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.

Data Collection

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.

Training

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.