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In section 2.4 of this guide, we briefly discussed how a user requirements specification (URS) fits into the process of purchasing laboratory informatics solutions for your clinical or research laboratory. The URS has been viewed as a means for the purchaser to ensure their needs are satisfied by the functionality of the software. Traditionally, this has turned into a "wish list" for the purchaser, which while somewhat practical still lacks in its finesse. One common problem in this wishlist approach is the risk of "requirements creep," where more functionality than is truly necessary is desired, inevitably leading to a state where no vendor can meet all the wishlisted requirements. This makes selecting a solution even more difficult, particularly without significant prioritization skills.

Noting the potential problems with this wishlist approach, LIMSpec—a specification document for laboratory informatics—took a new approach and turned to standards and regulations that drive laboratories of all types, as well as the data they manage. LIMSpec was rebuilt based on ASTM E1578-18 Standard Guide for Laboratory Informatics, as well as dozens of other standards and regulations, while still leaving room for a purchaser to add their own custom requirements for their industry or lab.

The rest of this chapter examines the specification documentation and research process that clinical and research labs may want to go through, largely from the perspective of using LIMSpec as the base tool. However, you don't strictly need to use LIMSpec to conduct this documentation and research; the information in this chapter can largely be applied with or without LIMSpec itself.

4.1 Develop a specification document tailored to your lab's needs

A specification is "a detailed precise presentation of something or of a plan or proposal for something." This concept of a specification as a presentation is critical to the laboratory seeking to find laboratory informatics software that fulfills their needs; they "present" their use case through the specification, and the vendor "presents" their ability to comply through documentation and demonstration (more on that later). However, even the most seasoned of presenters at conferences and the like still require quality preparation before the presentation. This is where the specification document comes into play for the lab.

Your lab's specification document—usually in the form of a user requirements specification (URS)—is the preparation to your presentation. There are numerous ways to approach the development of your specification documents, including brainstorming what your lab needs to be able to do with a laboratory informatics solution. But why re-invent the wheel when others have already go down that road? You could search for examples of such documents on the internet and customize them to your needs. The LIMSpec makes for one of the more thorough base documents to use, though you could use other example structured. For the purposes of this guide, we'll look at LIMSpec.

The version of LIMSpec included in Appendix 1 of this guide is a slightly tweaked version of the original LIMSpec 2019 document, omitting a few of the specialty laboratory functions that aren't applicable to clinical and research laboratories. You'll note that it's divided into five distinct sections, with numerous subsections in each:

• 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
• 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 and quality management
• Specialty Laboratory Functions (minus non-relevant industries)
  • 18. Statistical trending and control charts
  • 21. Forensic case and data management
  • 22. Public health data management
  • 23. Veterinary data management
  • 24. Scientific data management
  • 25. Health information technology
• 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
• 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