EQA Planning and Organizing Module
PLANNING AND ORGANIZING AN EXTERNAL QUALITY ASSESSMENT
(EQA) SCHEME
Purpose:
To provide participants with an overview of the principles for
planning and organizing an EQA scheme, and introduce the
resource checklist needed for implementing EQA
Learning
Objectives:
At the end of this module, participants will be able to:
 Describe an effective laboratory network for AFB smear
microscopy that will assure an acceptable level of technical
proficiency
 Describe the role of the NRL in implementing TB
laboratory EQA activities in a country
 Compile a checklist of critical resources required for
implementing EQA
 List the recording and reporting forms that will be needed
for EQA implementation
 Plan and organize an EQA scheme in compliance with a
step-wise approach
Content Outline:
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

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Handout and
exercises:
Appendix:
AFB smear microscopy network
Checklist of critical resources required for implementing
EQA
Step-wise approach for implementing EQA
Documentation
Training of personnel
Exercise: Calculation of essential supplies and controllers'
workload
None
AFB SMEAR MICROSCOPY NETWORK
An effective smear microscopy network should have a sufficient numbers of
geographically disperse centers to create easy access for the patients, but not be so large
that it is impossible to control for quality performance. Proficiency in AFB microscopy
requires that positives are regularly encountered by the technicians; therefore a
sufficiently high number of suspects must be available for each center. The frequently
used rule of thumb is to have one microscopy center per 100,000 population, or that a
technician should encounter at least 1 positive smear per week. Wide variations may
occur to reconcile exigencies of proficiency and accessibility, and the situation in
countries or areas with a high prevalence of TB will be different from those with a low
prevalence of tuberculosis. If the incidence of smear-positive TB is 1 case per 1,000, a
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EQA Planning and Organizing Module
population of 100,000 will yield 100 cases per year, equivalent to at least 4 positive
smears per week, so a center serving a sparsely populated area may still see the minimum
of 1 case per week. On the other hand, a few big centers equipped with fluorescence
microscopes might be the best option to provide excellent diagnostic service in a large
city.
Thus, it is important to provide TB smear microscopy services that are accessible to the
entire population, yet maintain an acceptable level of technical proficiency. To
accomplish this objective, a network of laboratories with the necessary equipment,
supplies and competency in acid-fast sputum smear microscopy supported by larger
regional laboratories and overseen by a NRL, is required. The sputum smear microscopy
network is typically organized according to the three levels of general health service.
Peripheral laboratories are located at primary health centers or district hospitals. Staff
should have technical proficiency to perform sputum smear microscopy utilizing ZiehlNeelsen (ZN) staining. Peripheral laboratories must be visited on a regular basis by a TB
supervisor, who has been adequately trained to evaluate the basic functions of the
microscopy laboratory and by a laboratory supervisor from a higher level laboratory.
Peripheral laboratories should observe internal quality control procedures, participate in
panel testing rounds (if any) and be trained in proper storage of smears for blinded
rechecking.
Intermediate regional or provincial laboratories exist in larger hospitals or cities. Staff
have technical proficiency to perform ZN microscopy, and may have capacity to perform
fluorescence microscopy, culture and drug susceptibility testing, according to the NTP
policy. Fluorescent microscopy (FM) is a now an accepted tool for diagnosis of
tuberculosis in high volume settings and in high HIV prevalence areas as well. Therefore,
FM can also be used at peripheral centers. In the framework of the EQA blinded
rechecking program, intermediate laboratories should be capable of selecting slide
samples from peripheral laboratories, providing the first control level (and eventually also
the second level to resolve discrepancies in larger countries). Whenever possible,
intermediate laboratories should support panel testing activities if applicable, by
ordering/receiving panels from the NRL and distributing panels to peripheral
laboratories; collecting the panel testing results and panel sets, and forwarding them for
review to the national level, according to the procedures developed by the NTP. If
approved by the NTP, intermediate laboratories with proper training can also analyze the
EQA results, provide constructive feedback to peripheral laboratories and regularly
forward the EQA reports to the national level. Intermediate laboratories should be
capable of training laboratory technicians and providing on-site problem-oriented
supervision based on blinded rechecking and panel testing data. Intermediate laboratories
also submit requests for laboratory supplies and distribute laboratory supplies among
peripheral laboratories.
A Central laboratory may exist as a part of a central public health laboratory, a research
laboratory, or as an upgraded laboratory in the country’s principal tuberculosis
institution. It serves as the national reference laboratory (NRL) for the TB program, with
staff competent in direct ZN microscopy, fluorescence microscopy, culture and drug
susceptibility testing. The NRL plays an essential role in organizing and maintaining the
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EQA Planning and Organizing Module
TB laboratory network, developing guidelines, ensuring high quality and standardized
smear microscopy, and therefore must have the capacity to provide training and external
quality assessment. The NRL must be properly staffed and equipped to perform EQA
activities, including general planning and coordination of EQA, manufacturing and
validation of panels, organization and coordination of panel testing rounds, provision of
the second control level for resolving discrepancies under a blinded rechecking program.
The NRL should provide a detailed final analysis of EQA results, submit EQA reports to
NTP management, and provide constructive feedback to lower levels. The NRL should
be capable of providing supervision to intermediate and peripheral laboratories for
specific quality problems. The NRL also submits requests/orders for laboratory supplies
to NTP management, and distributes supplies to intermediate levels. In large (populous)
countries there may be operational advantages in designating one or more regional
reference laboratories. Such laboratories must work in close collaboration with the
national reference laboratory.
CHECKLIST OF CRITICAL RESOURCES REQUIRED FOR IMPLEMENTING
EQA
When considering implementation or expansion of EQA processes, NTP managers and
NRL staff should consider both the currently available and the necessary resources.
Resource requirements for each EQA method are listed below.
1. Panel Testing
 Procedures for preparing panel testing slide sets.
 Reference laboratories capable of preparing test slide sets. Consider biosafety
issues (availability of a properly functioning biosafety cabinet is a mandatory
prerequisite), availability of equipment (centrifuge, vortex, etc.) and supplies
(slides, slide boxes, reagents, plastic centrifuge tubes, pipettes etc.).
 Adequate number of qualified laboratory staff to prepare slide sets. Consider the
impact of the additional workload for panel sets preparation.
 Functional microscopes at national, intermediate and peripheral laboratories.
 Availability of appropriate slide boxes for sending slide sets to intermediate /
peripheral sites. Box type and capacity will be determined based on the
distribution scheme and transport conditions.
 Mechanism for distributing slide sets to peripheral sites without breakage or loss
(mail, courier). Consider collaboration with the intermediate level laboratories.
 Adequate funds for sending slide sets to intermediate and peripheral laboratories
and returning slide sets to NRL for review if necessary.
 Staff for analyzing results. Consider additional workload for data collection and
analysis.
 Forms and communication system for reporting results back to program
supervisors, test sites and technicians. All forms should be unified throughout the
country.
 Process for corrective action and retraining if necessary.
 Adequate funds to support retraining efforts.
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EQA Planning and Organizing Module
2. Blinded Rechecking
 Adequate number of laboratories and staff at intermediate and national levels
capable of rechecking slides (1st and 2nd controllers respectively). Consider
additional workload. When planning blinded rechecking the workload of
controllers is crucial for the success of the program; additional workload should
be distributed evenly and be appropriate. If the main intermediate laboratories are
already overloaded, consider using high performing and accessible peripheral
laboratories that can accommodate the additional work.
 Functional microscopes at national, intermediate and peripheral laboratories.
 National guidelines for the entire blinded rechecking process, including data
analysis and resolving discrepancies.
 Infrastructure to support collection of slides including:
o Properly trained staff to perform problem-solving supervisory visits
o Sufficient stock of slides and availability of slide boxes (usually 100-slide
capacity boxes) for storage of all slides at peripheral sites as defined by the
program.
o Mechanism and funds to deliver slide samples to a higher level laboratory
for rechecking, availability of slide boxes to store discordant slides.
o Forms and communication system for reporting results of rechecking back
to program supervisors, test sites and technicians. All recording and
reporting (R&R) forms should be unified throughout the country.
 Process for corrective action and retraining if necessary.
 Adequate capacity to support corrective actions including funds and personnel to
retrain supervisors and technicians as needed.
3. On-Site Supervision
 NRL staff to perform on-site supervision visits for intermediate and peripheral
laboratories annually. Consider availability of transportation.
 Intermediate level laboratory staff to perform on-site supervision visits to
peripheral laboratories annually, or more frequently if needed: upon identification
of very poor performance based on results of panel testing or blinded rechecking.
Consider availability of transportation.
 Properly trained TB supervisors capable of assessing basic operations in
peripheral AFB smear microscopy laboratories quarterly.
 Appropriate checklists to assess performance and operational conditions in
laboratories.
 Mechanism for implementing corrective action, including retraining if needed.
 System to provide on-site supervision results to the peripheral laboratory and back
to the NTP or NRL on a timely basis.
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EQA Planning and Organizing Module
STEP-WISE APPROACH FOR IMPLEMENTING EXTERNAL QUALITY
ASSESSMENT
In order to be effective, the laboratory EQA system should be introduced using a gradual,
stepwise process and only after considerable planning and critical assessment of current
strengths and weaknesses. External quality assessment of TB laboratory services will be
unachievable and unsustainable without a national policy on the development of
tuberculosis laboratory services as part of the TB control strategy. This policy should
support capacity building to strengthen competency and commitment at the national
reference laboratory, and the establishment of a structured laboratory network closely
integrated with the national tuberculosis program. In countries where tuberculosis is
diagnosed in the private sector, every effort should be made to collaborate with these
laboratories to ensure high standards for diagnosis at all levels. Of course all of this is
dependent on allocating adequate resources.
In order to successfully implement EQA, it may be reasonable to start by selecting a pilot
region and establishing good communication strategy with relevant authorities in the
region. EQA activities require a lot of resources, so it will always be necessary to
advocate for support of good laboratory performance and reliable laboratory data. All
EQA data should be collected, monitored and analyzed with the intention of using them
to illustrate the added value of quality lab services to health outcomes. Programs should
develop mechanisms for implementing appropriate corrective measure and always
consider EQA activities as being tools for continuous education and quality
improvement.
A systematic approach to developing and implementing EQA in a country or region
should include the following recommended steps (please refer to the summary table
below):
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EQA Planning and Organizing Module
Step
1. Make a chart of the laboratory
network, showing relationships
and functions at different levels.
Compile a comprehensive list of
all peripheral sites.
2. Conduct detailed inventory of
available resources (actual and
projected), including staffing,
microscopes, supplies (slides and
slide boxes), and the budget.
Key issues
 The network should be supervised by a
central laboratory (or NRL).
 A laboratory network integrated with the
NTP is the ultimate goal for effective
tuberculosis control.
 Laboratories at intermediate levels
should support peripheral level.
 Laboratories at intermediate levels must
always have updated information about
all peripheral sites they supervise.
 It is critical to know the number of
laboratory personnel at all levels.
 Technicians should have received
appropriate training to perform AFB
microscopy.
 Each laboratory must have an
appropriate (x1000 magnification)
properly functioning microscope.
 There must be an efficient system for
ordering and delivering supplies.
 The laboratory environments should be
suitable for tuberculosis microscopy.
 There should be effective
communication between laboratories and
the NTP.
 Laboratories should have appropriate
administrative support (staff, forms,
registers, computer systems).
 There should be adequate financial
resources for laboratory services.
Comments
 Where a formal network is not yet
established, as an interim measure, a
provincial or regional laboratory may
support EQA in local peripheral
laboratories.
 If laboratories are not integrated with the
NTP, another agency or organization
(e.g., non-governmental organization
NGO) may take responsibility for EQA.


Efforts should be directed at establishing
a minimally acceptable level of
microscopy service, including adequate
numbers of properly trained technicians,
replacement of bad microscopes, routine
attention to minor repairs of laboratory
equipment including microscopes,
adequate supplies, mechanisms for
communication, and program
supervision.
Current and potential financial resources
from both government and NGO sources
should be assessed.
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EQA Planning and Organizing Module
Step
3. Collect data on laboratory
workload including data on
positivity rates, and assess
adequacy of relevant resources.
Key issues
 It is critical to know:
o the annual volume of smear
examinations in each microscopy
unit,
o the average and range of slide
positivity rates,
o whether there are both high volume
and very low volume peripheral
laboratories.
Comments
 Minimum volume of testing at peripheral
sites should be sufficient to maintain
proficiency in smear microscopy, but not
so burdensome as to compromise
quality.
 Recommended volume per technician is
at least 10-15 smears/week, and no more
than 20 smears/day.
 Laboratories processing <500 slides per
year may not be able to maintain
proficiency.
4. Evaluate status and effectiveness
of any current EQA activities.
Assess reasons for current
problems and limitations.



It is critical to understand:
o the current EQA activities,
o the results, strengths and
weaknesses of existing activities,
o any efforts that have been made to
improve performance (details of
corrective actions should be
documented).
TB supervisors should be trained to
evaluate basic functions of a microscopy
laboratory.

Even sub-optimal EQA activities may
provide data on the current level of
performance, helping to define the need
for expanded activities with mechanisms
for improvement.
Data from TB supervisors may help
identify critical problems, including nonfunctional microscopes and inadequate
supplies. Results of EQA should be
documented and forwarded to NTP/
NRL and/or intermediate level
supervisor.
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EQA Planning and Organizing Module
Step
5. Plan specific steps for
establishing or improving EQA
methods, including timetable for
establishing minimal,
intermediate and optimal level
activities.
Key issues
 Define realistic short term and long term
options for implementing or expanding
EQA.
 Define methods that fit best with the
available resources.
 Collaborate with the important partners
to include them in the implementation
and improvement process.
 List each action step by its priority.
 Make a timetable for implementing each
action step.
6. Define and obtain necessary
resources.

It is critical to know:
o if additional resources are available,
o potential sources for obtaining
additional staff, equipment,
microscopes, and supplemental funds,
o timetable for obtaining new resources,
o what data is required to justify the
need for additional resources.
Comments
 Consider the current level of
performance, if known, as well as any
EQA activities currently in place.
 In the initial stages of establishing EQA
activities, very little information about
performance will be known. Test panels
may be the most efficient method to
assess performance status. However,
frequently repeating test panels may add
little information.
 Establishing a comprehensive
countrywide rechecking program may
take several years; therefore annual
panel testing may be needed as an
interim step.
 In some areas with low incidence of
tuberculosis or very few microscopy
problems, a labor-intensive rechecking
program may not be justified to detect
only a few errors. Routine panel testing
may be more cost effective.
 Planning should attempt to minimize the
gap between available and required
resources.
 Long term planning may be necessary to
obtain adequate resources to fully
implement EQA at the optimal level.
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EQA Planning and Organizing Module
Step
7. Pilot test, document results.
Key issues
Comments
8. Evaluate and modify plan based
on results of the pilot test.

Analyze implementation problems that
were discovered during the pilot test.
Suggest possible solutions for the
problems prior to expanding EQA.
Particular attention should be given to
feasibility of workload, and to issues of
validity of the controls.
Analyze the types of identified
performance problems.
Suggest corrective actions, if possible.
Check resources available to implement
corrective action to improve
performance.
Estimate additional resources needed to
expand EQA activities.

Has corrective action resulted in
improved performance?


9. Expand EQA based on results of
pilot tests and resource
availability.




10. Assess impact.
11. Modify or expand the plan as
needed.

Planning may include intermediate steps,
such as:
 limited panel testing;
 countrywide or selective panel
testing, followed by gradual
implementation of rechecking;
 gradual implementation and
expansion of rechecking after pilot,
without any panel testing.
Improvement over time indicates that
EQA methods are feasible and effective.
Availability of resources at central and
intermediate levels will determine the speed
at which EQA can be implemented or
expanded.
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EQA Planning and Organizing Module
DOCUMENTATION
No program can be effective without regular collection, processing and analysis of data to
support ongoing evidence-based decision making. Therefore, relevant guidelines, as well
as forms for recording and reporting that suit the local situation, must be available. Once
prepared and piloted, the checklists, data sheets and other EQA related documentation
will ensure that EQA activities are implemented in a standardized and effective manner.
The NTP and NRL must take a leading role in preparing documentation, and training
personnel. The following guidelines, documentation, and recording and reporting forms
are recommended:
- General:
o Guidelines for quality control in laboratories
o AFB laboratory performance and stock of consumables quarterly report
for each laboratory
o AFB laboratory performance aggregate results of multiple laboratories quarterly/annual report
- Panel Testing:
o Guidelines for manufacturing panel sets of smears
o Guidelines for conducting panel testing rounds
o Pre-validation log for AFB panel testing slide batches
o Logbook/accompanying list for test slide sets
o Panel testing individual results recording and feedback form
o Post-validation logbook/aggregated results for test slide sets
o Panel testing report of multiple laboratories for district supervisor & NTP
- Blinded Rechecking related documentation:
o Blinded rechecking comprehensive guidelines per laboratory level
o Blinded rechecking individual laboratory results form
o List of discordants form
o Blinded rechecking aggregate results quarterly/annually report form
- On-site supervision related documentation:
o Guidelines for on-site supervision
o Check-list for supervisory visits (short version, for district supervisors)
o Check-list for supervisory visits (comprehensive version, for laboratory
supervisors)
The documents and forms listed should eventually be included into the laboratory quality
manual. Versions of EQA-related recording and reporting forms provided in the EQA
Workshop in a Box can be used as templates for designing country specific
documentation.
TRAINING OF PERSONNEL
Once the NTP decides to implement EQA activities in a particular region, it is essential
that all personnel involved receive appropriate information and training. Every possible
effort should be made to maintain effective communication among different laboratory
organizational levels, and NTP managers. EQA will not be effective unless all involved
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EQA Planning and Organizing Module
personnel have a clear understanding of EQA principles and practices. All involved
personnel should also be aware of their individual roles and responsibilities in the
planned activities. To help formalize this, job descriptions (formal scope of work) can be
developed for personnel involved in implementing EQA activities at different
organizational levels. EQA coordinators at the national and higher intermediate levels
should receive comprehensive training in laboratory external quality assessment with
emphasis on EQA planning, technical and implementation issues. EQA coordinators and
re-checkers at lower levels must be familiar with sputum smear microscopy techniques as
well as all technical and implementation issues relevant to their respective roles. For
these purposes NTP managers should consider using the materials in the EQA Workshop
in a Box to develop a customized workshop in their country that reflects local
requirements.
Key messages:
-
EQA implementation requires strengthening the microscopy network which
usually consists of three levels: national, intermediate and peripheral.
-
In order to be effective, the laboratory EQA scheme should be introduced in a
gradual, stepwise process and only after considerable planning and critical
assessment of the strengths and weaknesses of the current situation.
-
Once the NTP decides to implement EQA activities in a particular region, it is
essential that all involved personnel receive appropriate information and training.
All documentation should be standardized.
-
All EQA data should be collected, monitored and analyzed with the intention of
using them to illustrate the added value of quality lab services to health outcomes.
11