Clinical
documentation.
What clinical safety officers, commissioners, and procurement teams need to see before a pilot. Each section here is a summary. Full documentation is available to commissioners on request under NDA.
Labas is not a medical device.
Labas GP is a clinical coordination platform. It structures patient history, orchestrates recall, and delivers the results of diagnostic tests into the GP's workflow. It does not diagnose. It does not prescribe. It does not apply clinical codes. It does not recommend tests or treatments. These are enforced architecturally, not as policy.
The medical devices involved in a Labas session are point-of-care analysers, portable X-ray and ultrasound units, all of them CE-marked, factory-calibrated, and already in everyday NHS use. Labas orchestrates them. It does not manufacture, modify, or reinterpret them.
Under UK MDR 2002 and the MHRA's definition of a medical device, software that does not diagnose, treat, monitor, predict, or prognosticate disease is out of scope. Labas is categorically out of scope. Our architectural guardrails are documented; a full MHRA position paper is available to commissioners on request.
Care Intelligence, specifically.
Labas's recall engine evaluates a catalogue of rules against published NICE guidelines and NHS screening programmes, using calendar intervals only. It does not interpret clinical values, compute risk scores, or recommend tests or medications. Clinical values such as HbA1c, INR, and eGFR are surfaced to the GP as facts to read; the rule itself never branches on them. Every action on a flag is GP-initiated and logged against the named clinician with a timestamp. The full rule catalogue, with firing conditions and code references, is available to commissioners and Clinical Safety Officers under NDA.
We orchestrate. The CE-marked devices measure. The GP decides. Three different roles, enforced at the software level.
DCB0129 clinical
safety case.
A full clinical risk management case file is maintained to NHS Digital standard DCB0129. It covers the Labas platform end to end: pre-consultation, the mobile diagnostic unit, the point-of-care results pipeline, the Advice and Guidance integration, and the Care Intelligence recall engine.
The full hazard log, mitigation matrix, training records, and senior clinical co-signatory details are held under NDA and shared with commissioners, Clinical Safety Officers, and procurement teams on request. Contact info@labasgp.com.
NICE recall
intervals.
Clinical decision-making is the GP's job. Labas does not make clinical decisions. What Labas does is track your patient list against the monitoring and recall intervals NICE specifies, and surface patients who are due. The GP decides what to do about them.
A GP may legitimately see a diabetic patient annually if clinical judgment says so. Care Intelligence does not correct the GP. It only raises a hand when the calendar has moved past the NICE interval and asks whether the GP wants to act.
DCB0160 deployer pack.
DCB0160 is the complement to DCB0129. Where DCB0129 is the manufacturer's clinical risk case, DCB0160 is the deploying organisation's. Each GP practice or care home operating Labas is responsible for their own DCB0160 safety case file.
To support this, Labas provides every pilot site with a DCB0160 implementation pack: a pre-filled template safety case covering the deployment scope, integration points, local hazards, and the mitigations Labas has already put in place upstream. The deployer reviews, localises, and signs. A single named contact at Labas is assigned to each deployer for the lifetime of the pilot.
Request the full documentation pack.
Commissioners, Clinical Safety Officers, and procurement teams can request the full DCB0129 safety case, the MHRA position paper, the DCB0160 deployer pack template, and the NICE recall configuration schedule. We send under NDA, typically within one working day.