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PEPFAR Quality Control and Method Validation Pre-training Knowledge Check

This PDF contains a prerequisite worksheet that should be completed prior to taking the PEPFAR QC Workshop.

QC Challenge Name __________________________________________ Date ________________ Please write legibly. 1. To describe a Gaussian distribution, we need only 2 statistics, what are they? 2. What do the slash marks indicate in the following multirule: 1:3s / 2:2s / R:4s / 4:1s? 3. Why is it harder to quality control a measurement procedure with a low Sigma? 4. If the SEc is 5.1, what does that value convey regarding the method’s performance? 5. Name 4 actions a site can implement when the Sigma is low for an analyte. 6. Using the SEc and Sigma-metric values for benchmarking purposes, which 2 analytes would you target further for investigation? Analyte SEc Sigma-metric ALT 1.5 3.15 AST 5.1 6.75 Bilirubin, Total 2.0 3.65 Creatinine 4.1 5.75 Glucose 4.1 5.75 Total Protein 6.0 7.65 7. Using the analytes in Question #6, list the analyte(s) where a single rule criterion would be appropriate? HILS1750 Effective Date: 12/16/2016 Complete the sentences using the provided choices. You may use the choices more than once. TRUE ACCEPTS TRUE REJECTS FALSE ACCEPTS FALSE REJECTS 1. When the mean assigned on the QC chart is not the observed mean, there is an increase in ____________ and ____________ . 2. When the SD assigned on the QC chart is smaller than the observed SD, there is an increase in ________________ . 3. When the SD assigned on the QC chart is larger than the measured SD, there is an increase in _________________ . Complete the sentences using the provided choices. You may use the choices more than once. INCREASE DECREASE NOT CHANGE 1. If the TEA limits become narrower, the TE will _______________, and the SEc will __________________ . 2. If the mean shifts further from the true value and the SD remains the same, the TE will ______________, and the SEc will _________________ . 3. If RE decreases and the bias remains the same, the TEA limits will and the SEc will __________________ ________________, . 4. If the mean shifts further from the true value and the SD increases, the TE will ________________, and the SEc will ____________________ . 5. If only the bias increases, the TE will _________________, and the SEc will . _________________ 6. If the TE increases, the TEA limits will ___________________, and the SEc will ________________________ . HILS1750 Effective Date: 12/16/2016 Match the correct definition to the corresponding term. There will be one definition remaining when you have competed the matching. TERM DEFINITION A The number of SDs a data measurement lies from the 1 ____ SDI peer mean B The comparison or ratio of the laboratory’s coefficient 2 ____ TE of variation to the peer’s coefficient of variation. C The total variation of the laboratory’s value from the 3 ____ TEA true value; combined effect of random and systematic errors D The number of SDs the mean can shift before exceeding 4 ____ CVI the TEA quality specifications E The standard deviation expressed as a percentage of the 5 ____ SEc mean; the relative standard deviation F Specifies the maximum acceptable variation from the true value; the amount of error that can be tolerated without invalidating the clinical usefulness of the result HILS1750 Effective Date: 12/16/2016 From the following choices, select the best choice for each graph that completes the sentence: The current population demonstrates __________ . A. an increase in imprecision B. an emergence of a positive bias C. a decrease in imprecision D. a normal distribution E. a change in accuracy F. an emergence of a negative bias G. none of the above choices 1. ______ 2. ______ +4SD +4SD +3SD +3SD + 2SD + 2SD + 1SD .+ 1SD X X -1SD , - 1SD ,- 2SD . - 2SD -3SD -3SD . 4SD -4 SD 3. ______ +4SD +3SD + 2SD 1SD X -1SD -2SD| -3SD -4SD HILS1750 Effective Date: 12/16/2016 From the following choices, select the best choice for each graph that completes the sentence: The L-J chart demonstrates __________ . A. an emergence of a positive bias B. an emergence of a negative bias C. the mean assigned to the chart is not the measured mean D. the SD assigned to the chart is greater than the measured SD E. the SD assigned to the chart is less than the measured SD F. none of the above choices 1. _____ 2. _____ +4SD +4SD +3SD +3SD ,+ 2SD + 2SD + 1SD 1SD X X -1SD 1SD ,- 2SD ,- 2SD -3SD -3SD 4SD 4SD 3. _____ +4SD +3SD + 2SD + 1SD X , - 15D ,- 2SD -3SD -4SD HILS1750 Effective Date: 12/16/2016 Based on the diagram, list the four key numbers and their values. Provide a definition for each key number. The z-factor used for TE is 1.65. Key Number Value Definition 1. 2. 3. 4. TE = 33.2 umol/L RE = 13.2 umol/L Lower Upper Limit Limit 450 500 550 umol/L umol/L umol/L HILS1750 Effective Date: 12/16/2016

  • Prerequisite
  • pre req
  • pre requisite
  • qc challenge