LII:LIMSpec 2022 R2

Title: LIMSpec 2022 R1

Author for citation: Shawn E. Douglas

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: May 2022

Many specification documents for laboratory informatics systems have been compiled over the years. Most of them tend to focus on a potential client's "wishlist" of features for a given system. This updated version of a revised LIMSpec is different; it attempts to take a regulatory-, standards-, and guidance-based approach to building a specification document for laboratory informatics systems. The specification is built out upon on more than 100 resources, with ASTM E1578-18 Standard Guide for Laboratory Informatics and its requirements list chief among them. After the introduction and methodology, various requirements are organized and listed in a methodical order, each supported by one or more regulations, standards, guidance, or accreditation requirements documents. Finally, LIMSpec 2022 closes with a few tips on putting the specification to use.

The 2022 update adds almost 30 new resources, and it updates or replaces another 11. Examples of significant additions include CLSI QMS22 Management of Paper-based and Electronic Laboratory Information, ACMG Technical Standards for Clinical Genetics Laboratories, and WADA International Standard for Laboratories. Some verbiage on existing requirements was also slightly tweaked where necessary.

The table of contents for LIMSpec 2022 R1 is as follows:

1. Introduction and Methodology

Introduction

Methodology

2. Primary Laboratory Workflow

1. Sample and experiment registration

2. Sample management

3. Core laboratory testing and experiments

4. Results review and verification

5. Sample, experiment, and study approval and verification

6. Reporting

3. Maintaining Laboratory Workflow and Operations