By Nancy Ross MS, MT(ASCP)cm, CQIA (ASQ), CLC (AMT), CQM/OE (ASQ); Irwin Z. Rothenberg;
Graham K. Mafela, MLS(ASCP), MBA
This article explores the evolution of quality management in clinical laboratories, highlighting the shift from traditional, analytically focused quality control to a comprehensive, data-driven approach across the total testing process. It examines how errors increasingly originate in pre- and post-analytical phases, emphasizing the critical role of informatics in standardizing workflows, improving communication, and enabling real-time quality monitoring. It also introduces emerging applications of artificial intelligence (AI) and machine learning (ML), demonstrating their potential to detect patterns, predict risks, and transition laboratories from reactive to proactive quality systems. Key considerations for successful implementation, including data readiness, meaningful metrics, and organizational culture, are also discussed.
LEARNING OBJECTIVES
Upon completion of this article, the reader will be able to:
- Differentiate between analytical, pre-analytical, and post-analytical phases of laboratory testing.
- Describe the evolution of laboratory quality management systems by explaining the shift from reactive, QC-focused models to proactive models.
- Discuss concepts of digital and informatics-driven quality management through examples of standardized, auditable workflows.
- Discuss the importance of the role of artificial intelligence and real-time quality indicators in modern laboratory practice by including predictive analytics, data readiness, and team involvement.
About the Presenters
Nancy Ross MS, MT(ASCP)cm, CQIA (ASQ), CLC (AMT), CQM/OE (ASQ) 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. 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.
Course Includes
- 1 Lesson
- 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 May 2027.
NIU is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program.
