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.
IBL regulates over 1,000 clinical labs across the state, including hospitals, clinics, doctor's offices, and long-term care facilities. IBL's clinical lab inspector performs inspections for complex laboratories and monitors proficiency test events.
Labs beginning operation must complete and submit both of the following forms:
Idaho Laboratory Registration Form
Federal CLIA 116 Lab Registration Form
Idaho Clinical Laboratory Registration Renewal Form
Idaho Clinical Laboratory Change of Information Form
Clinical Lab FAQs
How do I file a complaint against a clinical laboratory?
You can file a complaint by calling the Laboratory Improvement Section at (208)-334-0528. You can remain anonymous in reference to the complaint. You can also view CLIA's Complaints brochure and find information on how to file a complaint with the Federal office of the Centers for Medicare and Medicaid Services.
CMS Website with CLIA Information
Idaho Rules for Laboratories in Idaho
Code of Federal Regulations (CLIA Law)
Informational CLIA Brochures
Lab Director Responsibilities Brochure
FDA Website for Test Complexity
Certificate of Waiver (CoW) Resources:
Waived Test Booklet
List of Waived Tests
Provider-Performed Microscopy (PPM) Resources:
List of PPM Tests
Certificate of Compliance or Accreditation (CoC or CoA) Resources:
CLIA Interpretive Guidelines
What Do I Need to Do to Assess Personnel Competency?
Writing a Plan of Correction
Writing an Allegation of Compliance
Lab Improvement Section Manager:
Idaho Bureau of Laboratories
2220 Old Penitentiary Rd
Boise, ID 83712
Phone: (208) 334-0528
Fax: (208) 334-4067