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| ==2. Economic and practical justifications for a LIMS==
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| As a lab manager or stakeholder in your organization, you've concluded that a [[laboratory information management system]] (LIMS) makes a lot of sense for solving some of the challenges your lab faces. But you're not the primary decision maker for LIMS acquisition and deployment. At some point, you will have to present your case (i.e., provide justification) for the LIMS to management, and the material included in this chapter will help you make that case. There are different approaches to the justification of LIMS in the laboratory; the methodology you adopt should be based on your understanding of the technology and the dynamics of your management structure. In some cases, presenting practical aspects of a core organizational system like LIMS will be sufficient, while in others a more rigorous analysis will be warranted.
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| This chapter will examine this justification process by first encouraging your organization to look at the factors that are closest to the lab's essential laboratory functions. From there, we can look at the more traditional economic and practical considerations, justifications, and benefits that can help you with your presentation to management. This allows us to lead into the following chapter, which will discuss the importance of management buy-in, as well as how to pitch the LIMS project to management and critical stakeholders.
| | '''Title''': ''LIMS Selection Guide for Materials Testing Laboratories'' |
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| ===2.1 Organizational justifications: Why is it important?===
| | '''Edition''': First Edition |
| Before we get into the more classical aspects of justification, we need to look at those factors that are closest to your lab's essential operations. It's all well and good for us to broadly speak about the typical challenges, requirements, and considerations for labs of all types; some important deductions can be made by looking at the industry as a whole. However, no two laboratories are alike, and the challenges, requirements, and considerations for your laboratory may very well differ from the typical. This is why it's vital to not only use broad facts to justify LIMS acquisition but also integrate those facts within the context of your own lab. A series of important questions sets the stage for better explaining why the LIMS is necessary and beneficial to the lab. Questions that need to be asked include:
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| *Why is acquiring a LIMS important to meeting the goals of your lab?
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| *What problems does the LIMS solve that currently affect your lab?
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| *What operational, financial, and personnel improvements do you expect to see in your lab because of LIMS implementation?
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| *Why is this important to the larger organization, as well as those outside the lab?
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| No "one size fits all" justification template exists for a pivotal system like a LIMS. It can be the basis for restructuring your lab's operations and changing how it operates. Additionally, the justification for LIMS acquisition and deployment is—as the above questions emphasize—more than a dollars-and-cents consideration, although ultimately, it boils down to that. Management often thinks in terms of cost, and the further someone is in the corporate organizational chart from lab operations, the more financial issues become a driving factor in understanding the impact of a LIMS. They may need to be educated on the benefits of LIMS to lab operations, as well as the organization's bottom line. If lab budgets are tight, money may be a driving factor in that department. In other cases, it might be more straightforward, as reported by one oil company: “In our case, it pays for itself the day LIMS prevents one single day of refining gone to waste.”<ref name="SegalstadCost15">{{cite web |url=https://www.rdworldonline.com/cost-of-lims-true-pricing-includes-more-than-purchase-implementation-and-annual-licensing/ |title=Cost of LIMS: True Pricing includes more than Purchase, Implementation and Annual Licensing |author=Segalstad, S. |work=R&D World |date=18 May 2015 |accessdate=05 July 2023}}</ref> Similar cases can be made for any regulated industry. Yes, it’s a money issue, but that is considerably removed from the lab's budget. The justification needs to be viewed from more than one perspective.
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| Let's now address each of those four questions.
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| ====2.1.1 Why is acquiring a LIMS important to meeting the goals of your lab?====
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| Presumably, your organization has set out a series of business goals as part of a strategic planning process. Those developed goals should be purpose-driven, actionable, measurable, and forward-focused over a sufficiently long period of time to be fully indicative of the organization's long-term vision.<ref name="CoteHowToSet20">{{cite web |url=https://online.hbs.edu/blog/post/strategic-planning-goals |title=How to Set Strategic Planning Goals |author=Cote, C. |work=Business Insights Blog |publisher=Harvard Business School Online |date=29 October 2020 |accessdate=05 July 2023}}</ref> Having these goals on-hand are critical for any organization-specific justification of LIMS acquisition and deployment. These goals should, in theory, represent how upper management and key stakeholders view the organization's pathway to success. If you can match LIMS acquisition justification to those organizational goals, you'll have a better chance of getting through to management. If you can further make that goal-guided justification relevant and current to what's happening in the present, then all the better; "the goals that are timely and pressing are those that earn priority."<ref name="CoteHowToSet20" />
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| Perhaps one of the organizational goals is for timely, accurate analytical results that are cleanly reported, with the belief that such service will earn repeat business in the future, which is a boon to the organization seeking consistency in its operational income. The lab manager who understands the benefits of a LIMS could then link a LIMS to fewer analytical errors and more timely error checking due to the automated nature of the system, as well as more rapid reporting and result distribution to clients. The lab manager could then tie these benefits to the original organizational goal, even providing theorized examples of improved return on investment (ROI) and how those savings could pay for the LIMS in relatively short order.
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| ====2.1.2 What problems does the LIMS solve that currently affect your lab?====
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| If you're part of a mature, long-standing lab, there are likely to be some problems or challenges that have been identified as impacting your lab. Now is a good time to see how a LIMS can potentially aid with those problems and challenges. But new labs can also benefit; if your lab is new, the strategic planning process should have included risk analysis that successfully captures currently viewed and potential future risks to the business and achieving its mission-critical goals and priorities.<ref name="GartnerStrat23">{{cite web |url=https://emtemp.gcom.cloud/ngw/globalassets/en/insights/strategic-planning/2023/documents/strategic-planning-ebook-2023-risk.pdf |format=PDF |title=Strategic Planning Essentials |publisher=Gartner, Inc |date=2023 |accessdate=05 July 2023}}</ref> Drawing upon these risks helps you envision potential future problems you lab may encounter, as well as how a LIMS can help mitigate or prevent them.
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| An easy real-world example may be found with the challenges clinical labs encountered at the onset of the [[COVID-19]] [[pandemic]]. Those with manual, paper-based workflows that still saw high-throughput activity buckled and cracked under the workloads that the pandemic pressed upon them.<ref name="USAIDAVis22">{{cite web |url=https://www.usaid.gov/sites/default/files/2022-05/USAID-A-Digital-Health-Vision-for-Action-v10.28_FINAL_508.pdf |format=PDF |title=A Vision for Action in Digital Health, 2020-2024 |publisher=USAID |date=May 2022 |accessdate=05 July 2023}}</ref><ref name="BarnesGoing22">{{cite journal |url=https://www.clinicallabs.com.au/media/4165/pathology-focus-newsletter-june-2022-vic-qld-aclmar-news-nat-03898-digital.pdf |format=PDF |title=Going paperless: The world has changed |journal=Pathology Focus |author=Barnes, C. |issue=18 |date=June 2022 |publisher=Australian Clinicalabs |accessdate=05 July 2023}}</ref><ref name=":0">{{Cite journal |last=Weemaes |first=Matthias |last2=Martens |first2=Steven |last3=Cuypers |first3=Lize |last4=Van Elslande |first4=Jan |last5=Hoet |first5=Katrien |last6=Welkenhuysen |first6=Joris |last7=Goossens |first7=Ria |last8=Wouters |first8=Stijn |last9=Houben |first9=Els |last10=Jeuris |first10=Kirsten |last11=Laenen |first11=Lies |date=2020-08-01 |title=Laboratory information system requirements to manage the COVID-19 pandemic: A report from the Belgian national reference testing center |url=https://academic.oup.com/jamia/article/27/8/1293/5827002 |journal=Journal of the American Medical Informatics Association |language=en |volume=27 |issue=8 |pages=1293–1299 |doi=10.1093/jamia/ocaa081 |issn=1527-974X |pmc=PMC7197526 |pmid=32348469}}</ref> Not only was keeping up with workloads on paper more difficult, but also tracking specimens and providing timely reporting to the [[Centers for Disease Control and Prevention]] (CDC) were especially challenging. Acquisition and implementation of a LIMS or [[laboratory information system]] (LIS) suddenly made more sense for its ability to better help manage increased test demand through improved test ordering methods, standardized order sets, timely shipping notifications, automated triaging, additional data mining, and smoother reporting both internally and to stakeholders (i.e., patients, governing bodies, policymakers).<ref name=":0" /> Yes, there's a cost associated with the LIMS or LIS, but solving the paper-based challenge can make sense in the long-term for many such labs.
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| ====2.1.3 What operational, financial, and personnel improvements do you expect to see in your lab because of LIMS implementation?====
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| You likely aren't pushing for the acquisition and deployment of a LIMS without some expectation of operational, financial, and/or personnel improvement occurring as a result. Of course, you can't go to management and wave around vague claims of improvement without any research and evidence to back up your assertions. This is where things get a bit tricky, potentially necessitating speculative examination of current and post-implementation workflow methods, ROI calculations, and surveys of lab personnel, to name only a few. It may also require an extensive demonstration of one or more potential LIMS by their respective vendors, including real-life examples of the lab's own analyses and workflows worked into the demonstrations. In the end, the lab manager and stakeholders will be looking to link LIMS implementation to expected improvements in quantifiable and qualifiable ways.
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| | '''Author for citation''': Shawn E. Douglas |
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| | '''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International] |
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| ====2.1.4 Why is this important to the larger organization, as well as those outside the lab?====
| | '''Publication date''': ??? 2023 |
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| ===2.2 Economic considerations and justifications===
| | Description goes here... |
| The previous chapter's Table 1 compared 1980-era concessions, considerations, and justifications for maintaining an existing lab's operations vs. acquiring and deploying an on-premises LIMS. While those same aspects largely pertain to today's on-premises LIMS installation, most of the costs of hardware, installation, IT support, data storage, etc., go away with a cloud-based LIMS installation. Suddenly the economic justification for a LIMS looks rosier due to the reduced costs associated with having your LIMS securely hosted by another entity. The core cloud LIMS could be available on an annual basis for less than the cost of one person, easily justified through productivity improvements, improved data governance, and improved regulatory compliance. For example, the average annual salary for a government lab worker is
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| $43,757 (2022 average)<ref name="FPLabWork23">{{cite web |url=https://www.federalpay.org/employees/occupations/laboratory-working |title=Occupation Index: Laboratory Working |work=FederalPay.org |date=2023 |accessdate=05 July 2023}}</ref>, which is very close to the base pay for a lab technician in Boston, Massachusetts (2023).<ref name="GDHowMuchLab23">{{cite web |url=https://www.glassdoor.com/Salaries/boston-lab-technician-salary-SRCH_IL.0,6_IM109_KO7,21.htm |title=How much does a Lab Technician make in Boston, MA? |work=Glassdoor |date=14 June 2023 |accessdate=05 July 2023}}</ref>
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| The first year’s charges for a basic cloud-based LIMS with two concurrent users, including one-time and annual recurring charges, are less than that yearly salary value. The yearly recurring charge is less than a third of that technician's income. As you add on functions such as instrument interfacing, both the initial and recurring costs will increase, and so will the productivity gains through faster, more efficient data entry and automation. Additionally, cloud-based LIMS largely eliminates the need for on-site server hardware, software installation, and IT support. (Note: It is not our position that people should be laid off to justify the added cost of a LIMS, but some future hiring may be avoided or deferred.) Yes, training still needs to be provided, as does support for instrument connections. However, the latter can be phased in on an as-needed basis. | | The table of contents for ''LIMS Selection Guide for Materials Testing Laboratories'' is as follows: |
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| ====2.2.1 Factors that can offset costs====
| | :[[User:Shawndouglas/sandbox/sublevel10|1. Introduction to materials and materials testing laboratories]] |
| | ::1.1 Materials testing labs, then and now |
| | :::1.1.1 Materials testing 2.0 |
| | ::1.2 Industries, products, and raw materials |
| | ::1.3 Laboratory roles and activities in the industry |
| | :::1.3.1 R&D roles and activities |
| | :::1.3.2 Pre-manufacturing and manufacturing roles and activities |
| | :::1.3.3 Post-production quality control and regulatory roles and activities |
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| ===2.3 Practical considerations and justifications===
| | :[[User:Shawndouglas/sandbox/sublevel11|2. Standards, regulations, and test methods affecting materials testing labs]] |
| | ::2.1 Globally recognized materials manufacturing standards |
| | :::2.1.1 American Society of Civil Engineers (ASCE) materials standards |
| | :::2.1.2 ASTM International Volume 15.04 |
| | :::2.1.3 Canadian Standards Association (CSA) A3000 series |
| | :::2.1.4 International Organization for Standardization (ISO) 10993 |
| | :::2.1.5 Metal Powder Industries Federation (MPIF) Standard 35 family |
| | ::2.2 Regulations and laws around the world |
| | :::2.2.1 21 CFR Part 175 and 176 - United States |
| | :::2.2.2 Building Standard Law - Japan |
| | :::2.2.3 The Furniture and Furnishings (Fire) (Safety) Regulations 1988 - United Kingdom |
| | :::2.2.4 National Environment Protection (Used Packaging Materials) Measure 2011 - Australia |
| | :::2.2.5 Surface Coating Materials Regulations (SOR/2016-193) - Canada |
| | ::2.3 Standardized test methods for materials |
| | ::2.4 Materials laboratory accreditation |
| | :::2.4.1 A note about engineering and construction materials testing |
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| ====2.3.1 Tangible benefits====
| | :[[User:Shawndouglas/sandbox/sublevel12|3. Choosing laboratory informatics software for your materials testing lab]] |
| | ::3.1 Evaluation and selection |
| | :::3.1.1 Technology considerations |
| | ::::3.1.1.1 Laboratory informatics options |
| | :::3.1.2 Features and functions |
| | ::::3.1.2.1 Base features |
| | ::::3.1.2.2 Specialty features |
| | :::3.1.3 Cybersecurity considerations |
| | :::3.1.4 Regulatory compliance considerations |
| | :::3.1.5 System flexibility |
| | :::3.1.6 Cost considerations |
| | ::3.2 Implementation |
| | :::3.2.1 Internal and external integrations |
| | ::3.3 MSW, updates, and other contracted services |
| | ::3.4 How a user requirements specification fits into the entire process (LIMSpec) |
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| ====2.3.2 Intangible benefits====
| | :[[User:Shawndouglas/sandbox/sublevel13|4. Resources for selecting and implementing informatics solutions]] |
| | ::4.1 LIMS vendors |
| | ::4.2 Consultants |
| | ::4.3 Professional |
| | :::4.3.1 Trade organizations |
| | :::4.3.2 Conferences and trade shows |
| | ::4.4 LIMSpec |
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| ==References==
| | :[[User:Shawndouglas/sandbox/sublevel14|5. Taking the next step]] |
| {{Reflist|colwidth=30em}}
| | ::5.1 Conduct initial research into a specification document tailored to your lab's needs |
| | | ::5.2 Issue some of the specification as part of a request for information (RFI) |
| | | ::5.3 Respond to or open dialogue with vendors |
| ==Citation information for this chapter==
| | :::5.3.1 The value of demonstrations |
| '''Chapter''': 2. Economic and practical justifications for a LIMS
| | ::5.4 Finalize the requirements specification and choose a vendor |
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| '''Title''': ''Justifying LIMS Acquisition and Deployment within Your Organization''
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| '''Edition''': First Edition
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| '''Author for citation''': Joe Liscouski, Shawn E. Douglas
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| '''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International]
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| '''Publication date''':
| | :[[User:Shawndouglas/sandbox/sublevel15|6. Closing remarks]] |
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| <!--Place all category tags here-->
| | :[[User:Shawndouglas/sandbox/sublevel16|Appendix 1. Blank LIMSpec template for manufacturing labs]] |
| | ::A1. Introduction and methodology |
| | ::A2. Primary laboratory workflow |
| | ::A3. Maintaining laboratory workflow and operations |
| | ::A4. Specialty laboratory functions |
| | ::A5. Technology and performance improvements |
| | ::A6. Security and integrity of systems and operations |
| | ::A7. Putting those requirements to practical use and caveats |
| | ::A8. LIMSpec in Microsoft Word format |
