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. 2015 Jun;13(3):183-94.
doi: 10.1089/bio.2014.0105.

Quality management of biorepositories

William E Grizzle  1   2 , Elaine W Gunter  3 , Katherine C Sexton  1 , Walter C Bell  1   2
Affiliations

Quality management of biorepositories

William E Grizzle et al. Biopreserv Biobank. 2015 Jun.

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.

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Figures

<b>FIG. 1.</b>
FIG. 1.
demonstrates the heterogeneity of tissues that may affect the results of research. (A) (hematoxylin and eosin [H&E] stain; original magnification ×200) demonstrates that extensive lymphoid inflammation (blue circle) is present between uninvolved breast tissue (green arrows) from a case of cancer. (B) (H&E, ×400) shows lymphoid inflammation (blue circle) adjacent to breast cancer (red arrows) and uninvolved breast (green arrows). (C) (immuno-staining for E-cadherin with a hematoxylin counterstain, original magnification ×400) shows metastatic breast carcinoma to a lymph node. The carcinoma with brown immune-staining (red arrows) is mixed with lymphoid cells (blue circle). (D) (H&E, ×100) is a metastatic colorectal carcinoma (red arrows) to the liver with extensive necrosis (black boxes). (E) (H&E, ×100) demonstrates uninvolved glands of the prostate (green arrows) (cancer case) intermixed with lymphoid inflammation (blue circle). (F) (H&E, ×200) demonstrates lymphoid inflammation (blue circle) between uninvolved benign appearing colon glands (green arrow). A color version of this figure is available in the online article at www.liebertpub.com/bio.
<b>FIG. 2.</b>
FIG. 2.
A Minimum Quality Control examination for each tissue specimen provided for research. Aliquot 4 AB is processed to a paraffin block, and sections from it represent the QC diagnoses for both specimens 4A and 4B.
<b>FIG. 3.</b>
FIG. 3.
demonstrates very extensive and expensive QC via use of frozen sections including macrodissection and molecular analysis.
See this image and copyright information in PMC

References

    1. Grizzle WE, Sexton KC, Bell WC. Quality assurance in tissue resources supporting biomedical research. Cell Preserv Technol 2008;6:113–118 - PMC - PubMed
    1. Centers for Disease Control and Prevention. Fourth Report on Human Exposure to Environmental Chemicals, 2009. Atlanta GA: US Department of Health and Human Services, Centers for Disease Control and Prevention; Available at http://www.cdc.gov/exposurereport/pdf/fourthreport.pdf Accessed 8April2015
    1. Gunter EW, McQuillan GM. Quality control in planning and operating the laboratory component of the Third National Health and Nutrition Examination Survey (NHANES III). J Nutr 1990;120:1451–1454 - PubMed
    1. Pirkle JL, Brody DJ, Gunter EW, et al. . The decline in blood lead levels in the United States: The National Health and Nutrition Examination Surveys (NHANES). JAMA 1994;272:284–291 - PubMed
    1. Gunter EW, Lewis BL, Konchikowski SM. Laboratory methods used for the Third National Health and Nutrition Examination Survey (NHANES III), 1988–1994. As contained in NHANES III Reference Manuals and Reports, NCHS CD-ROM, Centers for Disease Control and Prevention, Hyattsville, MD, October, 1996

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