Remote Donor Release in Plasmapheresis Open Access

Blood and plasma donors have to pass a donor health questionnaire and a screening for vital signs prior to donation [1, 2]. This important step of donor release is managed differently in European and non-European countries. Some countries require donor release to donation by a physician while others do not [3]. In Germany, the presence of a physician was mandatory during the blood or plasma collection process according to the German Transfusion Act [4]. In 2023, a modification of the Transfusion Act came into force allowing the use of telemedicine. Current hemotherapy guidelines allow the use of telemedicine procedures for the release of eligible donors.

The aim of the present study was to investigate the feasibility of telemedicine procedures in qualified plasma donors with inconspicuous donor questionnaire and screening results. To do so, remote release of donors was evaluated with respect to practicability, impact on the workflow, and donation safety in plasma centres.

Qualified plasma donors were asked to participate at a pilot study about remote donor release when they entered the centre and registered for donation. Remote donor release via telemedicine was tested on 2 days each in the donation centres in Cottbus (centre A) and Dresden (centre B) as well as Koblenz (centre C) and Mannheim (centre D). On August 27 and 28, 2024 donors from centre A with an inconspicuous medical history and inconspicuous screening results were released to the donation by a physician who was present in centre B. On September 3 and 4, 2024, donors from centre C were released by a physician at centre D via the same procedure. There was no telemedical communication between donors and physician as only donors with an inconspicuous health questionnaire and inconspicuous screening results were included in the study. Donors who did not pass the donor health questionnaire and/or the screening tests had to be seen by a physician present in the donation centre. This physician was also responsible to manage donor side effects in the case they occurred. Only experienced repeat donors were included in the pilot study. The blood plasma management system (BPMS, release 1.7, European Blood and Plasma Service, Vienna, Austria) software was used as tool for the plasma donation process. Venipunctures in the donors were performed by trained technicians and nurses.

All participating donors were informed in detail about the pilot study and signed informed consent. Donors reserved the right to withdraw from the pilot study at any time without to be obligated to provide a reason. Participants had to answer digitally a donor questionnaire and were screened for vital signs (blood pressure, heart rate, temperature, and body weight) prior to donation. Thresholds of capillary haemoglobin level were ≥12.0 g/dL in female and ≥13.5 g/dL in male donors. Donors with an inconspicuous medical history and inconspicuous screening results meeting eligibility criteria according to current guidelines were released to donation by a physician who was not present in the donation centre.

The PCS2 blood cell separator (Haemonetics, Braintree, USA) was used for plasma collection without saline compensation. Sodium citrate anticoagulant (4% w/v, Biomedica, Prague, Czech Republic) was used at an anticoagulant-to-blood ratio of 1:16. After donation, donors were asked to fill in a questionnaire about the procedure and the telemedical procedures (Fig. 1). A rating scale was offered to give an assessment of telemedicine with respect to safety, as well as to rate the possible process improvement/time savings. In addition, donors had the opportunity to rate in free text fields what they liked and what they had concerns about.

Additionally, receptionists and physicians were asked to fill in a questionnaire about the telemedicine procedure. Employees were asked on the basis of an evaluation scale to rate the usefulness of telemedicine procedures, possible simplification of work, and other aspects of the procedure (e.g., acceptance by donors, integration into routine, concerns, and suggestions for improvement) in free text fields.

To assess donor safety, adverse events (AEs) were documented and the severity and causal relationship to plasmapheresis were rated. All data collected were documented in an Excel database sheet (Microsoft, Redmond, USA) designed for the pilot study. Mean and standard deviations were calculated for the rates given by donors and staff.

In total, 243 donors were included in the study. In donation centre A, 145 out of 163 donors (89%) and in donation centre C 98 out of 192 donors (51%) fulfilled the inclusion criteria and were actually released for donation via telemedical procedures by a physician in center B and D, respectively. Donors not fulfilling the inclusion criteria, e.g., donors who were admitted due to necessary examinations, donor information or deviating information in anamnesis and/or conspicuous screening results were admitted to the standard release procedure by a physician present in the donation centre. Only two donors objected to participate and were excluded from the study.

Following their donation visit on the respective test days, all donors included in the study were asked to fill in an evaluation questionnaire. Only one donor in centre C did not fill in the questionnaire. Four questionnaires in centre A were returned incompletely.

On average, the usefulness of a routine introduction of telemedicine procedures was rated “fine” (mean 4.2) or “fine” to “excellent” (mean 4.6) in both centre A and centre C. The average of all donor ratings was 4.4 (“fine”).

The feeling of safety when donating was rated by the donors on average as “excellent” (4.8), even when using telemedicine procedures. Possible time savings through the use of telemedical procedures were rated by donors in centre A with an average of 3.6 (“neutral” to “fine”) and in centre C with 4.3 (“fine”). The average overall rating of all donors was also “fine” (4.0). Most frequent free text answers of the donors about the studied telemedicine procedure were “faster than conventional donor release” and “no impact on donation safey.”

After termination of the remote donor approval physicians (“teledoctors” (n = 2) as well as doctors from the donation centres (n = 5) and all reception staff (n = 8) were surveyed about the pilot study. The usefulness of a routine introduction of telemedicine procedures was rated “fine” (mean 4) to “excellent” (mean 5) by all reception staff. Receptionists were administrative staff, and they were trained in donor screening. They were not involved in the plasmaphereses procedure. The average rating was 4.4 (“fine”). The reduction in workload was rated by the reception staff as “neutral” (mean 3) to “excellent” (mean 5). On average, the reduction in workload was rated 4.5 (“fine” to “excellent”). The time saved in donor release and the reduced waiting time were rated positively.

Physicians were asked the same questions about routine introduction of telemedicine procedures and its impact on the work in the donations. Physicians rated the usefulness of a routine introduction of telemedicine procedures as “fine” (mean 4) or “excellent” (mean 5). Only one physician rated the meaningfulness as “moderate” (2). The average rate of all physicians was 4.4 (“fine”). The reduction in workload was rated “fine” (4) to “excellent” (5) by all physicians. The average rating was 4.6 (“fine” to “excellent”).

Physicians assessed the improved efficiency of the workflow as well as a possible time saving in donor release as positive. In centre A, all physicians participating in the survey stated that time savings would only be possible if the screening of the donors was carried out by interviewers.

Only one AE was reported in 243 donations (0.41%). After termination of the donation, one female donor experienced mild dyspnoea, which resolved rapidly.

Digitisation is an important tool in healthcare to optimize the workflow of medical processes, documentation and the assignment of personnel. Qualified staff is continuously decreasing resulting in difficulties to provide adequate healthcare management. According to the annual report 2023 of the German Medical Association the number of retired physicians is more than 100,000 [5]. Nowadays, more than 97,000 physicians are older than 60 years and this trend is ongoing due to the demographic change. This will have a deep impact on patient healthcare including the supply with blood products.

Telemedicine offers the opportunity to optimize limited medical resources. It allows for virtual consultations, improved access to specialists, enhanced continuity of care, remote monitoring of diseases, and rural healthcare access [6]. In the field of plasmapheresis, the introduction of telemedicine allows remote donor release thereby significantly reducing the number of physicians in the centre. Even more, it would be possible that a physician serves more than one donation centre by remote access.

The results of this pilot study show that remote release of inconspicuous plasma donors can be easily implemented in routine practice. There were no safety concerns both from donors and staff. Donor safety is of utmost importance and is a key factor in telemedicine procedures. Safety was rated “fine” to “excellent” in both centres, and we assume that routine introduction of remote release of donors will have no negative impact on well-being of donors. Staff rated the usefulness of the donor remote release as “fine” on average. Employees also noticed a potential for optimizing the work flow facilitating the donation process (average rating “excellent”).

The differences observed in the proportion of donors actually released by telemedicine between centre A (89%) and centre C (51%) can be attributed to different procedures in the recruitment of study donors. In centre A, all donors who came to centre for an examination or sample collection were “sorted out” in advance and not included in the validation. In centre C, these donors were also included in the validation but were not admitted via telemedicine release because they did not meet the requirements. Accordingly, the proportion of donors not released by telemedicine in Koblenz was higher.

On the basis of the pilot results, the introduction of telemedicine-safe procedures for release of donors with an inconspicuous medical history as well as inconspicuous screening results by a physician who is not present in the centre can be recommended. However, before routine introduction, a more detailed process description and, if necessary, adaptation of the workflow will be helpful.

The present study can be considered as a first step of telemedicine in donor release which became possible by the modification of the German Transfusion Act. It may reduce the number of physicians present in the donation centre and a physician outside the centre may serve several centres with remote donor releases. A next step could be that one physician is only present in the donor centre for medical donor examination and taking care for donors at risk for possible side effects, e.g., first time donors, donors with low body weight. This requires dedicated donor appointments and well trained staff for emergency situations. Staff must be able to bridge the time from the beginning of a severe emergency situation until an emergency physician arrives at the centre. Furthermore, it has to be discussed if physician assistants can overtake the tasks of a physician because no severely ill patients are in the donation centre. Finally, no presence of a physician in the donation centre might be the last step. This is real world reality in some European and US plasma donation centres [3].

This study has some limitations: firstly, this is only a pilot study with 243 donors and the results may not be extrapolated to higher number of donors in routine use of telemedicine. Secondly, donor recruitment for the study was different in the centres and this might bias the evaluation results. Thirdly, work flow optimization in routine use of telemedicine may have an impact on the acceptance of the procedure both by donors and staff.

In summary, the results of our pilot study show that remote release of donors for plasma donation is feasible and safe. There was no relevant donor concern about the telemedicine procedure with respect to donation safety. Digital applications offer innovative solutions to manage donation processes in times of shrinking numbers of qualified staff.

We thank all donors for participating in the study. We are deeply indebted to both participating donor care teams and physicians.

Approval by an Ethics Committee was not required for this type of research according to national guidelines. All participating donors were informed in detail about the pilot study and signed informed consent.

The authors are employees of Octapharma Plasma GmbH, Langenfeld, Germany.

Octapharma Plasma GmbH funded the study.

All authors designed the study, collected and analysed the data. R.M. wrote the first draft of the manuscript. All authors critically reviewed, revised, and approved the final version of the manuscript.

The data that support the findings of this study are not openly available.