Quality assurance in relation to medical laboratory accreditation

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Dr. TA Varkey PhD, Managing Director, Medilab Speciality Laboratories, Kochi explains the need of Quality Control in Clinical Laboratories and how Quality assurance can be made on various procedures done.

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Quality assurance in relation to medical laboratory accreditation

  1. 1. Quality Assurance in relation to Medical Laboratory Accreditation Dr. T.A. Varkey Medilab Specilaity Laboratories India Pvt. Ltd., Kochi, Mobile: 9447031471
  2. 2. QUALITY “ Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skilful execution; it represents the wise choice of many alternatives.” William A. Foster
  3. 3. QUALITY The ISO 9000 definition of quality is ― the degree to which a set of inherent characteristic fulfils requirements.
  4. 4. Fundamentals of Measurement QUALITY ACCURACY PRECISION REPRO DUCEBILITY RESOLUTION
  5. 5.  Accuracy is the closeness of agreement between the result of measurement and the true value of the measurand  Precision is the closeness of agreement between the results of successive measurements of the same value of a quantity carried out under identical conditions at short intervals of time.
  6. 6.  Resolution is the smallest difference between indications of a displaying device that can be meaning fully distinguished  Reproducibility is the closeness of agreement between corrected results of measurement of the same value of a quantity when measurements are made under different conditions
  7. 7.  Precise but not Accurate
  8. 8.  Accurate but not Precise
  9. 9.  Precise and Accurate
  10. 10. Quality Assurance  Quality Assurance encompasses all measures taken to ensure the reliability of investigations to give the best patient care  Quality assurance includes the evaluation of patient preparation and specimen collection, as well as the pre analytical, analytical, and post analytical phases of laboratory testing.  Quality assurance measures are implemented to detect irregularities in analytical results
  11. 11. The Quality Assurance Cycle Patient/Client Prep Sample Collection Reporting •Data and Lab Management •Safety •Customer Service Personnel Competency Test Evaluations Sample Receipt and Accessioning Record Keeping Quality Control Sample Transport Testing 12
  12. 12. Internal Quality Control( I.Q.C)  IQC is the action of detecting errors that would invalidate the medical usefulness of laboratory results. IQC enables the detection of Day-to Day performance problems and assures the precision of clinical laboratory tests. An IQC system requires results from two levels of quality control sera on 20 consecutive days. The mean and 2SD limits are established for each analyte at both levels. SD values are then plotted on a Levey Jennings chart and the SDI is used to observe the deviations from the mean.
  13. 13. External Quality Assessment( E.Q.A)  External quality assessment schemes allow laboratories to monitor their accuracy and compare performance with other laboratories.  The laboratory is unaware of the parameter values, this is known as „blind analysis‟ of an EQA sample
  14. 14. Medical Laboratory Accreditation • Credibility of test results is extremely important where diagnosis depends on these results. Laboratory results must be reliable. • For the reliable test results, the data must be accurate, precise & reproducible.
  15. 15. Concept of Laboratory Accreditation • This is possible only when the laboratories performing these tests are competent. • The concept of Laboratory Accreditation was developed to provide a means for third-party certification of the competence of laboratories.
  16. 16. Why Accreditation • • • • • • Improve quality Demonstrate commitment to quality Comply with International Standards Harmonisation of working processes Control of Laboratory Services Rationalisation of Services
  17. 17. Formal recognition of competence of laboratory by Accreditation body has many advantages • Potential increase in business due to enhanced customer confidence and satisfaction • Savings of time and money due to reduction or elimination of re-testing • Better control of laboratory operations due to in-built Quality Assurance System and competent man-power • Increased Confidence in test results and personnel performing work.
  18. 18. Formal recognition of competence of laboratory by Accreditation body has many advantages • Customers can identify Accredited Laboratories from directory of Accredited Laboratories. • Users of Accredited Laboratories enjoy greater access in Domestic and International market • Improved medical tourism through reliable & acceptable Medicare as per International Standards
  19. 19. * NABL * In India, laboratory accreditation scheme is operated by the National Accreditation Board for Test & Calibration Laboratories (NABL), an autonomous society under the Department of Science & Technology, Govt. of India.
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