Question
Is the referring laboratory still liable when it sends a test out to a reference lab?
Short answer
Usually yes, at least in part. The ordering clinician and the patient have a relationship with the laboratory whose name is on the report, so a claim commonly names the referring laboratory regardless of who ran the assay. Your own professional liability is the policy that responds first, and whether you can recover from the reference laboratory afterwards depends on the agreement between you.
Why the referring lab stays in the frame
Send-out testing is routine. Something falls outside your menu or your certification, so it goes to a reference laboratory and the result comes back into your report.
From the perspective of the clinician who ordered it and the patient affected by it, the laboratory they dealt with is you. That is enough to be named, and being named is what triggers defense costs whether or not you are ultimately found responsible.
Where things actually go wrong
The failures cluster at the handoffs rather than in the analysis. Specimen integrity in transit, including temperature and time limits. Identification and labelling errors that occur before the sample leaves. Transcription of the result back into your system. Delay in returning a time-sensitive result. Reporting a result without the reference laboratory’s interpretive caveats or reference ranges intact.
Several of those are entirely within your control, which is precisely why your own policy is the one being asked to respond.
What your professional liability covers
Your form generally responds to your own acts and omissions, which covers the handoff failures above. What is less certain is a claim arising purely from the reference laboratory’s analytical error where you did nothing wrong but are named anyway.
The useful question for your broker is whether the policy funds your defense in that situation even where the ultimate fault lies elsewhere, since defense is the cost you will actually incur. Vicarious liability wording is the part to look at.
The agreement with the reference laboratory is the lever
The send-out agreement is where recovery is decided, and it is often signed as an operational formality rather than reviewed as a risk document.
Look for an indemnity running in your favour for their analytical errors, evidence of professional liability at a limit proportionate to the volume you send, a waiver of subrogation, and clarity on which party carries the specimen while it is in transit. Many such agreements are silent or run the indemnity the other way.
What to do with this
Treat reference laboratories as vendors requiring the same certificate review as any other, using the checks in the vendor certificate entry, and keep evidence of chain of custody and transit conditions because that record is what defends the handoff allegations.
If the direction of travel is the opposite one, and you are bringing previously sent-out work in house, that is a change in scope with its own notification consequences, covered in the new test menu entry.
Primary sources
Sources and references
This answer draws on the following regulatory, statutory, and standards-body sources. Coverage availability and program structure also depend on carrier appetite and underwriter discretion not captured by these sources.
- CMS - Clinical Laboratory Improvement Amendments (CLIA)https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments
Related practice areas
Insurance clauses in this area
Related questions
- What should a laboratory check on the certificates of insurance it receives from couriers and vendors?
- Does a laboratory’s insurance automatically cover new tests added to the menu?
- What insurance does a CLIA-certified clinical laboratory need?
- What insurance does a US lab need to receive specimens from outside the United States?
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