Updated 28 Sep 2026
What NABL 112A actually asks of an LIS
The 18 Dec 2024 specific criteria are not a marketing badge. They are two identifiers, an audit trail, interface verification, critical-call records, and amendments that do not pretend to be the original.
Two identifiers, every screen
NABL 112A and ISO 15189:2022 both want the patient identified by more than a first name on a queue. In Atom LIMS that is UHID plus the name, and the accession on the sample. A barcode that does not scan is not an identifier. A printed paragraph of the UHID is not a barcode.
If your current software shows a nickname on the worklist and the UHID only on the report, an assessor can stop there.
The interface is a device, and it must be verified
112A asks that accession-to-report, including instrument interfaces, is verified after install and again after a change, on a defined set of sample types. A vendor saying “we support Mindray” is not that worksheet.
Atom LIMS stores a ten-sample comparison: instrument value, LIS value, signed off by whom, on which date. Unmapped codes go to a holding queue. Auto-filing an unknown barcode is how you fail this clause.
Critical results are a conversation, not a red cell
7.4.1.3 wants documented notification, read-back, and escalation. A highlighted number on a PDF is not a call. Atom LIMS blocks release of a configured critical until the call record exists.
Amendments
7.4.1.8: a revised document, marked as such, with a reason, pointing at the original. Editing yesterday’s HTML and hitting save is how labs used to do it. That is not an amendment.
What an LIS cannot fake for you
Staff competence, internal audit, EQAS subscriptions, and the quality manual remain the lab’s. Software can keep lots, Westgard, BMW quantities, and a specialty-wise report register. It cannot sit the exam.