The following are the Specimen Receipt values used while receiving shipments at Alliance Biorepositories. For each of these specimen quality receipt values, there is an associated biorepository staff action and a notification comment to the CRA. The comment to the CRA will be communicated via email notification upon receiving the specimen at the Biorepository.
Status Value | Description | Applicable Specimen Types | Alliance Biorepository Staff Action | Email notification to CRA | |
|---|---|---|---|---|---|
| 1 | Acceptable | Sample has been received at the Biorepository in good condition. | 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 protocol or CSM, but is still usable. | All | Accession and Store | Specimen is usable; in the future, please remember to ship within the time period specified in the protocol or CSM. |
| 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 or CSM requirements. |
| 7 | Alert-Incomplete ID | A sample has been received whose physical label is incomplete as per protocol or CSM 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 or CSM requirements. |
| 8 | Alert-Improper collection container | A biospecimen (such as blood) was collected in the incorrect tube type or fixative type. 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. Please ensure that all future specimens are collected and preserved with the tube or container type as specified in the protocol or CSM. |
| 9 | Alert-Improper specimen collected | A sample has been received which is not an expected specimen as per the study protocol or CSM; but it can still be processed and is a usable substitute for the protocol / CSM defined specimen. (e.g. unstained slides were submitted in place of fixed tissue scrolls) | All | Accession and Store | Specimen is usable. Please ensure that all future specimens are collected as specified in the protocol or CSM. |
| 10 | 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. |
| 11 | 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 Manager WITHIN 24 HOURS. |
| 12 | Alert-No Path Report | A clinical, surgical pathology tissue specimen(s) was submitted either with no pathology report. | Tissue | Obtain the Path Report from the site. Accession and store if path report is provided. If site unable to provide path report, return to submitting site. | Please email a de-identified version of the appropriate Surgical Pathology Report to the Alliance Biorepository Manager WITHIN 24 HOURS. |
| 13 | Alert-Missing data on Path Report | A clinical, surgical pathology tissue specimen(s) was submitted with a pathology report that either does not match or cannot be reconciled with the physical identity of the submitted tissue. | Tissue | Accession and store if corrected path report is provided. If site unable to provide corrected path report, return to submitting site. | Please email a de-identified version of the appropriate Surgical Pathology Report containing necessary information mentioned in Protocol or CSM to the Alliance Biorepository Manager WITHIN 24 HOURS. |
| 14 | Alert-Not refrigerated | Biospecimen was to be sent with a cold pack to be maintained at refrigerated temperature. There was either no cold pack in the shipment or the cold pack was received at ambient temperature. 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. |
| 15 | 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 Specimen | 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. |
| 16 | Unacceptable-Clotted | Blood sample is clotted and can not be properly processed | Blood | Accession and Destroy with Director approval | Contact the Alliance Biorepository Manager to determine if a replacement specimen can be recollected and submitted. Please ensure that all blood is properly collected in anticoagulant tubes, per protocol or CSM requirements. |
| 17 | Unacceptable-Damaged | Sample is broken, crushed, shattered, or otherwise physically damaged beyond recovery. | All | Accession and Destroy with Director approval | Contact the Alliance Biorepository Manager to determine if a replacement specimen can be recollected and submitted. Please ensure that all specimens are properly packaged to avoid damage. |
| 18 | Unacceptable-Delayed sample shipment* | Sample was held beyond the window of time allowed by protocol or CSM and is no longer usable. | Blood, Formalin Fixed Tissue, Stool, CSF, Saliva and Urine | Accession and Destroy with Director approval | Contact the Alliance Biorepository Manager 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 protocol or CSM. |
| 19 | 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 Alliance Biorepository Manager to determine if a replacement specimen can be recollected and submitted. Please ensure that collection materials are not expired prior to collection. |
| 20 | Unacceptable-File not readable | Digital File submitted is not readable and therefore it is unacceptable. | Digital Specimen | Accession and Destroy with Director approval. | Contact the Alliance Biorepository Manager to determine if a replacement digital specimen can be recollected and submitted. |
| 21 | 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 Alliance Biorepository Manager to determine if a replacement specimen can be recollected and submitted. Please ensure that all specimens are properly packaged to avoid freezing. |
| 22 | Unacceptable-Hemolyzed | Blood sample is hemolyzed; cannot be processed further, and is unusable | Blood | Accession and Destroy with Director approval | Contact the Alliance Biorepository Manager to determine if a replacement specimen can be recollected and submitted. Please ensure that all blood is properly collected and shipped per protocol or CSM requirements. |
| 23 | 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 Alliance Biorepository Manager OR destroy with Director approval | Please contact the Alliance Biorepository Manager IMMEDIATELY to resolve this conflict. Please ensure that all specimens are accurately labeled per protocol or CSM in future submissions. |
| 24 | Unacceptable-Improper collection container | A biospecimen (such as blood) was collected in the incorrect tube type or fixative type. The specimen can not be processed per protocol or CSM. (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 Alliance Biorepository Manager 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 or CSM. |
| 25 | Unacceptable-Incorrect Magnification | Digital file submitted has incorrect magnification and therefore cannot be used. | Digital Specimen | Accession and Destroy with Director approval. | Contact the Alliance Biorepository Manager to determine if a replacement digital specimen can be recollected and submitted. |
| 26 | Unacceptable-Incorrect Specimen | A sample has been received which is not an expected specimen for the study as per the protocol or CSM. | All | Reject; Accession and triage to quarantined storage; Resolve discrepancy with the Biorepository Manager OR destroy with Director approval | Please contact Alliance Biorepository Manager to resolve this issue. Please ensure that all specimens shipped are as defined by the study protocol or CSM in future submissions. |
| 27 | Unacceptable-Lipemic | Blood sample is lipemic; cannot be processed further, and is unusable | Blood | Accession and Destroy with Director approval | Contact the Alliance Biorepository Manager to determine if a replacement specimen can be recollected and submitted. |
| 28 | 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 Alliance Biorepository Manager to determine if a replacement specimen can be recollected and submitted. Please ensure that all future specimens are completely labeled, per protocol or CSM requirements. |
| 29 | Unacceptable-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) | Accession and store if path report is provided. If site unable to provide path report, return to submitting site. | Please email a de-identified version of the appropriate surgical pathology report to the Alliance Biorepository Manager WITHIN 24 HOURS. |
| 30 | 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 Alliance Biorepository Manager to determine if a replacement specimen can be recollected and submitted. |
| 31 | Unacceptable-Not in shipment | Shipment was delivered at the repository, however, sample listed on BiomS packing slip is physically not in the shipment | All | Reject; Do not accession | Contact Alliance Biorepository Manager to resolve this conflict. Please ensure that all specimens are accounted for in future submissions. |
| 32 | 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 Alliance Biorepository Manager to determine if a replacement specimen can be recollected and submitted. |
| 33 | Unacceptable-QNS | Quantity not sufficient; Sample is too limiting to process and is unusable | All | For blood, stool, or urine-accession and Destroy with Director approval. For tissue, return to submitting site. | Specimen quantity is less than requested and not usable. Please contact the Alliance Biorepository Manager to determine if a replacement specimen can be recollected and submitted; ensure that the requested specimen quantity is collected in future submissions. |
| 34 | 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 Alliance Biorepository Manager 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. |
The asterisk( *) against two of the Unacceptable quality values indicates that these two are not included in the calculation of the collection sites' Quality performance metrices.
Note: Color Coding
Acceptable - Green
Alert - Orange
Unacceptable - Red
Newly Planned, not yet active - Blue
CSM: Correlative Science Manual - Each trial protocol document or associated Correlative Science Manual (CSM) must specify how to collect, prepare and ship specimens to the appropriate Alliance Biorespository site.