Limit

1
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2

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

3
????? ???? ?????

• ??????? ????
• ????? 1392

4
????? ????? ???? ?????
??????? ?? ????? ???????
??????? ??????? ??????
????? ????? ????? ?????
????? ????? ?? ?????
????? ???? ?????
???? ??
?????? ?? ????? ? ???? ?????
Limit check
5
????? ????? ????? ???? ?????

• ?????? ??????? ???? ?? ???(????? 20 ??????)
• ?????? ??? ????? 5 ??? ???????? 4 ??? ?????
• ?????? ??????? ? ?????? ?????
  

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

6

• ???? ??? ?????? ?? ?? ?? ????????? ???????? ?????
  ??? ??? ???? ????? ???? ????? ????? ??????? ????.
  ??? ?????? ????? ?????? ?? ?????? ???? ?? ??????
  ?? ????????? ???????. ????? ?? ???? ??? ? ??
  ????? ?? ????? ????? ?? ?? ????? ?????? ? ??????
  ??? ????? ???? ??????? ???.

7
???? ???? ?????
?????? ?? ??? ?? ???? ?? ?? ????????? ???? ????
???? ? ???? ?? ????? ????? ??? ?? ?? ?? ??? ?????
?? ??? ?????. ???? ???? ???? ?? ?????? ?? ???? ??
???? ???? ?????? ????.
8
????? ???? ????

• ??????? ?? ?????? ???? (????? Tonks)
• ????? ??????
• ?????? CLIA
• ????? ????? ???????
• ??????? ????????

9
Performance criteria for TSH screening Of newborn

• Functional sensitivity 1 mIU/L
• CV Ideally lt10
• Acceptable lt20

10
????? ?????Guassian distribution

• ???? ?? ?? ?????? ????? ???? ????? ?? ?????
  ??????? ??? ??? ????? ? ????? ????? ???.
• ?? ????? ????? ??????? ? ????? ? ??? ?? ?? ?????
  ?????.

11
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13

• ?? ?? ??? ????2 ????? ?? ?? ???? ????? ??????
  ???.
• ?? ???? ???? ????? ??? ?????? ?? ?? ??? ????? ???
  ???? ??? ??? ??? ??????? ??????? ????.

14
?????? ??? ?????

• ???? ?????? Levey-Jenning
• ????? ???????
• ????? ?????? ?????? ?????

15
Levey-Jennings Chart

• ??? ??????? ? ????? ???? ??? ????? ????
• ??? ?? ??? ? ??????? ?? ???? ???? ???? ???? ??
  ????? ????? ???? ?? ??? ???? ?? ??? ?? ????? ??
  ??????.

16
Levey- Jenning

• ?????? 2sd ?? ???? ??? ???? ?? 5 ?????
• ?????? 3sd ?? ???? ??? ???? ?? 1 ?????

17
Levey-Jennings Chart
3SD
2SD
1SD
Mean
-1SD
-2SD
-3SD
Day
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Levey-Jennings Chart - Record Time on X-Axis and
the Control Values on Y-Axis
Time (e.g. day, date, run number)
19
Levey-Jennings Chart -Plot Control Values for
Each Run
99 101 93 110 95 88 87 91 99 85 11
Time (e.g. day, date, run number)
20
Levey-Jennings Chart -Record and Evaluate the
Control Values
3SD
2SD
1SD
Mean
-1SD
-2SD
-3SD
Day
21
Westgard Rules

• ?? ??????? ?? ??? ?????? ???? ?????? ?????? ????
  ?? ????? ???? ????????? ?????? ???? ???? ?? ???.

• R4S rule
• 41S rule
• 10X rule

• 12S rule
• 13S rule
• 22S rule

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13s Rule when the control limits are set as the
mean plus 3s and the mean minus 3s. A run is
rejected when a single control measurement
exceeds the mean plus 3s or the mean minus 3s
control limit.
23
12s Rule when the control limits are set as the
mean plus/minus 2s. In the original Westgard
multirule QC procedure, this rule is used as a
warning rule to trigger careful inspection of the
control data by the following rejection rules.
24
22s Rule reject when 2 consecutive control
measurements exceed the same mean plus 2s or the
same mean minus 2s control limit.
25
R4s Rule reject when 1 control measurement in a
group exceeds the mean plus 2s and another
exceeds the mean minus 2s.
26
41s Rule reject when 4 consecutive control
measurements exceed the same mean plus 1s or the
same mean minus 1s control limit. 
27
10x Rule reject when 10 consecutive control
measurements fall on one side of the mean.
28
Westgard Rules
29
??????? ???? ????? WHO

• ???? ???????? ????? ????? ?? ??????? ? ?? ?????
  ?? ????? ?????? ????? ???? ???? ???.
• ???? ?? ?????? ???? ?? ?????? 2 SD mean ????
  ?????? ?? ????? ?? ????? ???? ??? ? ???? ?????
  ??? ???? ????? ???? ???? ????.
• ??? ?????? ????? ?? ??? ????? ?? ????? ( ??? ???
  ?? ??????? ???? ???? ) ?????? ?? ????? ?????? ??
  ????? ???? ?? ???? ??????? ? ????? ???.
• ?????? ?? ??? ?? ????????? ???? ????? ? ????
  ???? ??? ??????? ?????? ???? bias ??????? ??
  ???? ??????? ? ????? ????.
• ???????? ???? ????? ?? ????? ??????? ?????? ???
  ??????? ??????????? ??? ?? ???? ?? ????? ????.

30
Cusum

• ?????? ??? ????? ?? 20 ??? ? ?????? ??????? ?
  ?????? ?????
• ????? ???? ???? ????? cusum ? ???? ???? ??????
  ????
• ?????? ??? ????? ?? ?? ??? ???? ??????? ?????? ??
  ?? ???????
• ??? ???? ????? ????? ?? ??? ???

31
?????

• ???? cusum ???? ???? ?? ?????? K ???? ??
  ??????? ????? ?? ???. (/- 1 s)
• ????? ???? ?? ?? ?????? h ???? ???.
• /- 2.7 s ???? ?? ?????
• ????? ???? ?? ?????? ?? ?????? ???? ???? ????
  ?????
• ????? ??? ?????

32
Reference

• Westdgard quality control rules.
• ???? ????? ????? ?? ???????????? ???????????????
  ???? ?????? ???? ????? ???.

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