Course Description:

The supervised clinical lab practices course aims to develop that Medical lab sciences is a broad field which plays a crucial role in the diagnosis and research. Disciplines like microbiology, chemical pathology, histopathology, hematology, immunohematology, molecular biology, immunology & serology, tissue typing/HLA, endocrinology, toxicology, cytogenetics, cytopathology, virology and parasitology have all made significant contributions in improving the health of people all around the world. Good lab practices (GLP) embodies a set of principles that provides a frame work in which laboratory studies are planned, performed, monitored, archived and reported. In the era of modern technology, laboratory diagnostic tests in conjunction with a patient history and physical examination confirm the diagnosis and provide valuable information about a patient health status and response to therapy. In addition to these, laboratory findings are also essential for epidemiological surveillance and research purposes.

Learning Outcome:

On completion of this course, students will possess the theoretical knowledge, practical skills, and abilities to:

• Explain and apply the major principles and practices of laboratory administration, supervision of various lab disciplines and budgeting.

• Use leadership skills, help his/her team and organization make progress and act in the right way.

• Use quality assurance principles and practices to ensure the accuracy and reliability of laboratory tests.

• Interpret and evaluate patient results and suggest appropriate additional confirmatory tests.

• Understand lab investigations and form an accurate differential diagnosis.

• Implement standard operating procedures (SOPs) & influence the other staff to adhere with biosafety measures.

• Explain the working principles, methodologies and clinical significance of laboratory procedures in diagnosis and treatment of disease.

• Use educational methods to present information and develop instructional materials.

• Communicate effectively with laboratory personnel, other health care professionals, patients and the public.

Course contents:

Theory:

1. INTRODUCTION TO PRINCIPLES OF GOOD LAB PRACTICE

• Introduction, The fundamental points of good lab practice, The good lab practice principles

2. RESOURCES

• Management, Personnel, Facilities: buildings and equipment

3. CHARACTERIZATION

THE TEST ITEM: Date of dispatch, Number of containers or items, type of contents and quantity, identity of the test item, batch numbers, identity of the person responsible for the dispatch, Name of the transporter and type of carrier.

4. QUALITY ASSURANCE

• Protocol (or study plan) review, Sop review, Planning (master schedule, inspection plan), Audits and inspections, Quality assurance statement, Quality inspections of suppliers and contractors, Issuing and archiving of QA files and reports

PRACTICALS

• Internal Audit, External Audit, Proficiency testing, Accreditation, Lab Record Keeping, Laboratory information system, Optimizing Laboratory workflow and performance, Procurements of Lab Consumables and instruments, Budgeting of Labs, Inspections of Labs

Recommended Books:

• Good Laboratory Practice Training Manual for the trainee. 2nd Edition by World Health Organization.

• Good Clinical Laboratory Practices in Pakistan 2019. Editors Aamer Ikram, National Institute of Health, Pakistan Rita Guenther and Benjamin Rusek, NASEM, United States.

• Henry’s Clinical Diagnosis and Management by Laboratory Methods. 22nd Edition by Richard and Matthew.

• Manual of Laboratory Medicine Third Edition Armed Forces Institute of Pathology (AFIP) Rawalpindi-Pakistan 2005.

Evaluation System (Exam, assignments):

Three tests & one send-up written examination including objective & subjective (SEQs, LEQs) type questions
Weighing of internal assessment(10+10= 20 marks ) = 50 % passing, 80-95% for good-excellent internal assessment also based on class performance, and attendance.
Theory: 90 Marks
Practical: 90 Marks

Classes Schedule:

Monday: 09:40 AM - 10:20 AM

Tuesday: 09:40 AM - 10:20 AM

Friday: 09:00 AM - 09:40 AM

Start Date: February 15, 2021