Idaho Licensing Requirements
National Links
- Nationwide Laboratory Director Regulations
- Dec. 28, 2024 CLIA Changes effective Dec. 28, 2024
- Nationwide High Complexity Requirements
- CE Courses for Laboratory Directors
- Online Access to CLIA Certification QCOR (See below)
- Pay your CLIA fee at Pay.gov
- Forms CMS116 Application
- eCFR 42 CFR Part 493
- State Operations Manual
State-Specific CLIA Applications
Any Idaho laboratory performing tests on humans for the purpose of diagnosis, treatment, or assessment of health must have a license from the Centers for Medicare and Medicaid Services (CMS) as part of the Clinical Laboratory Improvement Amendment (CLIA) program. The CLIA regulations can be found at the CMS website. This license certifies a laboratory’s ability to accurately determine lab test results.
See FAQs related to CLIA Certification including how to determine if your practice is considered a laboratory, what types of CLIA certificates are available, and how to get a CLIA certificate.
16.02.06 Quality Assurance for Idaho Clinical Laboratories
“01. Registration Timeframes. (7-1-21)T
- Every person responsible for the operation of a laboratory that performs tests on material derived from the human body must register such facility with the Department within thirty (30) days after first accepting specimens for testing. (7-1-21)T
- Existing laboratories must submit a completed laboratory registration form every two (2) years and indicate any changes in laboratory operations. (7-1-21)T
- Registration Form. Each laboratory must submit its registration information on the Department-approved form. These forms are available upon request from the Department. Each completed registration form must include the following information: (7-1-21)T
- Name and location of the laboratory; (7-1-21)T
- Name of the laboratory director; (7-1-21)T
- Types of laboratory tests performed in the laboratory; and (7-1-21)T
- Other information requested by the Department that it deems necessary to evaluate the performance of the laboratory. (7-1-21)T”
Application: https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads/cms116.pdf
2220 Old Penitentiary Road, Boise, Idaho 83712, emailed to LabImprovement@dhw.idaho.gov, or faxed to 208-334-4067.
The CLIA Certificate of Waiver cost $180.
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.