Therapeutic apheresis (TA) is an important treatment modality used in the emergency management of auto‐immune diseases, thrombotic microangiopathy, poisoning, hyperviscosity syndromes and hyperleukocytosis. 1 Limited local accessibility is an issue, particularly in regional and remote areas. 2 Traditionally, patients in these areas requiring inpatient TA have been compelled to seek treatment at large regional centres or metropolitan hospitals. This requires long‐distance inter‐hospital transfer for inpatients, which is expensive to the area health service, isolates patients from their families and may result in treatment delay. 3 , 4 For outpatients, the costs and inconvenience of regular travel to metropolitan centres are onerous. Previously, the only local alternative was to receive TA in a local intensive care setting using renal replacement therapy machines. This is expensive, time‐consuming for this indication and less effective. 5 , 6 , 7
We outline the methods we used to establish a regional TA unit, including planning, capital purchasing, infrastructure, staff training, service model, business rules and clinical governance. We further include our experience with the service over 5 years.
Orange Hospital is a 220‐bed teaching hospital and referral centre in Western New South Wales (NSW) Local Health District in Australia, a geographically large rural and remote health district that provides healthcare for approximately 250–300 000 patients. Orange Hospital has on‐site specialty physicians representing renal medicine, haematology, gastroenterology, neurology, respiratory medicine, medical and radiation oncology, palliative care, geriatrics, infectious diseases and intensive care. A well‐staffed and equipped blood bank is on site, and there is a large and active outpatient haemodialysis unit.
Anecdotal evidence demonstrated a need for a local TA service, and this had been flagged as a potential service expansion as early as 2013, though the size of the need was difficult to ascertain as these patients received out‐of‐area treatment.
A steering committee consisting of medical, nursing and administrative staff drawn from the departments of haematology, renal medicine and the Haemodialysis unit was established to undertake a feasibility study; develop a business case; and develop a clinical governance framework consisting of business rules, procedures and protocols, and guidelines for the service.
It was estimated, based on historical data concerning known local patients and transfers to metropolitan areas, that the expected annual workload would be approximately 100 procedures with annual new patient numbers of 5–10. These numbers were considered an underestimate of clinical need. It was assessed that this volume of work would be the minimum necessary to justify a unit and be able to maintain nursing staff procedural skills.
A previous business case had been unsuccessful because of financial concerns, with the major obstacles identified being the initial cost of the machine (including training costs), ongoing cost of disposables and maintenance costs. It was, however, estimated that the savings in the transfer of patients alone would at least partially offset the initial outlay and on costs, even without taking into consideration procedure‐related revenue.
To further strengthen the business case, it was decided to approach the local community for funding, and Cadia –Newcrest mines generously provided seeding funds to allow the purchase of a Terumo BCT spectra optia machine. The submitted business case, which included provisions for maintenance, the cost of disposables and the need for a replacement machine in the future, was subsequently approved, and a service provision model and procedures and protocols were written for nursing and medical staff.
The TA unit is supervised by the departments of haematology and renal medicine, each of which provides a co‐director. For complex cases, assistance and advice are provided by the intensive care unit (ICU) at Orange Hospital and the department of immunology at Westmead Hospital. The unit is based in the haemodialysis unit and is a closed unit. Access requires referral to haematology or renal medicine, which take responsibility for clinical decisions related to TA, organising procedures, obtaining informed consent and liaison with the referring team as indicated.
Referrals are accepted from the local health district and from locations out of area where the burden of travel is an important consideration. During office hours, referrals are directed to either the renal physician or haematologist rostered on and out of hours to the haematologist on call. Although the machine is theoretically portable, procedures are restricted to Orange Hospital. Inpatients are transferred to Orange Hospital. For outpatient treatment, supported accommodation is available within a 5‐minute walk of the hospital.
Patients are then reviewed for suitability for plasma exchange, with treatment decisions based on the American Society for Apheresis guidelines. 1 For cases where there is a plausible biological basis for plasma exchange but evidence is lacking, or where effectiveness is questionable but the patient is in extremis and bereft of options, an intensive care physician is also involved in the discussion.
Initial nursing staff training was provided by Terumo, and further training for new staff and a credentialling programme for nursing staff have been developed locally. Ongoing education of staff is organised locally, and funding has been made available from within the unit to sponsor attendance at local and international conferences.
Data regarding all procedures are maintained, including patient demographics, laboratory data, technical aspects of the procedures, details of venous access, blood product replacement, anticoagulant use and complications of the procedures. Maintenance logs for the machine are kept. Regular unit meetings are held to discuss operational issues, all serious adverse events, and the revision of procedures and protocols, as well as planning, including planning for machine replacement. In the event that the machine is unavailable, patients requiring TA will be redirected to the closest hospital where the service is available. Urgent, acute TA may also be performed in the ICU using a haemodialysis machine if required. In addition, the purchase of a second TA machine was approved recently, which will improve the reliability of the service.
The TA unit began operation on 17 February 2017, and in the period until 1 January 2022, 760 procedures in 36 patients were performed (Table 1 ). The median age of patients was 58 (18–86) years; most patients were female. Most of the referrals were from new diagnoses in the area with three patients on maintenance treatment referred. Two of these patients were referred due to the COVID‐19 pandemic, with its attendant travel restrictions, and because of patient preference for treatment closer to home (Table 2 ). Two overseas visitors also received treatment. The indications for plasma exchange and cytapheresis for this cohort are found in Table 1 . Stem cell collection is currently outside the scope of practice.
Table 1
Patient demographics and indications for therapeutic apheresis
Data presented as numbers (%) otherwise indicated.
| Characteristics | Patients ( n = 36) |
| Median age (years) | 58 (18–86) |
| Females | 21 (58.3%) |
| Number of procedures per patient | 21.1 (total 760) |
| Indication for therapeutic plasma exchange | |
| Hyperviscosity (multiple myeloma and Waldenstrom macroglobulinaemia) | 8 (22.2%) |
| Myasthenia gravis | 6 (16.7%) |
| Thrombotic microangiopathy | 4 (11.1%) |
| Vasculitis | 3 (8.3%) |
| Chronic inflammatory demyelinating polyneuropathy | 3 (8.3%) |
| Atypical haemolytic uraemic syndrome | 2 (5.5%) |
| Anti‐glomerular basement membrane disease | 2 (5.5%) |
| Catastrophic antiphospholipid syndrome | 1 (2.8%) |
| Neuromyelitis optica | 1 (2.8%) |
| Antibody‐mediated pulmonary fibrosis | 1 (2.8%) |
| Focal segmental glomerulonephritis | 1 (2.8%) |
| Acute renal transplant rejection | 1 (2.8%) |
| Guillain‐Barre Syndrome | 1 (2.8%) |
| Indication for therapeutic cytapheresis | |
| Leukapheresis/Chronic myeloid leukaemia | 1 (2.8%) |
| Plateletpheresis/Essential thrombocythemia | 1 (2.8%) |
| Adverse events (number and percentage of all procedures) | 5 (0.66%) |
Table 2
Patterns of referral
| Place of residence of patients | Number of patients ( n = 36) |
| Orange, New South Wales | 12 |
| Bathurst, New South Wales | 2 |
| Dubbo, New South Wales | 2 |
| Forbes, New South Wales | 2 |
| Lithgow, New South Wales | 2 |
| Molong, New South Wales | 2 |
| Other, consisting of 1 patient each from: | 14 |
| New South Wales: Blayney, Cobar, Condobolin, Canowindra, Cowra, Kains Flat, Kincumber South, Leeton, Littleton, Parkes, Walgett | |
| Bairnsdale, Victoria | |
| France | |
| Nepal |
There were only five major adverse events in three patients, giving a major complication rate of 0.65%: one patient developed endocarditis due to a line infection; another patient developed a line infection; one patient who developed hypotension required ICU admission and also developed a central line‐associated thrombosis. All patients recovered from their complications.
The unit ongoing costs were completely covered by revenue from medicare billings. We estimate the savings to the public purse from not transferring patients to metropolitan centres to be not inconsiderable over the period of the unit's operation. The savings to the patients and their families, both financial and social, cannot be calculated but would be substantial, the nearest TA unit from Orange being a 4‐h drive away.
Discussion
We present our experience establishing a TA service at Orange Hospital and our operational experience over 5 years. The estimated service need has been at least 50% over that initially expected, and we suspect that not all patients who could be treated locally are being treated at Orange Hospital. Despite the extra activity, the service has been financially self‐sufficient. The availability of a local TA service obviates the financial burden from many angles, in particular costly inter‐hospital transfers and accommodation for accompanying family members. While it would be helpful to analyse the potential financial benefits of offering therapeutic apheresis locally, this is beyond the scope of the paper.
There is a great deal of interest currently in rural healthcare provision where significant illness poses great challenges to service delivery, patients and their families. The transfer of patients for treatment has significant psychosocial and economic morbidity. The distances involved often make it difficult for families to visit their loved ones and provide support, while staying at accommodation near metropolitan hospitals can be very expensive. Coupled with the difficulty in obtaining beds in metropolitan centres, treatment locally is a very attractive option.
The authors believe strongly that many treatments currently viewed as 'metropolitan only' can be delivered safely and more efficiently locally and that the main barriers to increasingly complex care in rural services are a lack of awareness of the level of care that can be delivered in a rural setting, a metropolitan‐centric mindset that is largely driven by traditional models of care, poor resourcing of rural healthcare and inertia. Our experience is that with very modest resourcing, adequately trained staff and good business models and care pathways, TA can be safely and sustainably provided in a rural setting. To our knowledge, Orange Hospital has the only TA unit in rural NSW and probably Australia. Local availability of the service has greatly improved accessibility for patients.
In conclusion, rural and regional areas are suitable locations for therapeutic apheresis provided they are adequately resourced. The availability of this service enables the management of a variety of life‐threatening conditions locally, allowing timely delivery of care. It also helps to obviate the psychosocial and economic morbidity from inter‐hospital transfers. Our experience demonstrates that a clinically and economically viable service in the rural setting can be provided.
Acknowledgements
The authors would like to acknowledge A/Prof Philip Crispin (Canberra Hospital) for critically reviewing the manuscript. Open access publishing facilitated by Australian National University, as part of the Wiley ‐ Australian National University agreement via the Council of Australian University Librarians.
Funding: None.
Conflict of interest: None.
References
1. Padmanabhan A, Connelly‐Smith L, Aqui N, Balogun RA, Klingel R, Meyer E et al . Guidelines on the use of therapeutic apheresis in clinical practice ‐ evidence‐based approach from the writing committee of the American Society for apheresis: the eighth special issue. J Clin Apher 2019; 34: 171–354.
2. Smith JW. Therapeutic apheresis services provided by a community blood bank. Transfus Apher Sci 2003; 28: 181–185.
3. Lennox A, Wright B, Bragge P. How can we improve the decision to transfer patients from regional or rural hospitals? In: BehaviourWorks Australia MU , ed. Australia: Briefing Document Melbourne; 2019.
4. Mackie B, Kellett U, Mitchell M, Tonge A. The experiences of rural and remote families involved in an inter‐hospital transfer to a tertiary ICU: a hermeneutic study. Aust Crit Care 2014; 27: 177–182.
5. Keklik M, Çelik S, Yıldızhan E. Comparison of centrifugal and membrane filtration modalities on therapeutic plasma exchange. J Clin Apher 2022; 37: 217–222.
6. Webb TN, Bell J, Griffin R, Dill L, Gurosky C, Askenazi D. Retrospective analysis comparing complication rates of centrifuge vs membrane‐based therapeutic plasma exchange in the pediatric population. J Clin Apher 2022; 37: 263–272.
7. Hafer C, Golla P, Gericke M, Eden G, Beutel G, Schmidt JJ et al . Membrane versus centrifuge‐based therapeutic plasma exchange: a randomized prospective crossover study. Int Urol Nephrol 2016; 48: 133–138.