Tissue Collection and Transportation
Standard Operating Procedure (SOP 06.001)
PURPOSE
The purpose of this document is to outline standardized procedures for the TJUH Brain Biorepository to follow during the process of tumor tissue collection and transportation from the operating room to the biorepository laboratory. Tissue samples are collected from patients that have given their consent to participate in the tumor biobank program only if there is tissue in excess of that required for clinical diagnosis.
SCOPE
This standard operating procedure (SOP) describes how tissues should be collected and transported. The SOP does not cover detailed safety procedures for handling Human Biological Materials (HBMs) and it is recommended that personnel follow institutional biosafety guidelines.
REFERENCE TO OTHER TJUHBB SOPS OR POLICIES
- TJUHBB POL 02.001 Chemical Hygiene Plan
- TJUHBB POL 02.002 Laboratory Safety Policy
- TJUHBB POL 01.001 Quality Management Plan
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 | Obtain patient consent; transportation of tumor tissue, harvesting, processing, and storage |
Circulating Nurse | Notifies pathologist and laboratory prior to tumor resection |
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 | Quantity |
---|---|
Insulated Ice Box | 1 |
Sterile Specimen Container | Depends on Quantity |
Sterile Disposable Forceps | 1 |
Sterile Disposable Scalpel | 1 |
Sterile Disposable Petri Dish | 1 |
Pre-filled, Pre-labelled 2.0 mL Cryotubes | Depends on Quantity |
DEFINITIONS
See the TJUHBB Glossary.
PROCEDURES
This procedure is intended to ensure that tissue samples will be collected from consented participants in a safe, timely, and efficient manner while eliminating the risks of contamination. To facilitate the use of innovative genomic and proteomic techniques, banked tissue that has been adequately processed is vital to obtaining products with high integrity and quality.
Tissue Collection – General Considerations
- The scientific utility of the data obtained from the analysis of tissues is directly related to the quality of the tissue specimen.
- Cellular and molecular integrity are most affected by factors such as specimen and tissue type, conditions of tissue hypoxia, method of preservation, conditions of storage, pre-excision hypoxia and tissue product extraction methods. The following factors must be the focus of the process to obtain and maintain tissue with suitable integrity for innovative research:
Minimizing the time the tissue is subjected to hypoxic conditions, as this initiates the cell death mechanisms and subsequent degradation process. Use of agents or treatments to inactivate degrading enzymes for preserving nucleic acid integrity.
Preservation of tissue as fresh frozen, if the intended use is for nucleic acid analysis.
Storage of frozen tissue and products at appropriate temperatures especially if storage is for longer periods of time.
* Avoiding contamination with surrounding histological distinct tissue or co-processed samples if the product is intended for studies involving nucleic acid amplification.
Avoid Formalin
Never place tissue intended for banking as a fresh frozen specimen in formalin. Operating room staff must be warned that all tissue should be received fresh in normal saline.
Transporting of Tissue from the Operating Room to the Biorepository Laboratory
- The biorepository manger should contact the operating room staff prior to the beginning of cases marked for tissue donation to the biorepository. Staff should be alerted to contact the manager twenty minutes prior to tissue harvest (either cross clamp or resection) to ensure adequate time for the manager to be on hand prior to tissue extraction.
- Prior to transport, patient information should be documented on the Tissue Specimen Form.
- Upon arrival, patient information on the Tissue Specimen Form must be confirmed with the operating room staff.
- Aler the operating room staff that the repository is ready for collection and ask for a sterile specimen cup to be placed on the surgical field.
- Receive biospecimens that are surplus to clinical needs and diagnosis deemed by the acting clinician (either the surgeon or the neuropathologist)
- The biorepository technologist must designate the time of ischemia (when blood vessels were clamped or when tissue was extracted from the body) as well as when the tissue was placed on ice.
- Transport the tissue from the operating room to the biorepository laboratory on ice.
Prepare tissue collection kits in advance.
Warning
No more than 30 minutes should elapse between the time of biopsy/resection and time of freezing of a given sample. Records must clearly document the actual time period.
Sample Rejection
Fresh tissue from the operating room must be quickly processed in order to maximize RNA integrity. Accurate times must be kept by either the circulating nurse or the biorepository collector for warm ischemia (from when blood supply to tumor is cut), cold ischemia (time on ice), and flash freezing.
- Any specimen for which there is no record of warm ischemia must be rejected.
- Any specimen for which the warm ischemia time exceeds 30 minutes must be rejected.
- Any specimen for which the cold ischemia time exceeds 30 minutes must be rejected.
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 -
Jewell, S. et al. Analysis of the Molecular Quality of Human Tissues, an experience from the Cooperative Human Tissue Network.
Am. J. Clin. Pathol. 2002:118:733-741. -
Guideline – Fresh Tissue Working Group of BIG and NCI breast cancer Cooperative Groups
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