planning organizing directing Motivating controlling 6 Management Process

管理流程 ¡ 規劃(planning) ¡ 組織(organizing) ¡ 導引(directing), (Motivating) ¡ 控制(controlling) 6

Management Process: Planning ¡ Purposes Achieve objectives Implement ideas Offset uncertainty and chance Make things happen Gain economical operation Facilitate control Deal with change 7

Management Process: Planning ¡ The basic elements of planning center around four points Evaluation of present condition The time factor Collection and analysis of data A hierarchy of plans with the medical laboratory 8

Management Process: Planning ¡ Steps Specify objectives that are specific, reasonable, and attainable Establish planning premises Determining alternative courses of action Selecting the best course of action Implementing the plan 9

Management Process: Planning ¡ A good plan Is based on stated objectives Indicates clearly ¡What is to be done ¡How it will be done ¡When it will be done ¡Where it will be done Is consistent with departmental goals Is flexible 10

Management Process: organizing ¡ Principles Objectives Authority Responsibility Scalar principle Unity of command coordination 11

Management Process: organizing ¡ Staffing Job description and specifications for each position Recruitment of personnel Placement of personnel Inducing of personnel Orienting of personnel Instructing of personnel 12

Management Process: Directing ¡ Principles Each person is unique People work to satisfy their own need People respond to leadership Communication is essential to directing ¡ Kinds Issuing order Delegation ¡ 標準作業程序 13

Management Process: controlling ¡ Steps Establishing standards Measurement performance Taking corrective action ¡ A checklist for control What to look for ¡ Quality ¡ Cost efficiency ¡ Productivity 14

Management Process: controlling ¡ A checklist for control Where to look ¡Personnel ¡Parameters of quality control When to look ¡At regular times and by ‘dropping in’ When to act ¡When deviation from standards occurs 15

Attitudes（態度） ¡Knowledge 96 ¡Hard working 98 ¡Attitude 100 21

實驗室品質管理相關的規範 ¡ ISO 9000 ¡ ISO/IEC 17025 ¡ ISO 15189 ¡ 特定要求 ISO 15190 ISO 5725 受聘僱外國人健康檢查作業規範 CLSI……. . e. g. CLIA, UKNEQAS e. g. ISO 15189 e. g. ISO 17025 e. g. ISO 9000 24

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Quality Control (QC) ¡ Applying statistical process control to detect changes which might exceed quality requirements in the analytical procedures implemented as quality practices: Number of controls per run Control rules required for each test system Levey-Jennings’ QC charts Patient data QC charts 31

臨床檢驗品質管理 ¡ 內部品管 (Intra-lab Quality Control) (Internal Quality Assessment) Real time, daily, monthly, yearly ¡ 外部品管 (Inter-lab Quality Control) (External Quality Assessment) Correlation, peer group comparison, quality assurance program (QAP), proficiency testing (PT) 32

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QC Rules 34

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Precision & Accuracy ¡ Precision: 精密度 SD 標準差 CV 變異係數 CVI 變異係數指數 ¡ Accuracy: 準確度 Mean 平均值 Bias 偏差 SDI 標準差指數 37

醫學實驗室的品質管制 ¡ Traceability + quality system (proficiency testing) ¡ Accuracy + precision ¡ Bias + SD/CV 40

Control (Westgard) rules ¡ 12 s ¡ Single rule ¡ 13 s ¡ Multiple rules ¡ 22 s ¡ 6 Sigma (6σ) ¡ R 4 s ¡ 41 s ¡ 10 x 42

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檢驗資訊系統 Delta check 11/1/2020 Limit check 49

Thank You for Your Attention! 11/1/2020 56