How to Build a Diagnostic Laboratory Partnership

The best diagnostic partnerships are designed around what each side genuinely needs — and around the compliance lines neither side can cross.

Draft — owner to review

Diagnostic partnerships take many forms: an assay developer licensing to a reference laboratory, a hospital outreach program partnering with a specialty lab, or two laboratories sharing a test menu. The structure matters less than clarity about who does what, and why.

Start with fit

Does each party bring something the other cannot easily build?
Are the quality systems and certifications compatible?^[1]^[4]
Who owns the customer relationship, the data and the results report?

Define quality responsibilities in writing

The laboratory performing testing remains responsible for meeting CLIA requirements for that testing. Agreements should be explicit about specimen handling, method changes, proficiency testing and result reporting.^[1]

Respect the compliance lines

U.S. federal law prohibits offering or paying remuneration to induce referrals of items or services reimbursable by federal health care programs.^[2]

A separate federal statute, enacted in 2018, specifically addresses remuneration for referrals to laboratories and applies more broadly than federal programs.^[3]

Advisor's analysis

Compensation that tracks referral volume is the pattern most likely to draw scrutiny. Fair-market-value, fixed arrangements reviewed by healthcare counsel before signing are worth the time and fees.

Plan the exit from day one

Termination, transition of patients and data, and what happens if either party is acquired should all be agreed before launch — when goodwill is highest.

→ To find candidate partner laboratories or post a partnership opportunity, see LaboratoryVortex.

Sources

[1] U.S. Centers for Medicare & Medicaid Services, “Clinical Laboratory Improvement Amendments (CLIA).”
[2] Legal Information Institute, Cornell Law School, “42 U.S.C. § 1320a-7b — Criminal penalties for acts involving Federal health care programs.”
[3] Legal Information Institute, Cornell Law School, “18 U.S.C. § 220 — Illegal remunerations for referrals to recovery homes, clinical treatment facilities, and laboratories.”
[4] College of American Pathologists, “CAP Accreditation Programs.”

Bracketed numbers link to sources. Passages labelled “Advisor's analysis” are interpretation, not cited fact.

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