Course Title: Quality Control & Laboratory Management Course Code: CLS 494 Program: Bachelor of Clinical Laboratory Sciences Department: Clinical Laboratory Sciences College: College of Applied Medical Sciences Institution: Taibah University Version: V2 Last Revision Date: 17/01/1438 AH A. General information about the course: 1. Course Identification 1. Credit hours: (2 CH) 2 T 2. Course type A. ? University ? College ? Department ? Track ? Others B. ? Required ? Elective 3. Level/year at which this course is offered: Level: 8 Year: 4 4. Course general Description: This course focuses on the principles, methodologies, and tools necessary to maintain and improve the quality and efficiency of laboratory services. It integrates theoretical knowledge with practical applications to ensure the reliability of laboratory testing, which is critical for patient care and clinical decision-making. Students will delve into various aspects of laboratory management, including leadership, financial management, human resources, and operations management. The course emphasizes the importance of adhering to national and international regulatory standards. The course also prepares students for leadership roles in the clinical laboratory environment and encourages a culture of lifelong learning and ethical practice. 5. Pre-requirements for this course (if any): Medical Bacteriology 2 (CLS 362) Clinical Biochemistry 2 (CLS 368) 6. Co-requisites for this course (if any): None 7. Course Main Objective(s): • Implement quality control procedures and manage laboratory operations efficiently. • Navigate regulatory landscapes and accreditation processes. • Uphold ethical standards and ensure patient safety. • Employ critical thinking and problem-solving skills in laboratory management. • Foster a culture of continuous improvement and professional development. No Mode of Instruction Contact Hours Percentage 1 Traditional classroom 30 100% 2 E-learning 0 0 3 Hybrid • Traditional classroom • E-learning 0 0 4 Distance learning 0 0 3. Contact Hours(based on the academic semester) No Activity Contact Hours 192. Lectures 30 193. Laboratory/Studio 0 194. Field 0 195. Tutorial 0 196. Others (specify) 0 Total 30 B. Course Learning Outcomes (CLOs), Teaching Strategies and Assessment Methods Co de Course Learning Outcomes Prog PLO Teaching Strategies Assessment Methods 1.0 Knowledge and understanding 1.1 Understand the core principles of quality control, including the processes needed to ensure the accuracy and reliability of laboratory results and the impact of quality control on patient care. K2 5. Interactive Lectures (intended to provide a solid foundation of knowledge on each topic while also stimulating students' curiosity for additional reading and exploration). 6. Group discussion (Faculty will encourage questions, discussion, and critical thinking during each lecture) • Final exam: (Section 2: Short answer questions) 1.2 Exhibit comprehensive knowledge of regulatory requirements for clinical laboratories, and key concepts of laboratory management, including organizational structure, policies, financial management, and leadership's role in fostering quality and efficiency K3 • Final exam: (Section 1: MCQ) de Course Learning Outcomes Prog PLO Teaching Strategies Assessment Methods 2.0 Skills 2.1 Implement quality control measures, optimize laboratory workflows, and ensure compliance with biosafety regulations to maintain a safe and efficient laboratory environment S1 1. Group Project (Assign group projects that require students to collaboratively design a quality control system for a hypothetical laboratory, considering budget constraints, regulatory requirements, and workflow efficiency.) 2. Practical Simulations (Introduce computer simulations to give students virtual experience with laboratory management software systems, including how to input and interpret data.) • Group Project 2.2 Exhibit the ability to independently identify problems within laboratory processes and apply critical thinking skills to develop and implement appropriate solutions S2 3.0 Values, autonomy, and responsibility 3.1 Adhere to professional ethics in clinical laboratory management, independently solve problems, and contribute to continuous quality improvement through audits and staying updated on advancements V2 1. Debate and Discussion: Use case studies to present a real laboratory challenge, and then guide students to analyze and resolve these challenges through structured decision-making frameworks. 2. Problem-Based Learning (PBL): resent students with incomplete or ambiguous scenarios that require investigation and decision-making, fostering autonomy in learning and problem-solving. • Presentations • Role-Playing in laboratory scenarios C. Course Content No List of Topics Contact Hours 73. Principles of Quality Control in the Laboratory 2 74. Principles of Quality Assurance and Regulatory Compliance 2 75. Risk Management, Safety, and Biohazard Control 2 4. Management Fundamentals in Clinical Laboratories 2 5. Quality Control Methodologies and Applications 2 6. Statistical Methods for Quality Control in Laboratory Practice 2 7. Developing and Implementing SOPs 2 8. Laboratory Information Systems and Data Management 2 9. Quality Management Systems: CBAHI and CAP 2 10. Instrument Calibration, Verification, and Maintenance 2 11. Financial Management and Budgeting 2 12. Ethical Considerations and Professional Conduct 2 13. Competency Assessment, and Performance Improvement 2 14. Autonomy and Independent Problem-Solving 2 15. Revision 2 Total 30 D. Students Assessment Activities *Assessment Activities (i.e., Written test, oral test, oral presentation, group project, essay, etc.). No Assessment Activities * Assessment timing (in week no) Percentage of Total Assessment Score 128. Assignment Week 12 10 % 129. Midterm examination (written) Week 8-9 20 % 130. Continuous Assessment (Oral Presentation, Group project) All over the course 30 % 131. Final written examination Week 17-18 40% E. Learning Resources and Facilities 1. References and Learning Resources Essential References Laboratory quality management system: handbook. World Health Organization. (January 1, 2011) Supportive References National Standards for Clinical Laboratories & Blood Banks (First Edition 2015) Electronic Materials COLA’S inSights (https://www.cola.org/trainingdevelopment/colas-insights/) Other Learning Materials NA 2. Required Facilities and equipment Items Resources facilities Classrooms Technology equipment Projector + Smartboard Items Resources (projector, smart board, software) Other equipment (depending on the nature of the specialty) F. Assessment of Course Quality Assessment Areas/Issues Assessor Assessment Methods Effectiveness of teaching Instructor ü Direct Method (Rubrics) ü Indirect Method (Questionnaire on the course by the end of the semester) Effectiveness of Students' assessment Head of the department Student achievement is verified by the head of the department. Quality of Learning resources Instructor Student ü Course Report. ü Course Evaluation Survey (CES) Achievement of Course Learning Outcomes Instructor Students ü Direct Method (Rubrics) ü Indirect Method (Questionnaire on the course by the end of the semester) ü Course Evaluation Survey (CES) Effectiveness of Assessment Results Instructor ü Course Report ü Grade Report Analysis ü Course Evaluation Survey (Indirect) Assessors(Students, Faculty, Program Leaders, Peer Reviewer, Others (specify) Assessment Methods(Direct, Indirect)