Nebraska Clinical Laboratory Requirements

The Nebraska Department of Health and Human Services (DHHS) states on its CLIA page, verbatim: "The State of Nebraska does not have licensure requirements for CLIA laboratories or CLIA lab personnel. Nebraska fully participates in the Federal CLIA program. Any laboratory or lab personnel operating in the State of Nebraska or testing samples from the State of Nebraska must follow the federal CLIA regulations." So the verdict is firm: no Nebraska lab or personnel license — but specialty rules still apply (disease reporting, a forensic DUI analyst permit, and workplace drug-testing confirmation — see Nebraska-specific rules below).

Scope of this guide

This guide addresses a typical independent commercial clinical laboratory testing human specimens; it is not a legal opinion or final facility-opening checklist. Hospital/facility rules, out-of-state testing permits, and payer enrollment are separate questions — confirm each with the state authority. On licensure the position is concrete: no state lab or personnel license, but specialty rules apply. Before relying on this guide, verify with the state: ownership/facility type, testing complexity and specialties, and whether specimens are collected or tested in-state.

State agency

Nebraska Department of Health and Human Services, Division of Public Health — Licensure Unit, Attn: CLIA Labs. The state's CLIA program certifies, inspects, and monitors clinical labs for compliance with federal CLIA regulations and investigates complaints.

CLIA program: (402) 471-4363
DHHS main number: (402) 471-3121
TDD: (800) 833-7352
Fax: (402) 742-8319
Email: DHHS.AcuteCareFacilities@nebraska.gov
Mail: DHHS Licensure Unit, Attn: CLIA Labs, PO Box 94669, Lincoln, NE 68509-4669
Physical address: 301 Centennial Mall South, Lincoln, NE
Nebraska DHHS — CLIA Clinical Labs

Facility requirements — no separate Nebraska license (state-declared)

No separate state licensure — per the state's own declaration on the Nebraska DHHS CLIA page: "The State of Nebraska does not have licensure requirements for CLIA laboratories or CLIA lab personnel."

Facility types — independent vs. hospital-based vs. physician-office labs:

There is no state-level distinction between facility types; all operate under the same federal CLIA framework.
Independent laboratories need a CLIA certificate matching their test complexity — one certificate per testing location under federal CLIA rules.
Hospital-based labs are not separately state-licensed; their CLIA certificate applies like any other site's.
Physician-office labs commonly hold a Certificate of Waiver or a Provider-Performed Microscopy certificate — the standard federal options apply identically in Nebraska.

Nebraska-specific rules

No lab or personnel license — but three state rules bind Nebraska labs directly:

Disease reporting (173 NAC 1). Laboratories must make reports as described in 173 NAC 1-004, 1-005.02, and 1-006. Labs testing Nebraska residents must also send specified isolates to the Nebraska Public Health Laboratory. DHHS notes that many facilities in Nebraska are required to report reportable diseases through automated electronic laboratory reporting (ELR).
Forensic DUI analyst permit (177 NAC 7). The one individual permit DHHS issues: a Class D permit to perform chemical tests analyzing an individual's urine for drug content, covering analyses for the determination of drug content in urine while driving under the influence of drugs. It does not affect clinical laboratories — but a toxicology operation doing law-enforcement work in Nebraska needs to know it exists.
Workplace drug testing. Nebraska's employer drug-testing law requires that a positive drug screen be subsequently confirmed by gas chromatography-mass spectrometry (GC-MS), or another scientific testing technique that has been or may be approved by the department. Tox labs serving Nebraska employers must be able to meet that confirmation standard.

What federal CLIA requires

A CLIA certificate for the testing your lab performs — apply on Form CMS-116, CLIA Application for Certification (PDF).
A laboratory director and qualified personnel for your test complexity — see Zilgene's personnel reference pages below.
Proficiency testing enrollment for regulated analytes, plus quality control and quality assessment programs. (Zilgene recommendation: keep a current test list that matches your certificate — DHHS requires it with the application and on certificate-type changes.)

Nebraska's application package

CMS-116 alone isn't enough. DHHS requires the full package, submitted with original signatures by mail or email:

CLIA Application for Certification form (CMS-116)
CLIA Ownership Information Form
List of Tests Performed

Fees and renewals

The State of Nebraska does not collect CLIA user fees. Labs receive a CMS fee coupon and can pay via pay.gov.
Renewal bills go out six months before certificate expiry for Waiver, PPM, and Accreditation labs. For Certificate of Compliance labs, renewals are mailed 12 months prior to the current certificate expiration date.

Reporting changes

Director change: a new CMS-116 is required for PPM, Compliance, and Waiver labs. For Accreditation labs, director changes go directly to the accrediting organization.
Certificate-type change: a new CMS-116 plus a new test list.
Ownership change: file the CLIA Ownership Information Form.

Personnel requirements — no state personnel licenses

Nebraska's own CLIA page declares no licensure requirements for CLIA lab personnel; no technologist, technician, or director license was found. Personnel must meet the federal CLIA qualification rules for your test complexity — and confirm personnel requirements with DHHS. See Zilgene's personnel reference pages:

Forms and references

Form CMS-116 — CLIA Application for Certification (PDF) — your CLIA certificate application; part of the DHHS package.
CLIA Ownership Information Form (DHHS) — filed with the application package and again on any ownership change.
List of Tests Performed (DHHS) — filed with the application package and again on any certificate-type change.
Form CMS-209 — Laboratory Personnel Report (PDF) — keep your personnel roster current for surveyors.
CMS State Operations Manual, Appendix C (PDF) — federal survey procedures and interpretive guidelines (current Appendix C, Rev. 233 — the same document DHHS links).
Nebraska DHHS — CLIA Clinical Labs — the state's CLIA page, including its explicit no-licensure declaration, certification & fees, FAQs, and complaint info.
Zilgene FAQ — common CLIA and certification questions, answered.

Inspection preparedness

DHHS's CLIA program does the inspections — it certifies, inspects, and monitors clinical labs for compliance with federal CLIA regulations, and investigates complaints. Program surveyors verify that the specialties, sites, and director on your CMS-116 match current operations, that your CMS-209 personnel roster is current, and that your test list matches the certificate. Have all three ready before they arrive, and keep complaint-response readiness up between routine surveys.

How Nebraska differs from federal CLIA

Nebraska's DHHS declares the state CLIA-only outright: "Nebraska fully participates in the Federal CLIA program." There is no state lab license and no personnel licensure. What Nebraska adds on top of CLIA: a three-form state application package with original signatures, defined change procedures, state disease reporting with isolates to the Nebraska Public Health Laboratory, the forensic DUI analyst permit (177 NAC 7), and GC-MS confirmation for workplace drug testing.

How Zilgene can help

Zilgene guides laboratories through CLIA certification, personnel qualification, and inspection readiness nationwide. Contact us for a free first consultation — every engagement is scoped and quoted upfront.

Official links

Nebraska Department of Health and Human Services

Last verified: October 2026