PRINCIPLES OF QUALITY ASSURANCE

(QA) & QUALITY CONTROL (QC)

Advanced Quantitative Microscopy Training Workshop

Jakarta, October 2019
Challenges in Microscopy
• Clinicians do not trust Malaria Lab results
• lack of commitment to support the laboratory services
• poor quality of microscopy,
• difficulties in maintaining microscopy facilities in good
order;
• logistic problems and high costs of maintaining adequate
supplies and equipment
• lack of adequate training and retraining of laboratory staff;

• delays in providing results to clinical staff;

Quality Assurance &
Quality Control
• QA – planned and systematic
activities designed to detect,
minimize and correct deficiencies in
Laboratory internal analytical
process, to ensure that the Laboratory
results are accurate before release.
• QC – operational techniques and
activities used to monitor and
evaluate the analytical process that
produce patient results.
Laboratory
Design
• There is sufficient working
surface and space for each
member of the laboratory staff.
• There is a an adequate electrical
supply for the microscope(s).
• There is adequate storage space
for reagents, equipment and
storage of slides.
• Laboratory chairs and/or stools
are suitable for microscopy.
• KAIZEN
Standardized
Microscopy
Procedures

• malaria diagnostic
procedures must have
SOPs covering basic
microscopy maintenance,
blood film preparation and
staining
Supply Chain
• Methods used to
obtain reagents and
supplies for the
Laboratory.
• high quality work
depends directly on
the quality of the
equipment and
reagents available.

• effective supply
chain provide
required supplies
that are needed to
Pipette
• Used to measure and deliver accurate
volume of blood onto the slide.
• We calculate the number of parasites from
blood volume
• What volume do you use for your
Microscopy?
Pipette

• Calibration of
pipettes ensures
reliable, precise,
accurate, verifiable,
reproducible and
integrity needed for
reliable parasite count
Weighing
Balance
• Designed for precise weighing of
small mass of Giemsa powder, salts
and other reagent powder.
• Before measuring, it needs to be
recalibrated to read 0.00000g
• Quality Control should be applied
on Weighing Balance periodically
or before use.
• What would may go wrong if
weighing balance are not
calibrated?
pH Meter
• The laboratory has a pH
meter that reads to 2 decimal
places.
• The pH meter is calibrated
with calibration buffers
according to manufacturer’s
directions.
• small differences in pH
(such as between pH 7.0 and
• pH 7.2) can make significant
differences in stain quality
Effects of Buffer on Malaria parasite
features
• What can happen if the
QC is not done on pH
Meter?
• ? Cell inclusions
• ? Parasite cytoplasm
• ? Parasite nuclear
MICROSCOPES

• A binocular microscope
with an x7 or x10
eyepiece and an oil
immersion
• lens (x100) with a
built-in electrical light
source is the “gold
standard”.
Microscopes
Slides
• Only high quality microscope
slides, free of surface abrasions and
purchased from a
• reputable dealer, should be used for
malaria microscopy. They should
be scrupulously free
• from grease, moisture or fungus
and should, therefore, be cleaned
and stored before use.
Giemsa Stain
• The alcohol based Giemsa stain is the “gold
standard”.
• Stain the nucleus red and cytoplasm blue
• The laboratory has a Stain QC Register recording
the
batch number and expiry date of supplies received, the
QC results on each batch (staining time, staining
quality,
optimal pH of use) and any problems encountered.
• Commercially Giemsa stain or Laboratory prepared
Giemsa stain from Giemsa powder are both
acceptable.
• What happened if you use poor Giemsa stain?
Methanol
• Methanol is Analytical
Reagent (AR) grade.
• Methanol is supplied to the
laboratory in the original
sealed container as supplied
by the manufacturer, and is
not repackaged by the
supplier.
Personnel Training
• Competency in microscopy is the
ability of a microscopist to
perform an accurate examination
and correct reporting of a malaria
blood film.
• correctly identify the components
of normal blood to an accuracy of
>95%;
• correctly identify malaria ring
forms, schizonts and gametocytes
to an accuracy of >95%;
• correctly recognize and identify P.
falciparum to an accuracy of >95;
• identify non-P. falciparum malaria
species to an accuracy >80%;
Microscopist Workload (1)
• Excessive workloads are a
major factor contributing to
poor performance
• sensitivity of diagnosis is
directly related to the time
available to examine blood
film
• Sensitivity decreases when
the number of slides
exceeds the workload
capacity of the microscopist.
• 30–40 slides can be
effectively read per day.
Microscopist Workload (2)
• Sensitivity decreases
when the number of
slides exceeds the
workload capacity of
the microscopist.

• 30–40 slides can be

effectively read per day.
 Full concentration
 Well-prepared
blood smear
requires full
concentration.

 Enthusiasm in
your work.

 Passion for what

you do.
THANK YOU...