Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems<\/p>\n","protected":false},"excerpt":{"rendered":"
Preface In 2001, ASTM Committee E31 decided to restructure its operations, with the intent of focusing on standards-development issues such as security, privacy, and the electronic health record. Part of the reorganization plan was to explore the option of transferring responsibility for nine E31.13 standards to NCCLS. The NCCLS Area Committee on Automation and Informatics, at its meeting in April 2002, reached a positive assessment of the value of the ASTM standards and encouraged the NCCLS Executive Offices staff to pursue negotiations with ASTM on transferring these standards to NCCLS. Following this transfer, these nine standards (formerly ASTM E792; E1029; E1238; E1246; E1381; E1394; E1466; E1639; and E2118) have been redesignated as NCCLS standards LIS1 through LIS9. The Area Committee on Automation and Informatics has assumed responsibility for maintaining the documents and will revise or update each document in accord with NCCLS Administrative Procedures. This document is the equivalent of ASTM E1246 but has been redesignated and is now maintained by NCCLS. This document has been approved as an American National Standard (ANSI\/ASTM E1246-01).<\/p>\n
1. Scope 1.1 This practice describes a system for collecting data, maintaining records, and reporting on the reliability of operating clinical laboratory computer systems.1 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<\/p>\n","protected":false},"featured_media":1843,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_cat":[26],"product_tag":[],"yoast_head":"\n