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HAND-OUTS Quality Control

HAND-OUTS Quality Control

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Clinical Chem Quality Control
Clinical Chem Quality Control

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Categories:Topics, Art & Design
Published by: John Henry G. Gabriel IV on Jul 14, 2010
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04/18/2014

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Quality Control and Quality Assurance in a Clinical Chemistry Laboratory
 
Annabel Lapuz-Carungin, MD, RMT, PT, RN, RM, MANTypes of Analysis done in a Chemistry Laboratory
 
Qualitative
 
Qualitative analysisseeks to establish the presence of a givenelementorinorganic compoundin a sample.Qualitative organic analysis seeks to establish the presence of a givenfunctional groupororganic compoundin a sample.Quantitative
 
Quantitative analysisseeks to establish the amount of a given element or compound in a sample
 
Laboratory quality controlDesigned to detect, reduce, and correct deficiencies in a laboratory's internal analytical process priorto the release of patient results and improve the quality of the results reported by the laboratory.Quality control is a measure of precision or how well the measurement system reproduces the sameresult over time and under varying operating conditions.
 
Laboratory quality control material is usually:
 1.
 
Run
at the begi
nn
i
n
g of each shift2.
 
After a
n
i
n
str
um
e
n
t is serviced3.
 
Whe
n
reage
n
t lots are cha
n
ged4.
 
After calibratio
n
 5.
 
Whe
n
patie
n
t res
u
lts see
m
i
n
appropriate
 
I
nternal standard
 
An internal standard inanalytical chemistryis achemical substancethat is added in a constant amount to samples, the blank andcalibrationstandards in achemical analysis. This substance can then be used for calibration by plotting the ratio of theanalyte(substance to bemeasured) signal to the internal standard signal as a function of the analyte concentration of thestandards. This is done to correct for the loss of analyte during sample preparation or sample inlet.
I
nternal Standard
 
The internal standard is a compound that matches as closely, but not completely, the chemical speciesof interest in the samples, as the effects of sample preparation should, relative to the amount of eachspecies, be the same for the signal from the internal standard as for the signal(s) from the species of interest in the ideal case.Adding known quantities of analyte(s) of interest is a distinct technique calledstandard addition
 
,which is performed to correct formatrix effects.
 
I
nternal Standards or controls
 
Furthermore, standards or controls should have the same matrix as patient specimens, includingviscosity, turbidity, composition, and color;Simple to use, stable for long periods of time in large enough use quantities to last at least one yearand liquid controls are more convenient than lyophilized controls because they do not have to bereconstituted minimize pipetting error.
 
Calibration
 
Calibration is thevalidationof specificmeasurementtechniques and equipment. At the simplest level, calibration is a comparison between measurements-one of known magnitude orcorrectness made or set with one device and another measurement made in as similar a way aspossible with a second device.
 
Calibration
 
The device with the known or assigned correctness is called thestandard.
 
The second device is the unit under test (UUT), test instrument (T
I
) or any of several other names forthe device being calibrated.This process establishes the calibration of the second device, with important limitations.When should
I
recalibrate and what criteria should
I
use?
 
Recalibration criteria:
 1. Ma
nu
fact
u
rer's reco
mm
e
n
datio
n
 2. If the calibratio
n
is expired3.
R
estore previo
u
s perfor
m
a
n
ce
When should
I
recalibrate and what criteria should
I
use?
 
CL
I
A 88 requires that laboratories recalibrate an analytical method at least every six months.
 
Manufacturers will recommend a calibration frequency determined by measurement system stabilityand will communicate in product inserts specific criteria for mandatory recalibration of instrumentsystem. These may include:
 1.
Reagent lot change
2.
Major component replacement
3.
I
nstrument maintenance
4.
New software installationStandard Curve
 
A standard method for analysis of concentration involves the creation of acalibration curve.This allows for determination of the amount of a chemical in a material by comparing the results of unknown sample to those of a series known standards.
 
I
f the concentration of element or compound in a sample is too high for the detection range of thetechnique, it can simply be diluted in a pure solvent.
 
Standard Curve
 
I
f the amount in the sample is below an instrument's range of measurement, the method of additioncan be used.
 
I
n this method a known quantity of the element or compound under study is added, and thedifference between the concentration added, and the concentration observed is the amount actuallyin the sampleQuality assurance
 
I
t refers to planned and systematic production processes that provide confidence in a product'ssuitability for its intended purpose.
 
I
t is a set of activities intended to ensure that products (goods and/or services) satisfy customerrequirements in a systematic, reliable fashion.QA cannot absolutely guarantee the production of quality products, unfortunately, but makes thismore likely.
 
Quality assurance
 
QA includes regulation of thequalityof raw materials, assemblies, products and components; servicesrelated to production; and management, production and inspection processes.
 
I
t is important to realize also that
quality 
is determined by the intended users, clients or customers,not by society in general: it is not the same as 'expensive' or 'high quality'. Even lowly bottom-of-the-range goods can be considered quality items if they meet a market need.
 
Quality assurance versus quality control
 
Quality control emphazises testing and blocking the release of defective products, quality assuranceis about improving and stabilizing production and associated processes to avoid or at least minimizeissues that led to the defects in the first place.Quality AssesmentQuality Assessment - quality assessment (also known as proficiency testing) is a means to determinethe quality of the results generated by the laboratory.Quality Assessment may be external or internal, examples of external programs include NEQAS,HKMTA, and Q-probes.
 
Terminology
 
REAGENT
I
t is "a test substance that is added to a system in order to bring about a reaction or to seewhether a reaction occurs".Examples of such
analytical reagents
includeFehling's reagentandTollens' reagent. Terminology
 
When purchasing or preparing chemicals, "REAGENT-GRADE" describeschemical substancesof sufficientpurityfor use inchemical analysis
 
,chemical reactionsor physical testing.
 
Variables that affect the quality of results
 
 
T
he ed
u
catio
n
al backgro
un
d a
n
d trai
n
i
n
g of the laboratory perso
nn
el
 
T
he co
n
ditio
n
of the speci
m
e
n
s
 
T
he co
n
trols
u
sed i
n
the test r
un
s
 
R
eage
n
ts
 
Eq
u
ip
m
e
n
t
 
T
he i
n
terpretatio
n
of the res
u
lts
 
T
he tra
n
scriptio
n
of res
u
lts
 
T
he reporti
n
g of res
u
lts
The educational background and training of the laboratory personnel
 
Skills of Phlebotomist
 
Knowledge on patient preparation, amount of sample to be used, test tube to be used andtechnical procedure on drawing blood sample (Prolonged tourniquet application)The condition of the specimens
 
Skills of the laboratorian who analyze the sample receive.
 
 
Verification of sample label
 
 
Checking for quantity and quality of sample
 
whether sample arrived on the specified time from the exactraction time, whethersample sample maintained proper transportation
 
 
Ensuring that reagents and equipments
are calibrated a
n
d pass QC
Errors in measurementTrue value - this is an ideal concept which cannot be achieved.
 
Accepted true value - the value approximating the true value, the difference between the two valuesis negligible.
 
Error - the discrepancy between the result of a measurement and the true (or accepted true value).
 
Sources of error
 
I
n
p
u
t data re
q
u
ired - s
u
ch as sta
n
dards
u
sed, calibratio
n
val
u
es, a
n
d val
u
es of physical co
n
sta
n
ts.
 
I
n
here
n
t characteristics of the
q
u
a
n
tity bei
n
g
m
eas
u
red - e.g. CF
T
a
n
d HAI titre.
 
I
n
str
um
e
n
ts
u
sed - acc
u
racy, repeatability.

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