The Clock Has Already Run Out

In September 2022, the world’s standard for medical laboratory quality — ISO 15189 — was updated. For the first time, Point of Care Testing (POCT) was folded directly into it, not as an optional annex, but as a core requirement. The 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.

This article is not about scaremongering. It’s about understanding exactly what changed, what the real-world consequences are, and what a practical path forward looks like.

1. What Actually Changed in ISO 15189:2022

The 2012 version of ISO 15189 covered medical laboratories. Point of Care Testing sat in a separate standard — ISO 22870:2016 — and was treated as a specialist extension. That separation is now gone.

ISO 15189:2022 absorbs ISO 22870 entirely. Annex A of the new standard contains normative (mandatory) additional requirements specifically for POCT. “Normative” means you cannot treat them as optional guidance.

The key new requirements for POCT services:

• A named, qualified individual must be appointed as responsible for POCT quality — with clearly documented authority, not just an informal arrangement.
• Decentralised testing sites must be formally linked into the laboratory’s quality management system — community devices cannot exist outside the governance structure.
• Results must be traceable: to the device, the operator, the QC status, and the patient record — automatically, not by manual transcription.
• Clinical approval is required for any test or service provided, with documented oversight.
• Operator certification must be actively managed — expired credentials cannot be left undetected.

Source: UKAS ISO 15189:2022 Transition Guidance; POCT Innovators, “How do the changes impact POCT?”

2. The Deadline Has Passed. What Happens Now?

UKAS was unambiguous: laboratories that had not transitioned their accreditation to ISO 15189:2022 by 6 December 2025 had their accreditation under the 2012 standard suspended for up to six months. If the outstanding actions are not completed within that window, accreditation is withdrawn. The organisation then has to reapply from scratch.

That is not a minor administrative inconvenience. Accreditation underpins clinical credibility, regulatory standing, CQC inspection outcomes, and — increasingly — NHS procurement decisions.

For community POCT specifically, the compliance gap is wider than it might appear from within an acute trust. Secondary care devices are largely connected — they’ve benefited from structured IT infrastructure and POCT coordinator oversight for years. Community devices — glucose meters in GP practices, CRP analysers in urgent care centres, urinalysis devices in community clinics — have largely been managed manually. Results written on paper, transcribed into records by hand, QC checks stored in ring binders.

That model does not meet the 2022 standard. Full stop.

3. The Real Risk Is Not the Fine — It’s the Patient

Compliance matters because regulators require it. But the reason the standard was updated in the first place is patient safety.

Unconnected POCT devices create a specific category of risk that is easy to underestimate until something goes wrong:

• Results that never reach the patient record — either because the transfer failed silently, or because manual transcription was skipped.
• Results misattributed to the wrong patient — a known risk with manual entry that middleware eliminates by locking results to the device, operator, and patient ID.
• QC failures that go undetected — with no automated monitoring, a device running out of calibration can produce results for days before anyone notices.
• Operators with lapsed competency continuing to test — because no system has flagged the expiry.

NHS England’s own guidance on integrating POCT into virtual wards and urgent community response is explicit: results should be automatically transferred to LIMS, EPR, and shared care records. Where middleware does not exist, it states that “professionals may need to manually enter results” — but flags this as a gap to be closed, not an acceptable long-term position.

Source: NHS England, “Integrating in vitro point of care diagnostics: guidance for urgent community response and virtual ward services”

Research cited in the POCT community consistently identifies the same failure modes: data that is not transmitted, results that are delayed or misattributed, systems that are out of sync, data loss. These are not hypothetical risks. They are the documented, everyday reality of unconnected community POCT.

Source: Jarred Evans & Seetal Sall (Cardiff & Vale UHB), PDR Research: “Designing for Connection: Why Data, Interoperability and Real-World Practice Are Critical”

4. The Vendor Lock-In Problem

Many POCT teams are aware of the connectivity requirement. The reason it hasn’t been solved faster is not ignorance — it’s the architecture of the market.

Most device manufacturers offer proprietary connectivity solutions that only work 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 middleware systems — none of which talk to each other, and none of which give the POCT coordinator a single view of what is happening across sites.

This fragmentation is the root cause of the governance gap in community POCT. It is also the reason why vendor-neutral, manufacturer-agnostic middleware has become the architecture of choice for NHS pathology networks looking to build a sustainable solution.

A vendor-neutral platform connects any device to any EPR or LIMS — regardless of manufacturer. Add a new device? The driver already exists in the library. Change your EPR? The middleware adapts. Expand into community sites? The same platform covers them all, under one governance framework.

5. What ‘Connected’ Actually Needs to Deliver

Connectivity is necessary but not sufficient. ISO 15189:2022 compliance requires an operational layer on top of connectivity. Here is what that looks like in practice:

Operator certification management

The standard requires active management of operator credentials. In practice, this means the system must know who is certified, for which devices, and when that certification expires. When it expires, the operator should be locked out automatically — not when someone remembers to check a spreadsheet.

QC monitoring and device inventory

Every device on every site needs to be visible in one place. QC status, calibration history, last used, and any flagged anomalies should be accessible without the POCT coordinator having to visit each site. Community sites — often managed remotely — make this especially important.

Automated audit readiness

UKAS assessors do not wait for you to build a report. The compliance record needs to exist continuously, not just before an inspection. AI-powered audit tools can now generate inspection-ready reports automatically — tracking every test, every operator, every QC result, against the requirements of the standard.

Abnormal result flagging and outbreak detection

When POCT results flow into a central platform across multiple sites, patterns become visible that are invisible when each site operates in isolation. A cluster of elevated CRP results across three community clinics in the same postcode over 48 hours is a public health signal — but only if someone can see across all three sites in real time. Automated outbreak detection tools now make this possible.

6. The Bigger Picture: NHS DDC and Neighbourhood Pathology

ISO 15189:2022 compliance is not happening in a vacuum. NHS England’s Diagnostics Digital Capability (DDC) programme for 2026/27–2029/30 has identified “Connecting Neighbourhood Pathology” as a priority workstream. The language of the programme is explicit: the aim is to create a POCT layer that survives LIMS transitions, connects community devices, and feeds results into EPRs and shared care records automatically.

This is not a future ambition. It is active NHS policy, with funding implications and procurement consequences.

POCT services that build compliant, connected infrastructure now are positioned to access that funding and to demonstrate the governance maturity that NHS England is looking for. Services that remain unconnected will face an increasingly difficult procurement and inspection environment.

7. A Practical Starting Point

If you’re a POCT lead or coordinator reading this, the question isn’t whether connectivity is necessary. It is. The question is how to make progress without a major capital project or a year-long procurement cycle.

Start with a gap analysis against Annex A of ISO 15189:2022. Map your community devices — every site, every device, every operator — against the requirements for connectivity, traceability, and certification management. That map will tell you where your highest risks are.

Then look at what a manufacturer-agnostic platform would need to connect to cover those devices. The key questions to ask any potential supplier:

• Does your platform connect to my existing EPR and LIMS without bespoke development?
• Do you have pre-built drivers for my device portfolio, including community devices?
• Are you GDPR, DTAC, DCB-0129, and DSPT compliant?
• Can your platform generate ISO 15189:2022 audit-ready reports automatically?
• Do you support operator certification management with automatic lock-out?

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.

If you’d like help navigating ISO 15189:2022 compliance, or want to understand how our platform can support your POCT service toward CQC approval or UKAS accreditation, get in touch: yog.challagulla@citizencarehealth.com or Carl.demarco@citizencarehealth.com

Sources & References

• UKAS: ISO 15189:2022 Transition Process Guidance — ukas.com
• The Biomedical Scientist: ISO 15189 UKAS Transition Update (May 2025)
• POCT Innovators: “ISO 15189:2022 — how do the changes impact POCT?”
• NHS England: “Integrating in vitro point of care diagnostics: guidance for urgent community response and virtual ward services”
• PDR Research / Cardiff & Vale UHB: “Designing for Connection: Why Data, Interoperability and Real-World Practice Are Critical” (Jarred Evans & Seetal Sall)
• NHS England: Point-of-Care Testing national guidance — england.nhs.uk
• World Health Expo: “Errors in Point-of-Care Testing: An Aladdin’s Cave of Treasures” (Nov 2024)
• POCT Innovators Blog Series 3: “Connected Care: The Middleware and Apps Behind Decentralised Diagnostics”