A multicenter evaluation of heterogeneity in cellular therapy processing laboratory procedure times to assess workload capacity.

Autor: Thibodeaux SR; Division of Laboratory and Genomic Medicine, Department of Pathology and Immunology, Washington University in St. Louis School of Medicine, St. Louis, Missouri, USA., McKenna DH; Molecular & Cellular Therapeutics and Department of Laboratory Medicine & Pathology, Division of Transfusion Medicine, University of Minnesota Medical School, Minneapolis, Minnesota, USA., Szczepiorkowski ZM; Department of Pathology and Laboratory Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.; Institute of Hematology and Transfusion Medicine, Warsaw, Poland, USA., Fontaine MJ; Department of Pathology, University of Maryland School of Medicine, Baltimore, Maryland, USA., Kelley L; Cell Therapy Facility, Department of Immunology, Moffitt Cancer Center, Tampa, Florida, USA., Reems JA; Department of Medicine, Division of Hematology and Hematologic Malignancies, University of Utah, Salt Lake, Utah, USA., Young PP; American Red Cross, Biomedical Services Headquarters, Washington, DC, USA.; Department of Pathology, Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Jazyk: angličtina
Zdroj: Transfusion [Transfusion] 2020 Aug; Vol. 60 (8), pp. 1811-1820. Date of Electronic Publication: 2020 Jul 12.
DOI: 10.1111/trf.15899
Abstrakt: Background: Growth in size and complexity of clinical hematopoietic progenitor cell (HPC) transplant programs necessitates parallel increases in cellular therapy laboratory (CTL) workload. Typically individually developed, HPC product processing is labor and time intensive. Variation in procedure type and numbers across CTLs complicates direct comparisons, and benchmark data are not readily available.
Study Design and Methods: Studies were undertaken at seven CTLs. Transplant volume and staff numbers were determined. Staff recorded time performing tasks broken down into steps: paperwork, product acceptance, transport/infusion, processing, and cryopreservation. Times were added to obtain total times for 15 common CTL procedures.
Results: Annual transplant volume ranged from 53.4 to 463.2, with products processed by a range of 2 to 10 dedicated CTL staff. Paperwork time constituted 23.7% to 62.3% total time; product processing time accounted for 1.8 (for National Marrow Donor Program product receipt) to 62.6% (for red blood cell reduction of allogeneic HPC products from bone marrow) of total processing time. Mean time for 15 procedures ranged from 1.27 to 8.28 hours (standard deviation range, 0.35-2.71 hr). Mean time for products from bone marrow versus peripheral blood was 6.6 ± 2.0 versus 5.5 ± 1.1 hours (p = 0.02). Cryopreservation (6.5 ± 1.6 vs. 4.4 ± 0.85 hr; p < 0.01) and manipulation (6.4 ± 1.5 vs. 4.4 ± 0.85 hr; p < 0.01) added time.
Conclusion: CTL procedures are time intensive, with wide intra- and inter-CTL variation. Paperwork accounted for substantial portion of total time across procedures. Bone marrow source, cryopreservation, and manipulation contributed to longer times. These findings provide concrete data on which to build regarding CTL workload capacity.
(© 2020 AABB.)
Databáze: MEDLINE
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