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Introduction to AST IQCP The Individualized Quality Control Plan (IQCP) is the Clinical Laboratory Improvement Amendments (CLIA) Quality Control (QC) policy that will become effective as an alternative.

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IQCP applies to all nonwaived testing performed, including existing and new test systems. All CLIA specialties and subspecialties except Pathology are eligible for IQCP.

Waived Testing. As defined by CLIA, waived tests are simple tests with a low risk for an incorrect result. They include: Certain tests listed in the CLIA regulations. Tests cleared by the FDA for home use.

The IQCP process includes: Risk Assessment, Quality Control Plan (QCP), and Quality Assessment (QA).

You can enroll your laboratory or testing site in the CLIA program by completing an application (Form CMS-116 ) available on the CMS CLIA website or from your local State Agency . Send your completed application to the address of the local State Agency for the State in which your laboratory or testing site is located.

Individualized Quality Control Plan (IQCP)

No, you do not need an IQCP for a waived test. If your test is categorized and approved by the FDA as waived, you must continue to follow manufacturer's instructions for this test and you are encouraged to follow good laboratory practices.

It includes many practices that a laboratory already uses to ensure quality testing beyond requiring that a certain number of QC materials be tested at a designated frequency. IQCP applies to all nonwaived testing performed, including existing and new test systems.

What is waived testing? By the CLIA law, waived tests are those tests that are determined by CDC or FDA to be so simple that there is little risk of error. Some testing methods for glucose and cholesterol are waived along with pregnancy tests, fecal occult blood tests, some urine tests, etc.

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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
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
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