The Basics of Non-Conforming Event Management for Clinical Laboratory Services
Continuing Education Credits
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.
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.
Course Outline
- Introduction to Non-Conforming Event Management
- The Laboratory Quality Management System and Non-Conforming Events
- 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 events that may impact patient care. Arrange the steps of the process in the order that they should be completed.
- Terms Used in an NCE Management Program
- Reportable Events
- Other Reportable Events
- Corrections, Corrective Actions, and Preventive Actions
- Corrective and Preventive Action
- Risk
- Root Cause
- Which of the following options incorrectly describes corrective and preventive actions (CAPA)?
- A laboratory has ordered 500 disposable lab coats but only receives 450 in the shipment. The shipping department immediately sends the laboratory the 50 missing lab coats. What does this action describe?
- 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
- The Joint Commission (TJC)
- Det Norske Veritas Germanischer Lloyd (DNV GL)
- Laboratory-Developed Tests
- Clinical and Laboratory Standards Institute (CLSI)
- True or False: Non-conforming event management procedures are not required by some accrediting agencies.
- 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
- True or False: The Laboratory Director has been notified by the Risk Management department that a physician suspects his patient’s laboratory results caused a near-miss in treatment options.Since no actual harm was done to the patient, this is NOT an example of a situation when an NCE should be reported.
- True or False: 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 on the monitor shows that there are increased numbers of outliers for this test system. This is an internal data source for corrective/preventive action.
- Using Corrective Actions versus 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 scientist (MLS) investigates. The findings indicate that the incorrect result was documented in the test report. Which statement best describes a corrective action process applied to this problem?
- 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 the following represents a preventative action for this incident?
- Basic Steps of an 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, which of the following questions is typically not part of the analysis?
- 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 laboratory supervisor is searching for evidence of the effectiveness of a change in the ordering process intended to reduce the cost of disposable pipettes. Which of the following may serve as appropriate evidence?
- 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?
- True or False: 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: Intermediate
Intended Audience: Medical laboratory scientists, medical laboratory
technicians, laboratory supervisors, and laboratory managers. This course is
also appropriate for MLS and MLT students and pathology residents.
Author Information: Lisa Dewey, MLS(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.
The author has no conflict of interest to disclose.
Reviewer Information:
Sheryl A. Whitlock, MA.Ed, MLS(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, including 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.
Joshua J. Cannon, MS, MLS(ASCP)CMSHCM received his Bachelor
of Science and Master of Science in Medical Laboratory Science from Thomas
Jefferson University in Philadelphia, PA. He holds Medical Laboratory Scientist
and Specialist in Hematology certifications through the ASCP Board of
Certification. He was a professor at Thomas Jefferson University for seven
years before transitioning into his current role as Education Developer at
MediaLab by Vastian. His areas of expertise and professional passions include
clinical hematology and interprofessional education.