Quality Control Requirements For Waived Testing at Dave Morris blog

Quality Control Requirements For Waived Testing. Quality control • follow manufacturer’s instructions • frequency of qc is defined by the manufacturer • external controls run as required. Waived tests include test systems cleared by the fda for home use and those approved for waiver under the clia criteria. The requirements in this checklist for quality control and calibration are different for waived testing, as compared to nonwaived. Clia ’88 classifies testing into four complexity levels: Quality control results, including internal and external controls for waived testing, are documented. Qualification and training, quality control (qc) (unless specified as required in the test system instructions), proficiency testing (pt), quality.

PPT CLIA Waived Testing for Physician Office Labs PowerPoint
from www.slideserve.com

Qualification and training, quality control (qc) (unless specified as required in the test system instructions), proficiency testing (pt), quality. Clia ’88 classifies testing into four complexity levels: Quality control • follow manufacturer’s instructions • frequency of qc is defined by the manufacturer • external controls run as required. Waived tests include test systems cleared by the fda for home use and those approved for waiver under the clia criteria. Quality control results, including internal and external controls for waived testing, are documented. The requirements in this checklist for quality control and calibration are different for waived testing, as compared to nonwaived.

PPT CLIA Waived Testing for Physician Office Labs PowerPoint

Quality Control Requirements For Waived Testing Clia ’88 classifies testing into four complexity levels: Quality control • follow manufacturer’s instructions • frequency of qc is defined by the manufacturer • external controls run as required. Qualification and training, quality control (qc) (unless specified as required in the test system instructions), proficiency testing (pt), quality. Waived tests include test systems cleared by the fda for home use and those approved for waiver under the clia criteria. The requirements in this checklist for quality control and calibration are different for waived testing, as compared to nonwaived. Clia ’88 classifies testing into four complexity levels: Quality control results, including internal and external controls for waived testing, are documented.

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