Biospecimen Lifecycle

Pre-Acquisition - biospecimen Molecular Integrity Antibiotics and other drugs
Anesthesia: Type and Duration
Arterial clamp time
Blood loss pressure variations
Blood and Fluid administration

Patient - The biospecimen exists in situ within the specific biologic context of the patient.
RCHSD Admission
COTA
Consented COTA Scan EMR?
Daily List of Consented EPIC?

Medical/Surgical Procedures
Examples include administration of antibiotics, anesthesia and other drugs. At this point anesthesiologists, nurses, and doctors may introduce variables into the procedure that change the biologic context of the "specimen" and, as a result, cause dynamic changes in the molecular profiles within the "specimen."
Warm Ischemia Time < 30 Minutes
Cold Ischemia Time 30 min < 2hr
On call transport specimen
Rapid Triage of Specimen

Acquisition
Various methods of acquiring the "specimen" may introduce specific types of stress or trauma to the living specimen. Examples include time delays (from handling to delivery), and packaging (changing exposure to desiccation or oxidation.)
Unique study number Barcoding
Collection supervised by Rady Children's Pathologists
Asceptic technique
No thaw/Freeze Cycle - Aliquot

Handling/Processing
Preparation variables introduced prior and during biologic stabilization of the specimen include: time @ RT, RT, type and time in fixative, method & rate of freezing, size of specimen aliquots. Human involvement contributes to this process.
Flash Freezing: LN2, OCT
Diseased tissue: Cancer/Non-cancer
Adjacent non diseased tissue
Controlled fixation

Post-Acquisition
Transport and Handling
Room Temp and Time spent at room temperature
Freezing - storage temperature
Fixative Type and Time spent in fixative

Quality Control/Assurance
H&E section of all banked tissue
Review by board certified pathologists
Correlate and Verify pathologic diagnosis
Viable Tumor content score

Bioinformatics
Velos/eResearch/eSample
Clinical data
Sample tracking
Inventory control

Storage
Variables include storage temperature, duration, progressive dehydration, desiccation and oxidation may contribute to this process.
CryPlus LN2 Storage
-80C Biomedical
Freezer Monitored 24/7
Emergency Response on-call
Back up power and LN2

Distribution - Variation sin transport may lead to alterations in the specimen. Package, transport and receiving all contribute to this type of variations.
Access to materials electronic request
Investigator Application Instructions Agreement Package
Biobank Committee review and approval

Scientific Analysis

Different methods of analysis for various classes of biomolecules may be affected by any of the factors already mentioned. Even with a single analytical method, each individual investigator and technician involved in the specimen analysis may contribute to such variation.

Restocking
Environmental variables may be introduced through the return of unused samples from research laboratories to storage.

Effects on clinical outcomes:
• Morphological analysis/diagnosis
• Skewed clinical chemistry results
• Potential for incorrect therapy when diagnostic is paired with therapeutic (e.g., HER2)

Effects on research outcomes:
• Variations in gene expression
• Variations in post-translational modification (e.g., phosphorylation status)
• Potential for misinterpretation of artifacts as biomarkers