Book:LIMS Buyer’s Guide for Cannabis Testing Laboratories/Laboratory testing of cannabis and its derivative products/Certification and reporting of results

2.4 Certification and reporting of results

Providing accurate and timely results is an important part of any laboratory operation. Given the expanding regulatory atmosphere surrounding cannabis testing, and the need for cannabis consumers—especially medical marijuana users—to have a safe product to use, consistent and accurate testing is especially vital. By extension, the results must be certified as accurate and rapidly reported in a clear and concise fashion, not only to appease clients but also lawmakers and regulators. This means compliant certificates of analysis (COAs) and mandated results reporting to state and local bodies and their track-and-trace software platforms.

2.4.1 Certificates of analysis

As far as what precisely must appear on a COA or lab report, there's little in the way of standardization, though some U.S. states have outlined requirements for what must be included in such reports. The Oregon Health Authority's Oregon Administrative Rules, Chapter 333, Division 64, Section 0100: Marijuana Item Sampling Procedures and Testing stipulates that any report must include total THC and total CBD (by dry weight) and, if discovered, "up to five tentatively identified compounds (TICS) that have the greatest apparent concentration." It also lays out requirements for pesticides, failed tests, limits of quantification, and specimen identifiers such as test batch number.^[1] California dictates reported values for cannabinoids and contaminates be shown on the COA with three significant figures and water-activity level at two significant digits, as well as "pass" and "fail" statuses, demographics, sample history, test methods used, and more.^[2] Pennsylvania provides another example with its medical marijuana program (28 Pa. Code Chapter 1171), which includes a section on test results and reporting (1171.31). The regulations stipulate reporting by electronic tracking system, with stipulations on using certificates of analysis which include lot/batch number and the specific compounds and contaminants tested.^[3]

Regulations aside, it's largely up to the laboratory—and often by extension, the software they're using—to decide how a report is formatted. Some labs like Seattle-based Analytical 360 offer clean, color-based certificates of analysis, with high-magnification photographs, the chromatogram, potency, cannabinoid content, contaminant content, and explanation of limits, with the name of the approving analyst.^[4]^[5] Others may simply generate a computer printout with the basic data and a legend.^[6] Reports may originate from the measuring device itself (e.g., an integrator in a chromatography device), a middleware or data station attached to the instrument, or a LIMS that accepted data from the instrument.^[7]

Be sure to consult your state and local regulations to confirm what aspects are mandatory to include in your COAs.

2.4.2 Track-and-trace and chain of custody

RFID Tag for Medical Cannabis Plants in Colorado.jpg

At least in the U.S., given the federal status of recreational and medicinal marijuana, labs operating in cannabis-legal states still have to be particularly mindful of their operations for fear of breaking even a state or local regulation, potentially putting the lab out of business. Samples are tracked internally from receipt to distribution or destruction. However, it's often not enough to issue certificates of analysis and keep careful track of the cannabis samples that move in and out of the laboratory; sample activity must be tracked every single step of the way through laboratory workflows. This is particularly true in states that mandate track-and-trace (sometimes called "seed-to-sale") monitoring and reporting. In that case, keeping data siloed in the lab isn't an easy option to work with. States mandating the use of a particular track-and-trace software platform means either manually transferring data from the lab's systems—or, worst case, from the lab's paper documentation—to the mandated track-and-trace software. This is where integration between the lab's data management platform and the state's system proves useful.

Below are representative examples of the most commonly used track-and-trace software systems that cannabis testing laboratories are required to use and integrate with:

BioTrackTHC: As both a track-and-trace system and an enterprise resource planning (ERP) solution, BioTrackTHC streamlines data management and workflows from cultivation and processing to laboratory testing and dispensation. Compliance features include customized reporting to meet government-specific needs, tracking of destruction and waste activities, transport manifests, recall tracking, regulation labels, workflow management, and more. The software has also been adopted by state governments such as Illinois, Hawaii, New Mexico, and New York.^[8]

Leaf Data Systems: Similar to BioTrackTHC, Leaf Data Systems is used by both industry operators and government agencies trying to regulate the cannabis industry. The system can manage data at all points along the cannabis lifecycle, from cultivation and processing to distribution, testing, and sale. Leaf can handle customized reporting depending on state or municipality, as well as customizable alerting to ensure enforcement activities are effective. The software has been adopted by the governments of Pennsylvania and Washington.^[9]

Metrc: Developed by Franwell, Metrc represents another major solution used by not only businesses in the cannabis supply chain but also state and local governments. Special features include trend analysis, employee activity tracking, credentialing, and process metrics. States using it include California, Colorado, Massachusetts, Montana, and the District of Colombia, among others.^[10]

SICPATRACE: Perhaps less known in the U.S., the Swiss company SICPA has been involved in security inks and financial security for many decades.^[11] It introduced its SICPATRACE software in 2007 for governments to better "fight counterfeiting, illicit trade and tax evasion."^[11] It has since been adopted for regulatory activities involving tobacco, alcohol, and now cannabis. Among its technological features is the use of multi-layer label security that incorporates multiple ways to track and trace products, batches, and samples. In the U.S., SICPATRACE has been adopted by several California counties.^[12]

Also of note is the somewhat new concept of "tag-and-trace," the molecular application of DNA markers in a plant to allow for forensic tracking across the supply chain. Products like ETCH Biotrace may eventually also be part of the integrated workflow for cannabis testing laboratories.^[13]