QC & release
The sequence is enforced, not remembered.
No review before QC passes. No release before every live result is called.
A person makes every decision on this page — pass or fail, approve or reject, sign and release. The software’s job is the order of events: nothing downstream of a decision can happen before the decision, and no report can leave while anything is still waiting on you.
A report released before anyone looked at the controls.
The run finished late, the queue was long, and the reporting tool printed what the instrument wrote. Two days later somebody notices the no-template control amplified — and now there is a corrective-action file, a recall letter, and a director explaining how a report left the building before anyone looked at the controls. Nobody in that story was careless. The software treated the order of events as a suggestion, and the night shift paid for it.
Three rules, and none of them is a setting.
These rules are built into the product. No setting relaxes them, and no role skips them.
Review is locked until QC passes.
A person marks the run pass or fail. The software will not infer it from the numbers, and until that decision exists, no result on the run can be called.
Release is locked until every live result is called.
Approve, inconclusive or reject — every result gets a named human decision. The release action opens when the last one lands, and not a moment before.
The count runs over the run’s current result IDs.
Re-import the results and the count falls back to nought. A call left behind by a re-run has never satisfied this gate, so yesterday’s decisions cannot ship today’s report.
Is there an override? “No. Not a hidden one, not an admin one. There is an amendment, and an amendment leaves a trail. That’s the design.”
The letterhead is part of the gate.
Release checks the report’s face as well as its results. Seven fields are required before anything leaves: lab name, laboratory director, CLIA number — your laboratory license number — address, phone, lab email and logo. A report with a blank where one of those belongs is not a clinical document, so the gate names the missing field and links straight to the setup that fixes it.
When the approver and the releaser match, it says so. Then it lets you through.
In a two-person lab the director approves and the director releases, and pretending otherwise would lock real labs out of their own reports. So the software flags it — once, in writing, on the record — and steps aside. Staffing is your policy; our job is making sure it happened on purpose.
Fax, website and tax ID are outside the gate. On purpose.
A gate is credible for what it declines to block as much as for what it blocks. Fax, website and tax ID are letterhead niceties — blocking a lab’s first report over a fax number would be theatre. And in the other direction, QC itself stays out of the software’s hands: it will not decide whether your controls behaved, because nobody who wasn’t in the room should be making that call.
One more state the software is honest about: a report that has been released but not yet paid for is payment-locked — released is released, but the download waits for the invoice. Billing and release stay two separate facts, each recorded on its own.
Your policy. Our sequence.
Thresholds, control rules, who approves and who signs — all yours. The order of events — QC, review, calls, release — is ours to hold, downstream of your LIS and your instrument, where the report actually leaves. And there is no override on any of it: there is an amendment, and an amendment leaves a trail.
Where this sits — and why it isn’t a LIS →Amendments live with reports & templates →
Watch it hold on one of your own runs.
Import a result file, leave one result uncalled, and try to release — it will count what’s missing, name it, and wait. Your first released report is free and doesn’t need a card.