The Western Cape Blood Service closely subscribes to the basic requirements for operation as set out in the Human Tissue Act (Act 65 of 1983).
In a nutshell, the Act prescribes that all human blood and blood products used in South Africa may only be provided by an organisation, institution or person licensed to operate in accordance with the regulations relating to human blood and human blood products. These regulations are also issued in terms of the Human Tissue Act and amended from time to time.
Meeting the Minimum Requirements
The Western Cape Blood Service meets and aims to exceed the minimum standards for the collection, storage, processing and issuing of human blood and blood products by establishments licensed to operate within the borders of South Africa.
While such minimum standards must be regarded as obligatory for all establishments, it remains the prerogative of individual establishments to introduce standards and criteria over and above those laid down – provided that they supplement the standards and do not modify or conflict with them.
The standards are therefore not intended to replace detailed specifications and standard operating procedures, but should be used in the preparation of the operating procedure, as well as to complement the provisions of the Human Tissue Act and the regulations under which the discipline of blood transfusion may be practised in South Africa.
Failure to meet the specified requirements, mentioned below, is deemed to be a deficiency.
- If the Chief Executive Officer is not a registered medical practitioner – the responsibility for all medical matters must be delegated to a registered medical practitioner (Medical Director), who is qualified by training and/or by experience in blood transfusion and related matters, who shall have the responsibility and authority for all medical and technical policies and procedures, and for all supportive services which relate to the safety of recipients and donors.
- The licensee shall undertake to provide adequate clinical consultation facilities in respect of the practice of blood transfusion therapy and the management of complications arising therefrom.
- Strict confidentiality must be observed by all employees of an establishment with regard to all information pertaining to blood donors and recipients in whose treatment the establishment is involved.
The National Blood Transfusion Council continuously updates, and at least every four years reviews these standards, which are published from time to time.
- The Western Cape Blood Service’s position paper with respect to the Amalgamation of Blood Services in South Africa.