Blood Collection
Standard Operating Procedure (SOP 05.001.2)
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. The purpose of this document is to outline standardized procedures for the TJUHBB biobank to follow for blood collection.
SCOPE
This standard operating procedure (SOP) describes how blood should be drawn. This SOP does not cover detailed safety procedures for handling blood, and personnel must follow institutional bio-safety guidelines. When blood collection is subcontracted, the subcontractor must follow institutional 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
- TJUHBB SOP 08.02.002 Blood Processing and Storage
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, transport blood, process blood |
Anesthesiology Department | Draw blood from patient |
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) | 2 x 4 mL Lavender top tubes |
Needles of appropriate gauge number | 1 |
Tourniquet | 1 |
Alcohol wipes (70%) isopropyl alcohol | 2 |
Gauze sponges for application to site from which needle has been withdrawn | 4 |
Adhesive bandages/tape to protect venipuncture site after collection | 1 |
Needle/sharps disposal unit | 1 |
Gloves (non-latex recommended) worn to protect patient and phlebotomist | 1 pair |
Syringes that may be used in place of evacuated collection tubes in certain circumstances. | 2 x 10 mL |
DEFINITIONS
See the TJUHBB Glossary.
PROCEDURES
This procedure is intended to ensure that blood samples will be obtained from consented participants in a safe and efficient manner while eliminating the risks of contamination. Blood products are a precious resource in the tumor biobank and procedures must be followed to obtain products with high integrity and quality.
Timing for Blood Collection
- Preferably, 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.
Peri-operative Blood Draw
If blood collection is not possible pre-operatively (either due to repeated unsuccessful venipuncture or patient refusal) peri-operative blood is an acceptable substitute. The blood is drawn after anesthetic induction is achieved, either through venipuncture or withdrawal from an existing arterial line.
Documentation
If peri-operative blood is taken, it must be noted in the biorepository database that the blood draw was peri-operative and specify the method by which the blood was drawn (venipuncture vs arterial-line).
- Identify the person responsible for processing the blood collection and arrange for timely processing (Refer to TJUHBB SOP 08.02.002 – Blood Processing and Storage for further details).
Blood Collection Procedure - Preparation
- Personnel qualified by training to draw blood must perform blood collection.
- Identify the patient, verify identification, and check that informed consent has been obtained.
- Record the time that blood was drawn.
- Assess patient’s physical and mental disposition and determine if this is the appropriate time to draw blood.
- Be courteous, professional, and sensitive to the patient’s needs. Ensure that all communications are discreet and respectful of patient confidentiality.
- The anesthesiologist will draw blood for the biobank.
Transport of Blood Sample to Pathology or Biobank Lab for Processing
- Verify patient information (in keeping with privacy and ethical policies) and ensure that it corresponds with the information on the labels on blood collection tubes.
- The biobank manager should transport labelled tubes to the specified area at the biobank for processing blood samples.
- Transport EDTA tubes at room temperature unless otherwise specified.
Warning
Do not allow the samples to freeze or be exposed to an ambient temperature of greater than 25° C.
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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