Patient precision testing

O 1 Old Dominion University, VA. U.S.A. (1990)

Taipei Medical University, Taipei, Taiwan (1980) 2 ( , ) 3

(TAF)) (ISO 15189) 4

5 (planning)planning)) (planning)org)anizing)) (planning)directing)), (planning)Motivating)) (planning)controlling))

6 Management Process: Planning Purposes Achieve objectives Implement ideas Offset uncertainty and chance Make things happen Gain economical operation F)acilitate 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 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

16 Deming) Juran (planning)fitness for use) Crosby

Feig)enbaum 17

18 19

20 Attitudes Knowledge Hard working Attitude

96 98 100 21 Precision Accuracy

22 (turnaround time, TAT) ( ) 23

ISO 9000 ISO/IEC 17025 ISO 15189 ISO 15190 ISO 5725 e.g. CLIA, UKNEQAS e.g. ISO 15189 e.g. ISO 17025 e.g. ISO 9000 CLSI.. 24

Some holes due to active failures (eg. mistakes, procedural violations ) Hazards Failed or Absent Defenses Other hol e s due to l a tent condi t i

o ns Losses (eg. faulty equipment, lack of staff training ) James Reason Swiss Cheese Model (1990) Reason(2000)4 25 / LIS

109/03/02 26

delta check limit check




30 Quality Control (QC) Applying statistical process control to detect changes which might exceed quality require ments in the analytical procedures impleme nted as quality practices: Number of controls per run Control rules required for each test system Levey-Jennings QC charts Patient data QC charts 31 (Intra-lab Quality Control) (Internal

Quality Assessment) Real time, daily, monthly, yearly (Inter-lab Quality Control) (Extern al Quality Assessment) Correlation, peer group comparison, quality ass urance program (QAP), proficiency testing (PT) 32 33 QC Rules 34

35 Standard Deviation Index (SDI) SDI (planning) peer g)ro up) (planning)accuracy) SDI SDI=(planning) - ) / 36 Precision & Accuracy Precision: SD CV

CVI Accuracy: Mean Bias SDI 37 38

/ (planning) ) 39 Traceability + quality system (proficiency testing) Accuracy + precision

Bias + SD/CV 40 41 Control (Westgard) rules 13s Single rule

Multiple rules 22s 6 Sigma (6)) 12s R4s 41s 10x 42 (Quality Indicator)

43 QC

Level Level Rerun QC OK Finished ,follow upfollow up

Reagent Parameter

Chemistry K Factor Calibration Standard Calibration Type _________ Target Value SD, TE QC Chart

Seal Piece Sample Syring ,follow up ,follow up Control

_________________ Sample probe Rinse unit Cuvette __________ Ca,follow upP,follow upMg

TP,follow upALB Protein Standard TBIL,follow upDBIL n Standard Bilirubi

340nm GOT,follow up GPT,follow up LDH,follow up BUN Lamp __________

Mean value SD,follow upCV% TE allowable Remarks Keep on File ____ 44


46 Delta check Limit check Panic check

109/03/02 47 Delta check Limit check Panic check 48

Delta check 109/03/02 Limit check 49

109/03/02 50 109/03/02 51

109/03/02 52 -- 109/03/02 LIS LIS PHS

PHS PHS 53 5 109/03/02 54

Ability Peer group Third party 55 Thank You for Your Attention! 109/03/02 56

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