PEPFAR Quality Control and Method Validation Activity 12 Handout 1: QC Summary Investigation

130 Handout 1: QC Summary Investigation 1207 Investigation of Summary QC Problems * Analyte Under Investigation _________________ Instrument _________________ Date _________________ QC Flags: TE > TEa ________ SEc < 2.0 ___________ SDI > ± 2.0 __________ CVI > 1.0 ____________ Controls Affected: Level 1 ________ Level 2 ___________ Level 3 __________ Other ____________ Data & Calculations Relating to Four Key Numbers (in units) Level 1 Level 2 Level 3 Target TEa Mean Assigned to chart N Value N Value N Value Current actual Cumulative Peer Group Method All-group Method SD Assigned to chart N Value N Value N Value Current actual Cumulative Peer Group Method All-group Method TE on current data SEc on current data 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