Clinical1 Quality Control - 10

Quality Assurance / Quality Control
An Overview for
MLAB 2360 – Clinical 1
Quality Assurance & Quality Control
• Quality assurance (aka QA)

• refers to planned and systematic processes that
provide confidence of a product's or service's
effectiveness. – Wikipedia
• It makes ‘quality’ a main goal of a production.
• From the lab perspective, it is the all of the

procedures, actions and activities that take place to
be sure the results given to the physician are
accurate.
• Quality Control (QC)

• A procedure or set of procedures intended
to ensure that a manufactured product or
performed service adheres to a defined set
of quality criteria or meets the
requirements of the client or customer.
• In the laboratory that means ....…

• What do you think that means?
• At the very basic level in the laboratory, Quality

Control - QC refers to the measures that must be
included during each assay run to verify that the
test is working properly.
• This requires the routine gathering & processing

of data obtained by testing controls along with
patient samples.
• The processing of the data very often requires
use of statistical procedures.
• An important tool in the statistical

analysis is determining:
• Standard Deviation (SD) - a measure of

the scatter around the arithmetic average
(mean) in a Gaussian distribution (Bell
curve, or normal frequency distribution)
• Quality Assessment and Quality Control

measures must include a means to identify,
classify, and limit error.
True Value
• True value – an ideal concept, which cannot

be achieved
• Accepted True value – The value

approximating the ‘True Value’; the
difference between the two values is
negligible.
Error
• Error
• Error is the discrepancy between the
result obtained in the testing process and
its ‘True Value’ / ‘Accepted True Value’
Error
• Sources of Error
• Reagents
• Standards
• Technique
• Environment
• Specimen collection, handling etc.
• Many more
Error
• Types of Error
• Pre-Analytical error
• Includes clerical error, wrong patient, wrong
specimen drawn, specimen mis-handled, etc.
• Through Quality Assurance measures, the laboratory
tries to maintain control over these factors
• Well trained phlebotomy staff
• Use of easy patient & specimen identification methods,
such as bar code identification.
• Willingness to be information resource and / or trainers for
physicians and floor personnel often involved with specimen
collection.
Error
• Types of Error
• Analytical error
• Random or indeterminate
• Hard or impossible to trace, ie fluctuations in elect.
temp, effects of light, etc
• Systematic or determinant
• Have a definite cause, ie piece of equipment that fails to
function properly, poorly trained personnel, contaminated
reagent
• Through Quality Control measures, such as always
running controls, the laboratory limits these errors.
Error
• Types of Error
• Post-Analytical error
• Errors that occur after the testing process is
complete.
• Clerical errors very possible here as well.
• Test result fails to get to the physician in a timely
manner
• Quality Assurance measures must be implemented
if problems identified.
• (My opinion – these seem to be the hardest to control. )
Statistical concepts
• Gathering data
• For some procedures, control results are positive
or negative (yes it worked, or no it did not)
• Examples?
• For other procedures, such as those that produce

a data result, you must tabulate the data over a
period of time and perform statistical analysis
• Examples ?
• When there are data results, they can

be laid out and evaluated.
• Measures of Central tendency
(
how numerical values can be expressed as a
central value )
• Mean - Average value
• Median - Middle observation
• Mode - Most frequent observation
• Another way of reviewing data

• Dispersal / or how the individual data points are
distributed about the central value
( how spread out are the
numbers ? )
• Another way looking at a Gaussian curve:
• This slide and the next
Introduction to Clinical Chemistry – Quality Control
• What does the normal pattern look

like? & what is it called? (random
dispersion)
Levey Jennings chart examples follow
• Shift – when there are 6 consecutive data results on

the same side of the mean
• 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.)
• 95% confidence limit (± 2 SD) - 95% of all the

results in a Gaussian distribution
• 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:
• Reference solutions
• Biological in nature
• Have an ‘assigned’ value
• Used exactly like a standard.
• Examples:
• 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.
• 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.
• 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
• 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
• Common Westgard rules
• 13s
• A single control measurement exceeds three
standard deviations from the target mean
• Action - Reject
• 12s
• A single control measurement exceeds two
standard deviations from the target mean
• Action – must consider other rule violations
• This is a warning
• 22s
• Two consecutive control measurements exceed
the same mean plus 2S or the same mean minus 2S
control limit.
• Action – Reject
• R4s
• One control measurement in a group exceeds the
mean plus 2S and another exceeds the mean minus
2S.
• 41s
• Four consecutive control measurements exceed
the same mean plus 1S or the same mean minus
1S control limit.
• 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)
• 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

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Quality Assurance / Quality Control

• Quality assurance (aka QA)

• It makes ‘quality’ a main goal of a production.

• From the lab perspective, it is the all of the

• Quality Control (QC)

• In the laboratory that means ....…

• At the very basic level in the laboratory, Quality

• This requires the routine gathering & processing

• An important tool in the statistical

• Standard Deviation (SD) - a measure of

• Quality Assessment and Quality Control

• True value – an ideal concept, which cannot

• Accepted True value – The value

• For other procedures, such as those that produce

• When there are data results, they can

• Another way of reviewing data

• What does the normal pattern look

• Shift – when there are 6 consecutive data results on

• Trend – when there is a consistent increase OR

• 95% confidence limit (± 2 SD) - 95% of all the

• Control results - compared to their own range of

• Patient values – compared to published normal

• James O. Westgard, PhD

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