Documenting specimens processed or frozen outside an expected window

Many specimens have specific time requirements for processing. These would include things like PBMCs, pharmacology, and single copy assay (SCA) specimens. Such specimens need to be collected, processed, and frozen following specific instructions.

LDMS has a set of condition codes that can be utilized when such specimens are not processed as scheduled.

Table 1. Condition codes for specimen processing exceptions
Code Description Usage
OPR Outside Protocol Requirements The specimen was drawn during the protocol-defined window, but not in a manner consistent with the protocol. For example, if a participant was supposed to be fasting but was not, this code would apply.
OSW Outside Visit Window The specimen was collected correctly, but outside the window for the visit as specified by the protocol.
PST Processed After Specified Time The specimen was collected and processed into aliquots, but the processing was done after the time frame specified by the protocol. This is commonly applicable for PBMC and pharmacology specimens.

If these conditions apply, the condition code should be set cascaded to all affected aliquots, or (if applicable) set at the primary. You should also use the comments field in the Details window for the aliquots to explain why the condition code was selected.

If the assay results are supposed to be entered or read by LDMS for the study, but the assay will not be run due to the improper specimen handling, you can document this in Specimen Management. Find the specimen(s) and right-click on it to select Test Setup . Assign the test (if not already assigned), but then select Test Not Run . Use the Reason field to indicate why the test will not be performed.