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Specimen Labels: Content and Location, Fonts, and Label Orientation, 1st Edition

The purpose of this standard is to reduce human errors currently associated with the lack of standardization of labels on clinical laboratory specimens. The standard identifies the required human-readable elements to appear on specimen labels and specifies the exact locations, fonts, and font sizes of these elements.    

This document is available in electronic format only.

This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of January 2018. The document’s next scheduled review is generally five years after the reaffirmation date.

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Chairholder: Charles D. Hawker, PhD, MBA, FACB

Date of Publication: April 28, 2011

ISBN Number: 1-56238-748-0

Order Code Print: print not available

Edition: First

Pages: 52

CLSI AUTO12 Additional Details

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The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

CLSI AUTO12 Abstract

Clinical and Laboratory Standards Institute document AUTO12-A—Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard was developed to reduce the unacceptably high incidence of mislabeled specimens in clinical laboratories. The standard specifies locations and formats for the required human-readable elements that must appear on the label for each clinical laboratory specimen (except labels with limited space, eg, slides and pediatric specimens), a standard label size of 2 × 1 inches (50.8 × 25.4 mm), and an exact required location and format on this label for other commonly used elements. The patient’s name is judged to be the single most important element in correct specimen identification and is always to be in the top left corner on each label. The standard also specifies rules for truncation for long patient names, the location and size of the bar code on each label, a list of the most commonly used variable elements that can appear on specimen labels, and the required orientation of labels on specimen tubes.