Cannabis LIMS for QA and Medical Research

Requirements Checklist

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The LabLynx LIMS/LIS Solution, like any professional application, requires initial setup. This includes users, preferences, any customizations desired and many other items that constitute the scope of implementation. Although it is designed to be simple and quick to implement and use, there are still certain elements of this scope definition that must be addressed. Proper planning and preparation ensure the system meets your needs as completely as possible, and in the shortest possible time. Here is a checklist of requirements to be met before setting about the implementation of your LabLynx Solution. They can be broken down into four categories:

1. Laboratory Checklist

2. Product Demonstration

3. Scope of Work

4. Issue Agreements

Laboratory Checklist

Of course when planning setup of the LIMS/LIS for your lab, foremost among considerations are the lab’s specific characteristics and requirements. So here’s a checklist to help make sure you have those considerations covered. Use these to provide information to LabLynx support or to help you clarify your situation in your own mind:

CLIA Information

If your lab is subject to CLIA regulations, then you will need to supply:

1. CLIA Number

2. CLIA Certificate Type

3. CLIA Tests Performed In (Where are the tests performed?)

Lab Information

1. Do you have any other applications that should be interfaced to in some way, e.g. EHR, PMS, SDMS, ERP, MES, etc.?

  1. What is it?
  2. If not, why not, and how do you currently manage data?

2. Do you have a current LIMS/LIS?

  1. What is it?
  2. If not, why not, and how do you currently manage lab data?

3. How many locations does your lab have?

4. What types of instruments, if any, do you have (models, etc. can be listed later)? Are you planning to get one/some?

5. Are any instruments integrated to your current software?

6. What tests do you perform? This will need to be a complete list, with parameters/analytes and ranges (or criteria for pos/neg or pass/fail, if appropriate) and any calculations/formulas, before beginning Setup & Training.

Contacts

1. Users

2. Administrator(s)

3. Accounting

4. Vendors/Suppliers

Additional Information

1. Instrument List (specific make, model) with parameters

2. Your Time Zone

3. Any Special Considerations

Your Laboratory LIMSpec

The Laboratory Informatics Institute has published a LIMSpec for the Laboratory that includes many explanatory and relevant feature and function specifications for most types of labs. You can use it to query potential vendors about their products, services, pricing and more. The LIMSpec, with responses to many specifications, is included in this manual as Appendix B – Datasheet/User Requirements Specification (URSpec).

Product Demonstration

Certainly before bringing software into your lab you’ll want to see it in action. LabLynx offers a complete set of tutorial videos demonstrating each feature and function, so you can feel familiar and comfortable with it before you start using it. For subscribers who need more functionality, perhaps integrations, etc., a live online demo may be desired as well.

The product demonstration is an integral part of pre-planning in such cases. But it is more than that. The demo offers a unique and valuable opportunity to exchange information within the context of the application – which means you can ask about how a function works and see it right then and there. Equally, it is a perfect tool for communicating needs and expectations to LabLynx (or another vendor), and for LabLynx to ask questions about how you do things and how you would like to do them in the new system.

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A demo session is typically done online, which is useful for a couple of reasons. One, it means you can schedule – and reschedule if necessary – at your convenience with little in the way of logistics to arrange. And two, it is recorded, so everyone is clear on what was promised and what wasn’t, how things were shown to work, etc., and and also you can review parts you may have missed or not quite understood, and you can share it with others who then also get a look at the LIMS or LIS.

To help you make sure you get the very most out of your demo session, here’s a checklist of things to make sure get covered:

Define Requirements

Customers know their lab, but it is extremely common to be a little uncomfortable in the area of Laboratory Informatics. Vendors know their products and informatics, but it is up to the lab to communicate their specific needs. The problem is that often labs don’t really know their needs when it comes to informatics – partially because they really may not know what the technology and specific app are capable of doing.

It’s the job of the vendor to help you understand what the product can do to help you manage your data. It’s your job to communicate what kinds of data you have and what needs to be done with them. The Laboratory Informatics Institute’s LIMSpec is a good tool to help you set expectations. Some of the kinds of information you need to be able to define include:

  • Number of users
  • Roles of users
  • Workflow(s)
  • Number and kinds of instruments
  • Any examples of reports and instrument output files
  • What are your “pain points”?

Demonstrate to Requirements

As you share your information, the LabLynx representative will show you exactly how each need is met in the system. Once you feel comfortable that you understand how it works in each case (and you may well discover needs you didn’t know you had, or solutions you didn’t know existed), you’ll want to be forming a picture of exactly which functionality you want to include in your budget (remember options can be added either initially or later), and begin to formulate a scope together with your LabLynx representative.

Add Assays/Tests to Sample

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Discuss

HealthCloudPOL, like many systems, includes certain things as standard, but also has other optional services and features available. Make sure you know the difference. Your LabLynx LIMS solution includes in its standard implementation:

1. Signed Agreements. These consist of the BAA (if clinical) and SA. Nothing can get started until these are signed and returned. They are the last planning step before implementation, or, if you like, the first step in implementation.

2. App Provisioning. Once the signed document(s) are in place, your LabLynx LIMS or LIS solution is installed on the LabLynx, Inc. Cloud Infrastructure, ready for Setup and Training.

3. Free Support Services. Ask about the unlimited free support services that are included with every HealthCloudPOL account. Clarify which, if any, of the functions, features or services that you want are in addition to the demonstrated functionality and free support services.

4. Help Desk. Every LabLynx customer gets a Help Desk account, which provides timely and comprehensive support, the ability to request new Plugins and/or services and to interactively monitor progress. You can ask to see a demonstration of its capabilities.

Discuss Optional Plugins and Services

Your LabLynx representative will be more than willing to explore with you any features, functions or services you have in mind that aren’t part of the default application. We’ll help you decide what’s important and what can wait, and work with you on how best to budget. There are three kinds of additional items, so find out how the ones you want are priced:

1. Fixed Fee Items. Some items are priced as “fixed fee”, including Plugins, which means there is a price for that item, and it is delivered at that cost – no more, no less.

2. Hourly Blocks. Groups of hours, usually in 4- or 8- hour blocks, are available in some cases for any work you would like done, e.g. training. This method of payment ensures you control your budget dynamically, and is the default system for HealthCloud POL.

3. Subscription Fee Items. Some items are priced as ongoing subscriptions, usually monthly or annually. These include, typically, things like interface warranty/support plans.

Scope of Work

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The LabLynx LIMS/LIS is specifically designed to be simple, quick and easy to set up and use, so it’s not like many enterprise-level applications that require a project to implement. Nevertheless, it is important to use the Laboratory Checklist and Product Demonstration to help you decide what you want and don’t want in your LIS solution. It can include multiple instrument interfaces and connection to your EHR, billing services and more – or it may be the standard, free LIS alone, or something in-between. Elements of this scope fall under the general categories of:

1. Application – The core of your LabLynx solution is the LIMS or LIS itself, which is affordable and comes with the HealthCloudPOL Support Resources described in the manual and website (http://lablynx.com).

2. Add-Ons – Any number of Implementation Options are available either initially or at any time thereafter. Choose from among them to define what you want now, and for the short, medium and long term.

3. Services – All services are listed and discussed in the Services and Implementation Options sections of the manual.

Issue Agreements

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Once you have a good idea of your scope, you’re ready to sign up and get going! The last part of the Requirements Checklist to complete is the signing of the SA (and BAA if applicable).

Once they are in place and the subscription fee is remitted, the activity starts. Your Help Desk account is set up, the site will be provisioned and you’re on your way.

The documents are always stored in your Help Desk project itself. Keep copies for your own records. They can even be uploaded into the Document Record Management area of your LIMS/LIS itself if you like, for easy reference.