CLSI AUTO10 A : 1ED 2006

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Definitions
4 Design of Algorithms
  4.1 Data Elements
  4.2 Algorithm-Based Decisions
  4.3 Reporting of Results
  4.4 Selective Suppression of Autoverification
5 Regulatory Compliance
  5.1 Statutory Obligation
6 Validation of Algorithms
  6.1 Logic
  6.2 Independent Data Observations/Collection (monitoring
      of data in/data out)
  6.3 Algorithm Updates
  6.4 Software Updates
  6.5 Validation Tools
  6.6 Periodic Revalidation
References
Additional References
Summary of Comments and Subcommittee Responses
The Quality System Approach
Related CLSI/NCCLS Publication

Provides a new set of guidelines to take laboratorians beyond traditional autoverification to the next generation, allowing the use of more sophisticated algorithms to meet laboratory needs, as well as accurately reflecting the medical philosophy of the laboratory. It provides a framework for each laboratory to easily design, implement, validate, and customize rules based on the needs of its own patient population.

This guideline specifies recommendations for the design, building, implementation, validation, and compliance of the algorithms used for autoverification of laboratory results. The intended users of this guideline are information system vendors; hospital, reference, independent, and physician office laboratories; data management vendors; instrument manufacturers; and those involved in point-of-care testing. This guideline is not intended to provide test parameter rules or limits for practicing medicine or methods for confirmation of result delivery. This guideline does not address hardware specifications, interface specifications, connectivity, or software configuration. Security measures are beyond the scope of this document and are assumed to be covered by country-specific policies. For additional information, refer to the current edition of CLSI document AUTO11—IT Security of In Vitro Diagnostic Instruments and Software Systems.