Chapter 21: Haematological procedures
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Legal and professional issues
Other regulations that require compliance for apheresis procedures, if being used in the field of stem cell transplantation, include the Human Tissue Authority ([55]) Code of Practice 6: Donation of Allogeneic Bone Marrow and Peripheral Blood Stem Cells for Transplantation and FACT‐JACIE's ([40]) International Standards for Cellular Therapy Product Collection, Processing and Administration.
Cell separator procedures should only be performed after a written and signed order from the medical team. The administration of any drugs and fluids used should be in accordance with a Patient Group Direction or a written prescription.
Competencies
Apheresis should only be performed by specially trained operators who are deemed competent to work at an advanced level. Nurses must always operate within their scope of practice (NMC [86]). Training packages should address the theoretical base and clinical skills needed to work as an apheresis nurse and should be carried out in accordance with local standard operating procedures. It is usual for the manufacturers of cell separator machines to offer training days and supply training materials, for example workbooks. This is often supported by work‐based learning with a mentor or practice facilitator. Academic modules at university level are offered in some countries. Training should cover the assessment and management of patients and donors (including paediatrics if appropriate) undergoing apheresis, as well as the technology used to carry out the applications. Other training needs, dependent on particular centres, may include:
- principles of basic haematology, coagulation and immunology
- stem cell mobilization procedures and principles of stem cell transplant
- knowledge of the diseases for which apheresis is required
- collection of specific blood components by apheresis
- recognition and treatment of common complications
- validation of procedures and processes within a quality management system
- regulatory, legal and professional issues.
A suitable assessment, designed to determine the level of competence, must be performed and documentation of knowledge and technical ability must be maintained (FACT‐JACIE [40], Howell et al. [52]). Apheresis nurses must also ensure that their cardiopulmonary resuscitation training is up to date (FACT‐JACIE [40]).
Consent
The routine of obtaining consent from patients and donors undergoing apheresis represents good clinical practice (MHRA [77]). Clearly written explanatory literature or other forms of information should be available to assist in obtaining informed consent. This should include any drugs or replacement fluids that may be used (Howell et al. [52]).
If the apheresis procedure is being undertaken as part of a stem cell transplantation procedure, all regulations and principles pertaining to consent apply, as discussed in the Bone marrow harvest section.
