PEPFAR Quality Control and Method Validation Activity 11 Worksheet: PT Calculations

Worksheet: PT Calculations 1106 Effective Date: 12/6/2016 HILS1746 Directions: Calculate the SDI and Limits of Acceptability. Based on the acceptable range, determine your grade for the survey sample. The first two rows are completed for you. CLIA acceptable performance for free thyroxine is Target Value + 3SD of the PT group. Test Evaluation and Comparative Method Statistics Unit of Measure Limits of Acceptability Peer Group Sample Your Mean SD S.D.I Result Lower Upper Your Grade Z Free Thyroxine (ng/dl) CH-01 4. . 4.64 0.26 45 (4.5-4.64)/0.26 = 4.64 - 3(0.26) 4.64 + 3(0.26) = acceptable - 0.5 =3.86 5.42 Siemens Advia Centaur, XP CH-02 2.4 2.66 0.19 59 (2.4 - 2.66)/0.19 2.66 - 3(0.19) 2.66 + 3(0.19) acceptable = - 1.4 = 2.09 =3.23 Siemens Advia Centaur rgt CH-03 1.0 1.13 0.08 45 CH-04 1.8 2.07 0.14 33 CH-05 2.2 2.37 0.12 45 The survey sample CH-01 is above / below the group's mean (target value). Your result is group SDs from the peer group's mean. The survey sample CH-02 is above / below the group's mean (target value). Your result is Circle one _ group SDs from the peer group's mean. The survey sample CH-03 is above / below the group's mean (target value). Your result is Circle one group SDs from the peer group's mean. Circle one The survey sample CH-04 is above / below the group's mean (target value). Your result is group SDs from the peer group's mean. Circle one The survey sample CH-05 is above / below the group's mean (target value). Your result is group SDs from the peer group's mean. Circle one SDI enables your laboratory to assess your performance in the context of peer laboratories. Even though the performance is satisfactory for this analyte, your assessment of free thyroxine testing may indicate a problem with accuracy) precision) for your laboratory check all that apply 117 Worksheet: PT Calculations 1106 Effective Date: 12/6/2016 HILS1746 Peer Mean Lower Limit Upper Limit CH-02 CH-01 - 3SD -2SD -1SD OSD +1SD +2SD +3SD Using the SDI calculated for each survey sample, draw a circle to indicate the location of your survey samples in relationship to the peer group's mean. CH-01 and CH02 are done for you. 118