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Bone Marrow Sampling and Transplants

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Bone marrow transplant is a potential cure for several diseases, including cancer and specific genetic disorders. Notably, this procedure is applicable for patients suffering from aplastic anemia, certain types of leukemia, severe combined immunodeficiency disease (SCID), Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma, thalassemia, sickle-cell disease, and certain cancers.
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Validation plan of bone marrow collection, processing and distribution using the failure mode and effect analysis

Luciana Teofili¹, Maria Bianchi², Caterina Giovanna Valentini²

¹Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario A. Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy; Sezione di Ematologia, Dipartimento di Scienze Radiologiche ed Ematologiche, Università Cattolica del Sacro Cuore, Rome, Italy.

|December 6, 2021

Summary

This study introduces the Failure Mode and Effect Analysis (FMEA) to validate bone marrow (BM) collection, processing, and distribution for hematopoietic stem cells (HSCs). The FMEA methodology improved procedures and ensured consistent quality in HSC transplant programs.

Keywords:

FMEA allogeneic hematopoietic stem cell transplant bone marrow harvest bone marrow processing validation plan

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Area of Science:

Hematology
Transplant Medicine
Quality Management Systems

Background:

Bone marrow (BM) is a critical source of hematopoietic stem cells (HSCs) for pediatric and adult transplantation.
Joint Accreditation Committee (JACIE) standards mandate rigorous procedures for BM collection, processing, and distribution.
Transplant teams must validate and revise procedures to ensure quality and compliance.

Purpose of the Study:

To describe a methodology for fulfilling JACIE requirements for BM handling.
To implement a validation plan for BM collection, processing, and distribution procedures.

Main Methods:

Utilized the Failure Mode and Effect Analysis (FMEA) methodology for process validation.
Divided the BM handling process into five phases, 17 subphases, and 22 activities.
Identified 28 failure modes and assigned Risk Priority Numbers (RPNs) to assess risks.

Main Results:

FMEA identified critical issues, leading to substantial procedural changes for some activities.
Specific indicators were identified for monitoring critical steps.
The process validation resulted in improved procedures and risk containment.

Conclusions:

This is the first study to apply FMEA in an HSC transplant program.
FMEA is a valuable tool for identifying critical issues and guiding procedural improvements.
The FMEA approach enhanced process consistency and quality in HSC transplantation.