CLSI AUTO8 A : 1ED 2006

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.