The Ethiopian Public Health Institute Ministry of Health-Ethiopia

Chapter 9

Quality Assurance of Malaria

Laboratory Diagnosis

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 Content Outline

• What is quality assurance (QA)?

• The Need for accurate malaria laboratory diagnosis and errors compromising
quality

• Objectives of quality assurance programs

• Challenges in malaria laboratory diagnosis

• Principles of QA in malaria laboratory diagnosis

• Components of quality assurance in malaria microscopy

• Quality assurance (QA) of malaria RDTs

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 Learning Objectives

At the end of this chapter participants will be able to:

• Describe quality assurance

• Describe the necessity of accuracy in malaria diagnostic laboratories

• State the objectives of quality assurance programs

• Describe the challenges in malaria diagnosis

• Describe the principles of QA in malaria laboratory diagnosis

• Describe the components of QA in malaria microscopy

• Describe Quality Assurance (QA) of Malaria RDTs

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 Quality Assurance of Malaria Laboratory Diagnosis

Activity 9.1. Self-Reflection

Instruction: Read the following question and
answer it.

Question: what is quality assurance?

Time: 3 minutes

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 Quality Assurance……Cont’d
•Quality Assurance (QA) is a system designed to improve the reliability and
efficiency of laboratory services.

•Components of QA :
• Quality Control (QC): A systematic internal monitoring of work practices, technical
procedures, equipment, and materials including quality of stains.
• External Quality Assessment (EQA): A process to assess laboratory
performance. It includes
• Panel testing
• Blinded rechecking
• Onsite evaluation
• Quality Improvement (QI): the components of malaria microscopy services are
analyzed with the aim to identify and permanently correct any deficiencies
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 Quality Assurance……Cont’d

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 Errors compromising quality laboratory diagnosis

Activity 9.2. Think/Pair/share

Instruction: first think about the following question and
then discus in pair with a participant sitting next to you and
share your idea.

Question: Describe the significance of accurate laboratory

diagnosis of malaria and errors compromising quality?

Time: 3 minutes

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 Errors compromising ……Cont’d

• Laboratory errors can be seen at three different vital

steps:

Pre Post
Analytical
analytical analytical

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 Errors compromising ……Cont’d

Pre-analytical

Incorrect test request

Incompletely filled request forms

Poor or inadequate patient preparation

Poor methods of specimen collection, labeling & transportation

Use of dirty slides

Defective equipment (microscope, weighing balances)
Improper use of equipment

Substandard or expired reagents

Poor reagent preparation and storage

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 Errors compromising ……Cont’d

Analytical phase
Poor procedure in film preparation and staining
Unqualified or incompetent laboratory staff
Non-adherence to SOPs

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 Errors compromising ……Cont’d

Post- analytical phase

Poor reporting and recording
 Inaccurate calculations/computation/transcription
Delay in returning results to the clinician
Incorrect/misinterpretation of results

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 QA of Malaria Laboratory Diagnosis: Objectives
Activity 9.3. Self-reflection
Instruction: Read the following question and
answer it.

Question: Describe the goals of quality assurance

programs in medical laboratories?

Time: 3 minutes

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 QA of Malaria Laboratory Objectives….Cont’d

To improve the overall performance of laboratory personnel at

each level of the laboratory system

To sustain the highest level of accuracy (in sensitivity and

specificity) in confirming the presence of malaria parasites

To monitor Malaria laboratory diagnostic procedures, reagents

and equipment systematically

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 QA of Malaria Laboratory Diagnosis: Challenges
Activity 9.4. Think/Pair/share
Instruction: First think about the following
question and then discus in pair with a participant
sitting next to you and share your idea.

Question: what could be challenges for malaria

diagnosis in medical laboratories?

Time: 3minutes
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 QA of Malaria Laboratory Challenges…Cont’d

Poor competency in microscopy and RDT, particularly at the

peripheral level

Faulty microscopy and logistic problems

Delays in providing microscopy results to clinicians

Lack of adequate training and re-training

Lack of QA and supervision of diagnostic services

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 Principles of QA in Malaria Laboratory Diagnosis
Activity 9.5. Self-reflection
Instruction: Read the following question and
answer it.
Question: Describe the principle of quality
assurance in malaria laboratory diagnosis?

Time: 3 minutes

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 Principles of QA Diagnosis….Cont’d

An effective QA scheme must be:

Realistic, feasible and sustainable
Compatible with the different situations and needs of each country
A catalyst for change to a culture of quality
Able to promote the best quality in the prevailing circumstances
Able to appropriately recognize and accredit good performance
Identify diagnostic settings (laboratories) and laboratory personnel
with serious problems that lead to poor performance

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 Success in QA of Malaria Laboratory Diagnosis
Depends Upon:
Agreement with quality standards
Availability of supplies/equipment/and infrastructure
Condition of microscope
Training of Laboratory personnel
Regular supervision
Quality of reagents and stains
Cleanliness
Work load
 Technical ability and type of techniques use

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 Success in QA… Cont’d

QA in malaria laboratory diagnosis includes:

Correct specimen collection
Preparation of good quality blood films
Staining using quality reagents from a reliable source
Examination using a quality electric binocular microscope
Correct interpretation and reporting
 Therefore , incorrect, delayed, or misinterpreted tests :
 Have serious consequences for patients and community
 Undermine confidence in the diagnostic service
 Waste scarce resources
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 To Implement QA for Malaria Laboratory Diagnosis

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 Components of Quality Assurance
Activity 9.6. Self-reflection
Instruction: Read the following question and
answer it.

Question: Describe the components of quality

assurance?
Time: 3 minutes

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 Components of QA….Cont’d

Quality Control (QC)

External Quality Assessment (EQA)

Quality Improvement (QI)

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 Components of QA….Cont’d
• Quality Control (QC)

IQC comprises those measures implemented by the diagnostic

facility (laboratory) during each test to verify that the procedure is

correct or working properly.

Example:
 Checking the quality of stain using control blood films

 Checking the internal control line in RDTs

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 Components of QA….Cont’d
• External Quality Assessment (EQA)
Is a system of objective checks on laboratory results by means
of an external agency.
Its objective is to help laboratories to identify errors and
improve practices for better performance
 It is a means of assessing a laboratory’s performance. Hence,
its performance is determined, areas of weakness identified,
and corrective measures undertaken.

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 Components of QA….Cont’d
• Quality Improvement (QI)
A Process by which the components of microscopy and RDT
diagnostic services are analyzed with the aim of identifying
and permanently correcting any deficiencies.

Data collection, data analysis, and creative problem solving

are skills used in this process.

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 External Quality Assessment (EQA) Scheme

National EQA Networking Structure

1.National Level:
• Responsible for planning, budgeting, implementing and monitoring the QA network.

2.Regional Level :
• Responsible for supervising and monitoring activities to maintain the quality of the district and peripheral laboratories.
• Provide feedback of EQA scheme
• Planning and implementation of training and retraining activities
• Ensuring equipment is maintained in good working order.
• Ensure supply chain does not break down

3.Peripheral Level : Comprises

• Primary malaria diagnostic facilities (health posts) and
• Secondary malaria diagnostic facilities, such as laboratories within a hospital or health centers that deal with inpatients and
outpatients

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 EQA Methods

Panel Testing/PT/

Blinded Rechecking

Onsite Supervision

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 EQA Methods…cont’

1. Panel Testing/PT/
Refers to the process by the laboratory performs malaria
microscopy on a set of prepared slides received from the
reference Laboratory.
Used to check the staining procedure as well as the ability of
the technician to recognize and identify any malaria parasite
present.

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 EQA Methods…cont’
Major Advantage
 It provides a rapid picture of the proficiency of many
laboratories in a country (or region).
 Distribution of the same panel to different
laboratories will
 Identify sites most in need of improvement and
 Allow comparison between sites.

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 EQA Methods…cont’
Activities in Panel Testing
• Panel slides are arranged in set of ten slides which comprises five stained
and five unstained blood films.
• Source of panel slides are national and regional reference laboratories.
• Health facility laboratories at all levels of the public health laboratory
system in the public & private sectors are eligible.
• The laboratories are assigned a unique code number which is common to
all NEQAS.
• Panels are packed and shipped using standard procedures for handling
hazardous material.
• Feedback for participant laboratories will be sent within 30 days up on
scoring the results.
• A final summary report and improvement plan will be developed for
appropriate corrective actions.
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 EQA Methods…cont’
2. Blinded Rechecking
• Refers to randomly selected slides collected from the “testing” laboratory are
reexamined at higher level Laboratories (selected EQA Centers).
• Huge amount of resources needed to be mobilized to conduct the rechecking
• Detect malaria misdiagnosis in routine work and assess the overall quality of
testing.
• Misdiagnosis in routine examination is more frequently caused by different
reasons such as:
• High workload
• Poor equipment and
• Lack of reader’s skill

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 EQA Methods…cont’

• Designed to check stained blood film for:

• Appropriate size and thickness,
• Quality of staining,
• Quality of the specimen
• Accuracy of result .
• It reflects a true performance of laboratories offering routine
diagnostic services at the peripheral level

• Checks not only the result of the blood film, but also the
performance of the stain and quality of blood film.

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 EQA Methods…cont’

Activities in Blinded Rechecking

Slide Storage in the Health Facility
• All positive and negative slides need to be stored in a slide box
or dust free carton box, and away from excessive heat and
humidity until the slides have been selected.
• Store slides consecutively according to laboratory number so
there is a direct link between the results in the laboratory
register and the slide location.
• Selection must be done from the laboratory register and not
directly from the slide storage boxes.

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 EQA Methods…cont’

Systematic Slide Selection Techniques

• Thirty(30) slides per health facility should be re-examined
every three months for EQA.
• Ten stained malaria slides are selected each month to
determine accuracy: 5 positive slides and 5 negative
slides.
• If less than 10 slides are examined in the facility, select all
slides for rechecking.

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 EQA Methods…cont’

Systematic Slide Selection Techniques…

• If the number of positive slides examined is less, make up
the difference with negative slides.
• Malaria slides selection should be done every month and
then leftover slides would be discarded.

• If the test volume is high, the slide selection procedure shall

be conducted on weekly basis by the laboratory
head/quality officer, that will also allow slide review for
patient follow up.

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 EQA Methods…cont’

Systematic Slide Selection Techniques…

• The slide selection process is a task to be done by designated
quality officer s/supervisors at Zonal/District and Federal
Hospital laboratories .

• During collection of selected slides the supervisors:

 Copy the results of the selected slides from laboratory
registration book into appropriate form
 Check conformity of the laboratory #s of selected slides
on the registration book with the selected slides’ numbers
and the test results of the selected slides recorded on the
format .
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 EQA Methods…cont’

Slide Selection Schedule:

• If slides are selected weekly, select as follows:
 Week 1 - randomly select 2 positive slides & 1 negative
slide
 Week 2 - randomly select 1 positive slide & 1 negative slide
 Week 3 - randomly select 1 positive slide & 1 negative slide
 Week 4 - randomly select 1 positive slide & 2 negative
slides

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 EQA Methods…cont’

Random Selection:
• Count the number of negative slides per month; for example the total
negative slides are ‘X’.
• Divide by ‘5’ and round up. For example ‘X’ / 5 = ‘Y’ (rounded)
• Take ‘Y’ small pieces of paper and number them 1, 2, 3 . . . ‘Y’.
• Mix them in a container and pick one, for example 3
• Start at the 3rd negative slide in the register, and select that one. Select
every ‘Y’th negative then after.
• If you do not get enough slides, keep selecting each ‘Y’th slide a second
time around.
• Follow the same procedure for the positive slides. If the number of
positive slides examined is less, make up the difference with negative
slides.
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 EQA Methods…cont’

Random Selection…
• Copies the results of the selected slides from laboratory registration book are
recorded into form ‘Annex-D’.
• Blank form of ‘Annex-E’ and the selected slides are to be given for the 2 nd
readers at higher level laboratory for rechecking and result recording.
• Discrepant slide test result(s) [between readers 1 & 2] are to be re-checked by
3rd reader and recorded on a blank form ‘Annex-F’ to in the laboratory any
further discrepancy [between readers 2 & 3] shall be resolved by joint review.
• Feedback to the participant site with comments and recommendation in 2
weeks time.
• Compiled summary report of the participant sites shall be sent to the regional
laboratory quality assurance officer for further analysis and quality service
interventions

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 EQA Methods…cont’

• Selected Slide Result Recording Form for Rechecking (Annex C - 1)

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 EQA Methods…cont’

Result Record Form for Rechecking (2nd Reader) (Annex C - 2)

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 EQA Methods…cont’

• Result Record Form for Rechecking (3rd Reader for Discordant Result) (Annex C.3)

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 EQA Methods…cont’

Performance Notification Form (Annex C - 4)

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 EQA Methods…cont’

Annual Feedback Form for Participant Health Facility in Blinded Rechecking (Annex C – 5)

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 EQA Methods…cont’

• Blinded Rechecking Result Analysis

A = Number of slides reported as positive by both readers

B = Number of slides reported as positive in routine testing by the laboratory but found
to be negative by the cross-checker (false positives)
C = Number of slides reported as negative in routine testing by the laboratory but
found to be positive by the cross-checker (false negatives)
D = Number of slides reported as negative by both readers

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 EQA Methods…cont’

Blinded Rechecking …Cont`d

Result analysis:
1. Percentage of slides in agreement, i.e. percentage of positive slides
correctly identified and percentage of negative slides correctly identified:
% Agreement = True positive + True negative = (A+D) x 100
Total A+B+C+D

2. False positive rate (% false positives)

3.False negative rate (% false negatives)

False Negative Rate= False Negative x100 = Cx100
True Negative + False Negative D+C
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 EQA Methods…cont’

Grading Performance of Slide Rechecking Cycle

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 EQA Methods…cont’

3. Onsite Supervision
 Is a comprehensive assessment of essential elements of
laboratory quality system using standard supervisory
checklist.
Is an ideal means of obtaining a realistic picture of the
conditions and practices in a laboratory.
Provides opportunity for immediately identify sources of errors,
provide onsite corrective actions t, and implement appropriate
measures to resolve problems.
Would be done for both microcopy and RDT service facilities
three times a year by quality officers /malaria experts/ partners
working on malaria diagnostics quality improvement.
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 EQA Methods…cont’

Onsite Supervision….. Cont`d

Sufficient time must be allotted to observe all the activities associated
with malaria diagnostic:
 Laboratory organization  Performance of internal QC
 Availability of functional and result record keeping
equipments practice

 Laboratory supplies storage &  Reagent quality

inventory  Review of laboratory practical
 Availability & usage of SOPs skills (preparing blood films,
staining & reading), work load,
safety & waste disposal
system

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 EQA Methods…cont’

• Onsite Supervision… Cont`d

• Higher level laboratory supervisors/quality officer are in charge
of onsite supervision program for microcopy centers.

• Zonal Laboratory experts and/or Zonal malaria experts are in

charge of the onsite supervision program for health posts

• All supervisors need to follow the standard onsite supervision

SOP

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 EQA Methods…cont’

• On-Site Supervision Checklist

Should be completed during the visit and discussed with the test
performer before the supervisor leaves the health facility.

Filled checklists should be submitted to the onsite supervision

organizer after completion of each visit.

Feedback would be reported to each respective health facility in a

month period and summary reports would be submitted to the regional
& national reference laboratories.

Implementation of the feedback/corrective actions should be followed

up.
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 EQA Methods…cont’

Quality Indicators for Malaria Microscopy

The following are quality indicators for malaria laboratory
diagnosis:
Laboratories should have SOPs, Job Aids and Bench Aids
for malaria microscopy diagnosis, and adhere to the
procedures.
Qualified staff
Functional Equipment
Reagent preparation and storage
Quality control
EQA (External Quality Assessment)
Correct blood film specimen
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 Quality Assurance (QA) of Malaria RDT Diagnosis

Activity 9.7. Think/Pair/share

Instruction: first think about the following question
and then discus in pair with a participant sitting
next to you and share your idea.
Question: Describe quality assurance of malaria
RDTs and its aspects?

Time: 3minutes

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 QA of Malaria RDT…..Cont’d

• This include
Monitoring of the technical standard
Minimize environmental abuse
Training and onsite evaluation
Interpretation by end-users.

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 QA of Malaria RDT…..Cont’d
To provide quality RDT malaria diagnosis service there
should be a proper implementation of QA at each of the
following process
Planning for RDT introduction
Procurement
Lot Testing: Pre- and Post- market evaluation
Monitoring Performance in the Field
Training and Instructions for Users
Use of Results and Community Education
Storage and Transport
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 QA of Malaria RDT…..Cont’d
• Quality Assurance (QA)…Cont`d
 Monitoring each steps (Pre – Analytical; Analytical &
Post – Analytical) of a test procedure to ensure that tests
are performed and interpreted correctly

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 QA of Malaria RDT…..Cont’d
• Pre- Analytical phase in RDT

Store and transport RDT within temperature ranges

recommended by the manufacturer

Check expiry date of RDT prior to use

Check integrity of packages prior to use

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 QA of Malaria RDT…..Cont’d

• Analytical Phase
Ensure packages are opened only prior to testing
Ensure tests are performed as per the manufacturer
instruction
Read results as per the manufacturer instruction only
Avoid too much or too little blood and/or buffer
Avoid using buffer from different box

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 QA of Malaria RDT…..Cont’d
• Post - Analytical Phase
 Reporting and recording
E.g. for Care start Pf/pan test result
 Pf
 Pf and pan
 Pan
 Avoid incorrect or misinterpretation of results
 Ensure that RDTs are not re-used.
 Ensure that all used RDTs and accessories are discarded in
a safe place for disposal
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 Summary
• Quality Assurance (QA) is a system designed to improve the reliability
and efficiency of laboratory services
• Accuracy of malaria diagnosis could be compromised by errors
introduced at the pre-analytical, analytical and post analytical phases.
• The goal of quality assurance in malaria laboratory diagnosis id to
achieve highest level of accuracy (in sensitivity and specificity) in
confirming the presence of malaria parasites
• The challenge to achieve quality in malaria laboratory diagnosis is
associated with poor quality of microscope, RDT, lack of trained staff as
well as lack of quality supplies.
• Components of QA are QC, EQA and Quality Improvement (QI)
• There are three type of EQA methods, which are PT, onsite supervision
and blind rechecking
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 The Ethiopian Public Health Institute Ministry of Health-Ethiopia
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