Quality control and Quality assurance Flashcards
General definition of quality
General definition of quality - Value of services
The Product produced by clinical labs is INFORMATION
data or results
Why monitor quality in a Clinical Lab
- Ensure that results delivered are valid and the information is of value and is reliable
- If the QC results are off, what does it say for the patient results?
- Compliance with CLIA Standards and regulations
Quality levels
QC–> QA–> TQM
Standard( calibrator)
- A material of known value used to standardize (calibrate) any analytical
procedure and thereby determine the value of an unknown (patient) - Use for verification/validation
Primary standards
- Primary
- A solution generally containing a single purified solute (e.g. glucose) in a pure
solvent (e.g. water).
Secondary standards
- Secondary
- A material with an established value(s) determined by assay against a
primary standard. It may contain one or more constituents.
Serum calibrator
- contains numerous constituents (solutes)
- uses serum as the solvent
- solutes are of equivalent purity to those used in primary standards
- solutes added to solvent (serum) on the basis of analytical weighings.
Controls
(Quality Control)
* A stable substance which contains one or more known constituents used to
verify the accuracy and precision of a method * Use for runs
Shelf life-
compare usage
* Use 1 mL/day
* Control 1: $2/mL, 100 mL, 1 month shelf life * Control 2: $5/mL, 100 mL, 6 month shelf life
Box pricing
- Compare price per mL, not per box
Ideal:
Three levels
* Low level (abnormal) * Normal level
* High level (abnormal)
Linearity of instrument
- Controls must read within the linear range of the instrument
TSH Immunoassay
which one is correct
Immunoassay Control Set A
* Low Level (1.03 – 1.23 μIU/mL)
* Normal Level (7.5 – 9.6 μIU/mL)
* High Abnormal Level (27.9 – 34.5 μIU/mL)
Immunoassay Control Set B
* Low Level (3.0 – 5.0 μIU/mL)
* Normal Level (8.0 – 10.0
μIU/mL)
* High Abnormal Level (45 – 55 μIU/mL)
Lab considerations
Laboratory Considerations:
1. TSH Decision Limits: Low (<3 μIU/mL), Normal (3-10
μIU/mL), High (>10 μIU/mL
2. Linearity of Instrument: Linear to 50 μIU/mL
Levy Jennings Chart
- If a control point falls outside the +/- 2SD of the mean value, the control results are considered to be “out of control” and patient samples cannot be run or reported.
- NOTE: ONE control point out of 20 outside of +/- 2 SD is acceptable (95% confidence limits)
- If the control values falls within the +/- 2SD of the mean value, the QC results are “in control” and patient results may be reported
Westgard multi- rules
- set of rules based on a statistical analysis of controls
- System of criteria to determine if a system is “in control”
- Can be used with one control (within) or more than one control (across)
Multirules
- Simply: More than one rule
- Example:
- My diet allowance:
- Onedonutperday
- No more than 3 donuts in a week
- Cannot have 1⁄2 of a donut more than 5 days in a row
West guard rules
Set of rules to determine if analytical run is “in control” or “out of control”
13s rule
when a single control measurement exceeds the mean plus 3s or the mean minus 3s control limit.
12s
-when control limits are set as mean plus/minus 2s.
- when outside this limit then the machine shuts off.
22s
Reject when 2 consecutive control measurements exceed the same mean plus 2s or the same mean menus 2s control limit
R4s
Reject when 1 control measurement in a group exceeds the mean plus 2s and another exceeds the mean minus 2s
41s
Reject when 4 consecutive control measurements exceed the same mean plus 1s or the same mean minus 1s control limit.
41s rule
The criteria which must be met to violate this rule are
-Four consecutive results
- greater than 1s
- on the same side of the mean