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
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 Consistency

Understanding Processes Accuracy
Morale Conditions Effectiveness
 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
Cross-Checking for Quality

 Sputum Dispatch Register

 Facility TB Register
 Lab Register
 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 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.
 Proper Registration is a 6-Part Process

1. Suspects are 3. Suspects are

registered confirmed as
cases or not
2. Specimens SSD
Lab
Register 4. Results sent
sent to Lab Register
back to clinic

5. Lab results are 6. Confirmed

recorded in CASES are
SSD for each registered in
suspect SSD Facility TB TB
Register Register
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 the
SSD Register/ TB Register and the Lab Register

SSD Lab
Register Register

Facility
Register
 1.Check the lab register to see that all
suspects from the SSD and their
respective specimens are recorded.

1. Patient One Pt One Specimen

Pt Two Specimen
2. Patient Two
Pt Two Specimen
SSD 3. Patient Three
Pt Two Specimen
Lab
Register Register
Pt Three Specimen
 2. Check the SSD to be sure there are
recorded results for every suspect

Pt 1. Sputum Smear Positive 1. Sputum Smear Positive

2. Sputum Smear Negative
Pt 2. Sputum Smear Negative
2. Sputum Smear Negative
SSD Pt 3. Sputum Smear Positive
2. Sputum Smear Negative
Lab
Register Register
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.

1. Sputum Smear Positive 1. Sputum Smear Positive

Pt 2. Ruled out- Not Registered 2. Sputum Smear Negative

TB SSD
Register 3. Sputum Smear Positive
Register
3. Sputum Smear Positive
 If you find a case in the Lab register which is NOT in the SSD
register, then a case has been missed.

Sputum Smear Positive Sputum Smear Positive

Sputum Smear Positive Negative
Negative
SSD Lab
Register Sputum Smear Positive
Register
?? Sputum 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.

Sputum Smear Positive Sputum Smear Positive

Sputum Smear Positive Negative

TB Negative
Lab
Register Sputum Smear Positive
Register
?? Sputum Smear Positive

In these situations the case needs to be entered

and treatment commenced ASAP.
 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!!

Patient 1 Pt. 1 Sputum SS+

Patient 2
Patient 2
SSD ?? Lab
Patient 3
Register Register
Patient 3
??

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 Laboratory
Infectious 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

Positive (and Scanty)

Negatives and Positive (and Scanty )
– Expressed as a %
 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

Scanty and Positive

Negatives and Scanty and Positive
– Expressed as a %
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

Scanty and 1+
Scanty and all Positive

– Expressed as a %
 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