Blood and Marrow Transplant and Cellular Immunotherapy Program, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.
The James Cancer Hospital and Solove Research, Columbus, Ohio.
Biol Blood Marrow Transplant. 2019 Jan;25(1):179-182. doi: 10.1016/j.bbmt.2018.08.017. Epub 2018 Aug 21.
Blood and marrow transplant (BMT) programs worldwide frequently employ a quality management professional who is charged with securing quality and maintaining regulatory requirements. Although many BMT programs employ an individual to oversee quality management, there are no standard definitions of the education, training, and core competencies needed to successfully perform this role. The goal of this article is to propose the required qualifications and responsibilities of the BMT professional who oversees quality management and to elicit discussion to standardize such a role in BMT and cellular immunotherapy programs. Our results could serve as a model for quality managers in other complex healthcare environments. The recommendation and findings are primarily limited to cell therapy centers in North America.
全球的血液和骨髓移植(BMT)项目通常都聘请一位质量管理专业人员,负责确保质量并满足监管要求。尽管许多 BMT 项目都聘请了一位人员来监督质量管理,但对于成功履行这一角色所需的教育、培训和核心能力,并没有标准的定义。本文的目的是提出负责监督质量管理的 BMT 专业人员所需的资质和职责,并引发有关在 BMT 和细胞免疫治疗项目中规范这一角色的讨论。我们的研究结果可以为其他复杂医疗保健环境中的质量管理人员提供借鉴。该建议和发现主要限于北美的细胞治疗中心。