Course Outline
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- Quality Management System (QMS)
- Quality Management System (QMS) Overview
- Definitions
- The Quality System Essentials (QSEs)
- Path of Workflow
- Staff Knowledge and Participation
- The quality manager is writing a new quality procedure to comply with changes in the accreditation agency's requirements. The agency requires that the...
- A new laboratory manager is revising the Quality Management Program. He is working to divide the workload among appropriate laboratory staff. Which of...
- Match the Quality Essential with the appropriate descriptor.
- The laboratory manager and supervisors are charged with involving all staff members in the QMS. Which of the following is a true statement regarding s...
- Quality Assessment and Quality Control
- Differentiation of Quality Assessment and Quality Control
- The laboratory management is revising the quality assessment program. Quality controls for all test systems are in place and compliant with the accred...
- In the clinical chemistry department, quality control is performed with each run of patient testing. A new technologist completing orientation asks th...
- Documenting the Quality Management System
- Documentation of the Quality Management System
- The laboratory manager is reviewing quality documentation in preparation for a compliance survey. The compliance organization checklist requires a doc...
- The quality manual outlines the laboratory's quality management system. Which of the following personnel should have access to this manual?
- Compiling a Quality Manual
- The laboratory director is reviewing the quality manual for an upcoming compliance survey. As the policies are revised and approved, the director is d...
- A laboratory director for a new laboratory is reading compliance requirements mandated by the accreditation organization. The accreditation agency req...
- Quality Assessment Plan
- The quality assessment plan for any laboratory is comprehensive. Which of the following statements is true and related to the plan?
- All employees review the laboratory's quality assessment plan. Which of the following testing phases must be incorporated into this plan when construc...
- Quality Assessment Reviews
- The laboratory managers are working to revise the standing quality assessment plan due to a deficiency in a recent survey. Which of the following aspe...
- Several new employees' personnel files lack some qualification documentation. Which of the following represents the next appropriate step?
- Regulatory Agencies and Quality Assessment
- Regulatory Requirements
- Match the agency with the requirement for compliance
- 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.
Course Description: Quality is vital to all laboratory operations. This course describes how an organization must establish a structured system to provide guidance and requirements for maintaining quality in the entire laboratory operation. It applies to all employees and describes how a quality management system specifies roles, responsibilities, activities, actions, and documentation systems for maintaining a quality operation within the laboratory.
Author Information: Sheryl A. Whitlock, MA. Ed, MT(ASCP)BB owns 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 in Glenside, Pennsylvania. She has more than 35 years of experience in laboratory science. She has written and published textbooks and laboratory manuals and contributed to numerous online and print articles in laboratory medicine.
Reviewer Information: Kevin F. Foley, PhD, DABCC, MT, SC, is the director of clinical pathology for the Kaiser Permanente Northwest region. He also teaches clinical chemistry at Oregon Health Sciences University. Dr. Foley earned his PhD in clinical pharmacology and toxicology at East Carolina School of Medicine in North Carolina. He received a PhD in clinical pharmacology and toxicology from Brody School of Medicine, Greenville, NC. He has worked in laboratory medicine for over 15 years, starting his career as a medical technologist.
