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DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES Form Approved OMb No. 0938-0581 clinical laboratory improvement amendments clia application for certification i. The valid OMb control number for this information collection is 0938-0581. The time required to complete this information collection is estimated to average 30 minutes to 2 hours per response including the time to review instructions search existing data res.

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Related content

CMS 116 | CMS
Form #. CMS 116. Form Title. CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 (CLIA)...
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clia - MIEMSS
The CLIA application (Form CMS-116) collects information about your laboratory's operation...
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R3103CP (PDF) - CMS Manual System
Nov 3, 2014 — the NPI in Item 32a of the CMS-1500 claim form or on the ANSI X12 837...
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On each claim, the CLIA number of the laboratory that is actually performing the testing must be reported in item 23 on the CMS-1500 form.

The Clinical Laboratory Improvement Amendments (CLIA) Program regulates labs testing human specimens and ensures they provide accurate, reliable, and timely patient test results no matter where the test is done. CMS oversees all lab testing (except some research) done on humans in the U.S. through CLIA.

Waived tests are simple tests with a low risk for an incorrect result. Nonwaived tests, also called Moderately Complex tests, are those tests that require a number of criteria to be met prior to the operator running the tests.

As defined by CLIA, waived tests are “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” Examples of waived tests include: dipstick urinalysis, fecal occult blood, urine pregnancy tests, and blood glucose monitoring.

The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.

Some waived tests have potential for serious health impacts if performed incorrectly. For example, results from waived tests can be used to adjust medication dosages, such as prothrombin time testing in patients undergoing anticoagulant therapy and glucose monitoring in diabetics.

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.

The issuance of the CLIA Fees for renewal is an automated process with no action required on the part of the laboratory. The Certificate of Waiver is issued to a laboratory to perform only waived tests. This certificate does not waive you from all CLIA requirements.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
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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