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Step 2.
Get a CLIA Certificate of Waiver
The LeadCare II blood-lead test is a CLIA-waived system. All facilities that use the system to perform blood-lead tests must have a CLIA Certificate of Waiver and must follow the manufacturer's recommendations for test performance and quality control. Those performing the test must also comply with applicable state and local laws, some of which impose additional requirements on users. Click on the links below for more information and downloadable forms.
What does the LeadCare II system's CLIA-waiver designation mean?
The FDA sets the bar very high in classifying tests as "waived." Accordingly, less than one percent of all laboratory tests are so classified. Manufacturers must prove through a rigorous application process that the test employs methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or that it poses no reasonable risk of harm to the patient if the test is performed incorrectly. The FDA not only reviews clinical trial, performance, and accuracy data, it also assesses the instruction manual to ensure that it adequately prepares a potential user to operate the system correctly right out of the box without extensive training or special credentials. In addition, as part of the clearance process, the FDA evaluates the manufacturer's recommendations for quality control, maintenance, and practices that users must follow when performing the test.
Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed. The final CLIA regulations were published in the Federal Register on February 28, 1992. The requirements are based on the complexity of the test and not the type of laboratory where the testing is performed. On January 24, 2003, the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) published the final CLIA Quality Systems laboratory regulations that became effective April 24, 2003.
CLIA categorizes test methods into three levels of complexity (Waived Complexity; Moderate Complexity, including Provider-Performed Microscopy Procedures; High Complexity). The more complicated the test, the more stringent the requirements. For laboratories performing moderate and/or high complexity tests, CLIA specifies quality standards for proficiency testing, facility administration, general laboratory systems, pre-analytic, analytic, and post-analytic systems, personnel qualifications and responsibilities, quality control, quality assessment, and specific cytology provisions. For labs performing only waived tests, CLIA requires a Certificate of Waiver, and labs are required to follow the manufacturer's recommendations for test performance and quality control.
More details
To purchase a LeadCare II system, call (800) 305.0197
To request details on the LeadCare II test:
Doctors click here
Public health click here
