Applying laboratory quality principles to real world point-of-care testing systems

By Kathleen David, MT(ASCP), Jeanne Mumford, MT(ASCP)


Upon completion of this article, the reader will be able to:

  1. Discuss the need for a quality management system (QMS) in point-of-care testing (POCT). 
  2. List the quality system essentials that are recommended for a laboratory QMS. 
  3. Describe how each quality system essential can be applied to a POCT program. 
  4. Differentiate between quality assurance (QA) and quality control (QC).

About the Authors

Kathleen David, MT(ASCP) is the Associate Director for Point of Care at TriCore Reference Laboratories in Albuquerque NM, which covers all of New Mexico. She has been in the lab field for over 48 years and in POCT for over 25 years. Her work encompasses 3 health systems, with 16 hospitals and over 120 clinics, urgent care centers, free-standing ED/UC, and physician offices performing POCT 

Jeanne Mumford, MT(ASCP) is the Pathology Manager for Point-of-Care Testing (POCT) for Johns Hopkins Medicine. Jeanne offers 23 years of experience in point-of-care testing regulatory oversight, quality assurance projects, and laboratory inspection preparedness and planning as a medical laboratory scientist. She participates in many professional organizations including the Critical and POCT Division of AACC and the CLSI Expert Panel for POCT.

Photo credit: 211245608 © Megaflopp |

Not Enrolled

Course Includes

  • 1 Article
  • 1 Test
  • Course Certificate
  • MLO and Northern Illinois University (NIU), DeKalb, IL, are co-sponsors in offering continuing education units (CEUs) for this issue’s CE article. CEUs or contact hours are granted by the College of Health and Human Sciences at Northern Illinois University, which has been approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® program. Continuing education credits awarded for successful completion of this test are acceptable for the ASCP Board of Registry Continuing Competence Recognition Program. Readers who pass the test successfully (scoring 70% or higher) will receive a certificate for 1 contact hour of P.A.C.E.® credit. The fee for this continuing education test is $20. This test was prepared by Amanda Voelker, MPH, MT(ASCP), MLS, Clinical Education Coordinator, School of Health Studies, Northern Illinois University, DeKalb, IL.

    Level of Instruction: Intermediate
    Passing scores of 70 percent or higher are eligible for 1 contact hour of P.A.C.E. credit. This test is no longer valid for CEUs after February 28, 2025.

    NIU is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program.