Nebraska

Nebraska Department of Health and Human Services, Public Health Division. Clinical Laboratories. 

Under CLIA, a laboratory is defined as a “facility that performs testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of human beings.” This program certifies, inspects and monitors clinical labs for compliance of federal CLIA regulations, and investigates complaints received to ensure clinical laboratory testing is accurate, effective and reliable.

NOTE: The State of Nebraska does not have licensure requirements for CLIA laboratories or CLIA lab personnel. Nebraska fully participates in the Federal CLIA program and 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.

(1) Title 471. Nebraska Medical Assistance Program Services. Chapter 18. Physicians’ Services

“18-001.02 Independent Clinical Laboratories: In addition to the provider agreement, independent clinical laboratories must meet the following requirements:

1. When state or applicable local law requires licensing of independent clinical laboratories, the laboratory must be licensed under the law; and
2. The laboratory must meet the health or safety requirements of the Department of Health and Human Services (HHS).

For a Nebraska independent lab to be an approved provider under NMAP, the Division of Medicaid and Long- Term Care must receive a copy of Form CMS-1539, “Medicaid/Medicare Certification and Transmittal,” (see 471-00-66) which displays current Medicare certification from the CMS Regional Office. The CMS Regional Office updates certification information and sends the information to the Division according to the federal time frame which is currently in effect for independent clinical laboratory surveys. For an out-of-state independent clinical lab to be an approved provider under NMAP, the Division must request verification of certification from the CMS Regional Office. The Division approves or denies enrollment based on the certification information received from the CMS Regional Office.”

Application: https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads/cms116.pdf 

To be initially certified as a CLIA lab in Nebraska, you must complete the following forms:

(a)  CLIA Application for Certification form (CMS-116)

(b)  CLIA Ownership Information Form

(c)  List of Tests Performed

(2) Submit these documents with original signatures to:  DHHS Licensure Unit, Attn: CLIA Labs PO Box 94669, Lincoln NE 68509-4669 or email them to DHHS.AcuteCareFacilities@nebraska.gov

Phone Number: (402) 471-4363; Fax Number: (402) 742-8319

Online Access to CLIA Certificates

CMS is now making CLIA certificates available online at no cost via the QCOR Lookup Tool.  All certificates generated after September 27, 2023 should be available for download.  Click HERE to access the Tool and choose “CLIA Laboratory Lookup” from the left menu bar (2nd option from the top).  When you click the entry for the laboratory, a box containing the laboratory information and a link to the certificate will pop up in a new window.