Professional Documents
Culture Documents
Felix Dambula
Biomedical Sciences
Mzuzu University
SLIPTA Checklist
International Standards organisation
Standard: As part of the Laboratory internal quality
control systems L-J charts shall be used to monitor
quantitative tests on a daily basis and reviewed
routinely. ISO 15189: 5.6.1
The Quality Assurance Cycle
Patient/Client Prep
Sample Collection
Personnel Competency
Reporting Test Evaluations
•Data and Lab
Management
•Safety
•Customer
Service Sample Receipt
and Accessioning
Record Keeping
Design forms
Give examples
Controls
Known concentration of the analyte
Use 2 or three levels of controls
Include with patient samples when performing a test
Used to validate reliability of the test system
Ideal characteristics
Values cover medical decision points
Process…
Levey-Jennings Chart
A graphical method for displaying control results and
evaluating whether a procedure is in-control or out-of-
control
+3SD
+2SD
+1SD
Mean
13S rule
-1SD violation
-2SD
-3SD
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Day
Westgard – 22S Rule
2 consecutive control values for the same level fall
outside of ±2SD in the same direction, or
Both controls in the same run exceed ±2SD
Patient results cannot be reported
Requires corrective action
22S Rule = Reject the run when 2 consecutive control measurements exceed the same
+2SD or -2SD control limit
+3SD
+2SD
+1SD
Mean
22S rule
-1SD
violation
-2SD
-3SD
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Day
When a rule is violated
Warning rule = use other rules to inspect the
control points
Rejection rule = “out of control”
Stop testing
Identify and correct problem
Repeat testing on patient samples and controls
Do not report patient results until problem is
solved and controls indicate proper performance