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CLSI AUTO8 A : 1ED 2006

Current
Current

The latest, up-to-date edition.

MANAGING AND VALIDATING LABORATORY INFORMATION SYSTEMS
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

12-15-2006

Publisher

Clinical Laboratory Standards Institute

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Terminology
  3.1 Definitions
  3.2 Acronyms
4 Computer System Facilities
  4.1 Environmental Conditions and Safeguards for Proper
      System Operations
  4.2 Preventive Maintenance for Computer Systems
  4.3 Disaster Recovery
5 Systems Programs
  5.1 Laboratory Accreditation/Regulatory Requirements
  5.2 Security/Access
  5.3 Changes to Existing Programs or Validation of New
      Programs
6 Data
  6.1 Registration and Requisition Information
  6.2 Data Entry
  6.3 Computer Calculations
  6.4 Autoverification of Transmitted Results
  6.5 Generated Reports
7 Quality Assurance Standards/CQI
  7.1 User Responsibilities
  7.2 Database Maintenance
  7.3 Certification of Interfaces
  7.4 Problem Reporting and Tracking
  7.5 Train Staff
  7.6 Postimplementation Monitoring
  7.7 Documentation and Record Retention
References
Additional References
Appendix A - Sample Change/Addition Request Form
Appendix B - Example of Change/Addition Request
Appendix C - Validation Script
Summary of Consensus Comments and Committee Responses

Provides guidance for developing a protocol for validation of the laboratory information system (LIS), as well as protocols for assessing the dependability of the LIS when storing, retrieving, and transmitting data.

DevelopmentNote
Supersedes NCCLS AUTO8 P. (01/2007)
DocumentType
Standard
ISBN
1-56238-624-7
Pages
74
PublisherName
Clinical Laboratory Standards Institute
Status
Current
Supersedes

CLSI EP19 : 2ED 2015 A FRAMEWORK FOR USING CLSI DOCUMENTS TO EVALUATE CLINICAL LABORATORY MEASUREMENT PROCEDURES
BIS IS/ISO 15189 : 2012 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE
I.S. EN ISO 15189:2012 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE (ISO 15189:2012, CORRECTED VERSION 2014-08-15)
CLSI M52:2010(R2020) Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems
CLSI H57 A : 1ED 2008 PROTOCOL FOR THE EVALUATION, VALIDATION, AND IMPLEMENTATION OF COAGULOMETERS
PREN ISO 15189 : DRAFT 2011 MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE
UNE-EN ISO 15189:2013 Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
11/30173018 DC : 0 BS EN ISO 15189 - MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE
CLSI M52 : 1ED 2015 Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems, 1st Edition
DIN EN ISO 15189:2014-11 Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
UNI EN ISO 15189 : 2013 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE
CLSI GP37 P : 1ED 2011 QUALITY MANAGEMENT SYSTEM: EQUIPMENT
CLSI H57 P : 1ED 2007 PROTOCOL FOR THE EVALUATION, VALIDATION, AND IMPLEMENTATION OF COAGULOMETERS
CLSI I/LA33 A : 1ED 2009 VALIDATION OF AUTOMATED SYSTEMS FOR IMMUNOHEMATOLOGICAL TESTING BEFORE IMPLEMENTATION
ISO 15189:2012 Medical laboratories — Requirements for quality and competence
BS EN ISO 15189:2012 Medical laboratories. Requirements for quality and competence
CLSI QMS13 A : 1ED 2011 QUALITY MANAGEMENT SYSTEM: EQUIPMENT
CLSI I/LA33 P : 1ED 2009 VALIDATION OF AUTOMATED DEVICES FOR IMMUNOHEMATOLOGIC TESTING PRIOR TO IMPLEMENTATION

CLSI AUTO13 A2 : 2ED 2003 LABORATORY INSTRUMENTS AND DATA MANAGEMENT SYSTEMS: DESIGN OF SOFTWARE USER INTERFACES AND END-USER SOFTWARE SYSTEMS VALIDATION, OPERATION, AND MONITORING
CLSI AUTO4 A : 1ED 2001 LABORATORY AUTOMATION: SYSTEMS OPERATIONAL REQUIREMENTS, CHARACTERISTICS, AND INFORMATION ELEMENTS
CLSI LIS4 A : 1ED 2003 GUIDE FOR DOCUMENTATION OF CLINICAL LABORATORY COMPUTER SYSTEMS
CLSI AUTO10 A : 1ED 2006 AUTOVERIFICATION OF CLINICAL LABORATORY TEST RESULTS
CLSI AUTO1 A : 1ED 2000 LABORATORY AUTOMATION: SPECIMEN CONTAINER/SPECIMEN CARRIER
CLSI AUTO5 A : 1ED 2001 LABORATORY AUTOMATION: ELECTROMECHANICAL INTERFACES
CLSI AUTO3 A : 1ED 2000 LABORATORY AUTOMATION: COMMUNICATIONS WITH AUTOMATED CLINICAL LABORATORY SYSTEMS, INSTRUMENTS, DEVICES, AND INFORMATION SYSTEMS
CLSI POCT1 A2 : 2ED 2006 POINT-OF-CARE CONNECTIVITY

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