PEPFAR Quality Control and Method Validation Activity 12 Handout 2: Alk Phos Report

Handout 2: Alk Phos Report 1208 Monthly Evaluation Unassayed Chemistry Lab 1234 Attached are your QC reports. Based on comparisons to the reported peer group, the parameters listed below may require investigation or review. Monthly: SDI CVR #Labs #Points Alkaline Level 1 2.50 0.56 91 4576 Phosphatase Level 2 2.53 0.56 91 4586 U/L 37° C Corrective Action: Reviewed by:_________________________ Date: ___________________ HOOD05162002658134 Effective Date: 9/8/2017 Laboratory Performance Overview Unassayed Chemistry Lab 1234 Level 1 2.0 Alkaline Phosphatase U/L 1.0 1.0 210 CVR O Peer Method SDI: 2.50 1.89 -1.0 CVR: 0.6 0.3 # Labs: 91 429 # Points: 4576 17443 -2.0 Level 2 2.0 Alkaline Phosphatase U/L 1.0 1.0 210 CVR O Peer Method SDI: 2.53 2.01 -1.0 CVR: 0.6 0.2 # Labs: 91 428 # Points: 4586 17362 -2.0 HOOD05162002658134 Effective Date: 9/8/2017 Suggested Interpretation The following interpretations should be used as guidelines only. Each laboratory should determine whether a review of accuracy and/or precision is necessary and whether corrective actions may be required. 2.0 A C Acceptable Performance. B B Acceptable to Marginal Performance − 1.0 May indicate the need to investigate test A system accuracy or precision. C Marginal Performance − Corrective 1.0 210 CVR action may be necessary. O HOW A • -1.0 Your laboratory coordinates for accuracy B and precision based on your peer group. -2.0 C Your laboratory coordinates for accuracy and precision based on the method group. Note: SDI is a statistical estimate of accuracy. Note: CVR is a ratio of monthly laboratory CV to monthly peer group CV and is an estimate of precision. Corrective Action: _______________________________________________________ ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ Reviewed by:_____________________________ Date:_________________ HOOD05162002658134 Effective Date: 9/8/2017 Laboratory Comparison Report Unassayed Chemistry Lab 1234 Analyte Level 1 Level 2 Mon Cum Mon Cum Alkaline Phosphatase U/L Your Lab Mean 119.0 106.7 496.0 458.1 SD 3.10 5.78 9.90 17.06 CV 2.6 5.4 2.0 3.7 (Peer) CVR 0.6 1.1 0.6 1.1 (Method) CVR 0.3 0.6 0.2 0.3 (Peer) SDI 2.50 -0.12 2.53 0.05 (Method) SDI 1.89 0.62 2.01 1.10 # Points 60 1195 57 1152 Peer Group Mean 106.6 107.3 455.3 457.3 Instrument X SD 4.95 5.22 16.10 14.92 CV 4.6 4.9 3.5 3.3 # Points 4576 123777 4586 122800 # Labs 91 157 91 154 Group Values by Method Mean 100.7 100.5 411.0 409.0 SD 9.68 9.84 42.22 44.44 CV 9.6 9.8 10.3 10.9 # Points 17443 446805 17362 444519 # Labs 429 757 428 750 HOOD05162002658134 Effective Date: 9/8/2017 Laboratory Histogram Unassayed Chemistry Lab 1234 Alkaline Phosphatase U/L +2 SD 117.7 Peer 112.5 - - Mean Group 107.3 Range 102.1 -2 SD 96.86 Level 1 Jan Feb Mar Apr May Jun Jul Aug Sep Jct Nov Jec Cumulative Mean 107.0 2.40 2.50 2.80 12.60 19418 12.48 2.70 2.90 3.10 5.78 SD 2.60 CV 2.4 110 # Points 84 +2 SD 487.1 Peer 472.2 Mean Group Range 442.4 427.4 -2 SD Level 2 Sep Nov Dec Cumulative Jar Feb Mar Apr May Jun Jul Aug c Meag 458 49 50 8.80 47.50 10.20 45148 8.20 445.0 40240 9.30 19 17.06 18 16.90 1.6 7.40 9.90 1.7 20 122 3 # Points HOOD05162002658134 Effective Date: 9/8/2017