Beyond QC: Lot-to-Lot Verifications and Proficiency Testing Best Practices

Dr. Alec Saitman will share best practices for developing lot-to-lot comparison programs, weighing the benefits and challenges of purchasing large reagent lots, and establishing performance criteria using Total Allowable Error as a guide. The session will also address proficiency testing—covering its purpose, common pitfalls in handling PT materials, and strategies for leveraging PT data to predict and prevent future failures.

This presentation is the fifth webinar in the series, From CLIA to Competency: Raising the Standards of Excellence in Clinical Laboratory Practice.

Objectives:

• Describe the regulatory and accreditation requirements for lot-to-lot verification of reagents and test systems.

• Design lot-to-lot verification processes that use definable acceptance criteria

• Perform and interpret lot-to-lot comparison studies to ensure analytical consistency and accuracy.

• Explain the role of proficiency testing (PT) in laboratory quality assurance and compliance.

• Evaluate laboratory performance against PT and verification results to implement corrective and preventive actions.

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Dr. Alec Saitman, PhD, C(ASCP), DABCC (CC, TC)

Associate Professor and Director of Chemistry and Toxicology

Dr. Alec Saitman completed PhD training in total synthetic organic chemistry at the University of California, San Diego. He then went on to complete fellowship training in Clinical Chemistry and Toxicology in the Department of Pathology at the University of California, San Diego. He is board-certified by the American Board of Clinical Chemistry (ABCC) in Clinical Chemistry and Toxicological Chemistry.

Dr. Saitman is currently an Associate Professor of Pathology and Laboratory Medicine at Oregon Health and Sciences University (OHSU) and serves as the director of chemistry and toxicology. His research focuses on the development of small molecule quantitation assays using mass spectrometry. His areas of interest include laboratory stewardship and laboratory informatics. He is particularly interested in establishing efficient production workflows to meet the growing testing demands in his laboratory.

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