AABB Chapter 09

Page 1

C h a p t e r

9

Storage, Monitoring, Pretransfusion Processing, and Distribution of Blood Components 䊱 William B. Lockwood, PhD, MD; Jill Leonard, MT(AMT); and Sandy L. Liles, MT(ASCP)SBB

L O O D C O M P O N E N T manufacturing processes following collection have undergone marked changes in selected areas in the past few years and, yet, have remained relatively unchanged in other areas. New technology in automated component preparation, new regulatory and minimal acceptable final component requirements, and new computer capabilities have influenced the quality-oriented procedures that blood centers, blood banks, and transfusion services use in today’s manufacturing model. This model incorporates Food and Drug Administration (FDA) current good manufacturing practice (cGMP) regulations, originally published for drugs1 and revised to include biologics,2 from receipt to issue of the blood and blood component. The common thread that is found in cGMP and other regulatory bodies’ rules

B

(Clinical Laboratory Improvement Amendments; state laboratory statutes) or volunteer laboratory accrediting organization policies (College of American Pathologists; AABB; The Joint Commission; American Osteopathic Association) is maintaining the safety, quality, potency, purity, and identity of blood and blood components. The manufacturing facility demonstrates that it is following these concepts through the utilization of policies, processes, and procedures found in written standard operating procedures and associated records. Review of these documents assists these agencies, and the facility, in determining that cGMP compliance in storing, monitoring, pretransfusion processing, and distributing blood and blood components is achieved (see Chapter 3 for additional regulatory details).

William B. Lockwood, PhD, MD, Clinical Professor, Department of Pathology and Laboratory Medicine and Director, Transfusion Services and Tissue/Bone Bank, University of Louisville Hospital and NortonKosair Children’s Hospitals; Jill Leonard, MT(AMT), Administrative Supervisor, Clinical Laboratory, University of Louisville Hospital; and Sandy L. Liles, MT(ASCP)SBB, Technical Specialist, Transfusion Services, Norton Hospital, Louisville, Kentucky The authors have disclosed no conflicts of interest.

283 Copyright © 2008 by the AABB. All rights reserved.

9


Turn static files into dynamic content formats.

Create a flipbook
Issuu converts static files into: digital portfolios, online yearbooks, online catalogs, digital photo albums and more. Sign up and create your flipbook.
AABB Chapter 09 by Mohaddisah Amjad - Issuu