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Clinical1 Quality Control - 10
Clinical1 Quality Control - 10
An Overview for
MLAB 2360 – Clinical 1
Quality Assurance & Quality Control
• 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?
• 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