Brass tacks of NCCLS automation standards
Editor’s note: The laboratory automation systems survey on pages 46-57 of the May issue of CAP TODAY asks vendors whether various components of their systems conform to NCCLS Standards Auto 1-5. Following is an explanation of those standards.
The NCCLS Area Committee on Automation and five subcommittees composed of more than 200 people from 30 countries have developed five interrelated standards addressing the design, compatibility, and integration of automated clinical laboratory systems worldwide. The standards follow.
AUTO1-A Laboratory automation: specimen container/specimen carrier provides standards for designing and manufacturing specimen containers and carriers used for collecting and processing liquid samples, such as blood and urine, for clinical testing in laboratory automation systems. Key points include specifications for: (1) collecting, transporting, and processing specimen containers and carriers; (2) multiple- versus single-specimen container carriers; (3) vertical placement of specimen containers in the carrier; and (4) the pitch and width for specimen container carriers.
AUTO2-A Laboratory automation: bar codes for specimen container identification provides specifications for using linear bar codes on specimen container tubes in the clinical laboratory and on laboratory automation systems. Key points include specifications for: (1) the bar-code symbology (Code 128); (2) phasing out all other types of symbologies by 2003; and (3) placement of the label on the specimen container. A maximum of three labels, including the manufacturer’s label, are recommended for the specimen container, although four may be used.
AUTO3-A Laboratory automation: communications with automated clinical laboratory systems, instruments, devices, and information systems provides standards to facilitate the accurate and timely electronic exchange of data and information between the automated laboratory elements. Key points include specifications for: (1) the design of laboratory automation information architectures and models that harmonize efforts with the Japanese Committee for Clinical Laboratory Standards and Health Level Seven; (2) the components required for communicating within the laboratory environment using the laboratory equipment interface specification developed by ASTM; and (3) a functional control model, which describes the connectivity between the laboratory automation system, laboratory information system, and various laboratory instruments.
AUTO4-A Laboratory automation: systems operational requirements, characteristics, and information elements describes the operational requirements, characteristics, and required information elements of clinical laboratory automation systems. This information is used to determine the status of a clinical specimen within the clinical laboratory automation system, as well as the status of the components of the clinical laboratory automation system. Key points include specifications for: (1) the requirements and performance of laboratory automated systems; (2) the status of specimens during sample analysis and data processing; (3) the status fields defining specimen attributes and characteristics; (4) defined error conditions/exceptions messages; and (5) quality control data.
AUTO5-A Laboratory automation: electromechanical interfaces provides guidance for developing a standard electromechanical interface between instruments and specimen-processing and specimen-handling devices used in automated laboratory testing procedures. Key points include specifications for: (1) laboratory automation system functions; (2) vendor responsibilities; (3) the point of reference (Figure 2); (4) X, Y, Z directions in which sampling can occur; (5) target zone and clearance zones; (6) dimensions among instruments and specimen-processing and specimen-handling devices and automated systems; and (7) ergonomic factors.
For more information about NCCLSstandards, visit the organization’s Web site at www.nccls.org or contact the NCCLS Executive Offices at 610-688-0100 or email@example.com.