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Quality control in clinical biochemistry

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Quality control in clinical laboratory (Biochemistry)

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Quality control in clinical biochemistry

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  2. 2. 2 of 58Quality Control in Clinical Biochemistry Ashok Katta “Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives.”
  3. 3. 3 of 58Quality Control in Clinical Biochemistry Ashok Katta Importance of laboratory test in clinical medicine Lab tests constitute only one part of the diagnostic process in clinical medicine. In fact, it has been stated that an experienced physician may arrive at a relatively accurate diagnosis in ~80% of cases, based solely on a thorough history and physical examination. However, there is no doudt that, nowadays, biochemical and other lab tests are almost always an important part of the overall diagnostic process. The use of biochemical investigation and lab tests is, helping physicians and healthcare workers make diagnoses and other clinical judgment.
  4. 4. 4 of 58Quality Control in Clinical Biochemistry Ashok Katta The results obtained from laboratory analyses are used to… diagnose, prescribe treatment, and/or Monitor the health or progress of the patient. Since such importance is placed upon test results, they must be as reliable and accurate as possible.
  5. 5. 5 of 58Quality Control in Clinical Biochemistry Ashok Katta Who determines if a patient gets a statin? We do !
  6. 6. 6 of 58Quality Control in Clinical Biochemistry Ashok Katta Who determines if a patient gets a Dx of DM? We do !
  7. 7. 7 of 58Quality Control in Clinical Biochemistry Ashok Katta Who determines if a patient gets a prostrate biopsy? We do !
  8. 8. 8 of 58Quality Control in Clinical Biochemistry Ashok Katta Who determines if a patient gets dialysis? We do !
  9. 9. 9 of 58Quality Control in Clinical Biochemistry Ashok Katta How do we know we are right? Do we?We do !
  10. 10. 10 of 58Quality Control in Clinical Biochemistry Ashok Katta LAB-1 LAB-2 LAB-3
  11. 11. 11 of 58Quality Control in Clinical Biochemistry Ashok Katta Fasting Plasma Glucose < 110mg/dl = Non-DM On two or more occasions can make the diagnosis of Diabetes Mellitus Fasting Glucose >110 mg/dl = IFG Fasting Glucose >126mg/dl = DM LAB-1 LAB-2 LAB-3
  12. 12. 12 of 58Quality Control in Clinical Biochemistry Ashok Katta To know the answer for this question, first you should understand How Clinical Biochemistry Lab works. How do we know we are right?
  13. 13. 13 of 58Quality Control in Clinical Biochemistry Ashok Katta Errors in the clinical Laboratory
  14. 14. Equipment Reliability Reagents Poor trained technicians Work load managemen t Poor result verification Non- validated tests Time pressures Under- staffed Why do laboratory errors occur? Poor Quality Management
  15. 15. 15 of 58Quality Control in Clinical Biochemistry Ashok Katta Types of Error Random error An error which varies in an unpredictable manner in… Magnitude Sign Difficult to eliminate but repetition reduces the influence of random error Example – error in pipetting Can be minimized by training, supervision and by SOPs Systematic error An error which, in the course of a number of measurements of the same value of a given quantity remains constant under same condition. Systematic errors create a characteristic bias in the test results and can be accounted for by applying a correction. Example - change in the reagent batch or modifications in testing method.
  16. 16. 16 of 58Quality Control in Clinical Biochemistry Ashok Katta Testing Response Laboratory Workflow Patient Pre-analytical Analytical Post-analytical Test Request Patient preparation Sample Collection Sample Transport Sample Receipt Testing Review Lab Interpretation Reporting Record Managment
  17. 17. Laboratory Workflow Patient Preparation Sample Collection Sample Receipt Sample Transport Reporting •Data & Lab Management •Safety •Customer Service Quality Control Testing Record Keeping
  18. 18. 18 of 58Quality Control in Clinical Biochemistry Ashok Katta 3 phases of laboratory testing: Pre-analytical, analytical and post-analytical Pre-analytical—specimen collection, transport and processing Analytical—testing Post-analytical—testing results transmission, interpretation, follow- up, retesting.
  19. 19. 19 of 58Quality Control in Clinical Biochemistry Ashok Katta Effects of Pre-analytical Variables on the Quality of Laboratory Testing What are pre-analytical variables ? These are variables that can occur from the time when the test is ordered by the physician until the sample is ready for analysis. The pre-analytical stage is the most important. Pre-analytical variables account for upto 75% of laboratory errors. The analytical stage & post analytical stages depend primarily on the integrity of the specimen submitted to the laboratory. Laboratory staff involved in specimen collection have a direct impact on the outcome of patients lab results.
  20. 20. 20 of 58Quality Control in Clinical Biochemistry Ashok Katta The Pre-Analytical process Identify the patient: Get A Suitable Sample Transport to Lab Receive In Lab: Prepare For Testing:
  21. 21. 21 of 58Quality Control in Clinical Biochemistry Ashok Katta Examples of possible preanalytical variables: Patient Identification: - It is important to identify a patient accurately so that blood is collected from the correct person. - Drawing blood from the wrong person, or labeling the correct patient’s sample with a different patient’s label can certainly contribute to laboratory error. (Mislabeling ???)
  22. 22. 22 of 58Quality Control in Clinical Biochemistry Ashok Katta Analytical phase Standardisation Calibrators Reagents Test conditions Quality Control External Quality Assurance (EQA) Internal Quality Control (IQC) How do we know we are right?
  23. 23. 23 of 58Quality Control in Clinical Biochemistry Ashok Katta Factors influencing quality: Post-analytical • Right recording and reporting • Right interpretation – Range of normal values • Right turnaround time • Report to right user
  24. 24. 24 of 58Quality Control in Clinical Biochemistry Ashok Katta Quality control & Quality Assurance Quality control Refers to the measures that must be included during each test run to verify that the test is working properly Aim: • To ensure that the results generated by the tests are correct Quality Assurance Defined as the overall program that ensures that final results reported by the laboratory are correct. Aim: • Ensure that Right test is carried out on Right specimen and Right result and Right interpretation is delivered to Right person at Right time.
  25. 25. 25 of 58Quality Control in Clinical Biochemistry Ashok Katta Quality Assurance in Laboratory Quality assurance in Laboratory involves…… Internal Quality Control (IQC) External Quality Assurance (EQA)
  26. 26. 26 of 58Quality Control in Clinical Biochemistry Ashok Katta Internal Quality Control (IQC) Done daily in the laboratory Applied to all work processes and to every test done in the lab. IQC procedures identify problems immediately.
  27. 27. 27 of 58Quality Control in Clinical Biochemistry Ashok Katta Internal Quality Control (IQC) Examples Daily recording of temp in refrigerator / incubator Repeating tests Following SOPs Advantage Mistakes can be avoided Quality of test results are raised
  28. 28. 28 of 58Quality Control in Clinical Biochemistry Ashok Katta IQC Program Internal Quality Control program depends on the use of.... Internal Quality Control (IQC) specimen Levey Jennings Charts The use of statistical methods for interpretation.
  29. 29. 29 of 58Quality Control in Clinical Biochemistry Ashok Katta What is control? Material that contains the substance being analysed Used to validate reliability of the test system. Run after calibrating the instrument Run periodically during testing
  30. 30. 30 of 58Quality Control in Clinical Biochemistry Ashok Katta Steps in Implementing Quality Control Obtain control material Run each control daily along with patient sample. OR Run each control 20 times over 30 days Calculate mean and ± 1,2,3 SD Mean 1SD 1SD 2SD 3SD 2SD 3SD
  31. 31. 31 of 58Ashok KattaQuality Control in Clinical Biochemistry Levey- Jennings Chart Graphically Representing Control Ranges
  32. 32. 32 of 58Quality Control in Clinical Biochemistry Ashok Katta 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 Day +1SD +2SD +3SD -1SD -2SD -3SD Levey-Jennings Chart Mean = 100 ±1SD = 95-105 ±2SD = 90-110 ±3SD = 85-115
  33. 33. 33 of 58Quality Control in Clinical Biochemistry Ashok Katta Levey-Jennings Chart - Record and Evaluate the Control Values 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 Day +1SD +2SD +3SD -1SD -2SD -3SD
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  36. 36. 36 of 58Quality Control in Clinical Biochemistry Ashok Katta Westgard Rules “Multirule Quality Control” Uses a combination of decision criteria or control rules Allows determination of whether an analytical run is “in-control” or “out-of-control”
  37. 37. 37 of 58Quality Control in Clinical Biochemistry Ashok Katta Westgard Rules 12S rule 13S rule 22S rule R4S rule 41S rule 10X rule (Generally used where 2 levels of control material are analyzed per run)
  38. 38. WARNING RULES -  Warning 12SD : One of two control results falls outside ±2SD. Alerts tech to possible problems. Not cause for rejecting a run. Control Rules – Westguard Multirule Chart
  39. 39. WARNING RULES -  Warning 22SD : It detects systematic errors & is violated when two consecutive IQC values exceed the mean on the same side of the mean by 2SD.  SENSITIVE TO SYSTEMATIC ERROR Control Rules – Westguard Multirule Chart
  40. 40. WARNING RULES -  Warning 41SD: It is violated if 04 consecutive IQC values exceed the same limit (mean  1SD) & this may indicate the need to perform instrument maintenance or reagent.  SENSITIVE TO SYSTEMATIC ERROR Control Rules – Westguard Multirule Chart
  41. 41. MANDATORY RULES -  Mandatory 13SD: It is violated when the IQC value exceeds the mean by 3SD. The assay run is regarded as out of control. SENSITIVE TO RANDOM ERROR Control Rules – Westguard Multirule Chart
  42. 42. MANDATORY RULES -  Mandatory R4SD : It is only applied when the IQC is tested in duplicate. This rule is violated when the difference in SD between the duplicates exceeds 4SD. SENSITIVE TO RANDOM ERROR Control Rules – Westguard Multirule Chart
  43. 43. MANDATORY RULES -  Mandatory 10x : Reject the run when 10 consecutive control measurements fall on one side of the mean. SENSITIVE TO SYSTEMATIC ERROR Control Rules – Westguard Multirule Chart
  44. 44. 44 of 58Quality Control in Clinical Biochemistry Ashok Katta When a rule is violated QC Data 12s 13s 22s R4s 41s 10x Report Results “Out of control” Take Corrective Action
  45. 45. 45 of 58Quality Control in Clinical Biochemistry Ashok Katta If QC is out of control Stop testing Identify and correct problem Repeat testing on patient samples and controls Do not report patient results until problem is solved
  46. 46. 46 of 58Quality Control in Clinical Biochemistry Ashok Katta Solving out-of-control problems Identify problem Refer to established policies and procedures for remedial action.
  47. 47. 47 of 58Quality Control in Clinical Biochemistry Ashok Katta Possible Problems Degradation of reagents or kits Control material degradation Calibration error Operator error An outdated procedure manual Equipment failure
  48. 48. 48 of 58Quality Control in Clinical Biochemistry Ashok Katta EXTERNAL QUALITY CONTROL / ASSESSMENT E Q A S
  49. 49. 49 of 58Quality Control in Clinical Biochemistry Ashok Katta External Quality Assessment A system for objectively checking the laboratory’s performance using an external agency or facility.
  50. 50. 50 of 58Ashok KattaQuality Control in Clinical Biochemistry EQA Important for improvement A measure of laboratory performance
  51. 51. 51 of 58Quality Control in Clinical Biochemistry Ashok Katta EQA process EQA organization / Provider Laboratory Corrective Action EQAS samples Sent regularly Analyze Return results Evaluation EQAS performance report
  52. 52. 52 of 58Quality Control in Clinical Biochemistry Ashok Katta Calculation of VIS Designated Value [DV] = 120 mg % Participant's result = 95 mg% % Variation [%V] = Participant's Result – [DV] ---------------------------------- X 100 Designated value 120-95 X 100 = 25 X 100 120 120 = 20.8 Variance Index = %V X 100 = 20.8 X 100 = 277 CCV 7.5 VIS = 277
  53. 53. 53 of 58Quality Control in Clinical Biochemistry Ashok Katta • Check the VIS & OMVIS values for each parameter every month • Check if your value is close to DV • Closer it is lower will be your VIS & better is your lab’s accuracy • Remember If your VIS is < 50 it is regarded and given as zero score •Even if >400, it is still given as 400 only
  54. 54. 54 of 58Quality Control in Clinical Biochemistry Ashok Katta Interpretation of VIS VIS Performance <100 Very good 100 -150 good 150 -200 satisfactory room for improvement > 200 Not acceptable • If VIS of >200 on two or more occasions for the same analyte, them check your standardization procedures & calibration • Indicates an accuracy problem (systematic error / bias )
  55. 55. 55 of 58Quality Control in Clinical Biochemistry Ashok Katta Interpretation of VIS Check the monthly OMVIS. OMVIS Performance < 100 Very good - your result are very close to DV 150-200 Need to take care of those parameters > 250 You are probably reporting many wrong results & you should take urgent steps to locate the problem and correct them
  56. 56. 56 of 58Quality Control in Clinical Biochemistry Ashok Katta Performance of our Lab in EQAS
  57. 57. 57 of 58Quality Control in Clinical Biochemistry Ashok Katta
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  61. 61. 61 of 58Ashok KattaQuality Control in Clinical Biochemistry Key Messages A QC program allows the laboratory to differentiate between normal variation and error. The QC program monitors the accuracy and precision of laboratory assays. The results of patient testing should never be released if the QC results for the test run do not meet the laboratory target values.
  62. 62. 62 of 58 Contact no. – 07418831766 E mail – ashokkt@gmail.com For more presentation visit - http://www.slideshare.net/ashokktt Ashok Katta Dept. of Biochemistry, Dhanalakshmi Srinivasan Medical College, Perambalur

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