Clinical Lab Certification

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 1,400 CLIA-Certified Laboratories in Idaho, 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.

CLIA information
Frequently asked questions

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.

Self-assessment

The self-assessment tool will help you review the CLIA requirements for your laboratory and to help perform internal audits of your facility. Use of this self-assessment tool does not ensure a deficiency-free survey, but can help your lab be more aware of the regulations that you are responsible for. Please contact our office with any questions.

Proficiency Testing

PT Dos and Don’ts will provide answers to a few common questions regarding proficiency testing requirements under CLIA.

Recalls

Find FDA Medical Device Recalls, including all types of medical devices including laboratory test systems and reagent kits. Select the year of recalls you want to view or search the device recall database.

Newsletter

Find current and past issues of the the Clinical Forum Newsletter.

Register a Complaint against a CLIA-certified Lab
Contacts
Michael Dillon
Lab Improvement Section Manager