Course Outline
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- 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
- Requirements for Management
- CLIA '88 Requirements
- Accreditation by the College of American Pathologists (CAP)
- American Association of Blood Banks (AABB)
- 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)
- Non-conforming event management procedures are not required by some accrediting agencies.
- Match the following agency to the descriptive statement related to the regulatory/accreditation requirement or guidance
- 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
- 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
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.
