MLT230: Chapter 07: Quality Management. All Answers

MULTIPLE CHOICE 1. If alerted to a control problem when using Westgard multirules, an analyst should first: a. assess the analytical method, equipment, reagents, and specimens. b. rerun controls several times until ...

MULTIPLE CHOICE 1. If alerted to a control problem when using Westgard multirules, an analyst should first: a. assess the analytical method, equipment, reagents, and specimens. b. rerun controls several times until the values finally are acceptable. c. call the laboratory manager. d. call the manufacturer’s repair hotline. 2. Upon examination of the week’s analytical run of plasma glucose tests, you notice that four consecutive normal control values are +1 s (standard deviation) from the mean. In your QC report, you note that Westgard multirule _____ has been broken and realize that this rejection rule is sensitive to _____ error. a. 14s; random b. 41s; systematic c. R4s; systematic d. 4Rs; random 3. Upon examination of the week’s analytical run of plasma glucose tests, you notice that four consecutive normal control values are +1 s (standard deviation) from the mean. In your QC report, you note that a Westgard multirule has been broken and realize that this rejection rule is sensitive to a specific type of error. An example of this type of error would be: a. poor pipetting technique. b. incubator temperature change. c. improper calibrator preparation. d. unstable photometer. 4. Preparation of a CLSI-defined procedure document of an analytical protocol is a means of controlling which one of the following types of variables? a. Analytical b. Preanalytical c. Postanalytical d. Reproducibility 5. Which one of the following would be considered a postanalytical variable in regard to laboratory services? a. Test ordering b. Specimen acquisition c. Test procedures d. Result reporting 6. The Westgard multirules for quality control were designed to interpret control data and to aid in troubleshooting. The rule stated as 22s is interpreted as meaning: a. one control value has exceeded ±2 s from the mean. b. two consecutive control values have exceeded the mean ±2 s. c. two consecutive control values have exceeded the mean ±1 s. d. four consecutive controls have exceeded the mean ±2 s. 7. Lean Production: a. involves use of simulated patient specimens made from a common pool to determine the “quality” of a laboratory’s performance using standard deviation calculations. b. is a quality performance goal that requires a specific number of standard deviations of process variation to fit within the tolerance limits for the process. c. is a quality process that focuses on creating more value by eliminating activities that are considered wasteful. d. is a set of international standards for quality management produced by the International Organization for Standardization. 8. Which one of the following would be considered a cost of nonconformance? a. Performing preventive maintenance on analyzers b. Employee training c. Repeating an analytical run because the QC is out of range d. Sending an employee to a fire safety class 9. Six Sigma processes: a. use simulated patient specimens made from a common pool to determine the “quality” of a laboratory’s performance using standard deviation calculations. b. are quality performance goals that require a specific number of standard deviations of process variation to fit within the tolerance limits for the process. c. are focused on creating more value by eliminating activities that are considered waste. d. are international standards for quality management produced by the International Organization for Standardization. 10. Upon examination of the control chart of the week’s analytical run of serum creatinine, you notice that 10 consecutive level II control values lie on the same side of the mean. In your QC report, you note that Westgard multirule _____ has been broken and realize that this rejection rule is sensitive to _____ error. a. 10; random b. 10; systematic c. X10; random d. X10; systematic 11. Upon examining a Levey-Jennings control chart for analyte X, you notice that on day 6 the one control was 2.5 s from the mean and the duplicate control was +3.3 s from the mean. Which of the following Westgard control rules was/were broken? a. 41s and 22s b. R4s and 13s c. R4s and 22s d. 22s only 12. Which one of the following statements concerning the use of internal control materials is incorrect? a. Use of control materials can aid in the identification of assay malfunctions that lead to unreliable data. b. Serum controls are prepared from human serum pools and are analyzed in analytical runs that are separate from patient samples. c. QC data are collected over a period of time and statistically analyzed using measures of central tendency. d. Controls that exceed specific limits are examined with the Westgard rules to determine what kind of error is present and what actions are to be taken. 13. In regard to a Gaussian distribution, ±2 s from the mean encompasses _____ of values. a. 99.7% b. 98.0% c. 95.5% d. 68.2% 14. Random error would be caused by: a. contaminated reagents. b. pipetting errors. c. inappropriate preparation of calibrators. d. low volume reagent blanks. 15. According to CLIA regulations, a score of _____ must be attained on three consecutive external proficiency test challenges for a laboratory to be accredited and continue patient testing. a. 50% b. 60% c. 70% d. 80% 16. You have received your proficiency test results from the accrediting agency and note that your creatinine result was unacceptable at greater than 2 SDI from the group mean. The value that was entered on your survey report form was 15 mg/dL. The group method mean was 1.3 mg/dL, with a method standard deviation of 0.3 mg/dL. You realize that your laboratory made an error in entering the result. If you had entered 2.0 mg/dL as the result on your survey report, what would the correct SDI be? a. 45.6 SDI b. 4.56 SDI c. 1.08 SDI d. 0.67 SDI 17. You have received your proficiency test results from the accrediting agency and note that your creatinine result was unacceptable at greater than 2 SDI from the group mean. The value that was entered on your survey report form was 15 mg/dL. The group method mean was 1.3 mg/dL with a method standard deviation of 0.3 mg/dL. You realize that your laboratory made an error in entering the result. If you had entered 2.0 mg/dL as the result on your survey report, would the recalculated SDI now be in agreement with the rest of the laboratories in the testing program? a. Yes b. No c. Cannot determine from information given 18. Two types of error may be encountered during chemical analysis of a substance. The type of error that occurs as a result of contaminated calibrating solutions would be _____ error. a. systematic b. random c. analytical d. calibration 19. You arrive at the clinical chemistry laboratory one morning and discover that personnel from the third shift left you the QC sheet from the thyroid-stimulating hormone (TSH) run. The technician has circled the level I TSH control values, and you realize that all six of the level I control values are +3 s from the mean. No results have been released. Now it’s your decision regarding what to do next. First, which Westgard rule(s) has (have) been violated? a. 22s b. 41s c. 13s d. All of the above rules have been broken. 20. You arrive at the clinical chemistry laboratory one morning and discover that personnel from the third shift left you the QC sheet from the thyroid-stimulating hormone (TSH) run. The technician has circled the level I TSH control values, and you realize that all six of the level I control values are +3 s from the mean. No results have been released. Now it’s your decision regarding what to do next. What is your decision regarding the release of results in the problem stated in the preceding question? a. Hold all results, reject the run, and troubleshoot. b. Release results and do nothing else. c. Release all results and troubleshoot. d. Call the manufacturer’s representative and ask him what to do. 21. You arrive at the clinical chemistry laboratory one morning and discover that personnel from the third shift left you the QC sheet from the thyroid-stimulating hormone (TSH) run. The technician has circled the level I TSH control values, and you realize that all six of the level I control values are +3 s from the mean. No results have been released. Now it’s your decision regarding what to do next. What kind of error is most likely occurring? a. Random error due to pipetting errors b. Systematic error due to calibration issues 22. According to the five-Q framework, the “QP” refers to quality: a. programming. b. planning. c. processes. d. precision. 23. What is the role of quality planning in the five-Q framework of quality? a. To monitor the laboratory as a whole for result quality b. To monitor the statistical analysis of results c. To ensure that the laboratory's performance satisfies quality requirements d. To identify the cause of a problem and find a remedy for that problem 24. The first step in the development of an in-service training program using an instructional system for employee competency in the laboratory is: a. direct observation of routine patient test performance. b. preparation of a written procedure. c. implementation of a schedule. d. a needs assessment or gap analysis.