Blood samples for research work
Donor safety
Collection of blood samples on an informal basis from colleagues presents the same risks to health and safety as the collection of samples from patients or volunteer study groups. Blood from screened, anonymised sources such as tissue banks, out-of-date or surplus transfusion blood should always be used in preference, when possible.
These guidelines on sampling procedures, if followed, should ensure that risks are properly controlled and the rights of donors are respected.
Doner safety
- The collector must be competent in taking blood samples, or supervised by an experienced colleague until competent.
- Always sit, or preferably lie, the donor down before taking blood. Whenever feasible, samples of >20ml should be taken with the donor lying down on a couch.
- If you are taking blood with the donor seated, ensure there is sufficient space immediately adjacent to lie the donor down should they faint.
- Blood collection should be carried out away from public areas.
- For samples of >50ml the sample must be collected in a proper clinical room with a physician, nurse or first aider available to assist with faints. (The local OH clinic may be willing to assist with sample collection).
- For samples of >200ml a hemoglobin estimation should be carried out prior to collection. Samples should not be taken from men if hemoglobin is lower than 13.0g/dl. Samples should not be taken from women if hemoglobin is lower than 12.0g/dl.
- Where blood is to be collected regularly from a donor, a record of donations & the total collected should be maintained. The total (including donations elsewhere) should not exceed 500ml in a 6 month period for men or 250ml in 6 months for women unless approved by a research ethics committee. A record should be maintained of how often a person has donated to ensure this limit is not exceeded.
User safety
All blood & serum samples must be treated as potentially infectious and safe sharps practice (see below) followed when taking or handling blood. Negative tests for known blood-borne viruses do not rule out the possibility of infectious agents being present in a sample.
No-one should work with their own blood samples if the intention is to transform lymphocytes. In the event of an accidental exposure, their immune system will not challenge the transformed cells.
User safety
The Health and Safety (Sharps Instruments in Healthcare) Regulations 2013 require use of safer sharps devices in medical treatment. While it does not apply when taking blood from volunteer donors for research purposes, The College OH and Safety Departments recommend best practice is followed where venepuncture procedures are necessary. Existing equipment should be replaced with safer sharps devices and gloves should always be worn.
Departmental “Phlebotomists” will need to familiarise themselves with the safety features of equipment prior to use.
- Unguarded hypodermic needles and syringes must not be used for venepuncture
- Use collection equipment specifically designed to reduce the risk of inoculation injuries such as the BD Vacutainer® Eclipse™, Safety -Loc™ Blood Collection set (Butterfly)
- Always wear gloves when taking blood
- A sharps disposal container should be located adjacent to the donor during the procedure, for immediate disposal of sharps and used equipment
- Needles must never be recapped
- Never carry used sharps in your hand
- Venepuncture equipment must never be re-used
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Sharps injuries must be reported as an accident and advice sought from the local OH Service as soon as possible
Volunteers should be asked not to donate if they think they may be infected with a blood-borne virus or become a regular donor if they think that they may be at risk of infection from, for example, sexual partners in the future. The information card as shown below can be used for this purpose, to avoid embarrassment or inadvertent breach of confidentiality.
Regular donors should be screened for evidence of blood-borne viral infections such as HIV, HBV and HCV before commencing donation and later if they think they may have been exposed to risk of infection. Confidential screening for this purpose can be arranged with the College Occupational Health Service.
| Donor Information | For reasons of safety, you must not donate |
|---|---|
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Donation of blood for research is voluntary and you should not be placed under any pressure to do so. You do not have to agree to give a blood sample nor need to explain why, should you choose not to donate. |
If you know, or think that you might be infected with hepatitis B or hepatitis C If you know, or think that you might be infected with HIV— the ‘AIDs’ virus If you have a sexual partner who is infected with hepatitis or HIV If you are unwell at the moment If you are anaemic or receiving treatment for anaemia or iron deficiency. If you are, or may be, pregnant If you have given blood in the last 1 month (if more than 100ml is requested) |
The card only lists exclusion criteria relating to infection control and donor protection. The researcher may need to specify additional exclusion criteria to avoid use of samples that may confound test results, e.g. the donor taking drug treatment or the donor suffering from haematological disease.
Collection of blood samples from colleagues or other volunteers counts as experimentation on human subjects.
Unless sample are being collected only for teaching purposes formal approval by a Research Ethics Committee is likely to be required before collection can be take place. If the cell content of samples taken for any reason are stored rather than used immediately after collection, a Human Tissue Licence may also be required.
For further guidance on human tissue and ethics approvals go to the Joint Research Office website.
You can also find codes of practice on the Human Tissue Authority website.