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Regulating the Safety and Effectiveness of Clinical Laboratory Testing

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Manage episode 455199472 series 2396871
Content provided by ARUP Laboratories. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by ARUP Laboratories or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://staging.podcastplayer.com/legal.
Many people in the healthcare profession know that clinical laboratories are under more rigorous regulatory scrutiny than just about any other area of medicine. What they may not know is that the New York State Department of Health (NY DOH) was the pioneer in laboratory regulation, starting long before the implementation of either the FDA Medical Device Amendments or the Clinical Laboratory Improvement Amendments (CLIA) of 1988. In this interview, Beverly Rauch, MS, director of the NY DOH’s Clinical Laboratory Evaluation Program (NY CLEP), describes its process for granting permits, inspecting laboratories, and approving assays, and what the new FDA LDT rule might mean for the program.
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91 episodes

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iconShare
 
Manage episode 455199472 series 2396871
Content provided by ARUP Laboratories. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by ARUP Laboratories or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://staging.podcastplayer.com/legal.
Many people in the healthcare profession know that clinical laboratories are under more rigorous regulatory scrutiny than just about any other area of medicine. What they may not know is that the New York State Department of Health (NY DOH) was the pioneer in laboratory regulation, starting long before the implementation of either the FDA Medical Device Amendments or the Clinical Laboratory Improvement Amendments (CLIA) of 1988. In this interview, Beverly Rauch, MS, director of the NY DOH’s Clinical Laboratory Evaluation Program (NY CLEP), describes its process for granting permits, inspecting laboratories, and approving assays, and what the new FDA LDT rule might mean for the program.
  continue reading

91 episodes

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