Module
PLANNING AND ORGANIZING
EXTERNAL QUALITY
ASSESSMENT
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Content Overview
• AFB smear microscopy network
• Checklist for critical resources required
for implementing EQA
• Step-wise approach in implementing
EQA
• Documentation
• Training of personnel
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Effective Microscopy Network
1. TB smear microscopy services: accessibility vs. maintenance of
acceptable level of technical proficiency:
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Laboratories processing less than
500 slides per year need closer attention
to assure proficiency
2. Consideration of network’s density:
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One microscopy center
per about 100 000 population
National
Intermediate
Peripheral
3. Three typical levels of organization
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Peripheral Laboratories
Service area: district
• Perform routine sputum smear microscopy
• Follow internal quality control procedures
• Store routine smears for blinded rechecking
• Participate in panel testing rounds (if and
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when appropriate)
Record and report laboratory data
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Intermediate Laboratories
Service area: province / region
• Conduct routine sputum smear microscopy
• Provide technical support to peripheral level
• Training of laboratory personnel
• Management and maintenance of equipment
• Preparation, distribution of reagents
• Supervision of peripheral laboratories;
laboratory data collection (monthly, quarterly,
annual reports) and analysis
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Intermediate Laboratories (cont.)
Service area: region / province
• Implementation of EQA practices:
• Support of panel testing activities
• Distribution of panel sets
• Collection of panel testing results
• Implementation of the blinded rechecking program
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Determination of sample size,
Collection of slides,
Rechecking of slides by the first controller
Submission of discordant slides to the second controller
to resolve discrepancies
• On-site supervision
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Central Laboratory (NRL)
Service area: national (regional) scale
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Formulates and promotes implementation of national
policies regarding TB laboratory services
Provides technical support for intermediate and
peripheral levels when appropriate
Plans and monitors training of laboratory personnel at
various levels
Conducts training courses for core laboratory personnel
Make recommendations on standard equipment, stains,
consumables etc.
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Central Laboratory (NRL) – cont.
Service area: national (regional) scale
• Plan and implement EQA activities in
collaboration with intermediate level
• Manufacturing of panel sets and conducting panel
testing rounds
• Resolving of discrepancies (the second controller’s
functions) under the blinded rechecking
• Conducting on-site supervision
• Collect and analyze TB laboratory EQA data
• Collaborate with NTP personnel as appropriate
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Critical Resources
for EQA Implementation / Expansion
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Panel testing
Procedures, capability and capacity for preparing PT slide sets:
• consider BIOSAFETY!
NRL staff:
• Additional workload
• for panel sets preparation
• for data collection and analysis
• provision of feedback to participating labs
Equipment:
• NRL: biosafety cabinet, centrifuge, vortex etc.
• All levels: functional microscopes
• NRL and intermediate level: computer, printer, copy machine,
means of communication (telephone + fax+ internet)
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Critical Resources
for EQA Implementation / Expansion
Panel testing (cont.)
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Supplies, reagents and consumables
Mechanisms / funds
• for distribution of panel sets to participating laboratories (mail,
courier, on-site supervision visits)
• for returning slide sets to NRL for review, if necessary
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Forms and means of communication
Process / funds for corrective actions and retraining, if
necessary
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Critical Resources
for EQA Implementation / Expansion
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Blinded rechecking
Adequate number of rechecking laboratories
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Sufficient number of staff
• 1st and 2nd controllers capable of comfortably absorbing
additional workload on slides’ rechecking
• to perform problem-solving supervisory visits
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Functional microscopes, in sufficient quantity, at all
levels:
• microscopes for controllers
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Critical Resources
for EQA Implementation /Expansion
Blinded rechecking (cont.)
• National guidelines for the entire blinded
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rechecking process including data analysis and
resolution of discrepancies
Mechanism / funds to deliver slides to a higher
level laboratory for rechecking
Supplies: slides and slide boxes
Forms and communication system
Process / funds / personnel for corrective action
and retraining if needed
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Critical Resources
for EQA Implementation / Expansion
On-site supervision
• Staff + availability of transportation:
• Laboratory staff:
• perform visits to peripheral labs (annually)
• TB supervisors:
• capable of assessing AFB smear microscopy basic
operations
• Checklists
• Mechanism for implementing corrective actions,
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including retraining if needed
Mechanism of feedback
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Process for EQA Planning and
Implementation
1. Make a chart of the laboratory network
2. Conduct inventory of available resources
(actual and projected)
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Staffing (# lab personnel at all levels)
Essential equipment such as microscopes
Essential supplies such as slide boxes
Budget (current and potential financial resources
from both government and other partners)
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Process for EQA Planning and
Implementation (cont.)
3. Collect data on laboratory workload
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Standardized laboratory reporting form
Data on positivity rates!
RECOMMENDED WORKLOAD per technician:
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At least 10-15 smears /week
No more than 20 smears / day
4. Evaluate status and effectiveness of any current EQA
activities; assess reasons for current problems and
limitations as well as successes
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Collaborate with laboratory and TB supervisors
Document all EQA data
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Process for EQA Planning and
Implementation (cont.)
5. Plan specific steps for establishment or improvement
of EQA methods
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Define realistic short term and long term options for
implementing or expanding EQA coverage
Define methods that fit best with the available resources
Collaborate with partners
List action steps by their priority
Make a timetable for implementing each action step
6. Define and obtain necessary resources
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Timetable for obtaining new resources
Consider terms of delivery of equipment and supplies
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Process for EQA Planning and
Implementation (cont.)
7. Pilot test, document results
8. Evaluate and modify plan based on results of a pilot
project
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Analyze implementation problems and successes
Suggest possible solution of problems prior to expanding
EQA
9. Expand EQA based on results of pilot tests and
resources availability
10. Assess impact
11. Modify or expand plan as needed
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EQA Gradual Implementation
• EQA implementation may include intermediate
steps, such as:
• Limited panel testing
• Countrywide or selective panel testing, followed by
gradual implementation of rechecking
• Gradual implementation & expansion of
rechecking after a pilot test, without any panel
testing
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How to Start Implementing EQA?
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Involve the authorities
Start simply
Start small
Pilot region
Start with a good communication strategy
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Interest of the programme
Aims and objectives
Confidentiality rules
Acknowledgment
Contacts
Timetable
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Pay Careful Attention to:
• The results
• The commentaries, feedback reports…
• Comments and recommendations from
participating labs
• Best ways of solving problems
• Best ways of recommending certain techniques
• Therefore, perfect is not too much!
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Documentation
• No program is effective without regular
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collecting, processing and analysis of data for
evidence-based decision making
Availability of relevant guidelines,
standardized R&R forms, datasheets,
checklists etc. is of crucial importance
NRL plays a leading role in preparing
documentation and training personnel
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Training
• All personnel involved in implementation of
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EQA activities must receive appropriate
information and training
Clear understanding of EQA principles and
practices
Clear understanding of roles and
responsibilities
Effective communication among different
laboratory organizational levels
Customization workshop
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How to Be Successful
EQA requires resources, so make the best use
of EQA participation:
• Advocate for good lab performance!
• Use data to illustrate the added value to health
outcomes
• Thoroughly monitor EQA results
• Participate in implementing corrective actions
• Consider EQA as
• Continuous education tool
• Quality improvement tool
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Key Messages
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The progress in EQA implementation requires
strengthening of microscopy network
EQA should be introduced in a gradual, stepwise
approach
All personnel involved in EQA activities should be
appropriately trained
All documentation should be standardized
All EQA data should be thoroughly monitored and
analyzed:
• use of data as an illustration of laboratory performance
improved quality and added value to health outcomes
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