Revenue · 5 of 7 services
Startup and buildout
Concept to certified laboratory, on a date.
Concept to certified · One plan, one date · Every workstream
What you receive.
A laboratory opening late is almost never late for one reason. It is late because six workstreams were tracked separately and the dependencies between them were discovered in sequence. One plan, one date, one person holding it.
- A master plan with every workstream on one timeline and one date
- Space and layout requirements written before a lease is signed
- An instrument and platform selection with no commission behind it
- CLIA and state licensure filings prepared and tracked
- A full quality system, procedures and validation plan
- A staffing plan with the CLIA roles named and recruited
The workstreams
Six tracks, one date.
Regulatory
Certificates, licensure, accreditation choice.
Space
Layout, utilities, safety, inspection readiness.
Instruments
Selection, install, service agreements.
Quality
Procedures, validation, quality control.
People
Director, supervisors, technologists, training.
Revenue
Credentialing, contracts, billing setup.
The engagement
Feasibility first, then build, validate and open.
Feasibility and plan
Month 1
Build and filings
Months 2 to 4
Validation and training
Month 5
Go-live and first survey
Month 6 onward
Before you engage
Price: phased fee, by workstream.
Lead: a named partner, in your proposal.
How it starts: a 20-minute call, then a written scope and fee before any work begins.
Questions
How long does a laboratory take to open?
It depends on complexity, space, and your state. We build the timeline from your specifics at the feasibility stage rather than quote an average.
Can you do only part of it?
Yes. Most clients bring us in for the regulatory and quality tracks and run the build themselves.
Do you sell instruments?
No. We operate no laboratory and sell no instruments, which is why our platform advice is worth reading.
Cited on this page
- 42 CFR Part 493, laboratory requirements (ecfr.gov)
- CMS Form CMS-116 and instructions (cms.gov)
Citations link to the official text. Nothing here replaces the current checklist issued by your accrediting body, and we read that checklist with you rather than in place of you.
Open on the date you committed to.
Twenty minutes, then a written scope. Nothing starts until you sign it.