Book:LIMSpec 2022 R2
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LIMSpec 2022 R1
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 is as follows:
- 1. Introduction
- 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. Closing remarks
- Putting LIMSpec to use
