Blood Processing and Storage
Standard Operating Procedure (SOP 05.002.1)
PURPOSE
Blood samples are drawn from patients that have been through the informed consent process and agreed to participate in the tumor biobank program. Blood samples are obtained by personnel qualified to draw blood from patients in the cancer center, the hospital or in the physician’s office. Processed blood products are an important tumor biobank resource.
SCOPE
This standard operating procedure (SOP) describes how blood should be processed, accessioned and stored. The SOP does not cover detailed safety procedures for handling blood and it is recommended that personnel follow institutional biosafety guidelines.
REFERENCE TO OTHER TJUHBB SOPS OR POLICIES
ROLES AND RESPONSIBILITIES
This SOP applies to all qualified tumor biobank personnel and clinical staff at the collection centers that are involved in recruiting patients and the acquisition of informed and voluntary consent. This may include the following personnel:
Tumor Biobank Personnel | Responsibility |
---|---|
Tumor Bank Manager | Transport, process and store blood and blood products |
MATERIALS, EQUIPMENT AND FORMS
The materials, equipment and forms listed in the following list are recommendations only and may be substituted by alternative/equivalent products more suitable for the site-specific task or procedure.
Materials & Equipment | Materials & Equipment (Site Specific) |
---|---|
Evacuated blood collection tubes for plasma (e.g. Lavender top tube with EDTA) with sample | |
2.0 ml cryovials | |
Centrifuge | |
Storage Boxes | |
Lymphoprep | |
Item required for Sepmate Protocol |
DEFINITIONS
See the TJUHBB Glossary.
PROCEDURES
This procedure is intended to ensure that blood samples obtained from consented participants are processed in a safe and efficient manner while eliminating the risks of contamination and loss.
Timing for Blood Collection and Processing
- Blood collection should be done pre-operation and as close as possible to the time when the tissue is donated to the biobank or at an alternative time, if appropriate for the research study.
Verification of Identification Information on Tubes
- As applicable, verify the accuracy of patient information (in keeping with privacy and ethical policies) and ensure that it corresponds with the information on labels on blood collection tubes.
Accessioning of EDTA Blood Tubes
- For EDTA (lavender-top) blood tubes, three (3) 7 mL lavender-top EDTA tubes will be provided in a standard bio-hazard bag with the corresponding de-identified labels.
- Upon receiving the blood collection tubes, one patient label should be placed on the side of each lavender-top tube after blood collection has taken place.
- Blood should be processed following the Sepmate Protocol (attached following this SOP).
Accessioning and freezing should occur within 4 hours of blood collection.
Rejection
Proper tracking of blood samples from the OR is critical to maintain quality banking standards.
- A sample may be rejected if it is unlabeled or the custody of the sample is undocumented.
- A sample may be rejected if it remains at room temperature for greater than two hours.
- A sample may be rejected if the integrity of the blood tube is compromised. This can include leakage or a broken/loose cap.
- A sample may be rejected if it has clotted before freezing or further processing for plasma and white blood cells.
Alternate Processing of Blood Samples
If blood has been collected in specific collection tubes for extraction of DNA or RNA then proceed with processing of these collection tubes as per established procedures for DNA and RNA processing and extraction.
APPLICABLE REFERENCES, REGULATIONS AND GUIDELINES
-
Declaration of Helsinki.
http://www.wma.net/en/30publications/10policies/b3/index.html -
Tri-Council Policy Statement 2; Ethical Conduct for Research Involving Humans; Medical Research Council of Canada; Natural Sciences and Engineering Council of Canada; Social Sciences and Humanities Research Council of Canada, December 2010.
http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/ -
Human Tissue and Biological Samples for use in Research. Operational and Ethical Guidelines. Medical Research Council Ethics
http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002420 -
Best Practices for Repositories I. Collection, Storage and Retrieval of Human Biological Materials for Research. International Society for Biological and Environmental Repositories (ISBER).
http://www.isber.org/Search/search.asp?zoom_query=best+practices+for+repositories -
US National Biospecimen Network Blueprint
http://biospecimens.cancer.gov/resources/publications/reports/nbn.asp -
National Bioethics Advisory Commission: Research involving human biological materials: Ethical issues and policy guidance, Vol. I: Report and recommendations of the National Bioethics Advisory Committee. August 1999.
http://bioethics.georgetown.edu/nbac/hbm.pdf -
Blood Collection: Routine Venipuncture and Specimen Handling. http://library.med.utah.edu/WebPath/TUTORIAL/PHLEB/PHLEB.html
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