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International Standard for
Therapeutic Apheresis Unit (TAUs)
Version 3.0 - December 2018



INTRODUCTION

Apheresis Medicine (AM) is that discipline of the medical arts and sciences concerned with the care and management of patients and donors involved in extracorporeal blood separation interventions used in the treatment of disease or in the collection of various blood constituents. It can arbitrarily be subdivided into three major care areas based on the status of the individual receiving the apheresis intervention: therapeutic apheresis (TA) where the individual is a patient being treated for a disease; donor/preparative apheresis where the individual is serving as a source of various blood products/derivatives for use in others; and donor/patient apheresis where the individual serves as the source of various blood-derived products for either allogeneic or autologous therapeutic use. Apheresis procedures associated with the latter two care foci are extensively regulated with facilities and organizations performing them typically being periodically assessed and certified by knowledgeable professionals. In contrast the area of TA has much more limited regulatory scrutiny typically performed in a limited manner by various clinically focused professional organizations where the major emphasis is on non-apheresis clinical care operations.

TA includes a wide range of therapeutic procedures that are based on the separation of blood components with subsequent removal of unwanted plasma or cellular components involved in the etiology of various hematologic, renal, neurological, and medical diseases in patients in whom other therapeutic approaches are totally or partially ineffective, sometimes not tolerated.

In Italy on an annual basis about 14,000 plasma-exchange treatments are performed per year using therapeutic apheresis procedures with approximately 7,000-8,000 photopheresis/extracorporeal photochemotherapy procedures also performed in patients with such conditions as graft versus host disease, or for the prevention or treatment of solid organ rejection, or in individuals with rapidly evolving auto-aggressive diseases and/or those refractory to established immunosuppressant regiments, or in patients with cutaneous T-cell lymphomas. Such a high rate of application of these forms of treatment translates to a procedural frequency that, when compared to the general Italian population, approximates to about 1 therapeutic apheresis procedure per year per every 2,900 residents. A frequency of this magnitude, if extrapolated on a European scale, would suggest that the number of TA procedures per year would equal approximately 170,000 TA treatments in all European countries combined. Even if reassessed by taking into account the different levels of technological availability in the various countries, the total aggregate number of TA interventions could still approach approximately 100,000 procedures per year.

As previously alluded to these therapeutic procedures can be characterized as a series of treatment sessions of high complexity that require the participation of staff with appropriate technical and nursing skills and medical expertise, the need for appropriate and pertinent documentation regarding the interventions, as well as dedicated facilities with organizational structures able to ensure operational efficacy, efficiency and patient safety. Specific skillsets and training requirements regarding the various practitioners in this field exist and in conjunction with advances in medical knowledge related to apheresis medicine help ensure continual enhancements in patient safety for those needing this therapy.

One source for continued knowledge advancement regarding the clinical indications for the use of therapeutic hemapheresis is the periodically updated Special Issue on the Clinical Applications of Therapeutic Apheresis: An Evidence Based Approach produced by American Society for Apheresis (ASFA) and published in its official organ, the Journal of Clinical Apheresis.

With the goal of establishing an organizational model that allows for the best application of existing knowledge and technology and to ensure safety, effectiveness, and efficiency for any and all pertinent therapeutic procedures, in a manner of continuous quality improvement, the construction of a document to help guide discussions regarding the formulation of standards is beneficial. Such models have been achieved by others with much success including the development of international standards regarding cellular therapies promulgated by the JACIE-FACT ( Joint Accreditation Committee ISCT-EBMT) – Foundation for the Accreditation of Cellular Therapy) collaborative which have been created and applied for standardization in the collection and clinical use of hematopoietic stem cells for transplantation. Such an approach in the construct of an organizational model pertinent to TA activities seems reasonable and desirable.

It is in this context that the Società Italiana di Emaferesi e Manipolazione Cellulare (SIdEM), in collaboration with the sector company Exem Consulting, has created a document regarding standardizations pertinent to TA: The International Standards for Therapeutic Apheresis Units (Standards TAU, Therapeutic Apheresis Units). It is hoped that such a document will facilitate discussions and actions in the international community leading to the construction of national organizational and quality models for facilities involved with TA activities and that in the near future, such a model based on these Standards could serve as a European operational frame of reference supporting a culture of and for patient safety and the continuous quality improvement in this therapeutic area. These International Standards have been created by a team of professionals and experts with the sole aim of identifying all the required information to ensure that facilities involved in TA may follow uniform and traceable operational guidelines engendering a continuous commitment to enhancing patient safety in TA.

It is envisioned the this document will serve as an operational tool that allows, in all centers of therapeutic apheresis, the introduction of a full-quality organizing model which may also, if appropriate, be integrated into any complete or partial organizational models already adopted and in use in those facilities. As such the Standards for TAU have been designed to define organizational structure requirements, procedures, and general management strategies that all therapeutic apheresis centers should follow to aid in the construction of an appropriate system of quality assurance, consistent monitoring, observation and the establishment and nurturing of a quality culture related to TA.

We believe that the implementation of these Standards will help ensure consistency in the management of patients, in the set up and performance of TA procedures, and guidelines for the proper recording and documentation of performed activities, based on functional and quality requirements developed and shared by AM professionals at national and international levels and in various educational forums.

The International Standards for TAU was designed to identify and define the minimum necessary organizing guidelines for centers performing therapeutic apheresis and are not intended to replace any regulations, laws, and national and international regulations currently in force in countries in which it may be applied. It is hoped that each TAU center which implements these standards will find them useful in the construction of a high quality TA management system that engenders a culture of continuous quality improvement with a focus on ever enhancing patient safety in the area of AM. (more)