The document provides a study guide for a final exam covering various topics related to clinical laboratory science. It includes 50 multiple choice questions testing knowledge of quality management, pre-analytical and analytical errors, equipment and inventory management, sample handling and processing, quality control, and internal and external audits. The key areas assessed include defining quality, recognizing sources of error, understanding personal protective equipment, sample labeling requirements, quality control procedures, and the audit process.
The document provides a study guide for a final exam covering various topics related to clinical laboratory science. It includes 50 multiple choice questions testing knowledge of quality management, pre-analytical and analytical errors, equipment and inventory management, sample handling and processing, quality control, and internal and external audits. The key areas assessed include defining quality, recognizing sources of error, understanding personal protective equipment, sample labeling requirements, quality control procedures, and the audit process.
The document provides a study guide for a final exam covering various topics related to clinical laboratory science. It includes 50 multiple choice questions testing knowledge of quality management, pre-analytical and analytical errors, equipment and inventory management, sample handling and processing, quality control, and internal and external audits. The key areas assessed include defining quality, recognizing sources of error, understanding personal protective equipment, sample labeling requirements, quality control procedures, and the audit process.
Total is 60 MCQs = 40 marks, 10 questions of the chapters covered in Midterm, 50 questions on
the chapters after the midterm 1. What does quality mean - lab quality ensures lab results are reliable, accurate and in timely manner. 2. Recognize errors that might occur in pre-analytical, analytical or post analytical stage 3. What does PPE mean? - Personal Protective Equipment: gloves, lab coat 4. The correct procedure to handle needles in the lab - Do not recap, needles should be disposed in sharp container 5. Benefit of equipment management (check handouts) - Helps to maintain a high level of laboratory performance - Reduces variation in test results = Reliable - Reduces interruption of services due to breakdowns and failures; Lowers repair costs - Increase instrument life - Increases safety for workers - Produces greater customer satisfaction 6. What is the correct action to be taken if we encounter problem with equipment? - Troubleshooting - call manufacturer - backup machine - send sample to reference lab 7. Benefit of inventory management - reagents and supplies are available all the time 8. What does Quantification mean? a process for calculating how much is required of any particular item for a given period of time. 9. Methods of quantification: - morbidity based: based on actual usage (health supplies actually used wastage–expired or spoiled supplies) - consumption based: based on the actual number of episodes (population size disease incidence) 10. Advantage and drawbacks of computerized stock management - Advantages: Exact current state of stock, product classification Management of expiration dates Statistics planning purchase orders Management of possible distribution Makes inventory tasks easier - Drawbacks: An on-site computer is needed Requires trained staff 11. Reagents orders according to the life span - if the life span is short 3 weeks, we do not place order for six months) 12. Patient identification and patient info should be included in the sample label - Name - Age - Physician - Test requested - Time 13. Components of lab handbook (policies and procedures) for good sample management - Instrument type, model number, serial number - Location in lab - Date purchased - Vendor contact information - Warranty - Spare parts 14. Sample requirements fasting or not, sampling timing - glucose and cholesterol test require fasting 15. Some analyte is affected by light and require to be transported in a dark container: - Bilirubin 16. Order of blood draw and anticoagulant 1. Blood Culture Bottles (Aerobic-Anaerobic) 2. Coagulation Tube 3. Serum Tube with or without clot activator, with or without gel separator 4. Heparin Tube with or without gel plasma separator 5. EDTA 6. Fluoride (Glycolytic Inhibitor) 17. Quality control is used to monitor accuracy and precision of the analytical stage 18. Examples of qualitative, semi-quantitative and quantitative test - Qualitative: growth or no growth, positive or negative, reactive or non-reactive, color change = Pregnancy test - Semi-quantitative: “trace amount”, “moderate amount,” or “1+, 2+, or 3+” = urine dipstick - Quantitative test: specific number 19. Causes of hemolysis: - Cooling down the sample below 0 - Vigorous shaking - Insufficient amount - Traumatic venipuncture 20. What do you expect to see in ABG sample with delayed analysis? - Low pH, low O2, high CO2, low Glu, and high Lac. 21. The storage recommendation for ABG sample from a patient with leukocytosis: - ABG samples should be analyzed within 30 minutes. - If delayed expected, use glass syringe and put it in slurry ice - If the patient has high WBC and platelets, analyze sample within 5 mins. 22. ABG samples should be analyzed immediately for patient with leukocytosis and thrombocytosis because WBCs and platelets are metabolically active and the parameters will change quickly.
23. Which Information should be included in the test request form?
- Name - Time of requested test - Physician 24. Levey-Jennings charts is QC chart 25. Definition of accuracy and precision - Accuracy: The closeness of measurements to the true value - Precision: The amount of agreement in the repeated measurements 26. Control: is used to ensure the procedure is working properly (green light) 27. Calibrator: is used to set the measuring points on a scale 28. When should calibration be performed? - Using new reagent with different and new lot number - New equipment - If QC value is out of the range 29. Definition of sensitivity and specificity - Sensitivity: The ability to detect small quantities of a measured component - Specificity: The ability of a method to measure only the component of interest 30. Standard deviation: measure of variation 31. Shift: control values are on one side of the mean for 6 consecutive days. 32. Trend: control moving in one direction– heading toward an “out of control” value 33. The correct action If QC is out of the range: stop analyzing the patient sample until the problem resolved 34. West guard rules: to evaluate the QC values and help in taking decision. 35. Review the west guard rules you might get chart and asked to identify the violation of which rules.
36. Causes of out-of-control range:
- Degradation of reagents or kits - Control material degradation - Operator error - Calibration error 37. Internal audit for the hematology lab at AGH hospital is conducted by a group from the same organization 38. Steps of auditing process (order) 1. Gather information 2. compare findings with documented management system 3. identify breakdown in system or departure from procedures 4. do something with audit results (audit outcomes report) 39. Correct order of corrective action process - Using problem-solving team: - Investigate root causes (root cause analysis) - Develop appropriate corrective action - Implement corrective action - Examine effectiveness - Record all actions and findings - Monitor 40. Internal audit is more flexible and cost less money 41. Lab director is responsible for Setting overall policies for internal audit program 42. Quality manager is responsible for Managing the internal audit program - Outcome of internal and external audit is to Identify root causes of problems and take corrective actions - Corrective and remedial actions are Steps taken to improve a process or to correct a problem 43. Definition of proficiency testing: A program in which multiple samples are periodically sent to members of a group of laboratories for analysis and/or identification 44. How to handle the proficiency testing sample: analyzed in similar manner to the patient sample using the same procedure and the same lab staff 45. Limitation of proficiency testing: it detects errors in the analytical stage only 46. On-site visit: evaluate the entire performance of the lab 47. What is Rechecking / retesting - Rechecking: samples must be collected randomly; blinded - Retesting: tested by reference laboratory; not blinded