RefWork:LIMS Buyer’s Guide for Cannabis Testing Laboratories/LIMS, informatics, and cannabis testing

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3. LIMS, informatics, and cannabis testing

Now that the tasks, equipment, and workflow of cannabis testing have been addressed, we can finally venture forth to discuss why and how data management software and laboratories make for a good marriage. We've discovered that not only is cannabis testing a highly regulated activity, but the regulations and standards surrounding that activity are scattered and inconsistent due in part to the dichotomy between state and federal approaches to cannabis. However, testing is valuable because it helps us learn more about the plant and its constituents, ensure the safety of products containing them, and improve a state of overall accountability of the cultivators and manufacturers. We've also looked at the analytical aspects of cannabis testing, from what gets tested to how it gets tested. The workflow of the cannabis testing lab has similarities across all lab types, though there are also many differences due to the substrate/matrix being tested, as well as the product's intended use. Those differences introduce additional testing challenges requiring unique workflows, procedures, and equipment. And how the results of all those tests get reported for both the client and the regulatory bodies introduces technical challenges. Despite all this, there are tools to help overcome all these challenges.

This chapter addresses how a well-crafted laboratory informatics solution like a laboratory information management system (LIMS)—particularly one developed with the cannabis testing laboratory in mind—can cut through the challenges of testing cannabis and securely manage all the data associated with the endeavor.

3.1 Informatics and automation in the cannabis testing lab

CBP Laboratories and Scientific Services (LSS), Springfield, Virginia - 44708018774.jpg

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.[1][2] 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.

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.[1][2][3] 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."[2] 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' ∆9‐tetrahydrocannabinol (THC) content.[4] And other laboratories are turning to a LIMS for automating laboratory workflows, sample management, document management, and other aspects of cannabis lab testing.[5][6]

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.[7][8] 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.

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?[9] 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?".

3.2 LIMS flexibility for cannabis testing and other markets

With a few minor exceptions (e.g., Colorado's limitation that "a Medical Marijuana Testing Facility shall not perform testing on Industrial Hemp"[10]), 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[11], 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[12][13], as do other forms of testing such as agricultural testing[14][15], cosmetic testing[13][16], and petrochemical testing.[17][18] 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.[1] 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.[1] 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.


3.3 Cannabis LIMS considerations

Programmer writing code with Unit Tests.jpg

Now that you have a rudimentary understanding of informatics in the cannabis testing lab, as well as the value of having a solution that is flexible, it's time to discuss the core of what makes a cannabis testing LIMS really shine. What are those vital features that distinguish a cannabis testing LIMS from an all-purpose solution? What challenges is the system truly poised to help you with in the lab?

A broad all-purpose LIMS will fill many a laboratory's needs; however, the cannabis testing laboratory requires a little more out of the LIMS it implements. A purposeful cannabis testing LIMS will address a number of important needs, described in Table 2.[19][20][21]

Table 2. What a purposeful cannabis testing LIMS will address for a lab
Cannabis testing need Details
Configurable sample registration screens optimized for the cannabis testing industry Even though some LIMS already provide the ability for users to define their own sample registration screens and fields, it doesn't necessarily mean the vendor will also include pre-loaded screens and preferences for a specific industry or scientific discipline. Those vendors tailoring sample registration screens and preferences specifically to cannabis testing lab requirements for launch-day deployment have a step up on other LIMS vendors.
Pre-loaded cannabis testing protocols, labels, and analytical reports End users of a cannabis testing LIMS will appreciate having a wide array of pre-loaded testing protocols, label templates, and report templates that support the testing of acid and neutral forms of cannabinoids, potency, strain, water activity, moisture content, pesticides, solvents, heavy metals, microbiological contaminates, fungi, mycotoxins, and foreign matter. This includes the ability to configure measurement units, as well as customize analytical reports such as certificates of analysis (COAs) for multiple state- and locally regulated testing scenarios.
Support for the creation and management of additional protocols, labels, and analytical reports As with pre-loaded protocols, labels, and analytical reports, providing users the ability to create and manage their own protocols, labels, and reports—including COAs—as the industry changes is critical.
Flexible specification limit sets for quality control A vital component of testing protocols that should not be overlooked is how flexible their test parameter/specification limit sets are. As regulations and standards concerning cannabis testing—across many different substrates/matrices—may change rapidly at the federal, state, and local level, adjustments to the limits declared within testing protocols must be easy to make. Additionally, the system should be capable of retaining older historic limit sets, such that past results can later be accurately linked to their original limit sets.[22] These limit sets can help improve quality control and the reporting of out-of-specification (OOS) samples and results.
Third-party system integration, with strong support for APIs for track-and-trace and other legally mandated reporting systems Seed-to-sale systems, like METRC, or other types of government-mandated reporting systems may have a web-based user interface (webUI) for manual entry of results data, or they may even support a .csv upload of data. However, manual entry of results can be time consuming and result in a higher likelihood of errors. As such, the more efficient way to report data to those types of systems is through more automated means, connecting your LIMS with a web-based application programming interface (API), typically provided by the vendor of the seed-to-sale or reporting software. This means the LIMS must either be pre-configured to connect with all the necessary APIs or be equipped to handle connection with any API.
Instrument integration with the instrument data systems common to cannabis testing From mass spectrometers and chromatography equipment to quantitative polymerase chain reaction (qPCR) systems and moisture balances, being able to accurately and securely transfer analytical data automatically improves turnaround time (TAT) and better ensures the accuracy of entered results (versus manual data entry). This is particularly important in the highly regulated industry that is cannabis testing.
Granular chain-of-custody at every step A seed-to-sale or "track-and-trace" system means always knowing the who, what, where, when, and how much of cannabis materials and related products in the industry life cycle. This concept is often referred to as the "chain of custody" of cannabis related material. This chain of custody is not limited to received cannabis samples, either; it also includes any subsamples and aliquots generated in the testing laboratory, as well as any disposed materials. As such, it's vital the LIMS be able to accurately document the chain of steps that received cannabis materials go through, from reception and retention to delivery and destruction.
Inventory reconciliation, including sample weight reconciliation Related to the "how much" of chain-of-custody tracking, sample weight reconciliation is an important element of avoiding regulatory violations.[23] The LIMS should be able to either automatically deduct sample and inventory quantities when consumed as part of a test (including subsamples and aliquots), or it should allow manual entry of such changes with background validation checks or warnings. For example, the system would need to clearly warn the user when attempting to pull more weight from a sample than exists, which would create a negative value.
Real-time alerts and issue tracking The requirement for maintaining quality testing outcomes for consumer safety and client satisfaction drives the need for prompt real-time alerts. Users must clearly and promptly be notified of errors and OOS results (via limit sets and other triggers) in order to, for example, identify health risks associated with a tested product or discover mislabeled product. These OOS results, as well as any other problems, should be tracked not only to notify clients but also to guide corrective action. Alerts and issue tracking are also useful for ensuring scheduled tasks are completed before they are due, or correcting processes if tests inadvertently become overdue.
Capacity and performance monitoring Whether an R&D cannabis lab or a quality assurance lab for cannabis, monitoring workloads, instrument allocations, scheduled tasks, OOS results, and any lab-specific performance indicators is vital for ensuring quick turnaround time (TAT), accurate results, productive workflows, and positive regulatory outcomes. Similar to issue tracking, capacity and performance tracking also help maintain quality testing outcomes and client satisfaction. Custom key performance measure (KPM) creation and management is also useful towards those efforts.
Strong data security and confidentiality When it comes to cannabis and protected health information (PHI), dispensaries are the most likely to require careful attention to consumer information.[24][25] However, that does not preclude laboratories from making strong efforts to protect sensitive personal data related to clients and their analyses (let alone to protect the lab's own validated methods and documentation). As such, cannabis testing labs should rely on a LIMS that uses industry-standard communication protocols and encryption methods to protect not only the data housed in the LIMS but also data moving in and out of it.
Accounting and billing support, including quoting and invoicing Carefully tracking expenditures and payments received related to cannabis activities is vital. This is especially true given that the non-hemp (low-THC) Cannabis plant is still technically illegal to grow and process in the eyes of U.S. federal law. As such, some business taking in money from cannabis-related activities have had problems with managing the financial aspects of their operations.[26][27][28][29] Given the remaining uncertainty of cannabis legalization in the U.S., and the natural benefits of managing accounting and billing within the LIMS, it makes sense that a LIMS should be able to accurately track receipts and more, down to the penny.
Secure web portal for client results review and test ordering Clients appreciate being able to submit test orders and view the results of their tests on a relatively independent basis. The secure web portal makes a useful time-saving and customer-friendly tool in that effort. However, the "secure" part of this requirement must be emphasized. Web-based attacks remain some of the most popular cybersecurity attacks, targeting the likes of online customer portals and WordPress sites for credentials and sensitive information.[30][31] As indicated previously, a vendor that focuses on strong data security will have an advantage in the implementation of such a web portal.
Functionality supporting ISO/IEC 17025, NELAC, ORELAP, ELAP, and Patient Focused Certification (PFC) compliance Cannabis testing laboratories and their necessary focus on quality is driven by standards and regulations, as well as accreditation to those standards and regulations. That burden can at times be heavy for laboratories, so having automation elements like a LIMS that provides functionality that assists with complying with those standards and regulations is immensely helpful. For example, ISO/IEC 17025 has a requirement that documents be managed in a specific way, an area where a well-designed LIMS is able to help.


3.4 Data privacy and management

Though "strong data security and confidentiality" was listed in Table 2 as a cannabis testing LIMS consideration, more should be said about that consideration. The security of data housed in the LIMS is paramount. Standards like ISO/IEC 17025 require it, as do laws and regulations in many U.S. states. But data security goes beyond complying with standards and regulations; it's an element found in broad areas of the cannabis industry itself.

3.4.1 Across the broad cannabis industry

In the fall of 2018, Canada legalized the purchase, growth, and consumption of marijuana in small amounts across the country.[32] Ahead of and after the official date of legalization, concerns were being raised about the protection of Canadian cannabis consumers' personally identifiable information (PII)[33], particularly in regards to data processed and stored in the United States.[34][35][36] In truth, comparisons of Canada's privacy laws with those of the United States existed well before the vote, with resources such as FindLaw detailing risks to any Canadian data transferred to the United States.[37] However, concerns grew that Ontario's mandated use of the e-commerce platform Shopify (until private retail outlets opened in April 2019) would put Canadian cannabis consumers' data at risk.[34][38] In particular, Canadian consumers remain worried that if their purchase history becomes available to United States government officials, who function in an environment of criminalization of cannabis use, they will not be allowed entry into the U.S. at minimum, or be treated as criminals upon attempting entry at worst. As such, some developers of cannabis data management software—such as Cova Software—have publicly acknowledged that any cannabis retail data for Canadian customers will remain in Canada "over and above the current legal requirements."[36] Yet even with data providers' intentions to follow Canadian privacy rules and recommendations, data breaches still occur, as happened with the Canada Post in November 2018.[33][39], further emphasizing the need for strict protocols and protections for cannabis consumer data.

In the United States, despite cannabis' federal prohibition, many states have been taking on various levels of legalization of cannabis. As Rachel Hutchinson of Foley Hoag LLP noted in March 2017, much like Canada, "[l]egalization has led to increased oversight and monitoring, as well as to the collection and storage of personally identifiable information ... [and the] threat of a federal crackdown leaves most customers resistant to creating any sort of paper trail."[40] In this sort of environment, where federal threats still exist, a patchwork collection of state-based laws have sprung up, including Oregon's Senate Bill 863, which prevents retailers of recreational cannabis from collecting and sharing customers' PII.[41] California has also implemented a variation of this type of protection for both recreational and medical cannabis consumers.[42] Of note is California's classification of medical marijuana identification cards as "medical information," which lends additional credence to the idea that medical marijuana consumers' PII held in dispensaries should be protected by U.S. Health Insurance Portability and Accountability Act (HIPAA) regulations.[43] However, without a unified policy and legal framework for cannabis use and its associated data, its difficult to foresee what future data collection and privacy regulations will look like in the United States. Despite this, some software development companies are betting on further demand for privacy of PII with the development of "personal privacy and HIPAA complaint cannabis consumer transaction solution[s]."[44]

Additionally, like Canada, concerns still abound concerning data privacy in the United States. Companies such as THSuite, LLC have already been found to inadvertently expose sensitive personal data—and possible even protected health information (PHI)—from multiple U.S. cannabis dispensaries, potentially violating HIPAA regulations.[24][25] As the anonymous author of the original report concerning THSuite points out, "most legal experts agree that dispensaries must follow HIPAA regulations just like any other health care provider," and even in a realm without legal risk, exposed data could mean "individuals may suffer backlash if their families, friends, and colleagues find out that they use cannabis."[24] Again, these issues firmly fall at the feet of the main problem of not having unified cannabis legislation, let alone not having a federally recognized legalized status of cannabis. With the unclear and mismatched state of law regarding cannabis user data protection, the onus still remain firmly with software developers and data managers in regards to thoroughly testing software and implementing (as well as enforcing) stricter controls such as encryption, intrusion detection, and authentication mechanisms.[25]

3.4.2 What this means for the lab

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While many cannabis testing laboratories won't be handling medical marijuana patient information, let alone dispensary sales information, lab managers must consider the data privacy issues of those realms and relate them to the data and workflows of the cannabis testing lab. What data must be protected? What standards must be followed to ensure that data's protection?

Take for example ISO/IEC 17025:2017, item 8.4.2, which requires a lab to have "controls" in place "for the identification, storage, protection, back-up, archive, retrieval, retention time, and disposal of its records."[45] The long-term implication here is that data should be clearly identified, securely stored, backed up and archived, and have clear information about their retention and disposal. The data should be thoughtfully "controlled" so it doesn't get lost or fall into the wrong people's hands. This is further evidenced by ISO/IEC 17025:2017, item 7.11.3, which calls for the data to be "protected from unauthorized access" and "safeguarded against tampering and loss."[46]

As such, it's obvious that cannabis testing labs, at a minimum, have to take data privacy and management seriously to stay in step with the ISO/IEC 17025 standard. That of course doesn't take into consideration any regulatory requirements for chain of custody and certificates of authority to be preserved by the lab for a specific period of time, nor does it account for any proprietary methods and business details that could potentially harm a lab in the wrong hands. Just like the personal health information of medical marijuana patients, and like the customer information of dispensaries, cannabis testing labs are charged with ensuring the security and privacy of the data they collect and manage.

To meet those requirements and more, a LIMS that includes functionality that helps labs support ISO/IEC 17025:2017, NELAC, ELAP, and Patient Focused Certification (PFC) requirements makes for a wise investment. Cannabis testing workflows can be difficult, as is the management of associated analytical instruments and their data. Throw in the complication of a semi-fractured regulatory atmosphere, and the cannabis testing lab is forced to operate with tight, enforced procedures to ensure not only the quality of tested cannabis substances but also the chain of custody of samples that come into the lab's possession. A LIMS that can carefully and automatically collect, manage, track, retain, and archive operational data—as well as the audit trails associated with those activities—is required to better maintain the security and privacy of that data, as well as the long-term viability of the lab.[20]

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Citation information for this chapter

Chapter: 3. LIMS, informatics, and cannabis testing

Edition: Summer 2021

Title: LIMS Buyer’s Guide for Cannabis Testing Laboratories

Author for citation: Shawn E. Douglas

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: August 2021