AST: QUALITY CONTROL AND

QUALITY ASSURANCE

OUTLINE
I. Purpose of QC and QA Program
II. QC Responsibilities of Manufacturer
and Laboratory
III. Recommended Frequency for QC
Testing
IV. Out-of-Range QC Results and
Corrective Action
V. Factors to Consider before reporting
Patient Results when out-of-range
QC results are observed
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Laboratory quality can be

defined as accuracy,
reliability, and timeliness of
reported test results
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PURPOSE OF QUALITY
CONTROL
QC includes the procedures to monitor the
test system to ensure accurate and
reproducible results.
The goals of the QC program are to
monitor:
Precision and accuracy of susceptibility
test procedures
Performance of reagents used in the
test
performance of persons who carry out
the tests and report the results
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Purpose of Quality
Assurance
A QA program helps to ensure that testing
materials and processes consistently provide
quality results.
QA includes
QC
calibration and maintenance of equipment
proficiency testing
training and competency assessment
monitoring, evaluating, and taking corrective
actions (if necessary)
recordkeeping
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Responsibilities
Manufacturers and labs have a shared
responsibility for quality:
QC testing is performed by manufacturers
to ensure that the testing materials and
reagents have been properly
manufactured
QC testing is performed by laboratories to
ensure that the testing materials and
reagents are maintained properly and
testing is performed according to
established protocols.
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Responsibilities of the
Laboratory
Storage under the environmental
conditions recommended by the
manufacturer (to prevent drug
deterioration)
Proficiency of personnel performing
tests
Use of current CLSI standards (or
manufacturers instructions for use)
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Responsibilities of the
Laboratory (2)

Adherence to the established

procedures
inoculum preparation
incubation conditions
determination of end points
Interpretation of results

Frequency of QC Testing
Media (e.g. MHA, MHAB, HTM)
QC each batch or lot with appropriate
QC strains before or concurrent with
their first use for testing patient isolates
Incubate at least one uninoculated agar
plate from each batch or lot overnight to
confirm sterility of the medium
Maintain records: lot #, expiry date,
date of QC and results

Frequency of QC Testing
Antibiotic Disks
(2)
Daily each day patient isolates are
tested
Weekly demonstrate satisfactory
performance with daily QC testing
before going to weekly testing
- 20- or 30-day plan
- The 15-replicate (3x5 day) plan

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Frequency of QC Testing
(3)
CLSI M02-A12
PAGE 54

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Frequency of QC Testing
(4)
CLSI M02-A12
PAGE 55

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Frequency of QC Testing
CLSI M100-S25 PAGE 153
DISK DIFFUSION
(5)

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Frequency of QC Testing
CLSI M100-S25 PAGE 173
MIC TESTING
(6)

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Frequency of QC Testing
(7)

CLSI M100-S25 PAGE 146

CLSI M100-S25 PAGE 150

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Frequency of QC Testing
(8)

CLSI M100-S25 PAGE 158

CLSI M100-S25 PAGE 162

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Out-of-Range QC Results
and Corrective Action
Categories of Out-of-Range QC Results:
Random due to chance
QC ranges are established to include
95% of results obtained from routine testing
of QC strains.
Identifiable
System-related
Every out-of-range QC result must be
investigated and documented
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Out-of-Range QC Results
and Corrective Action (2)
CLSI M02-A12
PAGE 46-47

Equipment:
- not functioning properly or out of calibration (e.g.,
pipettes)

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Out-of-Range QC Results
and Corrective Action (3)
Identifiable error if the reason can
be identified and easily corrected
identify the problem
correct the problem
retest the QC strain on the day error is
observed

If the repeated result is within range,

no further corrective action is
required.
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Out-of-Range QC Results
and Corrective Action (4)
If repeat results are still out of range,
system error is possible
Daily QC tests must be continued
until final resolution of the problem is
achieved
obtain a new QC strain
obtain new lots of materials
inform manufacturer about the problem
use an alternative method
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CLSI M100-S25 PAGE 156

CLSI M100-S25 PAGE 176 : TABLE 5G MIC

TROUBLESHOOTING GUIDE

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Reporting Patient Results

When QC is Out-of-Range
Options to consider
Suppress the results for an individual
microbial agent
Review individual patient or cumulative
data for unusual patterns
Use an alternate test method
use a reference laboratory until the
problem is resolved

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Thank you

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