November Event: Laboratory Developed Tests (LDTs): Regulatory Requirements and Challenges
Monthly Program:
Wednesday, November 14th, 2018
Laboratory Developed Tests (LDTs): Regulatory Requirements and Challenges
Program Speaker:
Claudia Ibarra, CCS, MB (ASCP)
Event Agenda: Date:
Wednesday, November 14th, 2018
Time: 5:15 – 6:00 PM Registration & Snacks
5:30 – 5:55 PM Speed Networking
6:00 – 6:05 PM Welcome and Announcements
6:05 – 7:05 PM Program Presentation
7:05 – 7:30 PM Q & A
LOCATION:
BD (former CareFusion)
3770 Torrey View Court
San Diego, CA 92130
View Map Program Topic:
Laboratory developed tests (LDTs) refer to an in vitro diagnostic test that is designed, manufactured and used within a single laboratory. Although the uses of an LDT may be the same as an FDA-cleared or FDA-approved in vitro diagnostic test, LDTs are not regulated in the same way. In fact, LDTs generally do not have any oversight or review by FDA prior to use. In 2010, FDA reconsidered its approach to LDTs and started a conversation with LDT stakeholders. However, the LDT topic remains complex and the method of enforcing LDTs is still under development eight years later.
Program Summary:
The program will provide an overview of Laboratory Developed Tests (LDTs) including:
FDA Perspectives from 2010 to now
Regulations pertaining to LDTs under Clinical Laboratory Improvement Amendments (CLIA) vs. FDA
Validation and implementation of LDTs in a CLIA laboratory
College of American Pathologists (CAP) regulations and checklist
Updates on state regulations (e.g. New York and California)
Audits and inspections, license renewals, proficiency testing
Personnel licensure and continuing education
Reimbursement strategies
Speaker Biography:
Claudia Ibarra has over 25 years of experience in the clinical diagnostic field. She is currently the Senior Vice President of Laboratory Operations at Exagen Diagnostics. Mrs. Ibarra joined Exagen Diagnostics in 2012 as head of operations, where she grew the clinical laboratory to 25+ scientists who perform over 10,000 tests per day in the area of rheumatology. Mrs. Ibarra started her career at the Children’s Hospital Ricardo Gutierrez where she was trained in Chemistry and Hematology. She worked in a variety of cutting-edge clinical laboratories in Argentina in the areas of Clinical Chemistry, Endocrinology and Immunology. Mrs. Ibarra was the Director of the Molecular Oncology Laboratory at Genoptix, a Novartis Company, where she expanded laboratory capacity ten-fold in five years and was in charge of the validation and transfer of new assays. Mrs. Ibarra also acted as the coordinator of the California State Clinical Genetics Molecular Scientist Training Program. Mrs. Ibarra holds a degree in Biochemistry with specialization in Clinical Laboratory Science from University of Buenos Aires, Argentina, a Clinical Chemistry license from the State of California, and a Molecular Biology license from ASCP.
Please make your reservation early. The online registration due date is Monday, September 17th, 2018. Credit Cards are accepted online only. Cash and Check are accepted at the door. There will be no refunds for cancellations.
Online Pre-registration
through Monday November 12th, 2018
credit card only $15 SDRAN Member, $25 Non-Member
Onsite Registration
cash or check only $25 SDRAN Member, $35 Non-Member
For Questions Email: programs@sdran.org
DIRECTIONS:
From the North 5:
I-5 South toward San Diego
Exit toward Carmel Mountain Rd
Left onto Carmel Mountain Rd
Left onto Torrey View Court
Facility is on the right
From the South 5:
I-5 North toward Del Mar
Merge onto I-5 local Bypass
Take Carmel Mountain Rd exit (32)
Turn right onto Carmel Mountain Rd
Turn left onto Torrey View Court
Facility is on the right
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