Compliance
Built for the audit you'll actually face.
Accreditation against NPAAC standards is what keeps an Australian pathology provider eligible for Medicare rebates, and ISO 15189 and NPAAC are assessed concurrently, in a single NATA assessment.
Regulatory position
- Dec 2025
- The sector completed a hard transition to ISO 15189:2022.[1]
- May 2026
- 670 facilities accredited to the new edition.[1]
- New Zealand
- The equivalent transition under IANZ was likewise compulsory.[3]
- Now
- Surveillance runs against strengthened pre-examination requirements.
“Accurate patient identification and specimen labelling are crucial to patient safety. Failure to comply with these requirements is a significant cause of patient morbidity and occasionally mortality.”
So the pre-analytical chain is no longer the informal stretch of pathology. It is assessed, clause by clause.
Section 1
What assessors verify, and what answers it
Every mechanism below is in the product today. Nothing on this page is roadmap.
Collection must follow written protocols with accurate patient identification.
Guided collection bench with identity verification before every collection and a 9-point NPAAC quality checklist, with the completed checklist recorded on the order.
In the product todayLabels must carry at least two patient identifiers, three where practicable.
The bench will not proceed until two identifiers are checked with the patient: name plus date of birth or phone.
In the product todayThe collector's identity must be traceable in service records.
Every collection is recorded against the signed-in collector, with timestamped photographic evidence.
In the product todaySpecimens and their records must be traceable, and uniquely identified at every stage.
Per-tube chain of custody from draw through shipment to lab receipt, including split-order “to follow” semantics.
In the product todayRecords sufficient for an assessor to reconstruct what happened.
190+ distinct audit event types across 24 categories, captured automatically on every mutation, with exportable assessor-ready reports. Designed for 7-year retention of the full audit record.
In the product todayCorrective action and root-cause discipline.
Incident management with structured RCA (5-Whys and Fishbone) and CAPA tracking, plus operational issue management.
In the product todaySection 2
Data protection, Privacy Act 1988
- Medicare numbers
- Encrypted with AWS KMS and masked by default. Full values are revealed only to authorised roles, and every reveal is itself audit-logged.
- Application logs
- No patient-identifying information in application logs, by design.
- Data residency
- Hosted in Australia, on AWS in Sydney.
Section 3 · exclusions
What we are not
PathLab Assist is excluded from TGA categories 14G/14J. It never diagnoses, interprets results or integrates with analysers.
PathLab Assist stops at the lab door. PathLab Exchange delivers the order into the lab's LIS over HL7 and reads back its acknowledgement. It does not replace the LIS, and results stay there.
Sources
- [1]NATAISO 15189:2022 transition completion (May 2026) and Standard Application Document (effective Feb 2026)
- [2]ACSQHCRequirements for Medical Pathology Services (NPAAC, 3rd edition 2018)
- [3]IANZISO 15189:2022 transition notice (New Zealand)
- [4]Services AustraliaApproved Collection Centres
- [5]Plebani M.Quality Indicators to Detect Pre-Analytical Errors in Laboratory Testing, Clin Biochem Rev (2012)
Walk the audit trail with us.
Bring your quality manager. We'll show the evidence, clause by clause.
Book a discovery call