tailieunhanh - Clinical Laboratory Improvement Amendments (CLIA)

The goal of these selection processes is to build a comprehensive view of the scholarly literature across the major formats: journals, conference proceedings, and now scholarly books. By careful evaluation of the content and format of each publication, Thomson Reuters assures not only that all citation indexes in Web of Science contain the most relevant and timely research, but also that rigorous Bibliographic Control will ensure that this research is discoverable. But comprehensive does not necessarily mean all-inclusive. With books, as with journals and conference proceedings, there is a need to select those publications that will most likely contain significant. | Clinical Laboratory Improvement Amendments Clia Laboratory Director Responsibilities What Are My Responsibilities As A Laboratory Director NOTE 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 Medicaid Services CMS published final CLIA Quality Systems laboratory regulations that became effective April 24 2003. IS IT SUFFICIENT THAT I MEET THE EXPERIENCE EDUCATIONAL AND TRAINING REQUIREMENTS FOR A LABORATORY DIRECTOR UNDER CLIA No in addition you must meet the regulatory responsibilities outlined below. You must demonstrate active involvement in the laboratory s operation and be available to the laboratory staff as needed. WHAT ARE MY OVERALL RESPONSIBILITIES As laboratory director you are responsible for the overall operation and administration of the laboratory including the employment of competent qualified personnel. Even though you have the option to delegate some of your responsibilities you remain ultimately responsible and must ensure that all the duties are properly performed and applicable CLIA regulations are met. It is your responsibility to ensure that your laboratory develops and uses a quality system approach to laboratory testing that provides accurate and reliable patient test results. WHAT IS THE QUALITY SYSTEM APPROACH In the quality system approach the laboratory focuses on comprehensive and coordinated efforts to achieve accurate reliable and timely testing services. The quality system approach includes all of your laboratory s policies processes