LABORATORY BUILD

Concept Overview

Many Healthcare providers have traditionally relied on independent clinical laboratories to provide advanced molecular testing for their population.  Community Direct’s (“Community”) new PCR technology, IP, products, and strategic partnerships have created an opportunity for long-term care providers to take control of the molecular testing process for their patient population.

Creating a laboratory for your facility can benefit you by reducing the costs of sending tests to third party laboratories or create a new revenue center for your facility by billing for molecular testing that is current processed and billed by third party laboratories.

Our service model is designed to give you 100% of the products, services, and support you need to create and manage your laboratory. 

What is Needed?

  • 2 Molecular platforms
  • Laboratory Fixtures
  • Assay/Reagent Packages
  • Fractional Laboratory Director
  • Fractional Technical Supervisor
  • Credentialing & CLIA Certification
  • Molecular validations
  • Laboratory Information System/LIS
  • Revenue Cycle Management
  • Laboratory SOPs
  • Laboratory Logistics
  • Laboratory Supply Chain
  • 1,000+ sqft of space
  • 1 Molecular Supervisor (recruited by Community)
  • 2 Bench Techs (recruited by Community)
  • Access to Administrative Team
  • Laboratory Budget

Community Advantages

Community has been involved in the build out and management of laboratories since 2015.  Over this time, Community has developed some strategic advantages that make building a laboratory for your organization a cost-effective endeavor:

Proprietary Technology

Our proprietary assay catalog for molecular diagnostics is ideal for any laboratory environment due to the speed and efficiency of the testing process (sample processing, amplification prep, and amplification).  Our proprietary direct PCR and pre-plated assays will reduce your laboratory’s run time by over 50%

Experience

Community has consulted with over 100 hospitals and independent clinical laboratories since our founding. Community’s experience gives it the ability to guide its clients to create a cost-effective and compliant model while avoiding many of the growing pains associated with a start up laboratory.

Science Team

Community has a group of experienced scientists that include fractional laboratory directors, fractional technical directors, and validation scientists. Ready deployment means our clients do not have to budget the time and monies to hire/train this staff.

Optimization Experience

Community’s validation science team has experience with major assay vendors and can validate your laboratory in a manner that reduces your assay expenses an average of 20% per test.

Ancillary Services

Non-clinical services such as Revenue Cycle Management, Supply Chain, and Logistics are part of Community’s core business, and its laboratory clients can plug into its existing infrastructure rather than recreating these services.

Optimization Experience

Community’s validation science team has experience with major assay vendors and can validate your laboratory in a manner that reduces your assay expenses an average of 20% per test.

Ancillary Services

Non-clinical services such as Revenue Cycle Management, Supply Chain, and Logistics are part of Community’s core business, and its laboratory clients can plug into its existing infrastructure rather than recreating these services.

Experience

Community has consulted with over 100 hospitals and independent clinical laboratories since our founding. Community’s experience gives it the ability to guide its clients to create a cost-effective and compliant model while avoiding many of the growing pains associated with a start up laboratory.

Next Steps

If this concept is a potential fit for your organization, the next steps are as follows:

1

Laboratory Feasibility

Prior to signing an engagement, we will gather information on your historical testing patterns to provide a financial forecast specific to your organization. This process will be feasibility only and not include workflow and processes. Those will be delivered upon engagement.
2

Engagement

If you decide to proceed with a laboratory build, we will execute a Statement of Work that will outline the step-by-step processes, workflow, staffing, timing, and budgets for your laboratory build.
3

Laboratory Validation

Once our Statement of Work is executed and budgets funded, we will begin all the processes detailed in the Statement of Work needed to bring your laboratory live.
4

Continued Laboratory Management

Once the laboratory is built and validated, we can continue our services to the laboratory from a clinical, operational, and regulatory standpoint.

Our goal in this project is to provide a turnkey solution for your organization and ensure all the staffing, processes, and standard operating procedures are in place to run an effective laboratory.