CLS 601
Laboratory Management & Quality Control

This course explains fundamentals of quality processes in order to achieve the highest levels of accuracy in results, and the principles of operational management in medical labs to meet the minimum requirements for operational excellence and CBAHI accreditation.

(CLS-601) Laboratory Management and Quality Control. Postgraduate 1st Year (Sem1). 

This is a core, first-semester postgraduate course in the MSc in Clinical Laboratory Sciences program. Aligned with the approved TPG-153 Course Specification, this 15-week curriculum is designed to transform postgraduate students into strategic, executive-level clinical laboratory leaders. The course is uniquely structured around a dual-pedagogical framework:

  1. The Quality and Technical Theme: Students master Total Quality Management (TQM), statistical quality control (Mean, SD, CV, Levey-Jennings charts, Westgard rules, and CUSUM), method validation, reference ranges, and section-specific quality protocols (Biochemistry, Hematology, Microbiology, Blood Bank, and Histopathology). This ensures complete compliance with national and international accreditation standards like CBAHI, CAP, JCI, and ISO.
  2. The Administrative and Leadership Theme: Weaving in advanced behavioral healthcare leadership models, students learn to navigate complex operational environments using the “Three Lenses/Ways of Seeing” framework (Individual, Organizational Design, and Political), the “HEAR” negotiating model, and laboratory financial budgeting.

 

A cornerstone of this course is “The Living Quality System Challenge,” a term-long active learning project utilizing a digital online QMS platform. Student groups act as an active “Laboratory Quality Unit” to map SOPs, log clinical incidents, perform 5-Why and Fishbone Root Cause Analyses (RCA), design CAPAs, and defend their system in a Mock Accreditation Audit. This hands-on project prepares students to manage laboratory resources efficiently and safeguard patient care.

Table of Lectures:

1: Introduction to Laboratory Management
2: Quality Assurance and Quality Control Principles
3: Statistical Quality Control
4: Quality Control Tools, Troubleshooting, and Corrective Actions
5: Standard Operating Procedures (SOPs)
6: Method Evaluation and Validation
7: Establishing Reference Ranges
8: Section-Specific Quality Control Protocols I (Biochemistry & Hematology)
9: Section-Specific Quality Control Protocols II (Microbiology, Histopathology & Blood Bank)
10: ISO/CBAHI Standards and Document Control
11: Laboratory Audits (People, Sample, and Technical Management)
12: Financial Management and Budgeting
13: Leadership and Problem-Solving Strategies
14: Change Management in Clinical Laboratory Medicine
15: Revision & Final Exam Preparation

Assessment Tasks and their grades:

Type of Assessment

Week

Grades

Continuous Assessment

1-13

15%

Midterm Exam (MCQs Only)

7

20 %

Group Project (Quality Audit)

10

25%

Final Exam (MCQs + Short Essay)

15

40%

Group Project (Creating SOPs)