State Laboratories Clinical Laboratory Improvement Amendments

Overview

The Alaska Department of Health works with the Centers for Medicare and Medicaid Services (CMS) to make sure labs in Alaska follow the rules of the Clinical Laboratory Improvement Amendments (CLIA).  

Any place that tests human samples to check for health problems or to help diagnose diseases is called a clinical lab. These labs must follow certain rules to make sure testing is done safely and correctly. The lab has to apply for and get a certificate from the CLIA program. 

CLIA certifications

Any facility or organization that tests human samples to diagnose, prevent, or treat a disease must have a CLIA certificate. This includes a wide range of settings—from large hospitals to small clinics. 

You need a CLIA certificate if your lab tests blood, urine, swabs, or other human samples—even if you only run a few tests a week.

Get certified

If your facility plans to test human samples for health reasons, you must apply for a CLIA certificate before starting any testing. Follow these steps to get started: 

Step-by-step process

1. Download and complete the CLIA Application (Form CMS-116) 
   1. This form asks for details about your facility, the types of tests you will perform, and how often you plan to do testing. 
2. Send the completed form to the Alaska CLIA State Agency
   1. Email the completed CMS-116 form to hss.dph.lab.clia@alaska.gov 
3. Wait for your certificate and pay the required fee
   1. Wait for your certificate and pay the required fee. Find the CLIA Certificate Fee Schedule (updated 2024) here.
   2. You can now pay online with a credit card (Instructions to pay online)
   3. Pay CLIA fees online at pay.gov
   4. Or pay by check through the mail: 
      1. Make check payable to: CLIA Laboratory Program 
      2. Mail check to: CLIA Laboratory Program, P.O. Box 3056, Portland, OR 97208-3056 
   5. Display your certificate in your testing area 
      1. You are required to post your CLIA certificate where it can be seen by staff and visitors. 

Report a Complaint or Incident

If you are worried about the quality of lab testing, you can make a complaint. This includes both patients and health care providers. You can learn more in the CLIA Complaint Brochure. 

To report a problem with a lab in Alaska, contact the Alaska CLIA office. The Consumer Complaints FAW (PDF) explains how to file a complaint. 

Resources