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STATE OF TENNESSEE DEPARTMENT OF HEALTH MEDICAL LABORATORY BOARD DIVISION OF HEALTH RELATED BOARDS 227 FRENCH LANDING, SUITE 300 HERITAGE PLACE, METROCENTER NASHVILLE, TN 37243 (615) 532-3202 1-800-778-4123.

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Related content

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There are five different CLIA certificate types which all are effective for a period of two years. Except for the Certificate of Compliance and Certificate of Accreditation, renewal of each certificate is accomplished by payment of the certificate fees.

What is a Waived Test? Based on the complexity of the tests, CLIA tests are categorized into three levels: waived, moderate complexity, and high complexity tests. CLIA defines waived tests as “Simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.”

Current Regulation: CLIA established three categories of tests: waived tests, moderate complexity tests, and high complexity tests.

The CLIA application collects information about a laboratory's operation, which is necessary to determine the type of certificate to be issued and the fees to be assessed. NOTE: If you have any questions regarding the completion of the CMS-116 form, contact the appropriate State Agency (PDF).

The purpose of a CLIA Certificate of Waiver is to ensure that laboratory standards are met which ensure timeliness, accuracy, and reliability of laboratory test results for patients. Diagnostic testing allows healthcare providers (doctors, nurses, etc.) to monitor and/or check for a variety of diseases and conditions.

CLIA regulatory requirements classify testing into three categories: high complexity, moderate complexity and waived.

The FDA categorizes diagnostic tests by their complexity—from the least to the most complex: waived tests, moderate complexity tests, and high complexity tests.

The CLIA application (Form CMS-116) collects information about your laboratory's operation which is necessary to determine the fees to be assessed, to establish baseline data and to fulfill the statutory requirements for CLIA. This information will also provide an overview of your facility's laboratory operation.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232