MDx Partners Abbreviated Laboratory Development & Oversight Project Plan:

​

Discovery Phase

• Lab evaluation and due diligence on the the medical group practice metrics (#of providers, payer mix, test volume, etc.)

• Feasibility analysis to include a pro forma

• Cost estimates

• Lab Development & Oversight Agreement reviews and execution

​

Planning & Design

• Lab space requirements determined

• Lab site reviews and selection

• Management of any necessary site improvements

• Instrument and equipment sourcing 

• Personnel sourcing, job descriptions and candidate selection

• Work flow design

• Lab information system (LIS) acquisition and web reporting solution

​

Pre-Launch Project Management

• Regulatory matters

• Sourcing for a licensed and qualified Lab Director (CLIA requirement for high-complexity testing)

• CLIA certification and compliance development

• CLIA site inspection preparation

• Pathogen & Antibiotic Resistance Assay development and validations

• Build-out of the LIS and report generator architecture

• Personnel training

• Laboratory consumables and supply inventory and ordering system

• Specimen collection materials and logistics

​

Laboratory Operations & Oversight

• Laboratory work flow and instrument maintenance

• Laboratory testing QC/QA

• Personnel supervision and on-going training

• Laboratory safety and biohazard waste plans and maintenance

• Development and validation of new assays

• Technical support

​

 

​

​

​

​

​