Abstract
The acquisition of telecommunication technologies in clinical practices is transforming medical care capabilities, whereas applying telemedicine in apheresis medicine has resulted in the revolutionary concept of “telapheresis.” This manuscript aims to describe the regulatory landscape of telapheresis by presenting the first “tele-ECP” (telemedicine-based approach to extracorporeal photopheresis) reported in the United Arab Emirates. The tele-ECP procedure was done successfully in a patient with chronic graft-versus-host disease, who, despite having one vascular access-related adverse event, it was solved promptly without further complications. Therefore, this telemedicine-based approach arose as a feasible practice, but required direct physical contact with other trained and privileged/credentialed staff.
Introduction
“Telehealth” and “telemedicine” practices constitute challenging ways to deliver health care. Levering their advantages in apheresis practices have resulted in the novel concept of “telapheresis,” which was initially addressed by the Public Affairs and Advocacy Committee of the American Society for Apheresis (ASFA). 1
In our experience, some circumstances catalyzed the adoption of telapheresis, as Abu Dhabi Stem Cells Center (ADSCC) launched its extracorporeal photopheresis (ECP) services during the coronavirus disease 2019 (COVID-19) pandemic. Therefore, considering the potential inability of patients and clinicians to attend our Apheresis Unit due to public health measures, such as lockdowns, staff sickness, we predetermined that applying a telemedicine-based approach to ECP (“tele-ECP”) could be required. Indeed, providing telehealth in emergency situations such as the current COVID-19 pandemic has demonstrated its usefulness in reducing the risk of cross-contamination, while proactive implementation of telecare produces more significant benefits in the long term compared to reactive measures. 2
ECP is a leukapheresis-based therapy where the patient's whole blood is collected and separated into its different components; the collected leukocytes (buffy coat) are treated extracorporeally with a photosensitizing agent and then exposed to ultraviolet-A irradiation before reinfusion. This procedure induces immune regulation and has been approved in the palliative treatment of cutaneous T-cell lymphoma, while many other indications have been successfully explored, including graft-versus-host disease (GvHD), rejection of solid organ transplantation, and certain autoimmune diseases. 3
Interestingly, the term “tele-ECP” is not reported in the PubMed database or mentioned in the ASFA position paper cited 1 or in its most recent publication led by Linz et al., 4 which comprises telemedicine considerations applied to apheresis-based technologies (ECP included). Still, we foresee an increase in tele-ECP-related literature within the next years.
This Case Report aims to describe the regulatory landscape of telapheresis by presenting the first tele-ECP procedure done successfully in the United Arab Emirates (UAE).
Tele-ECP regulation and encounter models
During a telapheresis encounter, the relationship between patient and physician shall remain unaffected and must meet existing codes of ethical conduct, laws, licensing, and regulatory requirements. 4
The UAE telemedicine regulations are covered at the federal and Emirate levels. The applicable federal laws include the relative to Medical Liability (Federal Law No. 4 of 2016), Use of Information and Communication Technology in Health Fields (Federal Law No. 2 of 2019), and the Practice of Human Medicine (Federal Law No. 5 of 2019), supported by additional UAE Cabinet directives, such as the Resolution No. 40 of 2019 governing telehealth services. 5
In the case of the local health authority of Abu Dhabi (Department of Health—DOH), the Standards on Telemedicine were issued in 2020 and shall be analyzed within the comprehensive regulatory framework of the Emirate, including the Abu Dhabi Healthcare Information and Cyber Security Standard, Data Management Policy and Data Standards, Policy on Health Information Exchange, Policy on Digital Health, Policy on Artificial Intelligence in the Healthcare Sector, Standard on the Internet of Medical Things Security, and Standard for Patient Healthcare Data Privacy. 6
Telapheresis practices in Abu Dhabi are regulated as “tele-medical interventions;” a summary of the traditional face-to-face and tele-ECP encounter models is shown in Figure 1.
Traditional face-to-face and tele-ECP encounter models*. (A) Traditional model: P travels to an apheresis/ECP center staffed with adequate personnel; (B) Mobile model: The apheresis/ECP service goes to P's location (credentials/privileges to work at the new healthcare facility are required); (C and D) Tele-ECP models: AP or P are geographically distant to the host facility, requiring an on-site EC provider.
Case presentation
A 36-year-old woman with a confirmed diagnosis of chronic GvHD (cGvHD) is undergoing ECP treatment at ADSCC. Her cGvHD affected mainly skin and liver after allogeneic hematopoietic stem cell transplantation in February 2018. At baseline, her cGvHD was graded as severe (US National Institutes of Health—NIH scoring criteria), which has been gradually diminished to moderate with a course of ECP and ruxolitinib as concomitant therapy.
Upon examination, she had skin tightness around her elbows, shoulders, knees, and hips, while ankles, feet, and hands were less affected. Hyperpigmentation areas are seen around the neck and upper chest and in flexural areas of knees and elbows; these patches and ranges of motion have improved considerably with the treatment mentioned above.
The patient has undergone ECP on different intensity cycles during the previous 11 months and was currently on one ECP procedure every 2 weeks. Photopheresis has been delivered on an out-patient basis through central venous access (Permacath catheter) using the Amicus® Blue Separator (Fresenius Kabi, Germany). Her previous adverse events consisted of mild iron deficiency anemia and elevated liver enzymes, which are well controlled at the moment of this report.
The 36th ECP session was re-scheduled twice at the patient's convenience. At the agreed date, the apheresis physician who provides ECP direct care during the procedure was diagnosed with a COVID-19 infection. Therefore, considering that further deferral was not convenient, her previous history of good tolerability to ECP, adequate training of the staff performing apheresis, and having an educated physician available (family medicine consultant), we decided to explore a tele-ECP approach during this session (corresponds to C model in Figure 1).
Informed consent was obtained from the patient, and her personal information was protected under principles of confidentiality. No technical incidents were reported in terms of effectiveness and security of the transmission, which was fluent in real-time and bidirectional. The patient experienced one access vascular-related adverse event, which was promptly solved thanks to the coordinated actions of the multidisciplinary team.
To the authors’ knowledge, this is the first report examining the feasibility of the tele-ECP fulfilling the DOH local requirements and aligned with the latest ASFA positions on telapheresis. 4 Table 1 summarizes the procedural parameters and primary tele-ECP services provided.
Summary of the photopheresis procedural parameters and tele-ECP services.
Vascular access blockage (grade 2, CTCAE v.5.0) that required TPA administration (alteplase) for its resolution.
ACD-A: anticoagulant citrate dextrose solution, solution A; CTCAE v.5.0: Common Terminology Criteria for Adverse Events v5.0; ECP: extracorporeal photopheresis; ICT: Information and Communications Technology; MNC: mononuclear Cells; tele-ECP: telemedicine-based approach to extracorporeal photopheresis; TPA: Tissue Plasminogen Activator; 8-MOP: 8-methoxypsoralen.
ADSCC met other ethical and regulatory provisions to support the tele-ECP in this case, such as:
- DOH-licensed facility to provide telemedicine services; - Privileging/credentialing and training of apheresis/ECP staff; - Adequate physical areas and infrastructure; - Availability of ane response team and one trained, educated colleague in apheresis/ECP; - Telecommunication technologies that guarantee patient privacy and confidentiality/security of the medical information; - Established financial/insurance provisions for reimbursement; and - Quality assurance and improvement policies with quality-related metrics in place.
Despite the vast experience of ECP practices and the emerging role of telemedicine in the last decades, we did not find other reports of tele-ECP. Finally, ADSCC's priorities include further strengthening our tele-capabilities in ECP and other apheresis procedures and developing them further to benefit the UAE community. The role of telemedicine is pivotal, and it must be further activated through collaboration with other clinicians and increasing its awareness among patients.
Conclusions
Tele-ECP procedures are feasible and promising telapheresis practices that avoid undesirable exposure to patients or clinicians to certain situations. This telemedicine-based approach demands coordinated actions from several stakeholders after fulfilling ethical and regulatory requirements. Nevertheless, despite having an ECP teleconsultant, it always requires direct physical contact with other trained and privileged/credentialed staff.
Footnotes
Acknowledgments
The authors gratefully acknowledge our patient, who underwent a tele-ECP procedure, and kindly agreed to the presentation of her case. We also thank the ADSCC ECP Group *, Laboratory scientists, ICT, Quality personnel, and other stakeholders for supporting this service.
*ADSCC ECP Group Members: Mariam Thabet Al Amin, Marlene Ponce Cato, Jerusha Kistan, Sadaf Brown, and Fatema Mohammed Al-Kaabi.
Author’s contribution
YMCA (1, 2, 3, 4, 5); MAM (2, 4, 5); JMRVR (2, 4, 5); JO (2, 4, 5); and YVC (2, 4, 5). All authors have agreed to be personally accountable for their contributions. (1) Conception and design; (2) acquisition, (3) analysis and interpretation of data, (4) manuscript writing, and (5) final approval of submitted version of the manuscript.
Declaration of conflicting interests
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The authors received no financial support for the research, authorship, and/or publication of this article.
