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Regulation of Laboratory Developed Tests

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Clinical <strong>Laboratory</strong> Reference System<br />

The Department <strong>of</strong> Health's Wadsworth Center is charged with<br />

oversight <strong>of</strong> clinical laboratories and blood banks operating in New York<br />

State.<br />

This oversight is carried out through the Clinical <strong>Laboratory</strong> Reference<br />

System.<br />

Reference system activities include:<br />

•on-site surveys <strong>of</strong> facilities<br />

•pr<strong>of</strong>iciency testing <strong>of</strong> laboratories<br />

•review <strong>of</strong> laboratory personnel<br />

•reviewing and approving laboratory-developed assays

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