During whole blood donation, a number of essential parameters must be determined to promote the collection of blood from voluntary blood donations according to the principles set in the conventions for the protection of human rights and dignity of the human being. Blood establishments are ultimately responsible for the quality and safety of blood and blood components collected but also for the safety and health of the blood donor.
- 1 First of all, all relevant information must be provided to prospective donors such as accurate educational materials that can be easily understood about the essential nature of the blood donation procedure, the components collected and the important benefits to patients. Furthermore, the reasons for the requiring of a medical assessment, health and medical history and the testing of all donations as well as the significance of the informed consent must be explained to the donor adequately.
- 2 All blood donors must undergo a screening process to assess their suitability; only healthy people with a good medical history can be accepted as donors, and their identity must be properly clarified at every single donation. All blood donors must be provided with accurate and updated information on HIV/AIDS and hepatitis transmission and must be given the opportunity for self-exclusion.
There must be a secure and unique donor identification, contact details and robust mechanisms that link each donor to the donation. The age limits for blood donors are a minimum age of 18 and a maximum age of 65 . However, in the recent past, the upper age limit has been extended to 68 or even to 71 years at some blood establishments.
- 3 Besides the exclusion because of obvious signs of infection, i.e. temperature above 38°C, it is essential to determine the infectious disease parameters for the following diseases:
- 4 Whole blood donations must not be collected from persons weighing <50 kg. A maximum of six standard donations per year can be collected from male persons and up to four donations from female persons. A minimum interval of 2 months between standard collections has to be observed. The maximum number of possible donations must not be exceeded under any circumstances. A standard whole blood donation must not exceed 500 ml. The haemoglobin concentration or haematocrit must be measured every time a donor attempts to donate. The minimum values to allow a donation are 125 g/l haemoglobin or 0·38 haematocrit for female donors and 135 g/l haemoglobin or 0·4 haematocrit for male donors. Individual donations below these values will only be permitted after consulting the responsible physicians.
- 5 For special blood donations, there are additional parameters that have to be taken into account. For plasmapheresis donations, the volume of plasma collected at each donation must not exceed 750 ml, and a minimum of 33 plasmapheresis procedures may be performed per donor per year. In addition, not more than 1·5 l of plasma is supposed to be collected per week. Furthermore, protein analyses, especially albumin and IgG must be performed at a regular basis, at least annually. The total protein count must not be below 60 g/l. The following requirements have to be taken into consideration for donors undergoing platelet apheresis. It must not be performed on individuals with a platelet count below 150 × 109/l. Also, donors must not be exposed to platelet apheresis procedures more often than once every 2 weeks. Exceptions can only be considered if they are HPA- or HLA-matched donations.
The requirements for the determination of essential parameters during blood donations reflect the necessity not only to protect the donor’s health but also to guarantee high-quality standards (specifications) for modern up-to-date blood products.