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Clinical workflow governance that watches and warns.

PathTest monitors your pathology HL7 message streams, detects workflow deviations the moment they occur, and generates the continuous evidence your accreditation body requires — without touching a single clinical system.

No write-back to clinical systems

No patient-identifiable data stored

Supports global accreditation standards

Live Governance Dashboard

LIVE

12,844

Messages monitored

86%

Baseline coverage

4

Active alerts

0

PHI stored

Critical

Workflow deviation detected — crossmatch routing

The problem

Pathology networks are flying blind on workflow integrity.

Critical deviations go undetected until it's too late

When integration engine patches or system upgrades alter clinical message routing, the change can go undetected for hours — long after it has affected the quality of test results and clinical decisions.

Accreditation evidence preparation is manual and costly

Quality Managers across pathology networks spend weeks before every accreditation cycle manually assembling evidence from disconnected systems — a process that is slow, error-prone, and impossible to scale.

Validating changes is slow and risky

Accepting a vendor patch or system upgrade without a validated evidence trail creates compliance exposure. The absence of structured regression evidence delays safe deployment and creates bottlenecks across the network.

PathTest connects to your existing pathology message infrastructure in a passive, read-only mode.

1

Connect

From monitoring to accreditation evidence — automatically.

All messages are processed with patient identifiers immediately removed at the boundary.

2

Protect

PathTest connects to your existing pathology infrastructure in read-only mode. No configuration changes to your clinical systems. No disruption to clinical workflows.

Your Quality Manager defines the expected behaviour for each critical workflow.

HOW IT WORKS

3

Baseline

PathTest continuously compares observed workflow behaviour against Approved baselines.

4

Detect

Every event is automatically recorded in an immutable evidence store and report.

5

Evidence

Platform

Built for pathology. Not adapted for it.

PathTest understands clinical workflows at the message level — the kind of precision that generic monitoring tools cannot provide.

Read-only by design

Passive monitoring — zero clinical risk

PathTest monitors your existing pathology message infrastructure without making any changes to it. There is no path from PathTest back into your clinical systems — this is an architectural certainty, not a setting. Which means it carries no clinical risk, and does not require clinical governance approval to deploy.

Not a medical device

Accreditation evidence generation

Every governance event is automatically written to a tamper-evident, cryptographically signed evidence store. NATA, UKAS, CAP, and ISO-aligned PDF reports are generated on demand.

NATA · UKAS · CAP · ISO

Automatic interface discovery

PathTest builds a live map of your pathology message dependencies from observed traffic — revealing the full picture of how your systems interconnect, including interfaces that may not be documented.

Real-time deviation detection

PathTest continuously compares live workflow behaviour against your approved baselines. The moment a deviation appears — routing, timing, field population — your team is alerted.

Continuous monitoring

Regression & validation support

Before accepting a system patch or upgrade, PathTest compares behaviour against your approved baseline and produces a structured evidence report. Faster, safer change acceptance with a documented trail.

Multi-site governance view

One platform across your entire pathology network. Aggregate compliance posture, site-level drill-down, and accreditation readiness at a glance for laboratory directors and CIOs.

Compliance & quality

The accreditation evidence your inspectors actually want to see.

ISO 15189:2022 now requires laboratories to provide continuous evidence of workflow assurance — not just point-in-time snapshots. PathTest is purpose-built to generate that evidence automatically, from live operational data, across every critical workflow in your network.

Every deviation, every baseline approval, every monitoring gap, every validation run is recorded in an immutable evidence store and available for inspection at any time — eliminating the manual evidence preparation burden ahead of accreditation cycles.

Supports NATA (Australia), UKAS (United Kingdom), CAP (United States) and ISO 15189 compliance readiness

Monitoring gaps automatically disclosed in reports as required by accreditation standards

Evidence records are cryptographically signed, immutable, and retained for 10 years.

Compliance Readiness Overview

Transfusion Medicine

Core Laboratory

92%

Approved

Microbiology

54%

78%

Approved

Haematology

Incomplete

88%

Approved

Next accreditation:

47 days

Evidence records:

2,847

Quality & validation

Better testing. Faster change acceptance. Stronger compliance.

PathTest gives your quality, IT and informatics teams the structured evidence and real-time visibility they need to confidently manage clinical system changes — without compromising patient safety.

01

Continuous baseline validation

PathTest establishes statistically validated baselines for every critical pathology workflow. Any deviation from those baselines — in routing, timing, or message content — is detected and recorded immediately, giving your team a continuous quality assurance layer.

Validation workflow

Baseline established and approved by QM

System change scheduled

Evidence report generated — deviations documented

PathTest observes change in test environment

Change accepted with full audit trail

PathTest accelerates change acceptance without compromising the evidence trail your accreditation body requires.

02

Structured regression evidence before every change

When a vendor patch or system upgrade is scheduled, PathTest compares behaviour against the approved baseline and produces a structured, dated evidence report. Your change management team has documented proof — not just a verbal sign-off.

03

Faster, safer patch and upgrade acceptance

With PathTest, your team can observe the effect of a change against a validated baseline before committing to production. Detected deviations are documented with the specific message and field involved, so your IT team can resolve the exact issue — accelerating safe acceptance.

04

Audit-ready gap disclosure

If a monitoring gap occurs — whether planned maintenance or unexpected — PathTest records it automatically and includes mandatory disclosure in any evidence report covering that period. Your inspectors see a complete, honest record.

Purpose-built for every stakeholder in pathology governance.

Who we serve

PathTest serves multiple roles within a pathology network — each with a view calibrated to their responsibilities.

Automated evidence generation

Every workflow event is automatically captured and stored as accreditation evidence. Your NATA, UKAS or CAP report is ready when you need it — not after weeks of manual preparation.

Instant deviation alerts

When a workflow deviates from its approved baseline, your team receives an immediate notification with the specific workflow, message type, and deviation detail.

Immutable audit trail

Every evidence record is cryptographically signed and locked for 10 years. Inspectors can verify that records have not been altered since the moment they were created.

Baseline capture tools

A guided workflow helps you define the expected behaviour for each critical clinical process. AI assists with suggestions — you review and approve every threshold.

Global standards

Aligned with the accreditation standards that matter — worldwide.

Pathology accreditation is a global obligation. Whether your laboratory operates under NATA in Australia, UKAS in the United Kingdom, CAP in the United States, or another ISO-aligned body, the underlying requirement is the same: continuous, documented evidence of workflow governance. PathTest is designed to generate that evidence.

ISO 15189:2022 represents a significant shift in how accreditation bodies expect laboratories to demonstrate quality management — moving from point-in-time inspection snapshots to continuous, real-time workflow assurance evidence. PathTest was purpose-built for this requirement.

PathTest is a clinical IT governance tool that supports compliance readiness. It is not certified, endorsed, or approved by NATA, UKAS, CAP, ISO, or any regulatory body.

NATA (Australia)

Automated evidence generation for ISO 15189 human pathology standard alignment.

Aligned

UKAS (United Kingdom)

Structured clinical interface evidence supporting UKAS Schedule of Accreditation.

Aligned

CAP (United States)

Real-time deviation records supporting CAP Laboratory Accreditation Program checklists.

Aligned

ISO 15189:2022

Continuous workflow assurance evidence supporting Clauses 8.2 and 8.9 management reviews.

Aligned

See PathTest working on real pathology data.

Request a demo to see how PathTest monitors clinical workflows, detects deviations in real time, and generates the evidence your accreditation body requires — without touching single clinical systems.

Works with your existing HL7 infrastructure — no changes required

Supports NATA, UKAS, CAP, and ISO-aligned evidence requirements

No patient-identifiable data stored at any point

Demonstrates compliance with ISO 15189:2022 continuous assurance requirements

Suitable for hospitals, health networks, and private pathology groups

See how PathTest provides governance without disruption. We'll be in touch within one business day.

PathTest-logo

Clinical workflow governance for global pathology networks. Continuous monitoring, real-time deviation detection, and accreditation evidence generation — without touching your clinical systems.

info@pathtest.org

Not a medical device

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