Forms and Resources
|Pre-Survey Packet Forms
CLIA application form, CMS-116
The official form issued by The Centers for Medicare & Medicaid Services (CMS) to apply for a CLIA certificate.
Disclosure of Ownership and Control Interest Statement- TN
The official form issued by the Tennessee CLIA State Agency (SA) to report changes in facility name, tax ID number and/or ownership.
|CMS-209 Laboratory Personnel Report Form
The official form issued by the Tennessee CLIA State Agency (SA) to list all laboratory personnel by their position within the laboratory setting. Included in the Pre-Survey Packet.
|CLIA Laboratory Specialties Test Volumes Form
The official form issued by the Tennessee CLIA State Agency (SA) to record the annual volume of all non-waived tests perform in the laboratory. Included in the Pre-Survey Packet.
|Payment Instruction Forms
|CLIA Payments Online
Instructions on how to use the Pay.gov system to pay your CLIA certificate fee electronically.
|Intra-Governmental Payment and Collection (IPAC) System
Instructions for federal facilities to set up automated funds transfers through the IPAC payment system.
|Provider Performed Microscopy Procedures – A Focus on Quality Practices
This booklet describes recommended practices for physicians, midlevel practitioners (nurse midwife, nurse practitioner, or physician assistant), and dentists who perform patient testing under a CLIA Certificate for PPM procedures. The booklet contains an overview of the regulatory requirements, resources including forms and examples, and an overview with images of common microscopic findings for the nine specific microscopic examinations that may be performed under a Certificate of PPM Procedures.
|Ready? Set? Test! Booklet
This booklet describes recommended practices for physicians, nurses, medical assistants, pharmacists, and others who perform patient testing under a CLIA Certificate of Waiver. The booklet contains tips, reminders, and resources along with forms and examples for use in your testing site.
|To Test or Not to Test? Booklet
This booklet describes considerations and preparations needed prior to performing waived testing and may assist those who want to implement and oversee waived testing or offer a new test under a CLIA Certificate of Waiver. The booklet contains tips, reminders, and resources along with forms and examples for use in your testing site.
|Developing an IQCP - A Step-By-Step Guide
This workbook is designed to assist in developing an IQCP for one or more test systems. Using an example scenario, the workbook guides you through a step-by-step process to develop an IQCP that can be sustained and modified, as needed, over time. You will evaluate your current quality activities and develop an IQCP worksheet which, when completed, can serve as your IQCP document. The approach outlined in this workbook is not mandatory or the only format for documentation, but is one example that can be used.
|The 6 Procedures of Competency Assessment
One page flyer citing the six (6) procedures for assessment of competency for all personnel performing laboratory testing.
One page flyer announcing the start of IQCP, with link for additional information.
|Microbiology Media Quality Control
One page flyer with helpful cited CLIA regulations regarding microbiology media quality control.
One page flyer providing tips on how to write an acceptable Plan of Correction.
One page flyer outlining helpful steps on how to prepare for a survey.
One page flyer with information on PT referral and why it matters.
One page flyer announcing a web-based training course provided by CMS. The course is designed to assist providers with the implementation of the CLIA regulatory requirement.
One page flyer announcing an increase in CLIA certificate fees, with a link to additional information.
The official website of the Clinical Laboratory Improvement Amendments (CLIA).
|FDA CLIA Test Complexity Database
Access the FDA CLIA database containing the commercially marketed in vitro test systems categorized by the FDA and by the Centers for Disease Control and Prevention.
|CDC CLIA Code of Federal Regulations 42 CFR 493
View the federal regulations applicable to all US clinical laboratories
Instructions on how to complete a CMS-116 Application for Certification Form, needed to obtain a CLIA certificate.