The Basics of Non-Conforming Event Management for Clinical Laboratory Services (by LabCE)

2 P.A.C.E. contact hour(s)

(based on 211 customer ratings)

Lisa Dewey, BS, MT(ASCP)
Reviewer: Jack A. Maggiore, PhD, MT(ASCP)

Course provided by LabCE.

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Included In These Course Packages

Continuing Education Credits

P.A.C.E.® Contact Hours (acceptable for AMT, ASCP, and state recertification): 2 hour(s)
Course number 578-019-17, approved through 5/30/2019
Florida Board of Clinical Laboratory Personnel Credit Hours - Supervision/Administration, Quality Control/Quality Assurance, and Safety: 2 hour(s)
Course number 20-576395, approved through 9/1/2018

Objectives

  • Recognize the importance of non-conforming event management as a means of achieving laboratory quality objectives.
  • Understand the purpose of corrective actions and preventive actions, including distinguishing between the types of actions.
  • Identify various data and tools used in managing corrective and preventive actions.
  • List the basic steps of a typical non-conforming event process.
  • Demonstrate an awareness and understanding of compliance concerns.

Customer Ratings

(based on 211 customer ratings)

Course Outline

  • Introduction to NCE Management
      • The Laboratory Quality Management System and Non-Conforming Events (NCEs)
      • Nurturing a Culture of Open Communication
      • Compliance
      • NCE Programs
  • Terms Used in a NCE Management Program
      • Reportable Events
      • Other Reportable Events
      • Corrections, Corrective Actions, and Preventive Actions
      • Corrective Action / Preventive Action
      • Risk
      • Root Cause
  • Regulatory and Accreditation Requirements
      • Requirements for Management
      • CLIA '88 Requirements
      • Accreditation by the College of American Pathologists (CAP)
      • American Association of Blood Banks (AABB)
      • Commission on Office Laboratory Accreditation (COLA)
      • The Joint Commission (TJC)
      • Det Norske Veritas Germanischer Lloyd (DNV GL)
      • Laboratory-Developed Tests and the Food and Drug Administration (FDA)
      • Clinical and Laboratory Standards Institute (CLSI)
  • Sources of Information About Non-Conformities
      • Sources of NCEs and Prioritizing Based on Risk
      • NCEs of External Origin
      • Examples of NCEs of External Origin
      • Examples of NCE's of Internal Origin
  • Using Corrective Actions vs. Preventive Actions in the Correct Scenarios
      • What to Report?
      • Distinguish Between Corrective Action and Preventive Action
      • Some NCE Scenarios
  • Basic Steps of a NCE Management Program
      • Management of Non-Conforming Events
      • Identification
      • Identification, continued
      • Reporting Form
      • Investigation
      • Analysis
      • Five Whys
      • Analysis: Cause and Effect Diagram
      • Analysis: Possible Root Causes
      • Implementation
      • Implementation, continued
      • Verification of Effectiveness
      • Verification
      • Verification, continued
      • Verification: Evidence
      • Why Verification May Fail
      • Communication
      • Communication, continued
      • Management Review
      • Documentation
  • Reporting Systems for Non-Conforming Events
      • Non-Conformity Reporting
      • Status Tracking
      • Trend Analysis
      • Trend Analysis: Pareto Charts
      • Summary
  • References
      • References

Additional Information

Level of Instruction: Basic to intermediate
Intended Audience: The target audience for this course is laboratory professionals who act in an administrative capacity or would like to increase their knowledge regarding laboratory administrative issues. The course is also appropriate for Clinical Laboratory Science students. 
Author Information: Lisa Dewey, MT(ASCP) has been a Medical Technologist since obtaining her Bachelor’s degree in Clinical Laboratory Science from the University of Illinois at Chicago. Lisa has experience working in various specialties in hospital and clinic laboratories, research & development, and commercial laboratories specializing in dried blood spot testing. She has held positions as a bench technologist, supervisor, and manager. She is currently the Quality Manager at Doctor's Data, Inc., a specialty reference laboratory. As an active Board Member of her CLMA chapter, Lisa is working to promote education and awareness in the Laboratory Science Industry.
Reviewer Information: Jack A. Maggiore, PhD, MT(ASCP) serves as the Assistant Laboratory Director of Chemistry and is Head of Research and Development at Doctor's Data, Inc. in Saint Charles, Illinois. Dr. Maggiore is a medical technologist, certified by the ASCP, with a Master of Science in Clinical Chemistry and Doctorate in Pathology from the University of Illinois. His expertise includes clinical instrumentation, method development and validation, quality assurance, medical device clinical trials, and scientific regulatory affairs. His clinical research interests include development of novel biomarkers for chronic diseases using blood spots and other non-conventional samples. Dr. Maggiore holds several medical device patents, has authored more than fifty peer-reviewed and invited publications and textbook chapters, and has presented his research findings at international scientific society meetings. Dr. Maggiore's mission is to work with health care professionals to empower consumers to take a more active role in their health maintenance. 

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