IQCP Support Resources
Supporting Your Risk Assessment and Quality Control Plan
Download IQCP Documents Below
The Clinical Laboratory Improvement Amendments (CLIA) program recently introduced the Individualized Quality Control Plan (IQCP) as a new quality control option for nonwaived testing. We are pleased to provide you with materials to support your IQCPs.
Important: These materials are not an IQCP for your Alere test systems. They are intended as an aid in the development of your IQCP Risk Assessment and Quality Control Plan.
Download IQCP Support Documents
Enter your information below to access and download documents. You will find the Instruction Guide as well as documents for the following products:
- Alere Determine™ HIV-1/2 Ag/Ab Combo
- Alere Afinion™ System
- TECHLAB®QUIK CHEK™ Assays
- TECHLAB® EZ VUE™
- BinaxNOW® Assays
- BinaxNOW® Malaria
- Acceava® H. pylori
- Acceava® Mono Cassette
- Alere Rubella-plus® System
- Alere™ hCG Combo Cassette
- Clearview® H. pylori
- Clearview® Mono
- Alere™ PBP2a SA Culture Colony Test
- Alere Triage® Parasite Panel
- Alere™ i
- Single Dip Test Abon (Urine Drug Test)
- ImmuTest™ Multi Drug Test
- Acceava® Mono II Test
- Alere iCassette® Drug Screen
- Triage® Drugs of Abuse Panel Plus TCA
- Alere BinaxNOW® Influenza A&B Card 2
IQCP Orientation Webinar
Need Additional Product Documentation?
The following link will direct you to our global documentation center. You can also access product information on your country site, by selecting the appropriate country flag in the left hand side navigation.
Additional Resources
- CMS IQCP General Information webpage
- CMS/CLIA IQCP Brochure [pdf 248KB]
- CLIA IQCP, Considerations When Deciding to Develop an IQCP Brochure [pdf 1.47mb]
- CLIA IQCP, What is an IQCP? Brochure [pdf 2.13mb]
- CMS IQCP Questions: Any questions about IQCP should be forwarded to IQCP@cms.hhs.gov
- CMS/CLIA Website
- Developing an IQCP
A Step-by-Step Guide by CDC
and CMS [pdf 5.38mb]
