Cholera

1. HTS Quality Assurance

2. Module 6 Contents – HIV Quality Control
1. Understanding HTS Quality Systems in South Sudan
2. Basic Terms Used in HIV Quality Assurance
3. Internal Quality Control Protocol
4. External Quality Control Protocol
5. Re-testing
6. Review & Exercise

3. Overview of Quality in HTS
• Quality HIV testing is central in any counselling and testing programme.
• Effective HTS services need quality approaches in HIV rapid testing.
• In order for clients to receive accurate test results within a reasonable time frame,
quality in testing must be maintained.
• HTS Quality control is essential for monitoring the quality of the HIV test in our
facilities.
• HTS quality program includes procedures and strategies (from within and outside the
facility) which we put in place in our respective health facilities in order for our clients
to receive accurate test results within a reasonable time frame

4. Overview of Quality in HTS…cnt’
• Quality is everyone’s responsibility and should not be compromised.
• Laboratory management and HTS supervisors have a key role in ensuring that all test
site personnel implementing the procedures adhere to highest quality standards and
use test kits approved by the MOH-RSS in all centers
• Effective HTS services need quality approaches in HIV rapid testing.
• Test kits should be the right type and in correct quantities and specimen should be
handled using acceptable standards.
• Standard test procedures, recording, and correct interpretation are important
components of quality assurance.

5. Reasons for Testing Errors
• No written standard operating procedures
• Unclear individual responsibilities
• Lack or poor training
• Poor quality products
• Improper handling of specimens
• Poor transportation and storage conditions
• Poor maintenance of equipment
• Absence of Quality Control procedures

6. Quality of HIV testing
•Behind any test result is a client who is depending on us for
right HIV test status
•Implication of starting a negative client on life long ART
•Implication of sending a way a positive client because of a
wrong negative result

7. Retesting in HIV testing
•Retesting to verify HIV-positive
diagnoses before initiating ART
• To ensure that individuals are not needlessly
placed on life-long ART (with potential side-
effects, waste of resources, psychological impact
of misdiagnosis), MOH recommends that all
individuals be retested to verify their HIV status
prior to enrolling in care and/or starting ART.
Retesting
New specimen
A different provider
Same testing
algorithm

8. Which facilities are doing Retesting to verify HIV-
positive diagnoses before initiating care or ART?
How?

9. Overview cont’d
 Quality Assurance components in HTS Targets the following program
areas at facility level
Following national HTS guidelines: Algorithm and Testing SOP, HTS Registers,
linkage and proper documentation
Participating in semi-annual National HIV/PT Program from NRL
Participating in Semi-annual Facility Internal Quality Control
HIV Test kits quality: storage and proper use, expiry, temperature
Following Standard test procedures, recording, and correct interpretation are
important components of quality assurance.
Testing personnel proficiency : training and supervision
Testing period/ window period
Follow up of Inconclusive results clients

10. Schemes for HTS quality in our facilities
Include
Internal quality control scheme/ blind samples at facility level
(Internal Quality Assurance)
Training, use of SOP, performance review, and following national
testing algorithm (Internal Quality assurance)
National proficiency testing panels from NRF (External Quality
assurance)

11. Module 6 Contents – HIV Quality Control
1. Understanding HTS Quality Systems in South Sudan
2. Basic Terms Used in HIV Quality Assurance
3. Internal Quality Control Protocol
4. External Quality Control Protocol
5. Re-testing & its SOP
6. Inconclusive Results & its SOP
7. Review & Exercise

12. a. Internal Quality Control (IQC)
• IQC refers to operational techniques that must be included in testing
procedure to verify that the requirements for quality are met.
• The aim of IQC is simply to ensure that the HIV test results generated by the
test are correct for the right person at right time.
• Internal quality control includes: evaluation of Testing personnel, test kits, &
documentation/HTS Register
• It considers the following:
• Pre-analytical (specimen collection),
• Analytical (results accuracy) and
• Post analytical (documentation) process to the actual test
• All IQC test results should be recorded in IQC worksheet and HTS register.
The IQC worksheet will be reviewed by supervisor, and filed in the facility.

13. Name of Facility: _________________________ Testing Point/Unit/Ward: ___________________________
Date Blind Sample Received: ____________/___________/_____________ Sample Condition (circle one): Good / Bad
Date of Testing: ___________________________ Period (Month/Year): Feb-18
Operator/ Tester Name: ___________________________________________
Batch/ Bag Code: _______________________
(Circle one)
Positive
Negative
Positive
Negative
Positive
Negative
Positive
Negative
Operators Signature/Date: ________________________/___________________
Supervisor Signature/Date: ______________________/__________________________________
________ ___ __ __ __ __ ___ _________ _______ ______ _______ _____ _____ ______ _____ _____ _____ _____ _____ ______
PT-1 PT-2 PT-3 PT-4
HTS IQC Focall Person Signature/Date: _______________________________/____________
HTS Supervisor Signature/Date: __________________________________/______________________
Facility HIV Testing Point Interanl Quality Control Work Sheet
Internal HIV Testing Point Proficiency/Blind Sample program worksheet
# Sample ID #
Test 1
Name:
Lot#
Exp:
Test 2
Name:
Lot#
Exp: Final Result
Comments/Evaluation
Result Result
(Circle one) (Circle one)
1 HTS- IQC: ______ NR R INV NR R INV
2 HTS- IQC: ______ NR R INV NR R INV
R INV
4 HTS- IQC: ______ NR R INV NR R
3 HTS- IQC: ______ NR R INV NR
INV
Leave Blank/ Official Use Only
PT Test Result Performaance Evaluation/ Grading
Final Evaluation
(Circle) Corrective Action Plan (Circle)
No Corrective Action Need
2. Fails any of 4 the PT Results
Unacceptable Result
Corrective Action Plan Needed
Note: For unacceptable Results; performImprovement plan as per IQC SOP and provide new batch of PT samples as confirmation of
completion of plan
1. Gets all 4 PT Test results Correct
Acceptable Result

14. Key Points Quality Control
• Each testing personnel is to receive 4 blind samples per testing cycle
• Ensuring high quality standards is everyone’s responsibility
• Proper transportation and storage of HIV test kits/commodities key to
quality results
• QC should be conducted regularly as specified in the HTS protocols
• Invalid QC results should be investigated, reported and responded to
timely
• HIV Testing Window period

15. Module 6 Contents – HIV Quality Control
1. Understanding HTS Quality Systems in South Sudan
2. Basic Terms Used in HIV Quality Assurance
3. Internal Quality Control Protocol
4. External Quality Control Protocol
5. Re-testing
6. Review & Exercise

16. b. External Quality assessment (EQA)
• External quality assessment is important to ensure that all the testing
points are performing to an external standard
• Its an evaluation of a test site by an outside agency or
personnel using proficiency panels (Dry tube sample)
• In South Sudan, National Reference Laboratory (NRL) semi-
annually distributes 6 DTS samples per site

17. Performing EQA/ NRL- PT
Key Roles and responsibilities for QC in DTS include the following:
• Verifying DTS components upon receipt,
• Rehydrating DTS,
• Testing according to SOPs,
• Recording QC results in the QC form (to be submitted back) and in the
HTS register.
• Supervisor must review the form before submission
• Implementing corrective actions in case of failure.

18. Performing MOH EQA Quality Controls
Steps when performing Quality Controls

19. Name of Facility: _________________________ Testing Point/Unit/Ward: ___________________________
Date Blind Sample Received: ____________/___________/_____________ Sample Condition (circle one): Good / Bad
Date of Testing: ___________________________ Period (Month/Year): Feb-18
Operator/ Tester Name: ___________________________________________
Batch/ Bag Code: _______________________
(Circle one)
Positive
Negative
Positive
Negative
Positive
Negative
Positive
Negative
Operators Signature/Date: ________________________/___________________
Supervisor Signature/Date: ______________________/__________________________________
________ ___ __ __ __ __ ___ _________ _______ ______ _______ _____ _____ ______ _____ _____ _____ _____ _____ ______
PT-1 PT-2 PT-3 PT-4
HTS IQC Focall Person Signature/Date: _______________________________/____________
HTS Supervisor Signature/Date: __________________________________/______________________
Facility HIV Testing Point Interanl Quality Control Work Sheet
Internal HIV Testing Point Proficiency/Blind Sample program worksheet
# Sample ID #
Test 1
Name:
Lot#
Exp:
Test 2
Name:
Lot#
Exp: Final Result
Comments/Evaluation
Result Result
(Circle one) (Circle one)
1 HTS- IQC: ______ NR R INV NR R INV
2 HTS- IQC: ______ NR R INV NR R INV
R INV
4 HTS- IQC: ______ NR R INV NR R
3 HTS- IQC: ______ NR R INV NR
INV
Leave Blank/ Official Use Only
PT Test Result Performaance Evaluation/ Grading
Final Evaluation
(Circle) Corrective Action Plan (Circle)
No Corrective Action Need
2. Fails any of 4 the PT Results
Unacceptable Result
Corrective Action Plan Needed
Note: For unacceptable Results; performImprovement plan as per IQC SOP and provide new batch of PT samples as confirmation of
completion of plan
1. Gets all 4 PT Test results Correct
Acceptable Result

20. QC Evaluation
• Evaluation of Results and Improvement Plan
• Evaluation of the results is based on: correctness of actual test results and
documentation based on SOP and algorithm.
• Acceptable result/evaluation is all the PT test results are correct
• Any wrong result from any of the PT samples provided is considered unacceptable
result
• If a report contains unacceptable results, immediate review of the results is
necessary as per IQC SOP

21. HTS QC Facility Roles and Responsibilities
Facility laboratory/ HTS Internal
Quality focal person (IQC)
• Semi-annully prepare blind samples for all the
testing points in their respective facilities
• Distribute the blind samples to the either HTS
supervisor or different testers
• Receive the completed IQC worksheet and check
for correctness
• Review and provide appropriate feedback to all
the different testers
• For testers with identified performance
challenge, support the counselors to do root
cause analysis and develop improvement plan
• Supports implementation of improvement plan
Facility points of test/ test providers:
• Receive the samples and store them
appropriately (4 degree Celsius refrigeration).
• Whenever possible, the PT samples are run
immediately upon receipt
• Where immediate run is not possible, store
appropriately and run PT not more than two days
• Document test results in the Internal quality
worksheet (see attached)
• Return the results to the HTS quality focal person
• Receive feedback and where necessary develop
and implement the improvement plan agreed
upon.

22. What is expected of the facility
Laboratory IQC Focal person
Internal IQC
• Prepare semi-annual blind samples for
each tester in the respective facilities
Prepare 4 blind samples for each tester
• Analyse the performance of IQC results
and provide feedback to the respective
testers
External QA/PT
• Receive PT panels from the reference lab
as per SOP
• Distribute PT panels to respective testers
• Submit back PT results to the NRL
Testing Point/ Testers
• Semi- annually test all blind
samples given to them as per
national algorithm and test SOP
• Submit back IQC test results to
the laboratory IQC focal person

23. Roles and Responsibilities
• Facility management/ HTS In-Charge
• Supervise HIV testing and linkage of patients at facility level
• Review testing data in the facility
• Make consumption summary data for ordering of test kits
• Coordination of the different testing points: quality testing and ordering of test kits
• Support & coordinate all HIV test kits consumption at all testing points: Ordering of
testing and management of consumption
• Laboratory Personnel:
• Semi-annually prepare IQC/blind samples to different testing points and give
results feedback for improvement
• Provide technical support to all testing points