Module PLANNING AND ORGANIZING EXTERNAL QUALITY ASSESSMENT

1. Module PLANNING AND ORGANIZING EXTERNAL QUALITY ASSESSMENT

2. Content Overview • AFB smear microscopy network • Checklist for critical resources required for implementing EQA • Step-wise approach in implementing EQA • Documentation • Training of personnel

3. Effective Microscopy Network • 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 • Consideration of network’s density: • One microscopy center per about 100 000 population • Three typical levels of organization

4. 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 when appropriate) • Record and report laboratory data

5. 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

6. 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 • 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

7. Central Laboratory (NRL) Service area: national (regional) scale • 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.

8. 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

9. 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)

10. 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

11. 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

12. 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

13. 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, including retraining if needed • Mechanism of feedback

14. Process for EQA Planning and Implementation • Make a chart of the laboratory network • 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)

15. Process for EQA Planning and Implementation (cont.) • 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 • 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

16. Process for EQA Planning and Implementation (cont.) • 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 • Define and obtain necessary resources • Timetable for obtaining new resources • Consider terms of delivery of equipment and supplies

17. Process for EQA Planning and Implementation (cont.) • Pilot test, document results • Evaluate and modify plan based on results of a pilot project • Analyze implementation problems and successes • Suggest possible solution of problems prior to expanding EQA • Expand EQA based on results of pilot tests and resources availability • Assess impact • Modify or expand plan as needed

18. 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

19. 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

20. 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!

21. 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

22. 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

23. 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

24. 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