Summary: Alliance clinical trials have an increasing requisite for the collection of a large number of biofluids. Currently, aliquots of biofluid samples are stored in conventional -80 freezers or (in the case of ABWUSTL) liquid nitrogen vapor. Current procedures require that clinical sites provide their own vials for biofluid sample aliquoting and storage (which are often in multiple and inappropriate sizes and formats for biobanking) and label these tubes by hand with multiple pieces of information to maintain a robust ‘chain of identity.’ This is difficult, time consuming, and resource straining for many clinical sites. If biosample tubes are labeled at the site, the biobank must remove / redact such labels and replace them with unique biobank identifiers before storage to maintain a de-identified chain of identity. This is burdensome and time consuming for biobanks and susceptible to sample misidentification. To address these limitations, the Alliance Biorepository at Washington University (ABWUSTL) plans to leverage a new facility at Washington University School of Medicine for the automated storage and retrieval of biofluid sample aliquots. The CTBI BioStore is essentially a Hamilton BioS robotic, high-density freezer unit.
The following step by step instructions will help you on how to collect and log the pre-labeled barcoded tubes in the NCI BioMS System. In case of any questions, please reach out to BioMS Help Desk by email. In Phase-1 of this initiative, only five fluid specimen types are allowed to use prelabeled barcoded tubes and those are listed below. The studies that would use these prelabled barcoded tubes will have detailed instructions and prelabled barcoded tubes provided as kits by the Biorepository. Collection sites must request kits in advance and ONLY use the prelabeled barcoded tubes supplied by the biorepository.
Buffy coat
Plasma
Double Spun Plasma
Serum
CSF
Step: 1 Login to BioMS and go to the Patient Checklist page for the Patient. The patient id shown here is a ficitous patient and the study is a Test Study. Identify the timepoint and specimen to be collected.
Step: 2 Enter the collection date for the fluid specimen; plasma. You can do this by simply clicking the checkbox against it. System will put the collection date and time as current date and time which can be changed, if needed. Also, if the collected quantity is less than the default Quantity shown, then change the quantity to the correct total quantity value at this step. In the example shown here, only 2 tubes totalling 4ml is collected. Therefore, the quantity is changed to 4ml from the default value of 6ml.
Step: 3 Next, click the form icon against the plasma specimen which will open the Specimen form. You may enter any comments at the top but this is not mandatory. However, Specimen Barcodes are Mandatory and must be entered as shown below. In the following example, CRA was able to collect only 2 out of 3 required tubes and entered the Tube barcodes as shown. CRA must enter NA (Not Applicable) against the third tube as it is Mandatory.
Step: 4 Upon clicking save, Specimen status changes to Collected as shown below.
Step: 5 Next, click to Go To Shipments button on the Patient Checklist Page and you will be taken to the Specimens and Shipments page as shown below. Please note that the Specimen Barcodes are displayed along with Specimen on this page.
Step: 6 Select the checkbox against the specimen and then click the green arrow to put the specimen into a Shipment. Select the created shipment and then click send. Please note that the BioMS Shipment Manifest shows the barcodes of the tubes against the specimen in the Specimen Table. Also, the same information is displayed under specimen comments. In addtion, there is a note ” Pre-labeled barcoded tubes are included in this shipment” that appears on the BioMS Shipment Manifest as an alert to the Repository staff.
Step: 7 Print the Shipment Manifest and include it along with the specimens in the Shipment. This completes the steps in collecting and shipping a fluid specimen using a prelabled bar coded tube. When the Repository receives the Shipment and specimens, Repository staff will scan the barcodes on the tubes and if those are found different than the barcodes on the BioMS Shipment Manifest, then site user will be contacted for further clarifications. An image copy of the printed BioMS Shipment Manifest (PDF) is shown below.
