1. 1 Module PLANNING AND ORGANIZING EXTERNAL QUALITY ASSESSMENT

2. 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. 3 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

4. 4 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

5. 5 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

6. 6 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

7. 7 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

8. 8 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.

9. 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. 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. 11 Critical Resources for EQA Implementation / Expansion Blinded rechecking Adequate number of rechecking laboratories Sufficient number of staff 1 st and 2 nd 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. 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. 13 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

14. 14 Process for EQA Planning and Implementation 1. 1.Make a chart of the laboratory network 2. 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)

15. 15 3. 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. 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.)

16. 16 5. 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. 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.)

17. 17 7. 7.Pilot test, document results 8. 8.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 9. 9.Expand EQA based on results of pilot tests and resources availability 10. 10.Assess impact 11. 11.Modify or expand plan as needed Process for EQA Planning and Implementation (cont.)

18. 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. 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. 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. 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. 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. 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. 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