SATiBA Introduction: Prof Michael Pepper, President and Chairman SATiBA Board
"SATiBA’s vision is to unify, align and develop the industry through collaborations between members as well as Government, partners and international role players.” 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.
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 in its operational definition of tissue banking: cornea, bone and tendons, skin, heart valves, stem cells, blood and blood related products, amnion and gametes. There is a need for the industry to take responsibility and to self-regulate. This is largely due to the fact that the regulatory framework is limited. SATiBA recognizes this can only be achieved through cooperation and agreement between the various stakeholders.
SATiBA’s vision is “to unify, align and develop the industry through collaborations between members as well as Government, partners and international role players” http://www.satiba.org.za/about-vision.php. Specifically, SATiBA aims to promote: global tissue banking standards in South Africa; collaboration between members as well as Government, partners and international role players to the primary benefit of patients; greater access to cells and tissues; equality and fair utilization of cells and tissues; and fair and ethical tissue procurement, banking and distribution. Above all, SATiBA’s foundation is built on fair, objective and ethical practices that protect the privacy, dignity and best interests of our patients, partners and colleagues alike.
The SATiBA Board meets on a quarterly basis and is constituted and renewed on the basis of directives laid out in the Memorandum of Incorporation http://www.satiba.org.za/about-moi.php. At present the board is comprised of Prof Michael Pepper (President and Chairperson); Sandra Venter (Vice-President); Dr Yvonne Holt (Treasurer); Dr Robert Crookes (Secretary); Yvonne Cordner; Charlotte Ingram; Cleo Ndhlovu; Carol Tonnesen and Kuben Vather.
|
|
|
|
SATiBA AGM 2018
Date: 11 October 2018 Time: 10h00 – 16h00
Venue: Southern Sun O.R. Tambo International Airport Hotel
Agenda and relevant documentation to follow.
|
|
|
SATiBA Workshops 2018: Cleo Ndhlovu, Centre for Tissue Engineering
SATiBA successfully hosted 3 workshops and plan a further 2 before the end of the year. The first workshop for members was aimed at drafting guidelines for Cornea banking. The cornea is the eye’s outermost layer. It is the clear, dome-shaped surface that covers the front of the eye; and it plays an important role in focusing one's vision. This was a fruitful workshop where lots of ideas were shared to come up with a way to ensure that all Eye banks follow similar protocols pertaining to the consent process and donor identification.
The second workshop was to introduce SATiBA members to ISBT 128 barcoding and the IATA requirements for safe transportation of biological substances. Members learnt a lot from this workshop and took home some valuable information to be implemented in their work environments. For more information please visit these websites: https://www.iccbba.org/home/isbt-128-basics/what-is-isbt-128
https://www.biocair.com/services/regulatory-compliance
The latest workshop was held recently to put together guidelines for banking of amniotic membranes. Amniotic membrane is the innermost layer of the placenta consisting of a thick basement membrane and an avascular stromal matrix. It can be used as a graft and as a dressing to facilitate ocular surface reconstruction and to promote healing. It is important to ensure that all tissue banks involved in the banking of amniotic membranes also follow similar legal consent processes as well as apply similar selection criteria.
The next workshops are planned as follows:
18 September, 2018: Bone, tendon and skin banking guidelines
10 October, 2018: Heart valve banking guidelines
Details to follow.
|
|
|
|
The Tremendous Benefits of Working Together: Yvonne Cordner, South African Burn Care Trust
Over the last three years, there have been vast improvements in the awareness of burn treatments and in the supply of skin to certain centres to children who were severely burnt.
Previously survival rates for children with more than 40% TBSA (Total Body Surface Area) burns had a slim chance of survival and those that did survive suffered long periods in hospital with huge cost implications to the hospital concerned.
Children with a much higher TBSA of 90% burns have survived thanks to the supply of cadaver skin which ultimately translates into a shorter hospital stay and more importantly, reduces the duration of prolonged suffering for the patient.
Whilst we have just begun this journey our main focus now is to ensure system based referrals and skills transference leading to an increased supply of all tissue, which can be accessed by all of those in need.
SATiBA is providing a platform for us all to work together to effect the changes we all want to see.
|
|
|
|
What is MTA? Kuben Vather, SANBS
Google the word “Biobanking” and in 0.35 seconds you will have about 664,000 results. Clearly a lot of people have a lot to say about biobanking but what does this term really mean? The field of biobanking has many categories including animal, plant, environmental, human, microorganisms, etc. This article will focus on human material transfer from biobanks.
Biobanks were first created in academic institutions by researchers who wanted to store specimens for further research.
This evolved into storage of specimens by research laboratories, private laboratories and commercial companies. Up until recently, there has been no regulation related to biobanking in South Africa.
The National Health Act, 2003 Material Transfer Agreement of Human Biologic Materials (MTA) gazetted on 20 July 2018 defines a biobank as an institution or unit thereof that safeguards an organised collection of human biological material and associated data from different individuals, which are usually kept for an unlimited period of time, for the purposes of health research. The MTA stipulates that samples can only be stored if proper informed consent is obtained from the donor and research can only be performed on samples stored in a biobank if approved by an HREC. The obligations of the provider and recipient of human biological material and data is also clarified. HREC obligations are also defined in the MTA.
All institutions involved in research pertaining to human subjects shall use the MTA with immediate effect.
Website link for the MTA https://www.gov.za/documents/national-health-act-material-transfer-agreement-human-biological-materials-15-aug-2018
|
|
|
|
|
Update on the HPCSA Registration Project: Dr Charlotte Ingram & Alicia Venter, SANBS
The need to address the HPCSA registration of tissue retrieval technical staff, medical scientists and laboratory personnel operating within the fields of Tissue Banks and Cell Biology was identified early on in the establishment of the South African Tissue Bank Association (SATiBA). Initially, there had been much discussion for this requirement as a need for HPCSA registration relating to medical scientists and laboratory staff. However, it was recognised that in addition to this, it would be necessary to address those who retrieve corneas, skin, heart valves, bone and tendons.
People in these positions have a varied level of qualification, but there is no standard of academic qualification at the moment. While this field has become very specialised, there is currently no formal training or registration for these people in South Africa. This had become an area of concern as there is a lack of independent regulation within these areas of health activities. The fact that all of the abovementioned health care workers are handling and processing human tissue and in some instances performing diagnostic testing and reporting results affecting patient management, make it paramount that such a registration be considered & implemented officially by HPCSA. A formal body would not only provide credibility but also provide a way of setting standards and keeping individuals accountable.
Currently, no such a category exists within the Health Professions Council of South Africa. To accommodate these healthcare workers, communication was received from HPCSA in the form of 3 letters to various organisations operating within the tissue bank & cell biology spheres. The HPCSA indicated they would consider putting together a working group to investigate the establishment of a new category, namely that of Cell Biology. A call was made for the organisations to submit a 2-3 page document describing the scope of practice of the interested entities. Such a response needed to reach the HPCSA before the 31st of August 2018. The SATiBA Board made a decision to take up the request on behalf of the tissue banks and cell therapy related entities. It was agreed that a request is made for the establishment of two broad subcategories within the overall category of Cell Biology; one being that of Tissue Banking (TB), and the other that of Cell Therapy (CT). Prof Michael Pepper (current Chair of SATiBA) & Sandra Venter (SATiBA Vice-Chair) would respectively put together the scope and requirements for the new subcategories. Prof Michael Pepper would respond from SATiBA to HPCSA explaining the need for two subcategories: Cell Therapy & Tissue Banking & the scope requirements. Following on acceptance of such a request by HPCSA, a curriculum & assessment for the subcategories would need to be developed.
Furthermore, Cryo-Save & the South African Bone Marrow Registry (SABMR) would forward their scopes of practice for the medical scientists in the field of Cell Therapy for sharing with the HPCSA in the communication from Prof Pepper to HPCSA. We understand that a grandfather clause may be allowed & we would urge SATiBA to request as such.
It should be noted that the category for the discipline of Cell Biology has not been promulgated as there is no active training programme or accredited training institution. At this point, HPCSA did advise that Netcells submit a national curriculum & assessment should they wish the HPCSA Committee of Medical Scientists to recommend the establishment of the new category of Cell Biology. Netcells have taken a decision not to proceed along this route.
The SATiBA Board will send out a formal communication to SATiBA members once feedback from the HPCSA is received.
|
|
|
|
