QUALITY ASURANCE
Felix Dambula
Biomedical Sciences
Mzuzu University
SLIPTA Checklist
International Standards organisation
Standard: As part of the Laboratory internal quality
control systems L-J charts shall be used to monitor
quantitative tests on a daily basis and reviewed
routinely. ISO 15189: 5.6.1
The Quality Assurance Cycle
Patient/Client Prep
Sample Collection
Personnel Competency
Reporting Test Evaluations
•Data and Lab
Management
•Safety
•Customer
Service Sample Receipt
and Accessioning
Record Keeping
Quality Control Sample Transport
Testing
QA
The term quality assessment (Assurance) (QA)
refers to the overall process of guaranteeing quality
patient care and is regulated throughout the total
testing system.
Quality system refers to all of the laboratory’s
policies, processes, procedures, and resources needed
to achieve quality testing
QA program
Included in a QA program are procedure manuals,
internal quality control and external quality
control, standardization, proficiency testing (PT),
record keeping, etc.
Essentially, QA is the continual monitoring of the
entire test process from test ordering and specimen
collection through reporting and interpreting results.
Written policies and documented actions as they
relate to the patient, the laboratory, ancillary
personnel, and the health-care provider are required
Quality Control
Quality control refers to the materials, procedures,
and techniques that monitor the accuracy, precision,
and reliability of a laboratory test.
The term quality control covers that part of quality
assurance which primarily concerns the control of
errors in the performance of tests and verification of
test results. QC must be practical, achievable, and
affordable.
A Quality Control system is designed to ensure that
individual patient sample measurements are within
clinically acceptable limits
Routinely collect and analyze data from every test run or
procedure
Allows for immediate corrective action
Establishing a QC program
Establish written policies and procedures
including Corrective action procedures
Train all staff
Design forms
Assure complete documentation and review
Implementing QC program
Select high quality controls
Collect at least 20 control values over a period of 20-
30days for each level of control
Perform statistical analysis
Develop Levey-Jennings chart
Monitor control values using the Levey-Jennings chart
and/or Westgard rules
Take immediate corrective action, if needed
Record actions taken
Calibrator (Calibration standard)
Has a known concentration of the substance (analyte)
being measured
Used to adjust instrument, kit, test system in order to
standardize the assay
Sometimes called a standard, although usually not a
true standard
This is not a control
A biological matrix to which a known amount of
analyte has been added or spiked. Calibration
standards are used to construct calibration curves
from which the concentrations of analytes in QCs and
in unknown study samples are determined
Give examples
Controls
Known concentration of the analyte
Use 2 or three levels of controls
Include with patient samples when performing a test
Used to validate reliability of the test system
Ideal characteristics
Values cover medical decision points
Similar to the test specimen (matrix)
Available in large quantity
Stored in small aliquots
Ideally, should last for at least 1 year
Often use biological material, consider bio-hazardous
Types
Assayed
mean calculated by the manufacturer
must verify in the laboratory
Unassayed
less expensive
must perform data analysis
“Homemade” or “In-house”
pooled sera collected in the laboratory
characterized
preserved in small quantities for daily use
Monitoring QC data
Best way is to use graphs; L-J graphs
Process…
Levey-Jennings Chart
A graphical method for displaying control results and
evaluating whether a procedure is in-control or out-of-
control
Control values are plotted versus time
Lines are drawn from point to point to accent any trends,
shifts, or random excursions
Significance of L-J charts
Changes in accuracy of results are indicated by either a
trend that is a gradual changing in the mean in one
direction or a shift that is an abrupt change in the
mean (Fig. 7-4).
Changes in precision are shown by a large amount of
scatter about the mean and an uneven distribution
above and below the mean that are most often caused
by errors in technique.
Corrective actions
Corrective action, including the use of new reagents,
reagent strips, or controls, and the verification of lot
numbers and expiration dates, must be taken when
control values are outside the tolerance limits. All
corrective actions taken are documented according to
protocol
Proficiency Testing
PT is the testing of unknown samples received from an
outside agency. It provides unbiased validation of the
quality of patient test results.
WESTGARD RULES OF QC
Westgard Rules are multirule QC rules to help analyze
whether or not an analytical run is in-control or out-
of-control. It uses a combination of decision criteria,
usually 5 different control rules to judge the
acceptability of an analytical run.
12s
One control measurement exceeding 2 standard
deviations of control limits either above or below the
mean.
This rule is used a warning rule to trigger careful
inspection of the control data.
13s
This rule is commonly used with a Levey-Jennings
chart when the control limits are set as the mean +3
standard deviations of control limits. A run is rejected
when a single control measurement exceeds the mean
+3 control limits.
22s
The control run is rejected with 2 consecutive control
measurements 2 standard deviations of control limits
on the same side of mean with this rule.
R4s
This rule rejects a run if two control measurements in
a group exceed the mean with a 4 standard deviation
difference between the 2 controls
41s
This rule rejects a run with the 4th consecutive control
measurement exceeding 1 standard deviation on the
same side of the mean.
10x
This rule rejects a control run when there are 10
consecutive controls on the same side of the mean.
Examples
13S Rule = Reject the run when a single control measurement
exceeds the +3SD or -3SD control limit
+3SD
+2SD
+1SD
Mean
13S rule
-1SD violation
-2SD
-3SD
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Day
Westgard – 22S Rule
2 consecutive control values for the same level fall
outside of ±2SD in the same direction, or
Both controls in the same run exceed ±2SD
Patient results cannot be reported
Requires corrective action
22S Rule = Reject the run when 2 consecutive control measurements exceed the same
+2SD or -2SD control limit
+3SD
+2SD
+1SD
Mean
22S rule
-1SD
violation
-2SD
-3SD
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Day
When a rule is violated
Warning rule = use other rules to inspect the
control points
Rejection rule = “out of control”
Stop testing
Identify and correct problem
Repeat testing on patient samples and controls
Do not report patient results until problem is
solved and controls indicate proper performance
