Quality Management System
Continuing Education Credits
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. The course is applicable to all employees. It describes how a quality management system specifies roles, responsibilities, activities, actions, and documentation systems for maintaining a quality operation within the laboratory.
Objectives
- Differentiate quality assessment and quality control
- Outline the components of a quality management system inclusive of the quality assessment plan
- Describe the staff involvement in the implementation and on-going participation in the quality management system.
- Define and differentiate QMS and QSE
Course Outline
- Quality Management System (QMS)
- Quality Management System (QMS) Overview
- Definitions
- Quality System Essentials
- 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 laboratory specify components of quality in the laboratory. Which of the following represents appropriate components of laboratory quality?
- A new laboratory manager is revising the Quality Management Program. He is working to divide the workload among appropriate laboratory staff. Which of the following represents an accurate statement regarding the involvement of testing personnel in the quality management program? Select all that apply.
- Match the Quality System 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 staff participation?
- 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 accreditation agency. Which of the following represents an accurate statement about quality assessment and quality control testing?
- In the clinical chemistry department, quality control is performed with each run of patient testing. A new MLS completing orientation asks the supervisor to differentiate quality assessment from daily quality control testing. Which of the following is a correct statement regarding the data collected from the quality control testing?
- 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 document outlining a statement of intent for quality operations. Which of the following types of documents would include this statement of purpose?
- 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 discarding all old policies. Which of the following statements regarding the discarding documents is accurate?
- A laboratory director for a new laboratory is reading compliance requirements mandated by the accreditation organization. The accreditation agency requires step-by-step instructions for all test methods to be incorporated into the quality manual in one of the necessary document types. Which of the following documents would include these step-by-step instructions?
- 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 constructed?
- 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 aspects of the written plan could have resulted in a citation requiring corrective action?
- 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
- 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, MLS(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.
The author has no conflict of interest to disclose.
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.
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.