Tag Archives: hand

August 12, 2021

Reducing Cross Contamination in Your Lab

By Nathan Libbey

Cross Contamination

Cross Contamination – noun – “inadvertent transfer of bacteria or other contaminants from one surface, substance, etc., to another especially because of unsanitary handling procedures. – (Mariam Webster, 2021). Cross contamination is not a new concept in the clinical and food lab industries; many facilities have significant design aspects as well as SOPs to deliver the least amount of contaminants into the lab setting. For cannabis labs, however, often the exponential growth leads to a circumstance where the lab simply isn’t large enough for the number of samples processed and number of analytical instruments and personnel needed to process them. Cross contamination for cannabis labs can mean delayed results, heightened occurrences of false positives, and ultimately lost customers – why would you pay for analysis of your clean product in a dirty facility? The following steps can save you the headaches associated with cross contamination:

Wash (and dry) your hands properly

Flash back to early pandemic times when the Tik Tok “Ghen Co Vy” hand washing song was the hotness – we had little to no idea that the disease would be fueled mostly by aerosol transmission, but the premise is the same, good hand hygiene is good to reduce cross contamination. Hands are often the source of bacteria, both resident (here for the long haul; attached to your hands) and transient (easy to remove; just passing through), as they come into contact with surfaces from the bathroom to the pipettor daily (Robinson et al, 2016). Glove use coupled with adequate hand washing are good practices to reduce cross contamination from personnel to a product sample. Additionally, the type of hand drying technique can reduce the microbial load on the bathroom floors and, subsequently tracked into the lab. A 2013 study demonstrated almost double the contamination from air blade technology versus using a paper towel to dry your hands (Margas et al, 2013).

Design Your Lab for Separation

Microbes are migratory. In fact, E. coli can travel at speeds up to 15 body lengths per second. Compared to the fastest Olympians running the 4X100m relay, with an average speed of 35 feet per second or 6 body lengths, this bacterium is a gold medal winner, but we don’t want that in the lab setting (Milo and Phillips, 2021). New lab design keeps this idea of bacterial travel in mind, but for those labs without a new build, steps can be made to prevent contamination:

Try to keep traffic flow moving in one direction. Retracing steps can lead to contamination of a previous work station
Use separate equipment (e.g. cabinets, pipettes) for each process/step
Separate pre- and post-pcr areas
Physical separation – use different rooms, add walls, partitions, etc.

Establish, Train and Adhere to SOPs

Design SOPs that include everything- from hygiene to test procedures and sanitation.

High turnover for personnel in labs causes myriad issues. It doesn’t take long for a lab that is buttoned up with cohesive workflows to become a willy-nilly hodgepodge of poor lab practices. A lack of codified Standard Operating Procedures (SOPs) can lead to a lab rife with contaminants and no clear way to troubleshoot the issue. Labs should design strict SOPs that include everything from hand hygiene to test procedures and sanitation. Written SOPs, according to the WHO, should be available at all work stations in their most recent version in order to reduce biased results from testing (WHO, 2009). These SOPs should be relayed to each new employee and training on updated SOPs should be conducted on an ongoing basis. According to Sutton, 2010, laboratory SOPs can be broken down into the following categories:

Quality requirements
Media
Cultures
Equipment
Training
Sample handling
Lab operations
Testing methodology
Data handling/reporting/archiving
Investigations

Establish Controls and Monitor Results

Scanning electron micrograph shows a colony of Salmonella typhimurium bacteria. Photo courtesy of CDC, Janice Haney Carr

It may be difficult for labs to keep tabs on positivity and fail rates, but these are important aspects of a QC regimen. For microbiological analysis, labs should use an internal positive control to validate that 1) the method is working properly and 2) positives are a result of target analytes found in the target matrix, not an internal lab contamination strain. Positive controls can be an organism of choice, such as Salmonella Tranoroa, and can be tagged with a marker, such as Green Fluorescent Protein in order to differentiate the control strain. These controls will allow a lab tech to discriminate between a naturally contaminated specimen vs. a positive as a result of cross-contamination.

Labs should, in addition to having good QC practices, keep track of fail rates and positivity rates. This can be done as total lab results by analysis, but also can be broken down into customers. For instance, a lab fail rate for pesticides averages 4% for dried flower samples. If, during a given period of review, this rate jumps past 6% or falls below 2%, their may be an issue with instrumentation, personnel or the product itself. Once contamination is ruled out, labs can then present evidence of spikes in fail rates to growers who can then remediate in their own facilities. These efforts in concert will inherently drive down fail rates, increase lab capacity and efficiency, and result in cost savings for all parties associated.

Continuous Improvement is the Key

Cannabis testing labs are, compared to their food and clinical counterparts, relatively new. The lack of consistent state and federal regulation coupled with unfathomable growth each year, means many labs have been in the “build the plane as you fly” mode. As the lab environment matures, simple QC, SOP and hygiene changes can make an incremental differences and drive improvements for labs as well as growers and manufacturers they support. Lab management can, and should, take steps to reduce cross contamination, increase efficiency and lower costs; The first step is always the hardest, but continuous improvement cannot begin until it has been taken.

References

Margas, E, Maguire, E, Berland, C. R, Welander, F, & Holah, J. T. (2013). Assessment of the environmental microbiological cross contamination following hand drying with paper hand towels or an air blade dryer. Journal of Applied Microbiology, 115(2), 572-582.

Mariam Webster (2021. Cross contamination. Retrieved from https://www.merriam-webster.com/dictionary/cross%20contamination

Milo, M., and Phillips, R. (2021). How fast do cells move? Cell biology by the numbers. Retrieved from http://book.bionumbers.org/how-fast-do-cells-move/

Robinson, Andrew L, Lee, Hyun Jung, Kwon, Junehee, Todd, Ewen, Perez Rodriguez, Fernando, & Ryu, Dojin. (2016). Adequate Hand Washing and Glove Use Are Necessary To Reduce Cross-Contamination from Hands with High Bacterial Loads. Journal of Food Protection, 79(2), 304–308. https://doi.org/10.4315/0362-028X.JFP-15-342

Sutton, Scott. (2010). The importance of a strong SOP system in the QC microbiology lab. Journal of GXP Compliance, 14(2), 44.

World Health Organization. (2009). Good Laboratory Practice Handbook. Retrieved from https://www.who.int/tdr/publications/documents/glp-handbook.pdf

July 14, 2020

What Cannabis Businesses Need to Do to Adapt to COVID-19

By Arthur Gulumian

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How COVID-19 Impacted Cannabis Businesses

Before jumping into what cannabis businesses can do amid this pandemic, it is crucial to explore the specifics behind how the virus impacted the industry as a whole. From a surface level, it seems obvious what happened: dispensaries had to implement social distancing protocols, require both customers and employees to wear masks and limited the number of customers that can be present on the point-of-sale floor room. But COVID-19 did not merely make shopping experiences a tab bit inconvenient.

Cannabis producers, and especially those involved in manufacturing cannabis goods, experienced an apparent disruption in their production schedules. If the metals and plastics were sourced from Wuhan, Shenzhen or any other dense industrial area in China, supplies suddenly stopped coming, and producers were left with limited production options. Businesses did not consider the value of having various vendors and instead put all their stock in one source. A disruption in production inherently impacts dispensaries.

COVID-19 impacted more than just supply chains, however. For instance, investors are now less likely than before the pandemic to invest in early-stage cannabis companies. Competition for capital now far outweighs the supply for cannabis companies, and we have seen (and will continue to see) a drop in company valuations. Indeed, COVID-19 is affecting more than just currently existing operators but those yet struggling to create cannabis businesses of their own.

Vendors & Supplies

A broad survey conducted by the Institute for Supply Management (ISM) between February 22, 2020 and March 5, 2020 found that 75% of U.S. companies had experienced supply chain disruption as a result of the COVID-19 outbreak. An estimated 90-95% of all components utilized in cannabis vaporizer pens were sourced from manufacturers in Shenzhen, China. In contrast, very few companies used domestic manufacturers. While this is just one example, it is equally important to note that cannabis-specific equipment and supply shortages were not the only factors that disrupted cannabis businesses. Shortages of personal protective equipment (PPE) presented challenges for cannabis dispensaries, producers and manufacturers that continued to operate during the “shelter in place” orders.

Operators must establish a resilient supply chain. Do not simply limit your options to one specific region, as this can be a costly mistake. Operators must cultivate an in-depth understanding of their supply chain beyond critical suppliers and their stress points; they need to develop and follow a systematic supply process that takes potential disruptions and stress points into account. When vetting potential vendors, always ask detailed questions that elicit evidence-backed responses. Ask vendors where they source their materials from, whether they have any history of experiencing disruptions in their supply chain and what kind of setbacks they have suffered as a result of COVID-19.

Investing in Your Core Business

In light of COVID-19, operators must invest in solutions that increase efficiency and improve the customer’s experience. This entails ensuring your customer safely enters and leaves your dispensary with a product they are satisfied with—the essence of any retail operation. Your operation should focus on enhancing customer flow as opposed to encouraging aimless roaming. Having an open-space, Apple store style dispensaries might have been a popular option before, but times have changed, and dispensaries must adapt.

Guided purchases offer not just more efficient transactions, but also serve to ensure that your waiting room isn’t backed up with an endless stream of unmanageable customers. Depending on your locally-mandated COVID-19 protocols, your dispensary will likely not be permitted to hold a high number of customers in the store, nor should it during this pandemic. Each customer service representative must be active as opposed to passive, directly asking customers what they are interested in, offering product or strain choices when customers seem unsure and answering questions as thoroughly as possible to avoid confusion and inherently delays. Be sure to emphasize the value of guided purchases to your employees and how they can promote the safety of both themselves and their customers.

Maintaining Urgency

The uncertainty of COVID-19 and its impact on the general economy has left many individuals “clocked out.” Simply put, many people feel that they should wait until things go back to normal before making any critical decisions. As essential businesses, cannabis operators cannot afford to make this same mistake. Now is not the time to sit back, reflect and wait for the vaccine. Instead, operators must work to precisely assess how COVID-19 impacted their business and execute a clear plan of action to address foreseeable problems.

Execution is far more important than perfection; you’ll need to make changes on a dime and avoid spending excessive hours obsessing over debating specific actions rather than taking them. It is far more essential to get tasks done versus ensuring they are perfect. If something is not working in your business, it must be readdressed or removed entirely from the protocol. It is far better to make necessary changes now amid the pandemic as opposed to reactively waiting and seeing what may come next following it.

Stay nimble by cutting out any factors that may be slowing down your company’s efficiency. Is your point-of-sale system causing issues? Can you use a better payment processing tool? Are any employees underperforming? Are there any internal policies that may be hindering your employees’ ability to work as optimally as possible? These are some of the many factors that must be considered to ensure your business stays agile and adaptable. Determine what is working against you and execute a plan of action to address. Do not wait and do not take shortcuts around regulations.

Understanding the Shift in Purchasing Behavior

Regardless of whether or not a vaccine for COVID-19 is completed anytime soon, operators must know that there is no “returning to normal.” People’s habits and behaviors have changed due to this virus, whereas slow browsing of items might have been preferable for some individuals before COVID-19; this is likely not the case today. Furthermore, research groups like Accenture have found that most customers expect their shopping habits to change permanently.

Source: Accenture COVID-19 Consumer Research, conducted April 2–6. Proportion of consumers that agree or significantly agree.

In the study mentioned above, shopping more consciously is one of the two top priorities for customers during this pandemic. According to Accenture, “[c]onsumers are more mindful of what they’re buying. They are striving to limit food waste, shop more cost consciously and buy more sustainable options. Brands will need to make this a key part of their offer (e.g., by exploring new business models).” Furthermore, customers are now more likely to shop locally; this is why community engagement would be especially important to ensure you develop transparency and trust between your brand and your customers. Understanding this shift in purchasing behavior will remain one of the more crucial tasks of any cannabis operator.

Expanding Sales Avenues

More and more customers are now relying on online and curbside purchases than ever before. Dispensaries must look to their current sales avenues and determine where key focuses should be made. Use your sales data to determine where customers are making their purchases the most, be it through third-party delivery services such as Eaze, standard home delivery, online ordering or curbside pickup. Focus on identifying friction and streamlining the user experience on all customer-facing platforms and services. Equally, consider which platform your customers are using the most to make purchases; are they making more online purchases, or do most still prefer direct shopping at the store? Remember that having more products doesn’t necessarily mean more revenue. You must also identify which products are performing well and which have low margins.

These considerations can help strengthen your highest performing platform while working to fix any more inferior performing platforms. As stated before, stay nimble; if something is not working out, cut it out from your business model, and move forward. Do not be afraid to cut poor-performing platforms to hone your focus on the successful ones. Since post-COVID-19 shopping behavior is likely to stay permanent, these changes may still be applicable following a slowdown or cessation of the virus.

Delighting Your Customers

Virus or not, customer satisfaction remains one of the most crucially defining points for the future of your business. Your customers must be safe and must be happy with their purchase. To ensure this outcome, you need to maintain adequate safety policies while equally promoting streamlined purchases. Although a limited number of individuals may be annoyed with over-the-top safety precautions, most customers will enjoy the heightened security that comes alongside these types of measures.

Contactless service, such as having customers scan their identification upon entry or encouraging more credit card versus cash transactions, can increase customer satisfaction, as they will feel a stronger sense of security when shopping at your dispensary. Focus on streamlining curbside pickup. Things such as requiring vehicle descriptions (e.g., license plate numbers, color, make) for curbside pickup purchases can go a long way in helping employees quickly identify customers.

Equally, be sure there is hand sanitizer available near the entrance of your dispensary. This adds a further sense of security for your shoppers. Delivery should be consistent; delays and setbacks must be minimal to win the confidence of your customers. Take the extra steps to ensure your dispensary is clean and products hygienic. All these factors work to increase customer satisfaction while maintaining their safety, and more importantly, impact the level of trust your customers have in association with your brand.

Scaling Operations Taking Advantage of Limited Competition in Emerging Markets

As stated before, several individuals—including existing and emerging cannabis businesses—are clocked out following COVID-19. This mindset is not only detrimental for operations but can also impact how you scale your business. New markets are coming online and will continue to do so as regulators are increasingly incentivized to replenish government coffers. Riverside County in California, for instance, is now allowing for capless licenses for all cannabis business types. However, what remains the key focus for regulators is expanding the number of delivery and distribution operators. In Massachusetts, delivery endorsements for dispensaries are available without a set deadline to social equity applicants and do not have a defined cap. In Illinois, the cap for transporters was equally removed, and each applicant who scores above 75% will receive a license.

These types of licenses are now more valuable than ever before for two reasons. The first reason is that regulators are keener to award delivery and transporter licenses than other types. Secondly, customers now prefer home delivery over shopping in stores due to COVID-19. With more people clocked out during these times, you have far more opportunities and far fewer competitors during application processes. Use this time to truly develop a strategy for expansion, as the chance might not come so quickly again.

Conclusion

As a final point, be sure to expand your online presence during this time. Although you may not have the capacity to reflect your company’s personality and value through quick in-store transactions, you can use social media to encourage product reviews, social interactions, and recommendations. Invest in marketing through social media platforms. Platforms such as TikTok have helped form communities of like-minded individuals. Use platforms such as that to highlight your company’s personality and values, avoid being “salesy” and focus more on being funny, entertaining and just alive. Character adds value to your business.

People want to laugh, to feel safe and they want to live. Create social interactions and immersion and always prioritize being honest and transparent with your customers. This final point stands as equally as important as the rest of the considerations highlighted throughout this article. Stay nimble, stay active and stay alert! Do not view the chaos behind this pandemic as a pit, and instead see it as a ladder. Track down opportunities, do not be afraid of change, and, more importantly, do not wait for an answer to COVID-19, be the answer.

May 27, 2020

Priorities During the Pandemic: How to Run a Lab Under COVID-19

By Dr. Peter Krause, Udo Lampe

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During the COVID-19 pandemic, most testing laboratories have been classified as relevant for the system or as carrying out essential activities for national governments. Therefore, it is crucial to maintain activities and optimally assess the changes that are occurring, framed within the spread of the SARS-CoV-2 virus. Analytica Alimentaria GmbH, a testing laboratory with its headquarters in Berlin, Germany and a branch office in Almeria, Spain, decided to focus its management on the analysis of events and the options available, at the legal and employment level, to ensure continuity of activities and reducing, as much as possible, the damage for the parties involved: employees and company. Accredited by the International Accreditation Service (IAS) to ISO/IEC 17025:2017, Analytica Alimentaria GmbH is required to implement risk-based thinking to identify, assess and treat risks and opportunities for the laboratory. Since March 12, 2020 a crisis committee was established, formed by the six members of the company’s management, covering general management, human resources, direction of production, finance and IT. The committee meets every day and it intends to:

Minimize the risks of contagion
Be able to continue providing the service required by our clients
ensure that the company as a whole will survive the economic impact of the crisis
Take measures that are within the legality of both countries where the laboratory operates (Spain and Germany),
Manage internal and external communication related to the crisis

To achieve correct decision making, daily meetings of the committee were established, to review the situations that were presented day after day and the actions that should be carried out. Each decision was analysed in a prioritized, objective, collaborative and global way.

The basis of the lab’s action plan was a well-developed risk assessment. In addition to the risk of getting a droplet or smear/contact infection with the coronavirus SARS-CoV-2 (risk I) by contact with other people, psychological stress caused by changing working conditions (home office), contact options and information channels were also identified (risk II).

As a result of the risk assessment, the conclusion was that a mix of various measures is the best form of prevention:

Keep distance
Avoid “super spreader” events
Personal hygiene
Regular communication between managers and personnel about the current situation and possible scenarios

The risk assessment took both areas into account. The following assessment was developed together with an external specialist and focused on risk I:

Risk I	Assessment	Protective measures / hygiene plan
Organisation
Working hours and break arrangements	High	Limit the gathering of people and ensure a minimum distance: Relocated work, break and mealtimes Create fixed groups of shift-working staff Time gap of 20 min. between the shifts Enable home office wherever it is possible
Third party access	Moderate	Few but “well-known” visitors: Reduce the number of visits and keep internal contacts to a minimum Ensure the contact chain Inform visitors about the internal rules and obtain written consent
Dealing with suspected cases	High	Isolation and immediate leave of the company: Contactless fever measurement (in case of typical symptoms) Leave the company or stay at home If the infection is confirmed, find contact persons (including customers or visitors) and inform them about a possible risk of infection
Contact with other persons
Traffic route from home to work	Moderate	Avoid public transportation: Take a car, bicycle or go by foot Enable mobile work and teleworking
At work	High	Always keep a sufficient distance of 2.0 m from people: If minimum distances cannot be maintained, wear protective masks or install physical barriers (acrylic glass) Organize traffic routes so that minimum distances can be maintained (one-way routes, floor markings indicating a distance of 2 m) Use digital meetings instead of physical ones
Sanitary facilities	Moderate	Remove virus-loaded droplet as often as possible: Provide skin-friendly liquid soaps and towel dispensers Shorten or intensify cleaning intervals Hang out instructions for washing hands at the sink Include instructions for proper hand-disinfection
Canteens, tea kitchens and break rooms	High	One person per 10 m² = minimum: Reduce the number of chairs per table Informative signs in every room, indicating the maximum number of permitted persons
Ventilation	High	Diluting or removing bioaerosols (1 µm virus-droplets): Leave as many doors open as possible Regular and documented shock ventilation every 30 minutes or more frequently, depending on the size of window Operate ventilation and air-conditioning systems, since the transmission risk is classified as low here
Use of work equipment	Moderate	Use tools and work equipment for personal use: Regular cleaning with changing use (PC, hand tools, coffee machine, …) If possible, use gloves when using equipment for a larger number of users
Protective masks	Moderate	Use of protective masks as an additional measure, indicating that this does not replace keeping distance Recommend wearing masks in commonly used areas and explain that they do not protect yourself, but help to protect others Give clear instructions (written and oral) on how to use a mask correctly and explain the use and purpose of different mask-types Distribute masks freely

A number of guidelines and concrete measures addressing the risks related to health issues are already in place. Those health issues in risk group II are more closely related to the psychological effects of the crisis, however, are also more complex to mitigate. The key strategy is communication and, in particular, actively listening to all employees of the company.

Analytica’s robust company culture, based on values established in coordination with the whole staff, has been of significant help during the crisis. The some 150 staff members are organized by over 22 team coordinators. During the crisis, active communication has been intensified significantly. The crisis management team set up regular alignment meetings with all the coordinators and with individual persons with particular situations. This way, not only was it possible to explain the development of the crisis and the subsequent measures, the conversations with coordinators were also the most important source of information enabling the appropriate decisions. The coordinators, closely aligned and in sync with management, were then able to communicate with their team members with a high degree of confidence. One outcome of the communication was a measure that proved very effective in fortifying trust within the company: all measures and evaluations, as well as a chronological review, are published in a dynamic internal report and are made available, with full transparency, to all staff members. Besides the many individual and group alignment meetings (usually held by video conference), this has been a key measure to establish confidence and security within the company.

On the other hand, the company made a great effort to balance the effect of the general closure of kindergartens and schools in Spain and Germany. Each case where staff members were required to care for children at home was studied individually and agreements were established, adapting shifts and making use of time accounts, to allow childcare at home without significant loss of income.

The success of the measures is shown by the continuous work of both laboratories during the crisis. Besides the personal tragedy of a possible infection, the identified risk to the company has the consequence of a (partial) quarantine due to an infected person in contact with the staff and the consequent loss of work-power which might lead, in extreme cases, to a closure of the laboratory. According to the governmental regulation in Germany, if an infection occurs (confirmed by the health department), contact persons cat. 1 (more than 15 min. contact face to face) are identified and sent to quarantine. Other contact persons, e.g. contact persons cat. 2 (same room without face to face) must be identified quickly with the collaboration of the infected person and notified and, if necessary, sent in quarantine. In this case, there is a confirmed emergency plan that maintains the laboratory’s ability to work, defining replacements and alternative work-flow strategies.

It has been part of our strategy to validate all our measures with the relevant guidance documents made available by the official competent institutions. The German Federal Office for Public Safety and Civil Protection (Bundesamt für Bevölkerungsschutz und Katastrophenhilfe) has published a guide, “Crisis Management in Companies, 9-point Checklist” especially for critical infrastructure companies in the CoVid-19 crisis.

Having been classified as a core business enterprise (Spain) and “relevant to the system” (Germany), we consider it important to use them as a reference to confirm our level of alignment with your proposal for crisis management.

An important effect, relevant to any leader in times of crisis, is that the confirmation of all points of such a checklist provides certain peace of mind regarding the question: Have we done everything we could?

April 29, 2020

Essential Cannabis Businesses Must Protect Employees and Customers During COVID-19 With Sanitation and Social Distancing Practices

By David Laks

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Unlike their retail neighbors who have been forced to move inventory online to survive, many cannabis businesses are considered essential and remain open during the current pandemic. With that, though, comes a tremendous responsibility to maintain optimal protocol for safe operations and customer shopping.

Whether you run a retail or production operation, allow only essential vendors (i.e. delivery, service companies) into the facility and have non-essential staff telecommute, when possible. Some businesses may want to consider splitting shifts for the management team as well.

Each state and local municipality will have their own rules when it comes to protocols for open retail establishments. Where those are more stringent than the following recommendations, adhere to the more stringent rule.

Cannabis Production Facility Best Practices

While not being face-to-face with cannabis customers on a daily basis, production facilities are the first and possibly only ones to handle the raw product the customer will eventually consume. For this reason, it’s important to conduct a refresh training session on sanitation procedures and new COVID-19 protocol for all production employees. Consider the following critical procedures for cannabis production facilities:

Review current production sanitation procedures and adjust accordingly, focusing on high touch points and potentially contaminated surfaces. Include office items such as keyboard, phones, and kitchen areas.
Review the business’ call-in sick policy and make sure employees know they can – and should – do so if they’re under the weather.
Sanitize high touch points every 30 minutes or less.
Instruct employees to wash hands with soap and water for 20 seconds after blowing their nose, coughing, sneezing, going to the bathroom, before eating and when touching any communal surface, including door handles and surfaces. Wear personal protective equipment (PPE) at all times while working with raw product, including gloves and masks.
PPE can reduce the risks of spreading disease
If an employee coughs or sneezes in a production area, instruct them to do so into the elbow of their outer garment, and immediately change following proper donning techniques. Instruct them to avoid touching their face.

Cannabis Retail Facility Best Practices

Retail cannabis establishments must realize first and foremost that those with compromised immune systems may be frequenting their store to purchase medical cannabis. Consider, evaluate and appropriately publicize protocol relative to employee interactions with customers, including:

Enable mobile or order-ahead features along with curbside pickup and contact-less delivery, when possible. Where this isn’t an option, limit the number of customers in the store at a time.
Consider moving to appointment-only operations, or restricted hours for those over 65.
Reduce store visits by recommending patients order their prescription for the maximum allowable 60 days.
Designate an employee to champion personal sanitation and social distancing. Create an entry sanitation station and require all customers to use it upon entry. Maintain social distance of 6-ft. minimum between customers. Place markings on the floor to designate this.
Limit sales to only sealed products.
Sanitize high touch points twice an hour, including ID check booths, display cases, phones, keyboards, etc. and provide adequate PPE for all, including gloves, masks, etc.
Install separation barriers, like thick plastic or plexiglass at each cashier station.

The requirements of keeping an essential business open will vary by location and will likely change as the COVID-19 pandemic evolves. Regularly check for changes to the rules of your local jurisdiction and adapt accordingly.

April 21, 2020

Turning Over A New Leaf: Faces of Courage In A Pandemic

By Marguerite Arnold

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The cannabis industry is not immune from global setbacks. Discussions about how resistant the vertical is to this (next) setback have been widely disseminated, from mainstream news to the blogosphere.

Yes, the UN punted global reform down the pike another 9 months – affecting the international industry. And so far, the entire vertical has been left out of the relief bill in the United States (although there are lobbying efforts everywhere to correct the oversight on subsequent bills now almost inevitably in the legislative hopper).

However, there are signs that the industry is actually gaining credibility if not forging new victories during a time likely to go down as this century’s “Great Depression.”

Here is a look at some of the trends afoot that are already bearing fruit and bringing relief.

Cannabis Business Is Essential Business

Some important battles have been won in many states in the U.S. as well as several other countries (including but not limited to Canada). This starts with the designation of the industry as “essential,” at least on the medical side. The issue of delivery and cashless payments have been on the front burner just about everywhere. And this time, there are few if any objections with a national lobby to voice said concerns.

In Europe of course the conversation is also different depending on where you are, but there are still signs that things are clearly changing.

In the UK, authorities have made it easier for cannabis importing. In Germany, pharmacies are on the front line in a way unseen just about anywhere else.

And in Spain, with most patients reliant on cannabis clubs, the lockdown and subsequent hardship for the most vulnerable has led to widespread calls to make deliveries a possibility. Even if the clubs are not functioning as “lounges,” their operators might not get fined for opening their doors, much less “importing” product from the outskirts of town to a central distribution point.

Pivoting To Respond In Times Of Crisis

It is impossible to forget that the emergent industry has been on the forefront of the medical industry and certified production for a long time, even if that, at least up to this point, has received little respect.

Health Canada has asked testing labs to repurpose their activities for Covid-19 testing.

Canadian and American producers are also on the front lines of providing PPE (personal protective equipment) that can be multi-purposed. Masks, gowns and gloves have all been donated from multiple companies. Others are literally repurposing ethanol used for extraction to make hand sanitizer for vulnerable populations. More than a few, including in Europe, have directly been involved in helping to fundraise for foodbanks.

GMP Licensing and Other Developments Still Cooking

While some companies waiting for certification have been stymied because of a lack of foreign travel (EU-GMP requires German inspectors to travel to Canada for example), there are other indications that global companies are finding the way through anyway.

New deals are being inked all over the planet, including international provision deals from unlikely places. This is in part because new export and sales channels are being forged – literally out of desperation. See the story of Little Green Pharma and Astral Health, an Australian company now exporting to the UK (a first). Or the New Mexico company Ultra Health, which just started to export to Israel. Not to mention the source of Israel’s other international purchase of cannabis this month – from Uganda of all places.

Down under, things are certainly developing in an interesting way during the crisis. Indeed, New Zealand decided to proceed with its own cannabis cultivation, with signs that more reform is on the agenda for later in the year.

Back in the Northern Hemisphere, North Macedonia, home of one of the most developed cannabis economies adjacent to Europe, is literally one amendment away from entering the European and global business with flower as well as extracts (which is on the table this month as the government begins to reconvene.)

In summary, while times are tough, everywhere, the entrepreneurs who have forged their way through laws of man to create reform, are also showing up to battle against this century’s so far most emergent threat.

March 31, 2020

Soapbox

Home Office HACCP During COVID-19

By Nathan Libbey

1 Comment

With much of the world shutting down and many of us forced to take refuge behind our own doors, we have some time to reflect on what actions led to this. There has been, in my opinion, a clear disconnect between our actions and health outcomes. We need to bridge this gap; We now have a moment to build that bridge. We can start by reassessing our endpoint measurement of health and disease and focusing on what leading measures will impact our lagging results. Think of it as HACCP-lite or home office HACCP. Small changes in the way we think and behave can lead to significant change.

Lagging measures – Lagging measures make great headlines and typically measure an outcome. These are easily quantifiable and therefore receive a good deal of the focus.

Leading measures – Leading measures are inputs that happen during the process and in advance of an outcome. Leading measures are often difficult to quantify.

This week, Nathan started a “Germ Jar” activity with his kids to track washing.

We are currently focused on the lagging measures for a communicable disease, COVID-19. Illness and death numbers stemming from the pandemic continue to rise, as is expected with more available testing. It is easy for us to dwell on these numbers as they climb and dominate the news. A study in Australia last decade indicated that just over 1% of those experiencing flu like symptoms sought treatment and eventually got tested. I’m not going to use the tip of the iceberg cliché, but there it is. Focusing on the rapidly rising rates of COVID may be easy to do, but it won’t help our future selves.

What we should be doing during this time, however, is looking at our own leading behaviors and how changing them can help prevent this situation from reoccurring.

Here are some inputs we can rethink:

Hand washing – The average American uses the restroom 6-7 times per day. This week I started a “Germ Jar” activity with my kids (spring break week!) to track washing. If we wash our hands every time we use the restroom and every time we eat, that’s roughly 10X per day. Our leading indicator of household health, then, is 10 hand washes per day. This principle can, and should be applied to workplaces, including schools, airports and hospitals. What if we had mandatory handwashing prior to airport security and boarding? My estimation is that data would indicate a sharp decline in illness and transmission rates.
Disinfecting/Sanitizing – Similar to hand washing, cleaning surfaces serves as a vital indicator of future health. Examples, such as this District in Freeport, Il, indicate that increasing frequency of disinfecting can lead to a dramatic decrease in numbers sick. In my new office setting, we have set a goal via the Germ Jar of 3 times per day wiping down high touch surfaces. As we reenter close-proximity society, we need to have a better understanding of what high touch surfaces are, both for those who are tasked to clean them, as well as those that are doing the touching. Reduction of touches coupled with above washing behaviors post-touch can help prevent disease transmission.
Nathan’s daughter adding to the Germ Jar
Monitoring – Lastly, we need to do a better job at monitoring ourselves and our environments. In my new office, we have enacted a temperature check every morning and night. If we practiced symptom reporting (coughing, sneezing, chills) and monitored temperature in other settings, such as offices and schools, could we start to see pockets of infection and trends? Taking it a step farther, while we invest a tremendous amount of time and money into protecting our food supply from foodborne illness, we rarely discuss preventive monitoring for other diseases, such as influenza and now COVID-19. Technologies are rapidly coming available that will allow us to perform quick diagnostics of both individuals and environments. If we were to monitor the air and surfaces of a school nurse’s office, would we find data that could prevent transmission of disease? Can we transfer HACCP-lite to additional (all) settings?

Over the next weeks and months, we are going to be inundated by the spike in COVID illnesses and deaths. During this time, it is on each of us to realize how our past behaviors led to the state we are in. When we return, viruses will not be absent from the world, our hospitals, schools, offices or our bodies. We can, starting now, begin to measure and change our leading behaviors and begin to shape a healthier future.

June 19, 2019

Key Points To Incorporate Into a Sanitation Training Program

By Ellice Ogle

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To reinforce the ideas in the article, Sanitation Starting Points: More Than Sweeping the Floors and Wiping Down the Table, the main goal of sanitation is to produce safe food and to keep consumers healthy and safe from foodborne illness. With the cannabis industry growing rapidly, cannabis reaches a larger, wider audience. This population includes consumers most vulnerable to foodborne illness such as people with immunocompromised systems, the elderly, the pregnant, or the young. These consumers, and all consumers, need and deserve safe cannabis products every experience.

Sanitation is not an innate characteristic; rather, sanitation is a trained skill. To carry out proper sanitation, training on proper sanitation practices needs to be provided. Every cannabis food manufacturing facility should require and value a written sanitation program. However, a written program naturally needs to be carried out by people. Hiring experienced experts may be one solution and developing non-specialists into an effective team is an alternative solution. Note that it takes every member of the team, even those without “sanitation” in their title, to carry out an effective sanitation program.

Sanitation is a part of the Food and Drug Administration’s Code of Federal Regulations on current Good Manufacturing Practices (GMPs) in manufacturing, packing or holding human food (21 CFR 110). Sanitation starts at the beginning of a food manufacturing process; even before we are ready to work, there are microorganisms, or microbes, present on the work surfaces. What are microbes? At a very basic level, the effects of microbes can be categorized into the good, the bad, and the ugly. The beneficial effects are when microbes are used to produce cheese, beer or yogurt. On the other hand, microbes can have undesirable effects that spoil food, altering the quality aspects such as taste or visual appeal. The last category are microbes that have consequences such as illness, organ failure and even death.In a food manufacturing facility, minimizing microbes at the beginning of the process increases the chance of producing safe food.

Proper sanitation training allows cannabis food manufacturing facilities to maintain a clean environment to prevent foodborne illness from affecting human health. Sanitation training can be as basic or as complex as the company and its processes; as such, sanitation training must evolve alongside the company’s growth. Here are five key talking points to cover in a basic sanitation training program for any facility.

Provide the “why” of sanitation. While Simon Sinek’s TEDx talk “Start with why” is geared more towards leadership, the essential message that “Whether individuals or organizations, we follow those who lead not because we have to, but because we want to.” Merely paying someone to complete a task will not always yield the same results as inspiring someone to care about their work. Providing examples of the importance of sanitation in keeping people healthy and safe will impart a deeper motivation for all to practice proper sanitation. An entertaining illustration for the “why” is to share that scientists at the University of Arizona found that cellphones can carry ten times more bacteria than toilet seats!
Define cleaning and sanitizing. Cleaning does not equal sanitizing. Cleaning merely removes visible soil from a surface while sanitizing reduces the number of microorganisms on the clean surface to safe levels. For an effective sanitation system, first clean then sanitize all utensils and food-contact surfaces of equipment before use (FDA Food Code 2017 4-7).
Explain from the ground up. Instead of jumping into the training of cleaning a specific piece of equipment, start training with the foundational aspects of food safety. For example, a basic instruction on microbiology and microorganisms will lay down the foundation for all future training. Understanding that FATTOM (the acronym for food, acidity, temperature, time, oxygen and moisture) are the variables that any microorganism needs to grow supplies people with the tools to understand how to prevent microorganisms from growing. Furthermore, explaining the basics such as the common foodborne illnesses can reinforce the “why” of sanitation.
PPE for all employees at every stage of processing is essential
Inform about the principles of chemistry and chemicals. A basic introduction to chemicals and the pH scale can go a long way in having the knowledge to prevent mixing incompatible chemicals, prevent damaging surfaces, or prevent hurting people. Additionally, proper concentration (i.e. dilution) is key in the effectiveness of the cleaning chemicals.
Ensure the training is relevant and applicable to your company. Direct proper sanitation practices with a strong master sanitation schedule and ensure accountability with daily, weekly, monthly and annual logs. Develop sanitation standard operating procedures (SSOPs), maintain safety data sheets (SDS’s) and dispense proper protective equipment (PPE).

Overall, sanitation is everyone’s job. All employees at all levels will benefit from learning about proper sanitation practices. As such, it is beneficial to incorporate sanitation practices into cannabis food manufacturing processes from the beginning. Protect your brand from product rework or recalls and, most importantly, protect your consumers from foodborne illness, by practicing proper sanitation.

June 5, 2019

Disposable Gloves: The Unregulated Cannabis Threat

By Lynda Ronaldson

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Today in the states where medical and recreational cannabis is legal, cannabis products purchased from licensed facilities are required to have undergone testing by accredited labs. The compliance testing verifies advertised potency levels and checks for microbial contamination, herbicides, pesticides, fungicides and the presence of mold and mildew, among other potential contaminants.

Until recently, little attention has been given to disposable gloves and their possible involvement in the contamination of the products they handle. What factors should you consider when purchasing gloves?

Disposable Gloves Facts

Disposable gloves, like cannabis products, are not made of equal quality. There are several different types of disposable gloves on the market, and huge variations in glove quality and chemical compositions exist between and within each glove type.

Recent scientific studies have revealed how gloves produced in factories with poor manufacturing standards and raw material ingredients can contaminate the products they handle. High-level toxins in disposable gloves were found to affect lab results, toxins in gloves contaminated the food they touched, and pathogen contamination of unused disposable gloves has been proven. Should the cannabis industry take more interest in the disposable gloves they are using? With so much at stake if compliance test results are compromised, we think so!

Glove Procurement: Factors to Consider

What factors should you consider when purchasing gloves?

Industrial grade gloves- There is no such thing as an industrial grade glove certification, although it does give an incorrect impression that gloves are strong and resilient. Industrial grade means they have not been subjected to inspection nor have passed any specific testing requirements.
Food contact gloves are certified under FDA Title 21 CFR Part 177, which states the components of the glove comply with the FDA regulations and the gloves consist of “substances generally recognized as safe for use in food or food packaging.” Few controls exist for glove manufacturing relating to the reliability of raw materials and manufacturing processes, and costs can be reduced with the use of cheap, toxic materials.
Medical grade gloves have to pass a series of technical tests in order to meet the safety requirements specified by the FDA. Gloves are tested for puncture and abrasion resistance, must meet tension and elongation tests and are also tested for chemical substance resistance. Manufacturers of these gloves must receive 510k certification. As this study shows, even medical gloves can contain high levels of toxic ingredients, affecting laboratory test results.
The Acceptable Quality Level (AQL) refers to a quality standard for measuring pinhole defects- the lower the AQL, the less defects the gloves have. There are no AQL requirements for food grade or industrial grade gloves, meaning there are no guidelines for the number of failures per box. Medical grade gloves must have an AQL of 2.5 or less, meaning 2.5 failed gloves per 100 gloves is an acceptable level.
For Californian cannabis companies, are your disposable gloves Prop. 65 compliant? Accelerator chemicals, such as 2-Mercaptobenzothiazole (MBT) found in some nitrile gloves, have recently been added to the Prop. 65 chemicals known to cause cancer.

How Gloves Can Contaminate Products

Physical, chemical and microbiological hazards have been identified in disposable glove supply chains. Gloves of any grade are not tested for cleanliness (microbial and bioburden levels), raw material toxicity and chemical composition, or pathogen contamination.

100% of glove factories supplying the United States are based in Southeast Asia. These factories are generally self-regulated, with FDA compliance required for a rough outline of the ingredients of the gloves rather than the final product. Few controls are required for glove manufacturing relating to the reliability of raw materials, manufacturing processes and factory compliance or conditions. A clear opportunity exists for accidental or intentional contamination within the glove-making process, especially to reduce costs.

In order to safeguard their customers from product contamination, a selection of tests and certifications, some of which are unique within the glove industry, are being implemented by glove supplier Eagle Protect. These tests make sure Eagle’s gloves coming into the United States are made in clean, well run factories, free of any type of contamination and are consistent in material makeup to original food safe specifications. This glove Fingerprint testing program, consists of a number of proprietary risk reduction steps and targeted third-party testing methods, includes gas chromatography combined with mass spectroscopy (GC/MS); surface free energy determination; in vitro cytotoxicity analysis; and microbial viability-linked metagenomic analysis.

With a great deal of faith placed on a glove supplier’s ability to deliver disposable gloves sight unseen, we believe these tests are essential to further reduce risks or pathogen contamination associated with them, keeping your cannabis products safe.

May 9, 2019

Sanitation Starting Points: More Than Sweeping the Floors and Wiping Down the Table

By Ellice Ogle

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Sanitation is not just sweeping the floors and wiping down the table – sanitation has a wide-ranging function in a cannabis food manufacturing facility. For example, sanitation covers the employees (and unwanted pests), food-contact equipment (and non-food-contact equipment), trash disposal (including sewage), and more. Ultimately, sanitation systems maintain a clean environment to prevent foodborne illness from affecting human health. Fortunately, there are resources and tools to ease into establishing a robust sanitation program.

Overall, the main goal of sanitation is to produce safe food, to keep consumers healthy and safe from foodborne illness. With the cannabis industry growing and gaining legalization, cannabis reaches a larger, wider audience. This population includes consumers most vulnerable to foodborne illness such as people with immunocompromised systems, the elderly, the pregnant, or the young. These consumers, and all consumers, need and deserve safe cannabis products every experience.

To produce safe food, food manufacturing facilities in the United States must at least follow the Food and Drug Administration (FDA)’s Code of Federal Regulations Title 21 Chapter I Subchapter B Part 117, current good manufacturing practice, hazard analysis, and risk-based preventive controls for human food. Although cannabis is currently not federally regulated, these regulations are still relevant for a cannabis food manufacturing facility since the same basic principles still apply. Also, these regulations are a good resource to simplify a comprehensive sanitation program into more manageable components, between sanitary operations and sanitary facilities. With more manageable components, the transition is smoother to then identify the appropriate tools that will achieve a thorough sanitation program.

Sanitary operations

1) General maintenance of the facilities: The buildings and fixtures of the food manufacturing facility cover a lot of ground – hiring a maintenance team will divide the responsibility, ensuring the entire facility can be maintained in a clean and sanitary condition. Furthermore, a team can build out a tool like a preventative maintenance program to restrict issues from ever becoming issues.

Figure 1: Dirty Cloth Towel in Dirty “Sanitizer” Solution — Dirty Cloth Towel in Dirty “Sanitizer” Solution (an example of what NOT to do)

2) Control of the chemicals used for cleaning and sanitizing: Not all chemicals are equal – select the appropriate cleaning and sanitizing chemicals from reputable suppliers. Obtain the right knowledge and training on proper use, storage, and proper protective equipment (PPE). This ensures the safe and effective application of the chemicals in minimizing the risk of foodborne illness.

3) Pest control: Understand the environment within the facility and outside the facility. This will aid in identifying the most common or likely pests, in order to focus the pest control efforts. Keep in mind that internal pest management programs can be just as successful as hiring external pest control services.

4) Procedures for sanitation of both food-contact and non-food-contact surfaces: Developing sanitation standard operating procedures (SSOPs) provides guidance to employees on appropriate cleaning and sanitizing practices, to balance effective and efficient operations. A master sanitation schedule can control the frequency of indicated sanitation procedures.

5) Storage and handling of cleaned portable equipment and utensils: Cross contamination in storage can be minimized with tools such as controlled traffic flow, signage, training, color coding, and more.

Sanitary facilities

6) Water supply, plumbing, and sewage disposal: Routine inspections of plumbing, floor drainage, and sewage systems prevent unintended water flow and damage.

7) Toilet facilities: Clearly defining standards for the toilet facilities and setting accountability to everyone who uses them will ensure that the toilet facilities are not a source of contamination for the food products.

8) Hand-washing facilities: Good manufacturing practices (GMPs) include proper hand washing and proper hand washing starts with suitable hand-washing facilities. For example, frequent checks on running water, hand soap, and single use towels ensure that all hands are clean and ready to produce safe food.

9) Trash disposal: While trash can be a source of cross contamination, trash can also attract and harbor pests. Scheduling regular trash disposal and controlling traffic flow of waste are two ways to minimize the risk of cross contamination from trash.

Bonus

Even after meeting these requirements, sanitation programs can be more sophisticated. An example is to institute an environmental monitoring program to verify and validate that the sanitation program is effective. Another example is in identifying and measuring key performance indicators (KPIs) within the sanitation program that can improve not just the sanitation processes, but the operations as a whole. Principally, sanitation is cleanliness on the most basic level, but waste management can encompass sanitation and grow into a larger discussion on sustainability. All in all, sanitation programs must reshape and evolve alongside the company growth.

Sanitation is interwoven throughout the food manufacturing process; sanitation is not a single task to be carried out by a sole individual. As such, it is beneficial to incorporate sanitation practices into cannabis food manufacturing processes from the beginning. Protect your brand from product rework or recalls and, most importantly, protect your consumers from foodborne illness, by practicing proper sanitation.