title: Quality management of biorepositories.
abstract: Biomedical investigators require high quality human tissue to support their research; thus, an important aspect of the provision of tissues by biorepositories is the assurance of high quality and consistency of processing specimens. This is best accomplished by a quality management system (QMS). This article describes the basis of a QMS program designed to aid biorepositories that want to improve their operations. In 1983, the UAB Tissue Collection and Biobanking Facility (TCBF) introduced a QMS program focused on providing solid tissues to support a wide range of research; this QMS included a quality control examination of the specific specimens provided for research. Similarly, the Division of Laboratory Sciences at the Centers for Disease Control and Prevention (CDC) introduced a QMS program for their laboratory analyses, focused primarily on bodily fluids. The authors of this article bring together the experience of the QMS programs at these two sites to facilitate the development or improvement of quality management systems of a wide range of biorepositories.
authors.affiliation: 1Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, Alabama.|2Department of Pathology, University of Alabama at Birmingham, Birmingham, Alabama.
authors.forename: William E
authors.initials: WE
authors.lastname: Grizzle
authors.affiliation: 3Specimen Solutions, LLC, Tucker, Georgia.
authors.forename: Elaine W
authors.initials: EW
authors.lastname: Gunter
authors.affiliation: 1Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, Alabama.
authors.forename: Katherine C
authors.initials: KC
authors.lastname: Sexton
authors.affiliation: 1Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, Alabama.|2Department of Pathology, University of Alabama at Birmingham, Birmingham, Alabama.
authors.forename: Walter C
authors.initials: WC
authors.lastname: Bell
mesh_terms: D000068:Accreditation; D015982:Bias; D018070:Biological Specimen Banks / Q000592:standards*; D001826:Body Fluids; D002568:Certification; D054869:Clinical Audit; D006801:Humans; D011785:Quality Assurance, Health Care; D011786:Quality Control; D014015:Tissue Banks