The South African Tissue Bank Association (SATiBA) is a not-for-profit organization that aims to support all South African tissue banks in regulatory and legal matters, data collection, training, accreditation, quality assurance, communication and collaboration, and more.
While recognising that not all the elements of tissue banking are defined in the Health Act, and considering the need expressed by industry partners, SATiBA has decided to include the following disciplines in its operational definition of tissue banking: Cornea & eye; Skin; Bone & tendons; Heart valves; Stem cells, Blood and blood related products; Amnion; Gametes; and Bone marrow.
There is a need for the industry to take responsibility for its own future and development due to a lack of government support and funding, but this can only be achieved through cooperation and agreement between the various stake holders.
Regulatory and Legal Matters
Given the paucity of legislation and the inaccuracies therein combined with the increase in litigation, a move to greater self-regulation is becoming a necessity in disciplines that are highly technological and are advancing at a very rapid pace.
SATiBA’s activities are governed in the main by Chapter 8 of the National Health Act and regulations thereto and compels the tissue banks to work together, despite the perceived competition that may exist between some tissue banks.
The ideal would be for the entire South African transplantation community to buy into an electronic real-time system together. Such a system will potentially track organ and tissue donors and recipients, serology and medical records, outcomes and distribution, thus making it a complete system ensuring total traceability.
It is noted that there is no formal standard to accredit Tissue Banks and neither is there any official training available to tissue bank staff in South Africa. Overseas training comes at a high price and is most often declined due to a lack of funds. The result is ill-equipped and poorly motivated staff that has to learn from internet research and trial and error.
Accreditation and Quality Assurance
The new tissue banking regulations require “a policy on quality management and safety system based on the principle of best laboratory and manufacturing practice is put in place.” Such a system is best maintained through a formal accredited ISO Total Quality Management System. This however requires commitment and the necessary funds to establish.
Communication and collaboration
Improved communication and the ability to be more effective through collaboration is one of the main objectives of the association. Affiliation to international bodies could be easier through the Association.