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Director's Responsibilities under CLIA Responsibilities that may be delegated to a technical consultant:* Select test methodologies appropriate for the laboratory * Verify performance characteristics of test systems * Establish and implement proficiency testing program * Establish and maintain acceptable levels of analytical performance of test systems * Establish and monitor quality control and quality assurance programs appropriate for testing systems in use * Direct resolution of technical problems beyond the expertise of testing personnel and assure that patient results are not reported unless test systems are functioning properly * Evaluate competency of personnel performing all aspects of testing * Identify training needs of testing personnel and assure that appropriate training is received * Provide a procedure manual describing all aspects of testing Responsibilities that may be delegated to a physician consultant: * Ensure that test reports contain information necessary for interpretation of results * Ensure that consultation is available regarding quality of test results and their interpretation Responsibilities that may not be delegated: * Ensure quality laboratory services for all aspects of testing performed * Ensure that the physical plant is appropriate and safe * Employ a sufficient number of personnel with appropriate education to perform their duties and provide training as necessary * Specify in writing the duties of laboratory personnel, including consultants * If responsibilities are delegated, ensure that all duties are properly performed |
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This article may be republished in its entirety on your web site or in your newsletter under the following two conditions: 1) Include the following statement at the beginning or end of the article. "Republished with permission of the author, Margaret A Knapp MT(ASCP) CLS, of KnappˇFrazer Consulting. www.knapp-frazer.com ~ 707.539.6621" 2) Send copy of your publication or URL to KnappˇFrazer Consulting at time of republication. |
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