Regional
JACIE accreditation of a mobile collection and central processing facility – the South African experience
Tanya Glatt
South African National Blood Service, South Africa
Riana Cockeran
South African National Blood Service, South Africa
In South Africa, similar to other developing countries, the regulation and legislation regarding cellular therapy products require updating 1. In the absence of local standards, the South African National Blood Service (SANBS) aligns with best international practice and therefore embarked on a journey to apply for the Joint Accreditation Committee ISCT-Europe & EBMT (JACIE) accreditation 2, for the collection and processing of Haematopoietic Progenitor Cells (HPC). SANBS was awarded JACIE accreditation in February 2024. However in its true essence, abiding by JACIE standards is a constant process of continuously performing tasks in a quality-driven manner – this process started many years prior to 2024 and continues in our workplace daily.
JACIE defines 3 arms of an HPC Transplant (HCT) programme: the Clinical Unit (CU), the Collection Facility (CF) and the Processing Facility (PF). SANBS provides a mobile, decentralized CF and a fixed centralized PF that can support any CU in either the public or private healthcare sector in South Africa. This operating model is well-suited to a blood service such as SANBS which offers a vein-to-vein service over a wide geographical expanse. SANBS has a well-established logistics team and infrastructure that transports staff, instruments, blood and blood products throughout the country. This structure is an advantageous basis on which to build an HCT programme.
Various challenges need to be addressed in order to implement a successful HCT programme in a resource-limited country. These include the ability of a logistic system to be agile and transport staff and equipment by road or air often at short notice, the inability to react to early or delayed procedures, the transport and real-time reporting of CD34 flow cytometry samples that inform collection decisions, meticulous asset management and the training and competency of courier companies.
SANBS presently provides CF and PF services to 36 doctors at 16 CUs. These CUs have different constraints which include expertise, finances, infrastructure and support services and are situated in both the public and private healthcare sectors. Some CUs are highly experienced in HCT while others rely on SANBS to play an advisory role. In 2023, SANBS serviced 313 HCT patients, 70% autologous, 15% matched unrelated donors, 13% matched related donors and 2% haploidentical HCT, of which 60% were in the public healthcare sector. The public healthcare sector in 8 of our 9 provinces solely relies on SANBS to provide an HCT CF and PF, while the private sector can use SANBS or other parties 3. SANBS provides the same quality service irrespective if it is a public or private healthcare sector patient.
The requirements for JACIE accreditation emphasize quality, reproducibility of standards, continuous improvement and strict requirements in relation to years of experience of the medical directors, which can be a challenge in a newly established facility or newly appointed staff complement. At the time of writing this manuscript, according to the JACIE website (4) there were 217 JACIE accredited centres and 219 centres in process of JACIE accreditation internationally, of which three are in South Africa; two CF and PF centres (one accredited, one in process) and one CU in process 4. The presence of JACIE accredited facilities in South Africa shows the commitment to quality and excellence in our country.
Practical steps which assisted us in our JACIE accreditation journey include:
• Download and check the checklist – go through each item and assign staff to complete each one • Look at your organogram and assign appropriate roles as per JACIE requirements - staff may have overlapping roles but fill the mandatory roles urgently to comply with strict timelines • Initiate monthly quality and educational meetings with evidence of quality improvement and identifying gaps in processes and knowledge base • Schedule JACIE mandatory audits – even if you feel you are not ready and there are many findings, log these as occurrences and institute quality improvement plans to address them • Implement a validated document management system • Prepare a template for your quarterly and annual reports and then populate them timeously • Validate all instruments, consumables and processes including the transport of products between CF, PF and CU • Log occurrences – this is an important sign of quality improvement • Ensure ongoing training of all staff including nurses, technologists, couriers, and cleaners and document the evidence thereof
Successful implementation of a HCT programme requires ongoing collaboration between CU, CF, PF and registries. JACIE requires documented evidence of these relationships including meetings, communications and training. It requires continuous commitment and documentation of each small step taken to ensure a successful outcome.
JACIE accreditation is an objective way to give assurance to our patients, doctors, registries and donors that we are operating according to international best practice. This assurance is not dependent on the healthcare facility you visit, nor the geographical area that you reside in, but is crosscutting to all patients serviced. It provides independent evidence that the services we provide are in line with recommended guidelines and policies and that can be trusted. This stamp of approval is important for growing a programme and allows for collaboration with other institutions within the HCT arena.
References
1. Viljoen IM, Hendricks CL, Malherbe HL, Pepper MS. Regenerative medicines: A new regulatory paradigm for South Africa. Biochimie. 2022;196:123-30. 2. 8th edition of FACT-JACIE Standards 2021 Available from: https://www.ebmt.org/8th-edition-fact-jacie-standards. 3. South African National Blood Service, internal data. www.sanbs.org.za 4. JACIE Accredited Centres | EBMT; https://www.ebmt.org/jacie-accredited-centres; accessed 18 December 2024.
