The Basics of Non-Conforming Event Management for Clinical Laboratory Services (Online CE Course)

(based on 269 customer ratings)

Lisa Dewey, BS, MT(ASCP)
Reviewer: Sheryl A. Whitlock, MA.Ed, MT(ASCP)BB

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One fundamental element of a quality management system (QMS) includes the management of non-conforming events (NCEs). Its general purpose is to cultivate an environment in which problems or occurrences can be used in a positive way to improve the quality of laboratory services. This course discusses the importance of non-conforming event management as a means of achieving laboratory quality objectives. Various data and tools used in managing corrective and preventive actions along with a list of the basic steps for a typical non-conforming event process are described by the authors of the course.

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Continuing Education Credits

P.A.C.E.® Contact Hours (acceptable for AMT, ASCP, and state recertification): 2 hour(s)
Approved through 6/30/2025
Florida Board of Clinical Laboratory Personnel Credit Hours - Supervision/Administration, Quality Control/Quality Assurance, and Safety: 2 hour(s)
Approved through 6/30/2025

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 269 customer ratings)

Course Outline

Click on the links below to preview selected pages from this course.
  • Introduction to NCE Management
      • The Laboratory Quality Management System and Non-Conforming Events (NCEs)
      • Nurturing a Culture of Open Communication
      • Compliance
      • NCE Programs
      • Which of the following statements describes the relationship between Quality Management System (QMS) and Non-Conforming Events (NCE)?
      • As part of the QMS, regulating and accreditation agencies require that laboratories have an orderly method for detecting and evaluating errors and eve...
  • 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
      • How do corrective actions/preventive actions (CAPA) improve the quality of laboratory services?
      • A laboratory has ordered 500 disposable lab coats but only receives 450 in the shipment. The shipping department immediately sends the laboratory the ...
  • Regulatory and Accreditation Requirements
  • 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 NCEs of Internal Origin
      • The Laboratory Director has been notified by the Risk Management department that a physician suspects his patient’s laboratory results caused a ...
      • The laboratory's Quality Committee is evaluating its quality monitor for QC failures on a test system that has a history of poor performance. A trend ...
      • Origins of NCEs may be data sources that are external or internal origin. Categorize each of the following items as internal or external origin by dra...
  • Using Corrective Actions vs. Preventive Actions in the Correct Scenarios
      • What to Report?
      • Distinguish Between Corrective Action and Preventive Action
      • Some NCE Scenarios
      • A nurse calls the laboratory from the patient care unit to discuss the test results that the nurse feels may not be accurate. The medical laboratory s...
      • A patient sitting in a raised position in the hospital bed falls from the bed when the caregiver steps away to empty the basin of bath water. Which of...
  • 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
      • When analyzing NCEs, you may want to detect which of the following trends?
      • Implementation
      • Implementation, continued
      • Verification of Effectiveness
      • Verification
      • Verification, continued
      • Verification: Evidence
      • Why Verification May Fail
      • Communication
      • Communication, continued
      • Management Review
      • Documentation
      • New procedural steps have just been implemented in the Hematology laboratory in response to a non-conformity. What must be done next?
      • The basic steps of an NCE Management program must be performed in a specific order. Place in order the following NCE management program steps from beg...
      • The laboratory supervisor is searching for evidence of the effectiveness of a change in the ordering process intended to reduce the cost of disposable...
  • Reporting Systems for Non-Conforming Events
      • Non-Conformity Reporting
      • Status Tracking
      • Trend Analysis
      • Trend Analysis: Pareto Charts
      • Summary
      • In the Pareto chart shown, which NCE shows the greatest frequency?
      • In the same Pareto chart, the amount of risk associated with each category is shown to be the highest for corrected reports.
      • Which of the following represents a trend analysis?
  • 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: Sheryl A. Whitlock, MA.Ed, MT(ASCP)BB is the owner of ARK Laboratory Consulting, LLC. Sheryl served as the laboratory coordinator for the Student Health Services Laboratory at the University of Delaware for 15 years. Sheryl received her Master’s degree in Education from Arcadia University. She has more than 35 years of experience in laboratory science to include management, education, and hands-on bench experience. She has written and published textbooks and laboratory manuals as well as having contributed to numerous online and print articles in the field of laboratory medicine.

How to Subscribe
MLS & MLT Comprehensive CE Package
Includes 180 CE courses, most popular
$109Add to cart
Pick Your Courses
Up to 8 CE hours
$55Add to cart
Histology CE Package$69Add to cart
Histology CE User Increase$69Add to cart
Individual course$25Add to cart
Need multiple seats for your university or lab? Get a quote
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5 whys example_created by lisa dewey


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