Part-1 Basic concept Quality control in

Clinical Laboratory-Internal Quality Control

So, today discuss on basic understanding of internal quality control that is IQC in clinical
biochemistry laboratory. So, as we all know, laboratory system is a very complex
process, which will start from the pre-examination that includes the patient preparation
sample collection, then sample received sample transport, then there is examination
portion, and after that the post-examination, so, laboratories or laboratory system is
mainly divided into three parts that is pre-examination examination and the post
examination. So, in laboratory the errors which are occur, they are mainly classified as a
pre-examination of the pre-analytical errors, analytical errors, and then post-analytical
error. So, most of the error which occurs in the laboratory or the pre-analytical that will
around 40 to 50% of the total errors are in the pre-analytical part, but, again the
analytical portion will cause the error in the laboratory. So, the IQC is aim to minimize
this error in our laboratories. So, we want to minimize errors at our site. So, analytical
portion is completely in our hand. So, we have to minimize this okay. So, IQC is aimed
to decrease the analytical error in our laboratory. So, first of all, what is quality control,
what is quality control in the laboratory. So, quality control is defined as a fixed value
sample provided by the company to ensure the accuracy and the precision of all the
generated result in our laboratory right. So, whatever reports we are generating, they
are accurate and precise. So, to get this confidence, we should do the quality control.
So, before we start the IQ See, I just described two terminology that is accuracy and
precision, which is most most important when we deal with the quality control. So, first,
that is accuracy. So, accuracy is defined as how well a measurement agrees with the
accepted value. So, how well we are nearby to the target value right. So, that is
accuracy and precision that is how well a series of measurements agree with each
other. So, that is otherwise known as the reproducibility of the result. So, that is
accurate accuracy and then precision.
Okay, I just give some example here you can see there are multiple spot which are
somewhat far from the target value, but they are nearby to each other that means, these
results are precise, but not the accurate So, they are inaccurate Okay, in this figure, you
can see that they are the randomly scattered all over the whole chart right. So, these
are the inaccurate and imprecise result and here you can see, they are near to the
target, they are within the target value and they are near to each other. So, they are
reproducible also and they are accurate also that's why these results are accurate and
precise. So, we must try to get these type of result in our laboratory our result must be
accurate and precise. So, quality control samples what is quality control sample and
how they look alike. So, quality control samples are the pools of biological fluids which
must be resembles to the patient specimen. So, it is similar viscosity turbidity and
somewhat similar composition and the color like the patient sample okay. So, it
resembles to the patient sample they contain the multiple analytes that contain the
multiple parameters, they are usually prepared by the equipment equipment
manufacturer or the region manufacturers they are available in the different levels that
you will know they are in the different concentrations starting from the lower to the
higher side. So, we can check our performance or the and range and they can be acid
and the anessa acid that means they will provide the mean and standard deviation for
the analyte. And in another set, we have to determine our mean and SD by combining it
with the peer group. So, that is all about how the quality control samples must be. So
they are mainly of two types. That is Internal quality control and then external quality
control, but here, we are just mainly focusing on the eyepieces. So, we just learned
about internal quality control. So, what is internal quality control, so, internal quality
control are done on the daily basis before starting the patient sample analysis right. So,
in our laboratory, before we put any sample on the analyzer, we must do the internal
quality control it is a retrospective analysis because we know the value of the control
and we are just checking it out. So, that's why it is a retrospective analysis of the known
value sample they can be of different different level or different known value they are
generally named as level one level two and level three-level one that is for them lower
side of pathological value level two that is of normal value and level three that is higher
pathological valued, its frequency must be defined by the laboratory, but as per the
NFL, standard is 14189 2012 the comments at least be able to run one level one time a
day for the parameter having less than 24 hours per day to level one time a day for the
parameter in frequency of 25 to 75 days per day and two levels two times a day if you
are doing more than 75 tests per day for that particular analyte right. So, but you can
define your slps and you can change accordingly, but this is the minimum criteria you
have to follow, if you are going for the nmba accreditation and IQ See, it basically
measures the precision, there is no doubt that you will give the idea about the accuracy
also, but specifically it measures the precision of the particular analyte. So, by seeing
the Lj plot and everything that I will discuss later on, we can check the precision as well
as the accuracy. So, if you start IQs in your laboratory, how you will start What will you
check for and how will you document it. So, now, we will see that so, how to perform
IQC first by internal quality control from any recognized standardized vendor like buyer
ID or randox and then run the IQC everyday. So, frequency should be as I discussed
earlier frequency should be according to your lip size and equity according to your
requirement. So, when you run the QC value of that particular analyte will be plotted on
LG chart okay.

So, now we will see what is Lj chart. So, this is a diagrammatic presentation of lG lG
chart, LG chart is invented by Levy and Jennings in 1950 to see the accuracy and
precision of each parameter right. So, how will you make the LG chart so, the company
will prefer the brochure with the IQ sample? Okay, you can we just talk about the
albumin. So, here you can see if you are doing the Brock B BCG method for the
albumin, this is level one, this is level two Okay, they will provide you the mean they will
throw a reserved reference range okay. So, you to establish mean and SD provided by
the company. So, here you can see the mean for the Elven that is 4.19. Now, we have
to define the SD for that fear to deduct higher value or the lower value from the mean
the word we get that is to SD. So, if you want to get the SD fail to divide it by the two,
so, add this value as an SD for the all levels. So, just for example, for lb min min will be
4.19 and SD will be point 23. So, I have to feed this value in the instrument to will get
the chart somewhat like this. So, this is for the level one, this is for the level two, the
mean for the level one this is Greenland indicates the mean it is 4.19 and yellow line will
show the plus two SD and minus two SD red line will show the plus three SD and the
minus three three so mean for the level one is 4.192 sd will be point 46 in level two
mean will be 2.73 and two SD will be point 36. So, this is about the LG chart for lb when
you can make it you have to make it for them all the analytes for which you are doing
the IQC So, on the next day when you run the QC or IQs in the morning, you will get the
plot like these right. So, that is the Lj plot okay. So, I am not going in detail for that. So,
once you got the spot now the next part that will come interpretation of the LG chart
okay. So, what will you see when you are going to interpret the LG chart. So, first, you
have to decide whether to accept or reject that particular spot and for that, we will follow
the best gutturals that I am discussing the later portion then you have to check for the
accuracy and precision and you'll also see for the trend or shift is there or not okay. So,
starting from the acceptance and rejection of the point. So, to accept or reject the point
we use the control rules which is designed by the scientist Dr. James's first card and
their tools also known as the waste guard rules These rules are mainly divided into two
parts warning rule and rejection.

Okay these are some words the common rules which are defined by the with God they
are one-two s one three s two two s are forests and 10 x rule now, we see these Fiskars
rules one by one. So, starting from the first rule, that is one-two as that means there is a
one-point which is outside of two SP. So, you will find a spot right outside either on the
plus side or either on the minus side. So, any sport on outside of plus two SV or minus
two SP is considered as violation of one two s rule, this rule is a warning rule. So it just
trigger the careful inspection of the control data that means view to take care of this
parameter when you run the QC for the next time, so, it just gives a warning for the
result, but you're to accept the point second rule that is whisker restore one point this is
one three years right so, there is a one point outside of three SD it can be again it can
be one plus three SP or it can be at minus three SP right So, you can see one spot
which is outside of minus three SP So, it has violated the rule that is one three years it
is the rejection rule. So you have to reject them result right and you have to take some
corrective action for this point. third rule that is to two s two two s that means two
consecutive sports outside of two SV again it can be on positive side or it can be on
negative side okay. So, that is known as the two two s rule. This is again one of the
rejection rule, but you must keep in mind if you are doing two levels of QC and you get
points outside of two SD in both levels, it is considered as two twos. So, on the same
day, it is considered as true to as if both the values in both levels are outside of to SD
so, that is known as two two s rule that is again a rejection or failure to reject the values
and you have to take the corrective action for that fourth best girl that is considered as
our forez R stands for random and that is again a rejection rule. So, if there is a
difference between two consecutive points is more than four as we saw one point that is
on the minus to st side and that is on the plus to st side. So, that is the difference
between these two will be different between these two will be for st right that's why it is
known as R for sr that is random and the difference between two consecutive points will
be more than four SD. So that is one of the rejection rule. And lastly, the 10 x rule 10 x
that is a consecutive 10 value on same side of the main is considered his 10 acts rule,
but now it is some of the laboratory does not include it in the rejection rule and they will
derail their own mean okay. So, but as per the is God, this is the rejection rule if you get
10 consecutive value on the either side of the main then it is known as the 10 x rule
violation right and it is the rejection rule. Second point in the ikusi this is to check for the
accuracy and precision. So, if you see these QC Okay, I am going to see every day and
NGS plotted right in this portion, you can see the values are on the board side of the
means and it is again nearby the mean. So, this performance table performance it is
considered as accurate and precise performance right.

In second question, you will see that you will see that these jewels see that accuracy
will be the problem because you have not got any value on this side of the main means,
you are deviating far away from the mean and there are many points which are on the
outliers. So, this is precise, but it is not that accurate. And here you can see you are
varying on the both the side and there are many points which are outliers right here you
can see So, here is the problem again accuracy as well as the precision. So, our LG
plot for the each enlive should be like this, it should be within the range, okay. So, this is
my range, all sports are within the range, and they are on the both side of the main. So,
I need the performance like this for all them analyzed when I see the LG. So, check for
the accuracy and precision and lastly, check for the trend or the shift here you can see
that there is a gradual, you will find the trend, there is a gradual rise of the parameterize.
So, this is the trend and there is a sudden shift of the value from the perfect of the main
to the lower side of the main. So, this is known as the shift there is a sudden shifts,
there is a sudden change in the value that is known as shift and gradual change in the
value that is trends. So, you have to check for the trend and shift that will give you some
idea. So, I am not discussing this portion, but you must see for the trend in the shift.

So, once I have interpreted the LG chart and if my spot or my value is rejected, then
you're to identify the error, and then you have to take the corrective and preventive
action for that particular problem. So, first, we have to detect the error. So, these rules
like one-two s one threes and our forays are considered as a random error. So it is
accidental error. Whereas two two is four one is or 10 X is considered as a systematic
error. So there is some problem in your system or the machine right. So, accordingly,
you to classify your error. Now, what can be the render possible cause of random error,
this is just a list there are many reasons outside of this list right. So, it can be the power
fluctuation, it can be WP pitting of control sample or miss pipetting of sample
misplacement of control sample within the run there may be air bubble in water supply
there may be a air bubble in the region bottle. So, it may be due to air bubble or there
may be air bubble in the sample, this can be the random error in the QC region right
now, which are all sorts of systematic error, it can be due to delta filter bill, there is a
failing light source use of bad water right there is non region grade water in the taste
system. Yo, then the calibration and you're not followed it properly, you're not checked it
properly, whether it is within range or not might be a procedure like Elijah, there is a
change in the taste operator and degradation of reagent there may be due to a problem
with the storage. So this can be the error, it can be the reason for that systemic error.
So how to correct it what is what should be the protocol to correct the IQC if we get the
outlier. So first and foremost, when you get the outlier, first run the QC. So, these fields
some would rule out the problem if any bad keyword is there, or if there is any air
bubble in the reagent or in the sample or in the water supply. So it will be ruled out
when you rerun the quality control after that, so you don't get the result just changed the
region, especially in case of biochemistry, or the immune essay. Still, if you don't get
you change the QC material In this case most of the time, there are multiple parameters
on the outline side. Then if you've still failing for the getting the proper result you're to
calibrate the parameter, but you must be careful when you calibrate any parameter you
must check for the proper calibration. So, calibration factor is again within its range
right. So, it should be nearby it should not be FSA right. So, you have to check it
properly, check for the filter into it now, in fully automatic analyzer, you will see the
calibration graph for the filter under two bits and thereafter check for the precision still
you don't get anything you have to ask the technical person to check the instrument. So,
these protocol must be followed you can change your protocol according to your
requirement and according to your system right but this must be follow-through this is
how you correct the outliers then documentation of IQC So, once you are done with the
identifying the error, you have interpreted the LG chart, then you have to document it.
So, which documents are needed for the internal quality control, first daily control sheet
or the register then daily QC corrective action that is known as a catalog and you're to
monitor the monthly senior person that is coefficient of variance. So, this is an example
of daily control sheet, you have to write the values for the parameters for which you are
doing the IQ c you have to write the your corrective and preventive action right or
parameter, what is the problem with the parameter and what corrective action you have
taken? So, your you must turn maintain the IQC corrective preventive action sheet and
you have to monitor the monthly senior percent right likewise, in February the albumin
level one 6.4 7.5 likewise, you have to monitor your C percent these indicates your
precision and at the end of month, you have to evaluate the indicator for precision is
there any trend or trend is or not? Is there any biases or not? So, you have to check for
that. So, for that, there are some basic statistics for the internal quality control which
parameter used to calculate and which k parameter to to monitor right. So, the most
important parameter for the IQ is 2%. So, how we will get the senior person first year to
calculate the mean then you have to calculate the standard deviation and from these
your to calculate the CV percent there is a coefficient of variance to how we calculate
the mean this is very easy, the mean is the average of all the values right.

So, if I want to get a mean you're to sum up all the values divided by a number of
values, you will get the mean then you have to calculate for standard deviation, there is
the formula for standard deviation it is in the underwrote sigma x minus x bar whole
square divided by n minus one by that way you will get that standard deviation but
nowadays you can easily calculate it in the Excel city just feed your data and just with
the help of formula you can calculate the mean you can calculate the SD and you can
calculate them say a person, but this is just for the information and from that, you have
to calculate the coefficient of variance that is SD upon mean multiply by 100. So, it is
expressed as a percentage of the mean once I get the C percent, you follow the criteria
of plier 88 that is clinical laboratory improvement amendment okay for the acceptable
performance for the routine chemistry. So, if I get the C percent less than 10% full
album that is acceptable, but these are the very wide range you must decrease your C
percent year by year. Okay, you're to improve yourself every year right. So, don't target
it, but about this is not acceptable.

So, to summarize IQC as I told when the QC everyday frequency should be decided
according to your lab size, then the values port will be plotted on the LG chart of
respective parameter then do the relational algebra in which you have to first decide to
accept or reject the spot, you have to check for the accuracy and precision you have to
check for the trend in the shift. If the spot will be rejected value will be rejected, you
have to identify the error whether it is a random error or it is a systemic error and you
have to take the necessary corrective and preventive action whatever you take
corrective and preventive action you must have to documented okay and at the end of
month evaluate the monthly indicator for the recession trends and bias and
documentation is must for the daily and monthly basis of internal quality control. Okay,
so this is all about the internal quality control in the clinical laboratory. Kindly subscribe
to my youtube channel Polian Gandhi and for any query regarding medical
biochemistry, you can email me on [email protected]. Thank you for the patient.