Navigating the Regulatory Environment

1 NSH Contact Hour(s)
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Presented by: Traci DeGeer, BS, HT(ASCP)HTL, Leica Biosystems, OK

In the everchanging specialties of immunohistochemistry and molecular diagnostics, it has become increasingly important to understand the regulatory implications of the assays we bring into the laboratory. This presentation will introduce the different regulatory bodies under which a laboratory can be set up depending on its work and the structure it is set up in. Examples of regulatory bodies to be discussed are CAP, CLIA, GLP, etc.

See more courses in: Management/Laboratory Operations

Continuing Education Credits

NSH Contact Hours (acceptable for AMT, ASCP, and state recertification): 1 hour(s)
Course number WEB0119
Florida Board of Clinical Laboratory Personnel Credit Hours - Supervision/Administration, Quality Control/Quality Assurance, and Safety: 1 hour(s)
Course number 20-719456, approved through 6/1/2021

Objectives

  • Summarize the basic functions of different regulatory bodies associated with the anatomic pathology lab
  • Understand how the regulatory bodies can impact the histology laboratory
  • Discuss other types compliance guidance and where that fits in the histology laboratory

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1 NSH Contact Hour

Additional Information

Course Description: In the everchanging specialties of immunohistochemistry and molecular diagnostics, it has become increasingly important to understand the regulatory implications of the assays we bring into the laboratory. This presentation will introduce the different regulatory bodies under which a laboratory can be set up depending on its work and the structure it is set up in. Examples of regulatory bodies to be discussed are CAP, CLIA, GLP, etc.
 
Presenter Bio:  Traci DeGeer is the Product Innovation Manager for the BOND RX platform and Advanced Staining Business Unit at Leica Biosystems. In this capacity she helps access new technologies for the Life Science research business, manages relationships with partners, works with legal partners to put agreements in place and liaises with Business Units to meet partner/customer needs as technologies are being developed. Traci holds a Bachelor of Science, in Biology, an HT, HTL, and QIHC for the anatomic pathology lab and recently graduated the HBx core program. Traci also holds a patent in small molecule detection for PDL-1 and has spoken at over one hundred state, regional and global symposia on various topics. Traci also sits on the ASCP Board of Certification (HT, HTL and QIHC Exam) and is the current Education Chair for the National Society of Histotechnology.
Additional Information: This webinar was presented January 2019 as part of the NSH Laboratory Webinar Series 
 

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