Page Comparison

Acceptable                          

Sample has been received at the Biorepository in good condition.

All

Accession and Store

None.

Alert-Cauterized

Tissue shows gross cauterization artifact.

Tissue

Accession and Store

Specimen is usable; in the future, please avoid cauterized tissue.

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

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.

Alert-Hemorrhagic

Specimen shows gross hemorrhagic tissue

Tissue

Accession and Store

Specimen is usable; in the future, please avoid hemorrhagic tissue

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.

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.

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.

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.

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.

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.

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.

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.

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.

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. 

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 Alliance 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.

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.

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.

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

cannot 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.

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.

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.

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.

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.

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.