CDLSO Services

Laboratory Design and Buildout

Building a clinical laboratory is one of the most complex and high-stakes investments a healthcare organization can make. nuCARE’s CareLab360 program provides end-to-end support from initial concept through completed, compliant, operational laboratory — eliminating guesswork and reducing the risk of costly delays or design errors.
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Who this is for

  • Physician practices and groups bringing testing in-house
  • Specialty practices adding molecular, chemistry or immunoassay testing
  • Healthcare organizations relocating or expanding an existing laboratory
  • Entrepreneurs looking to build their own diagnostic laboratory

From concept to go-live

1

Feasibility and financial model. Test menu, staffing plan, production demands and instrument capabilities, and a full cost-of-operations model, so you know what it takes to run the lab before you commit to building it.

2

Design. Space planning, workflow design, instrument layout and ergonomics, including molecular containment where needed.

3

Equipment and procurement. Platform selection, vendor evaluation and contract negotiation, with terms that protect you during startup.

4

LIS planning. System selection and pre-implementation planning, including EMR and reference laboratory interfaces.

5

Validation. Method validation and verification for every test on your menu.

6

Licensure and inspection. CLIA certification, state licensure where required, and inspection
preparation.

6

Go-live. SOPs, staff training and a supported first run of patient testing.

One nuCARE project lead manages the plan across every stage, coordinating contractors, vendors and your team.

What's Included

  • Feasibility, financial modeling and test menu planning
  • Space planning and laboratory workflow design
  • Equipment selection, vendor sourcing and contract negotiation
  • Instrument layout and ergonomic workflow design
  • Design for CLIA, COLA, CAP and Joint Commission requirements
  • LIS planning and pre-implementation consulting
  • Project management from design through go-live

When the plan changes, the lab keeps moving

Weeks before launch, a new laboratory in New England lost its Laboratory Manager, the person who was to perform its PCR validations. nuCARE did not allow this loss to interrupt the project providing on- site support. The laboratory avoided restarting validation and inspection once a replacement was hired, and kept its path to revenue.

 

Contract terms matter from day one. On one buildout, nuCARE cut a manufacturer’s monthly reagent minimum from $30,000 to $16,000, eliminated a $48,000 annual service fee, and added early-termination and averaged-minimum protections to a 72-month agreement.*

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*These changes reduce contractual commitments and add purchasing flexibility; they are not guaranteed cash savings, since actual spend depends on testing volume.

After go-live: CARELab360

For laboratories that want long-term support once testing begins, CARELab360 provides ongoing management services, bringing laboratory leadership, quality, procurement and operational support together under one nuCARE relationship.
Ask about CARELab360

Planning a laboratory?

Tell us what you want to test, where, and when. We will help you decide whether and how to build.
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