Unit #6 - Basic Quality Control For The Clinical Laboratory: Cecile Sanders, M.Ed., Mls (Ascp)

Unit #6 - Basic Quality
Control for the Clinical

Laboratory
CECILE SANDERS, M.ED., MLS(ASCP)
Laboratory
Introduction
◦ The results obtained from laboratory
analyses are used to diagnose, prescribe
treatment, and/or monitor the health or
progress of the patient. Since such
importance is placed upon test results,
they must be as reliable and accurate as
possible.
Laboratory
Elements of a Total Quality Control Program
(may be referred to as QC, QA, or TCM,
among others)
◦ Current procedure manual
◦ Documentation
◦ Qualified personnel
◦ Fire and safety program
◦ Use of appropriate standards and controls
◦ External proficiency testing
Laboratory
Standards and Controls
◦ Standard
◦ A substance that has an exact known value and that, when
accurately weighed or measured, can produce a solution of an
exact concentration
◦ Also called “reference materials”
◦ Not usually used on a daily basis
◦ Used to calibrate new instruments, recalibrate instruments after
repair, at manufacturer’s recommended intervals, or if a method is
out of control
Laboratory
◦ Control
◦ A solution that contains the same constituents as those
being analyzed in the patient sample
◦ Most are commercially produced from pooled sera
◦ The manufacturer has analyzed each lot of serum for a
variety of test components and the expected range of
assay values for each component is provided to the
laboratory when shipped
Laboratory
◦ Control (cont’d)
◦ Controls are analyzed with each patient test or batch of
tests and the results are compared with the
manufacturer’s range of values
◦ For most tests, a “normal” control and an “abnormal”
control are analyzed with each patient test or batch of
tests
◦ Results are plotted on a QC record called a Levey-
Jennings Chart
Laboratory
Example of Levey-Jennings Chart
Laboratory
Accuracy - closeness of a result to the actual value
Precision – “reproducibility” or closeness of values to each other
Laboratory
Laboratory
Mean, Variance and Standard Deviation – these must be determined for
each test or analysis to be used for quality control
◦ Mean ( ) = the average for a set of values
◦ Standard Deviation (s or SD) = a measure of the scatter of the sample values
around the mean and is derived from the calculation of the variance (s2)
Unit #6 - Basic Quality Control
for the Clinical Laboratory
◦ Calculating the variance

Using Standard Deviation in QC

◦ When a set of values with a
normal distribution is plotted
on a graph, the distribution
of the values around the
mean forms a Gaussian
Curve (also known as a
normal frequency or normal
distribution curve)
Laboratory
Using Standard Deviation in QC (cont’d)
◦ Clinical laboratories establish the standard deviation for
each laboratory test or analysis
◦ A common choice is plus or minus 2 s or SD, most often
written as ± 2 s or ± 2 SD
◦ The mean and ± 2 SD are

plotted on a Levey-Jennings
chart (green line is ;  2 SD
are yellow lines)
Laboratory
Every time the control is run, the value is plotted on the L-J chart
Laboratory
As long as the control value are between the ± 2 SD lines on the L-J
chart (in this case, the lines are colored yellow), the control values are
“in control”
Laboratory
On the L-J chart below, note that values for days 5, 8, 11, 17, 25, and 27
are outside the ± 2 SD yellow lines. Therefore, controls on these days
are “out of control”
Levey-Jennings Chart with Values “In

Control”
Levey-Jennings Chart
Control Range 80-100
100
Control Values
95
90
85
80
1 2 3 4 5 6 7 8 9 10 11 12 13 14
Days or Runs
Trend
◦ An uninterrupted rise or decline away
from the mean
◦ When the 6th value with a rise or Levey-Jennings Chart
decline is reached (Day or Run #10 on Showing Trend 5 through 10
this graph), the values are “out of
Control Values
control” 100
90
80
1 2 3 4 5 6 7 8 9 10 11 12 13 14
Days or Runs
Shift
◦ An uninterrupted shift of values on one
side of the mean Levey-Jennings Chart
◦ When the 6th value on one side of the Control Range 80-100
mean is reached (Day or Run #10 on Showing Shift 5 through 10
this graph), the values are “out of
Control Values
100
control” 95
90
85
80
1 2 3 4 5 6 7 8 9 10 11 12 13 14
Days or Runs
Laboratory
The use of a single control is for very basic laboratory testing in waived
CLIA laboratories
In moderately and highly complex CLIA testing laboratories two controls
(usually a “normal” and an “abnormal”) must be run with each test or
batch of tests and Westgard Rules apply
Westgard Rules are beyond the scope of this course and will be covered
in advanced MLT courses
http://www.westgard.com/mltirule.htm
Laboratory
Whenever a patient’s test or a batch of tests are performed and the
control(s) is “in control”, the values obtained for the patient test(s) are
determined to be “acceptable” and can be released to the doctor as
accurate.
Whenever a patient’s test or a batch of tests are performed and the
control(s) is “out of control”, the values obtained for the patient test(s)
are determined to be “not acceptable” and CANNNOT be released to
the doctor as accurate until the problem is identified and resolved.
Laboratory
Errors in Laboratory Testing
◦ May occur at several points
◦ Preanalytical – errors made prior to testing the patient specimen
(Ex. Misidentifying the patient during blood collection, mishandling
specimen, etc.)
◦ Analytical – errors made in the testing process (Ex. Error in
procedure, instrument trouble, etc.)
◦ Postanalytical – errors made after testing (Ex. Typing the wrong
results in the computer, failure to notify physician in a timely
manner, etc.)
Laboratory
Errors in Laboratory Testing (cont’d)
◦ Random or Systematic
◦ Random Errors – cannot be absolutely identified (Ex.
Differences in techniques between workers, specimen
characteristics, etc.)
◦ Systematic Errors – variation that may make results
consistently higher or lower than the mean value for a
control (Ex. Trouble with the instrument, deteriorated
reagents, etc.)
Errors in Laboratory
Testing (cont’d)
◦ Our goal is to identify
systematic errors and
eliminate them!
My control results are
“out of control”! Now
what?
Laboratory
The following steps should be taken in order
when the control results are “out of control”
◦ Look at the procedure and evaluate your technique
(Ex. Did I use the right lot #? Are my reagents in
date? Did I make an error in the procedure?)
◦ Re-run the procedure, including controls
◦ If results are still out of control, clean/perform
maintenance on equipment and/or open a new
batch of reagents
◦ Contact supervisor
ALWAYS, ALWAYS,
ALWAYS:
DOCUMENT THE
PROBLEM AND
CORRECTIVE ACTIONS
TAKEN!!!!!
Laboratory
Click on the “Assignments” button on the
lower left of the menu for the assignment for
this unit.
Remember this is an ASSIGNMENT, so you
may use all instructional materials to
complete the assignment, including this
PowerPoint.
Laboratory
Resources
◦ Basic Clinical Laboratory Techniques, Estridge and Reynolds,
Thomson/Delmar Learning, Fifth Edition, 2008
Laboratory
CECILE SANDERS, M.ED., MT(ASCP),
CLS (NCA)
Laboratory
Introduction
◦ The results obtained from laboratory analyses are
used to diagnose, prescribe treatment, and/or
monitor the health or progress of the patient.
Since such importance is placed upon test results,
they must be as reliable and accurate as possible.
Laboratory
Elements of a Total Quality Control
Program (may be referred to as
QC, QA, or TCM, among others)
◦ Current procedure manual
◦ Documentation
◦ Qualified personnel
◦ Fire and safety program
◦ Use of appropriate standards and controls
◦ External proficiency testing
Laboratory
Standards and Controls
◦Standard
◦ A substance that has an exact known value and that, when
accurately weighed or measured, can produce a solution of an
exact concentration
◦ Also called “reference materials”
◦ Not usually used on a daily basis
◦ Used to calibrate new instruments, recalibrate instruments after
repair, at manufacturer’s recommended intervals, or if a method is
out of control
Laboratory
◦Control
◦ A solution that contains the same constituents as those
being analyzed in the patient sample
◦ Most are commercially produced from pooled sera
◦ The manufacturer has analyzed each lot of serum for a
variety of test components and the expected range of
assay values for each component is provided to the
laboratory when shipped
Laboratory
◦Control (cont’d)
◦ Controls are analyzed with each patient test or batch of
tests and the results are compared with the
manufacturer’s range of values
◦ For most tests, a “normal” control and an “abnormal”
control are analyzed with each patient test or batch of
tests
◦ Results are plotted on a QC record called a Levey-
Jennings Chart
Laboratory
Example of Levey-Jennings Chart
Laboratory
Accuracy - closeness of a result to the actual value
Precision – “reproducibility” or closeness of values to each
other
Laboratory
Laboratory
Mean, Variance and Standard Deviation –
these must be determined for each test or
analysis to be used for quality control
◦ Mean ( ) = the average for a set of values
◦ Standard Deviation (s or SD) = a measure of the scatter of
the sample values around the mean and is derived from
the calculation of the variance (s2)
◦ Calculating the variance

Using Standard Deviation in QC

◦ When a set of values with a
normal distribution is plotted
on a graph, the distribution
of the values around the
mean forms a Gaussian
Curve (also known as a
normal frequency or normal
distribution curve)
Laboratory
Using Standard Deviation in QC (cont’d)
◦ Clinical laboratories establish the standard deviation for
each laboratory test or analysis
◦ A common choice is plus or minus 2 s or SD, most often
written as ± 2 s or ± 2 SD
◦ The mean and ± 2 SD are

plotted on a Levey-Jennings
chart (green line is )
Laboratory
Every time the control is run, the value is plotted on the L-J
chart
Laboratory
As long as the control value are between the ± 2 SD lines on the L-J
chart (in this case, the lines are colored yellow), the control values are
“in control”
Laboratory
On the L-J chart below, note that values for days 5, 8, 11, 17, 25, and 27
are outside the ± 2 SD yellow lines. Therefore, controls on these days
are “out of control”
Levey-Jennings Chart with Values “In Control”

100
Control Values
95
90
85
80
1 2 3 4 5 6 7 8 9 10 11 12 13 14
Days or Runs
Trend
◦ An uninterrupted rise or decline away
from the mean
◦ When the 6th value with a rise or Control Range 80-100
decline is reached, the values are “out Showing Trend 5 through 10
of control”
Control Values
100
90
80
1 2 3 4 5 6 7 8 9 10 11 12 13 14
Days or Runs
Shift
◦ An uninterrupted shift of values on one Levey-Jennings Chart
side of the mean Control Range 80-100
◦ When the 6th value on one side of the Showing Shift 5 through 10
mean is reached, the values are “out of
Control Values
100
control” 95
90
85
80
1 2 3 4 5 6 7 8 9 10 11 12 13 14
Days or Runs
Laboratory
The use of a single control is for very basic
laboratory testing in waived CLIA laboratories
In moderately and highly complex CLIA testing
laboratories two controls (usually a “normal” and
an “abnormal”) must be run with each test or batch
of tests and Westgard Rules apply
Westgard Rules are beyond the scope of this course
and will be covered in advanced MLT courses
http://www.westgard.com/mltirule.htm
Laboratory
Whenever a patient’s test or a batch of tests are
performed and the control(s) is “in control”, the values
obtained for the patient test(s) are determined to be
“acceptable” and can be released to the doctor as
accurate.
Whenever a patient’s test or a batch of tests are
performed and the control(s) is “out of control”, the
values obtained for the patient test(s) are determined
to be “not acceptable” and CANNNOT be released to
the doctor as accurate until the problem is identified
and resolved.
Laboratory
Errors in Laboratory Testing
◦ May occur at several points
◦ Preanalytical – errors made prior to testing the patient specimen
(Ex. Misidentifying the patient during blood collection, mishandling
specimen, etc.)
◦ Analytical – errors made in the testing process (Ex. Error in
procedure, instrument trouble, etc.)
◦ Postanalytical – errors made after testing (Ex. Typing the wrong
results in the computer, failure to notify physician in a timely
manner, etc.)
Laboratory
Errors in Laboratory Testing (cont’d)
◦ Random or Systematic
◦ Random Errors – cannot be absolutely identified (Ex. Differences in
techniques between workers, specimen characteristics, etc.)
◦ Systematic Errors – variation that may make results consistently
higher or lower than the mean value for a control (Ex. Trouble with
the instrument, deteriorated reagents, etc.)
Errors in Laboratory
Testing (cont’d)
◦ Our goal is to identify
systematic errors and
eliminate them!
My control results
are “out of control”!
Now what?
Laboratory
The following steps should be taken in
order when the control results are “out
of control”
◦ Look at the procedure and evaluate your technique
(Ex. Did I use the right lot #? Are my reagents in
date? Did I make an error in the procedure?)
◦ Re-run the procedure, including controls
◦ If results are still out of control, clean/perform
maintenance on equipment and/or open a new
batch of reagents
◦ Contact supervisor
ALWAYS, ALWAYS,
ALWAYS:
DOCUMENT THE
PROBLEM AND
CORRECTIVE
ACTIONS
TAKEN!!!!!
Laboratory
Click on the “Assignments” button on
the lower left of the menu for the
assignment for this unit.
Remember this is an ASSIGNMENT, so
you may use all instructional materials
to complete the assignment, including
this PowerPoint.

Unit #6 - Basic Quality Control For The Clinical Laboratory: Cecile Sanders, M.Ed., Mls (Ascp)

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Unit #6 - Basic Quality Control For The Clinical Laboratory: Cecile Sanders, M.Ed., Mls (Ascp)

Uploaded by

Copyright:

Available Formats

Unit #6 - Basic Quality

Control for the Clinical

◦ Calculating the variance

Using Standard Deviation in QC

◦ The mean and ± 2 SD are

Levey-Jennings Chart with Values “In

◦ Calculating the variance

Using Standard Deviation in QC

◦ The mean and ± 2 SD are

Levey-Jennings Chart with Values “In Control”

You might also like