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“Patient Safety:

A Quality System Approach to POCT QC/QA”

Presented by Ellis Jacobs, Ph.D., DABCC, FACB

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Summary:  The quality management system approach applies a core set of “quality system essentials” to all operations in any health care service’s path of workflow.  There are multiple QA issues with POCT 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 mechanism for assuring the validity of test results.  The majority of errors in POCT are pre-analytical in nature, followed by post-analytical, with only 15% occurring during the analytical phase.  POCT technology has evolved to the level of autonomation, intelligent automation that detects single point failures and automatically stops the analytical process.  Never the less, 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.


Objectives:  After this webinar, you will be able to:

  • To understand what a Quality Management System is and what Quality System Essentials are.

  • To be able to describe the influence of POCT on the probability of occurrence of pre-analytical, analytical and post-analytical errors.

  • Understand the nature of QC procedures and be able to describe the differences between surrogate and non-surrogate Quality Control.

  • To be able to explain the critical factors to consider when deciding the appropriate POCT QC system to implement.

Vendor Sponsors:  Alere, Siemens, Accumetrics


About our SpeakerEllis Jacobs is the Associate Professor of Pathology at NYU School of Medicine and Director of Pathology at Coler-Goldwater Memorial Hospital.  Dr. Jacobs obtained a B.S. degree in Chemistry and Natural Sciences from Muhlenberg College in Allentown, PA, in 1974, and received his Ph.D. in Biochemistry from the University of South Carolina in 1979.  He completed postdoctoral training in Clinical Chemistry & Toxicology at the University of North Carolina, Chapel Hill in 1981. He joined the New York State (NYS) Department of Health (DOH) as the Director of the Clinical Laboratory Evaluation Program in 2002 and in 2005 was appointed Head of the NYS DOH Therapeutic Substance Monitoring and Clinical & Forensic Toxicology Proficiency Testing Programs, and Head of the NYS DOH Limited Service Laboratory Accreditation Program. He assumed his current positions in 2008. For over twenty years Dr. Jacobs has been involved in establishing clinical diagnostic regulatory and accreditation standards at the local, national and international levels.  Dr. Jacobs is active in the Clinical and Laboratory Standards Institute (CLSI) and has been a advisor and member of the US Technical Advisory Committee for ISO TC 212.

Last updated: 10/31/2011  Questions or corrections:  My Point of Point of Home