= Emerging. More than 5 years before clinical availability. (26.62%)
= Expected to be clinically available in 1 to 4 years. (38.91%)
= Clinically available now. (34.47%)
MSACL 2020 US : Shugarts

MSACL 2020 US Abstract

Topic: Practical Training

Podium Presentation in Room 6 on Wednesday at 14:00 (Chair: Grace van der Gugten)

What Do You Do When Your Good Assay Goes Bad?

Sarah Shugarts, Howard Horng

Presenter Bio(s): Dr. Sarah B. Shugarts is the Technical Director of Toxicology at Kaiser Permanente, Northern CA. She has a B.S. in Chemistry from Shippensburg University, a Ph.D. in Pharmaceutical Sciences and Pharmacogenomics from UCSF under Dr. Leslie Benet, did her Clinical Chemistry fellowship at UCSF under Dr. Alan Wu, and is board certified in Clinical Chemistry and in Toxicological Chemistry.
Dr. Howard Horng is an R&D Scientist in Special Chemistry at Kaiser Permanente, Northern California. He has a B.S. in Biochemistry from the University of California, Riverside, a Ph.D. in Pharmaceutical Sciences and Pharmacogenomics from the University of California, San Francisco (UCSF) under Dr. Leslie Benet, followed by a Clinical Chemistry fellowship at UCSF under Dr. Alan Wu.

Authors: Dr. Sarah B. Shugarts, Dr. Howard T. Horng
Kaiser Permanente, Northern California


Session Description:

What happens when an LC-MS/MS assay passes validation, is put into production, and then it breaks? This session will address strategies for managing an assay that fails upon or following implementation.

Two real world examples of LC-MS/MS assays that were fully validated and which failed following implementation will be discussed: 1) an assay failure due to an interference in a urine drug testing LC-MS/MS method; and 2) a failure due to difficult to resolve hardware issues in a urine catecholamines LC-MS/MS method.

The discussions will centre on 1) how we can avoid these situations in the first place! 2) what to do when a failure happens in order to continue to be able to provide patient results and 3) how to re-establish staff confidence in a test that has had problems.

Take Home Pearls:

1. No matter how fully you validate a method, there are still unknown unknowns that can happen when an assay is live.

2. You need to have a backup plan when a sudden and extreme method failure occurs that is not easily resolved in a few days.

3. Failures that occur after a full validation often require thinking outside the box, reaching out to multiple resources for help, and multi-tasking to maintain providing high quality results for patients while solving the problem.

Financial Disclosure

Board Memberno
IP Royaltyno

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