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The quality management system approach applies a core set of quality system essentials to all operations in any healthcare service’s workflow path. POCT has multiple QA issues and, due to the rapid availability of results, POCT data can be seen and acted upon prior to the application of QC checks or other external mechanisms for assuring the validity of test results. Most errors in laboratory testing are pre-analytical in nature, followed by post-analytical, with only 15% occurring during the analytical phase. However, even though POCT has seen an overall reduction in errors, most occur during the analytical phase. POCT technology has evolved to a level of intelligent automation that detects single point failures and automatically stops the analytical process. Nevertheless, QC procedures are an essential part of the quality management system and must be able to detect mistakes to enable immediate correction. Surrogate and non-surrogate QC are not completely redundant and do not detect all assay errors. It is necessary that the sources of error in the POCT analytical process be identified and an individualized quality control plan be developed that mitigates the risks of error to acceptable levels.

Learning Objectives:

  • Discuss what a quality management system is and what quality system essentials are.
  • Describe the influence of POCT on the probability of occurrence of pre-analytical, analytical, and post-analytical errors.
  • Assess the nature of QC procedures and describe the differences between surrogate and non-surrogate quality control.
  • Explain the critical factors to consider when deciding the appropriate POCT QC system to implement.

​​​​This basic-level, complimentary webinar is produced by Whitehat Communications. Whitehat Communications is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program.

About the Speaker

Ellis Jacobs
Ellis Jacobs, PhD, DABCC, FACB
EJ Clinical Consulting, LLC

Dr. Ellis Jacobs is an independent consultant and Adjunct Associate Professor of Pathology at The Mount Sinai School of Medicine. He has more than 30 years of career experience in hospital laboratory leadership, clinical laboratory regulatory oversight and the diagnostic industry, regarding provision of diagnostic services, regulatory compliance, quality systems, and product development and clinical evaluation. Dr. Jacobs obtained a B.S. degree in Chemistry and Natural Sciences from Muhlenberg College in Allentown, PA in 1974 and a PhD in Biochemistry from the University of South Carolina in 1979. He completed postdoctoral training in Clinical Chemistry and Toxicology at the University of North Carolina at Chapel Hill in 1981 and was Director of Stat Labs and POCT at The Mount Sinai Hospital for 19 years. Dr. Jacobs has been involved in establishing clinical diagnostic regulatory and accreditation standards at the local, national, and international levels. He is a former Director of the New York State laboratory accreditation program and was appointed head of the NYS DOH Therapeutic Substance Monitoring, Clinical and Forensic Toxicology Proficiency Testing, and Limited Service Laboratory Accreditation programs. He is past Chair of the CLSI Expert Panel on POCT and most recently (before becoming a consultant) was Director of Scientific Affairs for Abbott Rapid Diagnostics (formerly Alere).

We thank the South Carolina POC Network for their commitment to supporting continuing education.

Orchard Software is a proud sponsor of this P.A.C.E®-accredited opportunity on behalf of ​Whitehat Communications