PEPFAR Quality Control and Method Validation Activity 11 Handout: PT Examples

Handout: PT Examples HEMATOLOGY Analyte/Method Sample Reported Expected Result Result Mean SD SDI Grade Hematocrit (%) XE-06 18 16 – 19 17.3 0.4 1.8 Acceptable Instrument X XE-07 45 42 – 48 45.0 0.6 0.0 Acceptable XE-08 19 17 – 21 19.1 0.3 -0.3 Acceptable XE-09 44 41 – 48 44.6 0.7 -0.9 Acceptable XE-10 34 31 – 36 33.8 0.5 0.4 Acceptable Hemoglobin (g/dL) XE-06 5.8 5.3 – 6.2 5.76 0.07 0.6 Acceptable Instrument X XE-07 15.9 14.6 – 17.0 15.80 0.16 0.6 Acceptable XE-08 6.6 6.0 – 7.0 6.49 0.09 1.2 Acceptable XE-09 15.6 14.4 – 16.7 15.55 0.14 0.4 Acceptable XE-10 11.6 10.7 – 12.4 11.57 0.12 0.7 Acceptable Platelet Count XE-06 61 43 – 72 57.4 2.8 1.3 Acceptable (x 10E9/L) XE-07 489 363 – 606 484.8 11.0 0.4 Acceptable Instrument X XE-08 336 250 – 418 333.7 8.2 0.3 Acceptable XE-09 113 87 – 147 117.3 4.7 -0.9 Acceptable XE-10 209 158 - 265 211.8 7.0 -0.4 Acceptable RDW-CV (%) XE-06 10.1 15.8 – 16.7 16.31 0.12 -1.7 Acceptable Instrument X XE-07 14.6 14.2 – 15.0 14.62 0.11 -0.2 Acceptable XE-08 15.6 15.2 – 16.0 15.60 0.13 0.0 Acceptable XE-09 13.6 13.2 – 14.0 13.64 0.12 -0.3 Acceptable XE-10 15.3 14.9 – 15.6 15.24 0.11 0.5 Acceptable Red Cell Count XE-06 2.36 2.18 – 2.47 2.321 0.028 1.4 Acceptable (x 10E12/L) XE-07 5.28 4.89 – 5.53 5.208 0.051 1.4 Acceptable Instrument X XE-08 2.60 2.39 – 2.71 2.551 0.031 1.6 Acceptable XE-09 5.25 4.91 – 5.55 5.234 0.061 0.3 Acceptable XE-10 4.23 3.94 – 4.46 4.202 0.044 0.6 Acceptable Reticulocyte Count XE-06 6.10 4.62 – 6.74 5.676 0.352 1.2 Acceptable (%) XE-07 0.95 0.74 – 1.22 0.983 0.078 -0.4 Acceptable Instrument X White Cell Count XE-06 2.9 2.4 – 3.4 2.91 0.10 -0.1 Acceptable (x 10E9/L) XE-07 18.0 14.9 – 20.3 17.59 0.43 1.0 Acceptable Instrument X XE-08 6.9 5.6 – 7.7 6.68 0.19 1.2 Acceptable XE-09 3.0 2.4 – 3.4 2.90 0.10 1.0 Acceptable XE-10 6.7 5.8 – 7.9 6.85 0.19 -0.8 Acceptable HOOD05162002658134 Effective Date: 9/5/2017 COAGULATION Limits of Acceptability Plot of the Relative Distance of Your Results Test Specimen Your No. of from Target as Percentages of allowed Result Mean S.D. Labs S.D.I Your Grade Deviation Lower Upper Survey -100-----------Mean-----------+100 PT, quant CGL-11 28.5 27.51 1.04 190 +0.9 23.3 31.7 Acceptable (seconds) CGL-12 42.4 41.44 1.81 189 +0.5 35.2 47.7 Acceptable CGL-C 2010 28.5 27.34 0.97 190 +1.2 23.2 31.5 Acceptable CGL-B 2010 CGL-13 CGL-A 2010 CGL-14 11.5 11.28 0.25 189 +0.9 9.5 13.0 Acceptable -100 -80 -60 -40 -20 0 20 40 60 80 100 CGL-15 28.1 27.28 1.02 189 +0.8 23.1 31.4 Acceptable Activated CGL-11 56 53.5 1.6 183 +1.6 45 62 Acceptable PTT, quant CGL-12 72 70.4 2.6 183 +0.6 59 81 Acceptable CGL-C 2010 (seconds) CGL-13 58 53.3 1.6 181 +2.9 45 62 Acceptable CGL-B 2010 CGL-A 2010 CGL-14 29 27.5 0.7 180 +2.3 23 32 Acceptable CGL-15 56 53.2 1.6 182 +1.7 45 62 Acceptable -100 -80 -60 -40 -20 0 20 40 :60 80 100 Fibrinogen CGL-11 330.40 304.383 25.145 128 +1.0 243.50 365.26 Acceptable (mg/dL) CGL-12 346.80 333.150 21662 127 +0.6 266.51 399.78 Acceptable CGL-C 2010 CGL-13 293.40 304.898 25.646 128 -0.4 243.91 365.88 Acceptable CGL-B 2010 CGL-A 2010 CGL-14 325.20 309.180 25.129 128 +0.6 247.34 371.02 Acceptable 100 -80 -60 -40 -20 20 40 60 80 100 CGL-15 297.70 303.602 26.581 128 -0.2 242.88 364.33 Acceptable HOOD05162002658134 Effective Date: 9/5/2017 FULL BLOOD COUNT Number of Laboratories Enrolled 136 Number of Responses Received 99 Statistical Evaluations: Statistics have been calculated from the consesus of the robust mean Metrological Traceability: There is no metrological traceability of consensus values. Method used: (If n is less than 30 for each method, method statistics will not be displayed) Sample Label FBC 1 Analyte Name Units Your Consensus Sample Size Uncertainty of Response Z – Score Value (n) Std. Dev. Measurement White Blood Count 102 ul 4.50 -0.18 4.60 90 0.52 0.07 Red Blood Count 102 ul 3.36 -0.19 3.38 90 0.10 0.01 Hemoglobin g/dl 10.40 0.34 10.3 91 0.30 0.04 Hematocrit % 26.6 -0.78 28.5 91 2.37 0.31 MCV fl 79.2 -0.64 82.7 88 5.49 0.73 Platelets 103 ul 204 0.17 196 90 48.93 6.45 Sample Label FBC 2 Analyte Name Units Your Consensus Sample Size Uncertainty of Response Z – Score Value (n) Std. Dev. Measurement White Blood Count 102 ul 2.40 -0.59 2.62 89 0.37 0.05 Red Blood Count 102 ul 2.75 -1.80 2.87 89 0.07 0.01 Hemoglobin g/dl 7.40 0.00 7.4 90 0.22 0.03 Hematocrit % 19.4 -1.15 21.1 89 1.48 0.20 MCV fl 70.5 -0.88 74.5 88 4.52 0.60 Platelets 103 ul 142 0.32 132 89 31.13 4.13 HOOD05162002658134 Effective Date: 9/5/2017