Checklist of categories for troubleshooting in TTI Factors affecting Troubleshooting in TTI Lab controls used in assay testing Principles and Practices of ELISA and Rapid for TTI Screening Equipment Management in TTI Laboratory calibration of equipments used Documentation and Records in TTI Laboratory Root Cause Analysis and Process Improvement in TTI Laboratory External Quality Assessment Scheme and Proficiency Testing Waste management in transfusion centre Principle of Troubleshooting in TTI Lab

1. Troubleshooting inTTI
Presenter- Dr. Shiny
Moderator- Dr.Yadwinder Kaur

3. Example-
 You tested 90 samples for TTI. 7 of them were
positive for HCV both on ELISA and Rapid card
method.
 7 donors were notified and called. Repeat samples
were taken.
 All 7 repeat samples were negative for TTI.
 Proceed with troubleshooting.

4. Checklist of
categories for
troubleshooting
inTTI
 Correct Bag Labelling (donor forms)
 Correct Sample vial labelling
 Correct numbering of ELISA template
 Correct sample placement order (according to template)
 Proper sample dispension
 Proper functioning of equipments
 Proper waste disposal
 Proper reading of results
 Re checking of results (by another method/by 2 different individuals)
 Donor notification

5. To
troubleshoot
this case
 Match bag labels with sample vial labels and donor forms
(donor ID, name, blood group etc)
 REPEATTESTING of all samples with fresh samples taken from
the bag.
 Root caused analysis
 Higher technique ofTTI testing can be used (eg. NAT testing)
 Do not notify donors until results are clear.
 Discard the positive bags, note their donor id.

6. Factors
affecting
Troubleshooting
inTTI Lab
1. Quality Control inTTI Laboratory
2. Practices of ELISA and Rapid forTTI Screening
3. Equipment Management inTTI Laboratory
4. Documentation and Records inTTI Laboratory
5. Root Cause Analysis and Process Improvement in
TTI Laboratory
6. Donor Notification
7. Waste managementTTI Laboratory

8. Principles and
Practices of
ELISA and
Rapid forTTI
Screening
Result need to be verified as per kit insert and all
controls need to be passed. Frequent problems
encountered in ELISA are:
a) High background colour
b) No colour development ( false negative results)
c) Low colour development
d) False positive results
f) One row / one column colour development
Troubleshoot-
 RepeatTesting
 High technology testing

9. Equipment
Management
inTTI
Laboratory
 Evaluation of the performance with respect to
precision and accuracy of the equipment is required
followed by ability of the test to detect the disease in
terms of sensitivity, specificity, positive and negative
predictive value has to be done.
 Instrument should also be monitored by performing
periodic function checks to ensure quality and safety of
the test.

14. Documentation
and Records in
TTI Laboratory
 A master log of all documents is necessary.
 Stored documents and records must be protected from
unauthorized changes, inadvertent destruction,
damage (fire, water, rodents), unauthorized viewing
(confidential information) and inadvertent loss of data
(overwriting, system crashes)

15. RootCause
Analysis and
Process
Improvement
inTTI
Laboratory
 The main reason to perform RCA is that problems can
be a result of multiple factors so it is important to find
the cause and effect relationship to address it
effectively.
 Root cause analysis : Structured investigation that
aims to identify the true cause of a problem, and the
actions necessary to eliminate it.
 Scope:
a) Identify and describe the problem clearly
b) Distinguish between the root cause and other causal
factors
c) Establish a causal graph between the root cause and
the problem

16.  Six Main Activities of RCA:
1. Defining the Problem
2. Gathering the Data
3. Mapping the Information
4. Analyzing problems for contributory factors
5. Identifying and agreeing the root causes
6. Making recommendations and Reporting

17. External
Quality
Assessment
Scheme and
Proficiency
Testing
 EQAS in transfusion medicineBenefits of EQAS to
participating blood centres are-
a. Comparison with performance of other participating
labs
b. identification of problems relating to laboratory
processes, techniques and reagents
c. provision of information & education to improve
performance
d. encouragement of best practice
e. enhanced credibility of the laboratory
f. access to a network of labs for exchange of
information.

18. Donor
Notification
The basic principles of donor notification should involve
providing information to the donor
 Promptly
 Accurately
 confidentially
 and in a manner that alleviates anxiety and promotes
understanding.

19. Waste
management
in transfusion
centre
 About 15-25% of waste generated in anTTI is likely to
be hazardous.
 BMW is categorized into different categories
depending on the nature of waste which helps in
proper handling and disposal of it.

20. Principle of
Troubleshooting
inTTI Lab
is always
Correct Labelling and Documentation
Followed by
REPEATTESTING
when in doubt

21. REFERENCES
1. Blood donor notification and counselling: Our experience from a tertiary care
hospital in India Urvershi Kotwal,Veena Doda, Satyam Arora, and Swati
Bhardwaj
2. Online PilotWebinar Series on Quality Assurance inTransfusion Transmissible
Infections Testing byWHO
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