Faculty of Science

Objectives

To teach students the principles and procedures to be followed by medical laboratories involved in patient care and/or clinical research so as to provide consistent, reproducible, auditable, and reliable and trustworthy laboratory results; which contribute to good patient care and promote a positive attitude toward testing from a patient's perspective; Also to familiarize the students with the requirements of standards of ISO certification.

Contents

Evolution of GCLP; Elements of GCLP; Importance of GCLP in clinical diagnostics and clinical trials; synopsis of current topics in GCLP.

Assuring Quality of Testing: Internal quality control and CRM; Uncertainty of test results; Role and responsibilities of lab supervisors; EQAS / ILPT/ Split sample analysis; Inter-personnel evaluation; Blind specimen testing; Re-testing for QA; Biological reference intervals; Quality control vs Quality assurance.

GCLP in Molecular biology Laboratory: Do's and don'ts in molecular biology

Physical facility requirements for molecular biology – recommended floor plan; Reducing cross-contamination by good practices; Unidirectional approach; Swipe test; Safety in molecular biology – Ethidium Bromide usage and proper disposal;

Ethics in Laboratory Medicine: Ethics – A code for the clinical laboratory; Confidentiality of the patients details; Use of clinical samples for research; Financial / political influences

Laboratory Accreditation: Accreditation - what, why and how? Preparation for accreditation; Gap analysis; Establishment of quality system; Common NCs seen in Lab Accreditation – typical Scenario; Closure of Ncs.