Abstract
Background aims
Bone marrow (BM) is commonly used in the pediatric and adult setting as a source of
hematopoietic stem cells (HSCs). The standards of the Joint Accreditation Committee
of the International Society for Cell & Gene Therapy & European Society for Blood
and Marrow Transplantation (JACIE) include specific requirements regarding BM collection,
processing and distribution. To run this process, each transplant team develops a
series of JACIE-compliant procedures, customizing them with regard to local settings
and paths. Moreover, JACIE standards require that transplant teams validate and periodically
revise their procedures to keep the entire process under control. In this article,
the authors describe the methodology adopted in our center to fulfill the aforementioned
JACIE requirements.
Methods
The authors developed a validation plan based on the failure mode and effect analysis
(FMEA) methodology. According to the FMEA approach, the authors carefully revised
activities and procedures connected to BM collection, processing and distribution
at our institution. The entire process was initially divided into five main phases
(assessment of donor eligibility, perioperative autologous blood donation, preparation
of BM collection kit, BM harvesting and BM processing and distribution), comprising
17 subphases and 22 activities.
Results
For each activity, one or more failure modes were identified, for a total of 28 failure
modes, and a risk priority number (RPN) was then assigned to each failure mode. Although
many procedures were validated, others were subjected to substantial changes according
to the RPN rating. Moreover, specific indicators were identified for subsequent monitoring
to contain the risk of failure of steps emerging as critical at FMEA.
Conclusions
This is the first study describing use of the FMEA methodology within an HSC transplant
program. Shaping the risk analysis based on local experience may be a trustworthy
tool for identifying critical issues, directing strict monitoring of critical steps
or even amending connected procedures. Overall, the FMEA approach enabled the authors
to improve our process, checking its consistency over time.
Key Words
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Article info
Publication history
Published online: December 02, 2021
Accepted:
October 5,
2021
Received:
August 10,
2021
Identification
Copyright
© 2021 International Society for Cell & Gene Therapy. Published by Elsevier Inc. All rights reserved.
