?O?

1
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• ?O?
• ??????
• ???????????
• ???? ???

2
??

• ??
• ?????????????????
• Old Dominion University, VA. U.S.A.
• ???????? (1990)
• ??????
• ????????????????
• ?????? ??????
• Taipei Medical University, Taipei, Taiwan
• ??(1980)

3
??

• ??????? ????? ???????
• ????????????????
• ????????(???, ??)???????
• ????????????????????
• ??????????????
• ??????????????
• ?????????????? ????
• ???????????????
• ??????

4
? ?

• ????????? ???
• ?????????? ?????
• ????????? ?????
• ?????????? ????
• ????????
• ??????? ??????
• ??????????
• ???????????(TAF)
• ???????(ISO 15189) ?????

5
? ? ? ?

• ??
• ?????
• ?????
• ?????

6
????

• ??(planning)
• ??(organizing)
• ??(directing), (Motivating)
• ??(controlling)

7
Management Process Planning

• Purposes
• Achieve objectives
• Implement ideas
• Offset uncertainty and chance
• Make things happen
• Gain economical operation
• Facilitate control
• Deal with change

8
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

9
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

10
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

11
Management Processorganizing

• Principles
• Objectives
• Authority
• Responsibility
• Scalar principle
• Unity of command
• coordination

12
Management Processorganizing

• Staffing
• Job description and specifications for each
  position
• Recruitment of personnel
• Placement of personnel
• Inducing of personnel
• Orienting of personnel
• Instructing of personnel

13
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
• ??????

14
Management Process controlling

• Steps
• Establishing standards
• Measurement performance
• Taking corrective action
• A checklist for control
• What to look for
• Quality
• Cost efficiency
• Productivity

15
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

16
????

• ??
• ??????
• ????
• ???
• ????
• ???????????

17
?????

• Deming
• ????????????,????????????
• Juran
• ??????(fitness for use) ,??????????????
• Crosby
• ???????????
• Feigenbaum
• ???????,????????????
• ???
• ????????????????,?????????

18
?????????

• ????
• ????
• ????
• ?????????
• ????
• ?????
• ?????

19
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• ??
• ??????
• ?????????
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20
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• ????????
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• ??
• ???????????

21
Attitudes(??)

• Knowledge 96
• Hard working 98
• Attitude 100

22
?????????

• ????
• ????
• ??
• ????
• ??
• ???????

• ????
• Precision
• ????
• Accuracy
• ????

23
??????

• ??
• ????(turnaround time, TAT)
• ?????
• ?????
• ??(??)
• ???????
• ????

24
????????????

• ISO 9000
• ISO/IEC 17025
• ISO 15189
• ????
• ISO 15190
• ISO 5725
• ??????????????
• CLSI..

25
(No Transcript)
26
??????

• ??????
• ?????????
• ???/????????
• ????????? LIS

?????
?????

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• ????????

• ????????
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• ????

?????
2016/9/28
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? ? ? ? ? ?
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? ?
? ?
? ?
?????????? ????? ????? ????? ???? ?????
????? ???????????? ?????????????? ??????????? ??
???? ?????????????
?????? ?????? ?????? ?????? ?????? ????????
??????? ?? ?? ??????? ?????
?????? delta check limit check ???????
????????? ??????? ??????
???? ?????? ???? ???? ????? ????
28
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29
???????

• ????
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• ??????
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• ????
• ??????
• ????

30
???????
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31
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

32
????????

• ???? (Intra-lab Quality Control) (Internal
  Quality Assessment)
• Real time, daily, monthly, yearly
• ???? (Inter-lab Quality Control) (External
  Quality Assessment)
• Correlation, peer group comparison, quality
  assurance program (QAP), proficiency testing (PT)

33
(No Transcript)
34
QC Rules
 
35
(No Transcript)
36
Standard Deviation Index (SDI)

• ??SDI?????????( peer group)??
• ?????(accuracy)
• ?SDI????
• SDI(??? - ?????) / ????????

37
Precision Accuracy

• Precision ???
• SD ???
• CV ????
• CVI ??????

• Accuracy ???
• Mean ???
• Bias ??
• SDI ?????

38
????

• ???????
• ?????
• ???????

39
????????????????

• ??????
• ??/????
• ????
• ????

• ??(?)????
• ???????
• ????
• ????

40
??????????

• Traceability quality system (proficiency
  testing)
• Accuracy precision
• Bias SD/CV

41
??????

• ????
• ??
• ??????
• ????
• ??
• ???

42
Control (Westgard) rules

• 12s
• 13s
• 22s
• R4s
• 41s
• 10x

• Single rule
• Multiple rules
• 6 Sigma (6s)

43
???????????(Quality Indicator)

• ????????
• ??????
• ????????
• ??????????
• ???????

• ?????
• ?????
• ?????
• ?????
• ???????

44
??QC??
???????
??????
????Level
???????
??????
??Level??
??????? ????? ?
Ca,P,Mg??? ?
Seal Piece ? ??
Rerun??QC ?
??????? ?
Sample Syring ?? ??,??,?? ?
Reagent?? ? ???? ? ????? ?
?????? ? ???? ?
TP,ALB ? ?Protein Standard
OK?? ?
Control???? ? ?? ? ?? ?
???? ? ???? ? ?? ?
_________________
TBIL,DBIL ? ?Bilirubin Standard
Finished ??,follow up ?
Parameter?? ? Chemistry ? K
Factor ?
??340nm GOT, GPT, LDH, BUN ? ?Lamp ??
Sample probe ? ??
Calibration ?? ? Standard ?
Calibration Type ?
Rinse unit ? ??
????? ????? ?
Cuvette ? ??
?? __________ ?
?? _________ ?
?? __________ ?
Mean value?? ? SD,CV?? ? TE allowable?? ? Remarks
? Keep on File ? ??____ ?
Target Value SD, TE??
??QC Chart
???? ?
45
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46
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47
??????????

• ??????
• ????
• ????
• ????????
• Delta check
• Limit check
• Panic check
• ?????

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????????

• Delta check
• ??????
• Limit check
• ?????
• ?????
• Panic check
• ???

49
??????
2016/9/28
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?????????

• ?????
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• ??
• ????
• ??
• ??

2016/9/28
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?????
?????????,???????????,??????????????
2016/9/28
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?????
??????????,??????????????,?????,?????????????
2016/9/28
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????--?????????
LIS???? ? PHS????
2016/9/28
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????????
2016/9/28
55
?????????????????

• ?????
• ????
• Ability
• ????
• Peer group
• ?????
• Third party

56
Thank You for Your Attention!
2016/9/28