Laboratory quality – a comprehensive look

By Nancy Ross MS, MT(ASCP)cmp, CQIA (ASQ), CLC (AMT), CQM/OE (ASQ); Irwin Z. Rothenberg; Graham K. Mafela, MLS (ASCP), MBA 


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

  1. Discuss the original focus of laboratory quality.
  2. Describe the evolution of how quality monitoring is changing.
  3. Differentiate between quality control and quality assurance.
  4. List the steps of a complete quality management system (QMS).

About the Authors

Nancy Ross MS, MT(ASCP)cmp is a U.S. Navy–trained clinical laboratory scientist with over 20 years of experience in hospital, reference, and academic laboratory settings. She is the founder of Improov Consulting, Inc., a laboratory consulting company focusing on performance improvement and quality.


Irwin Z. Rothenberg MBA, MS CLS (ASCP) has over 40 years of experience in laboratory medicine. He previously worked as the technical writer / quality advisor at COLA Resources, Inc. and is now a freelance technical writer for Improov Consulting. Irwin has contributed articles to several professional publications including Physician Office Resources; AAFP-PT POL Insight; Medical Laboratory Observer; and COLA Insights.

Graham K. Mafela, MLS (ASCP), MBA has over 20 years of experience in laboratory medicine and has been providing consulting services since 2012. He is ASCP board-registered as a Medical Laboratory Scientist and holds an MBA from Indiana Wesleyan University. He is the Chief Operations Officer for Improov Consulting.

Photo credit: Photo 105848572 / Work © motortion |

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 November 30, 2024.

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