Keeping It Clear: Best Practices for Laboratory Policies and Procedures

Dr. Alec Saitman will cover the role of policies, procedures, work instructions, validation data, and IFUs in daily laboratory operations. He will outline common approaches to developing policies and procedures of varying size and scope, along with strategies for leveraging document management systems.

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

Objectives:

• Explain the regulatory requirements for laboratory policies and procedures under CLIA and accrediting bodies (CAP, TJC, COLA).

• Describe the difference between policy, procedure, and work instruction.

• Apply best practices for drafting clear and compliant policies tailored to laboratory operations.

‍

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.

‍