Laboratory #3

Quality Control

Laboratory #3
Quality Control
Skills= 19

Objectives:
Upon completion of this exercise, the student will be able to:
1. State the purposes/ uses of quality control in the Clinical Chemistry laboratory.
2. Use quality control results to determine the acceptability of test results.
3. Become proficient in the use and charting of control data, interpretation of control
values, and maintenance of an overall Q.C. program in chemistry.
4. Recall quality control information presented in previous MLT courses, to gain an
understanding and working knowledge of the principles of quality control in clinical
chemistry.
5. Discuss the concept of quality assurance as it applies to the clinical chemistry
laboratory.
6. Gain experience in plotting quality control data, performing statistical calculations,
and interpreting quality control data.
7. Properly prepare and store clinical chemistry control reagents.
8. Compare the composition of and uses for:
1. Calibrators
2. Standards
3. Controls
9. Define and calculate mean, mode, range, standard deviation, and % coefficient of
variation with 100 % accuracy.
10. Define accuracy, precision, reproducibility, and reliability.
11. Recognize shifts and trends in chemistry quality control and make suggestions to
troubleshoot QC problems.
12. Demonstrate understanding and proper usage of Gaussian distribution and its
application in Levy-Jennings control charts.
13. Recognize out-of-control results and follow-up using acceptable procedures.
14. Define the following terms: Quality Assurance, Quality Control

15. Compare assayed versus non-assayed chemistry controls.

Materials:
1. Calculator with square root function
2. Standard graphing paper
3. Computer with internet access, expected results of QC data.

Purpose
Quality control is an essential part of laboratory functioning which ensures that results are
reported with maximum confidence. A properly executed quality control program:
a. provides a record of precision and will demonstrate shifts and trends.
b. enable the tech to make a valid judgment on the accuracy of a measurement.
c. can monitor the performance of equipment or the analytical abilities of a technician.

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MLAB 2401- Lab #3
 Laboratory #3
Quality Control

In general, QC of clinical chemistry analyses is performed by assaying commercial control sera

on a daily basis and maintaining a record of these values. After a sufficient number of
measurements(usually more than 20 are required), an expected target range of acceptable
results can be established. A common way of doing this it to determine the mean and standard
deviation of the data. The acceptable range of values is then determined as the mean ± 2 S.D.
This range will include 95% of the data. The chance that an individual analysis would fall outside
the range may occur in only 1 of 20 subsequent analyses. When a control result falls outside the
target range, the tech must question the validity of the run and respond in some appropriate
fashion, such as repeating the control or perhaps repeating the entire run after trouble-shooting
the analyzer.

Discussion
Controls
Controls are solutions that resemble patient specimens and are used to test and monitor
instrument accuracy and performance. Controls can be lyophilized, assayed, or un-assayed.

Lyophilized Commercial Control sera

Commercial control sera is prepared by lyophilizing or freeze-drying either a pool of fresh-frozen
human serum or non-biologic solvents to provide constituents in a stable form. Manufacturers
usually market two levels of controls, often(misleadingly) referred to as ‘normal’ and ‘abnormal’
controls. Consistent values listed by the manufacturer are based on results of multiple
determinations performed by specific laboratories. Although commercial control seras have
been tested for certain infectious diseases, they must be handled with the same precautions
used when handling any human blood product. In addition, they must be reconstituted
accurately according to manufacturer’s directions and the testing procedures must be the same
for all specimens, control or patient, in order for the control to be used as a means of verifying
accuracy of the procedure.
In the laboratory, some control sera are prepared for use by reconstituting (rehydrating) the vial
with the exact amount of purified water or buffer as directed by each individual manufacturer.
Failure to do so could lead to inaccurate results, delay in reporting patient results, and possibly
skew the mean and range of the next month's QC.
Reconstituted sera should be labeled with the time and date of reconstitution, the time and date
of expiration, and initials of the technician.

Un-assayed vs Assayed Controls

It is possible to purchase un-assayed control sera. The data analysis is performed in-house and
each analyte, such as glucose, sodium, cholesterol, etc., are tested. The data is then collected,
and QC calculations are performed to determine the mean, SD, coefficient of variation, etc. as
applies to their lab. The manufacture only guarantees that all constituents within the lot number
of sera are uniform. Assayed control sera is more expensive. The manufacture has repeatedly
tested the sera for the wide variety of analytes commonly measured. The manufacturer provides
dilution directions and test results to the purchaser in a format similar to the following:

For the Hitachi 917 Instrument

Analyte Units Level 1 Control Level 2 Control
Mean Range Mean Range
Sodium mEq/L 127 123-131 156 152-160
Cholesterol mg/dl 147 132-162 319 287-351
BUN mg/dl 17 15-19 58 53-63
Glucose mg/dl 95 85-105 331 298-364

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MLAB 2401- Lab #3
 Laboratory #3
Quality Control

Calibrators
Calibrators consist of a material that has a known or assigned quantitative or qualitative value
for a specific analyte. This value is programmed into the analyzer’s computer to compare with
an unknown sample.

Procedure 1 - Locating QC results

1. Login to Blackboard and click on the Chemistry course.
2. Click on the Resources/Tutorials button.
3. Click on the QC folder, and open the Stanbio package insert.
4. Using the package insert, answer the questions found on the report page for this lab.

Procedure 2: Probabilities associated with Standard Deviation

1. Using your lecture material, complete the procedure 2 section on your report form.

Procedure 3 - Analysis and use of QC data

After repeatedly (at least 20 times) testing un-assayed control sera for a particular analyte, such
as glucose, the data must be processed using various statistical tools to determine the reliability
of the test results. Establishment of the ‘range of acceptable values’ is one of the most useful
outcomes as it allows the technician to quickly evaluate the acceptability of a subsequent batch
or test run and determine whether the patient values are acceptable.
1. Using the directions and hints provided below, calculate the mean, standard
deviation, andcoefficient of variation for the 20 glucose results listed on Procedure 3
of the Report Form. Complete the blanks for ±1,+2,& +3 standard deviations, range
of 95% confidence limits, upper and lower acceptable limit. Follow the Hints
provided.
A. After listing the glucose values on the left side of the QC form, list the sum of the
values at the bottom of the column.
B. Determine the mathematical average 0, make this value have the same number
of decimal points as does each individual value. List this value at the appropriate
place on the right side of the form.
C. In the second column (left side of the page), subtract the determined average
from each individual value; then square that number and place it in the 3rd
column.
D. Add the values in the ‘Difference from mean squared’ (3rd ) column, place that
number in the place provided at the column’s bottom.
E. Now, divide that number by the number of assays (also referred to as events or
data points) minus one. (OK, for this exercise, that number is 20 - 1 = 19)
F. Take the square root of this number. You have now determined ± 1 Standard
Deviation. Place that number (decimals and all) in the space provided.
G. Multiply the number obtained by 2 to get ± 2 Standard Deviations. Round this
number to reflect the number of decimals of each individual assay value and place
in the space provided.
H. Take the number from step F. and multiply it x3 and place it in the space provided.
I. Range of Acceptable limits (also called 95% confidence limits) - Take the
mathematical mean and add to it the ± 2 Standard Deviation number (this will
result in the Upper acceptable limit). Now subtract the ± 2 Standard Deviation
number from the mean (to obtain the Lower acceptable limit).
The range of values formed (from low to high) is the 95% confidence limit.

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 Laboratory #3
Quality Control

J. Calculate the % coefficient of variation using the formula provided on the report
sheet. Report with 1 decimal number.
2. After filling out the Report form, transfer the 20 consecutive glucose values to a
standard piece of graph paper to form a Levy-Jennings plot. Fill in the mean and ±
1, 2, and 3 SD values.
3. Circle all individual data out of ± 2 SD. Label / circle and identify any/all trends and
shifts.
4. HINTS:
A. When calculating the mean (x̄), you often get decimals. Keep only as many
decimals as is normally reported in the procedure. For example, if the procedure
is calcium phosphorus or magnesium (often reported with 1 decimal point) you
would keep 1 decimal, while glucose, sodium or cholesterol are reported in whole
numbers. When in doubt, check-out how the analyte is normally reported!
B. After calculating ± 1 standard deviation, you may again find extra decimals. For
the purposes of these exercises, report the decimals for ± 1 SD, multiply to
obtain ± 2 SD, then round to the appropriate number.
C. For purposes of standardization, calculate CV using 1 decimal.

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MLAB 2401- Lab #3
 Laboratory #3
Quality Control

Laboratory #3
Quality Control
Report Form
Points= 19

Name:__________________________
Date:__________________________

Instructions: To complete this exercise, the student must refer to laboratory #3- Quality Control
and the course lecture on Quality Control, Quality Assessment, and Statistics.

Procedure 1 - Locating QC results (Stanbio) (4 points)

1. What are the lot numbers and expiration dates for Control 1 and Control 2?

2. Find the assayed results of the following analytes and place the information, including
the units to be reported in the table provided.

Analyte Instrument/Methodology Control range

EXAMPLE: Beckman CX Level I _2.0-2.4 g/dL__
albumin
g/dL Level II _4.0-4.8 g/dL___
glucose Beckman CX Level I ____________
mg/dL (Hex)
Level II ____________
creatinine Hitachi 917 Level I ____________
mg/dL
Level II ____________
Total Olympus AU 400/640 Level I ____________
protein
g/dL Level II ____________
CK/CPK Mindray BS-200 Level I ____________
U/L
Level II ____________

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 Laboratory #3
Quality Control

Procedure 2 (5 points)
1. The curve drawing provided below - can have several names as indicated in the lecture
and lab guides. List two of them.
a.
b.

2. The curve at below-right represents a normal population for a stable analytical method. What
% of area is represented for each of the following?(see arrows)

1. ± 1 Standard Deviation ________

2. ± 2 Standard Deviations ________
3. ± 3 Standard Deviations ________

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 Laboratory #3
Quality Control

Procedure 3 (10 points)

Procedure: Glucose - ortho toludine

Lot number: 588762

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Quality Control

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MLAB 2401- Lab #3
 Laboratory #3
Quality Control

Name:___________________
Date:_____________________

Lab #3: Quality Control

Study Questions
Points= 22

Instructions: To complete this exercise, the student must refer to laboratory #3- Quality Control
and the course lecture on Quality Control, Quality Assessment, and Statistics. Legibly write your
answers on this paper. Unless otherwise noted, each question is worth one point.

1. Define (0.5 points each)

a. Trend

b. Shift

c. 95% confidence limits (target range)

2. After reconstituting control seras, what information must be placed on the label?

3. Contrast the following as to their composition, characteristics and use in chemistry

procedures. ( 1 point each)
a. Control

b. Calibrator

4. List at least two(2) precautionary measures that must be taken when preparing, handling
or using chemistry controls. ( 1point each)

5. List at least four popular (Westgard) control rules as pertains to the interpretation of
Levy-Jennings charts. (½ point each)
a.

b.

c.

d.

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Quality Control

12. Define: (0.5 point each)

a) Mean

b) Median

c) Mode

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Quality Control

14. A sudden shift in daily values on a QC chart could be the result of introducing new
variable with a test procedure. List two possible causes of a sudden shift. (2points)

15. List three(3) QC program purposes/ objectives. (3 points)

Situation:
After running a calcium procedure, the tech finds one control falls within acceptable limits, but
the second control is out of range, falling between -2 SD and -3 SD on the Levy-Jennings chart.

16. If the instrument is working properly, what is the percentage of probability that a
control values will fall within:
a. + 1 SD:_________
b. + 2 SD: _________

17. What is the probability that a control value will fall outside of the + 2SD range?

18. If the second control was out of range due to chance error, and the technician
repeats the “out of range” control immediately, what is the probability that the result
will fall within the + 2 SD range?

19. What is the technologists’ best course of action?

20. What do you recommend the technologist do if a STAT calcium is ordered?

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