LII:LIMSpec 2022 R1

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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
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
7. Document and records management
8. Resource management
9. Compliance management
10. Instrument and equipment management
11. Batch and lot management
12. Scheduled event management
13. Instrument data capture and control
14. Standard and reagent management
15. Inventory management
16. Investigation and quality management
4. Specialty Laboratory Functions
17. Production management
18. Statistical trending and control charts
19. Agriculture and food data management
20. Environmental data management
21. Forensic case and data management
22. Clinical and public health data management
23. Veterinary data management
24. Scientific data management
25. Health information technology
5. Technology and Performance Improvements
26. Instrument data systems functions
27. Systems integration
28. Laboratory scheduling and capacity planning
29. Lean laboratory and continuous improvement
30. Artificial intelligence and smart systems
6. Security and Integrity of Systems and Operations
31. Data integrity
32. Configuration management
33. System validation and commission
34. System administration
35. Cybersecurity
36. Information privacy
7. Putting those Requirements to Practical Use
Software developer considerations
Buyer considerations