Laboratories

Health Services and Resources > Laboratories > Clinical Lab Licensure

Bureau of Laboratories

Division of Laboratory Improvement

The Division of Laboratory Improvement implements state and federal laboratory licensure laws, which apply to the more than 8,000 clinical laboratories in Pennsylvania. On-site inspections, proficiency assessment and personnel training are used to help assure that laboratories are generating accurate and reliable results.

Clinical Laboratory Licensure

Documents

Clinical Laboratory Permit and Proficiency Testing Fees

May 18, 2012 Letter regarding Policy changes

Applications and Forms

In-State Clinical Laboratory License Application

Pennsylvania Clinical Lab Permit Application - Mobile Labs

Pennsylvania Clinical Lab Permit Application - Screening Sites

Out-of-State Clinical Laboratory License Application

Instructions for Completing the Out-of-State Clinical Laboratory License Application

Change of Status Form

CLIA Application for Certification (form CMS-116)

Clinical Laboratory Improvement Amendments

See the Centers for Medicare and Medicaid Services Clinical Laboratory Improvement Amendments (CLIA) website for information on federal requirements.