Module

OVERVIEW OF EXTERNAL
QUALITY ASSESSMENT

Content Overview

What is EQA?
EQA for AFB Smear Microscopy
Panel testing
Blinded rechecking
On-site evaluation

Advantages and disadvantages of EQA

methods
Identification of the most feasible EQA
method for a country

External Quality Assessment (EQA)

A system for objectively checking the

laboratorys performance using an external

agency or facility
Ensures customers (physicians, patients and
health authorities) that the laboratory can
produce reliable results
An indispensable part of a laboratory quality
management system
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The Quality System

Quality System
Essentials (QSE)
Set of coordinated
activities that function
as building blocks for
quality management

EXTERNAL
EXTERNAL
QUALITY
QUALITY
ASSESSMENT
ASSESSMENT

ISO 15189:2007
Requirements Regarding EQA

The laboratory should participate in

interlaboratory comparisons such as those

organized by EQA schemes

The lab management shall monitor the results

of EQA and participate in the implementation
of corrective actions

EQA Benefits

Allows inter-lab comparison of performance

Serves as an early warning system
Identifies systematic problems
Provides objective evidence of laboratory quality
Serves as an indicator for focusing improvement
efforts
Identifies training needs
Source of continuing education
Source of material for practice
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EQA for AFB Smear Microscopy

Consensus document:
External Quality Assessment
for AFB Smear Microscopy
(2002)

EQA Methods
for AFB Smear Microscopy
External Quality
Assessment (EQA)
a process to assess
laboratory performance;
allows to assess labs
capabilities and
performances by
comparing their results
with those obtained in
other labs in the network

Panel testing

Blinded rechecking

On-site supervision

Panel Testing Process

NRL sends out sets of stained and/or

unstained sputum smears for testing

Laboratory technicians analyze smears and
return results to NRL
Results are evaluated, scores are sent to
participants
Appropriate corrective actions are undertaken
(and documented), if needed
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National reference laboratory

A POSSIBLE SCHEME OF A
PANEL TESTING ROUND
Intermediate laboratory

Peripheral laboratories

Peripheral laboratories

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Blinded Rechecking

Random sampling of routine slides from a peripheral

laboratory for rechecking by a higher-level laboratory

The widely used system for rechecking of 10% of negative

and 100% of positive smear is no more recommended

The proposed blinded rechecking method is based on the Lot

Quality Assurance System (LQAS)

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A Proposed Scheme of Organizing Blinded

Rechecking for AFB Smear Microscopy
National reference laboratory
Intermediate laboratory
Discordant slides

SECOND CONTROLLER
FIRST CONTROLLER
Routine slides: random
sampling
Routine slides:
random sampling

Routine slides: random

sampling

Peripheral laboratories

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On-Site Supervision

Periodic visits to the laboratory to assess laboratory

practices to:
Obtain a realistic picture of laboratory practices
Provide assistance with problem areas, including training

Laboratory vs. TB supervisors

When planning site visits, to consider:
Frequency
Use of checklists
Follow-up visits
Monitoring corrective actions
Training

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EQA methods: Which one is better?

Advantages and drawbacks for all types

Influencing factors:
NTP goals set up for laboratory services
development
TB prevalence in the country
Centralization / decentralization of health
services
Resources available and projected
Cost, time
Logistical questions
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Panel Testing
ADVANTAGES

Low workload for a peripheral

center
Improves laboratory credibility
Rapid response countrywide
possible
Use of stained and unstained
smears can help to identify the
source of a problem
May lead to identification of faulty
equipment

DISADVANTAGES:

Does not measure routine

performance
High workload for NRL
May not be motivating to
improve daily performance

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Panel Testing: Indications for Use

Minimal first step for EQA with limited

resources
Rapid assessment of gross deficiencies
Evaluates proficiency of laboratory
technicians prior to and following training
A tool during problem-oriented supervision

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Blinded Rechecking
ADVANTAGES

Low workload for a peripheral

laboratory
Motivates to improve daily
performance
Reflects reality of routine
performance

DISADVANTAGES:

Higher workload for a higher

level center
Needs close adherence to
elaborated procedures
Can not be used with very
low positivity rates

Indications for use:

The best method for evaluating lab performance
Countrywide
Ongoing and permanent

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On-Site Supervision
ADVANTAGES

Direct personal contact

Motivating to staff
Observation of actual work
Identifies causes of errors
Permits verification of equipment

DISADVANTAGES:

Usually poor coverage

Labor intensive
Costly
Needs very good
supervisors

quality and function

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On-Site Supervision: Indications for Use

Complementary to rechecking and panel

testing for constructive feedback and problem

solving
Implementation and monitoring of quality
improvement measures
Data collection and flow of information among
laboratory levels

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EQA: Important Issue

Blinded rechecking or panel
testing should be complemented
by very targeted problemoriented supervision conducted
by a trained staff
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Situational Analysis:
How to Identify the Most Feasible EQA
method(s) For a Country? (I)
COUNTRY A:
Populous; vast territory
High burden of TB
Several hundreds of geographically dispersed
peripheral laboratories
Intermediate laboratories infrastructure is not well
developed; many intermediate labs experience lack
of staff
NRL is well equipped and staffed

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Situational Analysis:
How to Identify the Most Feasible EQA
method(s) For a Country? (II)
COUNTRY B:

Less populated (compared to Country A); compact territory

High burden of TB
Smear microscopy laboratory network: one microscopy
center for 100 000 population
High to medium positivity rates
Well developed structure of intermediate laboratories,
supervised by NRL
Lack / rotation of staff is a typical problem for many
laboratories
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Situational Analysis:
How to Identify the Most Feasible EQA
method(s) For a Country? (III)
COUNTRY C:

Populous country
Low burden of TB
Only few laboratories dealing with sputum smear
microscopy
Low volume sputum smear examinations; very low
positivity rates
AFB smear-positive specimens are rechecked at NRL
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Key Messages (I):

EQA can be defined as a system for objectively

checking the laboratorys performance using an
external agency or facility

EQA for AFB smear microscopy allows participating

laboratories to access their capabilities and
performances by comparing their results with those in
other laboratories in the network

EQA for AFB sputum smear microscopy include three

methods:
Panel testing
Blinded rechecking
On-site supervision

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Key Messages (II):

Effective use of each of EQA methods will

highly depend on resources, NTP goals, TB

prevalence, health services structure and the
stage of laboratory quality assurance activities
development in the country

Blinded rechecking or panel testing should be

complemented by very targeted problemoriented supervision conducted by a trained
staff

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