For quality diagnostic and research test results, biorepository specimen variables must be standardized

http://www.archivesofpathology.org/doi/abs/10.5858/arpa.2013-0250-CP

James A. Robb, Margaret L. Gulley, Patrick L. Fitzgibbons, Mary F. Kennedy, L. Mark Cosentino, Kay Washington, Rajesh C. Dash, Philip A. Branton, Scott D. Jewell, and Rosanna L. Lapham (2013) A Call to Standardize Preanalytic Data Elements for Biospecimens. Archives of Pathology & Laboratory Medicine In-Press.

Early Online Release

A Call to Standardize Preanalytic Data Elements for Biospecimens

James A. Robb , MD; Margaret L. Gulley , MD; Patrick L. Fitzgibbons , MD; Mary F. Kennedy , CT(ASCP), MPH; L. Mark Cosentino ,DPM; Kay Washington , MD; Rajesh C. Dash , MD; Philip A. Branton , MD; Scott D. Jewell , PhD; Rosanna L. Lapham , MD

Context.—Biospecimens must have appropriate clinical annotation (data) to ensure optimal quality for both patient care and research. Clinical preanalytic variables are the focus of this study.

Objectives.—To define the essential preanalytic variables (data fields) that should be attached to every collected biospecimen and to provide a complete list of such variables, along with their relative importance, which can vary, depending on downstream use, institutional needs, and information technology capabilities.

Design.—The College of American Pathologists Diagnostic Intelligence and Health Information Technology Committee sponsored a Biorepository Working Group to develop a ranked list of the preanalytic variables for annotating biospecimens. Members of the working group were experts in anatomic, clinical, and molecular pathology; biobanking; medical informatics; and accreditation. Several members had experience with federal government programs, such as the National Cancer Institute's Biospecimens and Biorepository Branch and National Cancer Institute's Community Cancer Center Program. Potential preanalytic variables were identified and ranked along with available supporting evidence, definitions, and potential negative effects if the variable was not attached to the biospecimen. Additional national and international stakeholders reviewed the draft manuscript.

Results.—The ranked listing of 170 preanalytic variables produced can be used as a guide for site-specific implementation into patient care and/or research biorepository processes.

Conclusions.—In our collective experience, it is often difficult to choose which of the many preanalytic variables to attach to any specific set of biospecimens used for patient care and/or research. The attached ranked list should aid in the selection of preanalytic variables for a given biospecimen collection.