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LIMSpec 2020: 3.10.1 Blank template for medical diagnostics and research labs

Title: LIMSpec 2020: 3.10.1 Blank template for medical diagnostics and research labs

Authors for citation: Shawn E. Douglas and Alan Vaughan

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: February 2020

About the LIMSpec (adapted from LIMSpec 2019 R1, Sept. 2019)

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 medical diagnostics and research lab LIMSpec is based on the 2019 version of the general LIMSpec, which attempts to take a regulatory-, standards-, and guidance-based approach to building a specification document for laboratory informatics systems. After the introduction and methodology, various requirements are organized and listed, supported by one or more regulations, standards, or guidance documents.

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 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 management

4. Specialty Laboratory Functions

18. Statistical trending and control charts

20. Environmental data management

21. Forensic case and data management

22. Public health data management

23. Veterinary data management

24. Scientific data management

25. Health information technology

5. Technology and Performance Improvement

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