Is IQCP required for waived tests?
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 IQCP in lab?
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.
What are the 3 steps of an individualized quality control plan IQCP )?
WHAT ARE THE 3 STEPS OF THE IQCP? The IQCP process includes: Risk Assessment, Quality Control Plan (QCP), and Quality Assessment (QA).
What are key components of risk assessment in IQCP?
The IQCP has 3 key elements:
- Risk Assessment (RA) includes the identification, evaluation, and mitigation of “significant”
- Quality Control Plan (QCP) describes the practices, resources, and procedures to control the.
- Quality Assessment (QA) monitors the ongoing effectiveness of the IQCP.
What is non waived testing?
Nonwaived testing is the term used to refer collectively to moderate and high complexity testing. Laboratories or sites that perform these tests need to have a CLIA certificate, be inspected, and must meet the CLIA quality standards described in 42 CFR Subparts H, J, K and M.
What is a QC test?
Quality control involves testing units and determining if they are within the specifications for the final product. The purpose of the testing is to determine any needs for corrective actions in the manufacturing process. Good quality control helps companies meet consumer demands for better products.
What is IQCP cap?
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.
What is quality control testing CLIA?
Related Pages. The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations require a laboratory to have quality control (QC) procedures to monitor the accuracy and precision of the complete testing process.
Why quality control is to be done?
Implementing quality control procedures ensures you are selling the best products to your customers. In addition, practicing quality control has a positive impact on employee conduct. Quality control can inspire employees to create high-quality goods leading to greater customer satisfaction.
What is individualized quality control plan?
What is the difference between waived testing and non waived testing?
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.
What are 3 examples of CLIA waived 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.
Do I 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 is a waived test?
Waived tests include test systems cleared by the FDA for home use and those tests approved for waiver under the CLIA criteria. Although CLIA requires that waived tests must be simple and have a low risk for erroneous results, this does not mean that waived tests are completely error-proof.
What is the iqcp option?
The IQCP option offers the laboratory flexibility for meeting regulatory QC requirements appropriate for the testing performed. IQCP is an all-inclusive approach to assuring quality.
What are the cap’s eligibility requirements for iqcp?
For nonwaived testing, the CAP has defined eligibility requirements for IQCP. Eligibility is limited to tests meeting both of the following criteria: The testing is performed in a discipline other than Anatomic Pathology (ANP) or Cytopathology (CYP). (Exception: tests in ANP or CYP that can be assigned to another discipline) and