QA, QC and TQM in MTB Diagnosis

1. Total Quality Management
Quality Assurance
and
Quality Control
in Tuberculosis Diagnosis
Mr. Shankar Shahi
Lab Technician (CMLT ,B.Sc. MLT, M.Sc. TQM)
Province public Health Laboratory
Bagmati Province
Mob. 9841467187
Email: shahishankar69@gmail.com

2. Quality:
The degree of excellence, characteristics which act
to satisfy a need
Control:
A person or thing used as a standard of comparison
for checking the results of a survey or experiment.

3. What is Quality Control ???
•Quality Control is the process of ensuring
manufactured product or performed service to
meet the requirements of the client or customer
expectations.

4. Quality Control in Laboratory:
•Quality control in the medical laboratory is a statistical
process used to monitor and evaluate the analytical process
that produces patient results.
•The goal of Quality control is to detect the errors and
minimize them.
•These errors includes all the errors arising from the sample
collection to the dispatched of the report.

5. Why
???

6. Quality is....
• invisible when GOOD
• impossible to ignore
when BAD
6

7. HOW To Maintain QC ???
By Using 5M Method:
 Manpower: Trained, Qualified, Competent
 Machines : Standard, Stable, Technical/user Friendly
 Materials: Stable, Efficient, Desired qt. & Validated
 Methods : Standard, sensitive and specific, validated
 Management: Supportive, Motivate, measurable
Follow PDCA cycle to improve service

8. 8
QualityAssurance
External Quality
Assessment
Internal Quality Control
Pre
analytical
Analytical
Post
analytical

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Internal Quality Control
•IQC should be carried as part of everyday routine work.
•Includes instrument, slides, pencil, marker, forms and
checking new lots of staining solutions
•EQA is a process to assess laboratory performance.
•Allows participating laboratories to assess their capabilities
by comparing their results with those in other laboratories in
the network

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Key Elements of Internal Quality Control
•Laboratory arrangement and Administration
•Laboratory Equipment
•Specimens and Request Form
•Staining Reagents
•Staining and Smear Examination
•Reporting

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Laboratory Arrangement and Administration:
•Perform Sputum microscopy in a secure, dedicated work
space
•Provide appropriate staff training and monitor their
performance
•Methods must comply with NTP guidelines

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Laboratory Equipment
•Maintain all laboratory equipment in a good working condition
•Keep dated service records for all equipment
•Monitor microscopes and balances regularly to ensure
consistent performance

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Specimens and Request forms
•Ensure request forms are completed and specimens correctly
labeled. (register---Container---Form)
•Reject specimens that are incorrectly labeled, leaking, or in
broken containers.
•Record the date specimens arrive in the laboratory.
•Evaluate the quality of sputum specimens.
•Record and monitor the number of salivary specimens received
by the laboratory.

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Staining Reagents:
• Label all reagents with the name, date of preparation, and the date first opened.
• Indicate date received, if staining reagents are prepared in another laboratory .
• Any material found to be unsatisfactory should be recorded as such and removed
from the laboratory immediately so it is not used.
• Limit stocks for six month supply. Rotate stock to ensure that oldest material is
used first.

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Staining and Smear Examination
• Filter carbol fuchsin regularly.
• Include positive and negative controls at least weekly.
• Read control slides before patient smears.
• Record the results of control smears

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Recording and Reporting
• Report microscopy results as soon as specimen is received.
• Record all work performed in standard format into the Laboratory
Register
• Analyze microscopy results on monthly basis to detect changes which
may indicate problems.

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What is External Quality Assessment (EQA)?
•A process to assess laboratory performance.
•EQA allows participating laboratories to assess their
capabilities by comparing their results with those in
other laboratories in the network.

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Why EQA?
•Identifies errors and is used to improve performance across the
laboratory network
•An important tool for communicating with and motivating staff
•Designed to resolve problems and not to punish staff

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EQA: Conducted at All Levels of Testing
NRL: National Lab
IL: Intermediate Lab
PL: Peripheral lab
IL
PL
PL
PL
PL
PL
PL
IL
PL
PL
PL
PL
PL
PL
PL
NRL
PL

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EQA Methods
Panel
Testing
On-site
Evaluation
Blinded
Rechecking

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What is On-site Evaluation?
Periodic site visits to assess laboratory practices
• Learn “where we are?”
• Identifies what is ‘good’ and what areas need
improving
• Collect information for
• Planning & implementation
• Monitoring
• Continuous improvement
Panel
Testing
On-site
Evaluation
Blinded
Rechecking

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Panel
Testing
What is Panel Testing?
Panel testing is conducted to improve and maintain proficiency in
AFB smear examination in all peripheral laboratories that provide
sputum microscopy service.
Panel slide preparation
• Sputum specimen used for panel slide preparation is not more
than 2 days old. Panel slides prepared are of negative and positive
of different grades.
Characterization of panel slides
• Each panel set consists of 10 known smears; five ZN stained and
five unstained. Both stained and unstained comprises of negative
and positive slides of different grades with code numbers.
Dispatch of panel slides
• Panel slides are packed in slide boxes and sent to districts.
• Laboratories are given one month deadline for reporting the result
to PHL from the date of panel slides receipt.
On-site
Evaluation
Blinded
Rechecking

24. Instruction for test laboratories
• Standardized form for reporting and recording of panel results are provided to
the technicians in the peripheral laboratories.
• Panel slides must be examined individually and not as part of a group effort.
Feedback :
• The reference laboratory must provide feedback to the peripheral laboratory,
including scoring for accuracy of the results.

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Blinded
Rechecking
What is Blinded Rechecking?
• Based on Lot Quality Assurance Sampling (LQAS):
• A random selection of specimens are collected from
the routine workload at the test site and sent to the
reference laboratory for validation
• Used to confirm that a laboratory meets national
performance goals
• Detects errors
Panel
Testing
On-site
Evaluation

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Why use Blinded Rechecking?
• The only EQA method to provide reliable assurance that a country has an
effective AFB microscopy network
• Reflects reality of routine performance by checking:
specimen quality
smear technique
stain performance
accuracy of reading
• Provides motivation to staff

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How is Blinded Rechecking Done?
1. Test lab stores all smears
2. Random sample collected
3. Sampled slides sent to control lab
4. Slides rechecked in blind reading
5. Results analysed
6. Report prepared for test lab
7. Follow-up site visit (if indicated)

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Technicians’ Responsibilities
Be a willing participant in the EQA program
Ensure all slides are stored in correct order
Maintain EQA records within the laboratory
Communicate outcomes to supervisors
Implement recommended corrective actions promptly

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Scenario
A FAMOUS football player has agreed to train with your National Football team.
However, upon arrival, the player admits that he has had a cough for one month.
Sputum samples are sent to your lab and you send out results of 2+ AFB on two
consecutive specimens.
His doctor does not believe your results!
How can you show your results are correct?

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Correct
Result
Correct Test
• Laboratory has
procedures to
perform
microscopy
Qualified Staff
• Microscopist
trained
• Lab register
signed by tester
Correct Equipment
• Microscope in
good working
order
• Maintenance and
cleaning records
available
Quality Control
•Reagents working
properly as
evidenced by QC
records of stains
•Current SOPs
readily available
EQA
• Laboratory’s
work is checked
by another
laboratory
Correct Specimen
• Labeled with
unique ID
• Completed
request
• Specimen ID
match Request

32. Monitoring the Quality of Lab
TQM
Quality
policy
QA
Good laboratory practice
Quality
control
………………………………
IQC EQA