Healthcare

Successful Implementation of Your Cannabis Testing LIMS

Implementation Overview

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If you have ever survived an enterprise-class software installation, you'll be relieved to know that LabLynx, Inc. implementations are not like that. Our solutions are deliberately designed to be implemented quickly and with a minimum of fuss. Whether you are simply setting up your LIMS, incorporating special customization and/or integration, or something in-between, the roll-out period is as smooth, efficient and pain-free as possible. Most setup is done through the user front end of the app itself, especially in the case of your cannabis lab's CannaQA LIMS, without the need for a development process. And training is done hands-on as you learn, from creating any additional tests you like with the limits/ranges you want to setting your own picklist choices and more, it can all be done in real time with an experienced instructor, and recorded for your convenience so you can share with others and review any time you want.

Standard implementation is quick and simple, with your solution online and ready to be set up the same day you sign your sales agreement. Users can follow the manual as our experienced staff work alongside you to set up any additional tests/ranges, lab information, additional users, clients, vendors, contract labs, instruments, inventory and/or other items included in initial setup, and learn how to use the system. Unlimited forum support is always included with your account.


Setup and training sessions, as well as any of a number of other features and services, can begin as soon as you are ready. Your implementation can include any of a number of components, depending on your particular solution and preferences. These can include:

LIMS Implementation

Setup & Training

Correct setup and training are crucial to the successful implementation and daily operation of your system. These services are normally included as part of your solution package, with manual materials and additional support team resources as backup.

Elements of standard setup and training include:

  1. Set up users
  2. Report setup
  3. Test setup
  4. Instrument-parameter mappings (if instrument interfaces are desired)
  5. Admin training
  6. User training
  7. System verification (can be factored into each process)


Set Up Users

LabLynx LIMS - Cannabis

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The first thing that is done once the LabLynx LIMS application has been initially provisioned on the LabLynx cloud infrastructure is the setup of at least one user, usually the main LIMS administrator. The online manual supports administrators with step-by-step instructions on setting up users in the User Management section. Default role-based access profiles already exist in the system, making it quick and easy to assign to users. (You can also copy and make changes to create new profiles with slightly different custom access privileges.)

Your LabLynx implementation engineer will help and instruct you, showing you how to set up users, including login ID and password, password expiration, inactivity auto-logout, etc., level of access and more.

Assign profiles

When setting up a user in the LIMS, a profile must be assigned that specifies the access level the user is allowed. For example, here are three default access level profiles that meet most standard laboratory needs:

  1. LIMS administrator: This is the top level of access, and it allows all administrative LIMS functions.
  2. Lab analyst: This is the standard lab user, with the profile designed for all standard laboratory functions.
  3. Office staff: This profile allows submitting of test requests/orders and viewing/issuing of reports. It does not allow results data entry or other laboratory activities.

As shown in the screenshot, access levels can be different for the same individual for each department or lab site. Again, the assignment of these profiles is performed during setup and training, described in the User Management section of the manual. Your particular access profiles will vary according to your specific requirements, and you can add and/or modify profiles to suit your needs.

Report Setup Info
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Your LabLynx CannaQA cannabis LIMS solution comes with a standard certificate of analysis (COA) report template already included based on your state or national requirements (see example). Setup will include simply adding your own lab logo, contact information, and authorized signatures. Any desired additions or modifications to notes, disclaimers, etc. may also be done if requested. Several other standard reports are also provided with the LIMS, including a barcode sample label (for the purposes of the LIMS, this is categorized as a report), turnaround time (TAT) report, bench worksheet, and sample backlog report. You can of course request additional reports. The LabLynx Report Builder app is also included with your solution, so you can also choose to make your own modifications or additional reports.

The dedicated report builder allows you to create and edit report templates of any kind, including sample, inventory, and product labels. You can choose to have a barcode on the label (or on any report), since the CannaQA LIMS supports both one- and two-dimensional barcodes of any type. And we keep up with the changing laws, regulations, and standards not only locally but also worldwide, so you can be sure your reports and product labels are compliant.

The LabLynx Report Builder is based on Active Reports and works like most report tools you may be familiar with, such as Crystal or SQL Services Reporting. The work area includes header, footer, and data sections, with controls that allow you to drag and drop elements such as images, data fields, line separators, etc. where you want them. It also supports the use of logic statements and calculations, such as the ability to display a given result or result range as "pass" or "fail," display only the fields for tests that were actually performed, populate charts and graphs, and more.


Test Setup

Probably the most important part of the LabLynx CannaQA LIMS setup is setting up the tests used in the lab. If this isn't correct and complete, then the LIMS core functionality is also jeopardized. Test setup training is included as part of standard setup and training provided by LabLynx. Instructions on how to perform test setup are also included in the online manual.

There are a number of test profiles specific to cannabis analysis that can be included in our LabLynx CannaQA LIMS, including some with calculated results. You can load the tests yourself, which is time-consuming, or you can choose to have them pre-loaded, with the limit sets required by your state or country. Tests include:

  • Cannabinoid Profile
    • CBC
    • CBD
    • CBD-A
    • CBG
    • d8-THC
    • d9-THC
    • THC-A
    • Total CBD
    • Total THC
  • Edible Cannabinoid Profile
    • As above, plus:
    • Total CBD mg/g
    • Total THC mg/g
  • GCMS Accredited Pesticide
    • Azoxystrobin D-4 (Surr)
    • Chlorfenapyr (Low Recovery)
    • Cyfluthrin (Low Recovery)
    • Cypermethrin
    • Dichlorvos D-6 (IS)
    • Methyl parathion
    • Permethrin (both)
  • GCMS R&D Pesticide
    • As GCMS Accredited Pesticide
  • LCMS Accredited Pesticide
    • Too many analytes to list (54)
  • LCMS R&D Pesticide
    • As LCMS Accredited Pesticide
  • Mold & Mildew
    • Total Mold
    • Total Yeast
  • Residual Solvent
    • Too many analytes to list (22)
  • Terpene
    • Too many analytes to list (19)
  • Water Activity

Each of these can also include mandatory review steps. There are ~1000 parameters (analytes) in your LabLynx CannaQA LIMS solution by default. But any tests that you want to use may need their parameters, ranges, limits, or specifications adjusted, instrument assigned, etc. before being activated and published for use. Additional new tests may be created if necessary. Results may include any alphanumeric values, including symbols (e.g., "<" and ">"), and may also be selectable, with user-defined choices (e.g., "present," "ND," "neg/pos," etc.), with multi-select also available.

If instruments are to be integrated, parameters must be mapped between the instrument and the LabLynx LIMS. This will be conducted as part of your LabLynx integration service. Instructions are in the manual as well, if you would like to review.

Additionally, any set of tests may be grouped as test panels, groups, or profiles (use the term you prefer) and assigned in a single click to samples. This is included in setup and training, and instructions are also provided in the "Test Group Management" section of the online manual.


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The LabLynx CannaQA LIMS can be delivered pre-loaded with all of the standard and required tests, parameters, and analytes.

The Test Management function in LabLynx is very flexible, so you can create any kind of test you do, including any number of process steps, in the order you specify (a collection of processes is called a "path"), and include any number and types of parameters or analytes, each with its own specifications, limits, or range.


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Test with custom path and multiple parameters and analytes


Instrument-Parameter Mappings

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As part of the required setup and training, any instruments used by the lab are entered into the Instrument Management area of the CannaQA LIMS. They can be interfaced so that orders and results are sent and received between your LabLynx CannaQA LIMS and the instrument, then the analytes (or parameters) must be "mapped" or translated so both entities speak a common language. This will be included if interfacing is selected as part of your solution package. Instructions on mapping parameters are also found in the LabLynx LIMS manual in the "Test Management" and "Instrument Management" sections.


Admin Training
LIMS Administrator training is key to successful operations
The LIMS administrator serves as the "go-to" person for anyone using the system, and is the primary contact for LabLynx, Inc., usually responsible for submitting any tickets to the help desk and for approving completed ones.


LIMS administrator (admin) training is the centerpiece of required setup of any LabLynx LIMS solution. The manual is designed to support you in accomplishing setup and training, delivered as part of your package. Training is hands-on, with guidance and collaboration from highly trained, experienced LabLynx LIMS professionals, and it includes initial setup/configuration. Training is conducted interactively online where it is recorded for reference and to help train others if/when needed.

The setup tasks completed and trained on during admin training include:


This training is supported by the above topics and more in the online manuals.

User Training
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User training is delivered by LabLynx, Inc. and managed in the help desk during implementation. Additionally, users make use of the manual and other LabLynx support resources. Training sessions are always online and recorded so that additional personnel may be trained later in a very cost-effective manner. Onsite training is also available if requested.

Unlike admin training, user training is aimed at training staff on how to use the LIMS only in relation to their particular roles. For instance, a user who only enters test requests need not be taught how to batch samples and enter results. Different access profiles are assigned by the LIMS administrator to other users according to job function. User training focuses on their specific job functions with regard to your specific LabLynx LIMS solution.


The areas covered in user training include some or all of the following:


For more on these topics, view them individually or refer to the manual.

System Verification
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The final step in the required setup of CannaQA LIMS is to review each of the functions by running trial samples through testing and reporting, including sample labels. This is called "system verification." It is a verification that the system is functioning as designed and as contracted.

This is included in LabLynx setup services, and you can also use the manual and any other support resources to help you verify functionality. If setup and training have been completed successfully, then the User's Guide can serve as a guide to creating functional scripts for completing verification.

If validation to a certain standard or certification (not to be confused with "verification") is required (e.g., California requires ISO/IEC 17025 accreditation), LabLynx will provide as much support to the accrediting agency as you need, including core test scripts and other documentation. The LabLynx CannaQA LIMS supports all applicable state and national standards and regulations.

Customization

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Your LabLynx solution is user-configurable so you can, from the beginning, do things such as:
  • modify existing tests and assays;
  • create your own tests and assays;
  • set your own choices in drop-down picklists;
  • hide or display fields;
  • rename fields and make them required;
  • upload your own logo for display on the results report; and
  • make your own custom reports.

However, your solution may also be customized, i.e., modified at the code level to your specifications and preferences through the purchase of custom plugins or hourly professional services. LabLynx's development professionals are at your service any time you want or need our help. Simply let us know what you want when you are defining your scope, or submit a request to the help desk at any time thereafter, and your system can be customized in any way you choose. Or, if you would like to directly access the back end yourself and do your own custom work, just select the Private Cloud dedicated server option and go to it on your own, though we'll still be here if you need us.

The Technical Stuff

If you are interested in doing your own customization, you can use standard non-proprietary languages like C#, JavaScript, VB Script, and SQL Server queries. The database is SQL Server, and you can also use any appropriate tools you would like to work with it. In fact, you can use SQL Services Reporting instead of the supplied Active Reports tool, if you prefer. We'll supply all table info you need, and we'll be happy to give you any information, materials, and general support you need.

You may be interested to know that core metadata tables have negative system ID valence, while added items carry a positive ID, helping keep any customization undisturbed when applying updates and upgrades. Looking to the future, we are considering technology like .Net core and jQuery, with the next major version to be released as Note JS with a PostgreSQL database. To integrate to our solutions, you can use REST API. Our LabVia interfacing management hardware-software module handles up to 10 separate nodes using Node Red SW and a Raspberry Pi custom box. Our solutions can be integrated to other software systems using ASTM, HL7, or proprietary protocols. We have also integrated to robotics, e.g. Hamilton PCR (VER NGS), and to cloud-based entities.

Integration

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Your LabLynx solution readily integrates with any other application, database, agency or device/instrument that is capable of being interfaced. LabLynx offers interfacing options to meet whatever your needs dictate. You can include integration services in your initial scope or request them at any other time through the help desk.

Connect your laboratory information system (LIS) to your electronic health record (EHR) so that patient information, assay requests and results are shared and automated. Also link instruments to the LIS so that requested assays are communicated to the instrument and results returned automatically to the LIS for review and reporting.

These and any other integrations—e.g., to billing services, reference labs, or a patient portal—are readily available, with many channels already in service for other customers and more released every day. Whatever it is, your integration plugin will be custom-configured to your unique needs.

For whatever integration needs your particular lab has—e.g., LOINC or SNOMED LIMS integrations for your environmental or water lab, chromatography devices, agency reporting systems—or any other kind of lab requirements you have, LabLynx will meet them for you.

Validation

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An important reason why many choose to use a LIMS or an LIS to manage their lab data is to help in meeting regulatory requirements like ISO 17025, 21 CFR Part 11, CAP, CLIA, CAP, HIPAA, A2LA, Meaningful Use and more. LabLynx, Inc. data management solutions are designed to support all applicable standards and regulations, and validation services are available to validate the system to any of these.

During the planning stages (see Requirements Checklist) you can specify any validation (or any other) services you require. These can also be contracted at any other time, by submitting a request to the help desk or contacting LabLynx, Inc. directly.

Go-live assistance

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A final service offered for LabLynx customers is support for daily operations. No matter how much pre-planning was done and how carefully the system is implemented, there is always the chance of unforeseen complications when you are trying to begin processing real orders. Go-live assistance from LabLynx or one of our certified partners ensures you have instant support as you launch your system. You can obtain go-live support by specifying it when scoping out your solution, by submitting a request ticket to the help desk or contacting us directly.

No matter how reliable and intuitive the system, it's always better to have experienced support and guidance around when making that first launch into daily use. And a help desk subscription and full support are also provided per your ongoing subscription or service plan.