1. Laboratories And EQA for effective Tuberculosis Control Programe
Gokarna Raj Ghimire
Senior Medical Technologist
National Tuberculosis Center

2. 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 TIMR

3. 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

4. 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

5. 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 microscope

6. Container 6

7. 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 Surkhet
EQA Overview

8. Mycobacterial Colonies on Egg based Culture Medium (LJ medium)8

9. Nucleic Acid Amplification tests
Gene Xpert : Fully Automated, Cartridge based, Real Time, Nucleic Acid Amplification Test (NAAT)
LPA: Manual PCR, Detection by Hybridization strip,

10. Specimen Transportation10

11. EXTERNAL QUALITY ASSESSMENT (EQA) IN NEPAL FOR SPUTUM MICROSCOPY
EQA Overview

12. 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
EQA Overview

13. EXTERNAL QUALITY ASSESSMENT
The Quality System
Quality System Essentials (QSE)
Set of coordinated activities that function as building blocks for quality management
EXTERNAL QUALITY ASSESSMENT
EXPLAIN that the laboratory operation consists of a complex system, with a whole set of events to begin with the ordering of a test, to the reporting of results back to the provider. And it is very important that all parts of this cycle or all aspects of the system work correctly. Any error in any part of the cycle can produce a poor laboratory result. To be sure that all parts of this laboratory system are working properly, a quality system approach to the laboratory setting is to be applied. In other words, all aspects of the laboratory operation need to be addressed to assure quality; this constitutes a quality system. Guidelines of the Clinical and Laboratory Standards Institute (CLSI) describe a quality management system model that consists of 12 essentials. Quality system essentials are set of coordinated activities that function as building blocks for quality management. According to CLSI quality management system model, external quality assessment forms a part of the Assessment quality system essential and is an indispensable part of a laboratory quality management system.
EQA Overview

14. 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
EXPLAIN that international standards stress the importance of laboratories’ participation in EQA schemes.
International Organization for Standardization has developed the standard named ISO 15189:2007 – Medical laboratories: particular requirements for quality and competence. This is a guideline for implementing quality systems in medical (clinical) laboratories. An independent external quality assessment of laboratory performance by a recognized scheme is the requirement of this standard.
NTP should establish a functioning mechanism to monitor the results of external quality assessment, to review and investigate discordant findings as to root causes and to provide with corrective and preventive actions, when necessary, based on results of investigations. All findings and recommendations for actions should be appropriately documented.
EQA Overview

15. 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
EXPLAIN that participation in EQA schemes is of benefit both for public health programs and individual laboratories:
1. Laboratory oriented objectives of EQA include:
Identification of possible insufficiencies in laboratory practices, and guidance of participants in corrective actions to be used for making these practices better;
Identification of reliability characteristics of methods, materials and equipment in routine-use and suggestion of appropriate corrective actions;
Evaluation and monitoring of training impact; assistance in preparation of future training;
Opportunity for continuous self-education
2. Public health oriented objectives of EQA:
Establishment of bases for results comparability during epidemiological surveillance and disease control;
Collection of information on laboratory measurements (intra- and inter-laboratory) in order to alert professionals and/or governments on results, traceability and harmonisation problems, and establishment of appropriate acceptable limits for results in a given prospective;
Collection of information on operating authorisations or laboratory accreditation.
Further education
Creation of a channel for communication
EQA Overview

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

17. Current EQA Structure If some slides incorrect If 100% slides correct
QCA at National Quality Control Centre (NTC)
National
Problem slides
If some slides incorrect
QCA at Regional Quality Control Centre
If 100% slides correct
Regional
DTLO
DTLO holds meeting to discuss results with PMCs
DTLO
District
PMC
PMC
PMC
PMC
PMC
Local
= Slides
= Feedback

18. Structure of Quality Control System
National TB Centre
Central level
Regional level
WDR
RTC
EDR
GoN/BNMT
CDR
NTC
FWDR
GoN/FAITH
MWDR
GoN
DPHO/DHO
District level
Periphery level
Microscopy Centre

19. Flow of Quality Control System
On Quarterly Basis
2. Send Collected Smear Slides With Form (QC 1)
Selecting by using LQAS
DTLO
1. Keep all Slides
3. Cross Check
Assessment (QC 2)
Report Feed-Back
(QC 3)
Microscopy
Centre
Regional Quality
Control Centre
RTLO
5. Supervision
Refresher Training
EQA Overview

20. 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
On-site supervision
Panel testing
Blinded rechecking
EXPLAIN that EQA for AFB smear microscopy consists of three methods that can and should be combined to evaluate laboratory performance. These methods include panel testing, blinded rechecking and on-site supervision.
EQA Overview

21. 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
EQA Overview

22. 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)
EXPLAIN that the old sampling system “10% of negative and 100% of positive” is not efficient, with over-sampling in some laboratories and under-sampling in others. Lot Quality Assurance System (LQAS) sampling allows the smallest possible but appropriate sample sizes.
STATE that detailed instructions on Lot Quality Assurance System (LQAS) are available in the Blinded Rechecking Module of this Workshop-In-A-Box.
EQA Overview

23. 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
EXPLAIN another EQA method – on-site supervision: it looks at specific testing areas of the laboratory, especially those that have been identified by a bad result to a panel testing or blinded rechecking scheme.
EQA Overview

24. 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
STATE that effective use of each of these methods will highly depend on the availability of resources, goals set up by the NTP, TB prevalence, centralization/decentralization of health services and the stage of laboratory quality assurance activities development in a country.
EQA Overview

25. Panel Testing ADVANTAGES 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

26. 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

27. Blinded Rechecking ADVANTAGES 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
Indications for use:
The best method for evaluating lab performance
Countrywide
Ongoing and permanent

28. On-Site Supervision ADVANTAGES 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
STRESS that on-site supervision is ineffective unless done by a well experienced / educated personnel.
EQA Overview

29. 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

30. EQA: Important Issue
Blinded rechecking or panel testing should be complemented by very targeted problem-oriented supervision conducted by a trained staff
EQA Overview

31. 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
DISCUSS WITH A GROUP what could be an appropriate strategy for EQA activities development in Country A.
Large numbers of decentralized peripheral laboratories and, in particular, poor developed infrastructure of intermediate laboratories make implementation of all EQA methods difficult:
Panel testing will result in high workload for NRL (preparation and distribution of uniform panels, review of results and preparation of feedback reports);
Blinded rechecking is impossible without properly established intermediate laboratory network: it will be difficult to assign the required number of controllers to ensure even distribution of rechecking workload and, consequently, appropriate quality of controllers’ work.
On-site supervision: NRL staff will not be able to visit all peripheral laboratories alone.
Extra thorough consideration and critical assessment of all strengths and weaknesses of the situation should be recommended; data on smear positivity rates should be collected as well.
As it is too difficult to implement the blinded rechecking program, it can be recommended to start with the panel testing program and take every effort to promptly develop intermediate level laboratories for further gradual implementation of the blinded rechecking program.
Information on AFB smear positivity rates will help determine the sampling approach for the blinded rechecking program. In areas with medium positivity rates (around 5%) the stratified sampling would be applicable.
EQA Overview

32. 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

33. 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

34. Thank You