QUALITY CONTROL IN HEMATOLOGY

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

2. 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

3. 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

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

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

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

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

8. 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

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

10. 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)

11. 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

12. 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

13. 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

14. Thank you!