#2: Keep maintenance of the “primary identifier” at the forefront of the chain of custody.
After original informed consent is given and the sample is collected, the most important part of the process is ensuring that all attributes follow the de-identified sample via a unique identifier. Samples that lose their “primary identifier” are useless for the purpose of medical research. Therefore, samples must be labeled with a customized barcoded cryolabel that is interfaced to a tracking/manifesting system so that every “hand off” is tracked electronically. Labs that do not utilize electronic tracking should follow samples via a manifest that includes information on the sample label, collection date, sample type, number of samples (for cases of multiple samples), and storage temperature. Both systems should incorporate accountability in each step in order to guard the identity of specimens and support quality improvement.
Similarly, the patient consent authorization is a critical piece of information that must be carefully tracked from collection to storage and eventual testing. And in the event the subject takes back their consent, there needs to be a documented process to show the specimen has been discarded.