Module 10: Understanding Laboratory Data

1. Module 10: Understanding Laboratory Data *Image courtesy of: World Lung Foundation

2. Learning Objectives • Describe how to monitor lab services - Proper reporting and recording • How to analyze data for - quality - effectiveness

3. Monitoring Laboratory Services

4. How do I work in the laboratory? • Communication between the laboratory and the clinic is the most important issue to look at • You can also collect some basic indicators on overall lab performance

5. What you probably can’t do • You won’t be able to assess the quality of smears / microscopy • Lab experts need to advise on safety protocols and correct use of equipment

6. These are the tools at your disposal

7. Benefit for BNTP • Measure key indicators related to quality of diagnosis • Accurate • Verifiable • Timely • Identify problems in implementing TB control activities (e.g., laboratory reporting delays) • Improve lab / program linkages and accountability • Influence laboratory practice

8. Cross-Checking for Quality Sputum Dispatch Register Facility TB Register Lab Register

9. Key Elements for Quality • Quality begins with DATA • Proper registration of • Suspects • Specimens • Results • Three Key Tools • Suspect and Sputum Dispatch Register (SSD) • Laboratory Register • TB Facility Register (for confirmed cases)

10. Lab Procedure for TB Microscopy 1. Patient details recorded (specimen container and request form) 2. Forms and container assigned lab reference number 3. Details entered in Laboratory Register. 4. Specimen quality checked and recorded 5. Smear prepared. 6. Specimen stained, examined 7. Results reported back to facility.

11. 3. Suspects are confirmed as cases or not 4. Results sent back to clinic • Suspects are registered • Specimens sent to Lab SSDRegister SSDRegister TB Register LabRegister 5. Lab results are recorded in SSD for each suspect 6. Confirmed CASES are registered in Facility TB Register Proper Registration is a 6-Part Process

12. Register Cross-checks • What is cross-checking? • Why is it important? • Who should do it? • How is it done? 

13. What are Cross-checks? Cross-checking is a simple task used to reveal many basic workflow and communications problems between the program and the laboratory. It should be done regularly, and in conjunction with laboratory staff.

14. SSDRegister FacilityRegister LabRegister Cross-checking involves theSSD Register/ TB Register and the Lab Register

15. SSD Register LabRegister • Check the lab register to see that all suspects from the SSD and their respective specimens are recorded.

16. SSD Register LabRegister 2. Check the SSD to be sure there are recorded results for every suspect

17. TB Register SSD Register 3. Next compare the SSD with the TB Register. Be sure that each confirmed smear-positive case is registered and has their smear-results recorded in the Facility Register.

18. SSDRegister LabRegister If you find a case in the Lab register which is NOT in the SSD register, then a case has been missed. ??

19. TBRegister LabRegister In these situations the case needs to be entered and treatment commenced ASAP. Similarly, if you find a sputum smear-positive case in the Lab register and SSD which is NOT in the Facility Register, then a case has been missed. ??

20. SSD Register LabRegister Conversely, if there are no data for a Suspect in the Lab Register, this means the specimens were not received or processed. Time to investigate!! ?? ?? In these situations, new specimens need to be submitted and inquiries made regarding specimen transport and receiving procedures.

21. Exercises • Divide into pairs. Using the handout conduct a lab and patient register cross-check DISCUSSION • What problems did you find? • What are the underlying issues? • How would you deal with them?

22. Communicating about Lab Issues The Laboratory Manager The District Coordinator

23. The Lab and the District Coordinator • Talking to the laboratory manager can be interesting. • Listen carefully and identify issues for follow-up. • A good tip: Make sure that you speak with the Lab Manager and Clinic Matrons separately, at least once per M&E Visit – even if it is just an informal conversation. 

24. Key Questions to Report on • Are there recording and reporting issues? • Are TB patients being lost? • Are AFB results received from the lab within 24 hours of specimen collection? • Are all TB smear and culture results reported by laboratories? • Is the lab receiving a good quality specimen that is well labeled?

25. What are we trying to achieve? Through communication we can:  Test level of knowledge  Gauge attitude and morale Seek guidance on priority areas 

26. Exercise - 20 mins • Divide into pairs. Using the handout as a guide, act out a typical discussion between a District TB Coordinator and a Lab Manager. The person doing the monitoring should take notes. After a 5 minute discussion, discuss findings. • Now start again, this time with your NTP Supervisor. Again, discuss your findings.

27. Analyzing Quality of Diagnosis - Advanced Positivity rate amongst TB suspects Positivity rate amongst follow-up examinations Proportion of low-positive suspects Consistency within series of smears from TB suspects

28. Evaluating a Laboratory Register ACKNOWLEDGEMENT: Mycobacterium Reference Laboratory Infectious Diseases Laboratories South Australia

29. Introduction • The Laboratory Register provides a wealth of information • should be reviewed regularly • is an internal Quality Control activity • findings are directly relevant to program management • Provides a simple, easy & rapid method of summarising the work conducted in a laboratory

30. Positivity Rate Among TB Suspects • Calculated by counting all examinations for TB suspects according to their results • numerator: total up all smear positive results • denominator: total up all positives plus negatives • Expressed as a %

31. Positivity Rate Among TB Suspects • Interpretation • varies considerably between countries • Expect 5-20% where TB is prevalent • >20% positivity rate • delayed patient presentation • delayed diagnosis • <5% positivity rate • over selection of TB suspects • large numbers of false-negative laboratory results

32. Positivity Rate Among Follow-up Patients • Calculated by counting all examinations for follow-up cases according to their results • numerator: total up all smear-positive results • denominator: total up all positives plus negatives • Expressed as a %

33. Positivity Rate Among Follow-up Patients • Expected Value: ~10% • Result dependent upon timing of follow-up sputums; if more at 2 months, then higher, but lower if collected late in treatment • A total absence of smear-positives for follow-up is impossible • <5% • poor staining or poor microscopy • poor quality specimens • misconduct

34. Proportion of “low positives” among AFB-positive TB suspects • Calculated by determining the proportion of smear positive specimens with a Scanty or 1+ result • numerator: total up all scanty + and 1+ results • denominator: total up all positives plus • Expressed as a %

35. Proportion of “low positives” among AFB-positive TB suspects • Expected Value ~ 40% • Lower result: • good quality staining but poor microscopy (detection requires time and high quality work) • Higher result • poor quality staining (fewer 3+) • poor quality microscope • contamination of CF with environmental mycobacteria

36. Concluding Comments • Evaluating a Laboratory Register in this way is a very useful tool contributing to Internal Quality Control of the laboratory • May be done monthly or quarterly • May be graphed to display long term trends in performance