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 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

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!