c

± a solution whose concentration of analyte is
?

 (calibrator)
if the standard is bad, then
3 

3  
included within
- if we do not recover the acceptable value
from a control, we assume?
include at least ? controls
If we get acceptable values for both controls,
we can assume that
Batch Assay
Controls run?

assumed to be 100% accurate
-used as a reference point with which
the values for the controls and patients¶
specimens are assigned.
all of the control and patient values have to be
inaccurate.
- if standard¶s conc. is high, all values will be
lower that they are supposed to be.
a biological specimen (similar in composition to
the patients¶ specimens) which is used to
assess the accuracy and validity of the entire
assay run.
we don¶t assume analyte conc. is 100%
accurate.
has an acceptable range of values, the random
analytical error of the assay method.
- included within each and every assay run.
- if we do not recover the acceptable
value from a control, we assume that there has
been a loss of accuracy during the run which
may affect the patients¶ values
including at least two controls within each and
every assay run for manual methods and for
"batch" analyzers.
two controls (usually a ³normal´ and an
³abnormal´) must be run with each test or batch
of tests
the assay was accurate and patient values are
reliable also.
two controls, each and every run
(laboratory testing procedure in which one test
is done simultaneously on multiple specimens)
Batch analyzer is an analyzer like TDx which
you can not add extra sample while it is
running. If you have a STAT sample
(emergency sample) you have to wait until
Batch analyzer completes the analysis of every
sample and then you can start the next
batch.This will increase the turn around time.

c

¬two levels of controls once per each 8 hour
shift.
However with random analyzer you can add
extra sample for analysis when the instrument
º

 

 is running. You can simply replace the STAT
sample with the next sample to be
analyzed.This will shorten the turn around time
for the test and TAT is very important to a lab
performance.
move away from their means in the same
If the standard is bad, both controls?
direction, out of acceptable limits.
the proper disposition of patient test values
when one or more of the assay run's controls Disregard patient values.
are outside of their acceptable ranges.
the frequency of a control to be "out-of-control,"
1 in 20
strictly due to random analytical error.
Bad controls
Calibration failure
Bad or wrong reagent
five causes of an assay being out-of-control
Problem with instrument (wavelength, settings, etc.)
Pipetting problem, calculation errors, sloppy technique
Contaminated glassware, cuvettes, etc.
Y. Plot the control value on the wall chart, disregard all
patients' values obtained from that assay run.
the steps that must be taken to remedy an out 2. Double check calculations, instrument settings, etc.,
of control situation. and make sure you used correct reagents, standards,



? ?

  
 
 ?  and techniques.


 3. Make sure that you have used the correct controls
and that they are in-date (fresh), with no signs of
degredation or contamination.
4. Repeat entire run (standards, controls, patients).

Y. the problem is either the standard or the controls.

2. Repeat step #4 using fresh aliquots of controls.
3. Don¶t keep running your controls over-and-over. If
they are out more than once,
If run is out-of-control again the problem something else other than random
chance! Get help from someone with more
experience (M.T., Lead Tech, etc.)
4. Report patient values after problem is resolved, and
patients have been re-assayed.

all control values will be shifted in the same

If the standard is bad,. .
direction If
If only one control is affected, the standard is the control


c

ü.K., then the problem is
Y. Plot or enter control value. Do not report patient
values for the tests involved.


 

? ?
 2. Make sure the control is ³in date´ (fresh), and that

   
  ? 

 
 you¶ve used the correct control.
the steps that must be taken to remedy an out
of control situation.
is sufficient to run only two controls on each
test performed on an analyzer per shift.
If all else fails, get a new set of controls. If another
control is out, consider?
If both controls shifting in the same direction
If controls are shifting in opposite directions
If only one control is having a problem
åevey-Jennings QC charts


  ?3
?



Œhifts
3
 Trends

3. Check for lot# changes in reagents (biggie for Vitros
analyzers), and may need recalibration.
4. Review QC for all tests on that control level. If all are
shifted, it¶s the control. If it¶s only one test, evaluate
for calibration problems. Calibration failure will
usually cause a shift in all levels of controls, however
it may not be bad enough to cause all levels of
controls to be out of acceptable range.
5. a reagent problem or calibration failure. Don¶t keep
running controls over and over. The usual problem here is
calibration failure. Verify by reviewing QC data for the
last few days. Recalibrate if necessary. If recalibration is
necessary, rerun the patients for that test.
recalibrate.
precision problem.
check that control.
üut-of-control results ± See Westguard
multirules
Trends ± very gradual, 5 or more values
moving in the same direction.
Shifts ± 5 or more values that deviate from the
mean in about the same degree, on the same
side of the mean.
anything that

 changes
1. Anything New (lot # of reagent)
2. Wrong controls
3. New spectrophotometer lamp
4. Contaminated or degrading standard
5. Evaporated standard
6. Contaminated control
7. Wavelength calibration incorrect
8. Photomultiplier tube or lamp suddenly
going bad.
anything that 



 changes
1. Degrading reagents
2. Degrading standards
3. Spectrophotometer lamp burning out
4. Room temp. changing
5. Controls degrading or evaporating

c

6. Pipettor beginning to malfunction

Accuracy - closeness of a result to the actual

value
Precision ± ³reproducibility´ or closeness of
values to each other

explain what Controls are specifically èow far your values are from the target value and
evaluating acceptable range
(2) Used to assess the accuracy and validity of the assay
? 1 SD ± 68.2%
Îaussian" (normal) distribution of values ? 2 SD ± 95.5%
? 3 SD ± 99.7%
what Gaussian distributions have in common control values have to fall with in +/- 2SD and
with the use of Controls. some exceptions are Westgard Muliti-rules
cannot be absolutely identified (Ex. Differences

  ? in techniques between workers, specimen
characteristics, etc.)
variation that may make results consistently
higher or lower than the mean value for a
? 

?
 ?
control (Ex. Trouble with the instrument,
deteriorated reagents, etc.)
how the "acceptable" ranges for controls (95.5% 95.5% will be within 2 standard deviations
Reference Intervals) are determined. from the mean
Ideally should be less than 5%
Coefficient of Variation (CV) 
Formula?
·
Y

12s one point out of 2 SD - accept
13s one point outside 3 SD ± reject
(across runs) 2 CüNSECUTIVE values
outside the same 2 SD
22s or
(within run) 2 CüNSECUTIVE values outside
the SAME 2 SD.
Reject



c

The range (difference) between
R4s two controls within a run exceeds 4 SD s.
This rule is only to be used within a run, not across runs.
Reject
4 CüNSECUTIVE control values on one side
of the mean and further than 1SD from
the mean.
41s
within one control across 4 consecutive runs
or
within 2 controls across 2 consecutive runs.
Reject
10 CONSECUTIVE values
on ONE side of the mean.
10x
Within one control across 10 consecutive runs
or
Check?
within 2 controls across 5 consecutive runs.
Reject ±calibration
Both controls are out of acceptable limits Bad standard
Standard too low - Diluted or you used a lower
Both controls are high means standard than you should have
High control values = low standard
Standard too high - concentrated or you used
Both controls are low means a higher standard than you should have
low control values = High standard
mandated by CLis-88 for all moderate and high
complexity tests
Proficiency Testing 6 A validation of your lab, your instruments,
your methods can produce quality results
6 3 times a year (challenge cycles)
documents that each individual can perform the
test accurately.
6 üne on üne instruction, demonstration,
Competency Testing reading SüP, written quiz and correctly
assaying several unknowns under
observation.
6 Done annually
use of the 



in
interpreting the results of Proficiency Testing
challenges.
*Used as a predictor of how your lab will do on
the next PT challenge
ideal target C.V. of an analytical method which
No more than ¼ the CLIA allowable PT range
will assure successfully passing Proficiency


c

Testing challenges.
6 If below, report ³Less than Blah mg/dL, analyte
how to correctly process and report 
 

? below assay range,´ where ³Blah´ is the lowest
(1) below the reportable range of the assay point of the assay¶s linearity. Do NüT report a
numerical value when it is below the known
analytical range of the assay.

 , dilute the specimen with an appropriate
diluent, reassay the dilution, correct for the dilution
how to correctly process and report 
 

?
factor and report that final value.
(2) above the reportable range of the assay
Add a comment that the value represents a dilution
of the original specimen.
monitors all variables or sources of error,
å
 


??
 program beginning with the ordering of the teat by the
(Process Control Program). physician, through the time the physician
receives the results.
3 ± one component of Lab QA
6 involves assaying at least 2 control
specimens(pools) within each assay when
using manual and batch analyzers, once
per shift for other Random Analysis

? 



3  
3
 

Analyzers.
6 Each control pool has an acceptable range
of values. If both controls are found to be
within their acceptable ranges, the assay
run is said to be ³in control´.

conditions that are monitored by
Statistical Quality Control.
1. reagent purity
2. Integrity of standards
3. Accuracy of pipettes
4. Cleanliness of glassware
5. Instrument calibration
6. Mechanical condition of instrument and
equipment used
7. Technologist¶s technique and calculations
8. Any other factor directly related to the assay

å
3    

Labeling pre-analytical
Timing of collection pre-analytical
centrifugation pre-analytical
Processing time pre-analytical
fasting pre-analytical


c

ürder of draw pre-analytical
Temperature analytical
Use of reagents analytical
Pipetting analytical
Procedure for informing physician post-analytical
Verification of calculations post-analytical