PEPFAR Quality Control and Method Validation Activity 12 Worksheet 2: Alk Phos Summary

Worksheet 2: Alk Phos Summary 1211 131 Investigation of Summary QC Problems Worksheet* Analyte Under Investigation Alkaline Phosphatase Instrument Unicel DxC Date _ 05/01/2013 _ QC Flags: TE > TEa ________ SEc < 2.0 ___________ SDI > ± 2.0____ ______ CVI > 1.0 ____________ Controls Affected: Level 1 ___ _____ Level 2 ______ _____ Level 3 __________ Other ____________ Y 12 Data & Calculations Relating to Four Key Numbers (in units) Level 1 Level 2 Level 3 Target 107.3 TEa 12.9 Mean Assigned to chart 14 N Value N Value N Value Current actual 60 119.0 Cumulative 1195 106.7 Peer Group Method 4576 (91) 106.6 All-group Method 17443(429) 100.7 SD Assigned to chart 1.0 N Value N Value N Value Current actual 60 3.10 Cumulative 195 5.78 Peer Group Method 4576 (91) 4.95 All-group Method 17443 (429) 9.68 TE on current data 16.8 SEc on current data -1.26 (Less than 0) Information Current data meet quality specifications: Level 1 Level 2 Level 3 The target values are valid: Level 1 Level 2 Level 3 The TEa limits are valid: Level 1 Level 2 Level 3 The current actual mean and SDI indicate a positive or negative bias compared to the target _ cumulative or peer mean, beginning this month or gradually since The current actual SD and CVI indicate increased imprecision compared to the assigned to chart cumulative or peer SD, , beginning this month or gradually since Patient results may be erroneously High Low Imprecise Action: Verify validity of all statistics used to generate within-laboratory and peer data Calculate mean and SD on recent data population Re-assign mean on QC chart: Level 1_ Level 2 Level 3 Re-assign SD on QC chart: Level 1 Level 2 Level 3 Re-assign target values: Level 1 Level 2 Level 3 Re-assign TEa limits: Level 1 Level 2 Level 3 Select QC rules and strategy to maximize error detection or minimize false rejection Initiate corrective action to reduce bias Initiate corrective action to reduce imprecision Arrange instrument service from manufacturer Temporarily discontinue reporting patient results Investigation performed by __________________________________ on ___/___/___ * Worksheet template modified from Brooks, Zoe (2001) Performance-Driven Quality Control, p181 HILS1746 Effective Date: 12/6/2016