Laboratories And EQA for effective Tuberculosis Control Programe

Gokarna Raj GhimireSenior Medical TechnologistNational Tuberculosis Center

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Introduction• The global burden of TB is high• Untreated smear positive cases are highly

infectious• Nepal has steady case finding rate (75%)• Treatment success rate (90 %)• Slide positivity rate still on average 10 % • DO NOT miss diagnosis• DO CORRECT TREATMENT FULL DOSE FULL PERIOD

OF TIMR2

• Laboratories and lab networks are a fundamental component of NTP.

• It provides testing for diagnosis, treatment monitoring, evaluating the success of treatment and surviellance.

• Laboratory should do:– New Initiatives– Strengthen the lab capacity including HR– Implement rapid and new diagnostic tests– Implement quality system and safety system

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• Strength of lab network reflects the success of NTP

• Good quality microscopic centers (ZN technique)• Fluorescence Microscopy (Auramine techniques)• Culture and DST (Solid and Liquid)• Molecular techniques, (Gene Xpert, LPA)• Trained staff• Good Quality management System

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Microscopy

• Microscopy remains mainstay of rapid, cheap, easy method of TB case detection

• ZN smear is still the most common test.• Low sensitivity, so look for advanced method • FM has high sensitivity• Concentrated technique with FM has more higher

sensitivity• Monocular microscope-binocular-fluoresence

microscope5

Container

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Culture and DST• Confirmed diagnostic test• Need high quality lab infrastructure, equipments and

HR• Useful diagnostic tools for EP cases, childhood TB

cases, HIV-TB cases, MDR-TB Cases, XDR-TB cases• FLD/SLD DST • Facilities are available at NRL/NTC and GENETUP• Purposed places: BPKIHS Dharan, RTC Pokhara, Mid

west Surkhet7

Mycobacterial Colonies on Egg based Culture Medium (LJ medium)

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Nucleic Acid Amplification tests

• Gene Xpert : Fully Automated, Cartridge based, Real Time, Nucleic Acid Amplification Test (NAAT)

• LPA: Manual PCR, Detection by Hybridization strip,

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Specimen Transportation

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EXTERNAL QUALITY ASSESSMENT (EQA) IN NEPAL FOR SPUTUM MICROSCOPY

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External Quality Assessment (EQA)

• A system for objectively checking the laboratory’s performance using an external agency or higher authority

• 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

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EXTERNAL QUALITY

ASSESSMENT

EXTERNAL QUALITY

ASSESSMENT

Quality System Essentials (QSE)

Set of coordinated activities that function as building blocks for quality management

Quality System Essentials (QSE)

Set of coordinated activities that function as building blocks for quality management

Requirements Regarding EQA

• The laboratory should participate in inter-laboratory comparisons such as those organized by EQA schemes ( Total 554 Microscopy centers are exists in Governmental organization and NGO/INGO/Private institution)

• The lab management shall monitor the results of EQA and participate in the implementation of corrective actions

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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

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

Current EQA Structure

National

Regional

District

Local PMC PMC PMC PMC PMC

DTLO DTLO

QCA at Regional Quality Control

Centre

= Slides = Feedback

QCA at National Quality Control Centre (NTC)

If 100% slides correct

If some slides incorrect

Problem slides

DTLO holds meeting to discuss results with PMCs

Structure of Quality Control System

National TB Centre

EDRGoN/BNMT

CDRNTC WDR

RTCMWDR

GoN

FWDRGoN/FAITH

Central level

DPHO/DHO District level

Regional level

Microscopy CentrePeriphery level

Flow of Quality Control System

On Quarterly Basis

1. Keep all Slides

Microscopy Centre

3. Cross Check Assessment (QC 2)

Regional QualityControl Centre

2. Send Collected Smear Slides With Form (QC 1)Selecting by using LQAS

5. Supervision Refresher Training

RTLO

DTLO

Report Feed-Back(QC 3)

EQA Methods for AFB Smear Microscopy

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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

On-site supervision

Panel testing

Blinded rechecking

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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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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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

ADVANTAGESADVANTAGES DISADVANTAGES:DISADVANTAGES:

•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

•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

ADVANTAGESADVANTAGES DISADVANTAGES:DISADVANTAGES:•Low workload for a peripheral laboratory

•Motivates to improve daily performance

•Reflects reality of routine performance

•Higher workload for a higher level center

•Needs close adherence to elaborated procedures

•Can not be used with very low positivity rates

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Indications for use:

• The best method for evaluating lab performance

• Countrywide

• Ongoing and permanent

On-Site Supervision

ADVANTAGESADVANTAGES DISADVANTAGES:DISADVANTAGES:

•Direct personal contact

•Motivating to staff

•Observation of actual work

•Identifies causes of errors

•Permits verification of equipment quality and function

•Usually poor coverage

•Labor intensive

•Costly

•Needs very good supervisors

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On-Site Supervision: Indications for Use

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• 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

EQA: Important Issue

Blinded rechecking or panel testing should be complemented by very targeted problem-oriented supervision conducted by a trained staff

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Situational Analysis Of EQA Nepal

• Medium Size Population; • Vast different territory• Low Burden of TB • Several hundreds of geographically dispersed peripheral

laboratories• RQCC’s (Intermediate laboratories’) infrastructure is not

well developed; many intermediate labs experience lack of staff

• NRL/NTC is not well equipped and sufficient staffed

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Key Messages (I):• EQA can be defined as a system for objectively checking the

laboratory’s 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 problem-oriented supervision conducted by a trained staff

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Thank You

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