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Quality Control in Laboratory

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Quality Control in Laboratory

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Quality Control in Laboratory

  1. 1. QUALITY CONTROL IN LABORATORY
  2. 2. QUALITY • Doing the right thing right, the first time and every time. • Is fitness for use “Juran”: a service which is free from deficiencies and meets customers need • It’s invisible when GOOD & impossible to ignore when BAD • Dimensions: Appro- priate- ness Time- liness Avail- ability Comp- etency Contin- uity Effec- tive- ness Effic- acy Effic- iency Preven- tion/ Early Detec- tion Respe- ct and caring Safety
  3. 3. QUALITY • Total Quality Management (TQM): a process of customer- driven quality improvement by having the lab monitor, its work to detect deficiencies & subsequently correct them to provide value. • Continuous Quality Improvement (CQI): It’s a management process or approach to continuous improvement of processes of providing healthcare services to meet the needs of patients.
  4. 4. QUALITY • Quality Assurance (QA): It’s the overall program that ensures that the final results reported by the laboratory are correct. It is concerned with much more: that the right test is carried out on the right specimen, and that the right result and right interpretation is delivered to the right person at the right time. • Quality Assessment (proficiency testing): It is a challenge to the QA and QC programs. It may be external or internal. It’s used to determine the quality of the results generated by the laboratory.
  5. 5. Data and Lab Management Safety Customer Service Patient/Client Prep Sample Collection Sample Receipt & Accessioning Sample Transport Quality Control Record Keeping Reporting Personnel Competency Test Evaluations Testing
  6. 6. Improvement in quality leads to reduction in costs Quality Costs Costs of conform- ance Prevention costs Appraisal costs Costs of nonconf- ormance Internal failure costs External failure costs
  7. 7. QUALITY GOOD QUALITY Support provision of high quality health-care Generate confidence in lab results Ensure credibility of lab POOR QUALITY  Inappropriate action (Over-investigation, Over-treatment, Mistreatment)  Loss of credibility of laboratory  Delayed action  Legal action
  8. 8. VARIABLES THAT AFFECT THE INTERNAL QUALITY • Outside laboratory Within laboratory Sample handling Patient preparation Requisition Sample receivingSample Collection Sample Transport Patient Doctor Analysis Reports Results
  9. 9. PRE-ANALYTICAL • Patient and specimen identification and labelling • Patient preparation • Specimen collection, storage and transportation • Specimen quantity • Mismatch of sample
  10. 10. ANALYTICAL • Internal quality control (IQC) It’s used on daily basis in the decision to accept or reject results of patients samples & enables the lab to describe and monitor the quality of its work. • External quality assessment (EQA) It permits a comparison of quality between laboratories and It is used to confirm results of IQC.
  11. 11. ANALYTICAL PROFICIENCY OF PERSONNEL Education, Training, Competence, Commitment, Adequate Number DOCUMENTATION Written Policies, Plans, Procedures, Instructions & Quality Control Procedures SPECIFICITY & SENSITIVITY OF TEST Cost Effective, Validated, Interpretable, Meets The Needs EQUIPMENT RELIABILITY Meet Technical Needs, Maintenance Friendly & Validated Procedural reliability Using Standard Operating Procedures REAGENTS STABILITY AND EFFICIENCY Stable, Efficient, Desired Quality & Validated USE OF CONTROLS Internal: Calibrated External: Supplied By Manufacturer
  12. 12. STANDARD OPERATING PROCEDURE (SOP) • It’s written instructions intended to document how to perform a routine activity. • High reliability organization (HROs) rely on standard operating procedure to ensure consistency and quality in their results.
  13. 13. POST ANALYTICAL • Right reporting • Right patient • Right interpretation • Right turn-around time (TAT)
  14. 14. ACCURACY VS. PRECISION • Accuracy - how close a measurement is to the accepted value (ACCURATE = CORRECT) • Precision - how close a series of measurements are to each other (PRECISE = CONSISTENT) • Quality Control is used to monitor both the precision and the accuracy of the assay in order to provide reliable results.
  15. 15. ICQ PROCEDURES • A stable control material which mimics patient’s sample is analyzed (day to day)• • Individual measurements are plotted on a control chart (Levey Jennings charts)• • Evaluation whether measurement is “in control” (Westgard multi-rules)
  16. 16. LEVEY JENNINGS CONTROL CHART (PLOTTING QC RESULT ) • Mean and SD of QC material (manufacturer) • Y-axis: control value X-axis: time of run • Most auto-analyzers plot the charts, otherwise they should be drawn manually. 80 85 90 95 100 105 110 115 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Mean +1SD +2SD +3SD -1SD -2SD -3SD Day
  17. 17. LEVEY JENNINGS CONTROL CHART (PLOTTING QC RESULT ) • Ideally should have control values clustered about the mean with little variation in the upward or downward direction • Imprecision = large amount of scatter about the mean. Usually caused by errors in technique • Inaccuracy = may see as a trend or a shift, usually caused by change in the testing process • Random error = no pattern. Usually poor technique, malfunctioning equipment. • Review charts at defined intervals, take necessary action, and document
  18. 18. WESTGARD RULES (EVALUATING QC RESULTS ) • It Detects whether results are “in control” or not. • It Detects the type of laboratory error. • It’s used to diminish the false rejection rate without compromising quality.
  19. 19. RANDOM ERROR, RE, OR IMPRECISION • It is described as an error that can be either positive or negative, whose direction and exact magnitude cannot be predicted, where the distribution of results when replicate measurements are made on a single specimen. • Usually, due to error in pippetting
  20. 20. SYSTEMATIC ERROR, SE, OR INACCURACY • It is an error that is always in one direction, displacing the mean of the distribution from its original value. • In contrast to random errors, systematic errors are in one direction and cause all the test results to be either high or low. • Usually, due to error in calibration.

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