ASTM E1246-01 PDF

1.1 This practice describes a system for collecting data, maintaining records, and reporting on the reliability of operating clinical laboratory computer systems. The reliability measure will be achieved by documenting the number, severity, cause, impact, and duration of the failures that a system experiences. This practice can be implemented with paper forms or computer records. The type of computer systems under consideration are those designed to assist the overall workflow of the laboratory, and generally include some or all of the functions of patient biographical data, test ordering, draw list printing, specimen check-in, workstation work list printing, test result entry, result verification, patient report printing, data archiving, quality control, and management report printing. This practice is applicable to all types of clinical laboratories, including major medical centers, teaching hospitals, community hospitals, referral clinics, emergency centers, health care maintenance organizations, specialty institutions, commercial laboratories, and private practices. The significance of portions of the reliability measure may be different in the different settings, but the measurement procedure is the same. This practice is not intended for computers inside instruments or for those systems designed to support a single workstation, although portions of this practice may be applicable.

1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.