The Clock Has Already Run Out
What ISO 15189:2022 Actually Means for Your POCT Service — and What Happens If You’re Not Connected
By Carl DeMarco, CEO, Citizen Care Health Solutions
In September 2022, the world’s standard for medical laboratory quality, ISO 15189 was updated. For the first time, Point of Care Testing was folded directly into it. Not as an optional annex. As a core requirement.
The UKAS transition deadline was 6 December 2025. That date has now passed.
If your community POCT devices are still unconnected, no middleware, no automatic result transfer to your EPR or LIMS, no audit trail, you are not compliant. That’s not a forecast. That’s where most community POCT services in the UK are right now.
What Changed
The old standard kept POCT in a separate document, ISO 22870:2016. That separation is gone. ISO 15189:2022 absorbs it entirely, and Annex A now contains mandatory requirements for point-of-care services: named individuals accountable for POCT quality, community devices formally linked into the laboratory’s quality management system, results traceable to device, operator, QC status, and patient record, automatically, not by hand and operator certifications that are actively managed, not filed and forgotten.
Laboratories that had not transitioned by December 2025 had their accreditation under the 2012 standard suspended. If the outstanding actions aren’t completed within six months, accreditation is withdrawn. The organisation reapplies from scratch.
The Real Risk Is Not the Fine
The standard was updated because of patient safety, not paperwork. Unconnected POCT devices produce a specific category of risk: results that never reach the patient record because manual transcription was skipped, results misattributed to the wrong patient, QC failures that go undetected for days, and operators with lapsed competency continuing to test because no system flagged the expiry.
Secondary care devices are largely connected; they’ve had structured IT infrastructure and coordinator oversight for years. Community devices have not. Glucose meters in GP practices, CRP analysers in urgent care centres, urinalysis devices in community clinics, most are still managed manually, with results on paper and QC checks in ring binders.
That model does not meet the 2022 standard.
Why It Hasn’t Been Solved Faster
Most POCT teams know they need connectivity. The problem is the market. Most device manufacturers offer proprietary middleware that only works with their own devices. A trust running glucose meters from one manufacturer, CRP analysers from another, and coagulation devices from a third ends up with three separate systems, none of which talk to each other, and none of which give the POCT coordinator a single view across all sites.
That fragmentation is the root cause of the governance gap in community POCT. It is also why vendor-neutral, manufacturer-agnostic middleware has become the architecture of choice for pathology networks building a sustainable solution. One platform, any device, any EPR or LIMS, one governance framework.
Where NHS England Is Heading
This is not happening in a vacuum. NHS England’s Diagnostics Digital Capability programme for 2026/27–2029/30 has identified “Connecting Neighbourhood Pathology” as a priority workstream. The aim: a POCT layer that survives LIMS transitions, connects community devices, and feeds results into EPRs and shared care records automatically.
POCT services that build compliant, connected infrastructure now are positioned to access that funding and demonstrate the governance maturity NHS England is looking for. Services that remain unconnected face an increasingly difficult procurement and inspection environment.
The standard has changed. The deadline has passed. The question now is what you do next.
Governance without connectivity is not governance. It is paperwork.
Read the full article
This is a summary. The full article covers the detailed ISO 15189:2022 requirements, NHS England’s DDC workstream alignment, practical gap analysis steps, and the key questions to ask any connectivity supplier.
If you’d like to discuss how this applies to your POCT service, get in touch: