The National Committee on Clinical Laboratory Standards (NCCLS), renamed as of 1 Jan 2005 as Clinical and Laboratory Standards Institute (CLSI), is an ANSI- accredited voluntary consensus standards developer who is a SDO member of the ANSI HITSP, having assumed that status in 1998. Its primary focus is the clinical laboratory, its management and the measurement procedures conducted there and elsewhere within healthcare settings. It was formed in 1970 and its headquarters is located in Wayne PA. It has ten Area Committees of which two: Laboratory Automation and Informatics and Alternative Site Testing relate directly to informatics and the EHR. In 2003 CLSI acquired the ASTM E-31 standards relating to Clinical Laboratory Information Systems (LIS-1A – LIS-9A). CLSI is Secretariat for the ISO TC 212 on Clinical Laboratory Testing and In Vitro Diagnostic Products. (See: http://www.nccls.org)
ASTM E-792 Guide for Procurement of a Clinical Laboratory Information Management System (CLIMS) [LIS3-A]
ASTM E-1029 Guide for Documentation of Clinical Laboratory Computer Systems [LIS4-A]
ASTM E-1238 Specification for Transferring Clinical Observations Between Independent Computer Systems[LIS5-A]
ASTM E-1246 Practice for Reporting Reliability of Clinical Laboratory Information Systems [LIS6-A]
ASTM E-1381 Specification for Low Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems [LIS1-A]
ASTM E-1394 Specification for Transferring Information Between Clinical Instruments and Computer Systems [LIS2-A]
ASTM E-1466 Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory [LIS7-A]
ASTM E-1639 Guide for Functional Requirements of Clinical Laboratory Information Management Systems [LIS8-A]
ASTM E-2118 Guide for Coordination of Clinical Laboratory Services Within the Electronic Health Record Environment and Networked Architectures [LIS9-A]