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Module 10: Understanding Laboratory Data. *Image courtesy of: World Lung Foundation. Learning Objectives. Describe how to monitor lab services - Proper reporting and recording How to analyze data for - quality - effectiveness. Monitoring Laboratory Services. - PowerPoint PPT Presentation
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Module 10: Understanding Laboratory Data
*Image courtesy of: World Lung Foundation
• Describe how to monitor lab services - Proper reporting and recording
• How to analyze data for - quality- effectiveness
Learning Objectives
Monitoring Laboratory Services
How do I work in the laboratory?
1. Communication between the laboratory and the clinic is the most important issue to look at
2. You can also collect some basic indicators on overall lab performance
What you probably can’t do
1. You won’t be able to assess the quality of smears / microscopy
2. Lab experts need to advise on safety protocols and correct use of equipment
These are the tools at your disposal
Talk Observe Analyse
Attitudes Actions ConsistencyUnderstanding Processes Accuracy
Morale Conditions Effectiveness
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
Benefit for BNTP
Sputum Dispatch Register Facility TB Register Lab Register
Cross-Checking for Quality
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)
Lab Procedure for TB Microscopy1. Patient details recorded (specimen container and request form)2. Forms and container assigned lab reference number3. Details entered in Laboratory Register.4. Specimen quality checked and recorded5. Smear prepared.6. Specimen stained, examined7. Results reported back to facility.
Proper Registration is a 6-Part Process
SSDRegister
1. Suspects are registered
2. Specimens sent to Lab
LabRegister
3. Suspects are confirmed as cases or not
4. Results sent back to clinic
SSDRegister
5. Lab results are recorded in SSD for each suspect TB
Register
6. Confirmed CASES are registered in Facility TB Register
Register Cross-checks
• What is cross-checking?• Why is it important?• Who should do it?• How is it done?
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.
Cross-checking involves theSSD Register/ TB Register and the Lab Register
SSDRegister
LabRegister
FacilityRegister
Pt One Specimen
Pt Two SpecimenPt Two Specimen
Pt Two Specimen
Pt Three Specimen
1.Check the lab register to see that all suspects from the SSD and their respective specimens are recorded.
SSDRegister
LabRegister
1. Patient One
2. Patient Two
3. Patient Three
1. Sputum Smear Positive
2. Sputum Smear Negative2. Sputum Smear Negative
2. Sputum Smear Negative
3. Sputum Smear Positive
2. Check the SSD to be sure there are recorded results for every suspect
SSDRegister
LabRegister
Pt 1. Sputum Smear Positive
Pt 2. Sputum Smear Negative
Pt 3. Sputum Smear Positive
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.
TBRegister
SSDRegister
1. Sputum Smear Positive
Pt 2. Ruled out- Not Registered
3. Sputum Smear Positive
1. Sputum Smear Positive
2. Sputum Smear Negative
3. Sputum Smear Positive
Sputum Smear PositiveSputum Smear Positive
If you find a case in the Lab register which is NOT in the SSD register, then a case has been missed.
SSDRegister
LabRegister
Sputum Smear PositiveNegativeNegativeSputum Smear PositiveSputum Smear Positive??
Sputum Smear PositiveSputum Smear Positive
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.
TBRegister
LabRegister
Sputum Smear PositiveNegativeNegativeSputum Smear PositiveSputum Smear Positive??
In these situations the case needs to be entered and treatment commenced ASAP.
Pt. 1 Sputum SS+
SSDRegister
LabRegister
Patient 1Patient 2Patient 2Patient 3Patient 3
??
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.
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?
Communicating about Lab Issues The Laboratory Manager The District Coordinator
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.
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?
What are we trying to achieve?
Through communication we can:Test level of knowledge
Gauge attitude and morale
Seek guidance on priority areas
Exercise - 20 mins
1. 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.
2. Now start again, this time with your NTP Supervisor. Again, discuss your findings.
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
Evaluating a Laboratory Register
ACKNOWLEDGEMENT:Mycobacterium Reference
LaboratoryInfectious Diseases Laboratories
South Australia
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
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 %
Positive (and Scanty)
Negatives and Positive (and Scanty )
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
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 %
Scanty and PositiveNegatives and Scanty and Positive
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
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 %
Scanty and 1+Scanty and all Positive
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
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