QUALITY CONTROL IN HEMATOLOGY Dr. A. Das Gupta President –International Laboratories Mentor – Hematology Services Super Religare Laboratories

The Role of a Clinical Laboratory The laboratory is critical to good medical practice; test results have major role in diagnosis and management of patients It has an ethical obligation to provide reliable (accurate), reproducible (precise) and cost-effective results and observations within a reasonable time frame (TAT) It should provide opportunity for training and career growth of professionals and laboratory personnel It should have a safe work environment Advance the speciality through research and innovation

Quality system begins and ends with the patient Pre-Analytic Patient/Client Prep Sample Collection Personnel Competency Test Evaluations Reporting Data and Lab Management Safety Customer Service Post-Analytic Sample Receipt and Accessioning Record Keeping Sample Transport Quality Control Testing Analytic

Commonly used terminologies Quality assurance Quality control (Internal QC, EQA, PT, Inter-laboratory comparisons & Standardization) Quality management Accuracy Precision/reproducibility Accreditation

Quality assurance (QA) Objective: QA in a laboratory is intended to ensure reliability of the laboratory tests

Quality Assurance Components of QA are related to the various phases of testing Pre-analytic phase Analytic phase Post-analytic phase

Process Flow – Quality Management Pre analytic Specimen collection Standard conditions Specimen transport Posture Test request recorded Tourniquet Analytic (IQC, EQA, Stdn.) Analysis Selected methods Instrument calibration & check Post analytic Data processing Records Reporting

Quality Management of Pre-analytic Phase Standardization of all aspects of blood collection, preservation and transport Includes evacuated tubes, anticoagulant, ratio of blood to anticoagulant, tourniquet, fasting, time of collection, labeling of sample, temperature, transport conditions and transit time

Quality Management of Analytic Phase Validation of tests, equipment Standardization of methods, reagents Reference intervals Calibration Internal quality control (IQC) External quality assessment (EQA)

Internal Quality Control IQC primarily ensures precision and reliability of results and is based on methods in actual use in the laboratory and consists of, Control charts with tests on control material Duplicate tests Delta check, comparison of current results with previous ones Consistency of mean values of patient data Correlation checks (e.g. blood film exam)

External Quality Assessment Involves participation in national and/or international EQA (Proficiency Testing[PT]) programmes Does not assess accuracy; rather it assesses the technical competence of a laboratory It also assesses the state of the art, identifies problems with instruments and reagents Individual laboratory’s result for each analyte/parameter is compared with the cumulative mean and SD derived from results returned by all participants

External Quality Assessment Results from laboratories using the same platform and reagents (peer group) are compared and performance is reported as “Deviation Index” (DI) or Z-score EQA also involves interpretation of the results Cell morphology is an important component of EQA EQA also promotes education and improvement in technology

WHAT DO WE ACHIEVE? Standardization of all functions the laboratory Quality monitoring Identify and correct problems Meet accreditation requirements (Accepted by NABL) “Quality culture” among employees

Thank you!