QC lockout and operator competency, in one system

Quick answer

Catenix locks out testing when the rules say it should. By default it blocks a device whose QC has failed and an operator whose certification is missing or expired or whose privileges are suspended, and it warns when QC or a competency assessment is overdue; each rule can be set to block, warn or log. On analysers that accept an operator list, such as POCT1-A2 devices, Catenix pushes a roster filtered by competency, so a lapsed operator cannot log in at the device. Competency is recorded against the six CLIA elements and can be exported as an inspection packet.

Point-of-care testing is done by many people on many devices, often far from the lab. Two questions decide whether a result can be trusted: was the device in control, and was the person trained and in date? A spreadsheet can record both. Only connected software can stop a test when the answer is no.

Why the device roster matters

Many point-of-care analysers keep their own list of operators. If that list is pushed from a system that ignores competency, a lapsed operator gets their access back the next time the list is sent. Catenix builds the roster from the competency record and sends it to every supported device at once, so the list on the device and the record in the office are the same list.

Competency records an assessor can use

Each operator and device pair is assessed against the six CLIA competency elements: direct observation, monitoring of results, review of records, observation of maintenance, testing of blind or proficiency samples, and problem solving. The coordinator sees expiring and expired certifications, overdue reassessments and suspensions on one screen, and can export an inspection packet as a single PDF.

In the UK the same records support ISO 15189:2022 and ISO 22870 expectations for POCT training and authorisation. See ISO 15189 for POCT.

QC that feeds the lockout

QC results arrive from the analyser, are graded with Westgard rules and plotted on Levey-Jennings charts. A failed rule creates a lockout for that device and a corrective-action record. US labs can document an Individualized Quality Control Plan (IQCP) in the same place. See Levey-Jennings and Westgard rules.

Questions people ask

Is there software that locks out a point-of-care analyser when QC fails?

Yes. Catenix blocks testing on a device whose QC has failed, can also block when QC is overdue, and records each lockout and any override.

Can it stop an untrained operator from testing?

Yes. Operators without a valid certification are blocked on that device model, overdue competency can be set to block too, and on analysers that accept operator lists the roster sent to the device leaves out lapsed operators.

Does it cover the CLIA competency requirements?

Competency is recorded against the six CLIA elements for each operator and device, with reminders and an exportable inspection packet.

Can a supervisor override a lockout?

Each rule has a severity of block, warn or log. Where your policy allows an override, it is recorded with who made it and the reason.

Related: Quality control · Operators and competency · POCT for pharmacies · QC software for POCT

Product and company names are trademarks of their owners and are used for identification only. Catenix moves, stores and displays results with traceability; it does not interpret results or give clinical advice. Reviewed October 2026.

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