AFT Specimen Receipt Values
The following are the Specimen Receipt values used while receiving shipments at AFT Biorepository. Each specimen quality has an action item listed for the biorepository staff as well as for the CRA. The comment to the CRA is communicated via direct email notification (color coded) upon receiving the specimen at the AFT Biorepository.
Color Coding
Acceptable - Green
Alert - Orange
Unacceptable - Red
Status Value                            | Description | Applicable Specimen Types | Biorepository Staff Action | CRA Comment in Email                           | |
---|---|---|---|---|---|
1 | Acceptable                          | Sample is okay and meets requirements. | All | Accession and Store | None. |
2 | Alert-Cauterized | Tissue shows gross cauterization artifact. | Tissue | Accession and Store | Specimen is usable; in the future, please avoid cauterized tissue. |
3 | Alert-Damaged | Sample is physically damaged but still usable. | All | Accession and Store | Specimen is usable; in the future, please ensure proper packaging to avoid specimen damage |
4 | Alert-Delayed sample shipment | Sample was held beyond the window of time allowed by study protocol, but is still usable. | Blood | Accession and Store | Specimen is usable; in the future, please remember to ship within the time period specified in the study protocol |
5 | Alert-Hemorrhagic | Specimen shows gross hemorrhagic tissue | Tissue | Accession and Store | Specimen is usable; in the future, please avoid hemorrhagic tissue |
6 | Alert-ID Conflict | A sample has been received whose physical label does not exactly match the BioMS packing slip but whose identity can be unequivocally imputed by the information provided. | All | Accession and Store | Specimen labeling conflict is resolved; please be certain to accurately label all future specimens per protocol requirements. |
7 | Alert-Incomplete ID | A sample has been received whose physical label is incomplete as per protocol but whose identity can be unequivocally imputed by the information provided. | All | Accession and Store | Incomplete specimen labeling is resolved; please be certain to completely label all future specimens per protocol requirements. |
8 | Alert-Improper collection container | A biospecimen (such as blood) was collected in the incorrect tube type or fixative type. Â The specimen may still be processed and stored, although the specimen may not be useful for certain downstream analyses. (e.g. Plasma was collected in a Heparin or ACD tube rather than an EDTA tube). | All | Accession and Store | Specimen may or may not be usable. Â Please ensure that all future specimens are collected and preserved with the tube or container type as specified in the protocol. |
9 | Alert-Limited Quantity | Quantity does not meet the required quantity, but can still be processed and is usable | All | Accession and Store | Specimen quantity is less than requested but specimen is still usable; please be certain to provide requested specimen quantity in future submissions. |
10 | Alert-Missing Documentation | Biospecimen was submitted without required documentation (e.g. Assay Request Form, Questionnaire). | All | Obtain missing documentation from the site | Please email required documentation to the Alliance Biorepository contact email WITHIN 24 HOURS. |
11 | Alert-No Path Report | A clinical, surgical pathology block(s) was submitted either with no pathology report or a report that either does not match or can not be reconciled with the physical identity of the tissue block | Clinical Tissue Block(s) | Obtain the Path Report from the site. | Please email a de-identified version of the appropriate Surgical Pathology Report to the Alliance Foundation Biorepository contact email WITHIN 24 HOURS. |
12 | Alert-Not refrigerated | Biospecimen was to be sent with a cold pack to be maintained at refrigerated temperature. Â There was either no cold pack in the shipment or the cold pack was received at ambient temperature. Â Specimen may or may not be compromised | All | Accession and Store | Specimen may or may not be usable. Please ensure that all future shipments include a properly refrigerated cold pack when indicated. |
13 | Received - Review Pending | Digital Specimen file has been received and the review is Pending. Once reviewed and found to be acceptable, the status will change to Acceptable and you will be notified.  | Digital Specimens | Accession and Complete Digital Specimen Review | Submitted Digital Specimen file has been received and you will be notified once the digital specimen review is completed. |
14 | Unacceptable-Clotted | Blood sample is clotted and can not be properly processed | Blood | Accession and Destroy with Director approval | Contact the appropriate protocol coordinator to determine if a replacement specimen can be recollected and submitted. Please ensure that all blood is properly collected in anticoagulant tubes, per protocol requirements. |
15 | Unacceptable-Damaged | Sample is broken, crushed, shattered, or otherwise physically damaged beyond recovery. | All | Accession and Destroy with Director approval | Contact the appropriate protocol coordinator to determine if a replacement specimen can be recollected and submitted. Please ensure that all specimens are properly packaged to avoid damage. |
16 | Unacceptable-Delayed sample shipment | Sample was held beyond the window of time allowed by study protocol and is no longer usable. | Blood, Stool, and Urine | Accession and Destroy with Director approval | Contact the appropriate protocol coordinator to determine if a replacement specimen can be recollected and submitted.  Please ensure that all specimens are shipped within the time period specified in the study protocol. |
17 | Unacceptable-Expired Collection Device | Biospecimen was collected using a tube, container, and/or reagent that was past its expiration date; quality of specimen cannot be ensured. | All | Accession and Destroy with Director approval | Contact the appropriate protocol coordinator to determine if a replacement specimen can be recollected and submitted. Please ensure that collection materials are not expired prior to collection. |
18 | Unacceptable-File not readable | Digital File submitted is not readable and therefore it is unacceptable. | Digital Specimen | Digital File submitted is not readable and therefore it is unacceptable. | Contact the appropriate protocol coordinator to determine if a replacement digital specimen can be recollected and submitted. |
19 | Unacceptable-Frozen | A sample intended to be received unfrozen has inadvertently been frozen and now can not be processed and is unusable | All | Accession and Destroy with Director approval | Contact the appropriate protocol coordinator to determine if a replacement specimen can be recollected and submitted. Please ensure that all specimens are properly packaged to avoid freezing. |
20 | Unacceptable-Hemolyzed | Blood sample is hemolyzed; cannot be processed further, and is unusable | Blood | Accession and Destroy with Director approval | Contact the appropriate protocol coordinator to determine if a replacement specimen can be recollected and submitted. Please ensure that all blood is properly collected and shipped per protocol requirements. |
21 | Unacceptable-ID Mismatch | A sample has been received whose physical label has no imputable correspondence with the associated packing slip or the BioMS manifest | All | Reject; Do not accession; Resolve discrepancy with the Program Manager OR destroy with Director approval | Please contact the appropriate biorepository and/or BioMS help desk IMMEDIATELY to resolve this conflict. Â Please ensure that all specimens are accurately labeled per protocol in future submissions. |
22 | Unacceptable-Improper collection container | A biospecimen (such as blood) was collected in the incorrect tube type or fixative type. Â The specimen can not be processed per protocol (e.g. Plasma was collected in a plain glass / serum / clot tube rather than an EDTA or Streck tube). | All | Accession and Destroy with Director Approval | Contact the appropriate protocol coordinator to determine if a replacement specimen can be recollected and submitted. Please ensure that all specimens are collected in the proper tube or container as specified in the protocol. |
23 | Unacceptable-Incorrect Magnification | Digital file submitted has incorrect magnification and therefore cannot be used. | Digital Specimen | Accession and Destroy with Director approval. | Contact the appropriate protocol coordinator to determine if a replacement digital specimen can be recollected and submitted. |
24 | Unacceptable-Incorrect Specimen | A sample has been received which is not an expected specimen for the study as per the study protocol. | All | Reject; Accession and triage to quarantined storage; Resolve discrepancy with the Program Manager OR destroy with Director approval | Please contact the appropriate biorepository and/or BioMS help desk to resolve this issue. Please ensure that all specimens shipped are as defined by the study protocol in future submissions. |
25 | Unacceptable-Lipemic | Blood sample is lipemic; cannot be processed further, and is unusable | Blood | Accession and Destroy with Director approval | Contact the appropriate protocol coordinator to determine if a replacement specimen can be recollected and submitted. |
26 | Unacceptable-No ID | A sample has been received with no physical identification. | All | Reject; Do not accession; Destroy with Director approval | Specimen will be discarded. Contact the appropriate protocol coordinator to determine if a replacement specimen can be recollected and submitted. Please ensure that all future specimens are completely labeled, per protocol requirements. |
27 | Unacceptable-Not Received | Shipment was never received at the Biorepository and might have been lost in transit. | All | Mark the Specimen(s) in the Shipment with Unacceptable-Not Received. | Contact the appropriate protocol coordinator to determine if a replacement specimen can be recollected and submitted. |
28 | Unacceptable - Not in shipment | Sample listed on BioMS packing slip is physically not in shipment | All | Reject; Do not accession | Contact the appropriate biorepository and/or BioMS help desk to resolve this conflict. Please ensure that all specimens are accounted for in future submissions. |
29 | Unacceptable-Poor Image Quality | Digital file submitted has poor image quality and therefore cannot be used. | Digital Specimen | Accession and Destroy with Director approval. | Contact the appropriate protocol coordinator to determine if a replacement digital specimen can be recollected and submitted. |
30 | Unacceptable-QNS | Quantity not sufficient; Sample is too limiting to process and is unusable | All | Accession and Destroy with Director approval | Specimen quantity is less than requested and not usable. Please contact the appropriate protocol coordinator to determine if a replacement specimen can be recollected and submitted; ensure that the requested specimen quantity is collected in future submissions. |
31 | Unacceptable-Thawed | A sample intended to be received frozen has inadvertently been thawed and now can not be processed and is unusable | All | Accession and Destroy with Director approval | Contact the appropriate protocol coordinator to determine if a replacement specimen can be recollected and submitted. Please ensure that all specimens are properly packaged with sufficient dry ice to avoid thawing. |
Note: Color Coding
Acceptable -Â Green
Alert -Â Orange
Unacceptable -Â RedÂ
Newly Planned, not yet active - Blue