1. CLINICAL LABORATORIES THE ROLE: A science that uses sophisticated instruments and techniques with the application of theoretical knowledge to perform complex procedures.

2. It provides critical information that lead to diagnosis, therapy and monitoring of various conditions. The lab strives to adhere to the three “R” principle of rapid, reliable and reproducible results. The lab technologists are the ultimate quality control in any laboratory.

3. The testing process is a complex one with many steps and errors can be made at any of them. Errors do occur due to combination of factors like: The human link sample collection and processing instrumentation/calibration lack quality checks etc

4. Complexity of a Laboratory System Data & Laboratory Management Safety Customer Service Patient/Client Prep Sample Collection Sample Receipt and Accessioning Sample Transport Quality Control Testing Record Keeping Reporting Personnel Competency Test Evaluations

5. Path of Workflow THE PATIENT Test selectionSample Collection Sample Transport Laboratory Analysis Examination Phase Report CreationReport Transport Preexamination Phase Result Interpretation Postexamination Phase

6. Most errors occur in pre/post analytical phases as compared to the analytical phase. Pre-analytical errors account for 40%, analytical 20% and post analytical 40%. All errors are equally bad. No error is worse than another. Continuous monitoring and tracking of error is critical to reliable laboratory services.

7. Of all laboratory errors, 4% are considered to have a major impact on patient care due to erroneous medical decisions based on misleading laboratory information. The permissible intrinsic range of error should be between 0.5 to 1.0% to achieve precision and reproducibility.

8. Main causes of error Procedure/ lack of skill Staff-orientation/shortage/ locum Documentation Sample errors Lack of audit Inadequate policy Poor skill mix Communication

9. Pre-analytical errors Personnel without appropriate training & understanding of blood collection process Patient identification and preparation errors Sample collection device, container, and procedure Sample handling, separation, transport and storage

10. Intra/Post analytical errors Erroneous validation of analytical data Failure in reporting-critical information Excessive TAT-verbal reports Failure of the diagnostic system Undetected failure in quality control Analytical interference Improper procedure.

11. Laboratory errors cost in time personnel effort patient outcomes

12. Solutions: More resources-staff/ automation Continuous staff development More competency checks New ways of working Skill mix Continuous error logging Monitoring the laboratory performance

13. Essential to all aspects of health care are laboratory results that are  accurate,  reliable, and  timely

14. MONITORING THE LABORATORY’S PERFOMANCE The performance of a laboratory is measured on: accuracy The 3 R’s TAT Proficiency testing Confidentiality Control of records etc

15. Questions like, Is the sample viable for processing? Is the test ordering satisfactory Do the tests need special conditions is the result reasonable? is the result consistent with the clinical findings? ……….. are the first steps towards quality checks.

16. Can be achieved through: Internal and External Quality Control. Internal checks like: -Blank testing -Negative and positive sample testing -Duplicate sampling -Sample replicating -Known concentration spiking -Equipment drift measurement/ calibration blank -Calibration

17. Quality Control is the application of statistical methods in order to determine the precision and ‘accuracy’ of a set of data.

18. How do we achieve QUALITY [excellent] performance in the laboratory?

19. QUALITY is ACHIEVED BY: Determining the customer’s precise requirements Ensuring that all resources, facilities and skills required to meet the customer’s requirements are available Planning, documenting and implementing management procedures to ensure that the customer’s requirements are met consistently Ensuring that staff are trained and provided with the resources to do the job right the first time

20. Ensuring that all activities are undertaken correctly Ensuring that when things go wrong, effective corrective action is taken to avoid repetition of errors Undertaking regular reviews and audits of all processes Total and organised commitment from management

21. Internal Quality Control (IQC) - Check, Detect & Rectify External Quality Assessment (EQA) - Checks level of performance of all laboratory’s procedures (pre/intra/post/analytical). - Uses result analysis to check on inaccuracy - Inter laboratory comparison of performance

22. Internal Quality Control Applied daily Three main components can affect the quality of routine laboratory work:- Personnel Reagents Instruments ……. remember! nobody and nothing is perfect:

23. Errors which can lead to wrong results are categorized into: systematic errors accidental errors basic errors Laboratories needs to recognize their existence

24. Systematic Errors Wrong volumes Wrong temperature setting Deteriorated reagents Contaminated water Wrong incubation time Wrong calibrator value or factor Wrong wavelength …Can be identified by accuracy control

25. Accidental Errors Careless pipetting Wrong reagents Wrong reagent preparation Wrong procedure Inexact timing Inconstant temperature Contamination These errors can be identified and minimized by day to day control of PRECISION (REPRODUCIBILITY)

26. Basic/ Primary Errors Processing of unviable samples Mix up of patient samples Mistakes in data transfer Poor documentation. These errors cannot be identified by Quality Control. They can however be minimized by improvement of the technologists care, education and resources.

27. Impact of Internal Quality Control Continuous detection and rectification of the Analytical Process.  Reagent-Equipment-Personnel-Specimen  Ensure the degree of both precision & accuracy of your results  Assure the quality and clinical applicability of your laboratory reports  Generate objective evidence of your analytical performance.

28. Precision (Reproduction of analytical results) Defined as the extent and pattern of variability of results ( Range of error of a method) Measured by calculating the standard deviation index (SDI) SDI = Lab result – ‘True’ Mean ‘True’ SD SDI shows the difference between a result and the mean, relative to the scatter of results around them.

29. Accuracy Ability to measure the actual value without bias. It’s a measure of how closely the results obtained agree with the “true value”

30. Levey-Jennins (LJ) Charts Data display to enable quick conclusions & monitor the characteristics of analytical variation with respect to time. An extension of a Gaussian Probability distribution.

32. Reason and benefits of IQC in medical laboratory Reasons: - Ethical and legal responsibility to supply correct analysis. Fast and reliable support for doctor’s diagnosis and therapy. Obligation to keep costs low. Benefits: Immediate information, whether the results of the current run are acceptable. If errors are detected the batch can be repeated - the doctor gets only reliable results. Quality of laboratory's work improves step by step Number of repeated test runs can be reduced, saving time and money.

33. More Benefits: Poor methods are identified and can be substituted by reliable methods. Early recognition of reagent or instrument damage Manager of laboratory gets objective information on quality of staff performance Technicians have simple but reliable tool to control and improve their own performance and gain more self - confidence Good reputation and acceptance of the laboratory increases

34. The silent diagnosis The Unknown As we know, there are known knowns. There are things we know we know. We also know there are known unknowns. That is to say we know there are some things we do not know. But there are also unknown unknowns, the ones we don't know we don't know.

35. An effective internal quality control guards against The Unknown Unknown Thank you Very Much