Clinical Laboratory Regulations

The Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) are federal laboratory regulations that apply to all clinical laboratories that test human specimens for diagnosing, preventing, or treating disease.

Worksite COVID Testing

In an effort to provide support to workplaces who may be doing COVID-19 testing, CMS has prepared materials to outline the simple steps necessary to do this. Generally, a CLIA certificate of waiver is necessary for a workplace to do testing. For information regarding CLIA requirements and the application process for workplace COVID-19 testing, please see the PDF Quick Start Guide for COVID-19 Testing in the Workplace and theWorkplace COVID-19 Testing Fact Sheet.

CLIA Certificates

There are several different CLIA certificates available depending on the level of testing performed by the laboratory. They include:

Certificate of Waiver
Certificate for Provider Performed Microscopy Procedures (PPMP)
Certificate of Compliance (laboratory is inspected by the State of Alaska)
Certificate of Accreditation (laboratory is inspected by accrediting organization)

The application should be signed and dated by the laboratory director. Once the application is processed, the laboratory will receive a CLIA bill in the mail. The lower portion of the bill should be mailed in with the laboratory’s payment.

Checks should be made out to “CLIA Laboratory Program” and mailed to:
CLIA Laboratory Program
P.O. Box 3056
Portland, OR 97208-3056

Please do not mail checks to the Alaska State Agency.

If a laboratory wants to make any changes to their CLIA certificate information, use the upper portion of the bill. Updates or changes should be mailed to:

Alaska State Public Health Laboratory
Attn: CLIA Surveyor
5455 Dr. Martin Luther King Jr. Ave
Anchorage, Alaska 99507

IF you have any questions about CLIA applications, certificates or bills, contact Katherine Ross.