Quality Assurance Overview

1. All human biological specimens are handled using sterile techniques. Tissue samples that are intended to be frozen are snap-frozen directly in liquid nitrogen within 30 minutes or less after surgical excision. Blood samples are frozen at -80 C within 4 hours after blood draw.
2. A representative piece of tissue is cut off and used to prepare a representative paraffin embedded tissue block and H&E slide.
3. The remaining sample is cut into 0.5 gm fragments. Each fragment is snap frozen individually in liquid nitrogen.
4. Samples must be pre-frozen in liquid nitrogen before they are placed in tubes to assure they do not stick to the tubes. Tubes must be pre-labeled.
5. Tissue samples are to be stored in liquid nitrogen.
6. Informed Consent must be obtained from each donor before sampling. Patient identification information must be de-identified.
7. Samples should be handled as potentially infectious. All reasonable efforts should be made to warn clients if specimens contain any known infectious agent.
8. Prior to shipment ProteoGenex will contact clients to provide the date of delivery.
9. At a time of shipment ProteoGenex will contact clients and will provide tracking # for shipment. All fresh/frozen samples are shipped on dry ice.
10. Be sure that the following items are included in the shipment:
    1. List of samples/packing slip
    2. Samples
    3. H&E slides (if requested)
    4. Complete clinical information, pathological (ProteoGenex), and clinical data are to be sent in electronic version
11. Pathology QC:
    1. Be sure that H&E slides are prepared from each fresh frozen tissue and from each FFPE tissue block collected for ProteoGenex
    2. Be sure each H&E slide is reviewed by pathologist to confirm tissue identity and normal histology and to ensure the representative cellular components are present in the specimen
    3. Be sure each H&E slide is compared with confirmed diagnosis in the pathological report
    4. Tissue samples with >50% of tumor cells will be acceptable for shipping to clients (unless requested otherwise)
    5. Pathologists pass or reject specimens
12. RNA QC:
    1. Be sure that extraction of total RNA was performed on all fresh frozen samples collected for ProteoGenex
       1. Small pieces of fresh frozen samples are cut on dry ice for RNA testing
       2. RNA is extracted using Trizol reagent
       3. RNA is analyzed using the Agilent Bioanalyser 2100
    2. Be sure that the RNA ratio of 28S to 18S peaks is equal or greater then 1.7
13. Clinical data QC:
    1. Be sure that all data are reviewed for accuracy and completion
    2. All data must be corresponding with pathology information