The Clinical and Laboratory Standards Institute (CLSI) has published a standard that identifies the human-readable elements that must be on specimen labels while specifying their locations and fonts.
The standard, entitled 'Specimen Labels: Content and Location, Fonts and Label Orientation; Approved Standard' (Auto12-A), also dictates the location and size of the barcode, while allowing adequate space for other label elements frequently used by laboratories, such as collection priority (routine and stat), source of specimen (nasal swab) and space for special instructions.
The development of Auto12 was prompted by published data that indicate an unacceptably high rate of mislabelled specimens in US laboratories.
Before Auto12, laboratory workers did not adhere to a standard format for clinical laboratory specimen labels, and the absence of such a standard is believed to be a contributor to the elevated error rate.
Charles D Hawker, scientific director of automation and special projects at Arup Laboratories in Salt Lake City, Utah, and chair holder of the committee that developed the document, said: 'Most hospitals and reference laboratories receive specimens from two or more sources, including those from their own hospital inpatients, as well as those sent from outpatient clinics, physicians' offices, affiliated hospitals and other clinics.
'The labels on these specimens often have different formats, fonts and content, all of which make it difficult for the laboratories' employees to prevent patient identification errors as they process and test specimens from these different sources.
'Auto12 is intended to provide standard formats, fonts and font sizes for the human-readable content of specimen labels, resulting in fewer identification errors,' he added.
The document aims to fulfil this purpose by specifying requirements for the format and location of five main elements of every specimen label: patient name; unique patient identifier; date of birth; specimen collection time and date; and designated space for the collector's identification.
In this way, the adoption and implementation of Auto12 will reduce the human errors currently associated with the lack of standardisation of labels on clinical laboratory specimens.
With some exceptions, such as slides and paediatric specimens that have limited label space, this standard applies to all laboratory specimens from the point of collection, including all transfers of specimens from one provider to another.
Auto12 is intended for use by healthcare providers, laboratory information system vendors, diagnostic vendors and vendors that manufacture labels and/or label printers, as well as for all other entities that collect, prepare or handle specimens and must use, print or read specimen labels.
The standard is to be implemented by these users within three years of its publication date as an approved standard, and it is expected that all organisations involved in the licensing and accrediting of laboratories will refer to Auto12 in their accreditation checklists used during laboratory inspections.
