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donors n Post-donation advice and care. 2.6 QUALITY SYSTEM The implementation of a quality system is a pre-requisite for a consistent approach to donor selection. Essential elements of a quality system in the donor selection process include: n An organizational structure that defines the authority, responsibility and reporting channels of all personnel, including written job specifications n Donor selection criteria, as part of the national guidelines for the BTS, to ensure uniform application in every facility in which blood donations are collected n Standard operating procedures (SOPs) that guide every process, procedure and task to ensure consistency, accuracy and donor adherence, including information on the necessary staff, facilities, forms, worksheets and references, such as: — Donor interview and assessment based on a standardized donor questionnaire 27 — Basic health check, including haemoglobin screening n Staff training and competency assessment, including a training curriculum and training records n Records system (electronic or manual) that ensures traceability and confidentiality, including: — Donor records associated with each donation, including completed donor questionnaires — Results of basic health check and haemoglobin screening — Donor deferrals and reasons for deferral — Adverse donor reactions n Periodic monitoring and evaluation of the donor selection process. The confidentiality of donor records and the traceability of donations should be assured at all times through the use of unique identification numbers for donors and donations, and a mechanism linking donors to donations. All instruments and equipment used in the donor selection process, such as weighing scales and devices for the measurement of body temperature, blood pressure and haemoglobin, should be maintained and calibrated in accordance with quality requirements. The health and safety of staff should be safeguarded, including protection from sharps injuries during haemoglobin screening (30,31). Special attention should be given to the disposal of sharps, effluent copper sulphate and other waste materials (32). The education and training of staff and regular quality monitoring are necessary for continual quality improvement. 2.7 DONOR HAEMOVIGILANCE Donor haemovigilance is a continuous process of data collection and analysis of adverse donor events and reactions in order to investigate their causes and outcomes; haemovigilance data should be utilized for clinical and public health decision making. All adverse events and reactions in donors should be identified, documented and reported. These data should be regularly analysed in order to undertake possible corrective and preventive actions. The goal of donor haemovigilance is to reduce the occurrence of adverse events and reactions and improve the outcomes both for donors and patients. All donors should be advised to inform the BTS of any ill-effects they suffer after donating, such as a delayed faint, or if they recall an illness or information that should have been declared before donation. Donors should also be asked to notify the BTS if they become unwell within 28 days of donation, particularly with an illness that they may have been incubating at the time of donation. This is especially important with an infection such as hepatitis A where prompt action may prevent infection in the recipient (33). Donor haemovigilance is a requirement of the quality system (34) and contributes to: n Improved donor safety through the implementation of corrective and preventive actions to avert the occurrence or recurrence of adverse donor events and reactions n Tracing of donors and withdrawal of donations that may have or could contribute to serious adverse reactions in recipients n Improved patient safety through better donor selection criteria and processes 28 n Epidemiological follow-up of the donor population. A rapid response system should be in place to share any relevant information related to adverse donor events and reactions for appropriate action to be taken for improving donor and patient safety. Information about any adverse effects in the recipients of transfusion should also be fed back into the donor haemovigilance system to improve donor selection. Also refer to Section 3.5 on adverse donor reactions and post-donation care. 2.8 MONITORING AND EVALUATION The process of donor selection requires on-going monitoring and evaluation to ensure that it achieves its objectives of ensuring donor and patient health and safety and a sufficient supply of safe blood and blood products. The main parameters to be monitored include: n Donor demographics and characteristics n Donor

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