CLINICAL CHEMISTRY LECTURE

To know if the method is reliable and he med tech is

meticulous, the values obtained will be reasonably
LESSON 3: Quality Control and Measurements close together, but will not be identical.
CENTER OF MEASUREMENT *- suppose to have a bell shaped curved called
GAUSSIAN DISTRIBUTION, after Johann Karl
⮚ Mean
F. Gauss who developed many of these basic
⮚ Median concepts draw a bell shaped curve= the peak of the
curved should represent the mean value for the data
⮚ Mode set
if the distribution of values or set is equally
distributed in each side of the graph (symmetrical
MEAN curve)
when the curve is non symmetrical the value of
the mean is still valid, but other descriptive term
RELATIONSHIPS OF DATA will be used.
⮚ Range - largest & smallest value in data
ACCURACY
⮚ Standard Deviation - represent the average
distance from the center of the data and every ⮚ How close the answer obtained lies to the
data set “true” value (*- not obtained by statistical
method)
⮚ Coefficient variation - allows to compare SDs ⮚ Defined by comparison of measured value to
with different unit the known value obtained from the reference
material (**- other refer to it as how close it is
to the bull’s eye-target)
⮚ The closer value to the target, the more accurate
the result

PRECISION
⮚ Can be defined numerically
● Indicates how close the single value are
to one another
GAUSSIAN ● Expressed by standard deviation
● The smaller the SD the more precise
the values are
● Coefficient variation (*- parameter is
expressed as percentage - can be
DISTRIBUTION monitored to assess consistency in
precision of an assay)
● Accuracy & precision are independent
⮚ AKA normal distribution of one another
⮚ It has a symmetric ● Main goal of quality analysis is to
distribution, which means achieve a high level of both precision
that half of the values fall and accuracy in the set of
from the left of the mean measurements
and the right of the mean NOTE: Usually lies on one side of
“bell curve the graph
⮚ X-axis : values obtained
⮚ Y-axis : frequency*
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 QUALITY CONTROL (QC) IN CC
⮚ QC- process of monitoring laboratory analyses
to ensure accuracy of results
● Monitor test performance, helps
identify problems with specific assay
system, and help health care staff
assess the reliability of results
● Encompasses every aspect of
laboratory operation from initial px
identification, sample acquisition to
the clear reporting of final laboratory
results
QC in laboratory is the responsibility of
laboratory data, physicians, nurses and other
health care providers required by the
government. A good quality control program
is a part of quality assurance, w/c
encompasses tge
QC MATERIALS
⮚ Sources Pool: human or animal
● Human: more expensive vs Bovine
serum (why?)*
⮚ Levels: one and two
● One - somewhere in “normal range”
● Tw o- values that are expected in
common diseases that involves the
particular constituents
⮚ Assayed or unassayed**
*-resembles the properties of px sample
being analyzed, particular in enzyme assays
**- assayed- more expensive
values falls w/in 2 +/- SD; there are
specific methods and instruments; suited for
test that are run infrequently
unassayed- usually have targets values,
w/c results falling somewhere near the target
values; performed in the test that are
performed frequently
statistics can be gathered,
laboratories are abled to compare their data
w/ other lab
TYPES OF ERROR
⮚ Random – no tend or no means of predicting it
violations includes: 1 (2S), 1 (3S), and R(4S)
GUGUA NATIONAL COLLEGES- BSMT3
Includes: Mislabeling the sample, pipetting errors,
improper mixing of sample and rgt, voltage
fluctuations and temperature fluctuations*
⮚ Systematic - seen as trend in data**
violations includes: 2(2S), 4(1S) and 10(x)
Includes: Improper calibration, deterioration of
reagents, sample instability, instruments drift, or
changes in standard material
*violations includes: 1 (2S), 1 (3S), and R(4S)
to assess the situation, the sample is
reassayed again using the same reagents, if a
random error occurred, the same mistake may not
happen again and result will be w/in appropriate
control limits
**- control values gradually rise or fall
violations includes: 2(2S), 4(1S) and 10(x)
if reassayed does not correct the problem by
bringing the control values in +/-2SD, further
analysis is necessary.
preparing new control materials,
restandardizing the assay, checking the wavelength
or other instrument settings, or making new rgts
rgst near to their expiration dates should be
discarded and remade, the lab records, for
calibration or schedule of calibration may point to a
need for a new standard curve. Good documentation
will permit easier correction of the problem in the
future
WESTGARD RULES FOR QC
✔ 1 (2S) - one control value exceeds +/- 2SD
from the mean
✔ 1(3S) - one control value exceeds +/- 3SD from
the mean
✔ 2 (2S) - two consecutive values exceed the
same limit +/- 2SD (*- the rule can apply on
two different control materials in the same run,
or to two successive analyses of the same
control material)
✔ R (4S) - one control value exceeds +2SD and
the other is -2SD (**- one material could show
 a value greater than -2SD while the other may
provide a value in excess of +2SD)
✔ 4 (1S) - four consecutive control values exceeds
either +1 SD or -1SD (***- the values must all
be in the same direction)
✔ 10 (x) - ten consecutive control results all lie on
the same side of the mean
NOTE: THIS FOR REANALYZED DATA
PROFICIENCY TESTING
⮚ Proficiency test - method used to validate a
particular measurement process
⮚ Proficiency samples - spx with known
concentrations of an analyte for the test of
interest
⮚ Samples are analyzed the same manner as px
spx and the result are reported to the
proficiency program
REFERENCE LABORATORIES IN PHIL
⮚ RESEARCH INSTITUTE FOR TROPICAL
MEDICINE
- dengue, influenza, TB and other
mycobacteria, malaria and other parasites,
bacterial enteric dse, measles and other viral
exanthems, mycology, enteroviruses,
antimicrobial resistance and engineering
disease.
⮚ NATIONAL KIDNEY AND TRANSPLANT
INSTITUTE
- hematology, immunohematology,
immunopathology and Anatomic pathology
⮚ SAN LAZARO HOSPITAL (SACCL)
- HIV/AIDS, hepatitis, syphilis and
other STI’s
⮚ EAST AVENUE MEDICAL CENTER
- environmental and occupational
health; toxicology and micronutrient assay
⮚ LUNG CENTER OF THE PHILIPPINES
GUGUA NATIONAL COLLEGES- BSMT3
- anatomic pathology and pulmonary
disease.
STRICT REQUIREMENTS FOR
PROFICENCY TESTING
⮚ The laboratory must incorporate proficiency
testing into its routine workflow
⮚ Test values/samples must not be shared with
other laboratory during the testing cycle
⮚ Proficiency samples are tested by bench
technical staff who normally conduct patient
testing
⮚ Testing should be completed within the usual
time it would take for routine patient testing
REFERENCE INTERVALS
⮚ Establish by scientific community or
manufacturers (*International Federation of
Clinical Chemistry (IFCC) has recommended
the used of reference range for the common
laboratory limits)
⮚ Establishing a reference interval - no existing
analyte or methodology in the clinical or
reference laboratory
● Costly; may require to test 120-700
individuals
⮚ Verifying a reference interval (transference)
- confirm the validity of an existing reference
interval for analyte using the same method and
instrument
● Requires at least 20 individuals
ESTABLISHING REFERENCE INTERVAL
⮚ Define an appropriate list of biological
variations and analytic interference for medical
literature
⮚ Choose selection and partition criteria
⮚ Complete a written consent form and
questionnaire to capture selection criteria
⮚ Categorize the potential reference individuals Stress Interference
based on the questionnaire findings
⮚ Exclude individuals from the reference sample Food/beverage recovery
group based on exclusion criteria ingestion

⮚ Define the number of reference individuals in

consideration of desired confidence limits and
statistical accuracy
⮚ Standardize collection and analysis of reference
specimens for the measurement of given
analyte
⮚ Inspect the reference value data and prepare a
histogram to evaluate distribution of data
⮚ Identify possible data errors or outliers and then
analyze the reference values
⮚ Document all of the previously mentioned steps
and procedure

SSELECTION OF REFERENCE INTERVAL

STUDY INDIVIDUALS
⮚ Requires defining the detailed
inclusion/exclusion criteria ; age and gender
⮚ Exactly define healthy/ normal donor for
associated reference values
⮚ Donor health status and subgroups in
individuals

PREANALYTIC AND ANALYTIC

CONSIDERATION
PREANALYTIC ANALYTIC
FACTORS FACTORS

Subject Precision
preparation

Prescription Accuracy
medications

Collection time Lot to lot

reagents

Sample storage Linearity

GUGUA NATIONAL COLLEGES- BSMT3