Concept and Construction of a Laboratory Individualized Quality Control Plan

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Author: Ginger A. Baker, MBA, MS, MT (AAB)
Reviewers: Barbara Cebulski, MS, MLS(ASCP); Mark F. Roller, MLS(ASCP)

An individualized quality control plan (IQCP) is a QC plan that is tailored to a laboratory's unique environment (eg, testing personnel, samples, reagents, and testing systems). An IQCP is a quality management tool intended to identify and minimize the risks that could lead to the reporting of erroneous laboratory test results. This course discusses the basic principles of risk assessment and risk mitigation and identifies the tools that are useful for risk assessment. The course taker will learn how to develop an IQCP plan that is based on risk management as well as monitor and document IQCP success.

Continuing Education Credits


  • Explain the intent of an individualized quality control plan (IQCP).
  • Discuss the basic principles of risk assessment and risk mitigation.
  • Identify tools that are useful for risk assessment.
  • Develop an IQCP plan that is based on risk management.
  • Monitor and document IQCP success.

Course Outline

  • Individualized Quality Control Plan (IQCP) Introduction
      • Individualized Quality Control Plan
      • Risk and Risk Mitigation
      • IQCP and the Clinical Laboratory Improvement Amendments (CLIA) for Laboratories Operating in the United States
      • IQCP and CLIA, continued
      • The development of an individualized quality control plan (IQCP) involves three major steps, as shown below. Place the three steps in the order in whi...
  • Tools for Risk Assessment
      • Crafting an IQCP
      • Risk Identification
      • Risk Assessment
      • Risk Assessment Using a Fishbone Diagram
      • Determining the Probability and Severity of Harm
      • Process Map
      • What action should be taken if it is determined that a risk (failure) has a low probability of occurrence?
  • Quality Control Plan
      • Creating a Quality Control Plan (QCP)
      • Quality Control (QC) Tools
      • All of these actions could lead to a reduction in errors; however, some actions are more effective than others. Drag each of the actions listed below ...
  • Monitor IQCP for Effectiveness
      • Making Sure it Works
      • Successful Risk Mitigation
      • If a failure occurs after the IQCP process has been completed, the Quality Control Plan (QCP) that was written should be discarded. The entire IQCP pr...
  • Applying IQCP Principles
      • Example
      • Example -- Listing Steps in the Process
      • Example-- Observation
      • Example-- Documenting Observations
      • Example, continued-- Assessing Risk
      • Process Map-- Risks Assessed
      • Example-- Creating a Quality Control Plan (QCP) To Control Test Quality and Minimize Risk
      • Creating a Quality Control Plan (QCP) To Control Test Quality and Minimize Risk, continued
  • Conclusion
      • Conclusion and Further Resource Information
  • References
      • References

Additional Information

Level of instruction: Intermediate
Author information: Ginger A. Baker, MBA, MS, MT (AAB) is a consultant in lean six-sigma laboratory operation and workflow design, professional speaker, author, Chief of US Business Development for BITAC and the Manager of Laboratory Operations, St. Peter’s Hospital, Montana. In her career Baker has helped shape Laboratory Medicine through her work on multiple CLSI committees. She has worked in a multitude of settings, from a rural critical care hospital to academic urban multifaceted organizations, veterinary specialty laboratories, corporate settings, and consultation services. She holds a Masters in Business Healthcare Administration and Masters of Science in Project Management. Baker has authored articles and conducted seminars in Point-of-Care Testing, Laboratory operations, and Health informatics.
Reviewer information: Barbara Cebulski, MS, MLS(ASCP) has over 40 years of experience in the medical laboratory profession as a technologist, section supervisor, and laboratory manager. She was an Inspection and Technical Specialist for nine years with the College of American Pathologists in the Laboratory Accreditation Program and, until her retirement in 2015, was Program Director for MediaLab, Inc. Barbara holds a Masters in Instructional Technology from Georgia State University.
Reviewer information: Mark F. Roller, MLS(ASCP) is the Point of Care (POC) Coordinator and Laboratory Safety Officer at Salem Health in Oregon. He graduated from Andrews University, Berrien Springs, MI and holds a Bachelor of Science degree in Medical Technology. Mark is currently enrolled in the Master of Science in Administrative Studies program at Missouri State University.

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