Statistical concepts

Shift when there are 6 consecutive data results on the same side of the mean

Statistical concepts
Shift when there are 6 consecutive data results on the same side of the mean

Statistical concepts
Trend when there is a consistent increase OR decrease in the data points over a period of 6 days. (A line connecting the dots will cross the mean.)

Introduction to Clinical Chemistry Quality Control

Introduction to Clinical Chemistry Quality Control

Introduction to Clinical Chemistry Quality Control 95% confidence limit ( 2 SD) - 95% of all the results in a Gaussian distribution

Statistical concepts
Important terms:
Standard
Highly purified substance, whose exact composition is known. Non- biological in nature Uses
Control or patient results can be compared to a standard to determine their concentration Can be used to calibrate an instrument so control and patient samples run in the instrument will produce valid results

Examples:

Statistical concepts
Important terms:
Reference solutions
Biological in nature Have an assigned value Used exactly like a standard. Examples:

Statistical concepts
Important terms:
Controls
Resemble the patient sample
Have same characteristics as patient sample, color viscosity etc.

Can be purchased as
assayed come with range of established values un-assayed - your lab must use statistical measures to establish their range of values.

The results of any run / analysis must be compare to the range of expected results to determine acceptability of the analysis.

Statistical concepts
Important terms:
Controls, cont. using 1 control level
Again the result of an individual testing of the control value is compared ONLY to its established range of values. If it is in control, the patient results can be accepted and reports released. If it is not in the range, results must be held until problem is resolved meaning testing must be repeated.

Statistical concepts
Comparing / Contrasting Controls and Patients Controls and patient samples similar in composition
Control results - compared to their own range of expected results Patient values compared to published normal values as found in reputable literature or as established by the laboratory

Statistical concepts
James O. Westgard, PhD
University of Wisconsin Teaches in CLS program Director of Quality Management Services at the U of W Hospital Westgard rules http://www.westgard.com/mltirule.htm

Quality Assurance & Quality Control Common Westgard rules

13s
A single control measurement exceeds three standard deviations from the target mean

Action - Reject

Quality Assurance & Quality Control Common Westgard rules

12s
A single control measurement exceeds two standard deviations from the target mean

Action must consider other rule violations

This is a warning

Quality Assurance & Quality Control Common Westgard rules

22s
Two consecutive control measurements exceed the same mean plus 2S or the same mean minus 2S control limit.

Action Reject

Quality Assurance & Quality Control Common Westgard rules

R4s
One control measurement in a group exceeds the mean plus 2S and another exceeds the mean minus 2S.

Action Reject

Quality Assurance & Quality Control Common Westgard rules

41s
Four consecutive control measurements exceed the same mean plus 1S or the same mean minus 1S control limit.

Action Reject

Quality Assurance & Quality Control Other QC checks

Delta checks
Compares a current test result on a patient to last run patient test, flagging results outside expected physiological variation. A 1981 study concluded delta checks are useful, despite a high false-positive rate. But another study suggests looking at delta checks with tests that have a high clinical correlation (e.g., ALT and AST)

Quality Assurance & Quality Control Other QC checks

Common quality indicator calculations MCHC
Hgb / Hct * 100 (expect 32-36)

Hemoglobin x3 = hematocrit Chemistry

Compare patient BUN / creatinine (10/1 20/1) Calculate electrolyte anion gap
Na (Cl + CO2) expect 12 4 mEq/L