Last June, we expressed, in our blog post “Guide to Quality Measures for Organ Transplantation”[i], our interest in being actively involved in the further development of a quality management methodology, where biovigilance and surveillance, will be introduced in the equation, so those final outcomes may be related to the organ donation specificities.
Today, in the midst of an unprecedented COVID-19 peak (Portugal has officially the highest number of infections and deaths per million inhabitants), our attention was brought back to traceability[ii] – defined as the ability to locate and identify the organ at each stage in the chain from donation to transplantation or disposal – and its challenges.
Traceability is a global challenge!
Today’s organ transplantation success is based on the extensive use of immunosuppressive therapies, which, in return, leave patients more vulnerable to disease. The unanticipated transmission of an infectious disease from an organ donor to the recipient(s) is, fortunately, a rare event but, when it occurs, it is associated with significant morbidity and mortality. Transplantation amplifies the transmission risks, as 8 organs (and over one hundred tissues) may be recovered and transplanted in as many patients, from a single donor.
Traceability’s credibility is also a supporter of rule of law enforcement; the stronger it is, the more it contributes to the prevention of the non-appropriate use of organs and substances of human origin[iii], helping the world to put an end to organ trafficking.
Governments, around the world, have established regulations and standards implementing vigilance and surveillance systems, to ensure early detection and prevention of risks, improving patient safety, while simultaneously reinforcing the trust in the national donation and transplantation network.
But, in a quest to ensure that all the organs procured are transplanted, there’s an ever-growing cross-border transfer and transportation of grafts[AF1]. As a result, traceability is today a global concern, that transcends borders. The uniqueness of identification at a national or regional level is not enough when cells, tissues, and organs can and do, travel worldwide.
The missing link – uniqueness
The end goal is clear: if an adverse event or reaction occurs, serious or not, all previous donations/transplantations must be traced, “including grading of severity, imputability (when applicable in case of a reaction) and the likelihood of recurrence and, if so, its impact[iv]
This requires the full map of the donor’s clinical history during his life span, and of all the “products” prepared from a single donor. This short statement results in a multitude of layers, a complex data network with multiple data owners, that extends across continents and must be retained for long periods of time[v],- according to the European Tissues and Cells Directive (requires information to be stored for 30 years – respecting data privacy.
This data network includes information about:
- The donor, including all relevant donor screening information.
- The patient(s), including screening information, as well as evidence regarding outcomes in the event of disease transmission, to facilitate informed decision making regarding the risk tradeoff between accepting an organ with an increased risk
- The procurement, organ retrieval, transportation, and transplant processes and any relevant event occurred in each of these steps
- … and of course, the registration of patient outcomes and post-transplant follow-up
- For tissues, production, storage, and distribution must also be considered
Reacting to this challenge requires:
- To uniquely identify globally each donor, each donation product, each recipient
- To ensure a complete and secure information trail globally across the multiple computerized systems that may be involved.[vi]
- To introduce end-to-end audit for traceability, to ensure weaknesses identification and rectification on a regular basis.
Policymakers have recognized the meaning of traceability and are legislating worldwide about the subject. In 2018 these global efforts originated WHO’s 2018 “- Notify Guide on Vigilance and Surveillance”, based on NOTIFY Project [vii] promoted by WHO, the Italian National Transplant Centre (CNT) and the EU-funded Project ‘Vigilance and Surveillance of Substances of Human Origin’ (MPHO V&S) in a major global initiative aimed at raising the profile of vigilance and surveillance (V&S) of substances of human origin and maximizing the didactic value of adverse outcomes, which supports the case for globally unique identification across all biologic materials – blood, cells, tissues, and organs. According to this report, International Cell Therapy Associations, as well as International Eye Banking Associations, have agreed to the adoption of standard terminology – the ISBT 128 – and this system implementation is underway.
The tissue banking and organ transplant communities have not reached that point yet..
How do we help promoting Traceability?
TransplantHUB® is a software developed to ensure effective management of solid organ donation & transplantation programs. It was developed to be a Country or Group of Countries’ unique repository of all the information of the donation and transplantation ecosystem: donors, recipients, organs, events, products used, resources involved, thus a powerful Traceability tool.
We are prepared to support healthcare efforts, around the world with TransplantHUB®.
To find out more about how we may help, please contact us and we’ll be more than happy to arrange a meeting and demonstrate it further.
[i] GUIDE TO QUALITY MEASURES FOR ORGAN TRANSPLANTATION, June 4, 2020, TransplantHUB, https://transplanthub.com/guide-to-quality-measures-for-organ-transplantation/, accessed 27/01/2021
[ii] NHS, NATIONAL OPERATING PROCEDURE NOP006v2 , 6th Dez 2016, Reviewed in September 2018, Transfer and Storage of Donor and Organ Characterization Information and Storage of Traceability Data
[iii] TRACEABILITY, Paulo
Ashford, 14 July 2010
[iv] 6th” edition of the “GUIDE TO THE QUALITY AND SAFETY
OF ORGANS FOR TRANSPLANTATION” , EDQM, European Council,
[v] INFECTIOUS DISEASE TRANSMISSION IN SOLID ORGAN TRANSPLANTATION: DONOR
EVALUATION, RECIPIENT RISK, AND OUTCOMES OF TRANSMISSION, Sarah L. White, PhD, William Rawlinson, FRACP, FRCPA, PhD, Peter Boan,
FRACP, FRCPA, Vicky Sheppeard, FAFPHM, Germaine Wong, FRACP, PhD,7, Karen
Waller, MBBS, Helen Opdam, FRACP, FCICM, John Kaldor, PhD, Michael Fink, MD,
FRACS, Deborah Verran, MD, FRACS, Angela Webster, PhD, FRCP, FRACP, Kate Wyburn, FRACP, PhD, Lindsay Grayson, MD, FRACP, FAFPHM, FRCP,
FIDSA, Allan Glanville, MD, FRACP, Nick Cross, MD, PhD, Ashley Irish, FRACP,
Toby Coates, FRACP, PhD, Anthony Griffin, FRACS, Greg Snell, MD, FRACP, Stephen
I. Alexander, MD, FRACP, Scott Campbell, FRACP, PhD, Steven Chadban, FRACP, PhD, Peter Macdonald, MD, FRACP, Ph D,Paul
Manley, FRACP, Eva Mehakovic, Vidya Ramachandran, MBBS, Alicia Mitchell, PhD,
and Michael Ison, MD, Dec 2018
[vii] The Notify
Booklet: Vigilance and Surveillance (V&S) of medical products of human
origin (MPHO) 15. [available at www.notifylibrary.org/sites/default/files/
booklet.pdf, accessed 29/01/2021