Do you need an IQCP for a waived test?
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 distinguishes between a CLIA test and a CLIA waived test?
Waived testing is laboratory testing that employs specific test methods designated under the Clinical Laboratory Improvement Amendments (CLIA) of the Food and Drug Administration (FDA) as “waived.” Waived testing is designated by CLIA as simple tests that carry a low risk for an incorrect result.
What is CLIA waived testing?
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.
What is the purpose of IQCP?
IQCP permits the laboratory to customize its QC plan according to test method and use, environment, and personnel competency while providing for equivalent quality testing.
What is a waive test?
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.
What is IQCP cap?
The “Individualized Quality Control Plan” (IQCP) is the Clinical Laboratory Improvement Amendments (CLIA) Quality Control (QC) procedure for an alternate QC option allowed by 42CFR493. 1250.
What is the CLIA iqcp?
The CLIA Individualized Quality Control Plan (IQCP) is a recently developed objective approach to performing quality control (QC) testing. It is an alternate QC option allowed under CMS regulation 42 CFR §493.1250 and applies to non-waived testing. Waived testing is not affected by IQCP.
Does iqcp apply to waived tests?
It does not apply to waived tests. While IQCP is voluntary, it will replace the current Equivalent Quality Control (EQC) procedure, which was designed as a standardized approach and intended to minimize the amount of external QC required and laboratory costs.
What are CLIA waived tests?
CLIA ’88 regulations addressed test complexity, proficiency testing, quality assurance, and other clinical laboratory processes establishing quality standards for clinical laboratory testing for patient diagnosis and treatment. CLIA waived tests are generally simple test that are non-technical.
What is iqcp (individualized quality control plan)?
The “Individualized Quality Control Plan” (IQCP) is the Clinical Laboratory Improvement Amendments (CLIA) Quality Control (QC) procedure for an alternate QC option allowed by 42CFR493.1250. The guidance and concepts for IQCP are a formal representation and compilation of many things laboratories already do to ensure quality test results.