Module 10

Quality Assurance of Malaria

Laboratory Diagnosis

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Learning Objectives

At the end of the module the learner should be able to

– Describe the principles of QA of malaria laboratory diagnosis
– Describe activities and networking of EQA schemes of malaria
laboratory diagnosis
– Describe Quality Assurance (QA) of Malaria RDT Diagnosis

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Content Outline
– Quality Assurance (QA) of Malaria Laboratory
Diagnosis
– QA of malaria laboratory diagnosis : Objectives &
Challenges
– Principles of QA in malaria laboratory diagnosis
– The QA Cycle
– Components of QA
– External Quality Assessment (EQA): Activities in
malaria laboratory diagnosis
– Organizational structure of EQA in malaria
laboratory diagnosis
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Quality Assurance of Malaria Laboratory Diagnosis
• 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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 Laboratory errors can be seen at three

different vital steps:

Pre Post
Analytical
analytical analytical

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Pre-analytical
– Incorrect test request

– Incompletely filled request forms

– poor or inadequate patient preparation

– Poor methods of specimen collection, labeling and 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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Analytical phase

– Poor procedure in film preparation and staining

– Unqualified or incompetent laboratory staff
– Non-adherence to SOPs

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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

• To ensure that diagnostic service is

– Manned by competent and motivated staff
– Supported by effective training and supervision to maintain high staff
competency and performance
– Supported by a logistics system ensuring quality and adequate supply of test kits,
reagents and equipment

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 QA of Malaria Laboratory Diagnosis : Challenges

• 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

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/equipments/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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To Implement QA for Malaria Laboratory
Diagnosis

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Generally:
• 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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 Components of Quality Assurance

 Internal Quality Control (IQC)

 External Quality Assessment (EQA)
 Quality Improvement (QI)

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 Internal Quality Control (IQC)

• 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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 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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 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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 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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 Panel Testing/PT/…. Cont`d
• 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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 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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 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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Blinded Rechecking… Cont`d

• 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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 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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 Activities in Blinded…….. Cont`d
Systematic Slide Selection Techniques
• Thirty 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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 Activities in Blinded ….. Cont`d
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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 Activities in Blinded …… Cont`d
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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 Activities in Blinded…..… Cont`d

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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 Activities in Blinded ..… Cont`d
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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Activities in Blinded …..… Cont`d
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
2nd 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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Selected Slide Result Recording Form for Rechecking (Annex C - 1)

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

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

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Performance Notification Form (Annex C - 4)

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

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 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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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)

False positive rate = False positive x 100 = B x100

True positive + False Positive A+B

3. False negative rate (% false negatives)

False Negative Rate= False Negative x100 = Cx100
True Negative + False Negative D+C

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Grading Performance of Slide Rechecking Cycle

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 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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Onsite Supervision….. Cont`d
Sufficient time must be allotted to observe all the
activities associated with malaria diagnostic:
– Laboratory organization – Reagent quality

– Availability of functional – Review of laboratory practical

equipments skills (preparing blood films,
– Laboratory supplies storage & staining & reading), work load,

inventory safety & waste disposal system

– Availability & usage of SOPs – Examining a few stained

– Performance of internal QC and positive and negative films by

result record keeping practice supervisors

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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 (HEW s).

• All supervisors need to follow the standard onsite

supervision SOP (Annex-I).

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 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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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

• This include

– Monitoring of the technical standard

– Minimize environmental abuse

– Training and onsite evaluation

– Interpretation by end-users.

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Quality Assurance (QA) of ………… 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-Purchase.
• Monitoring Performance in the Field.
• Training and Instructions for Users.
• Use of Results and Community Education.
• Storage and Transport.
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Quality Assurance (QA) of …. 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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Pre- Analytical Stage

– 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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 Analytical Stage
– 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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 Post - Analytical Stage
– 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
 What are the components of QA ?

 What are the types of EQA methods used in

malaria laboratory diagnosis?

 What elements does the Quality Assurance of

malaria RDT Diagnosis includes?

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Thank You!!

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