on whether its results can be trusted the same way a laboratory report is trusted. Point-of-care testing quality assurance is what makes that trust possible: a defined standard to meet, an accreditation body to check it, an external scheme to catch drift, and a named coordinator whose job is to keep all of it running quietly in the background. Any practice considering a new point-of-care device should ask who fills that role before asking which device to buy.