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PEPFAR Quality Control and Method Validation Activity 9 Handout: Monthly Review

This PDF contains information needed to complete Activity 9.

95 Handout: Monthly Review 905 SEc Monthly Review Log June May QC Target TE (in TEA (in 20XX 20XX Instrument Analyte Material Units Mean SD Value units) units) TEA% SEc SEC XYZ Analyzer ALT Level 1 U/L 27.8 4.3 27.6 2.3 7.3| 26.3 3.8 3.9 Level 3 U/L 200.0 9.8 198.0 18.2 52.1 26.3 3.5 3.5 XYZ Analyzer AST Level 1 U/L 48.0 1.1 47.0 2.8 7.1 15.2 3.9 4.0 Level 3 U/L 274.0 7.0 271.0 14.6 41.2 15.2 3.8 4 XYZ Analyzer Bili-Total Level 1 umol/L 10.4| 0.6 10.5 1.1 3.3 31.1 3.6 3.6 Level 3 umol/L 130.0 4.8 126.0 11.9 39.2 31.1 5.7 5.8 XYZ Analyzer Calcium Level 1 mmol/L 1.43 0.01 1.40 0.05 0.05 3.60 0.39 1.40 Level 3 mmol/L 3.21 0.04 3.19 0.09 0.11 3.60 0.72 2.20 XYZ Analyzer CK Level 1 U/L 800.0 5.0 81.0 727.3 24.5 30.3 -140.5 3.1 Level 3 U/L 635.0 25.0 638.0 44.3 193.3 30.3 6.0 6.0 XYZ Analyzer Creatinine Level 1 umol/L 44.4 0.7 44.5 1.3 4.0 8.9 3.9 3.9 Level 3 umol/L 565.0 8.0 559.0 19.2 49.8 8.9 3.8 3.9 XYZ Analyzer Glucose Level 1 mmol/L 3.44| 0.06 3.3 0.15 0.23 6.90 1.42 1.23 Level 3 mmol/L 20.39 0.39 20.20 0.83 1.39 6.90 1.44 1.33 XYZ Analyzer Potassium Level 1 mmol/L 2.60 0.10 2.59 0.18 0.23 8.70 0.50 1.04 Level 3 mmol/L 7.50 0.31 7.60 0.61 0.66 8.70 0.16 1.04 XYZ Analyzer Sodium Level 1 mmol/L 116.0 0.5 116.0 0.8 L.5 1.3 1.4 2.4 Level 3 mmol/L 157.0 0.8 157.0 1.3 2.0 1.3 0.9 1.8 XYZ Analyzer TP Level 1 g/L 42.0 0.2 41.6 0.7 1.4 3.4 3.4 3.6 Level 3 g/L 71.8 71.8 0.8 2.4 3.4 3.2 3.3 in HILS1746 Effective Date: 12/6/2016

  • TEA
  • sigma-metric
  • critical systematic error
  • SEC
  • SLIPTA
  • SLIPTA checklist
  • benchmarking methods
  • sigma scale
  • sigma
  • method performance