A call to standardize preanalytic data elements for biospecimens.
BACKGROUND
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.


OBJECTIVE
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.


METHODS
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 the 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 provided ranked list should aid in the selection of preanalytic variables for a given biospecimen collection.
From the Department of Pathology, University of North Carolina, Chapel Hill (Dr Gulley); the Department of Pathology, St Jude Medical Center, Fullerton, California (Dr Fitzgibbons); the College of American Pathologists, Northfield, Illinois (Ms Kennedy); the Department of Translational Medicine, Biogen Idec, Cambridge, Massachusetts (Dr Cosentino); the Department of Pathology, Vanderbilt Medical Center, Nashville, Tennessee (Dr Washington); the Department of Pathology, Duke Medical Center, Durham, North Carolina (Dr Dash); the Biorepositories and Biospecimens Research Branch, National Cancer Institute, National Institutes of Health, Rockville, Maryland (Dr Branton); the Department of Biospecimen Science, Van Andel Institute, Grand Rapids, Michigan (Dr Jewell); and the Department of Pathology, Spartanburg Regional Medical Center, Spartanburg, South Carolina (Dr Lapham).
James A
JA
Robb
Margaret L
ML
Gulley
Patrick L
PL
Fitzgibbons
Mary F
MF
Kennedy
L Mark
LM
Cosentino
Kay
K
Washington
Rajesh C
RC
Dash
Philip A
PA
Branton
Scott D
SD
Jewell
Rosanna L
RL
Lapham
D026683:Advisory Committees; D018070:Biological Specimen Banks / Q000592:standards* / Q000706:statistics & numerical data; D006801:Humans; D010336:Pathology / Q000592:standards / Q000706:statistics & numerical data; D012955:Societies, Medical; D014481:United States