Category: Compliance

AAB Files Brief in Support of PAMA Lawsuit

The American Association of Bioanalysts has filed in support of the American Clinical Laboratory Association lawsuit challenging the Medicare fee schedule implemented in January under the Protecting Access to Medicare Act (PAMA).

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FDA Regulation in Clinical Labs

According to FDA, today’s laboratory-developed tests are frequently manufactured using components and instruments that are not legally marketed for clinical use, and often rely on high-technology instrumentation and software to generate results and clinical interpretations.

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Risk Assessment for Clinical Labs

Shifting interpretations of the CLIA guidelines will allow clinical laboratories to develop alternative quality control policies, replacing equivalent quality control procedures, as of January 1, 2016. Rose Mary Casados, president of COLA Resources Inc, outlines the steps involved in establishing an Individualized Quality Control Plan.

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