LDT (Laboratory Developed Test) Documentation


Involved In Discussions
We are developing a LDT (laboratory developed test).
If you have any experience in this field – I have an urgent question re documentation.

The lab are objecting to recording all the work done on work instructions. They claim it is not necessary and takes up too much time. My background is pharmaceuticals and medical devices where there is no question that all work gets recorded. The question is, is there a difference for an LDT?

I would appreciate your speedy answer.

Ronen E

Problem Solver
Hi Mandy,

I don't see any reason why it should be different with LDTs.



Starting to get Involved
Hi Mandy!

I see that you are in Israel. What body is your laboratory regulated by? If you are your not pharma / med dev, and are taking American clinical samples and able to get paid through American insurance / Medicare / Medicade, then is your lab a CLIA / CAP / COLA accredited / certified lab?

If you are a CLIA lab, documentation requirements / expectations are bit more lax. That is one of the many reasons why FDA wants regulatory oversight (especially in regards to method development / design controls, validation, and reporting).

Also, if you are a CLIA lab, the inspector can have a huge impact on how much documentation is expected and in what area.

May I ask what kind of WIs are in question and if you are a CLIA lab, do you know what district is in charge of inspecting you?

For example, two years ago in Texas; our inspector would hound us in regards to how we documented our maintenance on instrumentation, personnel folders, and req forms but didn't focus too much on other critical areas like documentation of the creation of calibration curves, and QA/QC analysis activities. We had data generation documented on the LIS / LIMS, but I think we didn't validate the LIS / LIMS to the extent we should have - and never got in trouble.

Just as an aside. The FDA vs HMS / industry stakeholders is a huge button in the US right now. The FDA has promised to publish a final guidance this year but they are also trying to go through the Federal Register with the In Vitro Clincal Testing (IVCT - the alternative to LDT but truly the same thing with fewer 510(k) requirements), but because of the election and groups like the AACC, everybody is hanging in the air.

However, within this past year the CLIA inspections in the Texas and other States (California has been in the news more than others) within the US have become much for FDA-esk in several labs. They have been stricter especially in regards to QCs in Texas, shutting down labs in Dallas. However, from my contacts, it seems some States haven’t changed at all.

In my personal opinion from what I have been seeing of late, with or without FDA oversight, the way clinical laboratories are regulated and what type of documentation and document controls are required and expected are going to change. So you are probably very right to push for more documentation. Might as well get better 21 CFR 820 practices starting now instead of waiting until later. But again, this is all from the prospective that you need to follow 42 CFR 493 or 21 CFR 820.
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