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[[File:CBP Laboratories and Scientific Services (LSS), Springfield, Virginia - 44708018774.jpg|right|400px]]As seen in the previous chapters, analytical testing of cannabis is not a simple, one-size-fits-all process. Differing analytical matrices with a slightly fragmented but improving regulatory- and standards-based atmosphere, paired with downward pricing pressures and requests for quick turnaround times (TATs), means there are plenty of challenges for cannabis testing laboratories.<ref name="KaulManag20">{{cite web |url=https://www.labmanager.com/business-management/managing-a-cannabis-lab-22822 |title=Managing a Cannabis Lab |author=Kaul, S. |work=Lab Manager |date=03 June 2020 |accessdate=07 July 2021}}</ref><ref name="CannLab20">{{cite web |url=https://www.analyticalcannabis.com/articles/cannalysis-lab-decreases-processing-time-by-94-with-lab-automation-software-312343 |title=Cannalysis Lab Decreases Processing Time by 94% with Lab Automation Software |author=Cannalysis |work=Analytical Cannabis |date=08 April 2020 |accessdate=07 July 2021}}</ref> Workflows differ based upon the analyte being tested for and the substance in which they are contained. The sampling and anlysis of [[inflorescence]] material will look significantly different than sampling and analyzing from a cannabis edible, for example. The samples received in the lab must be tracked at every step, and results must be reported to not only clients but also state regulatory groups, typically in a secure electronic format. Quality control must be maintained, documents stored, and regulations followed. Managing all these and other aspects of the laboratory immersed in an already competitive industry leaves little room for failure. Applying automation in these cases may prove to be most beneficial.
With a few minor exceptions (e.g., Colorado's limitation that "a Medical Marijuana Testing Facility shall not perform testing on Industrial Hemp"<ref name="SOSMedicalMari">{{cite web |url=https://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=7094&fileName=1 CCR 212-1 |title=Medical Marijuana Rules - 1 CCR 212-1 |author=Department of Revenue, Marijuana Enforcement Division |publisher=Colorado Secretary of State |accessdate=07 July 2021}}</ref>), a laboratory licensed to analyze medical marijuana or recreational cannabis is most likely able to branch out to not only other types of cannabis testing but also testing within other markets. Consider the equipment most commonly used in cannabis analysis: [[chromatography]], [[spectroscopy]], [[mass spectrometry]], and [[polymerase chain reaction]] systems. What other types of laboratory testing use that sort of equipment? Environmental science laboratories are definitely using such equipment<ref name="PicóChroma20">{{cite journal |title=Chromatography–mass spectrometry: Recent evolution and current trends in environmental science |journal=Current Opinion in Environmental Science & Health |author=Picó, Y. |volume=18 |pages=47–53 |year=2020 |doi=10.1016/j.coesh.2020.07.002}}</ref>, arguably representing one of the easier lateral market expansions a cannabis testing lab can take. Food and beverage analyses also depend on all those equipment types<ref name="SchieberIntro08">{{cite book |chapter=Chapter 1: Introduction to Food Authentication |title=Modern Techniques for Food Authentication |author=Schieber, A. |editor=Sun, D.-W. |publisher=Elsevier |pages=1–17 |year=2008 |isbn=9780123740854}}</ref><ref name="RasheedNovel21">{{cite journal |title=Novel trends and applications of multidimensional chromatography in the analysis of food, cosmetics and medicine bearing essential oils |journal=Talanta |author=Rasheed, D.M.; Serag, A.; Shakour, Z.T.A. et al. |volume=223 |issue=1 |at=121710 |year=2021 |doi=10.1016/j.talanta.2020.121710}}</ref>, as do other forms of testing such as agricultural testing<ref name="LippPoly05">{{cite journal |title=Polymerase chain reaction technology as analytical tool in agricultural biotechnology |journal=Journal of AOAC International |author=Lipp, M.; Shilito, R.; Giroux, R. et al. |volume=88 |issue=1 |pages=136–55 |pmid=15759736}}</ref><ref name="WacooMethods14">{{cite journal |title=Methods for Detection of Aflatoxins in Agricultural Food Crops |journal=Journal of Applied Chemistry |author=Wacoo, A.P.; Wendiro, D.; Vuzi, P.C. et al. |volume=2014 |at=706291 |year=2014 |doi=10.1155/2014/706291}}</ref>, cosmetic testing<ref name="RasheedNovel21" /><ref name="JannatGelatin18">{{cite journal |title=Gelatin speciation using real-time PCR and analysis of mass spectrometry-based proteomics datasets |journal=Food Control |author=Jannat, B.; Ghorbani, K.; Shafieynan, H. et al. |volume=87 |pages=79–87 |year=2018 |doi=10.1016/j.foodcont.2017.12.006}}</ref>, and petrochemical testing.<ref name="KhanmohammadiCharct12">{{cite journal |title=Characterization of petroleum-based products by infrared spectroscopy and chemometrics |journal=TrAC Trends in Analytical Chemistry |author=Khanmohammadi, M.; Garmarudi, A.B.; de la Guardia, M. |volume=35 |pages=135–49 |year=2012 |doi=10.1016/j.trac.2011.12.006}}</ref><ref name="ImamAnal19">{{cite journal |title=Analytical approaches used in monitoring the bioremediation of hydrocarbons in petroleum-contaminated soil and sludge |journal=TrAC Trends in Analytical Chemistry |author=Imam, A.; Suman, S.K.; Ghosh, D. et al. |volume=118 |pages=50–64 |year=2019 |doi=10.1016/j.trac.2019.05.023}}</ref> Assuming a lab has or can acquire the in-house expertise for analyzing all these related matrices, analytes, and molecules, as well as the regulatory know-how (e.g., Environmental Protection Agency testing methodologies) and licensing, expanding into other markets beyond cannabis testing may be a realistic long-term proposition.


Broadly speaking, adding elements of automation to the cannabis testing lab can help overcome the demand of rapidly analyzing large sample volumes of cannabis products with a wide spectrum of matrices.<ref name="KaulManag20" /><ref name="CannLab20" /><ref name="GoldmanAutom21">{{cite web |url=https://www.technologynetworks.com/tn/webinars/automation-in-the-cannabis-hemp-testing-laboratories-of-tomorrow-344293 |archiveurl=https://web.archive.org/web/20210119211553/https://www.technologynetworks.com/tn/webinars/automation-in-the-cannabis-hemp-testing-laboratories-of-tomorrow-344293 |title=Automation in the Cannabis and Hemp Testing Laboratories of Tomorrow |author=Goldman, S. |work=Technology Networks |date=January 2021 |archivedate=19 January 2021 |accessdate=07 July 2021}}</ref> Those automation elements can take many forms. Analytical lab Cannalysis, for example, has added middleware "that integrates instruments, optimizes workflows and monitors performance to create a cohesive lab ecosystem."<ref name="CannLab20" /> The  Richland County Sheriff's Department Drug Identification Unit has turned to an automated dispersive pipette extraction (DPX) method with an automated liquid handler to speed up discriminate testing of cannabis' ∆<sup>9</sup>‐tetrahydrocannabinol (THC) content.<ref name="HorneFast20">{{cite journal |title=Fast Discrimination of Marijuana using Automated High‐throughput Cannabis Sample Preparation and Analysis by Gas Chromatography–Mass Spectrometry |journal=Journal of Forensic Sciences |author=Horne, M.; Mastrianni, K.R.; Amick, G. et al. |volume=65 |issue=5 |pages=1709–15 |year=2020 |doi=10.1111/1556-4029.14525}}</ref> And other laboratories are turning to a LIMS for automating laboratory workflows, sample management, document management, and other aspects of cannabis lab testing.<ref name="MCSImport20">{{cite web |url=https://www.moderncanna.com/cannabis-testing/importance-of-lims-in-hemp-testing-laboratories/ |title=Importance of LIMS in Hemp Testing Laboratories |author=Modern Canna Labs |date=29 September 2020 |accessdate=07 July 2021}}</ref><ref name="ApteTheRole19">{{cite web |url=https://www.labroots.com/webinar/role-lims-achieving-iso-17025-compliance-cannabis-testing-laboratories |title=The Role of LIMS in Achieving ISO 17025 Compliance in Cannabis Testing Laboratories |author=Apte, A. |work=LabRoots |date=27 March 2019 |accessdate=07 July 2021}}</ref>
If your lab is realistically considering this sort of market expansion, it's in your lab's best interest to consider a LIMS that is flexible enough to allow for the expansion of its portfolio of tests, protocols, workflows, and other laboratory management tools beyond those required for cannabis testing. Yes, a quality LIMS built for cannabis testing will offer preloaded cannabis testing protocols, labels, and analytical reports, as well as the ability to add new and customize existing protocols, labels, and analytical reports as standard methods and regulatory requirements evolve. Such a LIMS will also provide flexible specification limit sets for quality control, third-party system integrations with reporting and business solutions, instrument interfacing for all those chromatography and mass spectrometry devices, granular chain-of-custody, real-time alerts, issue tracking, and workload monitoring, to name a few. But all that functionality has important cross-over to environmental, food and beverage, cosmetic, and petrochemical analyses as well, including the ability to add and modify tests, protocols, and workflows associated with those analyses within the LIMS.


The LIMS has been a useful tool for laboratories since at least the 1980s, aiding with sample reception and management, test management, instrument management, and reporting.<ref name="LIMSHistory">{{cite journal |title=A brief history of LIMS |journal=Laboratory Automation and Information Management |author=Gibbon, G.A. |volume=32 |issue=1 |pages=1–5 |year=1996 |doi=10.1016/1381-141X(95)00024-K}}</ref><ref name="McLelland98">{{cite web |url=http://www.rsc.org/pdf/andiv/tech.pdf |archiveurl=https://web.archive.org/web/20131004232754/http://www.rsc.org/pdf/andiv/tech.pdf |format=PDF |title=What is a LIMS - a laboratory toy, or a critical IT component? |author=McLelland, A. |publisher=Royal Society of Chemistry |page=1 |date=1998 |archivedate=04 October 2013 |accessdate=07 July 2021}}</ref> Since its humble origins, the software has expanded to include a wide variety of additional functionality to support laboratory operations, as well as the lab's ability to adhere to standards, regulations, and accreditation requirements. The technology behind how they are deployed has even changed, with both on-site and cloud-based installations now available.  
This brings up another significant question to consider in cannabis testing LIMS acquisition: how flexible is your LIMS? How configurable is it? How customizable is it, despite some base similarities in requirements with other testing markets? Aspects of a LIMS lending to an expansion into other markets include:
 
* having the tools for creating and customizing sample registration screens for sample types beyond cannabis-related ones;
* having the tools for creating new, compliant test protocols, labels, and reports, as well as for managing them as industries change;
* offering sufficiently flexible protocol creation for adding most any specification limit sets, measurement units, substrates/matrices, etc.;
* being able to integrate with instruments and software systems beyond those common to cannabis testing labs, including handling most any API thrown at it; and
* having the functionality to help laboratories comply with the wide variety of standards and regulations found in other testing markets.
 
Even in 2021, as legalization efforts continue to march forward in the U.S. and standard methods continue to be developed, cannabis testing laboratories still face a number of challenges.<ref name="KaulManag20" /> Using automation tools like a LIMS is one way to overcome those challenges, particularly as the cannabis testing space gets more crowded, driving prices downward.<ref name="KaulManag20" /> However, you want to be sure the LIMS you choose is not only compatible with your budget but also able to tackle all your current and future testing needs, while helping you streamline processes and improve workflows. A sturdy LIMS capable of managing cannabis analyses while being flexible enough to allow your lab—whether you're an existing lab wanting to expand into other markets or a start-up lab eyeing broad horizons—to handle other analyses will be highly valuable in a time when the status of the fledgling cannabis industry continues to be in flux. In the end, no matter what type of lab you represent, your laboratory business model will be one to minimize risk while maximizing income. As such, diversifying into other markets with a flexible LIMS just makes sense.


With so many vendor options, features, and requirements, the selection of a LIMS for cannabis testing can be a bewildering process, requiring significant research and consideration. Not only will you be looking for the above functionality, but you'll also want to ask other important questions. How useable and customizable is the software? Does it have sufficient mechanisms for ensuring the integrity of the data it houses and manages? How well does the vendor maintain the software with updates and patches?<ref name="KyobeSelect17">{{cite journal |title=Selecting a Laboratory Information Management System for Biorepositories in Low- and Middle-Income Countries: The H3Africa Experience and Lessons Learned |journal=Biopreservation and Biobanking |author=Kyobe, S.; Musinguzi, H.; Lwanga, N. et al. |volume=15 |issue=2 |pages=112–15 |year=2017 |doi=10.1089/bio.2017.0006}}</ref> These questions and more are required when preparing to add or change the LIMS in your laboratory, including asking the question "how flexible is this LIMS?".


==References==
==References==
{{Reflist|colwidth=30em}}
{{Reflist|colwidth=30em}}

Revision as of 17:27, 19 August 2021

With a few minor exceptions (e.g., Colorado's limitation that "a Medical Marijuana Testing Facility shall not perform testing on Industrial Hemp"[1]), a laboratory licensed to analyze medical marijuana or recreational cannabis is most likely able to branch out to not only other types of cannabis testing but also testing within other markets. Consider the equipment most commonly used in cannabis analysis: chromatography, spectroscopy, mass spectrometry, and polymerase chain reaction systems. What other types of laboratory testing use that sort of equipment? Environmental science laboratories are definitely using such equipment[2], arguably representing one of the easier lateral market expansions a cannabis testing lab can take. Food and beverage analyses also depend on all those equipment types[3][4], as do other forms of testing such as agricultural testing[5][6], cosmetic testing[4][7], and petrochemical testing.[8][9] Assuming a lab has or can acquire the in-house expertise for analyzing all these related matrices, analytes, and molecules, as well as the regulatory know-how (e.g., Environmental Protection Agency testing methodologies) and licensing, expanding into other markets beyond cannabis testing may be a realistic long-term proposition.

If your lab is realistically considering this sort of market expansion, it's in your lab's best interest to consider a LIMS that is flexible enough to allow for the expansion of its portfolio of tests, protocols, workflows, and other laboratory management tools beyond those required for cannabis testing. Yes, a quality LIMS built for cannabis testing will offer preloaded cannabis testing protocols, labels, and analytical reports, as well as the ability to add new and customize existing protocols, labels, and analytical reports as standard methods and regulatory requirements evolve. Such a LIMS will also provide flexible specification limit sets for quality control, third-party system integrations with reporting and business solutions, instrument interfacing for all those chromatography and mass spectrometry devices, granular chain-of-custody, real-time alerts, issue tracking, and workload monitoring, to name a few. But all that functionality has important cross-over to environmental, food and beverage, cosmetic, and petrochemical analyses as well, including the ability to add and modify tests, protocols, and workflows associated with those analyses within the LIMS.

This brings up another significant question to consider in cannabis testing LIMS acquisition: how flexible is your LIMS? How configurable is it? How customizable is it, despite some base similarities in requirements with other testing markets? Aspects of a LIMS lending to an expansion into other markets include:

  • having the tools for creating and customizing sample registration screens for sample types beyond cannabis-related ones;
  • having the tools for creating new, compliant test protocols, labels, and reports, as well as for managing them as industries change;
  • offering sufficiently flexible protocol creation for adding most any specification limit sets, measurement units, substrates/matrices, etc.;
  • being able to integrate with instruments and software systems beyond those common to cannabis testing labs, including handling most any API thrown at it; and
  • having the functionality to help laboratories comply with the wide variety of standards and regulations found in other testing markets.

Even in 2021, as legalization efforts continue to march forward in the U.S. and standard methods continue to be developed, cannabis testing laboratories still face a number of challenges.[10] Using automation tools like a LIMS is one way to overcome those challenges, particularly as the cannabis testing space gets more crowded, driving prices downward.[10] However, you want to be sure the LIMS you choose is not only compatible with your budget but also able to tackle all your current and future testing needs, while helping you streamline processes and improve workflows. A sturdy LIMS capable of managing cannabis analyses while being flexible enough to allow your lab—whether you're an existing lab wanting to expand into other markets or a start-up lab eyeing broad horizons—to handle other analyses will be highly valuable in a time when the status of the fledgling cannabis industry continues to be in flux. In the end, no matter what type of lab you represent, your laboratory business model will be one to minimize risk while maximizing income. As such, diversifying into other markets with a flexible LIMS just makes sense.


References

  1. Department of Revenue, Marijuana Enforcement Division. CCR 212-1 "Medical Marijuana Rules - 1 CCR 212-1". Colorado Secretary of State. https://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=7094&fileName=1 CCR 212-1. Retrieved 07 July 2021. 
  2. Picó, Y. (2020). "Chromatography–mass spectrometry: Recent evolution and current trends in environmental science". Current Opinion in Environmental Science & Health 18: 47–53. doi:10.1016/j.coesh.2020.07.002. 
  3. Schieber, A. (2008). "Chapter 1: Introduction to Food Authentication". In Sun, D.-W.. Modern Techniques for Food Authentication. Elsevier. pp. 1–17. ISBN 9780123740854. 
  4. 4.0 4.1 Rasheed, D.M.; Serag, A.; Shakour, Z.T.A. et al. (2021). "Novel trends and applications of multidimensional chromatography in the analysis of food, cosmetics and medicine bearing essential oils". Talanta 223 (1): 121710. doi:10.1016/j.talanta.2020.121710. 
  5. Lipp, M.; Shilito, R.; Giroux, R. et al.. "Polymerase chain reaction technology as analytical tool in agricultural biotechnology". Journal of AOAC International 88 (1): 136–55. PMID 15759736. 
  6. Wacoo, A.P.; Wendiro, D.; Vuzi, P.C. et al. (2014). "Methods for Detection of Aflatoxins in Agricultural Food Crops". Journal of Applied Chemistry 2014: 706291. doi:10.1155/2014/706291. 
  7. Jannat, B.; Ghorbani, K.; Shafieynan, H. et al. (2018). "Gelatin speciation using real-time PCR and analysis of mass spectrometry-based proteomics datasets". Food Control 87: 79–87. doi:10.1016/j.foodcont.2017.12.006. 
  8. Khanmohammadi, M.; Garmarudi, A.B.; de la Guardia, M. (2012). "Characterization of petroleum-based products by infrared spectroscopy and chemometrics". TrAC Trends in Analytical Chemistry 35: 135–49. doi:10.1016/j.trac.2011.12.006. 
  9. Imam, A.; Suman, S.K.; Ghosh, D. et al. (2019). "Analytical approaches used in monitoring the bioremediation of hydrocarbons in petroleum-contaminated soil and sludge". TrAC Trends in Analytical Chemistry 118: 50–64. doi:10.1016/j.trac.2019.05.023. 
  10. 10.0 10.1 Cite error: Invalid <ref> tag; no text was provided for refs named KaulManag20