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[[File:LIMSpec.png|right]][[Book:LIMSpec 2019 R1|LIMSpec]] is an ever-evolving set of software user requirements specifications for laboratory informatics systems. The specification has grown significantly from its humble origins over a decade ago. Earlier versions of LIMSpec focused on a mix of both regulatory requirements and clients' "wishlist" features for a given system. The wishlist items haven't necessarily been ignored by developers, but they do in fact have to be prioritized by the potential buyer as "nice to have" or "essential to system operation," or something in between.<ref name="AasemAnalysis10">{{cite journal |title=Analysis and optimization of software requirements prioritization techniques |author=Aasem, M.; Ramzan, M.; Jaffar, A. |journal=Proceedings from the 2010 International Conference on Information and Emerging Technologies |pages=1–6 |year=2010 |doi=10.1109/ICIET.2010.5625687}}</ref><ref name="Hirsch10Steps13">{{cite web |url=https://www.phase2technology.com/blog/successful-requirements-gathering |title=10 Steps To Successful Requirements Gathering |author=Hirsch, J. |publisher=Phase2 Technology, LLC |date=22 November 2013 |accessdate=23 November 2021}}</ref><ref name="BurrissSoftware07">{{cite web |url=http://sce2.umkc.edu/BIT/burrise/pl/requirements/ |archiveurl=https://web.archive.org/web/20190724173601/http://sce2.umkc.edu/BIT/burrise/pl/requirements/ |title=Requirements Specification |work=CS451R, University of Missouri–Kansas City |author=Burris, E. |publisher=University of Missouri–Kansas City |date=2007 |archivedate=24 July 2019 |accessdate=23 November 2021}}</ref> This latest version is different, focusing strictly on a regulatory-, standards-, and guidance-based approach to building a specification document for laboratory informatics systems.
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.<ref name="AasemAnalysis10">{{cite journal |title=Analysis and optimization of software requirements prioritization techniques |author=Aasem, M.; Ramzan, M.; Jaffar, A. |journal=Proceedings from the 2010 International Conference on Information and Emerging Technologies |pages=1–6 |year=2010 |doi=10.1109/ICIET.2010.5625687}}</ref><ref name="Hirsch10Steps13">{{cite web |url=https://www.phase2technology.com/blog/successful-requirements-gathering |title=10 Steps To Successful Requirements Gathering |author=Hirsch, J. |publisher=Phase2 Technology, LLC |date=22 November 2013 |accessdate=18 November 2021}}</ref><ref name="BurrissSoftware07">{{cite web |url=http://sce2.umkc.edu/BIT/burrise/pl/requirements/ |archiveurl=https://web.archive.org/web/20190925003040/http://sce2.umkc.edu/BIT/burrise/pl/requirements/ |title=Requirements Specification |work=CS451R, University of Missouri–Kansas City |author=Burris, E. |publisher=University of Missouri–Kansas City |date=2007 |archivedate=25 September 2019 |accessdate=18 November 2021}}</ref>


At its core, LIMSpec is rooted in [[ASTM E1578|ASTM E1578-18]] ''Standard Guide for Laboratory Informatics''. With the latest version released in 2018, the standard includes an updated Laboratory Informatics Functional Requirements checklist, which "covers functionality common to the various laboratory informatics systems discussed throughout [the] guide as well as requirements recommended as part of [the] guide." It goes on to state that the checklist "is an example of typical requirements that can be used to guide the purchase, upgrade, or development of a laboratory informatics system," though it is certainly "not meant to be exhaustive."
Noting the potential problems with this wishlist approach, LIMSpec—a specification document for laboratory informatics solutions—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|ASTM E1578-18]] ''Standard Guide for Laboratory Informatics'', as well as dozens of other standards and regulations, while still leaving room for a software buyer to add their own custom requirements for their industry or lab.  


LIMSpec borrows from that requirements checklist and then adds more to it from a wide variety of sources. An attempt has been made to find the most relevant regulations, standards, and guidance that shape how a compliant laboratory informatics system is developed and maintained. However, the LIMSpec should also definitely be considered a continual work in progress, with more to be added as new pertinent regulations, standards, and guidance are discovered.
The rest of this chapter examines the research, documentation, and acquisition process that clinical and research labs needing laboratory informatics solutions will want to go through, with an emphasis on the utility of a sound requirements specification. While LIMSpec is offered as a solid starting point, you don't strictly need to use LIMSpec to conduct this process; the information in this chapter can largely be applied with or without LIMSpec itself.
 
If you've never worked with a user requirements specification document, the concept remains relatively simple to grasp. Merriam-Webster defines a "specification" as "a detailed precise presentation of something or of a plan or proposal for something."<ref name="MWSpec">{{cite web |url=https://www.merriam-webster.com/dictionary/specification |title=specification |work=Merriam-Webster |publisher=Merriam-Webster, Inc |accessdate=23 November 2021}}</ref> Within this organized "plan or proposal" are requirements. A requirement typically comes in the form of a statement that begins with "the system/user/vendor shall/should ..." and focuses on a provided service, reaction to input, or expected behavior in a given situation. The statement may be abstract (high-level), or it may be specific and detailed to a precise function. The statement may also be of a functional nature, describing functionality or services in detail, or of a non-functional nature, describing the constraints of a given functionality or service and how it's rendered.
 
An example of a functional software requirement could be "the user shall be able to query either all of the initial set of databases or select a subset from it." This statement describes specific functionality the system should have. On the other hand, a non-functional requirement, for example, may state "the system's query tool shall conform to the ABC 123-2014 standard." The statement describes a constraint placed upon the system's query functionality. Once compiled, a set of requirements can serve not only to strengthen the software requirements specification, but the requirements set can also be used for bidding on a contract or serve as the basis for a specific contract that is being finalized.<ref name="MemonSoftware10">{{cite web |url=https://www.cs.umd.edu/~atif/Teaching/Spring2010/Slides/3.pdf |format=PDF |title=Software Requirements: Descriptions and specifications of a system |author=Memon, A. |publisher=University of Maryland |date=Spring 2010 |accessdate=23 November 2021}}</ref>
 
The next chapter discusses the user requirements specification, using LIMSpec as an example. You'll learn how to shape such a specification to your laboratory's needs, how to issue the specification as a request for information (RFI), and how to get the most out of it when getting decision-related information from vendors. Additionally, in Appendix 1, you'll find a blank version of LIMSpec for practical use.


==References==
==References==
{{Reflist|colwidth=30em}}
{{Reflist|colwidth=30em}}
==Citation information for this chapter==
'''Chapter''': 5. Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources
'''Title''': ''Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research''
'''Edition''': 2022 Edition
'''Author for citation''': Shawn E. Douglas
'''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International]
'''Publication date''': January 2022
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Revision as of 19:09, 22 January 2022

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.[1][2][3]

Noting the potential problems with this wishlist approach, LIMSpec—a specification document for laboratory informatics solutions—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 software buyer to add their own custom requirements for their industry or lab.

The rest of this chapter examines the research, documentation, and acquisition process that clinical and research labs needing laboratory informatics solutions will want to go through, with an emphasis on the utility of a sound requirements specification. While LIMSpec is offered as a solid starting point, you don't strictly need to use LIMSpec to conduct this process; the information in this chapter can largely be applied with or without LIMSpec itself.

References

  1. Aasem, M.; Ramzan, M.; Jaffar, A. (2010). "Analysis and optimization of software requirements prioritization techniques". Proceedings from the 2010 International Conference on Information and Emerging Technologies: 1–6. doi:10.1109/ICIET.2010.5625687. 
  2. Hirsch, J. (22 November 2013). "10 Steps To Successful Requirements Gathering". Phase2 Technology, LLC. https://www.phase2technology.com/blog/successful-requirements-gathering. Retrieved 18 November 2021. 
  3. Burris, E. (2007). "Requirements Specification". CS451R, University of Missouri–Kansas City. University of Missouri–Kansas City. Archived from the original on 25 September 2019. https://web.archive.org/web/20190925003040/http://sce2.umkc.edu/BIT/burrise/pl/requirements/. Retrieved 18 November 2021.