PEPFAR Quality Control and Method Validation Activity 10 Handout 2: Monthly Review Log

108 Handout 2: Monthly Review Log " 1004 SEc and Sigma-metric Monthly Review Log June June 20XX QC Target TE (in | TEA (in 20XX Sigma- Instrument Analyte Material Units Mean SD Value # units) units) TEA % * SEC metric XYZ Analyzer ALT Level 1 U/L 27.8 1.3 27.6 1 2.3 7.3 26.3 3.8 5.4 Level 3 J/L 200.0 9.8 198.0 18.2 52.1 26.3 5.1 in XYZ Analyzer AST Level 1 U/! 48.0 1.1 47.0 2.8 7.1 15.2 3.9 5.6 1 Level 3 U/L 274.0 7.0 271.0 14.6 41.2 15.2 3.8 5.5 XYZ Analyzer Bili-Total Level 1 |umol/L 10.6 0.6 10.5 1.1 3.3 31.1 1 3.6 5.3 Level 3 umol/L 130.0 4.8 126.0 11.9 39.2 31.1 5.7 7.3 XYZ Analyzer Calcium Level 1 mmol/L 1.44 0.01 1.40 1 0.06 0.05 3.60 2 -0.6 1.0 Level 3 mmol/L 3.24| 0.03 3.19 0.10 0.11 3.60 2.2 XYZ Analyzer CK Level 1 U/L 80.0 5.0 81.0 1 9.3 24.5 30.3 4.7 1 3.1 Level 3 U/L 635.0 25.0 638.0 44.3 193.3 30.3 6.0 7.6 XYZ Analyzer Creatinine Level 1 umol/L 44.4 0.7 44.5 1 1.3 4.0 8.9 1 3.9 5.5 Level 3 |umol/L 565.0 8.0 559.0 19.2 49.8 8.9 3.8 5.5 XYZ Analyzer Glucose Level 1 mmol/L 3.42 0.05 3.39 0.1: 0.23 6.90 1 2.4 4.1 Level 3 mmol/L 20.19 0.29 20.20 0.49 1.39 6.90 3.1 4.8 XYZ Analyzer Potassium Level 1 mmol/L 2.59| 0.10 2.59 0.17 0.23 8.70 1 2 0.6 2.3 Level 3 mmol/L 7.53 0.37 7.60 0.68 0.66 3.70 -0.1 1.6 XYZ Analyzer Sodium Level 1 mmol/L 116.0 0.5 116.0 1 0.8 1.5 1.3 2 1.4 3.0 Level 3 mmol/L 157.0 0.8 157.0 1.3 2.0 1.3 2.6 XYZ Analyzer TP Level 1 g/L 42.0 0.2 41.6 0.7 1.4 3.4 1 3.4 5.1 Level 3 71.8 0.5 71.8 m g/L 0.8 2.4 3.4 4.9 # Target Value from * TEA % from 1 - package insert 1- desirable biological variation 2-inter-laboratory peer comparison 2-minimum biological variation 3- summary or cumulative data 3- optimal biological variation 4- CLIA proficiency testing HILS1746 Effective Date: 12/6/2016