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Individualized Quality Control Plan ICP Examples Susan E. Sharp, Ph.D., ABM, FARM Director, Airport Way Regional Laboratory Director, Regional Microbiology and Molecular Infectious Diseases Laboratories.
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Acceptability FAQ
Risk Assessment (RA) must include the five components (environment, testing system, testing personnel, specimen, and reagents) and entire testing process (pre-analytic, analytic and post-analytic).
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. The new CLIA IQCP quality control option was developed for nonwaived testing.
WHAT IS AN IQCP? IQCP provides a framework for customizing a quality control (QC) program for your test systems and your laboratory's unique environment.
WHAT ARE THE 3 STEPS OF THE IQCP? The IQCP process includes: Risk Assessment, Quality Control Plan (QCP), and Quality Assessment (QA).
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. The new CLIA IQCP quality control option was developed for nonwaived testing.
IQCP is an all-inclusive approach to assuring quality. 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.
Individualized Quality Control Plan (IQCP)
An IQCP is comprised of three parts, a risk assessment (RA), a Quality Control Plan (QCP), and a Quality Assessment (QA) plan. The RA is the identification and evaluation of potential failures and errors in a testing process.
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