Individual Lab Report Ci-Trol Nov,2016 ST VINCENT MEDICAL CENTER LABORATORY(LAB# 7300 ) 2131 WEST THIRD STREET LOS ANGELES CA USA 90057 Abnormal Fibrinogen (mg/dl) Abnormal Fbg Control - Lot# LFC SYSMEX CA 1500-1, DADE THROMBIN Nov 109.3 7.00 6.4 11 105.5 5.33 5.0 134 SYSMEX CA 1500/7000, DADE THROMBIN Period Avg. SD Avg. CV s # Points SDI CVI Nov 109.8 1 5.52 4.9 8 245-0.1 1.3 110.1 3.97 5.3 69 24790-1.2 1.0 Nov 110.8 6.09 4.6 12 348-0.2 1.4 110.5 4.53 5.4 92 34097-1.1 0.9 1. Individual means in peer 109.900, 116.600, 119.000, 105.462, 102.417, 108.431, 107.217, 109.300 Abnormal Fbg Control - Lot# LFC SYSMEX CA 1500-2, DADE THROMBIN Nov 106.0 N N 3 101.5 4.35 4.3 109 SYSMEX CA 1500/7000, DADE THROMBIN Period Avg. SD Avg. CV s # Points SDI CVI Nov 109.8 1 5.52 4.9 8 245-0.7 0.2 110.1 3.97 5.3 69 24790-2.2 0.8 Nov 110.8 6.09 4.6 12 348-0.8 0.3 110.5 4.53 5.4 92 34097-2.0 0.8 1. Individual means in peer 109.900, 116.600, 119.000, 105.462, 102.417, 108.431, 107.217, 109.300 APTT (seconds) Ci-Trol 1 - Lot# 548015 SYSMEX CA 1500-1, DADE ACTIN FSL Nov - N - - 25.9 0.42 1.6 845 SYSMEX CA 1500/7000, DADE ACTIN FSL Period Avg. SD Avg. CV s # Points SDI CVI Nov 25.3 1 0.22 2.0 6 418 - - 25.5 0.44 1.9 103 78095 0.8 0.9 1. Individual means in peer 25.300, 25.230, 25.530, 25.490, 25.021, 25.000 Nov 25.1 0.44 2.1 14 857 - - 25.3 0.49 2.1 260 191977 1.1 0.8 SYSMEX CA 1500-1, DADE ACTIN FSL Nov 60.3 1.21 2.0 55 59.8 1.34 2.2 924 SYSMEX CA 1500/7000, DADE ACTIN FSL Period Avg. SD Avg. CV s # Points SDI CVI Nov 59.2 1 1.06 2.2 8 546 1.0 0.9 59.7 1.07 2.3 102 78351 0.1 1.0 Nov 56.7 3.73 2.0 17 1005 1.0 1.0 57.4 2.99 2.5 262 194061 0.8 0.9 1. Individual means in peer 57.800, 58.430, 60.210, 60.010, 58.280, 58.480, 60.300, 60.200 Total Error Graph (= ) CLIA 132.180 105.517 CLIA 88.120 Total Error Graph (= ) CLIA 132.180 101.459 CLIA 88.120 Total Error Graph (= ) CLIA 29.340 25.868 CLIA 21.686 Total Error Graph (= ) CLIA 68.640 59.829 CLIA 50.734 Refer to the Siemens Hemostasis QAP Report Appendix for report definitions and calculations. Print Date & Time: 27-Jul-18 6:42:39 AM Part No.: D53852 Page: 1
Individual Lab Report Ci-Trol Nov,2016 ST VINCENT MEDICAL CENTER LABORATORY(LAB# 7300 ) 2131 WEST THIRD STREET LOS ANGELES CA USA 90057 APTT (seconds) SYSMEX CA 1500-2, DADE ACTIN FSL Nov 60.2 0.77 1.3 34 60.3 1.85 3.1 952 SYSMEX CA 1500/7000, DADE ACTIN FSL Period Avg. SD Avg. CV s # Points SDI CVI Nov 59.2 1 1.06 2.2 8 546 0.9 0.6 59.7 1.07 2.3 102 78351 0.6 1.3 Nov 56.7 3.73 2.0 17 1005 0.9 0.6 57.4 2.99 2.5 262 194061 1.0 1.2 1. Individual means in peer 57.800, 58.430, 60.210, 60.010, 58.280, 58.480, 60.300, 60.200 Clauss Fibrinogen (mg/dl) Ci-Trol 1 - Lot# 548015 SYSMEX CA 1500-1, DADE THROMBIN Nov - N - - 247.2 8.10 3.3 120 SYSMEX CA 1500/7000, DADE THROMBIN Period Avg. SD Avg. CV s # Points SDI CVI Nov 261.5 1 8.35 3.5 5 191 - - 257.8 7.25 4.2 74 27651-1.5 0.8 Nov 261.0 7.20 4.3 9 284 - - 261.0 12.15 4.5 101 36302-1.1 0.7 1. Individual means in peer 275.200, 263.800, 256.600, 255.865, 256.023 Prothrombin Time (seconds) Ci-Trol 1 - Lot# 548015 SYSMEX CA 1500-1, DADE INNOVIN Nov - N - - 10.7 0.22 2.0 844 SYSMEX CA 1500/7000, DADE INNOVIN Period Avg. SD Avg. CV s # Points SDI CVI Nov 11.0 1 0.14 2.2 6 436 - - 10.8 0.14 2.0 103 81577-0.7 1.0 1. Individual means in peer 11.000, 10.800, 11.060, 10.940, 11.150, 11.161 Nov 10.9 0.31 2.1 18 1014 - - 10.7 0.28 2.1 297 220172-0.1 1.0 SYSMEX CA 1500-1, DADE INNOVIN Nov 54.2 2.30 4.2 97 53.2 2.27 4.3 971 SYSMEX CA 1500/7000, DADE INNOVIN Period Avg. SD Avg. CV s # Points SDI CVI Nov 53.1 1 2.24 3.7 8 641 0.5 1.1 53.2 1.21 3.2 104 83097 0.0 1.3 Nov 52.8 1.84 3.4 19 1137 0.8 1.2 52.9 1.56 3.3 294 217987 0.2 1.3 1. Individual means in peer 48.900, 50.810, 53.490, 52.710, 54.485, 54.389, 54.200, 55.800 Total Error Graph (= ) CLIA 68.640 60.326 CLIA 50.734 Total Error Graph (= ) CLIA 309.307 247.225 CLIA 206.204 Total Error Graph (= ) CLIA 12.427 10.708 CLIA 9.185 Total Error Graph (= ) CLIA 61.221 53.234 CLIA 45.250 Refer to the Siemens Hemostasis QAP Report Appendix for report definitions and calculations. Print Date & Time: 27-Jul-18 6:42:39 AM Part No.: D53852 Page: 2
Individual Lab Report Ci-Trol Nov,2016 ST VINCENT MEDICAL CENTER LABORATORY(LAB# 7300 ) 2131 WEST THIRD STREET LOS ANGELES CA USA 90057 Prothrombin Time (seconds) SYSMEX CA 1500-2, DADE INNOVIN Nov 55.8 2.06 3.7 34 54.1 2.53 4.7 1108 SYSMEX CA 1500/7000, DADE INNOVIN Period Avg. SD Avg. CV s # Points SDI CVI Nov 53.1 1 2.24 3.7 8 641 1.2 1.0 53.2 1.21 3.2 104 83097 0.7 1.5 Nov 52.8 1.84 3.4 19 1137 1.6 1.1 52.9 1.56 3.3 294 217987 0.8 1.4 1. Individual means in peer 48.900, 50.810, 53.490, 52.710, 54.485, 54.389, 54.200, 55.800 Total Error Graph (= ) CLIA 61.221 54.061 CLIA 45.250 QAP Reports are designed primarily to summarize data on Siemens Hemostasis Controls. The Statistics are calculations from user input and are provided as a service to customers. No claim is made as to the validity of values, tests and methods beyond those specifically identified on Siemens Hemostasis Control inserts and product literature. Refer to the Siemens Hemostasis QAP Report Appendix for report definitions and calculations. Print Date & Time: 27-Jul-18 6:42:39 AM Part No.: D53852 Page: 3
Report Appendix DATA CODES Any code that may appear with data on Siemens Hemostasis QAP reports is listed here with a brief description. 1 This symbol prints next to the Avg when the number of peers in the peer group is 10 or fewer, signifying a small peer group. For these small sample sizes, the individual means of each peer in the group are printed at the end of the data for the control level. "-" This statistic was Not Calculated for the indicated data collection period due to the presence of incongruent data in the calculation. C This data has been changed or added by Siemens Hemostasis QAP at the request of your laboratory. G L N P S This value did not pass the Gross Outlier Check, which excludes extremely discrepent data that falls outside of present limits for each test. This data was not processed and is not included in QAP Reports. This value did not pass the Laboratory Outlier Check, which excludes values more than +/- 3 standard deviations from the lab s mean for the month. This value was excluded from the calculation of the lab s mean and SD for this month. The SD and CV for a set of control data points for an individual lab are not displayed when the number of points for the set is less than five. Your lab s mean did not pass the Outlier Check, which excludes lab means from peer statistics that are discrepant from the average peer mean. Your lab s All Shift mean did not pass the Outlier Check, which excludes lab means from peer statistics that are discrepent from the average peer mean. Data from all shifts has been excluded from the peer statistics. DEFINITIONS Avg. CV CVI The peer average mean is calculated by averaging the individual means in a peer group. Comparing the lab mean to the peer average can aid in evaluating analytical accuracy. The coefficient of variation is the SD expressed as a percentage of the mean and is calculated by dividing the SD by the mean and multiplying by 100. It is useful in evaluating precision. The coefficient of variation index compares the lab s CV to the peer group median CV for evaluating precision. The CVI calculation is: Lab CV Average CV Avg. CV Lot-to-Date describes a data collection period which includes all QC data received thus far for this control lot, either for the lab or the peer, as indicated. The peer average CV (coefficient of variation) is calculated by averaging the individual CV s in a peer group. Comparing the lab CV to the peer average CV aids in evaluationg precision. Print Date & Time: 27-Jul-18 6:42:39 AM Part No.: D53865 Page: 1
Report Appendix For Chemistry tests, the statistics for this peer group category are calculated by combining data submitted from peers using the same method principle, with any instrument and reagent. For Hemostasis tests, the statistics for this peer group category are calculated by combining data submitted from peers using the same method principle and reagent, with any instrument. SD SD SDI The SD is the standard deviation (SD) of all the acceptable current or cumulative () lab means used in the calculation of the, or J&J Vitros standard deviation index (SDI). The standard deviation for a lab represents the spread of a set of individual data points around their mean. It is useful in evaluating precision. The standard deviation index compares the lab s mean to the peer group average mean for evaluating accuracy. The reports identify the peer group used in the SDI calculation. The SDI calculation is: Lab mean - Avg. SD Total Error (TE) The statistics for this peer group category are calculated by combinig data submitted from peers using the same or similarly performing instrumentation, and the same reagent and reaction temperature (when applicable). Total Error (TE) refers to the total analytical error of a lab s analytical method and may be used to assess its inaccuracy and imprecision. The Total Error Graph compares the Total Error of the lab s analytical method to the Total Error Limits (calculated using the mean). To assess the acceptability of the lab s Total Error, the lab s mean +/-2 SD range is compared to the Total Error Limits. This range should be within the Total Error Limits. The Total Error Limits are calculated using test performance guidelines from one of the following: U.S. CLIA, Medical Society of Germany or +/- 3 SD. Using these guidelines, the lower and upper limits are established with this calculation: the Average +/- test specific guidelines. When such guidelines are not available, the limits are not calculated. When a Total Error Limit is exceeded, it may be necessary to investigate for sources of either inaccuracy or imprecision. While this information may assist with predicting proficiency testing performance due to peer and methodological differences, it is suggested that discretion be used in interpretation. In addition, the lab must define its own analytical goals for minimizing bias and imprecision, and medical decision levels. Print Date & Time: 27-Jul-18 6:42:39 AM Part No.: D53865 Page: 2