CAP Pro Course - Laboratory Management - Development and Implementation of a Quality Management System

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Author: Julie Ann West, PhD, MLS(ASCP)CM, SM(ASCP)CM
Reviewer: Alexandru Casapu, MBA, MLS(ASCP)CM, PBTCM

Continuing Education Credits

Objectives

  • Identify the essential components of a laboratory quality management system.
  • Assess preanalytic, analytic, and postanalytic processes through monitoring of quality indicators.
  • Incorporate patient safety goals into the quality management system.
  • Determine the effectiveness of the quality management system.

Course Outline

  • Identify the essential components of a laboratory quality management system.
      • The Laboratory Quality Management System (QMS)
      • Documents Included in a QMS
      • Quality Policy and Quality Manual Components
      • Additional Components of the QMS
      • QMS: Ensuring a Competent Staff
      • Continual Improvement (CI) Requires Teamwork
      • Summary of QMS Processes and Controls
      • A QMS may include which of the following document types?
      • A QMS consists of many elements, but which is considered essential?
      • Which of the following job titles represents an important role in the continuous improvement (CI) aspect and administration of the QMS?
      • Which of the following would not be a task of a newly-appointed quality manager responsible for the laboratory's QMS?
      • As a laboratory supervisor, you must abide by the Clinical Laboratory Improvement Amendments (CLIA). What is the proper time interval at which you mus...
  • Assess preanalytical, analytical, and postanalytical processes through monitoring of quality indicators.
      • Defining Quality Indicators
      • Key Indicators of Quality
      • Key Indicators of Quality, continued
      • Periodic Review of the QMS
      • Which of the following is an essential element of a QMS that deals with process improvement?
      • Review the accompanying graph. What is true concerning this key indicator?
      • Which of the following is an example of a key indicator of laboratory quality recommended by the College of American Pathologists?
  • Incorporate patient safety goals into the quality management system.
      • Patient Safety
      • Monitoring Patient Safety In the Laboratory's Path of Workflow
      • Patient Safety: Reducing Harmful Delays
      • Which of the following is an error that can occur during the postanalytical phase of testing?
      • Which of the following is an accurate definition of a sentinel event?
  • Determine the effectiveness of the quality management system.
      • Evaluation of the Quality Management System (QMS)
      • Corrective Action and Preventive Action (CAPA)
      • Which of the following is true with regard to the difference between a corrective action and a preventive action?
      • Which of the following must be included in a QMS?
      • Which of the following will not assess accountability and quality of a laboratory system?
  • References
      • References

Additional Information

Level of Instruction: Intermediate
Intended Audience: This program is designed as an educational and training tool for MLS, MT, and MLT personnel, medical laboratory science students and interns, pathology residents, and practicing pathologists.
Author:  Dr. Julie Ann West is certified by the American Society for Clinical Pathology (ASCP) as a Medical Laboratory Scientist (MLS) and as a Specialist in Microbiology (SM). In addition, Dr. West has earned a PhD in Public Health - Infectious Disease Epidemiology - and is Certified in Public Health (CPH) by the National Board of Public Health Examiners. Dr. West is experienced as a Technical Specialist, Safety Officer, Educator, and Lead in the Veterans Administration Healthcare System, and has prior experience as an Administrative Laboratory Director.
Reviewer Information: Alexandru Casapu, MBA, MLS(ASCP)CM, PBTCM, has over 20 years of experience as a medical laboratory scientist, section supervisor, and laboratory manager. He is the former Director of Clinical Laboratory Technology Program at Georgia Piedmont Technical College. He is currently a Program Director at MediaLab, Inc. Alex holds BS degrees in Biology and Medical Technology from Clark Atlanta University and an MBA from the University of Georgia.

This course is part of the CAP Competency Assessment Hub.

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