Concept and Construction of a Laboratory Individualized Quality Control Plan
Continuing Education Credits
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.
Objectives
- 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. Place the steps in the order in which they should occur in the process.
- 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. Match each of the actions listed below under either the heading "strong action" or "weak action."
- Monitor IQCP for Effectiveness
- Making Sure It Works
- Successful Risk Mitigation
- True or False: 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 process should be repeated and a new QCP should be written.
- Applying IQCP Principles
- Example
- Example: Listing Steps in the Process
- Example: Observation
- Example: Documenting Observations
- Example: Assessing Risk
- Example: Process Map
- Example: Creating a Quality Control Plan (QCP)
- Example: QCP to Control the Test Quality and Minimize Risk
- Conclusion
- Conclusion and Further Resource Information
- References
- References
Additional Information
Level of Instruction: Intermediate
Intended Audience: Laboratory administration and management to include medical laboratory scientists and technicians. This course is also appropriate for medical laboratory science students and pathology residents.
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 Master's in Business Healthcare Administration and a Master of Science in Project Management. Baker has authored articles and conducted seminars in Point-of-Care Testing, Laboratory operations, and Health informatics.
The author has no conflict of interest to disclose.
Reviewer Information: Judi Bennett, BSM, MLS, is an Education Developer with MediaLab by Vastian, bringing over 30 years of experience as a medical laboratory scientist. Before joining MediaLab in 2010, she held key leadership roles, including Clinical Laboratory Manager, Microbiology Supervisor, and Senior Systems Analyst at Gwinnett Health System in Lawrenceville, Georgia. Her extensive knowledge of laboratory operations, combined with a strong commitment to healthcare quality and education, fuels her passion for developing engaging and effective learning tools for the next generation of laboratorians.