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Module Module

PLANNING AND ORGANIZING PLANNING AND ORGANIZING EXTERNAL QUALITY EXTERNAL QUALITY

ASSESSMENTASSESSMENT

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Content OverviewContent 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

National

Intermediate

Peripheral

1. TB smear microscopy services: accessibility vs. maintenance of acceptable level of technical proficiency:

• Laboratories processing less than 500 slides per year need closer attention to assure proficiency

2. Consideration of network’s density:

• One microscopy center per about 100 000 population

3. Three typical levels of organization

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Peripheral Laboratories

• Perform routine sputum smear microscopy• Follow internal quality control procedures• Store routine smears for blinded rechecking• Participate in panel testing rounds (if and

when appropriate)• Record and report laboratory data

Service area: district

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Intermediate Laboratories

• 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

Service area: province / region

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Intermediate Laboratories (cont.)

• Implementation of EQA practices:• Support of panel testing activities

• Distribution of panel sets• Collection of panel testing results

• Implementation of the blinded rechecking program • 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

Service area: region / province

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Central Laboratory (NRL)

• 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.

Service area: national (regional) scale

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• 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

Service area: national (regional) scale

Central Laboratory (NRL) – cont.

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Critical Resources for EQA Implementation / Expansion

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.)• 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

• Forms and means of communication• Process / funds for corrective actions and retraining, if

necessary

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Critical Resources for EQA Implementation / Expansion

Blinded rechecking• Adequate number of rechecking laboratories • Sufficient number of staff

• 1st and 2nd controllers capable of comfortably absorbing additional workload on slides’ rechecking

• to perform problem-solving supervisory visits

• 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

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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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,

including retraining if needed• Mechanism of feedback

Critical Resources for EQA Implementation / Expansion

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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) • 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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3. Collect data on laboratory workload• Standardized laboratory reporting form• Data on positivity rates!• RECOMMENDED WORKLOAD per technician:

• 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• Collaborate with laboratory and TB supervisors• Document all EQA data

Process for EQA Planning and Implementation (cont.)

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5. Plan specific steps for establishment or improvement of EQA methods

• 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• Timetable for obtaining new resources• Consider terms of delivery of equipment and supplies

Process for EQA Planning and Implementation (cont.)

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7. Pilot test, document results8. Evaluate and modify plan based on results of a pilot

project• Analyze implementation problems and successes• Suggest possible solution of problems prior to expanding

EQA9. Expand EQA based on results of pilot tests and

resources availability10.Assess impact11.Modify or expand plan as needed

Process for EQA Planning and Implementation (cont.)

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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?

• Involve the authorities• Start simply• Start small• Pilot region• Start with a good communication strategy

• 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 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

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

• 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