ScopeGP referral to lab receipt
StandardsISO 15189:2022 · NPAAC
JurisdictionAustralia · Privacy Act 1988
StatusPilot ready · limited 2026 intake

For multi-site pathology collection networks

Every specimen,
evidenced.

The compliance system of record for pathology collection. Five of the seven steps between a GP referral and the lab bench currently leave no record. That is the gap assessors ask about.

Every action audit-loggedNot a medical deviceNot a LIS
190+distinct audit event types, captured automatically on every mutation
24audit categories, structured for assessor-ready export
9point NPAAC quality checklist at the bench, recorded on the order

Exhibit A

Can you prove what happened at every site?

1Referral written
2Patient arrives

The black box

Every step evidenced

3Referral interpretedUntracked
4Tubes selected & labelledUntracked
5Specimen collectedUntracked

No system of record

Audit prep by hand

No live visibility

6Specimen transported
7Specimen received at lab

PathLab Assist opens the black box.

The stakes

One assessment covers everything. Accreditation is what keeps a provider eligible for reimbursement, and pre-examination traceability is on the checklist.

Pre-analytical errors account for up to 70% of all mistakes in laboratory diagnostics. Plebani, Clin Biochem Rev 2012Most laboratory errors occur before the specimen reaches the lab, in test requesting, patient identification and collection. ibid.

Exhibit B

The requirement, and the mechanism that answers it

Three of the clauses an assessor opens, and what answers each. The full set is on the compliance page.

NPAAC SA8.5
What assessors verify

Collection must follow written protocols with accurate patient identification.

What the product does

A guided bench that will not proceed until identity is verified, then a 9-point NPAAC checklist.

In the product today
NPAAC SA8.2ISO 15189 SAD 7.2.6.1
What assessors verify

Specimens must be traceable at all times.

What the product does

Custody tracked per tube, not per shipment, from draw to lab receipt.

In the product today
Records and record-keeping
What assessors verify

Records sufficient to reconstruct what happened, available to an assessor.

What the product does

Every create, update and delete captured automatically, exportable as an assessor-ready report.

In the product today

Exhibit C

What the record actually looks like

Screens from the product as it runs today. No mockups, no stock imagery. Collected, received, and delivered into the lab's LIS.

Walk the audit trail with us.

Tell us how your collection network runs today. We reply personally to organise a walkthrough and, if it fits, discuss the pilot programme.

Book a discovery call
  1. You send the formEnough about your network that a first call can be useful.
  2. A person repliesNot an automated sequence. We say whether we think there is a fit.
  3. We walk the productA screen share on our own data, judged against how your sites run.