CAP Pro Course - Laboratory Management - Development and Implementation of a Quality Management System (2025 & 2026)

Author: Julie Ann West, PhD, MLS(ASCP)CM, SM(ASCP)CM
Reviewer: Joshua J. Cannon, MS, MLS(ASCP)CMSHCM

Continuing Education Credits

Objectives

  • Identify the essential components of a laboratory quality management system.
  • Assess pre-analytical, analytical, and post-analytical 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
      • As a supervisor or designee, which of the following would you decide not to include as one of the six core competencies to assess a clinical laborator...
      • A laboratory supervisor has an employee who has misinterpreted RPR results on three separate occasions. Other lab personnel have not had misinterpreta...
      • A laboratory supervisor is asked to cite examples of quality indicators, as required by their quality management system (QMS). Which of the following ...
      • With regard to laboratory testing, which one of the following types of documents lists the sequence of activities that are included in all phases of t...
  • Assess pre-examination, examination, and post-examination processes through monitoring of quality indicators.
      • Defining Quality Indicators
      • Key Indicators of Quality
      • Key Indicators of Quality, continued
      • Periodic Review of the QMS
      • A laboratory supervisor is preparing an annual quality report to present to their senior leaders. Which of the following would be standard and desired...
      • Which of the following is true concerning nonconforming events or adverse events?
      • Your job as laboratory supervisor includes support of the laboratory's QMS. You are asked to choose a few metrics to monitor laboratory quality. Which...
      • What is the primary reason for periodically reviewing the laboratory's quality management system (QMS)?
      • Which of these methods would be most effective in evaluating problem-solving skills as part of an employee's competency assessment?
  • 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
      • A medical laboratory scientist (MLS) runs a PSA test and obtains a result of 113 ng/mL. The patient had a previous result four days prior that had a r...
      • You want to ensure that patients are not harmed as a result of laboratory testing. Therefore, you want to identify and address risk-prone laboratory p...
      • A root cause analysis must be performed if a sentinel event occurs. A sentinel event is an unexpected event involving death or serious physical or psy...
      • A sentinel event investigation is necessary due to a serious unexpected injury to a patient. Which of the following activities is required in this inv...
  • Determine the effectiveness of the quality management system.
      • Evaluation of the Quality Management System (QMS)
      • Corrective Action and Preventive Action (CAPA)
      • An adverse event has happened in your hospital and an erroneous laboratory result was one of the contributing factors. What must you do to follow up?
      • A laboratory staff member is asked to evaluate their QMS, which went into use the previous year. Which of the following would be a useful way to asses...
      • A laboratory has just been inspected by its accrediting agency. The laboratory was cited for several deficiencies relating to quality issues. What pro...
  • 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 Information: 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: 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 an Education Developer. His areas of expertise and professional passions include clinical hematology and interprofessional education.

This course is part of the CAP Competency Assessment Hub.

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