Pennsylvania State Licensing Requirements
National Links
- Nationwide Laboratory Director Regulations
- Dec. 28, 2024 CLIA Changes effective Dec. 28, 2024
- Nationwide High Complexity Requirements
- CE Courses for Laboratory Directors
- Online Access to CLIA Certificates QCOR (See below)
- Pay CLIA fees at Pay.gov
- Forms CMS116 Application
- eCFR 42 CFR Part 493
- State Operations Manual
State-Specific CLIA Applications
Pennsylvania Department of Health, Public Health Division. Clinical Laboratories.
Pennsylvania Commonwealth Clinical Laboratory Act
(1) The Division of Laboratory Improvement implements state and federal laboratory licensure laws, which apply to Pennsylvania’s over 9,000 clinical laboratories. On-site inspections, proficiency assessment and personnel training are utilized to ensure laboratories generate accurate and reliable results.
(2) Documents
- Division of Laboratory Improvement Contact Information (opens in a new tab)
- Understanding Clinical Laboratory Regulations in Pennsylvania (opens in a new tab)
- Interpretive Guidance for Oversight of Clinical Labs (opens in a new tab)
(3) Applications and Forms
- Pennsylvania Clinical Laboratory Permit Application for In-State Laboratories (opens in a new tab)
- Pennsylvania Clinical Laboratory Permit Application for Out-of-State Laboratories (opens in a new tab)
- Pennsylvania Clinical Laboratory Permit Application to Operate Screening Sites (opens in a new tab)
- Pennsylvania Clinical Laboratory Permit Application to Operate a Mobile Laboratory
- Change of Status Form (opens in a new tab)
- CLIA Application for Certification (opens in a new tab) (Form CMS-116)
Questions from local agencies and laboratories concerning the reporting process may be submitted to the Department’s Bureau of Laboratories by mail or e-mail as follows:
Dr. James Lute, Assistant Bureau Director
Pennsylvania Department of Health
Bureau of Laboratories
110 Pickering Way
Exton, PA 19341-1310
jlute@pa.gov
610-280-3464
Online Access to CLIA Certificates
CMS is now making CLIA certificates available online at no cost via the QCOR Lookup Tool. All certificates generated after September 27, 2023 should be available for download. Click HERE to access the Tool and choose “CLIA Laboratory Lookup” from the left menu bar (2nd option from the top). When you click the entry for the laboratory, a box containing the laboratory information and a link to the certificate will pop up in a new window.